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5th Biosimilars Congregation 2014
The 5th Biosimilars Congregation 2014, held on September 10th in Mumbai, focused on the challenges and growth potential of the biosimilars market in India, amidst a backdrop of economic turbulence and regulatory obstacles. Key industry leaders discussed commercialization strategies, regulatory reforms, and the importance of capacity building to capture a significant market share by 2020. The conference aimed to foster collaboration and knowledge sharing among stakeholders to advance the biosimilars sector.
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5th Biosimilars Congregation 2014
- 1. KEY SPEAKERS:- Vimal Sanghavi,Vice President Clinical Trial Management, Jim Thorn, EMEA Marketing and Applications Leader, Martin Bluggel, CEO, Pranjal Bordoloi, Senior General Manager – Late Phase Clinical Trials & Pharmacovigilance Operations, Pravin Ghadge, Head-Medical Writing & Pharmacovigilance, Debolina Partap, AVP & Head Legal, Siddarth S. Chachad, Head - Clinical Development, Ashwani Pandita, Head Quality Management & Training, Chirag Trivedi, Director & Head of Clinical Study Unit, Manish Shah, General Manager, Global Clinical Operations, Suresh Maroli, Head Clinical Pharmacology, Sofi Joseph, Head – Regulatory Operations, Yasmin Shenoy, Senior Director - Regulatory Affairs, Milind Antani, Head - Pharma LifeSciences group, Amey Mane, DGM-Medical Affairs, V K Sharma, Associate Vice President, Ambrish Srivastava, Asst Vice President, Tej Krishen Bazaz, Director, Lambda SCIEX Separations (UK) Protagen Protein Services (UK) Lambda Reliance Life Sciences Wockhardt Cipla Glenmark Sanofi Wockhardt Reliance Life Sciences Pfizer Sanofi Nishith Desai Associates Wockhardt Unichem Laboratories Alkem Labs Thermo Fisher Scientific Plus Many More... Conference Hashtag - #VI_Pharma
- 2. ORGANIZED BY ASSOCIATE PARTNER SUPPORTEDBY 5th Biosimilars Congregation 2014 10th September 2014, Kohinoor Continental Hotel, Mumbai, India BRONZE PARTNER SILVER PARTNER SMS PARTNER GOLD PARTNER
- 3. CONFERENCE INTRODUCTION:- The biosimilarindustry had a tough 2013 driven by the Indian economy having to experience one of its most turbulent times. Indian bio-pharma sector decelerated to 5.2 per cent in 2013 from an average growth of 12 percent in the previous year. Adverse policy moves like the foreign direct investment (FDI), drug pricing, clinical trials and compulsory licensing made the matters worse. An overactive US FDA hauled up several leading Indian pharma companies for non-compliance. All these negative developments together turned 2013 into an 'Annus Horribilis’ for the Indian bio-pharma sector. The global biosimilars market is expected to be worth $19.4 billion by 2014, growing at a Annual Growth Rate (CAGR) of 89.1% from 2009 to 2014.The American products Follow-on protein market (including North America and Latin America) is expected to account for nearly 35.3% of the total income in 2014. By 2015, the sales of biosimilars is expected to hit USD 3.7bn, a near exponential increase from USD 378 million back in 2011. There are currently more than 80 biosimilars under development worldwide and this market could potentially become the only fastest-growing biologics sector by 2020. So, where did all this momentum come from? Why does biosimilars suddenly display an accelerated growth potential? And how have market dynamics received and encouraged this growth? If Indian biopharmaceutical players are to compete effectively on the global scale and capture 10% of the global biosimilars market by 2020, India’s private sector will have to invest a considerable amount of capital in building the necessary manufacturing capacity and skills base. At the same time, the Government of India will also have to provide the necessary enabling environment. India’s biopharma sector consists primarily of monoclonal antibodies, vaccines, recombinant proteins and diagnostics, and the guidelines for biosimilars are already in place. Almost 50 biosimilars have already reached the Indian market, and they are sold at discounts of as much as 85%, putting them within reach of the masses. Demand seems likely to grow considerably, as India becomes more affluent. US investment bank Goldman Sachs estimates that the number of Indians with annual incomes of between $6,000 and $30,000 may increase by 250-300 million during the next decade alone. The global biosimilars market has even more potential for the most efficient Indian biosimilars manufacturers, as the market will be characterised by price competition, even when there are only a less number of rival products. It is said, the manufacturers of branded products are likely to use second-generation products with more convenient administration schedules as a means of defending their territory. Few of these manufacturers may also try to crowd out the competition by producing their own biosimilars. So the competition is likely to be intense. One of the most critical problem faced in India is the inaccessibility to healthcare. To address this issue, the government needs to not only relook at its public health policy but also bring in various regulatory reforms including a smarter approval of pathway that cuts the cost of drug development to allow affordable innovations. Regulatory reforms also need to address issues related to intellectual property and also clinical trials. Use of technology for procurement and distribution will also enable better access to the drugs This conference will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry. Hence, this 5th Biosimilars Congregation 2014 will look at the multiple facets of biosimilars, ranging from the evolving regulatory landscape and challenges in clinical development, to the legal and economic aspects. This Biosimilars conference will focus on multiple aspects of biosimilar product development to successfully deliver safe, biosimilar products to the marketplace. By attending this conference you will gain a comprehensive outlook on the key issues surrounding biosimilars. This event will provide an important platform for Biosimilars stakeholders to discuss and share best practices in expediting Biosimilars development. It gives me great pleasure in welcoming all of you to the Virtue Insight’s 5th Biosimilars Congregation 2014. I wish and pray that all our efforts will be beneficial to our industries folks at large. WHY SHOULD YOU ATTEND:- broader scope bringing the whole communications value chain together? dedicated networking drinks time,meet the leading international vendors Expand your knowledge Get more from the event, with a Enjoy and make the best out of our showcasing the products of tomorrow in the co-located exhibition. of the latest business models and strategies in the high-level conference. Whether you are on the branded or generic side, you cannot afford to miss this opportunity to benchmark your tactics and strategies against the industry leaders who will be the first to traverse the pathway. Devise an immediate action plan for your biosimilar prosecution and litigation strategies in light of the barriers to entry, research and development costs, and regulatory hurdles, which are balanced against an enormous potential for increased profit margin KEY THEMES DISCUSSED AT THIS SUMMIT:- • • • • • • • • • • • • • • • • • • • Commercialization and development strategies to gain a competitive advantage Calculating possible revenue streams from biosimilar production How should the pharma and generics industries approach the quickly emerging and developing biosimilar market? What is the future of next generation Biosimilars? The commercial challenges and opportunities to develop Biosimilars The growing importance of biobetters over biosimilars Gain in-depth knowledge on role of technology transfer - How does this affect market access? How do policy makers shaping the contours of this new generic frontier, what implications they have for present biologic drug development & patent protection? Next generation monoclonal antibody development and clinical challenges faced with biosimilar drug development Technical case study for analytical and clinical comparability strategies The Legal/IP for Biosimlars How to maximise strategic partnerships to enter into the biosimlar market New frontiers in cell line development and opportunities in biosimilars How to reach the target audience more effectively and quickly. Evaluating the key criteria that has to be considered to gain speedy entry into Biosimilar market How global pharmaceutical market is turning to be more specialized & precise? Identifying the experience on follow on biologics, generics and biosimilars has been so far Gain up to date insight about the regulatory landscape and how it is effecting the industry Boost your industry knowledge and relationships by networking and learning from key industry and academic leaders WHO SHOULD ATTEND:- CSOs, CMOs, Vice Presidents, Presidents, Heads, Directors, Team Leaders, and Senior Scientists from the following roles: Biopharmaceuticals/ Biotherapeutics, Follow on Biologics/Follow on Proteins, Biologics/Biotechnology/ Biogenerics, Legal Affairs, Intellectual Property, Health Economics, Pricing and Reimbursement, Clinical Immunology, Principal Scientist, Chief Scientific Officer, Process Control and Analytical Technologies, Analytical Characterisation, Regulatory Compliance, Pharmacovigilance, Drug Safety & Risk Management, Quality Affairs/ Quality Control, New Product Development, Process Science, Portfolio Management, Research & Development, Business Development, Business Operations, Scientific Affairs, Commercial Affairs 5th Biosimilars Congregation 2014 10th September 2014, Kohinoor Continental Hotel, Mumbai, India
- 4. Biosimilar Clinical Trials– Challenges and Strategies 11:40 – Topic TBC 12:10 - Expanding the Role of Capillary Electrophoresis for the Development, Characterization & Quality Control of Biologics 08:30 – Coffee and registration 09:30 – Chairpersons’s opening remarks 09:40 – 10:10 – Reaching and demonstrating Biosimilarity by state of the art analytics 10:40 – Morning Coffee/Tea & Networking • Regulatory demand for demonstrating biosimilarity • Monitoring reference molecule • Matching critical quality attributes during development • Comparability exercise V K Sharma, Associate Vice President, Pranjal Bordoloi, Senior General Manager – Late Phase Clinical Trials & Pharmacovigilance Operations, Martin Bluggel, CEO, Speaker TBC, Jim Thorn, EMEA Marketing and Applications Leader, Unichem Laboratories Lambda Protagen Protein Services (UK) Medidata (UK) SCIEX Separations (UK) (https://www.linkedin.com/pub/v-k-sharma/23/ba/197) (https://www.linkedin.com/pub/martin-bl%C3%BCggel/2/891/89a) (https://www.linkedin.com/pub/jim-thorn/9/361/428) Morning Keynote Address 1: Morning Keynote Address 2: 14:30 – Safety Evaluation in Biosimilars 15:00 – Clinical trials of Biosimilars: Challenges and opportunities 15:30 – Afternoon Coffee/Tea & Networking 15:50 – Challenges in Patient Recruitment and Retention • Regulatory aspects of a Biosimilar clinical trial • Protocol development-Innovation in endpoints • Challenges in the clinical operations • Patient-centric approaches to increase patient recruitment • Enhancing the site capabilities to improve the patient experience • Social media and physicians involvement to improve patient recruitment and retention • Addressing the ‘weak link’ in medical research Pravin Ghadge, Head - Medical Writing & Pharmacovigilance, Amey Mane, DGM-Medical Affairs, Reliance Life Sciences Wockhardt (http://www.linkedin.com/pub/dr-pravin-ghadge- md/15/835/1a4) (https://www.linkedin.com/pub/dr-amey-mane/6/156/7b1) MARKET ANALYSIS CHALLENGES & OPPORTUNITIES 13:50 - Panel Discussion: Strategies to Improve Sponsor, Site, and CRO Moderator: Panellists: • Overview of recent trends in clinical research • Cultural considerations for a successful partnering • Effective biosimilars clinical study designs for india • Identifying the role of each stakeholder Chirag Trivedi, Director & Head of Clinical Study Unit, Tej Krishen Bazaz, Director, Manish Shah, General Manager, Global Clinical Operations, Ashwani Pandita, Head Quality Management & Training, Sanofi Thermo Fisher Scientific Wockhardt Glenmark Lambda (http://www.linkedin.com/pub/dr-chirag-trivedi/21/b0/344) (http://www.linkedin.com/pub/dr-tej-krishen-bazaz/17/776/612) (https://www.linkedin.com/pub/manish-shah/18/678/1a2) (http://www.linkedin.com/pub/ashwani-pandita-rqap- gcp/14/997/590) (https://www.linkedin.com/pub/vimal-sanghavi/11/bb9/577) Vimal Sanghavi, Vice President Clinical Trial Management, 5th Biosimilars Congregation 2014 10th September 2014, Kohinoor Continental Hotel, Mumbai, India 11:00 – Panel Discussion: Challenges And Opportunities For Biosimilars In Emerging Markets Moderator: Panellists: • Market size of biosimilars in the emerging market • Selling of biosimilars in the emerging markets having government protectionism • Competition concentration of biosimilars in the emerging market • Emerging markets that are highly attractive for biosimilars in india Ambrish Srivastava, Asst Vice President, Siddarth S. Chachad, Head - Clinical Development, Suresh Maroli, Head Clinical Pharmacology, Alkem Labs Cipla Reliance Life Sciences 12:40 - Networking - Take your discussions further & build new relationships in a relaxed & informal setting... luncheon
- 5. 17:00 – Chairperson’sclosing remarks and end of conference V K Sharma, Associate Vice President, Unichem Laboratories (https://www.linkedin.com/pub/v-k-sharma/23/ba/197) 17:10 - 18:00 Networking Drinks - Take your discussions further & build new relationships in a relaxed & informal setting... 16:20 – Panel Discussion: Regulatory Updates and Development Moderator: Panellists: • Clinical approvals for biosimilars • Regulatory differences between the DCGI, FDA, EMA and local agencies in india and other emerging markets such as china & SEA • How to demonstrate the process consistency and its requirements • Updates on Biosimilars guidelines in indian market • Regulatory demand for demonstrating biosimilarity Milind Antani, Head-Pharma LifeSciences group, Debolina Partap, AVP & Head Legal, Yasmin Shenoy, Senior Director - Regulatory Affairs, Sofi Joseph, Head–Regulatory Operations, Nishith Desai Associates Wockhardt Sanofi Pfizer (http://www.linkedin.com/pub/milind-antani/2/69a/5b5) (http://www.linkedin.com/pub/debolina-partap/1b/388/424) (http://www.linkedin.com/pub/sofi-joseph/12/307/632) 5th Biosimilars Congregation 2014 10th September 2014, Kohinoor Continental Hotel, Mumbai, India REGULATORY
- 6. FLOOR PLAN:- Bookyour stalls now before they run out !!! 1 2 5 3 4 CONFERENCEHALL1 CONFERENCEHALL2 CONFERENCEHALL3 1 Coffee / Tea / Networking Area POOL SIDE AREA NETWORKING LUNCHEON 4 5 6 2 3 REGISTRATION DESK 6 5th Biosimilars Congregation 2014 FLOOR PLAN - Book your stalls now before they run out !!! 7 7
- 7. Queries: Payment terms: Substitutions/name changesor cancellations: Indemnity: Fee: How we will contact you: Should you have any questions on bookings, Please feel free to contact us. Email: Web: India Office: Tel: +91 044 64536444 Virtue Insight requires the full amount to be paid before the conference. Virtue Insight may refuse entry to delegates who have not paid their invoice in full. There is a 50% liability on all bookings once made, whether by post, fax, or email. There is a no refund policy for cancellations received on or after one month before the start of the event. Should you decide to cancel after this date, the full invoice must be paid. Conference notes will then be sent to you. Unfortunately, we are unable to transfer places between conferences and executive briefings. However, if you cannot attend the conference, you may make a substitution/name change at any time, as long as we are informed in writing by email, fax or post. Name changes and substitutions must be from the same company or organization and are not transferable between countries. Virtue Insight reserves the right to make alterations to the conference/executive briefing content, timing, speakers or venue without notice. The event may be postponed or cancelled due to unforeseen events beyond the control of Virtue Insight. If such a situation arises, we will refund your registration fee and we will try to reschedule the event. The conference fee includes lunch, refreshments and conference papers provided on the day. This fee does not include travel or hotel accommodation. Virtue Insight's preferred method of communication is by email and phone. Please ensure that you complete the registration form in full so that we can contact you. Kohinoor Continental Hotel Andheri Kurla Road Andheri ( E ) Mumbai 400059 - India Tel: 91 22 66919000 / 91 22 28209999 General information Venue: info@virtueinsight.com http://www.virtueinsight.com www.virtueinsight.com News Updates: Please tick if you do not wish to receive email updates in the future Registration Form 10th September 2014, Kohinoor Continental Hotel, Mumbai, India Early Bird Discount Rate Till 28th July 2014 Standard Rate (From 29th July 2014) Group Discounts Group Discounts Spot Registration:- Methods of Payments: By Bank Transfer: 1 Day conference per delegate - Fee: INR 5,000 + Tax 1 or 2 delegates - per delegate - Fee: INR 06,000 + Tax 3 or 4 delegates - per delegate - Fee: INR 05,500 + Tax For 5 and above delegates - per delegate - Fee: INR 05,000 + Tax 1 Day conference per delegate - Fee: INR 07,000 + Tax Forename ............................Surname ................................ Job Title ..............................Company ................................ Official Contact Number ....................................................... Address ............................................................................. ............................................................................. Country ...............................Postcode.................................. Phone ..................................Fax ........................................ Email ................................................................................. I confirm that I have read & agree to the terms and conditions of booking..... (Please Tick) Signature ........................................................................... Complete and return the above registration form via post or email, together with your cheque payable to Virtue Insight. Virtue Insight 830092431 IDIB000V080 Indian Bank. 118 - 119, Indira Nagar, Valasaravakkam, Chennai 600 087,Tiruvallur district,Tamil Nadu, India By Cheque - Account Name - Account Number - Sort code - Bank Address - Registration Form Details: RESERVATION PRICING: