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6 ď‚ƒ August 2014
Pharma Bio World
INTERVIEW 12
“India need to improve the regulatory milieu to compete with other Asian countries” - Dr Subir Basak, President, Jubilant Drug Discovery and Development Services
FEATURES
12 20
Emerging Pharmaceutical Outsourcing Market - Dr Madhusudan Dabhole
29
Technological Transfer During Outsourcing - Ravi Bhola, Sindhu Vijayakrishnan, Pranav Mysore
32
Trends in Pharma Outsourcing - Thammaiah B N
34 29
Proactive Surplus Asset Management Releases Hidden Value for Top Pharma Businesses in India - Krishnamoorthy Vishwanathan
37
Gas Handling Systems for Pharmaceutical Industry - Nitin Godse
NEWS UPDATE
32
44
Press Releases
46
Pharma News
49
Biotech News
CORPORATE AFFAIRS 52
Product Trends
56
Events Diary
BACKYARD 37
57
Bookshelf
58
AD Index Next Issue Focus: Biopharmaceuticals Next Issue Focus: Intellectual Property
8 August 2014
Pharma Bio World
Pressure Range
Capacity
Discription
Sr No
M3/Min
CFM
Bar
1
Lubricated SCREW Compressor
0.23 to 43.70
8 to 1545
8 to 13
2
Oil Free SCREW Compressor
5.30 to 51.40
187 to 1815
8 to 10
3
Lubricated PISTON Compressor
.125 to 6.20
4.5 to 219
8 to 40
4
Oil Free PISTON Compressor
.156 to 1.30
6 to 45
8 to 40
5
BOGE FLEXPET
1.55 to 17.9
54 to 634
40
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interview
DR SUBIR K BASAK
“India need to improve the regulatory milieu to compete with other Asian countries”
Dr Subir Basak, President, Jubilant D r u g D i s c ove r y a n d D eve l o p m e n t Services in an interview with Pharma Bio World discusses emerging role of CROs in Indian pharmaceutical market Please brief us about the characteristics of the CRO sector in general, and in non-traditional trial regions in particular? Pharmaceutical companies are under pressure to reduce R&D costs and increase productivity in the form of launching novel drugs into the market to address unmet medical needs. CROs provide biotech/ pharmaceutical companies access to global reach, different science and to new technologies with less investments, and enable them to shift large fixed costs to variable costs. About 50 per cent of the clinical research is outsourced to CROs and the global CRO market is expected to be around USD 24 billion in 2014. The major CROs capitalise on the huge spending of global pharma companies in clinical outsourcing which is growing at an annual rate of 13.4 per cent by offering them faster, cost effective clinical trials and they have facilities in non-traditional locations like Latin America, India, China,Central and Eastern Europe and Russia. The non-traditional regions are gaining popularity due to ease of recruitment, prevalence of wide range of diseases, human resource with skill sets and most importantly treatment naïve population.Recruiting from non-traditional regions are becoming important for crucial clinical trials used for MarketingAuthorisation Applications (MAA) submission in EU.
12 August 2014
In non-traditional regions clinical trials are faster and cost effective and most of the major CROs have a presence in these regions. Most of the clinical trials in these are conducted by CROs. For eg, 70 per cent of trials in Peru and 30 per cent of trials in Argentina were conducted by CROs. In India and Brazil the regulatory process underwent some changes but still further reforms are required to ease and regularise the approvals. What are the differences between CRO and Functional Service Provider (FSP)? CRO’s provide end to end services from patient requirement, monitoring, data management and submission. Most of the CROs have global presence and can carry out trials in popular destinations. CROs are popular with pharma companies that do not have clinical development facilities. FSP model involves providing specific services within the clinical research like Data-Management, medical writing, biostatistics, and clinical programming. As FSP models gain maturity other functions like clinical site management, clinical & medical monitoring, pharmaco vigilance can be integrated. These functions can be efficiently operated independently in a cost-effective manner especially at Pharma Bio World
interview non-traditional regions with little oversight from sponsors. FSP are quite popular with the small CROs. Please elaborate on offshoring in pharmaceuticals? Offshoring means the clinical trials are conducted in non-traditional regions which are the emerging markets or the developing countries. These regions provide pharmaceutical companies faster clinical trials, ease of recruitment and importantly treatment naïve population. Since these regions are emerging markets and their potential in healthcare spending is rising, the pharma companies see them as lucrative markets and marketing approval of drugs in these regions would require local trials. The other factors contributing to trials in these regions is the availability of skilled human resource, cost advantage, varying ethnic response to drugs, IT infrastructure and data management facilities. What are the pros and cons of a company establishing its own captive unit rather than outsourcing to a third party? Establishment of a captive unit for clinical development in India involves huge investment, excessive use of internal resources that might require the commitment from top management, recruiting local employees sharing the values and cultures of the parent company. With captive unit the operations, management will be more or less similar to the parent company. As a CRO, how you see the relationship between sponsors and CROs? Relationship between a CRO and Sponsor had been Transactional, tactical or fee-forservice arrangement. In recent times this price dominating relationship has evolved into a strategic partnership with risk-shared business models and core competency is the dominant factor of the relationship. 16 August 2014
In general, the sponsor/CRO relationships are generally a blend of both tactical and strategic elements as per the requirements of the players. Tactical activities include execution of a contract, assessment of study-based cost and performance and decision making based on availability and cost. Strategic activities encompass shared decision making, performance assessment, shared risk and reward structures and decision based on long term objectives.
speaking investigators adds value to the clinical environment. 3) Cost: India provides cost advantage to the pharmaceutical companies scrambling to reduce cost and the time taken to market drug. Clinical research in India is 30-45 per cent cheaper that in developed markets like US and EU.
What factors to be considered while choosing an outsourcing partner?
Rising healthcare cost has put pressure on pharmaceutical companies to reduce cost and time to develop and market drugs. The Biotech/Pharma companies had to minimise their risk and their off-shoring partners CROs came up with innovative risk-shared models to drive global innovation. CROs are finance oriented service companies and CROs taking high risk approach similar to the biotech/pharma with the returns of CRO is a major challenge faced by CRO’s today. Regulatory bottlenecks which causes delay in approval strains the very principle of CRO being time advantageous.
Outsourcing of clinical services is not inclined to cost advantage alone but is increasingly tilting towards high quality services. This change makes it imperative to choose the deserving or right CRO. The following factors are essential to look for in selecting a partner; • Demonstrated expertise in conducting trials. • Experience in specific therapeutic area • Ability to recruit patients. • Access to investigators. • Financial stability. • Cost effectiveness. • Time advantage and ability to handle projects in varied regions. What are the drivers of CR environment in India? Globalisation of clinical research has been evident with the shift of clinical activities into Asia Pacific (APAC). India is evolving from being a manufacturing powerhouse in Pharma industry to a preferred destination for drug development and clinical research. Emerging markets like India are becoming the preferred off-shoring destination to conduct clinical research. 1) Huge and Fast growing pharmaceutical market in India with pharma sales expected to touch USD 27 billion in 2016 2) Conducive clinical environment with large treatment-naïve population available for recruitment. Good infrastructure with well-trained English
Currently what are the major challenges for CROs?
Kindly brief us about the legal aspects of R&D outsourcing in pharma industry The major legal aspect governing outsourcing in Pharma Industry is the adherence to Intellectual Property Rights. Intellectual property rights should be respected and forms the major clause in R&D outsourcing. Data security and confidentiality are important aspects in which all the data generated and process associated with project are included. N o w, m a n y p h a r m a c o m p a n i e s a r e seeking co-development deals to handle excess intellectual property. How does CROs play into this situation? Thousands of molecules discovered lie in the racks of several pharma companies. These molecules that have the potential to enter the clinic travel from bench to bed through co-development deals. Pharma Bio World
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interview Co-development deals exists as risk shared models where the CROs offer innovative business models to mitigate the risk of Biotech/Pharma companies, but in turn are rewarded when milestones are achieved and also share profit and losses with the biotech/pharma companies. In recent years, what factors have driven pharmaceutical companies to increase outsourcing? Spiralling healthcare costs, decrease in approval of new drugs has brought t h e p h a rm a c e u ti c a l c o m p a n i e s u n d e r pressure to reduce R&D costs and increase productivity. In order to reduce cost and to gain access to different knowledge, technology and high quality services the global pharma companies started looking for external partners. The global pharmaceutical companies through strategic collaborative partnerships gain access to large diverse pool of patients especially in India and China, educated medical investigators, conducive clinical environment possessing treatment naĂŻve population ideal for recruitment as trial subjects, huge cost advantage as it is 30-45 per cent cheaper than the developed countries and state of the art IT infrastructure and professionals to document the clinical findings for the regulatory bodies. The investments to already existing good medical infrastructure are happening and the government bodies are streamlining the bottlenecks in regulatory reforms which will reduce the time taken for approval. The drug discovery and development collaborative partners mitigate the risk and in turn also gain royalties on drugs that enter the market. The strategic collaborative partnerships provides cost & time advantage and also provides access to fast growing emerging markets with low cost manufacturing capabilities. All these factors contribute to increased outsourcing by pharma companies. 18 ď‚ƒAugust 2014
What is the Competitiveness of Indian CROs against the CROs of other countries?
and researchers in India. Growing KPOs in Pharma/Biotech space will create more jobs for these aspiring graduates.
Indian CROs have done well in manufacturing, chemistry and also in biology services. India is still a favoured destination for CRO, but still we need to develop our infrastructure and the government should do a lot more to create a sustainable model that makes us highly competitive as a CRO destination.
The global biotech/pharma companies other than cost advantage will gain access to huge emerging market in healthcare industry with healthcare spending increasing phenomenally.
India has become an attractive destination to global CROs due to the advantages of having a large number ofnaive untreated patients - (who are difficult to find in the developed world) and potential for economic trials. The success for Indian Pharma industry lies in the ability to retain cost advantage while maintaining quality standards and innovation in drug discovery and development. India has been making strides in the field of drug discovery and development and has witnessed a great deal of linkages across the world in the recent past.
In the regulatory perspective for pharmaceutical outsourcing, single window approval for clinical trials that will ease the approval process and stronger regulatory reforms that are innovation friendly and addresses the issues of recruited subjects is essential. CROs strengthening ties with academics to provide high end technology services. The relationship between CRO and global pharma should evolve from finance oriented relationship and the CROs should act as their off-shore destination which would pave way for the integration of the companies.
In India regulatory approval, in spite of recent moves to streamline process, takes 9 months; regulatory approval delays of up to 12 months are not uncommon in China. In contrast, approval times in Singapore take around three months which is on par with the west. Looking at the huge potential India holds as a CRO destination, we still need to improve the quality standards of clinical trials and regulatory milieu, to compete with other Asian countries.
Please tell us about the performance of Jubilant during the past few years?
Implication of KPOs in pharma, biotech space in India? There are 300,000 postgraduates and 1,500 PhD students qualify annually in biosciences and number of fresh scientists and engineers available every year is 700,000 according to a Confederation of Indian Industries (CII) studyand there is huge shortage for clinical investigators
What development would you like to see in pharmaceutical outsourcing?
Jubilant has carried out 52 collaborative partnerships in various therapeutic areas like Oncology, Metabolic disorder, CNS, Pain & Inflammation identified two candidates, placed three compounds in clinical development, and have a compound in Ph II trials for our collaborator. Our global partners have leveraged J u b i l a n t ’s f u l l y i n t e g r a t e d d i s c o v e r y platform that includes Informatics, Insilico, Structural Biology, In vitro/In vivo biology, DMPK, Tox, in addition to medicinal and process chemistry. Recently we have expanded our drug discovery collaboration with J&J and also signed new drug discovery partnership deals with Orion and GSK in multiple therapeutic areas. Pharma Bio World
Emerging Pharmaceutical Outsourcing Market Pharmaceutical industry outsourcing has grown during the past few years, and indications are that it will continue to grow through the next decade. Outsourcing has proven effective at reducing operational and infrastructure costs. This article explores the emerging outsourcing market, and discusses the trends, challenges and opportunities in pharmaceutical outsourcing.
O
utsourcing is a complex issue occurring when company’s contract out activities previously performed in-house or in-country to foreign (usually offshore) companies globally. In the terms of a SWOT analysis and using a modified Harvard-style case study that was subjected to the SWOT analysis, one can analyse business process outsourcing (BPO) to emerging markets, frequently called outsourcing or offshoring. The main advantage of outsourcing is that it allows a business to focus on core activities as called for by core competence, strategic alliance, and competitive advantage theories of international business. A transformational aspect of outsourcing is evidently very important for emerging markets but also for many companies in the developed world. Emerging markets are any place in this world that are in the process of rapid growth and industrialisation. India and China are considered the two largest from a pool of approximately 20-30 countries. In the recent past, western pharmaceutical companies have typically utilised CROs in China and India to perform tasks such as clinical development, data management and preclinical toxicology studies. Now, Chinese and Indian CROs are moving up in the R&D chain by offering more c h a l l e n g i n g s e r v i c e s i n c h e m i s t r y, assay development, and even in target identification.
Dr Madhusudan P Dabhole Group Manager – Bioprocess, R&D Richcore Lifesciences Pvt Ltd 20 August 2014
China, with approximately 20 per cent of world’s population is an emerging market in the pharmaceutical arena. A Significant savings in labor and laboratory set-up costs, as well as strong government incentive programs such as various tax exemptions, are attractive incentives for western-based sponsor companies. It is estimated that the clinical trial costs in
China are roughly 30 to 50 per cent of costs in western countries. Demand for drugs due to surge of diseases in various therapeutic areas and other health related problems, combined with a rising level of income, is enlarging China’s pharmaceutical market by more than 20 per cent a year and creating attractive opportunities for global pharmaceutical companies at a time when rates of growth in European and US markets are declining. Vendor Relationship Management Vendor Relationship Management (VRM) is a set of tools and services that help companies manage their vendor relationships. The advantage of Vendor Relationship Management is that the purchasing company has control of the process and the information that results from the interactions. Vendor Relationship Management came to the façade with Project VRM, a research and development project from The Berkman Center for Internet & Society. It was created in 2006 by Doc Searls, a fellow of Berkman. Vendor Relationship Management is based on the core belief that “free customers are more valuable than captive ones”. It aims to encourage purchasers to be free from the control of vendors. Doc Searls appears to be the main promoter of VRM but there are several detractors that do not believe that it will happen or work. The main obstacle seems to be persuading vendors to: 1) Give up the benefits of their saved data, thus allowing purchasers to benefit from the marketing advantages they previously owned. Pharma Bio World
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2) Introduce the processes and systems required to instigate VRM with multiple customers. 3) Allow purchasers to manage their own processes. 4) Implement the extra security features that would be required. The critical success factor depends on communication, performance management and responsibility between the company and the vendor. A full-time Vendor Manager, under the direction of the Contract Executive, works closely with the vendor, having day-to-day responsibility for the quality and cost effectiveness of the vendor’s services. Communication with the vendor will be both written and verbal (meetings). In addition, the vendor will be required to submit formal, written reports on key dates throughout the contract term. Depending on the contract arrangements, the vendor would submit invoices that reflect base line contract charges and charges for changes to the contract scope. Wherever possible, rates for additional and reduced work (by staff position or a predetermined unit of work) should be negotiated into the contract. Invoices should be submitted with a summary page and with backup detail sheets that reflect the programme components and the units of work. Effective issue resolution and Dispute Resolution procedures ensure that problems and disputes are handled as quickly as possible and are solved at the lowest possible management levels. Issues should be resolved using an Issue Resolution Process. An “issue” is a decision that needs to be made regarding how a task is to be completed or is perceived as a discrepancy in the deliverables completed or work performed by the vendor. Issues do not include work to be performed as part of the contract. If the Vendor Manager a n d v e n d o r ’s P r o g r a m m e M a n a g e r 22 August 2014
cannot agree, these issues should be escalated to the Contract Executive and the vendor’s Account Executive. The vendor would be responsible for estimating the size, effort and cost of any contract change. Since individual vendors have different methods for estimating, the Vendor Manager should agree on the methods to be used to determine size, effort and cost and document the agreed upon process. Every customer would genuinely appreciate the ability to interact directly and easily with the businesses they deal with in a simplified manner to resolve any problems if and when they arise or exchange their opinions and ideas to provide a feedback. This eventually benefits the vendor who responds to the customers and listens to their input and brings out products an services that appropriately serve the needs of the end-users. With that in mind, the implementation of VRM – from the customer’s perspective is an incredible business-customer partnership that will be winning proposition for all involved. The use of digital technology allows this basic need of every business met by a well-planned VRM programme. Not only individuals but also businesses of all sizes become ‘customers’ to those with whom they conduct business dealings. Essentially VRM helps (i) effective communication with the vendors (ii) convey their requirements or problems to be addressed by specific vendors (iii) analyse current needs and changes over a period of time (iv) ensure the products and services satisfy their needs on an ongoing basis (v) develop a mutually trusting business relationship (vi) provide an excellent support through reliable vendor response programme, (vii) develop a timely and dependable contact and resolution plan, (viii) enable honest and transparent communication (ix) ensure everyone is aware of proper VRM procedures and enforce it effectively.
Cost Reduction in Procurement There are many challenges that some of the customers face in the area of procurement. Before any improvement can happen, the first step always entails awareness, analysis, acceptance and acknowledgement of the desire to change. One of the biggest mistakes business executives is in their lack of understanding that learning how to get the best purchases is about building successful communication and friendships. Brainstorm to look for the best ways to reduce costs. Comparison shopping, buying in bulk, negotiating by building relationships and buying cyclically during sales are always going to be smart choices. Creating successful outsourcing strategy Outsourcing facility services can be a immense challenge for organisations that perform those functions using inhouse staff. But as even the most routine tasks become more complex, facility executives search for innovative ways to improve services and save money. Despite a steep learning curve, hiring service contractors is a logical business decision that, if implemented properly, can benefit an organisation for years. Following a few common-sense strategies from those who have already hired contractors to service significant portions of their facility operations can make the process less daunting. Identifying needs is the first step in developing an outsourcing strategy. “Start with an internal assessment,” says Kenneth Cooper, director of corporate real estate for Scholastic Inc. “Why do you want to outsource? Has the internal staff failed in some way? If it has, what’s to say the outsource staff won’t fail for the same reasons?” That issue must be addressed and corrected internally before any external partnership can succeed. Pharma Bio World
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Next, recognise what tasks can be successfully outsourced and what tasks must remain in-house. Realise that different organisations have different requirements, but generally the early focus should be on services readily available, says Andrew Millest, executive director of property services at Morgan Stanley. He further says “ services available in one market might not be available in others”. For example, in New York, it’s possible to find any type of service. In less mature markets, there are fewer choices. The most commonly outsourced tasks a r e t h e d a y - t o - d a y, l a b o r - i n t e n s i v e operational chores. “Service delivery functions, such as building management, administration, security, janitorial and food service, lend themselves well to outsourcing,” says Alan Abrahamson, asset management director for AT&T Global Real Estate. Regulatory Challenges When a company is looking for CRO and CMO partners it should be aware of domestic and foreign regulatory requirements. Due-diligence auditing will be necessary to thoroughly evaluate the alignment of the two parties for the upcoming technology transfer. Contracts must be written, and the company must conduct quality oversight of all contract manufacturers have a written quality agreement and other documents, to clearly identify the responsibilities of each party. It is important to have a project team working together on both ends in a p r o a c t i v e m a n n e r, t a r g e t i n g d a t e s , batches, and resources. Outsourcing clinical trials called for pressing awareness because there are no regulatory agencies with trained people and resources to actually monitor all drug trials overseas. There are some international and country guidelines, and 24 August 2014
laws, but their effective implementation is unclear. Companies must be assertive in discussing the outsourcing of clinical trials and provide information on their standards. Logistics and distribution must grant brand security and supply chain optimisation trough product serialisation, electronic pedigree documentation and effective tax rate (ETR). Due to regulatory requirements and limited outsourcing options, it may be challenging, at times, to find the right supply chain strategic partner; however, once partnership is accomplished, he must comply with new regulations to combat product counterfeiting, and concur to supply chain visibility and control. The outsourced partner must have cold chain management specialists, securing biotech and pharmaceutical companies’ strict regulatory compliance and product control. Regulatory outsourcing is now fairly well-established, with a large number of companies turning to partners to manage operational tasks, including report publishing and submission publishing. A smaller number have engaged partners to assist with submission planning and regulatory data management, and while only a small percentage are using outsourcing partners for regulatory information management, many plan to do so in the future. Across the industry, companies are waking up to the plethora of regulatory data that need to captured and updated, and more are assessing whether this may be best handled by an outsourcing partner. The one constant in outsourcing is change. While companies were once reluctant to outsource anything other than back office tasks, that’s no longer the case. Many pharmaceutical companies that outsource major projects, can end up managing relationships at arm’s length, because distance and lack of visibility of
project progress, may foster problems that will take more time to identify; often times the key to a successful outsourcing strategy in off shoring countries, lies in having a company person in place to mitigate business risks. Quality Management in Outsourcing Quality Management Outsourcing is strategic with providers focusing on a few profitable areas like supplier development, internal auditing and improvement events. According to David A Lalain, President Omnex Quality Culture, Quality Management outsourcing; Reduce operating costs: Experience has shown a 40-60 per cent reduction in costs from economies of scale, off-shore services and variable expense versus fixed costs of fulltime resources. Focus resources and energy on core processes: Quality demands involvement of your scarcest resource--your best people, due to high visibility and risk. These are the same resources that are key to growing your core business. World-class experience: It takes a great deal of time to teach your own people in the technical and complicated methods of quality management, and their only benchmark in many cases is entirely internal. Outsourcing brings a wealth of knowledge workers with specific skills honed from years of experience in all types of situations and businesses. Objectivity: Your partner is outside the political landscape and focused entirely on your success, because it ensures their success by definition. They can even instill confidence in your customers that an independent third party is looking out for their interests. Management attention: It’s an investment, and face it--management pays more attention to the ROI on any expenditure than it does on time spent by internal resources. As a partner, the Pharma Bio World
QMS outsource must have direction from and accountability to top management. Employee acceptance: It is much easier and less risky for an employee to air a sensitive issue with a third party than directly with their bosses. R i s k m a n a g e m e n t : O b j e c t i v i t y, accountability, knowledge/experience, and practically unlimited resources are there when/where needed, which means no surprises. Customer security: Your QMS outsource partner should be one voice of your Customer, ensuring their needs are known and met. At times they are your conscience when the all-to-often grey areas demand a dissenting voice. Less hassles: No succession planning, no turnover, no delays in critical projects for lack of resources add up to a better quality of life for the client. The functions included for QM outsourcing are QMS certification, QMS certification maintenance, improvement efforts, Supplier development, Training, Customer relationship management, Quality culture deployment, Knowledge management, Operational excellence and new product launch support. In QMS, the best partner can be summarised in the five R’s Results: Start with the end in mind. Set clear measurable goals and deliverables with your partner and expect regular updates regarding the key milestones. They must focus on your success not your satisfaction; they must be willing to tell you what you need to hear not just what you want to hear. Reputation: They need a proven track record and capabilities in all areas of the QMS you’re looking to outsource. If your organisation is global, so must Pharma Bio World
your partner be. You will want a full service provider who can manage the entire scope of work either first-hand or through subcontractors. This keeps the accountability with your selected partner but allows them to marshal the necessary resources to ensure the best solutions. Relationship: There must be trust and compatibility right down to the core values of both organisations. Your QMS outsource partner will impact on your overall Quality Culture, so a common value system is a must. Regulation: Even with the best relationship there needs to be controls. Set boundaries where needed to ensure the scope and expense don’t increase over time without clear agreement. Take responsibility to monitor progress on agreed-upon deliverables and provide timely feedback to your partner. Renewal: Keep the relationship strong through appropriate use of recognition and rewards for outstanding performance. The most appreciated rewards are more business and strong endorsements. As they meet and exceed your expectations, look for more opportunities to profit from your partnership. Technological Transfer During Outsourcing Outsourcing the production of key input is a widespread phenomenon in modern business. How the firms organise their production and whether they also sell the intermediate inputs to their rivals are very subtle and complex decisions that involve significant strategic considerations. The traditional firm theory would dictate that a firm confronted with the choice of inhouse production versus outsourcing would typically depend on the cost consideration, and the firm would choose the least cost option. There exists an independent input supplier who does not produce the final product. However, one of the final good
producers, say firm 1, has a superior technology to produce the key input in-house and then it can also participate in the input market to compete with the independent input supplier to sell the input to its rival (say firm 2). Firm 2 do not have the requisite technology to produce the input in-house; so it has to depend on the input market to source its input. In this setting we analyse the decision of firm 1 between outsourcing the input from the independent input suppler or producing it in-house and also the decision to transfer the technology to the independent input supplier. We would show that firm 1 would outsource the key input if the gap between its input production technology and that of the independent supplier is small, and it would produce the input in-house and also supply to its rival when the technology gap is large. When the outsourcing is done, firm 1 buys the input However, in an imperfectly competitive market structure, most decisions are based on complex strategic considerations and it is not surprising that a firm might outsource a key input from the outside supplier even though it can be produced cheaply in-house. In this paper we focus on such a scenario of outsourcing from the monopoly input supplier at a price much higher than its in-house production cost. However, the advantage of outsourcing stems from softening of competition in the final goods market and this in turn accrues to firm 1 through a payment for the technology sold to the independent input supplier. CMO Responsibilities The global contract manufacturing market is growing steadily with firms allocating up to four per cent of annual organisation revenues for contract manufacturing organisation (CMO) services, with a likely markup to 11 per cent within the next three years according to Frost and Sullivan. Recent customer research August 2014 25
from Frost & Sullivan’s analysis, which surveyed 312 global decision makers from biotechnology and pharmaceutical firms, reveals that of all parameters used in CMO agreements and selection, volume commitments ranks as the most important, followed by manufacturing capacity and site transfer capabilities.
12) Oversee the development of new products. 13) Create product roadmap. 14)Develop and measure key metrics around the business including user acquisition, conversion rates, engagement rates, satisfaction and renewal rates.
“While packaging, logistics and clinical trial supply are the most prevalent services currently being outsourced, organisations are particularly keen to leverage CMOs’ capabilities of outsourcing drug delivery technology services in the near future,” said Frost & Sullivan Customer Research Global Director Tonya Fowler. “Thirty-seven percent of respondents also stated they were likely to partner with a CMO that functioned as an external consultant, mainly in cases where they required manufacturing consulting.”
L i k e t h e s o f t w a r e i n d u s t r y, C M O s found that outsourcing dried up in slow times as customers retrenched and took diminished demand in house. It all depends on whether you believe there are 400 monoclonal antibodies in development and what you think the likelihood is that none, a few or many of the proteins identified by the human genome project and its offshoots will become products. If you believe that such proteins will have the same success that other proteins traditionally have enjoyed because of lack of safety problems, then the shortage theory may be correct. If on the other hand you think that safety questions associated with such proteins are a complete unknown — ie, you worry that the situation with cytokines such as interleukin-12, which had a disastrous clinical history, will be more the rule than the exception — then the overcapacity scenario may be more likely.
The main CMO responsibilities are to; 1) Facilitate growth, sales, and marketing strategies at an organisation. 2) Increase revenue generation. 3) Reduce costs. 4) Perform risk mitigation. 5) Prepare overall marketing strategy. 6) Develop programmes with quantifiable objectives to measure results. 7) Implement and manage marketing budget. 8) Leverage data and analytics to drive insights. 9) Modify or redirect business intelligence strategy. 10) Oversee and direct the efforts of the marketing team. 11) Develop segmentation, competitive analysis/market intelligence, prospecting, lead generation, product and market development, pricing, promotions, communications and budgets, sales force effectiveness, strategic planning, services units and revenue retention and growth. 26 August 2014
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to cut costs, reduce errors and improve productivity. Industry experts predict that Latin America and Europe will be the new outsourcing destinations in the near future. Brazil and Russia will make their presence felt in the global outsourcing market and China will continue to move ahead. The rising price of oil will put pressure on companies to take advantage of technology and outsource work to remain profitable. Big pharmaceutical companies will launch new drugs in the market at a fraction of the current cost by partnering with India, China, and Russia in molecular research and clinical testing.
A leading global pharmaceutical company turned to IT outsourcing to lower costs, improve IT efficiencies and diversify risk within its IT operation. The company’s objectives included: • Reduce IT costs – The Company wanted to reduce spending and move toward a “utility” model with an enhanced service catalog. • D i v e r s i f y o p e r a t i n g r i s k – A t t h e time, the company’s IT infrastructure operations were concentrated into a Cutting Cost in Outsourcing single, internally-owned and operated service center. To reduce the risk of With the outsourcing industry emerging an IT outage, the company needed to from the aftermath of the global recession, create some IT redundancies. there are a number of trends that give us • Global messaging transformation a glimpse of the future: – The company had an internally • Buyers will seek more standardised developed and supported email solutions from their outsourcing platform and was looking to migrate engagements, so they will have to to Microsoft Exchange globally. d i ff e r e n t i a t e t h e m s e l v e s t h r o u g h performance rather than pricing. Latest Trends in the Contract Services H e n c e p r i c i n g s t r u c t u r e s w i l l b e Industry stabilised to some extent. When developing an outsourcing solution, • S h a r e d a n d c o m m o n s e r v i c e s effective contract management is the were always considered a threat cornerstone of success. to outsourcing, but the trend is Outsourcing is a major change for changing. Sharing critical business existing staff. They are often accustomed and IT services has been proven to managing or even doing the work Pharma Bio World
themselves and may have a difficult time turning the responsibility for dayto-day activity over to a service provider. The change requires staff to manage a complex outsourcing contract and a new high-level relationship with a service provider. It’s important to manage the change and equip the new contract management team with tools and skills they need to be successful. The tools include a solid contract management process with an effective and flexible contract that has service levels, a performance management framework, defined reporting and interfaces, and change management and conflict resolution processes built in. The change management process is needed because it is impossible to consider every situation that could arise. What’s more, the simple reality of the situation is that, over the course of a long-term outsourcing contract, business needs will change. A change management process enables the facility executive to manage changes in scope or service levels using a predefined mechanism to set a fair and reasonable price. Putting a contract-management team in place is more challenging. Since the contract-management role often means a significant shift for the facility staff, it requires a careful matching of skill sets and sometimes a change in the culture of the facility management organisation. The contract manager must shift from managing resources to managing results and focus on the strategic issues that add value to the company. New job descriptions should outline the change in roles and responsibilities. At the same time, provide staff with guidance on the intent of the outsourcing relationship and the workings of the contract, service levels and performance management framework and give Pharma Bio World
them training or coaching on contract management principles. With a combination of well-defined service levels, structured performance measurements and effective contract management, the outsourcing initiative will deliver the benefits expected, including getting the correct level of service and successfully supporting the company’s core business.
Lawyers, Research Analysts, etc., which strengthens its position in the knowledge service industry.
Opportunities for India in terms of outsourcing are: • In services that require advanced English, like KPO, Content and Medicine, India will continue to excel. NASSCOM predicts that India will emerge as a global hub for knowledge services by 2015. I n d i a ’s R o l e i n t h e O u t s o u r c i n g • India has a large pool of EnglishIndustry speaking lawyers with expertise in foreign legal systems who can offer India continues to be the major legal support and patent services. destination for outsourcing because it A few Indian companies are already has been able to evolve with changing affiliated with American legal firms needs. NASSCOM, (National Association and they have captured a small part of Software & Service Companies) the of the American market. apex body of India’s premier IT software • I n d i a i s n o w t h e l e a d e r i n t h e and service (IT & BPO) companies, FA O m a r k e t w i t h m a n y F o r t u n e reported that India’s share in the global 500 companies already having their outsourcing market rose from 51 per cent outsourced operations in India with in 2009 to 55 per cent in 2010. India still firms like IBM, ACS and TCS etc. stands out for its customer service and • I n d i a h a s a b i g m a r k e t i n efficiency, so its future is bright. Today, pharmaceuticals, in terms of clinical customers are not only looking at costresearch and manufacturing. effective solutions for their outsourced Availability of talent for high-quality b u s i n e s s b u t a l s o f o r s k i l l e d s t a ff , trials and data management gives it enhanced productivity, service quality an edge over competitors. Ranbaxy, and business process excellence. India, a major Indian pharmaceutical firm, with its large population and multiplehas tied up with GlaxoSmithKline skilled people, would continue to be to manufacture certain compounds preferred for both back-end and front-end together. outsourcing. • Another vertical that presents great potential for India is Infrastructure Opportunities for the Indian Management Services. A wide range Outsourcing Industry of management services for IT infrastructure, application operations, IT security and maintenance can be The growth of Indian outsourcing industry provided. has been phenomenal. As markets • According to a study done by Booze worldwide are becoming knowledgeand Company, India will become a intensive, India has evolved to become dominant player in the Engineering the most preferred destination for R&D market which is expected to knowledge services. Knowledge Process expand to USD 1.4 trillion by 2020. Outsourcing may soon be the biggest India’s domestic market is expected to revenue grosser in India. India has contribute 10-15 per cent of the global a l a r g e p o o l o f s k i l l e d m a n p o w e r – ER&D services market. Chartered Accountants, MBAs, Doctors, August 2014 27
Pros and Cons of Pharma Outsourcing Outsourcing non-critical processes constitutes normal day-to-day business and best practice in industries such as aerospace, the automotive sector and telecommunications. Losing the non-value add stuff so that more time and budget is available to spend on the critical? A no-brainer, surely? But this is not yet the case in pharmaceuticals, an industry that transforms our lives with modern science, but whose approach to business processes can sometimes seem lackluster by comparison. Outsourcing is not a new concept to pharma per se. Manufacturing capacity and clinical trials are frequently outsourced; and truck loads of documents and paperwork are shipped to clinical research organisations (CROs) on a regular basis. But outsourcing an actual compliance-critical process? No way. Take for example pharmacovigilance; the terror of being sued over incorrect reporting of an adverse event, or putting the business reputation at risk has led the pharma industry to clutch these processes fearfully to their chest. The processes themselves are needed for compliance reasons and add little in terms of value, but plenty in terms of cost and added stress to the business. In the area of emerging markets, enhanced patent laws, better education systems and greater access to available patients has led to sponsors moving from “subcontracting commoditised work to seeking expertise for specialised products. So is it the fear factor that makes pharma companies ignore the benefits that outsourcing can bring? Well, intense scrutiny and regulatory pressures mean that a culture of extreme caution has developed when it comes to new ways of working. Many processes in pharmacovigilance are a burden to Pharma and ripe for 28 ď‚ƒAugust 2014
outsourcing. In a business making drugs based on, for example, acetylsalicylic acid, a product that has been on the market for well over 100 years, the chances are there is often no new knowledge to be gained from single case handling, yet the dogged reporting and analysis still has to take place in order to maintain compliance. The drugs do not contain intellectual p r o p e r t y, d o n o t t e l l t h e c o m p a n y anything useful and could easily be managed outside of the business. Forward thinking Pharma companies are beginning to wake up to this fact. Of course if a drug company fully owns a proprietary product that accounts for a significant proportion of its annual revenue, then chances are that they will want to keep every process concerning its safety in-house, because any margin for error puts the business at huge risk. However, for the larger pharma and generics companies with huge portfolios of non-proprietary products, there are several non-critical processes that it makes sense to outsource, even if they are needed from a compliance perspective, so that they can focus on the critical ones free from any distraction. So, how is Pharma going to cleanse the bad taste in its mouth about outsourcing process? They view it as high risk and highly complex: how do they ensure that they outsource only the right processes and cases? How do they ensure a compliance risk never slips in between them and the provider? It can be done. First, pharma companies should work with an outsourcing expert who knows their business intimately, and undertake a full risk assessment of their processes to decide which they can outsource and which they cannot risk. They then need to work with the provider to ensure that their understanding of risk priority and process is shared. They need to be crystal clear on who is responsible
and who is accountable for what. They should create a triage process to be followed so that, should a risk be spotted, it can be mitigated in good time. Then there are the practicalities; do their technologies enable them to share both information and data on cases in real time? Technology around transferring data and sharing case information is now advanced and safe, with applications like Microsoft SharePoint making it secure and easy to share information with a provider straight away. Basically, Pharma companies should be setting up a partnership where the potential for the unexpected to happen is reduced to almost nil. Pharma companies do not like surprises! Finally, European pharmacovigilance legislation is also changing to open the door for both outsourcing and collaboration. Volume 9a states that drug companies may now collectively submit their PSURs, for example for generic products, rather than individually. The authorities like it because they read one report instead of many. As for the pharma companies, the change in law means they can collaborate which other generics manufacturers and outsource their long-winded PSUR process and, at the same time, share the cost with other companies yet still remain fully compliant. That is one surprise that pharma companies might find that they like. It is expected that, within the next three years, life science companies will have completed a full assessment on which compliance driven, non-value adding processes they can outsource, and will be using drug safety experts and CROs to help them focus the value add in patient critical areas. Contact: madhusudan.d@richcoreindia.com Pharma Bio World
Technological Transfer During Outsourcing This article provides a holistic view of technology transfers during outsourcing.
Ravi Bhola
K&S Partners Intellectual Property Attorneys
Sindhu Vijayakrishnan Sr Associate K&S Partners Intellectual Property Attorneys
Pranav Mysore
Sr. Associate K&S Partners Intellectual Property Attorneys Pharma Bio World
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he idea of materialising innovations, technological advancements and the desire to achieve competitive edge in research and development, thrusts organisations to move towards testing different options and generate innovative products. Restricted research and development in a particular field could sometimes handicap an organisation from its competitors. Hence, there is a need for cross domain research that cuts across various applications and technologies, possibly achieved by way of collaborations or sometimes through outsourcing. The very concept of Outsourcing is one of the by-products of globalisation, depicting a different facet of Intellectual Property (IP) and technology, in general. In other words, this area requires at its very infancy, identification of which party is giving or contributing its technology, possibly an IP towards creation of a new IP, through outsourcing; and how the outsourcing is being achieved and governed through agreement.
ownership, identifying the sharing mechanism, and so on. Often most of service agreements like manufacturing agreement, marketing agreement, etc lack identifying and protecting IP related rights inter se. Therefore, identifying and protecting IP through agreement becomes an unavoidable prerequisite of outsourcing. Sometimes the recipient or the service provider may contribute towards i m p r o v i n g t h e I P. T h e i s s u e t h e n arises in relation to identification and ownership of such IP created under the agreements. Once the created IP is identified, the next step is towards protecting these rights by way of procurement of rights from the sovereign authority.
G e n e r a l l y, t h e m o m e n t w h e n i t i s said that an IP is being contributed towards creation of a new IP through outsourcing, the common question arising is that whether a license for background IP is being issued to the other party using it?
However, the identification of these aspects and understanding the sharing mechanism of the created IP is possible only from the associated agreement. More often than not, it is seen in situations involving overseas stake holders as the outsourcing party and Indian party as a service provider, that the agreements are generally very specifically drafted, clearly demarcating any IP generated in the process of and during outsourcing to be under the complete ownership of the overseas stake holder.
Answer to this is quite simple. Agreements should spell out what kind of license is being issued, for instance: whether license is royalty free, exclusive or non-exclusive, whether it is geography specific or not, whether the recipient can commercialise such IP or not, and so on. Accordingly, such agreements should clearly spell out requirements of ownership, identifying
In such a scenario, the research conducted, data generated as well as any IP created in the said process would come under the sole ownership of the overseas stakeholder, provided all the concerned assignments from the inventors are well in place. An associated issue is related to the raw materials employed in an invention, since ideally by providing required August 2014ď‚„ 29
funds, outsourcing party would expect service provider to procure all raw materials. H o w e v e r, i f o u t s o u r c e d t e c h n o l o g y requires usage of any specific biological material which has to be procured from within a specific country, eg: India, then service provider would have to comply with the legal requirements of that country in procurement of the raw material. Each nation has its own prerequisites in this area, the foremost objective being the protection and judicial usage of the available naturally occurring biological resource by a nation. For example, India is a signatory to the Convention on Biodiversity (CBD) and thus, heavily regulates access to her biological resources. In this scenario, the entire purview of outsourcing gets enhanced because new IP being created involves usage of biological material from another geographical location, which therein might have its own specifications and requirements. Sometimes, during process of outsourcing a large chunk of IP generally in the form of improvements is created, depicting high level of intellectual contribution by service provider/recipient. Hence, the IP created or improvised is identified, but the blocking stone in such a situation is the ownership and possible protection of such IP created. Does the party outsourcing the technology become its owner or will it by jointly held? Should the service provider/recipient be given license to use it? The agreement shall clearly envisage such events and capture a mechanism to address these issues. Interestingly, the entire situation takes a turn when the service provider and the party outsourcing the technology, 30 ď‚ƒAugust 2014
are at par with each other in terms of the technology they own as well as the disposition of finances. Then with mutual understanding, a hybrid model could be arrived at which leads to pooling of funds and co-ownership of the created IP, with an agreement in place which clearly identifies the issues of co-ownership, benefit sharing, requirement of any licenses, future royalty sharing and so on. The aspect of IP and the process of IP procurement in turn leads to other collateral issues associated with the nationality of the inventors, requirement of Foreign filing license, use of biological material in the invention, requirement of permission
is being used in an invention. Addressing all these aspects results in a mutually beneficial arrangement, partly on the lines of collaboration and partly on the lines of outsourcing. Moreover, it is often seen that outsourcing granted or filed IP’s would also include Tr a d e s e c r e t s a n d t e c h n i c a l k n o w how. This data, which may either by transmitted by the outsourcing party or by the service provider, is valuable and sometimes the very crux of outsourced technology. Besides, underneath the entire aspect of outsourcing is the basic question of confidentiality, wherein the outsourcing party needs to have
When outsourcing of a technology in turn leads to collaborative research and procurement of IP together by parties, various requirements have to be met with respective Patent Offices. under the Biodiversity Authority, so on and so forth. To be more specific, when outsourcing of a technology in turn leads to collaborative research and procurement of IP together by parties, various requirements have to be met with respective Patent Offices. eg: the requirement of Foreign filing license in India requires that if an Inventor residing in India is involved in any research, then a patent application for said research cannot be filed outside India without keeping the Patent Office informed of the same. Hence, in order to file the patent application outside India, the Inventor has to obtain a Foreign filing license. Similar forms of this requirement can be seen with other Patent Offices as well. The other aspect which requires due attention during such a collaboration is the requirement of any permission from the Biodiversity Authorities if any biological material procured from India
the trust that the data and research related information being shared is in safe hands and well protected by the service provider. This aspect of data protection, either of the data to be generated or the data provided for conducting research, forms one of the determining factors when any IP is being created during technology transfer. This is in view of the larger issue of data theft which has a direct bearing to the outsourcing party and the created IP the party intends to seek legal protection for. However, in absence of an express legislation to protect Data in India, it is essential to have a regulating mechanism in respective agreements. This would ensure that the data is protected at every stage of outsourcing and the service provider is also well informed on how to suitably execute the instructions provided by the outsourcing party, conduct research and sensitise Pharma Bio World
forward? In this space conglomerated within the domain of technology and IP, more often than not ‘technological skill set’ usually protected by some form of IPR, emerges as one of the factors determining this required change.
i ts e m p l o y e e s ab o u t c o n fi d e n ti a l i t y issues; making confidential information available to limited number of its employees on need-to-know basis. But a constantly pursued question is when does outsourcing of the technology happen? Is it when the size of the outsourcing company changes or is there a specific timing in the entrepreneurial world which determines this step
Pharma Bio World
Any IP landscape analysis would clearly showcase the impact that any advanced IP created would have on the said technology domain as well as possibly provide insight into the relevant market. It is therefore inevitable that in order to arrive at the advanced technology, the ladder would have the ‘possibly protected technology’ currently in existence as its stepping stones. Hence, when the outsourcing party aware of its financial and/or technological challenges plans to outsource, apart
from a well-drafted ‘agreement’, it will have to take a smart decision on what to disclose and what not to. A possible way would be to outsource the noncore technology on a ‘need-to-know’ basis. The nature of technological transfer is at times not restricted only to outsourcing. Technological transfer is a pseudonym in today’s world, wherein technological sharing and arriving at technological advancement happens on a regular basis. Technology transfer is a form of staying competitive in today’s world, strategically inclined towards globalisation and liberalisation. It is a form of staying competitive, not only i n t e rm s o f c o s t , b u t a l s o i n t e rm s of ability to take the products to the market faster. Contact: avishek@knspartners.com
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Trends in Pharma Outsourcing Attracted by the large pool of talents in developing countries whose technical skills and capabilities are being rapidly improved, increasing numbers of global pharmaceutical companies now include developing countries like India and China when they consider an outsourcing destination. This article discusses the latest development trends and the future development potentials of the global and Indian outsourcing market.
Thammaiah B N Country Director Kelly Services India 32 August 2014
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c c o rd i n g t o t h e Wo rl d He a l t h Organization- The global pharmaceuticals market is worth USD 300 billion a year, a figure expected to rise to USD 400 billion within the next three years. Despite the global economic downturn, the pharma sector has shown tremendous growth and this is not only due to India’s strength in pharma sector but also because of the thriving healthcare sector and improving healthcare standards. Experts predict the Indian pharmaceutical sector will see sales rising 14.4 per cent to USD 27 billion by 2016 and the primary reason for the rise is mainly socio-economic factors like increasing sales of generic medicines, growth in chronic therapies and greater penetration in rural markets in India. The country’s overall contribution to the global pharmaceutical industry is tremendous which is mainly in the field of manufacturing cost effective generic medicine and production of complex drugs. At the same time there is a large ageing population which has resulted in the demand for medicines and health products. India is among the top five emerging pharma markets and is a major hub for investment and expansion. Over the past few years, India is being seen as an important destination for the growth and development of the pharma sector. There has also been a rise in the number of R&D centers in India which has fuelled the discovery of new drugs. India has positioned itself as an attractive and apt outsourcing partner on the global pharma map; however, outsourcing remains concentrated in areas of manufacturing, chemistry and clinical research (though clinical research in recent terms has seen a dramatic downturn). India’s forte is in the field of biology and chemistry, at
the same time drug discovery services present a lucrative opportunity that can also be explored. The pharma growth rate in India is quite significant even as global companies are facing pressure from rising prices and shifting regulatory requirements, it is becoming difficult for global pharmaceutical companies to maintain a profitable business. Hence, many global companies are now venturing into outsourcing services which will help them in achieving cost and reduced burn out rates which directly lead to greater shareholder value. From the global point of view, many foreign companies are looking at India as a lucrative destination for outsourcing which makes the industry in India competitive and cost effective. Companies, particularly the larger and more established ones, are continuing to aggressively look for opportunities to cut costs and increase efficiency through outsourcing, with this continuing to benefit contract manufacturing and research organisations (CMOs and CROs). Pharma outsourcing continues to evolve and evoke a lot of interest in India. Majority of large Pharma players and mid-sized companies have adopted manufacturing and development services and have enhanced & upgraded their facilities to cash in on the Outsourcing wave. Companies once focused only on Domestic manufacturing & commercialisation, are now moving towards offering an array of contract services to MNC Big Pharma and other large players. However, there is increased competition from other emerging markets, China being the major threat to India’s outsourcing story. China boasts of better infrastructure, better & large scientific talent pool, Pharma Bio World
India has positioned itself as an attractive and apt outsourcing partner on the global pharma map; however, outsourcing remains concentrated in areas of manufacturing, chemistry and clinical research. industry friendly policies and well laid out regulatory guidelines. Contract Services like CRAMS, API development, Custom Synthesis, NCE development, Mfg contributes to about 30 per cent of the total revenues for any Pharma org. CRAMS and API development would be the major activities outsourced to India, and would be readily picked up by the established large players, and by standalone API manufacturers in India. Generic manufacturing will further gain speed as Patents continue to expire in the US and EU, provoking US generic players to outsource R&D and manufacturing to India. Drug Discovery services like Biology, NCE d e v e l o p m e n t , To x i c o l o g y a n d P r e Clinical is likely to see action as US Big Pharma look to rationalise and cut costs, by outsourcing these stages to reputed CROs in India. We have already seen big ticket contracts this year between US innovators and Indian CROs. Some of the key trends that are driving pharma outsourcing in India are; • Time Control: By reducing the time in the manufacturing/development of drugs can result in significant benefits. Due to limited resources and expensive product development costs, the company’s product development pipeline often gets hampered. Here CMOs and CROs can play a vital role in providing immediate access to advance technologies that can help in reduce time of production. • Emerging Market Advantage: India has become an attractive destination for pharmaceutical outsourcing, Pharma Bio World
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offering capable services at a lower cost which gives a cost advantage to CROs and CMOs. By effective outsourcing, companies also avoid capital investment and reduced drug development cost. • Managing Risks: Many companies are venturing into risk sharing outsourcing partnership to reduce their operation risk and sharing management and financial responsibilities. Through proper risk management, outsourcing enables companies to expand their R&D pipelines and provide a greater chance for a product to ultimately reach launch, thereby lowering overall business risks.
• Strategic Focus: As outsourcing relationships mature, companies shift their outsourcing strategies from pure vendor-buyer relationships to business alliance relationships. This often increases the likelihood of establishing successful, stable business relationships, improving outsourcing processes and internal resource planning, and reducing overall business risks. India produces millions of engineering and STEM graduates; it also has a
maturing pharmaceutical industry with specific skills in the respective fields, hence outsourcing provides expertise that a particular company is lacking in, it is also an opportunity to extend innovation and creative thinking beyond the company operation. Some of the key skills that are in demand in India at the moment over and above areas like clinical research are regulatory affairs in the pharma sector, innovation and tech transfer and medical chemist and specialists in quality assurance and quality control. Bioinformatics, protein expression and in-vivo pharmacology studies are areas that can be ventured into for possible outsourcing competencies. Developing capabilities and infrastructure in these areas may help Indian players become preferred outsourcing partners for pharma research. Companies are
interested to outsource and invest in countries like India and China to increase their cost efficiency. There is a major benefit of outsourcing which is not only limited to cutting costs but also helps in utilsing balance funds in innovation and R&D, which is the lifeline of the pharma sector. Today, both large and small pharma companies are relying on outsourcing services providers more than ever to accomplish their tasks and improve efficiency and productivity. Contact: Avantika.Samkaria@text100.co.in August 2014 33
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Proactive Surplus Asset Management Releases Hidden Value for Top Pharma Businesses in India In this article we take a look at how a pioneering whole-business approach to asset redeployment and the sale of surplus and idle laboratory and production equipment is helping companies in India maximise return on the significant investment they have made in these costly systems.
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cross the world, the chemical, pharmaceutical and biotech industries continue to show strong growth, and the Indian market is at the front of the pack. The consensus from a range of reports suggests that the industry in India has been growing at between 10 and 15 per cent per annum for the past five years. By 2020, estimates indicate the market will be worth approximately USD 55 billion. These remarkable levels of growth translate into a very dynamic marketplace, and huge opportunities. With the world’s biggest companies having set up in the Indian market, and many new businesses starting up locally, it is a really exciting time to be part of this sector. In 2013, a well known Indian research group claimed there were 4,655 manufacturing plants in India, employing a total of more than 345,000 people. Within these facilities, companies invest many millions of dollars in equipment, instrumentation and plant – the result: a very significant asset base. However, as projects are completed, or the emphasis of research shifts, or as companies merge and relocate or close facilities, equipment can fall out of use. In fact, industry surveys say that on average, 5 per cent of a manufacturing company’s global asset base is laying idle, and that most laboratory managers do not have good visibility of these underutilised assets. A New Approach Needs New Skills
Krishnamoorthy Vishwanathan Managing Director EquipNet India 34 August 2014
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Business managers are increasingly realising the hidden value that is sitting in their facilities. However, in order to achieve the best possible returns as assets are relocated or sold on, there is a requirement for formalised
processes, specialist knowledge of the industry and its equipment, dedicated resources, and a concerted effort to change management. Many companies lack the time or resources that are necessary to achieve this. Against this background, surplus asset management best practices have been evolving over the last decade. Specialist service companies, staffed by industry experts and proven project management professionals, have emerged to become leaders in the new field. They offer an approach and services that are significantly different from the ‘traditional equipment dealer or auctioneer’. As one of the preeminent vendors in this field, EquipNet provides a holistic approach to surplus asset management that balances the needs across an entire global enterprise. This is effectively illustrated using its ‘Value Control Model’. Figure 1 (on the next page) shows how a managed programme can be customised based on time, using: • A central tracking platform that provides communication and workflow tools and ensures exposure of assets throughout the business. • Va r i o u s d i s p o s i t i o n c h a n n e l s , including; redeployment, negotiated sales with managed pricing through an on-line marketplace, and competitive auction events. • Clearance, disposal and scrap programmes. Redeployment Having made a significant investment in evaluating, selecting and purchasing a piece of equipment, redeployment to another part of the business when its initial use is over will always delivering Pharma Bio World
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industry experience combined with a solid reputation is crucial to success. Innovative features to look for with online marketplaces include; • ‘Top-down’ offers rather than the more usual ‘bottom-up’ bidding model. • Expert evaluation of goods offered for sale from a proven, reliable team. • Accurate setting of sale prices. • Concentrated promotion of the marketplace platform and, within it, advertising of specific equipment. • Payment by results. Often, a company’s desire to recoup as much money as possible on surplus assets is superseded by time restrictions. In this case, liquidity becomes the highest priority. Auctions are dependable channel to achieve this goal however designing and managing a successful auction event depends on many factors. A specialist partner should advise on the right approach in each case; options might include online auctions, live/ webcast auction events, sealed bid and private treaty sales. Scrap and Disposals
Figure 1: Value Control Model
the highest on-going value for that asset. However, redeployment cannot be successfully and consistently achieved unless there is a central tracking platform installed within all company locations. Users should be able to post, track, identify and internally redeploy equipment that is not being used in its present location, ahead of moving to external sale. An established example is EquipNet’s ARMS (Asset Redeployment Management System) platform. This simple, yet robust programme sits behind a c o m p a n y ’s f i r e w a l l , a n d f e a t u r e s workflow management, multiple access levels for plant managers and executives across the business, in-depth search Pharma Bio World
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functionality, and comprehensive listing specifications, providing information that lets the company know what they have and where it’s located. Sales and Auctions If a company chooses not to redeploy an asset, a sale is the next logical step. The rise of the internet has seen the development of online marketplace packages to meet this need. When considering an online transaction however, particularly for a high-value and complex piece of equipment, the human touch is perhaps still the most important factor. Using a vendor with specific
In every business, there are those assets that hold very little value and are best dealt with through clearance, by donations, scrap and environmental recycling. Working with your chosen expert, you should expect to be advised of the scrap value of your idle equipment, presented with a comparison of that amount against the market value to sell it, together with a recommended strategy that will generate the highest rate of return for your company. In Practice Mid-way through last year (2013), a multi-national pharmaceutical company needed to close a development centre, located in Western India. August 2014 35
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With a timeframe of just five months to completely clear the facility so that another department could relocate into the building, the pressure was on. EquipNet managed this complex project from start to finish, meeting the deadline and realising more financial targets agreed for the sale of assets. A total register of 650 assets (a mix of analytical and laboratory instruments and R&D equipment) was created for the project. Market values were established by EquipNet’s equipment specialists, who confirmed that around 80 per cent of the value would be realised by 25 per cent of the assets. A negotiated sales approach – targeting sales to individual end users – was employed to dispose of the items. Everything was sold, and the facility was cleared on time. Importantly,
Often, a company’s desire to recoup as much money as possible on surplus assets is superseded by time restrictions. In this case, liquidity becomes the highest priority. all required government formalities for an ‘Export Oriented Unit (EOU)’ – including all statutory documentation and processes – were completed by the EquipNet specialists for both the client company and for the buyers of the assets. Summary Choosing when to invest internal resource in a specific activity and when to seek extra help is a tough but essential management task. Defining and focusing on core company strengths and
recognising the need for expert support in other areas ensures operational efficiency and can have a major impact on the bottom line. Surplus asset management is being recognised as increasingly critical, and many realise that they do not have the resource or skill base to tackle the issue in-house. With dedicated companies offering services to alleviate the burden, asset management is now joining the list of activities ripe for outsourcing. Contact: ellen.chesterman@kapleronline.com
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36 August 2014
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Gas Handling Systems for Pharmaceutical Industry This article takes a look at how to safely handle high purity gases in the biopharmaceutical and pharmaceutical plants.
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ndia is among the top five emerging pharma markets. Gas Handling practices at modern biopharmaceutical and pharmaceutical plants today are quite different than those at similar construction sites 20 years ago. In pharmaceutical industry, gases are required in two divisions – Manufacturing and Laboratory. In Manufacturing division gases are used for cryopreservation, blanketing, pH control, pressure transfer, process chilling, purging, wastewater treatment and other such processes. In Laboratory division gases are used in Process/Quality Control and R&D for hydrogenation process, reactors, analytical instruments etc.
Nitin Godse
Managing Director Excel Gas and Equipments Pvt Ltd Navi Mumbai, Maharashtra, India Pharma Bio World
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Commonly used gases are nitrogen, oxygen, hydrogen, argon, helium, air, carbon-di-oxide, HC gases, LPG, nitrous oxides apart from other gases and gas mixtures. Based on the nature of these gases they can be classified as; • Asphyxiant: Minimally toxic but poses danger to human health through asphyxiation when present in sufficient quantities. These gases, when released in closed environment, replace oxygen causing oxygen depletion. Ex-Nitrogen, Argon, Helium. • Corrosive: Corrodes material or tissue with which they come in contact. Mostly they affect in low concentrations over a long period of time. Ex-Ammonia, Chlorine, Nitrogen Di Oxide, Hydrogen Chloride gas. • Cryogenic: Has boiling point less than -90oC. Can cause severe burns to tissue and brittleness in materials. Ex-Nitrogen, Oxygen. • Flammable: Forms a flammable mixture when mixed with air at atmospheric temperature and
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pressure after attaining lower explosive level (LEL). Ex-Hydrogen, Hydrocarbon Gases. Inert: Does not react with other materials at ordinary temperature and pressure. They are colorless and odorless, as well as nonflammable and nontoxic. Still they pose danger to human health as they displace amount of oxygen in a confined place. Ex-Nitrogen, Argon, Carbon Di Oxide. Oxidant: Does not burn but will support combustion and they may also displace oxygen in air. Ex-Air, Nitrogen Oxides. Pyrophoric: Do not require a source of ignition to explode or catch fire. Pyrophoric gases will ignite spontaneously in air at or below 54°C. Ex-Silane. Toxic: Chemically produces lethal or other health effects. Ex-Chlorine, Carbon Monoxide, Di Borane, Hydrogen Sulfide.
Generally, end-users do not have the knowledge and expertise on the science behind gas handling systems. Hence major safety hazards are associated with handling of gases. We need to understand that handling of gases is different than handling liquids. Gases are compressible and therefore large quantities of gas fit under high pressure into confined containers like cylinders, bullets etc. Depending on the nature of gas they are filled at various pressures ranging from 2 bar to 220 bar and sometimes even higher. Uncontrolled release of this compressed gas will cause serious safety hazards and can lead to fatal accidents. Design precautions, Correct material and fabrication methods for gas handling systems, Hazard Analysis, operator trainings can avoid accidents in plant laboratories. Unfortunately, there are very limited regulations related to gas handling August 2014 37
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We need to understand that handling of gases is different than handling liquids. Gases are compressible and therefore large quantities of gas fit under high pressure into confined containers. systems available in India. Frequently referred standards and codes include NFPA 55 for Fire and related hazards, PESO for use of compressed gases and OSHA for safety of the users. Apart from these, ASME B31.8 is generally referred for designing and tubing. Recently FDA has become very stringent with regulations for pharma sector in particular. In India, from the past one year FDA has issued warning letters to more than eight major pharma companies, Form 483s to several more and even banned certain products manufactured by these companies. Mostly the issues highlighted are regarding good manufacturing practices. So it becomes very important to install gas handling systems and clean fluid handling systems with utmost care and after considering standards, codes and good manufacturing practices.
A typical complete gas handling system in a pharma sector would consist of three sections; • Gas source: Gas bank, generator, compressor, quads, bullets, cryo tanks. Storage and installation space. • Gas tubing with accessories and control systems: supports, tubing, tube fittings, valves, pressure gauges, regulators, inline purification panels, change over panels. • Safety features: flash back arrestors, safety relief valves, gas monitoring systems, leak detection systems, integration to BMS. The important factors to consider while choosing a Gas Handling System would be; • Type of gas. • Application of the gas. • Pressure requirement at source and user points.
• Flow requirement at all user points. • Ambient working condition where system is being installed. • Structure of the building where the system is being installed. • Codes and Standards applicable in the geographical region of installation. • Safety features required as per the nature of gases and applicable codes & standards. Designing of this system has to be with optimum cost, maximum efficiency with complete conformation to all safety aspects. A designer has to understand pressure and flow requirements at each user points. Line sizing has to be done according to scientific calculations to reduce unnecessarily higher sized lines there by controlling cost. Line layout has to be done keeping accessibility, maintenance activity and aesthetics into consideration. In earlier days copper and brass were preferred as material of construction, however, now stainless steel has become the material of choice due to its strength, corrosion resistance, durability and easy availability. Gas bank/source area and storage area has to be chosen and designed to ensure
Gas handling systems have to be always designed by qualified professionals who are aware of applicable standards, codes and good manufacturing practices. They should also be clear about nature of gases, materials of construction, control systems used specifically for gases, implication of gas purity, safety aspects in terms of explosion, fire or gas leakage. Most of the time the client is unaware of the complete requirements of the gas handling systems they need as piping systems is one of the utility to their core business. Hence the design team has to understand the stated and unstated requirements of the application and design a system accordingly after explaining the same to client. 38 August 2014
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Aesthetic installation
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Installation of Gas Handling System in a typical laboratory
safe ventilation, safety to environment and to avoid accidental manipulation of systems. The lines carry gases at high pressure and even small negligence or lack of professional approach during installation will lead to major safety incidents. Material has to be procured only from reliable sources with assured quality. Further, Installation has to be done by qualified and certified professionals only. While installation leak integrity has to be validated and specific precautions related to gases have to be taken, aesthetic finish is equally important. Connecting joints are done by ferrule type fittings, TIG welding or Orbital welding. Orbital welding is most preferred as it is almost hundred percent leak proof. Orbital welding also reduces contamination areas in fluid system reducing chances of viral colonies in the line. Touching upon safety aspects, there are inline safety features and offline safety features. Inline safety features include flash back arrestors, pressure relief valves, excess flow valves and vent lines. These systems h a v e t o b e p l a c e d e ff e c t i v e l y i n a gas line. O ff l i n e s a f e t y f e a t u r e s i n c l u d e g a s level monitoring system, leak detection s e n s o r, a u t o m a t i c s h u t o f f s y s t e m . Pharma Bio World
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These will be monitored on a gas monitoring system with audio visual alarms. Latest advancements have options for sending SMS alerts in case of an emergency, which enables us to monitor remotely. Integration into BMS (Building Management System) can activate fire safety system and shutoff some electrical grids as additional safety. As associate safety feature smoke detectors, water sprinklers and fire extinguishers at designated places are also required. However, this will be covered by fire safety system professionals. Thus installed gas handling system needs proper validations from time to time in order to ensure purity of gases, proper functionality of instruments and accessories. Again, this is to be done by authorised and trained personnel only. It involves complete leak audits, pressure testing, calibration of instruments and sensors, replacement of worn out/used up material and minor modifications as per user’s latest requirements. An AMC with proficient contractor is highly recommended to achieve the same. Some common problems faced by end users are; Reduced pressure at user points: Pressure and flow requirements of the
line have to be checked. Line sizing has to be checked. Source pressure has to be checked and line has to be checked for leakages. Corrosion of tubes: Nature of gases in the line has to be studied and suitable MOC has to be selected. Corrosion may be due to outside ambient and working conditions also. Functionality problems in valves and regulators: Bad material quality or improper handling by users. Excessive gas consumption: Pressure and flow requirements of line have to be checked. Leak audit has to be carried out. Impurities in gases: Purification panels have to be checked and activated. Leak audits have to be done. Line has to be checked for corrosion. Vibrations in lines: Pressure and flow requirements of line have to be checked. Line sizing has to be checked. Tube supports have to be checked. Aesthetically bad: Care has to be taken during installation. Cosmetic changes on case to case basis have to be looked into. If required, specific segments can be replaced. Unable to trace the gas lines for maintenance: Proper tagging and colour coding has to be done. As-built drawings should be updated and available. In all, handling gases safely is of paramount importance to avoid accidents and incidents. We have worst example of gas disasters like Bhopal Gas tragedy. The tragedy occurred because of small negligence. Small or big, accidents are always serious and we can avoid accidents only by pre planned precautionary measures. Selecting right contractor, right design and right material is the key to have peace of mind. Safe systems need not necessarily be costly, it can be achieved through right engineering. Contact: nitin@excelgas.com August 2014ď‚„ 39
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marketing initiative
A Global Supplier
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ommelag ® has made a name for “Both plants have recently installed new that is simple, safe and economical. itself as the inventor, technology lines and facilities for BFS bottelpack ® As an innovative and reliable industry leader and worldwide market systems, for filling biosimilars and partner rommelag® is placing a lot of leader of the Blow-Fill-Seal (BFS) vaccines, as well as the bottelpack ® emphasis on the provision of continuous technology. The core product, BFS Pharma Suite – and a designated BFS support, efficient advice and worldwide bottelpack® machines, as well as aseptic production facility also for customer support from highly qualified downstream machinery such as infusion operating customer-owned machines employees”. Mr Geiss recommends cap welding machines, high-voltage leak was opened last year.” prospective customers to study the company’s homepage for a more detectors, particle inspection machines or finishing lines, are distributed by sales The manufacturing facilities are based thorough impression of the product and and after-sales services in more than 80 at Kocher-plastik Maschinenbau GmbH service portfolio. countries around the globe. in Sulzbach-Laufen, Germany and Maroplastic AG, Reitnau, Switzerland. Recent product developments A strong group with decades of Finally, plastic film is manufactured at experience thermo-pack Kunststoff-Folien GmbH, The company continuously invests in the Gaildorf, Germany. “In 2013 both these development of products and services, Gerhard Hansen formed Thermo- locations have increased their capacity as well as in product innovations and the Pack Germany for PE plastic film through building extensions. At Kocher expansion of the service range, says Mr manufacturing, printing and sealing in we installed a bottelpack ® Training Geiss: “An example would be the recent 1952, and since then more than 50 years Centre for the implementation of high successful market introduction of the new generation of BFS bottelpack ® high of experience in plastic processing have quality training courses for customers.” ® put rommelag at the forefront of Blowperformance range, which is exclusively fitted with electrical drives that manage Fill-Seal technology. Initially starting Leading market position to reduce unit costs for our customers out with the extrusion of plastic film, the key driver for the group’s expansion The way rommelag ® sees its own yet again. During INTERPACK 2014 we was the invention of the BFS process position in the market is described by presented a brand new development of by the engineer Gerhard Hansen at the Mr Geiss: “Our international customers’ a VIM ampoules testing station for the beginning of the 1960s. This was followed expanding requirements in the field of automatic In-Process-Testing of BFSby the successive formation of machine pharmaceuticals are continuously met containers, as well as announcing a new building companies, sales companies by our newly developed strategies and optical particle-test-system.” and contract packaging companies. our ongoing developments. Step by step development, starting with the design of The main market for the BFS bottelpack ® ® Today the rommelag group consists packaging systems to the production of machines is the global pharmaceutical of an extensive network of specialised in-line equipment, which can be added field, mainly for packaging sterile locations, with the two sales offices to the BFS bottelpack ® machines – this is liquids, creams and ointments. A new operating in Buchs, Switzerland, in how we have reached the position of the and upcoming area are biosimilars and Waiblingen, Germany and the two leading systems supplier in this field”. vaccines, and the operation of BFS contact offices at Evergreen, CO, USA bottelpack ® Co-Extrusions-machines with and Shanghai, P R China. “We are a highly competent system multi-layer containers for sensitive filling supplier, equipped with extensive know- goods. “We are permanently innovating The contract packaging facilities, how and ingenuity, capable of designing and optimising our range of containers operating to current GMP standards, are and building according to individual and closures – like our Ready-to-uselocated at holopack Verpackungstechnik specifications,” he adds. “Customers Products of injection ampoules with GmbH in Untergröningen and Sulzbach, can rely on getting a unique range of integrated needles or the unit-dosage Germany and Maropack AG in Zell, products and services, enabling them ampoules for eye-, nose- and eardrops Switzerland. Investments are ongoing, to operate packaging processes with with integrated dosage chamber, making says General Manager Rudolf Geiss: BFS bottelpack ® systems in a manner preservatives redundant,” explains Mr Geiss. 40 August 2014
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marketing initiative Expansion ahead systems and BFS bottelpack ® additional devices are sold in over 80 countries worldwide, to customers in pharmaceuticals, cosmetics and technical products. The western industrial nations are important, with growing developments in Asia. “We are working on rolling out our market penetration on a global scale, within
both the existing and the developing application fields for our technology.” Mr Geiss expects further expansion for rommelag® in the coming years: “Our BFS technology can offer a whole range of benefits, like aseptic properties, safe and cost-effective production process, low unit costs, high tamper resistance and advantages in the transport, storage, handling and application of finished
packed products. Therefore we see a lot of additional growing space for our company, both within our key market of pharmaceuticals and also within others, like the cosmetics, food and technical product areas, which are yet to discover how they can profit from the mentioned benefits.” Visit: www.rommelag.com
Three Steps to Perfection Fifty years ago, rommelag® revolutionized plastic packaging technology with BFS.
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n 1963 Gerhard Hansen invented and built his first blow-fill-seal machine. In May 1964 he founded rommelag ® in Aarau, Switzerland to sell his products internationally. Today rommelag ® is a member of the Hansen Group headed by CEO Bernd Hansen, with sales companies in Switzerland, Germany, the USA and China. It is the world’s leading supplier of blow-fill-seal machinery, with the brand name bottelpack ®.
Customers throughout the world quickly recognized the advantages of plastic containers. Aseptic packaging by means of bottelpack ® blow-fill-seal systems is gaining increasing dominance. Plastic materials offer a number of advantages to manufacturers and users of infusion containers andampoules.
It’s a matter of three steps. All bottelpack ® 50_Years rommelag bottelpack machines operate according to the blowfill-seal principle (BFS). In a single It provides support to its customers automatic process they create containers in manufacturing trials, contract from thermoplastic granules (blow), manufacturing, process development, insert the contents (fill) and close them They are strong enough to be made very qualification and validation. Customers (seal). BFS technology does not require thin without risk of breaking, they are easily can even move their bottelpack ® the cleaning and sterilization processes collapsible, and they are chemically inert. that are essential in other kinds of Thus handling is easy and safe, not only machines to Holopack Pharma 2020 for production. container production. in hospitals but also in mobile operations. As a consequence they are finding To provide maximum security in the increasing use in countries like China and One can only hope that rommelag ®’s aseptic packaging of sterile liquids, India, where nationwide healthcare is still worldwide efforts to promote the use of aseptic plastic packaging meet creams, ointments and vaccines, the in the development phase. with success. After all, what’s at machines are equipped with additional stake is people’s most valuable asset: modules for quality assurance and Thanks to subcontracting by its sister monitoring. The modules include aseptic companies Holopack in Germany and their health. systems for automatic cleaning and maropack in Switzerland, rommelag ® is - Rudolf Geiss sterilization of lines that come into contact able to offer a diverse range of products General Manager with products. and services for packaging of liquids. Pharma Bio World
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press release Nova Medical Centers introduce EMI Option for All its Cash Patients Nova Medical Centers, the pioneers of short-stay surgery in India, have gone a step ahead in making quality healthcare accessible and affordable to its patients. Nova has tied up with Pine Labs, a leading company in payment solutions, to offer easy EMI options of 3, 6, 9 or 12 months, depending on the convenience of the patients. The parent company, Nova Medical Centers, has implemented this scheme across all its surgical centers, Nova Specialty Hospitals and fertility centers, Nova IVI Fertility. In India, a large segment of our population is not covered by health insurance which makes them susceptible to unforeseeable health related expenses. To address this need, the newly introduced EMI scheme offers multiple advantages such as easy and gradual payback of the treatment cost, reduced dependence on family/ friends in times of emergency and access to quality healthcare. The scheme would be especially relevant for medical procedures that are not covered by MediClaim. Suresh Soni, Founder and Chairman, Nova Medical Centers said, “Our aim is to make quality healthcare accessible and affordable to patients. Due to financial constraints, the working class population in India tends to ignore their health and ‘minor’ health problems are often put off till they become serious. With this EMI option, Nova aims to enable people to take better care of their health while not having to worry about unexpected healthcare expenses which need to be settled upfront.”
B&R Organises User Meeting in Shanghai
More than 100 machinery manufacturers, end users and partners from mainland China and Taiwan participated in B&R’s openautomation-themed User Meeting.
More than 100 machinery manufacturers, end users and partners from mainland China and Taiwan participated in the B&R User Meeting in Shanghai. The focus of the meeting was on open automation and how to flexibly respond to the future challenges facing the manufacturing industry.
Dr Xiao Weirong, Managing Director of B&R China, stressed the importance of advances in open automation for industrial equipment manufacturers. Open automation offers five important advantages: open integration, lasting technology, interchangeability, the possibility of further development and flexibility to respond to the future. “For
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industrial equipment manufacturers, open automation promises exciting market opportunities”, said Weirong. Business executives from various industries expressed their views on subjects such as knowledge management, training, project management, business operations, and energy efficiency as well as difficulties and challenges they currently face. The executives’ openness was received positively by the audience. “A higher level of open automation technology could mean huge opportunities”, said Xiao Weirong. However, this would require keeping the big picture in mind and laying a foundation by setting up architecture to support continuous innovation, he added.
Protagen AG Launches Landmark First Research Test Kit for SSc Protagen AG, a company dedicated to the development of powerful diagnostic tools to address some of the most severe autoimmune diseases, has launched its first ELISA research use test kit for Systemic Sclerosis (SSc), the ADxSSc Multilisa. Protagen developed the new assay to synergistically combine two proprietary, novel disease markers with two standard diagnostic markers to support medical research in autoimmune diseases. Systemic sclerosis is one of a number of complex autoimmune diseases that Protagen is working to address with research tools to help clinical researchers in their work to identify markers for improved diagnostics. This new introduction represents a key milestone in the company’s pipeline. ADxSSc Multilisa is intended for use as a scientific research-use only (RUO) product, and is in further clinical testing to build a diagnostic claim for early disease detection or stratification from August 2014.
Biocon Foundation Gets ‘Asia Best CSR Practices Award 2014’ Biocon Foundation has won the ‘Asia Best CSR Practices Award 2014’ hosted by CMO Asia at Singapore, as a part of World CSR Congress, in the ‘Best Community Initiative’ category for its ‘Community Cervical Cancer Screening Programme’. S Raman, Vice President & Head of Biocon Malaysia operations, received the award on behalf of Biocon Foundation at the 4 th Asia Best CSR Practices Awards held in Singapore on August 1, 2014. The Asia Best CSR Practices Awards recognise corporates in Asia that have had a significant and positive impact on people, communities and the environment. Pharma Bio World
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press release SRL Diagnostics Launches Echosens Fibro MeterVirus Viral Hepatitis is a silent killer as it rarely presents symptoms until very late. It is estimated that about 20 million Indians are Hepatitis B carriers and about 8 to 10 million have HCV infection. Due to advances in the management of liver diseases, particularly the evolving non-invasive tools have led to early screening and diagnosis of fibrosis and cirrhosis. On the eve of World Hepatitis Day, with an endeavor to provide accurate and non-invasive tool for assessing liver damage, SRL Diagnostics Limited (SRL), the largest diagnostics network in India, has launched a new reference test, Echosens Fibro Meter Virus through collaboration with Echosens France. Echosens Fibrometer Virus will be available for first time in India through all Fortis Labs / SRL Diagnostics Labs and its collection centres for just ` 3450. Chronic Viral Hepatitis patients with or without HIV coinfection are ideal candidates for this test and can consider it after appropriate consultation with treating clinician.
Cadila Organises Nationwide Walkathons for Osteoarthritis Awareness Cadila Pharmaceuticals Ltd has celebrated this Independence Day by organising ‘Freedom from Pain Walkathons’ on August 14, 2014, to increase awareness about osteoarthritis and problems faced by patients suffering from this disease. The walkathons were held across major cities of India, like Ahmedabad, Mumbai, Chennai, Kolkata, Hyderabad and Ambala.
calibration, shift test, and sensitivity tests. Equipped with ASTM Class 1, polished stainless steel Type II design weights, Essential Weights maintain the quality standards Rice Lake Weighing Systems upholds.
New Drugs to Boost Graft-VersusHost Disease Treatment Market The graft-versus-host disease (GVHD) treatment market value will increase from USD 297 million in 2013 to USD 407 million by 2018, at a Compound Annual Growth Rate (CAGR) of 6.59 per cent, according to research and consulting firm GlobalData.The company’s latest report states that this growth, which will occur over six major markets (6MM: the US, France, Germany, Italy, Spain and the UK), will be strongest in the five European countries (5EU), where multiple product launches will accelerate the market value at a CAGR of 9.26 per cent during the forecast period. GlobalData forecasts that both Jazz Pharmaceuticals’ Leukotac and Adienne Pharma’s Begedina will enter the GVHD market in 2018, with Leukotac being launched only in the 5EU. Due to their anticipated premium pricing, these drugs are expected to add over USD 18 million to the 6MM sales by the end of 2018. While multiple biologic products will fall off their respective patent cliffs by the end of the forecast period, Vavatsikou states that this will not impact the GVHD forecast for two important reasons.
Research shows that exercise is one of the best treatments for osteoarthritis. Exercise can decrease pain, increase flexibility, strengthen the heart and improve blood flow, maintain weight, and promote general physical fitness.
Roots Muticlean Moves on to New Premises in Bengaluru
Rice Lake Weighing Systems Unveils Essential Weights
Roots Muticlean Ltd l has moved on to it’s own new premises in Bengaluru, India . The move is a reflection of the company’s continuing success and a response to a growing demand for it’s floorcare equipment, from customers across the region.
Rice Lake Weighing Systems introduces Essential Weights, a new, customised set of three or four stainless steel test weights in a small, durable carrying case. Laboratory professionals no longer need to carry around large cases with unnecessary test weights. The weights are specifically tailored to your precision weighing equipment, maintaining best practices in routine laboratory calibration. Pharmaceutical and laboratory professionals can benefit from being able to customise configurations ideal for specific Pharma Bio World
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The new premise, located in a business and industrial hub in Bommasandra, gives a strategic advantage to the company. The premise contains a grand showroom, office space, product demonstration areas, well equipped service centre, hands-on training centre, and a self contained guest house. The building creates a dynamic environment to encompass the administrative, sales and service requirements of the customer. The logistics warehouse capacity has been adequately planned, allowing greater levels of stock and faster service turnaround time. August 2014 45
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pharma news Ipca Halts API Shipment from Ratlam During the recent US FDA inspection at the Ipca’s Active Pharmaceutical Ingredients (APls) manufacturing facility situated at Ratlam (Madhya Pradesh) the Company has received certain inspection observations in Form483 from the US FDA. Consequent to this, Ipca has voluntarily decided to temporarily suspend API shipments from this manufacturing facility for the US markets till this issue is addressed. This voluntarily stoppage of API shipments from the Ratlam manufacturing facility will also have impact on the Ipca’s formulations export business to the US market since the Company’s formulations manufacturing units situated at Piparia (Silvassa) and SEZ, Indore (Pithampur) use the APls manufactured from the Company’s Ratlam manufacturing facility for manufacturing formulations for the US market.
C i p l a t o M a r k e t B i o Q u i d d i t y ’s OneDose ReadyfusOR in EU Cipla Europe NV (Cipla) and BioQuiddity Inc recently entered into a commercial collaboration, covering the territory of the European Union and certain other European countries, for BioQuiddity’s OneDose ReadyfusOR in regional anesthetic applications for post-surgical pain management. Cipla intends to launch the CE Marked OneDose ReadyfusOR pre-filled with Ropivacaine under its own label into the German market late this year. The ready-to-use infusion systems are non-electric, ambulatory, and should enable seamless transition between sites of care. “Cipla is an excellent strategic partner for BioQuiddity and our pre-filled ready-to-use post-surgical pain product candidates,” said Mr. Joshua Kriesel President and CEO. “Cipla’s strong commercial record puts them in an outstanding position to detail the OneDose ReadyfusOR’s safety, sterility, and ease of use value proposition objectives.”
Pfizer Announces Submission of Palbociclib NDA to the FDA Pfizer Inc has completed the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for palbociclib. This NDA requests FDA approval of palbociclib, in combination with letrozole, for the treatment of postmenopausal 46 August 2014
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women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease. The submission is based on the final results of PALOMA-1, a randomised, Phase 2 trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients. Palbociclib received Breakthrough Therapy designation from the FDA in April 2013, for the first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer. This designation was based on interim data from the PALOMA-1 trial. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. Pfizer will communicate the Agency’s decision.
Celator Begins PK/PD Study of CPX-351 Celator Pharmaceuticals, Inc announced that the first patient has been enrolled in a Phase 2 pharmacokinetic and pharmacodynamics (PK/PD) study evaluating the effects of CPX-351 Liposome Injection on cardiac repolarisation in adult patients with acute hematologic malignancies, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS). This study will also include patients with moderate baseline hepatic and renal impairment, extending the range of safety and pharmacokinetic observations to this important group of patients. “We continue to work expeditiously to bring CPX-351 before the FDA as a potential new treatment option for patients with acute hematologic malignancies,” said Scott Jackson, Chief Executive Officer of Celator Pharmaceuticals. “The FDA requires clinical pharmacology studies for new drugs in development, so we are pleased to have this Phase 2 study underway to support our plans for a NDA submission. We expect to report top-line results from this study in the second half of 2015.” The open-label, single-arm, Phase 2 study is a thorough PK/PD assessment designed to: (1) measure the effects of CPX-351 on cardiac repolarisation following the first induction cycle of CPX351, (2) assess the impact of moderate hepatic impairment on cytarabine and daunorubicin pharmacokinetics, and (3) assess the impact of moderate renal impairment on cytarabine and daunorubicin pharmacokinetics. The study is expected to enroll 36 patients. Each patient will receive a first induction of CPX351 on days 1, 3 and 5 and, if necessary, a second induction for patients with reduced leukemia/MDS burden not yet achieving a leukemia/MDS-free state. Pharma Bio World
22-08-2014 19:21:12
pharma news U S F D A G r a n t s O r p h a n D r u g Cubist Pharma Recalls Nine Lots of Designation to Mirati’s Mocetinostat Cubicin from US Market Mirati Therapeutics, Inc announced that the US FDA has granted Orphan Drug Designation to mocetinostat, a spectrum selective HDAC inhibitor, for diffuse large B-cell lymphoma (DLBCL). In June, mocetinostat was granted Orphan Drug Designation as a treatment for myelodysplastic syndrome (MDS). Orphan drug designation is also being sought for bladder cancer patients with specific genetic alterations. Mocetinostat is being developed as a single agent treatment in patients with diffuse large B-cell lymphoma (DLBCL) and bladder cancer with specific genetic mutations in Histone Acetyl Transferases (HATs) that we believe to be critically involved in the pathogenesis and progression of these tumor types. Mocetinostat reverses aberrant acetylation resulting from HAT mutations and is predicted to halt tumor progression and reduce tumor burden in patients. Mocetinostat is also in Phase 2 clinical studies in combination with Vidaza as a treatment for intermediate and high-risk MDS. The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for underserved patient populations or rare disorders that affect fewer than 200,000 people in the United States. Orphan drug designation provides certain benefits, including market exclusivity upon regulatory approval if received, exemption of FDA application fees and tax credits for qualified clinical trials.
EU Regulator Okeys EYLEA Injection Regeneron Pharmaceuticals, Inc announced that EYLEA (aflibercept) Injection has been approved by the European Commission for the treatment of visual impairment due to Diabetic Macular Edema (DME). Bayer Healthcare plans to launch EYLEA in DME in the EU this quarter. EYLEA was approved in the United States for the treatment of wet Age-related Macular Degeneration (AMD) in 2011, for the treatment of Macular Edema following Central Retinal Vein Occlusion (CRVO) in 2012, and for DME in July 2014. EYLEA has also been approved in the EU and other countries for use in wet AMD and Macular Edema following CRVO. Regulatory submissions have also been made in Japan, Asia Pacific, and Latin America for the treatment of DME. In Japan, EYLEA has been additionally submitted for approval to regulators for the treatment of choroidal neovascularisation secondary to pathologic myopia (mCNV). A regulatory submission has been made in the US and the EU for EYLEA for the treatment of Macular Edema following Branch Retinal Vein Occlusion (BRVO). Pharma Bio World
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Cubist Pharmaceuticals, Inc is voluntarily recalling nine lots of CUBICIN (daptomycin for injection) to the user level following complaints of foreign particulate matter in reconstituted vials. The administration of particulate matter, if present in an intravenous drug, poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary embolism. Other events such as phlebitis, mechanical block of the capillaries or arterioles, activation of platelets or subsequent generation of microthrombi are also possible. Patients with a preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. Administration of a particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material. To date, no reports of adverse events have been associated with product complaints of particulate matter from these lots. CUBICIN is an intravenously administered prescription product indicated for the treatment of skin infections and certain blood stream infections. CUBICIN is supplied in a single-use vial packaged in a carton. CUBICIN was distributed Nationwide to multiple consignees.
Takeda’s Velcade Gets US FDA Nod The Takeda Oncology Company with its parent company, Takeda Pharmaceutical Company Limited, has announced that the US Food and Drug Administration (FDA) has approved Velcade (bortezomib) for the retreatment of adult patients with multiple myeloma (MM) who had previously responded to VELCADE therapy and relapsed at least six months following completion of prior Velcade treatment. The labeling update includes dosing guidelines as well as safety and efficacy findings for the use of VELCADE as a single agent or Velcade in combination with dexamethasone in patients previously treated with Velcade. Velcade retreatment may be started at the last tolerated dose. The approved retreatment sNDA consisted of a Phase 2 study and other supportive data. The Phase 2 international RETRIEVE trial showed a 38.5 per cent overall response rate (ORR) in multiple myeloma patients who had been previously treated with a Velcadebased regimen (median of two prior lines of therapy) and had previously achieved a partial response or better. The safety profile seen with VELCADE retreatment was consistent with the known safety profile of intravenous Velcade in relapsed multiple myeloma; no cumulative toxicities were observed upon retreatment. The most common adverse drug reaction was thrombocytopenia, which occurred in 52 per cent of the patients. August 2014 47
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pharma news Novartis Inks Licensing Deal with US FDA Approves Merck’s Belsomra TB Alliance Merck, known as MSD outside the United States and Canada, Novartis has signed an exclusive worldwide licensing agreement with the Global Alliance for TB Drug Development (TB Alliance) for compounds to fight tuberculosis (TB) that have been discovered at the Novartis Institutes for Tropical Diseases (NITD). According to the World Health Organisation, there are more than 8.6 million cases of tuberculosis each year, with more than 1.3 million deaths reported annually. TB is a global disease, but has its deadliest impact in resource-poor countries. Current therapies for TB require 6-30 month dosing regimes and there are increasingly drug resistant strains of TB emerging. “TB is one of the scourges of the developing world and new medicines are desperately needed to combat its continued spread,” said Mark C Fishman, President of Novartis Institutes for BioMedical Research. “TB Alliance is well placed to take our discoveries and compounds through development for the benefit of patients with TB.”
announced that the US Food and Drug Administration (FDA) has approved Belsomra (suvorexant) for adults with insomnia who have difficulty falling asleep and/or staying asleep.
Belsomra (pronounced bell-SOM-rah) is a highly selective antagonist for orexin receptors. Orexin is a neurotransmitter found in a specific part of the brain that can help keep a person awake. The mechanism by which Belsomra exerts its therapeutic effect is presumed to be through antagonism of orexin receptors. In the clinical trials to support efficacy, Belsomra was superior to placebo for sleep latency and sleep maintenance as assessed both objectively by polysomnography and subjectively by patientestimated sleep latency. The recommended dose of Belsomra is 10 mg, taken no more than once per night and within 30 minutes of going to bed, with at least seven hours remaining before the planned time of awakening. The total dose should not exceed 20 mg once daily.
Sanofi and MannKind Sign Licensing Deal for Afrezza Paladin Labs Launches Travelan Sanofi and MannKind Corporation have entered into aworldwide exclusive licensing agreement for development and commercialisation of Afrezza (insulin human) Inhalation Powder, a new rapid-acting inhaled insulin therapy for adults with type 1 and type 2 diabetes. The companies plan to launch Afrezza in the United States in the first quarter of 2015. Under the collaboration and license agreement, Sanofi will be responsible for global commercial, regulatory and development activities. Under a separate supply agreement, MannKind will manufacture Afrezza at its manufacturing facility in Danbury, Connecticut. In addition, the companies are planning to collaborate to expand manufacturing capacity to meet global demand as necessary. Under the terms of the agreement, MannKind Corporation will receive an upfront payment of USD 150 million and potential milestone payments of up to USD 775 million. The milestone payments are dependent upon specific regulatory and development targets, as well as sales thresholds. Sanofi and MannKind will share profits and losses on a global basis, with Sanofi retaining 65 per cent and MannKind receiving 35 per cent. Sanofi has agreed to advance to MannKind its share of the collaboration’s expenses up to a limit of USD 175 million. 48 August 2014
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Paladin Labs Inc has announced the launch of Travelan, a unique over-the-counter product to help reduce the risk of travellers’ diarrhea. Travelan is clinically proven to provide protection against the main cause of travellers’ diarrhea in 90 per cent of consumers who use it. Travelan is a convenient option for all those travelling to at-risk regions such as Central and South America, Mexico, Africa, the Middle East and Asia. It does not require a prescription, and is not associated with any significant side effects. It is estimated that there are over 5 million trips made by Canadians to at-risk regions every year. One-in-three Canadian vacationers have experienced, or have travelled with someone who has experienced, travellers’ diarrhea. Sources of Enterotoxigenic Escherichia Coli (ETEC) bacteria, which cause the majority of cases of travellers’ diarrhea, can include poorly cooked meat, contaminated raw vegetables or unpasteurised dairy products. Given that no food group can be regarded as “safe”, research demonstrates that three-quarters of Canadians have indicated that they would take a preventive for travellers’ diarrhea. Pharma Bio World
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biotech news Provectus Signs MoU to Commercialise AstraZeneca Posts Positive Results PV-10 in China from the Phase III Study of CAZ-AVI Provectus Biopharmaceuticals, Inc, a development-stage oncology and dermatology biopharmaceutical company, has entered into a Memorandum of Understanding with SinopharmChina State Institute of Pharmaceutical Industry (SinopharmCSIPI), the leader among all pharmaceutical research institutes in China, and Sinopharm A-THINK Pharmaceutical Co, Ltd (Sinopharm A-THINK), the only injectable anti-tumor drug research and development, manufacture and distribution integrated platform within Sinopharm Group. During the next three months, the parties will seek to enter into a definitive licensing contract, subject to additional negotiation, due diligence, and any required regulatory and corporate approvals. The parties will further address the details of the license; the use of the technology from Provectus to Sinopharm A-THINK in China; the process for commercialisation; and payments to Provectus (upfront, milestone and royalties). Provectus intends to manufacture PV-10 in the USA and Sinopharm A-THINK will distribute PV-10 in China. The MOU, which is governed by Chinese law, stems from negotiations led by Network 1 Financial Securities, a financial advisor to Provectus. The parties met at the headquarters of Sinopharm-CSIPI in Shanghai, China. In attendance were the senior management members of Sinopharm Group, as well as senior Provectus personnel. Provectus presented clinical and nonclinical data of its drug, PV-10. The experts and scientists from Sinopharm-CSIPI and Sinopharm A-THINK had an extensive and substantial discussion with the Provectus team. The MOU provides that “the parties agreed that PV-10 is an advanced innovative drug representing the oncology research trend worldwide, which will provide extensive economic and social benefits to the Chinese market.”
AstraZeneca has announced positive top-line results from RECLAIM-1 and RECLAIM-2, the pivotal Phase III studies investigating the potential of the antibiotic ceftazidime-avibactam (CAZ-AVI) as a treatment for hospitalised adult patients with complicated intra-abdominal infections (cIAI). CAZ-AVI consists of a cephalosporin (ceftazidime), an established treatment for serious bacterial infections, and a next generation non-beta lactam beta-lactamase inhibitor (avibactam). CAZ-AVI is being developed to treat a broad range of Gram-negative bacterial infections which are becoming resistant to antibiotics and pose an increasing threat to public health. The addition of avibactam protects ceftazidime from being broken down by betalactamases that are produced by resistant bacteria. The global RECLAIM-1 and RECLAIM-2 Phase III studies both evaluated the safety and efficacy of CAZ-AVI, administered intravenously as a two hour infusion (2000 mg / 500 mg) plus metronidazole, compared to meropenem, administered intravenously as a 30 minute infusion (1 g), in hospitalised adult patients with complicated intra-abdominal infections. Data from the RECLAIM-1 and RECLAIM-2 studies were analysed as a single-pooled dataset with the agreement of the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
NW Bio Bags Approval for Enhancement of Phase III Trial of DCVax-L
Isis Pharmaceuticals, Inc has earned a USD 2 million milestone payment from Biogen Idec related to the advancement of the ongoing open-label extension study of ISIS-SMN in children with spinal muscular atrophy (SMA).
Northwest Biotherapeutics (NW Bio), a biotechnology company developing DCVax personalised immune therapies for solid tumor cancers, has announced that, following a 9-month process of regulatory submissions and reviews by regulators in the US, UK and Germany, it has obtained regulatory approvals to make certain enhancements to its ongoing Phase III clinical trial of DCVax-L Glioblastoma multiforme (GBM) brain cancer. The enhancements will allow the statistical analysis of trial results to take account of a major new variable which has been identified in GBM research since the Company’s Phase III trial began, and will lower the threshold for satisfying the primary endpoint of the trial.
The open-label extension study of ISIS-SMNRx is offered to those children with SMA who have completed dosing in Isis’ previous studies. In this study, children with SMA are receiving a 12 mg dose of ISIS-SMN every six months for the duration of the study.
The Company has been blinded at all times, with no access to any data in the Phase III trial, and will remain fully blinded until the trial is completed. The changes relate to the statistical analyses that will be done at the end of the trial, and do not affect the treatment protocol, dosing, randomisation of patients or other such aspects.
Isis Pharma Gets USD 2 Mn Milestone Payment from Biogen Idec
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biotech news Igenica Biotherapeutics Gets SBIR Grant from NCI Igenica Biotherapeutics, Inc, a company focused on the discovery and development of innovative cancer antibodydrug conjugates (ADCs), has announced the award of a USD 215,740 Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) to support continued development of its SNAP site-specific ADC linker technology. SNAP technology, named for its speed and ease of use, overcomes the major limitations of current approaches by providing a simple, chemically-driven method for linking any anti-cancer antibody and small molecule cytotoxic drug to produce ADC products with optimal and uniform ratios of drug to antibody. “Drug companies are aggressively pursuing ADCs as powerful new anti-cancer medicines comprised of a monoclonal antibody, a linker and a payload,” said Mary Haak-Frendscho, PhD, chief executive officer of Igenica. “SNAP is a transformative, chemically-driven and broadly applicable technology that will accelerate the development of next-generation cancer therapeutics designed to selectively target cancer cells with potent cytotoxic agents. We are using this platform to strengthen our internal product pipeline and also will make it available to select partners.”
3SBio, DiNonA Ink Patent License Deal for Leukotuximab 3SBio Inc, a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, has entered into an exclusive license with DiNonA Inc. for the development, manufacturing and marketing of Leukotuximab, an anti JL-1 antibody for acute leukemia (AL), including acute myelocytic leukemia (AML) and acute lymphoblastic leukemia (ALL), in the territory of Greater China (including Mainland China, Taiwan, Hong Kong and Macau) and the Middle East (excluding Cyprus, Egypt, Israel and Turkey). In addition to an upfront payment, milestone payments will be made after completion of technology transfer, approval of Investigational New Drug (IND) application by the China Food and Drug Administration (CFDA), completions of Phase I to Phase III clinical trials and marketing approval in China. 3SBio will also pay DiNonA a sales-based royalty. Additional terms of the license are not being disclosed. 50 August 2014
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The incidence rate for AML is 1.6 per 100,000 annually; the incidence rate for ALL is 0.4 per 100,000 annually. In China, there are about two to three million existing AL patients. Among them, between 30,000 and 40,000 patients are newly diagnosed each year. Patients are currently treated with traditional chemotherapy and bone marrow transplant, both of which have major side effects.
H U YA B i o s c i e n c e , C Z C B D S i g n Partnership Deal HUYA Bioscience International, a leader in accelerating the global development of China’s pharmaceutical innovations, has announced a strategic partnership with the Changzhou Center for Biotech Development (CZCBD). This partnership will focus on advancing the worldwide potential of innovations from biopharmaceutical companies located in Changzhou that could meet critical global pharmaceutical pipeline needs. HUYA is one of the first companies to have recognised China’s potential to help meet the global need for new preclinical and clinical stage compounds. The company is focused on speeding the development and value creation for China sourced novel biopharmaceutical compounds in world-wide markets. HUYA has established a series of collaborations with leading universities and research institutes throughout China and has pioneered inlicensing of both preclinical and clinical stage compounds from the country. The CZCBD, an institutional unit fully funded and supervised by the Changzhou Science & Technology Bureau, is the first biotechnology development center to operate under local government supervision. It is dedicated to establishing a comprehensive bio-pharmaceutical innovation system and to transforming the output of the more than 800 biotechnology and pharmaceutical companies based within Changzhou. These companies and enterprises represent fields including biopharmaceuticals, chemical drugs, medical devices, equipment and consumables, traditional Chinese medicine, industrial biology, bioagriculture, bioenvironmental protection and bioenergy. This partnership enables HUYA and CZCBD to collaborate on promoting new drug development in China and worldwide. Local biopharmaceutical companies serviced by CZCBD will be able to leverage HUYA’s global biopharmaceutical knowledge and network, and consult with HUYA’s team of experts in drug development and commercialisation. In turn, HUYA will have the right of priority review to evaluate certain research and development projects of local companies supported by CZCBD, providing advice and consultation as needed. Pharma Bio World
22-08-2014 19:22:29
biotech news Cellceutix Closes Enrollment in Phase 2b P arc rit inib R ec eives Fa s t Tr a ck Trial of Brilacidin Designation from FDA Cellceutix Corporation, a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, has announced the completion of enrollment in its Phase 2b trial comparing Brilacidin to daptomycin (Cubicin) in patients with acute bacterial skin and skin structure infections (ABSSSI). Overall, 215 patients were randomised to one of three dosing regimens of Brilacidin (single dose 0.6mg/kg; single-dose 0.8mg/kg; 1.2mg/kg over three days) or seven days of once daily daptomycin. Brilacidin is the lead compound among a novel class of antibiotics known as defensin-mimetics. These compounds have shown great promise in preclinical and early clinical studies as potent antibiotics that can kill Staph aureus, including methicillinresistant Staph aureus (MRSA). Moreover, given the unique mechanism of action, among other attributes, there is low, if any, potential for the development of resistance. Finally, the results of the current study may demonstrate that Brilacidin could be given as a single-dose, which provides benefits for both patients and society.
RedHill Buys Oncology Drug Candidate from RESprotect RedHill Biopharma Ltd and RESprotect GmbH have entered into a binding exclusive option agreement for the acquisition of the oncology drug candidate RP101 and next generation compounds. RP101 is a proprietary, first-in-class, heat shock protein 27 (Hsp27) inhibitor, administered orally, which may prevent the induction of resistance to chemotherapy (chemoresistance), thus maintaining sensitivity of the tumor to chemotherapy and potentially enhancing patient survival. Under the terms of the agreement, RedHill has the option to acquire the worldwide exclusive rights to RP101 for all indications, other than to the pancreatic cancer indication in South Korea. RedHill has agreed to pay RESprotect for a one year option, which may be extended by RedHill under certain agreed terms. During the option period, RedHill may, at its discretion, conduct development activities with RP101. If RedHill elects to exercise the option, it will acquire the exclusive rights to RP101 for a total payment, for both the option and the acquisition of the rights, of USD 100,000, as well as potential milestone payments and tiered royalties on net revenues, ranging from single-digit to mid-teens. Pharma Bio World
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CTI BioPharma Corp has announced that pacritinib has been granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of intermediate and high risk myelofibrosis, including but not limited to patients with disease related thrombocytopenia, patients experiencing treatment emergent thrombocytopenia on other JAK2 therapy or patients who are intolerant to or whose symptoms are suboptimally managed on other JAK2 therapy. Pacritinib is an oral tyrosine kinase inhibitor with dual activity against JAK2 and FLT3. The drug candidate is currently being evaluated in two Phase 3 clinical trials, known as the PERSIST program, for patients with myelofibrosis. “We are very pleased that the pacritinib development program in myelofibrosis has been granted Fast Track designation, and we look forward to continuing to work closely with the FDA on this important drug candidate,” stated James A Bianco, MD, President and CEO. “We believe that pacritinib’s unique profile has the potential to serve an unmet medical need that currently exists in this patient population, particularly for those patients with disease or therapy-related low platelet counts.” The Fast Track process is designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. An unmet need is a condition whose treatment or diagnosis is not addressed adequately by available therapy. The purpose of the Fast Track designation is to make important new drugs available to the patient earlier. The Fast Track program also enables a company to submit sections of the NDA on a rolling basis as data becomes available.
BioRestorative Therapies Seeks Strategic Alliances in Japan and China BioRestorative Therapies, Inc, a life sciences company focused on adult stem cell-based therapies for various personal medical applications, has announced the engagement of Tokyo-based Solution Partners Ltd to develop strategic alliances in Japan and China for the Company’s technologies. The agreement includes introductions to potential strategic partners and other alliance candidates, with the goal of expansion and development of the Company’s ThermoStem programme, the Company’s stem cell delivery device used in connection with the Company’s brtx-DISCTM programme and the Company’s brtx-C Cosmetic programme. August 2014 51
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Atlas Cryo Reactor The Atlas Cryo Reactor offers trouble-free cooling of a range of round bottom flasks ideal for processes such as Grignard, diazotization and aldol reactions, ortho metalations, FriedelCrafts acylations, Michael additions and Birch reductions. Its sophisticated proprietary cooling technology and ‘in reactor’ temperature probe ensure accurate control of temperatures from +10 to ¬-80°C using mains power only; no dry ice, liquid nitrogen or water circulator required. Clip-on adapters and a quick latch mechanism enable the use of 100 or 500 ml flasks that can be exchanged in seconds, with no tools required. Powerful stirring up to 1,200 rpm is provided by the integrated magnetic stirrer; optional auto-aligning overhead stirring up to 800 rpm is also available. In addition, the system can be upgraded to include automated dosing, and pH monitoring and control. The Atlas Cryo Reactor is easy to use as a standalone module or, with other Atlas modules, can be connected to Atlas PC Software for full process automation, graphical display of reaction parameters and data logging of results.
Vision Sensor for Colour Applications Cognex Corporation offers the Checker 4G7C, an easy-to-use colour vision sensor that distinguishes parts by colour. Checker 4G7C delivers 376 x 240 inspection resolution with Ethernet support for industrial protocols and high-intensity white LED illumination for the detection and inspection of parts and features at up to 800 parts per minute. As part of the Checker 4G Series product line, Checker 4G7C includes the patented Checker internal trigger technology which provides several key advantages: does not require additional sensors to determine if a part is present; detects parts by locating a feature on a part, not just an edge; and tracks parts along the production line without requiring precise part handling. In addition to the new ability to inspect parts for colour, the Checker 4G7C provides the industry-leading features that the product line is known for including flexible optics, ease of setup, ability to add unlimited sensor tools to a job and intelligent pass/fail logic based outputs.
For more information, please contact:
For more information, please contact:
Syrris Ltd 27 Jarman Way, Royston Herts SG8 5HW, U.K. Tel: +44 (0) 1763 242 555 E-mail: info@syrris.com
Cognex Sensors India Pvt Ltd Regus Level 6 Pentagon Towers P2, Magarphatta City Hadapsar, Pune, Maharashtra 411 028 Tel: 020-40147840 | Fax: 91-020-66280011 E-mail: info.in@cognex.com
Strip Packaging Solutions The united expertise of the Kilian, Siebler and Promatic brands makes it possible: Romaco offer integrated solutions for manufacturing and packing tablets and effervescents for the pharma industry. The versatile Kilian KTP 420X high speed tablet press is ideal for the production of mono-layer, bi-layer or core tablets (tabin-tab), and it can also be used to compress poorly flowing materials. High availability, strict hygienic compliance and very simple handling are the hallmarks of the newest machine generation. The final tablets are fed to the sealing station of the Siebler HM 1-230 in up to sixteen lanes either via a direct connection to the heat-sealing machine or via a buffer bin. The servo-controlled separation of the tablets guarantees high feed rates and precise product positioning in the strip packs. The HM 1-230 ensures premium sealing quality by adapting the specimen seals to the characteristics of each individual product. The blend of Kilian and Siebler technologies means fewer start-up processes on the tablet press and reduces tablet waste and wearing parts to a minimum. For more information, please contact: Romaco Group Am Heegwald 11 76227 Karlsruhe, Germany Tel: +49 (0) 721 48040 | Fax: +49 (0) 721 4804 225 E-mail: susanne.silva@romaco.com
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Fluent Laboratory Automation Solutions Tecan offers the Fluent laboratory automation solution. Fluent is designed to offer end-to-end automation of cellbased and biochemical assay protocols, providing exceptional simplicity, productivity and confidence for the automation of experiments. Fluent provides high precision, superior throughput and extended walkaway time. Completely new from the ground up, it is available in three sizes – offering deck capacities from 30 to 72 microplates – to suit the throughput requirements of almost any laboratory. It simplifies cell-based workflows by allowing flexible integration of all the complementary devices required – including incubators, washers and readers – into a single, fully automated system. Even complex assays can be automated using the platform’s intuitive FluentControl software and built-in touchscreen interface, freeing researchers to focus on what really matters.
Standardised Water Pump KSB Pumps Ltd offers Etanorm Series pumps, which comprises of 43 pump sizes driven by either 2-pole or 4-pole motors. The selection chart has been extended by additional pump size, so those sizes can be selected even closer to the best efficiency point.In intensive work with CFD (computational fluid dynamics) for flow simulation KSB’s engineers have optimised the hydraulic contours. Thanks to the efficient hydraulic system the pump sets already meet the EU requirements (ErP) of Commission Regulation 547/2012/ EC for water pumps, which will come into force in 2015. The engineers placed a particular focus on an excellent suction behaviour and a low NPSH value, thus minimising the risk of cavitation and obtaining a smooth and stable pump operation. Confined casing gaskets ensure reliable sealing between pump casing and casing cover even in highly varying operating conditions. The finite element method (FEM), a calculation method for solids simulation, was employed to improve the rigidity of the pump sets.
For more information, please contact:
For more information, please contact:
Tecan Trading AG Seestrasse 103, CH-8708 Männedorf. Switzerland Tel +41 (0)44 922 81 11 Fax +41 (0)44 922 81 12 E-mail: info@tecan.com
KSB Pumps Limited Mumbai-Pune Road, Pimpri Pune, Maharashtra 411 018 Tel: 020-2710 1241 E mail: bipin.kode@ksb.com
Oil Lubricated Vacuum Pumps Toshniwal’s oil lubricated vacuum pumps of the TMS Series are single stage oil lubricated rotary vane vacuum pumps with oil re-circulation system. Pumping capacity range from 15 m 3/hr, 35 m 3/hr, 65 m 3/hr and 100 m 3/hr. Their TMS Series pumps has economical features, which matches together to achieve high pumping speed over the range of absolute pressure of 1,000 mbar to 0.5 mbar; high water vapour tolerance and low noise level; air cooled; no pollution; and built-in anti-suck back system. Designed for continuous operation at high intake pressure, the pump is used in various applications like pick and place, packaging, degassing, low boil distillation, solvent recovery, heat treatment, bottle filling, vacuum drying, etc. Toshniwal also provide special B Series oil lubricated pump for high pressure (rough vacuum) application upon request. For more information, please contact: Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road Chennai 600 010 Tel: 044-26448983, 26448558 E-mail: sales@toshniwal.net
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Photostability Chamber Mack Pharmatech Pvt Ltd offers photostability chamber in temperature range 20 to 50 oC with accuracy of ±0.2°C and uniformity ±1.0°C. Features PLC-based control system; 21 CFR software; test samples on fluorescent light or UV lights separately as well as simultaneously; lights automatically shut-off after a specified exposure level or time duration; HMI (touch screen display); standby refrigeration system; GSM technology; hooter system; full view glass door; bullet feet leveling legs; etc. For more information, please contact: Mack Pharmatech Pvt Ltd B-48, Malegaon MIDC, Sinnar Dist: Nashik, Maharashtra 422 113 Telefax: 91-02551-230877 E-mail: sales@mackpharmatech.com
Metering and Peristaltic Pumps Neptune offers its Series 7000 mechanically actuated diaphragm metering pumps specifically designed with water and wastewater applications in mind. The Series 7000 eliminates the use of contour plates on the liquid side of the diaphragm while the simple, straightthrough valve and head design allows for improved flow characteristics. The Series 7000 is self-priming, provides superior performance, and has a max capacity range up to 300 gph (1,135 L/h) at 150 psi. For more information, please contact: Dover India Pvt Ltd – PSG 40 Poonamallee By-pass Senneerkuppam, Chennai 600 056 Tel: 044-26271020, 25271023 E-mail: sales.psgindia@psgdover.com
SureSelect Clinical Research Exome Agilent Technologies Inc offers SureSelect Clinical Research Exome. SureSelect Human All Exon V5 was used as the core for the new design. The disease-relevant regions consist of gene targets including targets identified in OMIM, HGMD and NCBI’s ClinVar databases. Additional ancestry- and identity-informative content has also been. Custom content can be added using SureDesign, a free online design tool for SureSelect. The Clinical Research Exome targets approx 54 Mb of content and is optimized for coverage uniformity, enabling proportional performance improvement as sequencing allocation per library is increased. The SureSelect Clinical Research Exome can be paired with existing SureSelect kits to provide significantly reduced hybridization times and provide sequencing-ready libraries in just one day. Agilent’s SureSelect portfolio is the industry’s leading target-enrichment solution. SureSelect enables a solution for researchers to quickly and easily analyze specific regions of the genome, transcriptome and methylome. SureSelect is supported by SureDesign software that enables custom capability; Bravo automation platforms that enable reproducibility and high-throughput sample processing; 2100 Bioanalyzer and 2200 TapeStation for library QC; and SureCall software that enable streamlined analysis of genomic regions of interest from alignment to variant calling. For more information, please contact: Agilent Technologies Inc 5301 Stevens Creek Blvd Santa Clara, CA 95051, U.S.A. Tel: +1 408 553 7093 E-mail: susan_berg1@agilent.com
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Halogen Moisture Analyzer The HE53 entry-level halogen moisture analyzer encompasses Mettler Toledo’s tradition for Swiss quality in a no-frills, easy-to-use instrument making moisture analysis accessible to all. As a critical part of many quality control procedures, particularly in tod industry, HE53 halogen moisture analyzer provides reliable moisture results in just a few minutes, giving companies max control over their manufacturing processes and optimum product quality. The HE53 has been designed for simplicity to make it easy for even untrained operators to use.
BOD Incubator Mack Pharmatech Pvt Ltd of district Nashik, Maharashtra now offers BOD incubator in temperature range 10 to 60 o C with accuracy of ±0.2°C and uniformity ±1.0°C. Features Programmable Logic Controller-based control system; 21 CFR software; HMI (touch screen display); standby refrigeration system; GSM technology; hooter system; full view glass door; bullet feet leveling legs; tray spacing every ½“ adjustable. etc.
For more information, please contact:
For more information, please contact:
Mettler-Toledo India Pvt Ltd Amar Hill Saki Vihar Road, Powai Mumbai 400 072 Tel: 022-4291 0111 Extn: 256/115
Mack Pharmatech Pvt Ltd B-48, Malegaon MIDC, Sinnar Dist: Nashik, Maharashtra 422 113 Telefax: 91-02551-230877 E-mail: sales@mackpharmatech.com
Temperature and Humidity Transmitter Model-KM-THS-03/04/33/34 from Kusam-Meco is a compact and robust temperature and humidity signal transmitter for applications in monitoring for HVAC process/air conditioning/ environmental ventilation control and environmental monitoring for building/factory/clean room/lab and for storeroom/crisper/agriculture/food industry. Other important applications are for use in hospital/pharma industry/textile industry. It has high-tech sensor with high accuracy and long-term stability. It has LCD display with backlight, double line character and 3-wire loop connection of signal. The input humidity range is 0-100% and a wide temperature range from -40ºC~60ºC and output range is 4-20 mA. It is used in installation for indoor/duct-mounting/remote type with flange. It also has zero and span adjustment for output. The power supply used for this instrument is 24 V DC. It also has protection degree IP 65 (sensor: IP 20). For more information, please contact: Kusam Electrical Industries Ltd G-17 Bharat Indl Estate T J Road, Sewree (W),Mumbai 400 015 Tel: 022-24156638, 24124540, 24181649, 27750662 | Fax: 91-022-24149659, 27751612 E-mail: kusam_meco@vsnl.net / sales@kusam-meco.co.in
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events diary
Pharmac India 2014
PharmaLytica 2014
Date: 11th -13 th September 2014
Date: 25 th -27 th September 2014
Venue: Mahatma Mandir Exhibition Centre, Gandhinagar, Gujarat
Venue: BIEC, Bengaluru, India
Pharmac India is 5 th International Pharma Machinery, Equipment, Bulk Drugs, API, Pharma Lab, Pharma Pack & Material Exhibition in India. It has successfully brought together manufacturers and buyers on a common platform and contributed substantially towards the growth of the industry. Pharmac India 2014 is jointly organised by Orbit Exhibitions Pvt Ltd & Indian Drug Manufacturers’ Association(IDMA-GSB).
PharmaLytica is the combination of a trade fair and conference where participants can pick up on the latest industry trends, techniques and methods. It is a platform connecting the pharmaceutical community with outsourcing solution providers, including clinical trials, contract research, custom manufacturing, biotech, IT and analytical services.
Contact:
Rahul Deshpande Sr Manager - Projects Email: rahul.deshpande@ubm.com Tel: +91 22 61727165 | Mobile: +91 98209 02476
Ramesh Vartak 303, 3 rd Floor, Raindrops Building Opp. Yes bank CG Road Ahmedabad - 380009, Gujarat Mobile: +91 93216 53011 Email: ramesh.v@orbitexhibitions.com
Frost & Sullivan’s 6 th Annual India Healthcare Excellence Awards 2014 Date: 19 th September 2014 Venue: Taj Lands End, Mumbai Frost & Sullivan’s Annual India Healthcare Excellence Awards programme recognises companies for their superior planning, leadership, strategy, growth, innovation, integration, marketing, and financial performance. The award categories span across various healthcare segments such as Pharmaceuticals and Biotechnology, Medical Technologies, Healthcare Delivery Services and Special Awards. Contact: Akshata Mahtre, Ranjani Shanker Tel: +91-22-66072029 Mobile: +91-9884872658 Email: akshatam@frost.com; ranjanis@frost.com 56 August 2014
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Contact:
BioPharma India Convention Date: 18 th -19 th November 2014 Venue: Hyatt Regency, Mumbai BioPharma India Convention is a perfect platform for pharma and medical professionals to understand the biopharmaceutical sector in depth. The conference will highlight the new opportunities available in Indian biopharmaceutical sector. The conference is scheduled at the Grand Hyatt, Mumbai. Topics of the conference will be drug discovery and clinical trails to manufacturing. Professionals will get an opportunity to meet more than 80 speakers, 800 decision makers and 500 products. Be a part of this conference to know the latest developments in pharmaceutical sector and build business rapport with associates. Contact: Rebecca Koh Terrapinn Pte Ltd, 1 Harbourfront Place #18-01 Harbourfront Tower 1, Singapore 098633 Tel: +65 6322 2725 | Fax: +65 6271 2035 Email: rebecca.koh@terrapinn.com Pharma Bio World
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bookshelf Pharmaceutical Outsourcing: Discovery and Preclinical Services (Hardcover) Authors: Marguerita Lim-Wilby (Editor), William C (Jr) Stevens (Editor) Price: USD 69 No of Pages: 276 pages About the Book: This book is the first in a series on pharmaceutical outsourcing. The purpose envisioned by the authors and editors is to provide an understanding of how outsourcing works from the perspective of sponsor, internal customer, service provider, outsourcing service marketplace, principal investigator, project leader, and consultant. The authors of this book and the companies they represent hail from the Americas, Europe, Asia, and Australia, underscoring the fact that drug discovery is an international effort. The scope of the businesses covered include the one-person consulting company through to a sponsor among the largest in the industry. Written in the styles unique to each author, the reader will enjoy getting into the minds of the writer.
Outsourcing Clinical Development: Strategies for Working with CROs and Other Partners (Hardcover) Authors: Jane E Winter (Editor), Jane Baguley (Editor) Price: USD 190 No of Pages: 170 pages About the Book: The challenges facing large pharmaceutical companies are stark: sales are slowing and research and development costs are rising. There’s an overwhelming need to reduce development costs by as much as 30-40 per cent, whilst at the same time significantly shortening development cycle times. Pharmaceutical spend on outsourcing faces double-digit growth for the next three to five years and yet, if outsourcing is to meet these challenges, new models of collaborative and cooperative working are needed now. “Outsourcing Clinical Development” offers a guide to these new models and to future clinical outsourcing strategy.
Outsourcing Biopharma R&D to India (Hardcover) Author: P R Chowdhury Price: USD 204.25 No of Pages: 130 pages About the Book: Over the last decade, worldwide pharmaceutical and biotechnology companies have made India their choice for a research destination. Initially R&D was inclined more towards developing products for the Indian market within the country. This led to several multinational companies opening up production plants in India, primarily due to the globalisation of the Indian economy and offshoring jobs to India. Alongside, several global pharma-biotech majors ascertained large market requirements within the country and capitalised on the advantage of serving Indian customers. Strategies were devised to optimise operational expenses with the setting up of on-site R&D to develop products for local requirements. In view of this, this book seeks to explore various nuances of the outsourcing sector with respect to biopharma in India.
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ad index Sr. No
Page No
1
Aimil Ltd
2
B & R Automation
3
Boge Compressors (India) Pvt Ltd
9
4
Busch Vacuum India Pvt Ltd
5
5
Chemtech World Expo 2015
Inside Cover I
6
Citizen Industries
19
7
Gardner Denver Engineered Products India Pvt Ltd
10
8
Kimberly-Clark Hygiene Products Pvt Ltd
13
9
Mist Resonance Engg Pvt Ltd
23
10
NNE Pharmplan (India) Pvt Ltd
17
11
Pharma World Expo 2015
Inside Cover
12
Praj HiPurity Systems Ltd
Back Cover
13
SalesWorth Synergies Pvt Ltd
11
14
Warade PackTech Pvt Ltd
7
15
WaterEX World Expo 2015
Inside Cover II
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Client’s Name
21 Front Cover
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R.N.I. No.: MAHENG/2002/08502. Date of Publication: 26th of every month. Postal Registration No: MH/MR/SOUTH-284/2014-16 Posted at Patrika Channel Sorting Office, Mumbai 400001, on 26th & 27th of every month. Total Pages:- 60