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: email@example.com www.biosimilars-india.com
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: firstname.lastname@example.org
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 www.biosimilars-india.com, email email@example.com, 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
2nd Annual Ways to Register Online: www.biosimilars-india.com Tel +91 (022) 4046 1466 Fax +91 (022) 4046 1477 I N D I A 2 0 1 1 Email firstname.lastname@example.org 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. Signature: Line Manager: Job Title: Secretary/PA: Tel: Nature of Business: Number of Employees Annual Turnover Organisation’s Main Area of Business: Please tick one box Please tick one box Please tick one box 50,000 or more More than US$40 Million Biopharma Manufacturer Analytical Laboratory Trade Association 10,000 - 49,999 Biotechnology Manufacturer Ingredient Supplier Media 5,000 - 9,999 US$30 - US$40 Million 1,000 - 4,999 US$20 - US$30 Million Innovator Pharma Manufacturer Packaging Supplier Other 500 - 999 Generic Pharma Manufacturer Consultant 250 - 499 US$10 - US$20 Million 100 - 249 Less than US$10 Million CRO Regulator 1 to 99 CMO Academic Institute How to pay Full payment is required within 5 working days from date of invoice. Bookings received within 10 working days of the conference date can only be paid by credit card. Cheque Please ﬁnd enclosed a cheque for the amount of INR US$ made payable to UBM India Pvt. Ltd. Please send to address above (in WAYS TO REGISTER box) Bank Transfer Email (accounts contact) Invoice Address (if different from above Purchase Order No. (where applicable) To pay by bank transfer please send payments to: HSBC Bank, 52/60, MG Road, Fort Mumbai, 400 001, India. Beneficiary Name: UBM India Pvt Ltd. Type of Account: Current. MICR No: 400039002. IFSC Code: HSBC0400002. Swift Code: HSBCINBB. Bank Code/Bank ID: 039. Branch Code: 002. For INR and USD payments Account Number: 002-859882-004. Please fax a copy with delegate(s) and conference name of your bank transfer to +91 (022) 4046 1477. Please note that invoice will be sent separately. For invoice queries call: +91 (022) 4046 1466. Credit Card/Debit Card We accept Visa, MasterCard, Diners Club, American Express, and Maestro cards.To pay by credit card, please tick the box above and return this registration form to us. You will receive an invoice from email@example.com with a link where you can pay for your delegate fees securely through our payment portal, CC Avenue. For more information, please contact us at +91 (022) 4046 1466 or by email at firstname.lastname@example.org. We are unable to process credit card payments over the phone. Terms & Conditions: • Except as specified above, no refund or credits will be issued for other forms of cancellation. Payment: • UBM is not responsible for any loss or damage as a result of a substitution, alteration or cancellation/postponement of• Full payment is required within 5 working days from receipt of invoice. Your registration will not be confirmed an event. UBM shall assume no liability whatsoever in the event this conference is cancelled, rescheduled or until full payment is received and may be subject to cancellation. postponed due to a fortuitous event, Act of God, unforeseen occurrence or any other event that renders performance• All payments must be made in full before the conference date. All bookings received within 10 working days of this conference impracticable, illegal or impossible. For purposes of this clause, a fortuitous event shall include, of the conference can only be paid by credit card. but not be limited to: war, fire, labour strike, extreme weather or other emergency.• If your payment has not been received or cleared before the first day of the conference, you will be required to Accommodation: provide a credit card guarantee onsite to secure your participation. This will act as a guarantee for a period • Please note that accommodation and travel are not included in the conference fee. of 15 days and will only be processed if your official payment has not been received or cleared beyond • Orbitz are the officially appointed accommodation agency. Orbitz have secured allocations at conveniently located 15 days post the conference. hotels at discounted event rates. These rates are held for a limited amount of time, so please book early to avoid• Conference fees include entrance to the conference sessions, refreshments as per onsite schedule, and the disappointment. Call +91 (0)22 2410 2801/2/3 or email email@example.com conference papers. Please note that accommodation and travel are not included in the conference fee. Programme Changes:• Fees are subject to applicable taxes as per government rules and regulations. • Please note that speakers and topics were confirmed at the time of publishing; however, it may be necessary Pricing and Discounts: due to unforeseen circumstances to alter the content, timing, speakers or venue. UBM reserves the right to alter or• To be eligible for an Early Bird discount, the signed booking form must be received by close of business on modify the advertised speakers and/or topics if necessary. the relevant deadline date, with full payment received no later than 5 working days following date of invoice. • Any substitutions or alterations will be updated on the event website as soon as possible.• If payment is not received within 5 working days following date of invoice, the discounted rate will no longer Your Details: apply and the current rate at that time will be applicable. • By entering your details in the fields above, you agree to allow UBM India Pvt Ltd. and companies associated with• A group booking discount of 5% is applicable to bookings of 3 or more delegates and 10% to 5 or more delegates. the event to contact you (by post, telephone, sms, email or fax) regarding relevant products or services provided. Group booking discounts only apply if all delegates in the group book and pay at the same time. If at any time you do not wish to receive anything from UBM India Pvt Ltd. or carefully selected 3rd parties, Cancellation and Substitutions: please write to Manoj Ambardekar, Database Manager, UBM India Pvt Ltd. Sagar Tech Plaza A, 119, 1st Floor,• Once booked cancellation of delegate places cannot be made, however a substitution can be made at any time. Andheri Kurla Road, Saki Naka Junction, Andheri East, Mumbai, 400072, India, or email firstname.lastname@example.org. Please email details of the substitute delegate to email@example.com at the earliest opportunity. This contract is subject to Mumbai Jurisdiction law.• In the event that UBM cancels an event for any reason, you will receive a refund for 100% of the conference fee paid.• In the event that UBM postpones an event for any reason and the delegate is unable or unwilling to attend on Service Tax Registered No. AAACU8181DST001 the rescheduled date, you will receive a credit note for 100% of the conference fee paid. You may use this credit for another UBM event to be mutually agreed with UBM, which must occur within one year from the date of Customer Code: Web postponement.