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  1. 1. Biogenerics Follow-on-biologics Biobetters Biosuperiors Early Bird discounts! Book before Friday 17 June 2011 to save INR 5,000/ US$ 100 2nd Annual I N D I A 2 0 1 1 Navigating regulatory and R&D challenges and adopting the latest innovations to drive the successful commercialisation of Indian biosimilarsTwo-Day Strategic Conference: 14-15 July 2011 Holiday Inn Mumbai International Airport, Mumbai, India HEar outstanding prEsEntations from: rEal-lifE casE studiEs on: KK Tripathi, Adviser, Scientist ‘G’ and Member Secretary RCGM 4Regulatory Developments – understand the impact of local and department of Biotechnology international regulatory guidelines and the implications for your Brij Patel, Deputy Manager, Biologicals and Biotechnology Unit biosimilars strategy medicines and Healthcare products regulatory agency 4R&D and Process Development – gain in-depth guidance on (mHra) tackling complex R&D challenges to ensure the quality and safety of your biosimilars Roger L Williams, Chief Executive Officer, us pharmacopoeia 4Commercialisation – evaluate different partnership models and KV Subramaniam, President and Chief Executive Officer outsourcing strategies to drive the early profitability of your reliance life sciences biosimilars business Ganesh Kumraj, President Operations 4Innovations – benefit from a showcase of the latest emerging Bharat serums and Vaccines technologies to reduce the timeframe and cost of your biosimilar product development Cyrus Karkaria, President Biotech Division lupin pharmaceuticals Dhananjay Patankar, Vice President Biologics syngene international WHo sHould attEnd? Smita Singhania, Vice President and Head, Regulatory Affairs This conference has been designed specifically for VPs, Directors, mabpharm GMs and Heads of: Biologics, Biotechnology, R&D, Process Development, Formulations, Analysis and Testing, Regulation, and Rustom Mody, Chief Scientific Officer, intas Biopharmaceuticals Product Development from: Matthias Jöhnck , Head of Merck Millipore Chromatography Research and Development, merck, darmstadt • Biopharma Manufacturers • Equipment Suppliers • Biotechnology Manufacturers • Ingredient and Material Suppliers Anil Kukreja, Director Medical Affairs, roche products, india • Generic Pharma Manufacturers • Analytical Laboratories • Innovator Pharma Manufacturers • CRAMS Mahua Ganguly, Head Medical Affairs, Biogen idec, india Plus many more… Gold Partner Silver Partner In Association With Media Partners Organised By To register - Tel: +91 (022) 4046 1466 Fax: +91 (022) 4046 1477 Email:
  2. 2. ConfeRenCe Day one – ThuRsdAy 14 july 201108:30 Registration and refreshments 13:30 Lunch and networking09:00 Opening remarks from the Chair 14:30 Regulation in practice: Navigating stringent European regulations to successfully launch biosimilar drugs in EU markets09:15 Evaluating the potential role of India as a global leader in the • Determining the key challenges met in gaining biosimilar regulatory biosimilar market to leverage the opportunities available globally approval in Europe and devising strategies to surmount these Case study • Identifying the key drivers for the development of biosimilars and • Clarifying the location criteria for undertaking clinical trials Keynote address establishing India’s share of the market • Evaluating the level and type of data required to meet requirements • Determining India’s core strengths in biosimilars to underpin • Overcoming the documentation complexities encountered when the growth strategy seeking European approval • Overcoming the impediments and obstacles hampering the growth of • Summarising the lessons learnt to facilitate smooth approval for biosimilars in India Indian companies • Analysing the key action plan necessary to fast-track the Ganesh Kumraj, President Operations development of the Indian biosimilars market Bharat Serums and Vaccines KV Subramaniam, President and Chief Executive Officer Reliance Life Sciences 15:10 Clarifying the regulations specific to safety and efficacy for biosimilar product development and identifying how these are Market Overview evolving with international standards • Examining the scope of the evolving safety regulations and the09:45 Establishing the current size of the biosimilars market in India implications for biosimilar development in India and forecasting opportunities for the longer term • Evaluating the potential of new processes and technologies in aiding • Understanding the current size and potential of biosimilars in India biosimilar safety compliance and in regulated and semi-regulated markets • Identifying areas for improvement within pre-clinical and clinical • Evaluating the number of patents due to expire within the next trials to drive safety and efficacy five years and determining the optimal time to capitalise on these • Mapping out the latest safety guidelines for clinical trials opportunities when undertaken outside India • Comparing the Indian biosimilar market with global trends Smita Singhania, Vice President and Head, Regulatory Affairs and predicting the next steps and new opportunities MabPharm • Examining how therapeutic areas are evolving to identify new uses and opportunities for biosimilars 15:50 Afternoon refreshments and networking • Formulating a roadmap for success for the Indian biosimilars market to minimise costs and maximise return on investment Market Opportunities KV Anantharaman, Principal Analyst, Healthcare Research & Analysis 16:20 Maximising the potential of strategic partnerships to enter the Datamonitor biosimilar market • Identifying the need for strategic partnerships in the biosimilars space10:25 Morning refreshments and networking to access markets and minimise the cost and risk involved • Examining deals currently in place in the biosimilars market to11:00 Exploring the “dos and don’ts” of a biosimilar strategy – understand the scope and commercial potential of partnerships and examining the different real-life business models being used to the specific roles and responsibilities of partners • Determining the appropriate partnership model to adopt – exploring devise a roadmap for biosimilar success opportunities with research institutes, CROs and domestic and • Investigating how companies can successfully manufacture and international pharmaceutical companies commercialise biosimilars and remain in the market for the long-term • Establishing the key criteria for selecting a potential partner to drive • Evaluating the pros and cons of manufacturing biosimilar drugs for the progress in biosimilar product development Panel discussion short-term and then implementing an exit strategy at the right price • Aligning objectives to ensure a win-win scenario for all stakeholders • Applying lessons learnt from successes and failures in real-life Rahul Padhye, Head of Corporate Development scenarios to maximise the business potential of biosimilars Reliance Life Sciences • Identifying practical steps to strengthen the biosimilar market and formulate a robust strategy for future development 17:00 Investigating the latest trends in design and integrated concepts KV Subramaniam, President and Chief Executive Officer to ensure a cost-effective and efficient manufacturing process Reliance Life Sciences for biosimilars Cyrus Karkaria, President Biotech Division • Understanding the latest regulatory developments devised to drive Lupin Pharmaceuticals modernisation of the manufacturing facility Dhananjay Patankar, Vice President Biologics • Adopting the most up-to-date technology and equipment to Syngene International streamline the process and increase productivity and efficiency Hareesh Parandhaman, Assistant Director Business Development • Upgrading facilities and implementing emerging single-use Lupin Pharmaceuticals techniques to enhance the production process and minimise costs MS Mahadevan, Director, Strategic Marketing, Process Solutions Regulatory landscape Business Unit, Merck Millipore12:30 Defining the current regulatory position on biosimilars in India 17:40 Roundtable discussions: During this session the group will split into to gain swift and smooth entry into the biopharmaceutical market a number of smaller discussion groups, each focused on a specific • Evaluating the regulatory structure and key bodies in place in India to theme arising from the day’s presentations, and led by one of the support the development of the biosimilar industry speakers of the day. This is the perfect opportunity for delegates to • Determining how the regulatory framework is evolving to ensure bring their live challenges to the table, and benefit from the combined greater support and stimulation of the Indian biosimilar industry experiences and know-how of the roundtable leaders as well as fellow • Assessing the government incentives and initiatives currently in place delegates. Come armed with your most challenging questions and and planned, around Indian biosimilars leave with a toolkit of practical implementable solutions. • Clarifying the regulatory requirements around clinical trials, comparative analysis and documentation within India and when 18:30 Close of Conference Day One exporting to international markets • Establishing the regulatory perspective on the future direction of the Indian biosimilars market KK Tripathi, Adviser, Scientist ‘G’ and Member Secretary RCGM Department of Biotechnology WHat dElEgatEs at Biosimilars india 2010 Had to say: “13:00 Understanding the US Pharmacopoeia perspective on The conference was useful in providing knowledge on ” international regulatory models to predict and prepare for the impact on the Indian market regulatory guidelines and process development • Examining the role of US Pharmacopeia and the regulatory Mannan Khambati, Senior Manager, Bharat Serums and Vaccines framework around biosimilars • Applying learnings, experiences and data requirements from the “ European model to the Indian market Perfect blend of the topics based in biosimilars. All the speakers ” • Determining the probable shape of the regulatory guidelines for biosimilars in the US when they are finalised were well educated and experienced on the respective topics • Identifying and transferring key international findings from the Anita Ghagare, Senior Manager, Unichem Laboratories evolving biosimilars regulatory landscape to drive progress and growth in India Video presentation: Roger L Williams, Chief Executive Officer US PharmacopoeiaTo register - Tel: +91 (022) 4046 1466 Fax: +91 (022) 4046 1477 Email:
  3. 3. ConfeRenCe Day Two – FRIdAy 15 july 201108:30 Registration and refreshments 15:20 Showcasing emerging technologies in chromatography resin to increase the performance of different purification processes for09:00 Opening remarks from the Chair biomolecules • Evaluating traditional downstream processing technologies for Commercialisation in Practice active pharmaceutical ingredients • Understanding the latest developments in chromatography resin for09:10 Benchmarking Indian biosimilar product development against effective purification of monoclonal antibodies and recombinant proteins international companies to formulate a strategy for effective • Understanding the influence of resin surface modification technologies for commercialisation and global business success downstream processes • Comparing the quality and rate of product development to identify areas • Identifying the new bead strategies to increase the performance in for improvement and to focus expertise and investment different purification tasks • Streamlining processes and procedures to increase productivity and • Overcoming challenges in these technologies and applying lessons learnt reduce costs Matthias Jöhnck, Head of Merck Millipore, Chromatography Research • Adopting the latest advancements in technology and techniques to drive and Development, Merck, Darmstadt product development and take biosimilars to the next level • Identifying the USP and exploiting this to gain market acceptance and 16:00 Examining the successful development of biosimilars for specific achieve a competitive advantage in a highly populated market therapeutic areas • Devising a robust marketing strategy to access markets and successfully commercialise products (a) Oncology – Navigating the regulatory requirements Partha Ghosh, Director, Service Lead, Early Stage Development Europe, and guidelines for clinical trials to develop effective Parexel Consulting biosimilar drugs for oncology • Understanding the relevant regulatory requirements to be met09:50 Evaluating the future market potential of biobetters in comparison • Evaluating the different types of comparability studies to be to biosimilars to establish and capitalise on the opportunities in the undertaken to meet the innovator product characteristics long-term • Determining the key criteria for clinical trials to establish the • Defining biobetters within the pharmaceutical market and how they are safety of the product evolving to understand their full market size and potential • Assessing the challenges of matching biosimilars to the • Clarifying the latest regulatory guidelines around biobetters innovator product in terms of quality and characterisationPanel discussion • Determining the impact of biopharmaceutical patent expiry on both • Identifying transferable learnings and conclusions to apply to the Case studies biobetters and biosimilars Indian market • Examining the commercial potential for biobetters and biosimilars within Anil Kukreja, Director Medical Affairs, Roche Products, India the key biopharmaceutical areas of monoclonal antibodies, vaccines, glycoproteins, blood factors and insulin (b) Neurology – Understanding the specific requirements • Ascertaining the extent to which biobetters or biosimilars could be the for the development of biologics and biosimilars model for the future within the biopharmaceutical industry and product improvement techniques in the field of Brij Patel, Deputy Manager, Biologicals and Biotechnology Unit neurology Medicines and Healthcare products Regulatory Agency (MHRA) • Determining the regulatory guidelines that must be adhered to MK Sahib, Director Genomics and Biotechnology, Wockhardt • Undertaking the necessary trials and tests to successfully Rustom Mody, Chief Scientific Officer, Intas Biopharmaceuticals achieve the characterisation of the biosimilar • Transforming the manufacturing process through the latest10:30 Morning refreshments and networking equipment and facilities • Developing the most appropriate and effective marketing R&d Challenges strategies to successfully launch the product • Identifying techniques and learnings that can be applied to11:00 Overcoming the complexities involved in the cell biosimilar development for neurology in India development process to increase the overall yield Mahua Ganguly, Head Medical Affairs, Biogen Idec, India • Effectively identifying impurities and developing measures to minimise and suppress viruses within cells 16:40 Closing remarks from the Chair • Evaluating the various methods and technologies available to increase the yield of the cell line 17:00 Close of Conference Day Two • Establishing robust techniques to tackle stability issues in biosimilars • Redesigning the glycosylation process to make it more effective and efficient Laxmi S Rao, General Manager, Biotechnology Research Labs, USV11:40 Developing comparability packages to meet the global standard Gold Partner requirements for approvals of biologics Thermo Scientific Cell Culture and • Understanding the guidelines available to support the comparability of BioProcessing products deliver biological products proven solutions to support upstream • Determining the data expectations surrounding non-clinical and clinical and downstream applications. Our products portfolio and services are specifically studies to establish comparability designed to lend proven performance, improve your process efficiency, add flexibility • Developing strategies to address the challenges faced during the and fast track product development. We are your reliable partner from early stage development of comparability packages • Assessing the role of Quality by Design (QbD) in comparability development to commercial production. From a single source, you can optimize establishment studies production using our metabolic pathway design approach and augmented reality with Mahesh Bhalgat, Vice President, Biological E Single Use Solutions across your entire work flow. With a wealth of experience and knowledge behind every Thermo Scientific product, you are ensured that your Bio-12:20 Lunch and networking production process performs at its best.13:30 Developing robust approaches to the effective characterisation of Silver Partner biosimilars at all stages of product development GE Healthcare Life Sciences • Identifying different criteria which characterise a biosimilar product provides tools for drug discovery, • Incorporating measures around physical, chemical and biological properties into biosimilar comparability studies to effectively appraise similarity biopharmaceutical manufacturing and • Assessing the protein purity at all stages of development to identify and cellular technologies, so research remove any impurities cultivated during the process scientists and specialists around the • Addressing the factors influencing immunogenicity to improve world can be more productive, effective development of the biosimilar drug and creative. Our vision is to be the start-to-finish bioprocessing solution provider, the • Ensuring that the same safety and efficacy levels are achieved with the partner of choice in cell and protein research, and the leader in life sciences services. biosimilar as the innovator drug to meet international quality standards Building on our broad expertise across life sciences, we are firmly committed to Rustom Mody, Chief Scientific Officer, Intas Biopharmaceuticals help researchers understand life at a molecular level and develop solutions that can Innovations in Biosimilars prevent, diagnose, treat, and cure disease. With our “healthymagination” initiative, we invite the world to join us on our journey as we continue to drive innovation focused on14:10 Establishing the latest innovations in drug delivery systems for reducing costs, increasing access, and improving quality and efficiency in healthcare biosimilars to enhance the ultimate efficacy of the product • Outlining the regulatory guidelines for drug delivery systems such as injectables, oral and patches • Establishing the criteria for clinical trials and documentation required for these various delivery systems Promote your Business • Exploring the different platforms available for biosimilar drug delivery and the latest developments to maximise their potential in improving the Sponsoring or exhibiting at Biosimilars India 2011 is Exhibition Floor Plan product an excellent way to promote your business to a highly • Evaluating the specific challenges associated with the different platforms and targeted group of key decision-makers with a specific Coffee & leveraging the latest innovations to overcome these interest in CRaMS, analytical labs, ingredients and Lunch point Vinod Kuberkar, Head Contract Services materials. we have a range of business development Intas Biopharmaceuticals and marketing and sales solutions that will be tailored14:50 Afternoon refreshments and networking to specifically deliver on your business objectives. To find out more about how you can make the most of your participation at this event, contact Cherwyn Martins sales Manager, on +91 (022) 6612 2692 +91 98339 98003 or email ©2011. UBM India Pvt. Ltd. This programme may change due to unforeseen circumstances. UBM India Pvt. Ltd. reserves the right to alter the venue and/or speakers.
  4. 4. Biogenerics Follow-on-biologics Biobetters Biosuperiors 2nd Annual I N D I A 2 0 1 1 Navigating regulatory and R&D challenges and adopting the latest innovations to drive the successful commercialisation of Indian biosimilars Two-Day Strategic Conference: 14-15 July 2011 Holiday Inn Mumbai International Airport, Mumbai, India Dear Colleague, CPhI Conferences is delighted to bring you its 2nd Annual Biosimilars India 2011, an essential two-day conference. With the Indian biosimilar market expected to grow to US$ 580 million by 2012, and new uses for biosimilars in new therapeutic areas being developed daily, now is the time to take action and strategically position your company to capitalise on the host of opportunities available. But are you fully prepared to meet the unclear local and international regulatory requirements and cumbersome multiple clearances surrounding biosimilars? Do you feel hindered by a lack of access to capital, demanding R&D challenges and expensive manufacturing processes? Are you equipped to devise a robust strategy for successful commercialisation of your biosimilar products? Attend Biosimilars India 2011 to gather implementable solutions and practical guidance to tackle all of these challenges and more. Building on the success of our 2010 event, we bring you a revised and refreshed agenda that deep-dives into the most timely regulatory, R&D and commercial challenges facing the Indian biosimilars industry today. Biosimilars India 2011 has been thoroughly researched with representatives from the local and international pharmaceutical market to bring you two intensive days of practical insights, analyses, benchmarking and facilitated networking. Just some of the highlights of this year’s programme include opportunity to: • Hear the Department of Biotechnology and US Pharmacopoeia define the current regulatory position on biosimilars in India and determine the implications of international regulations for the Indian market • Join Reliance Life Sciences as they evaluate the potential role of India as a global leader in the biosimilar market • Learn from Datamonitor the current size of the biosimilars market in India and forecast the growth opportunities • Benefit from a panel of experts including Lupin Pharmaceuticals, Syngene International and Reliance Life Sciences exploring the “dos and don’ts” of a biosimilar strategy to ensure commercial success • Investigate the latest innovations in biosimilars with Merck Millipore and Merck Darmstadt to identify opportunities to streamline processes and reduce the costs of product development • Hear from Intas Biopharmaceuticals on how to develop robust approaches to the effective characterisation of biosimilars at all stages of product development • Examine the successful development of biosimilars in practice through in-depth case study examples of their therapeutic applications with Roche Products India and Biogen Idec India Additional speakers from MabPharm, Bharat Serums and Vaccines, Wockhardt, USV, Biological E and Parexel Consulting will also be sharing their unique experiences, unrivalled expertise and technical know-how with you. Now is the time to take a step back and contemplate your biosimilar strategy. Take the reigns, ensure your place at this high-level forum and position yourself at the cutting-edge of the latest trends and opportunities in the biosimilar market. We look forward to welcoming you at what is sure to be a solution-packed two days. Yours sincerely, Oby George Programme Manager CPhI Conferences P.S. The enclosed brochure contains the full list of in-depth topics and outstanding speaker line-up. To secure your place at a discounted price, please visit, email, call us on +91 (022) 4046 1466, or complete and return to us the booking form in the conference brochure.7 Great Reasons to AttendRegulatory guidance – hear the latest regulatory developments around biosimilars and gain in-depth insights from key regulators, including DBT and US Pharmacopoeia andtheir plans to support the biosimilar industryRevised and refreshed agenda for 2011 – based on extensive research with past delegates and key representatives from the biopharmaceutical industry, the 2011 agendawill tackle all of your most current challengesReal-life case studies – benefit from practical insights from the leading practitioners such as Intas, Reliance Life Sciences, Merck and many othersImplementable technical solutions – tackle your most complex and expensive R&D challenges and streamline your manufacturing processesCommercialisation strategies – learn from the experts how to enter new markets, how long to remain in the biosimilar market and how to formulate a strategy to achievecommercial viability and business successExtended networking – take advantage of a host of facilitated networking opportunities specifically designed to drive new business opportunitiesFrequent Q&A sessions – put your most pressing concerns and queries to the experts and get your business-critical questions answered
  5. 5. 2nd Annual Ways to Register Online: Tel +91 (022) 4046 1466 Fax +91 (022) 4046 1477 I N D I A 2 0 1 1 Email Two-Day Strategic Conference Post Conference Department, 14-15 July 2011 UBM India Pvt Ltd, Sagar Tech Plaza A, 615-617, Holiday Inn Mumbai International Airport 6th Floor, Andheri Kurla Road, Saki Naka Junction, Mumbai Andheri East, Mumbai, 400072, India India Indian Delegate @ INR 35,000 + 10.3% Service Tax = INR 38,605 Book and pay before Friday 17 June 2011 International Delegate US$ 1,295 + 10.3% Service Tax = US$ 1,428.39 Indian Delegate @ INR 40,000 + 10.3% Service Tax = INR 44,120 Standard Price International Delegate US$ 1,395 + 10.3% Service Tax = US$ 1,538.69 Title: First Name: Surname: Company Name: Job Title: Department: Address: Tel: Fax: Email: By providing your email address you consent to being contacted by email for direct marketing purposes by UBM India Pvt. Ltd. *I have read and agree with the terms and conditions. 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