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Informedia proudly presents the inaugural
conference on
For more details, visit
Best Practice ...
10.00 am Evaluating the implications of moving global R&D
offshore vs outsourcing to India
Globalisation of drug developme...
3.30 pm
Dr Sham Nikam, Chief Scientific Officer
Nycomed Pharma USA
Evaluating the current status of drug R&D in India
Mr Uma Nandan Misra
Vice President, Operations and Site Manager
AstraZeneca Pharma
11.50 am Case Study - Achieving operati...
About Informedia
Informedia India Pvt Ltd is a leading conference organiser
which specialises in professional high level b...
Hotel J W Marriott
I / We / would like to attend / nominat...
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Global Pharmaceuticals R&D Programme


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Global Pharmaceuticals R&D Programme

  1. 1. Informedia proudly presents the inaugural conference on For more details, visit Best Practice in Service Outsourcing Conference: 3rd - 4th December 2008 | Venue: Hotel J W Marriott, Mumbai Global Pharmaceuticals Research & Manufacturing India 2008 Global Pharmaceuticals Research & Manufacturing India 2008 n nActis Biologics nAll India Institute of Medical Sciences nAmgen India nAstraZeneca Pharma nCadila Pharmaceuticals nDr Reddy's Laboratories nEisai India nEli Lilly &Co. nEvolva Biotech nFDA Maharashtra State nGlaxoSmithKline Pharmaceuticals nInstitute of Clinical Research India nNishith Desai Associates nNovartis nNycomed Pharma USA nPfizer nSandoz nSanofi–Aventis nTakeda Global Research and Development nUSV nWockhardt nWyeth nZydus Cadila Abbott India Top Level Speakers from Ü Ü Ü Ü Ü Find out how to outsource your clinical trials to India Harness the benefits of Indian CRAMS/CSOs within the current global pharma business model Evaluate the implications of moving global R&D offshore to India Examine the influence and input of biotech companies in the Indian pharma market Learn about the emerging and innovative business models for partnerships and collaboration Key Note Speakers Mr Ranga Iyer President OPPI and Managing Director Wyeth Mr Suhas Chaudhari Joint Commissioner (Greater Mumbai) FDA Maharashtra State Uma Nandan Misra Vice President - Operations & Site Manager AstraZeneca Pharma Mr Ranjit Shahani Vice Chairman, Managing Director and Country President Novartis Mr Harjit Singh, Senior Development Manager, Takeda Global Research and Development, UK Principal Media Partner Media Partners Online Media Partners International Media Partner
  2. 2. 10.00 am Evaluating the implications of moving global R&D offshore vs outsourcing to India Globalisation of drug development processes What impact will Indian CROs have on shaping the global R&D landscape? Indian CROs view on the offshoring operations - how do they view their interaction and experiences when working with US and European pharmas? l m m Dr Chandrashekhar Potkar Managing Director, Clinical Research Pfizer 8.30 am Registration 9.00 am Chairman's Welcome and Opening Address 9.35 am Harnessing the benefits of Indian CRAMS/CSOs within the current global pharma business model Comparing CRO (Contract Research Organisation) and CM (Contract Manufacturing) activities within India, externally and looking at prospects for future development Retrospective analysis of how the CRAMS/CSOs business model has evolved - where we are now? Analysis of the long-term prospects for the CRAMS/CSOs industry and its ultimate effect on the Indian pharma business l m m Dr Ish Khanna Dr Reddy's Laboratories USA Mr Ranjit Shahani Vice Chairman, Managing Director and Country President Novartis 9.10 am Overview of the Indian pharma sector in an economic context What is the current development status of the industry? Is the cost advantage of investing in India now diminishing because of escalating operating costs? Dealing with the declining ROI of pharma businesses - proposed solutions to maintain sustainable growth of the industry Indian pharma in comparison to other emerging markets: China, South East Asia and Latin America Evaluating offshore process outsourcing from a regulatory and cost perspective Predicting future prospects: how the Indian economy is expected to develop - where will we be in 2020? l m m m m l Globalisation of the Indian pharma industrySession I: Wednesday 3rd December, 2008DAY 1: 2.40 pm Three years on from the Indian Patents Act 2005 Myths about patents Features of the Act Unfinished agenda Path forward l l l l Mr Ranga Iyer President, OPPI and Managing Director Wyeth 3.05 pm Pharmacovigilance, PMS and PSUR in India: Current status and the road map. Assessing the development of methodologies for monitoring drug safety Addressing the increasing concerns over drug safety and post-approval surveillance Ensuring proactive pharmacovigilance throughout the product lifecycle Improving patient safety by increasing the transparency of safety data Transferring the pharmacovigilance advancements of the West to emerging markets Exploring the relationship between pharmacovigilance and risk management l l l l l Mr YK Gupta Head, Department of Pharmacology, Zonal Pharmacovigilance Centre All India Institute of Medical Sciences 10.25 am Morning Refreshments & Networking Break 11.20 am The evolving regulation landscape in India Discussing the current Indian regulatory environment Recognising the requirements of Indian regulations towards approval of drugs developed Ensuring effective protection of intellectual property rights and development processes Standard operating procedures for conducting clinical trials in India - Schedule Y of the Drugs and Cosmetics Act in India and guidelines for biomedical research l l l l Dr Surinder Singh Drugs Controller General of India * Mr Suhas Chaudhari Joint Commissioner (Greater Mumbai) FDA, Maharashtra State 10.55 am Harmonisation of the global pharma regulatory environment Evaluating the impact of globalisation on the pharma regulatory landscape and how this will affect research and manufacturing processes Finding a common set of regulations which are acceptable to all countries l l Indian and worldwide regulatory policies and legislative framework Session II: 2.00 pm The viewpoint from two industry specialists on managing legal and regulatory considerations in clinical outsourcing The patent regime and present status of R&D in India Government initiatives to shorten the clinical trials application time Clinical research landscape in India Discussing the market prospects for further development Analysing the reason for the gap in the amount of research between India and the rest of the world Investigating pharmacovigilance practices in India for the clinical trials market and for future REITs l m l m m l Dr SK Gupta, Director General Institute of Clinical Research India Ms Gowree Gokhale, Partner Nishith Desai Associates For an Updated Conference Programme, Please log on to: * Awaiting final confirmation 12.30 pm Luncheon 11.45 am SPEED NETWORKING The quicker way to do business 3rd - 4th December, 2008 Global PharmaceuticalsGlobal Pharmaceuticals Research & Manufacturing India 2008
  3. 3. 3.30 pm Dr Sham Nikam, Chief Scientific Officer Nycomed Pharma USA Evaluating the current status of drug R&D in India Drug discovery in India, along with CROs in Indian pharma industry Exploring the contract research market from preclinical to phase 3 Emerging opportunities for conducting exploratory proof-of concept studies Trends on outsourcing drug discovery and development (DD&D) Producing cost-effective NCEs (New Chemical Entities) targeting lifestyle, resistant infectious diseases with improved efficacy and minimal side effect Producing a pipeline of promising drug candidates - DD&D and NCEs l m m l m m 4.15 pm Dr PM Murali, Managing Director Evolva Biotech Building an indigenous value based ecosystem for cost effective drug discovery in India. Six key aspects leading to a sub half billion dollar NDA in the future Indian discovery landscape INVESTMENT: Arrival of startup VCs redefining the discovery landscape in India – those with longer acceptable incubation periods for their ROI and a higher risk taking ability EXPERTISE: Influx of returning Indians from elsewhere with prior experience in drug discovery and development FACILITIES: Availability of world class CRAMS/CSOs in biology, chemistry and pharmacology RESEARCH CONSULTANTS: Networking with scientific clusters of excellence, who are willing to collaborate with industry INTERFACE & SCALEUP OPERATIONS: English speaking population and FDA approved facilities – both available with largest numbers outside United States CLINICAL TRIALS: Huge patient population with diversity and CSIR's efforts in systematic mapping of heterogenicity, enables effective clinical trials, pharmacogenomics and pharmacovigilance l l l l l l Dr Veena Jaguste, Director, Global Development Operations, Amgen India 4.40 pm The impact of outsourcing on drug development performance and implications for more effective collaboration with CROs Clinical research and trials outsourcing - overcoming challenges and impediments Incorporating emerging regions into clinical development plans - a unique set of opportunities and challenges l l Mr Harjit Singh, Senior Development Manager Takeda Global Research and Development UK 5.05 pm Clinical research and trials outsourcing - challenges and hurdles in India Conducting phase 1 and 2 clinical trials in India Clinical quality assurance and its significance in global drug registration Clinical safety and risk evaluation in trials Conducting ethical clinical trials Managing clinical trial sites successfully Feasibility studies for investigational site selection Non clinical: technical and operational procedures and how to address them l l l l l l l 3.55 pm Afternoon Refreshments & Networking Break Mr Sanjeev Saxena Chairman and CEO Actis Biologics Evaluating the influence and input of biotech firms on the Indian pharma market Evaluating global biotechnology development and India's role in the process Ensuring global biotech opportunities within India and overseas Gaining advantage of innovative bio-technologies Forming partnerships with Indian biotech firms l l l l 9.10 am Thursday 4th December, 2008DAY 2:R&D in India: the landscape of opportunities and challenges Session III: 8.30 am Registration 9.00 am Chairman's Opening Remarks Emerging trends in biotechnologySession IV: Benefits of contract manufacturing for Indian producers Session V: 10.40 am Morning Refreshments & Networking Break 9.35 am Mr Subash Kapre * Executive Director Serum Institute of India Key issues affecting biopharmaceutical manufacturing Manufacturing biologics from the CMO (Contract Manufacturing Organisation) perspective Where is biopharma manufacturing going in the next 10 years? Regulatory initiatives impacting biopharmaceutical development and manufacturing Entry of biosimilar and bio-generic products Ensuring quality and safety in bio-processes Strategies for ensuring product comparability and safety after manufacturing process changes l l l l l m 10.00 am Global harmonisation and the perception of Indian CM to the rest of the pharma industry Evaluating international trends and global harmonisation opportunities CMO management throughout the relationship between CMO and outsourcer lifecycle Obtaining and understanding how process changes can affect the structure and biological activity of the final product (in technology transfer) Implementing successful approaches in manufacturing Evaluating the role of globalisation on the regulatory landscape and manufacturing process Contract manufacturing - in house vs outsourcing Emerging fields in the pharma outsourcing market - why should you outsource manufacturing and risk costly technology transfer delays? A critical assessment of the current manufacturing outsourcing strategies l l l l l l l l Mr Sanjit Lamba, President and CEO Eisai India Mr Lakshminarayana Neti, Director Operations Abbott India For enquiries write to jayesh.kanaskar@informedia-india.com5.40 pm Informedia’s Cocktail Reception 5.30 pm Chairman's Closing Remarks and End of Day One * Awaiting final confirmation 3rd - 4th December, 2008 Global PharmaceuticalsGlobal Pharmaceuticals Research & Manufacturing India 2008
  4. 4. Mr Uma Nandan Misra Vice President, Operations and Site Manager AstraZeneca Pharma 11.50 am Case Study - Achieving operational excellence in a pharma manufacturing plant Cultural transformation Aligning manufacturing priorities with business Identifying & monitoring critical performance parameters Engaging all employees for continuous improvement Achieving excellence in focussed areas l l l l l 12.55 pm Luncheon 2.10 pm Implementing strategies to ensure that the contractors comply with quality agreements Compliance with GMP requirements Demonstrating how cGMP is essential for survival in the pharma business Gain a competitive edge with a GMP compliant designed facility Learn the importance of well written procedures, validation, documentation and SOPs for cGMP compliance l m m m Dr PM Naik Project Director Zydus Cadila Evolving partnering and business modelsSession VI: 2.35 pm Implementation of risk management strategies in outsourced manufacturing Risk and risk management in pharmaceutical and biopharmaceutical outsourcing Measuring risk as a preventative technique - ensuring operational excellence Identifying, understanding and rating risk throughout all processes Implementing effective methods to avoid risk Identifying and overcoming cost issues in CM outsourcing l l m m m Mr TS Anand Director, Contract Manufacturing and Outsourcing Dr Reddy's Laboratories 3.00 pm Innovative models of collaborating opportunities with CRAMS/CSOs Different models of collaboration that can be established between Indian firms and MNCs New business and partnership models evolving in India In and out licensing of drug discovery research Partnering opportunities - strategic involvements l l l l Ms Mukta Arora Head of Global Sourcing Eli Lilly & Co. 3.45 pm External sourcing in the pharma space Requirements for external sourcing Basic aspects of external sourcing Challenges faced by the Indian pharma business as compared to international businesses and other sectors How do you choose the right partner? Relationship building for the longer term - an essential part of the pharma business Legal and contractual issues l l l l l l Mr Debabrata Gupta Director and Chief Operating Officer USV 4.45 pm 4.35 pm End of Day Two and Close of the Conference Chairman's Closing Remarks 4.10 pm What are the strengths that the outsourcing organisation is looking for while selecting the CRAMS/CSOs? What the contract givers and contract acceptors should be aware of to continue long-term business relationships Who is the owner of the intellectual property developed during the cooperation and why? How to face audits from the outsourcing organisation to get approved as a CSO Why continuous communication is essential in such a relationship Why the customer should be kept informed of the failures and mistakes that take place At what stage does the product need to be optimised during CRO or CSO? How process changes from established practice could affect the customer and the relationship l l l l l l l Dr Sunil Kanvinde Deputy General Manager, Technical Services Sandoz 11.10 am Two key opinion leaders demonstrate how to establish successful technology transfer in CMO to ensure an effective manufacturing process Technology transfer for outsourcing and contract manufacture Implementing technology transfer to ensure an effective manufacturing process Critical factors and timelines for a successful technology transfer Success factors during process comparability and validation Developing and implementing clear quality agreements with CMOs Incorporating knowledge to ensure process comparability, validation and GMP requirements l l l l l l Mr KK Ambardar, General Manager, Contract Manufacturing, Cadila Pharmaceuticals Dr Ashoke Banerjee, Executive Director GlaxoSmithKline Pharmaceuticals 12.15 pm Panel Session: Two industry leaders viewpoint on quality management - developing and implementing sustainable quality agreements with CMOs What are the ‘rules of engagement’ between the sponsor and client for proper management of mutual quality and quality-regulatory needs in an outsourcing arrangement? One size does not fit all - How to design and put a workable and sustainable quality management system into practice? How does a quality agreement separate or link to other agreements like commercial and technical? What are the regulatory and legal requirements that should be addressed in a quality agreement? How should critical quality activities of change management, deviations, investigations, product release, GMP audits and regulatory inspections be integrated in to a good quality agreement? l l l l l Mr Satish Rajkondawar, Senior Director, External Manufacturing Site, Sanofi-Aventis Mr Viswajit Sahu, DGM Contract Manufacturing Services, Wockhardt 3.25 pm Afternoon Refreshments & Networking Break 3rd - 4th December, 2008 Global PharmaceuticalsGlobal Pharmaceuticals Research & Manufacturing India 2008
  5. 5. About Informedia Informedia India Pvt Ltd is a leading conference organiser which specialises in professional high level business conferences targeted at senior management in a number of industry sectors. We are a subsidiary company of the Expomedia Group Plc., a leading International media group with offices in 13 countries worldwide. Dedicated to in-depth research, our conferences provide you with relevant information about what you want to know, when, and from whom. Straightforward and industry oriented, our conferences are a very time efficient way to gain a head start and secure your competitive advantage. Our focused events create a platform to network with both new and experienced peers from various industries and feature the most relevant case scenarios in order to equip you with valuable knowledge and current know-how. Attracting the industry's most powerful and influential delegates àBusiness Development àClinical Research Outsourcing àManufacturing àDrug Discovery & Development àMedical Affairs àPharmaceutical Development àPharmacoviligance àPreclinical Development àProcurement àProduction Planning & Manufacturing àPurchasing àQuality Control & Assurance àRegulatory Affairs àRisk & Safety Assessment Heads of Divisions àCXOs àProject Directors Who will be there? The Global Pharmaceuticals conference has been developed with the following executives in mind: Which industry sectors should attend? àPharmaceutical Companies àBiotech Companies àCROs and CMOs àPharmaceutical Manufacturers àResearch Laboratories and Institutes àBusiness Consulting Firms àGovernment Institutions and Regulators àPrivate Equity Funds àVenture Capitalists Sponsorship... helps you to do business and deliver your message to the Global Pharmaceutical market. Contact our Sponsorship Director on or call +91 22-28500104 in India and +44 (0) 1923 491 067 in the UK to tailor your package Q.1 Could you benefit from presenting a case study or hosting a workshop in front of your target audience and demonstrating your expertise? If your answer is yes to any of these questions then the Global Pharmaceuticals Research and Manufacturing India 2008 is the most important place for you to be. 6 simple questions to determine value from sponsorship Q.2 Do you want to do business with senior decision makers from the leading Pharmaceutical and Biotech companies from India, Asia and the rest of the World? Q.3 Can you benefit from the impact of outsourcing on Clinical Research or Contract Manufacturing? Q.4 Can you provide a solution to the bad perception of manufacturing from a CMO's perspective? Q.6 Do you want to collaborate on drug development performance with CRO's? Q.5 Are you able to demonstrate the best way to run effective proof of concept trials? Sponsoring the Global Pharmaceuticals Research and Manufacturing India 2008 forum will enable you to: Raise your company’s profile Increase your chances of being chosen as the logical choice of supplier, when they hear and see you can exceed their needs. Don't pass business opportunities by, whilst your competitors walk away with them. Find your all year round marketing solution There are a limited number of opportunities for you to get your message across to the leading International Pharmaceutical and Biotechnology Companies, so act now to avoid disappointment. Put simply, you can't afford to miss out! The conference helps you to overcome common business development hurdles, like access and face to face networking with the right people with hours of scheduled networking time. Global Pharmaceuticals will put you face to face with people that matter in this industry. Join our existing partners at this prestigious event
  6. 6. REGISTRATION FORM HOTEL INFORMATION Hotel J W Marriott I / We / would like to attend / nominate the following Please tick I enclose my Cheque/Draft payable to INFORMEDIA INDIA PVT. LTD. by post at 204-205, Town Centre, Andheri-Kurla Road, Sakinaka, Andheri (E), Mumbai - 400059 I am paying by bank transfer (copy attached) I cannot attend this event but I would like to purchase the Conference Documentation for Euro 150 + 12.36 % Service Tax Please do not include me on your mailing list REGISTER NOW in 3 Easy Steps Call: Sarfraz Patel Cell: +91 98 33487628 Tel: +91 22 40820183 Fax: +91 22 28509590 Register Online 1 2 3 Delegate 1 Delegate 2 Delegate 3 Designation Tel/Mobile/Fax Email ID Organisation Address Approving Authority Name Pin Code Name/ Designation Signature Feesareinclusiveofallprogrammedocuments,lunchonbothconferencedaysandrefreshments.Thefeesdo not cover travel and accommodation costs. Following completion and return of the registration form including the authorized signature, full payment is required within 5 working days from receipt of invoice. PLEASE NOTE: payment must be received prior to the conference date. Admission to the event cannot be guaranteedifthepaymenthasnotbeenreceivedbyInformediaIndiaPvt.Ltd. Provided the total fee has been paid, substitutions can be made at any time free of charge. Cancellations must be received in writing bymail or fax 5 working days before the conference in order to qualify for a Credit Note which will be valid for 6 months after the date of issue. Thereafter, a Credit note cannot be issued. Nonpaymentornon-attendancedoesnotconstitutecancellation.If,foranyreason,InformediaIndiaPvt.Ltd. decides to cancel or postpone this conference and / or workshop/s, Informedia India Pvt. Ltd. is not responsibleforcoveringairfare,hotelorothertravelcostsincurredbythedelegate.Incaseofcancellationor postponement, the fee qualifies for a credit note equal in value for any future event organized by Informedia IndiaPvt.Ltd. All Intellectual Property Rights in all materials produced or distributed by Informedia India Pvt. Ltd. in connectionwiththiseventisexpresslyreservedandanyunauthorizedduplication,publicationordistribution isprohibited. Event programme content and the event venue can be subject to change without notice and does not impact theTermsandConditionsspecifiedin1.and2. With his or her signature, the delegate acknowledges that they have read and understood all terms of this contractincluding,withoutlimitation,theprovisionsrelatingtocancellationandtopaymentterms. Terms & Conditions 1. 2. 3. 4. Please note that 12.36% service tax will be applicable on the above mentioned fees Fees Package Euro 1,399Euro 899 For International DelegatesFor Indian Delegates Conference: 3rd - 4th December 2008 | Venue: Hotel J W Marriott, Mumbai Juhu Tara Road, Mumbai - 400 049, India Tel: +91 22 66933000 Fax: +91 22 66933100 Best Practice in Service Outsourcing Global Pharmaceuticals Research & Manufacturing India 2008 Global Pharmaceuticals Research & Manufacturing India 2008