Drug Discovery & Development of Innovative Therapeutics India

Event Overview
This conference has been expanded and enhanced to showcase how international and Indian companies are actively incorporating India as part of a global strategy to accelerate drug discovery, become more efficient in clinical development or to strategically position themselves to take advantage of India's rapidly expanding pharmaceutical marketplace. Two conference tracks: "Discovery to Innovation" and "Clinical Trials in India" will feature multiple case studies from Western companies who are actively leveraging the "India Advantage" through on-the-ground R&D activities in India or through partners and CROs in India. Speakers will share their day to day practical experiences, challenges, and lessons learned. In addition, top Indian pharma and biotech companies like Ranbaxy, Dr. Reddy's, Biocon, Nicholas Piramal, Wockhardt, Torrent, Avesthagen, Dabur and others have confirmed as speakers to share their companies' R&D strategies and partnership objectives as they expand their R&D capabilities and global initiatives.

Objective
India's pharmaceutical and biotechnology market is growing exponentially and new regulations, more start-up companies and expanding capabilities in R&D mean constant change and new opportunities to leverage India as part of your own R&D efforts. Whether you are interested in outsourcing activities from discovery to preclinical to reduce R&D cost, finding partners for risk-based scientific R&D, learning about the emerging business models for partnerships in India, outsourcing clinical trials in India to take advantage of cost savings or to gain access to India's diverse patient population or setting up your own R&D operation in India…by attending this event, you will gain enough information and make enough contacts to equal months of due diligence…in only three days!

Event Highlights

50+ Speakers

NEW! "Meet the Speakers"

NEW! Rapid-fire Partnering

NEW! Business Card Exchange

Company Showcases

NEW! Two Conference Tracks

NEW! Networking Dinner

Poster Presentation Session

Site Visits to ACT & ICICI

Learn About East-West Alliances and Evolving Partnering/Business Models to Help You Find Partners and Collaborators

Attend this event and learn how to leverage the "India Advantage" in your drug discovery or clinical development efforts.

Learn About East-West Alliances and Evolving Partnering/Business Models to Help You Find Partners and Collaborators

Risk-share R&D anti-cancer collaboration - Dr. Reddy's/ClinTec

Joint development collaboration - Eli Lilly/Nicholas Piramal

The genesis of an East-West collaboration - William Harvey RI/Nizam's Institute

Taking outsourcing to the next level - Wyeth/GVK

Explore New Strategies for Discovery and Research Innovation

Preclinical development challenges - Merck

Translating innovation into therapeutics - Imperial College London

Becoming a research-based pharma company - Ranbaxy

Novel approach for the treatment of diabetes - Torrent

Antibacterials and phage-based technologies - GangaGen

Evaluate How Conducting R&D in India Can Be Part of Your Global Strategy

Establishing a development operation in India - Genzyme

Innovative biologics: offshoring vs. outsourcing - Actis Biologics

Establishing an R&D center in India - Nektar Therapeutic

Leveraging India to develop drugs with genetic chemistry - Evolva Biotech

Hear the True Story About How India is Positioned for Clinical Trials through Multiple Case Studies

Case study of a major multinational phase III respiratory study - Altana

Conducting a global clinical trial in India: A case study - AstraZeneca

Case Study of a Clinical Trial for Depression - Targacept

Partnering and outsourcing with CRO's and hospitals

True costs, capabilities and strengths/weaknesses in India

Plus! Featured Sessions on…

Pre-Conference Workshop: Emerging Trends in Biotechnology

The investment landscape of pharma/biotech in India

What's next in Indian biotechnology? - Avesthagen, Biocon, Intas

Agenda
Optional Pre-Conference Workshop
Wednesday, October 10, 2007
| DAY ONE | DAY TWO | DAY THREE |
Emerging Trends in Biotechnology
The role of biotechnology in delivering new products and technologies to the market has been well documented. As India's biotechnology industry becomes more sophisticated, new opportunities are emerging to capitalize on the growth of the expanding market for biotherapeutics. This workshop will provide an overview of emerging biotechnology trends, technologies and applications for product development.
8:30 Morning Refreshments and Business Card Exchange
9:00 Chairperson's Welcome and Opening Remarks
Nalini Motwani, Ph.D., President, ApoLife, Inc., USA
9:05 RNAi Technologies and Other Biologics Initiatives at Merck
Bharatt M. Chowrira, Ph.D., Vice President, Sirna Therapeutics; Executive Director, Worldwide Licensing & External Research, Merck and Co., Inc., USA
9:35 Antibodies and Beyond Antibodies
Nalini Motwani, Ph.D., President, ApoLife, Inc., USA
10:05 Refreshment Break
10:30 Emerging Biotechnologies
Ramani A. Aiyer, Ph.D., Chief Scientific Officer, Actis Biologics
11:00 Intellectual Property Trends in Biotechnology
Janet M. McNicholas, Ph.D., Partner, Bell Boyd & Lloyd, LLC, USA
11:30 Panel Discussion
12:00 Close of Workshop and Luncheon for Workshop Attendees

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Main Conference - Day One
Wednesday, October 10, 2007
| PRE-CONFERENCE WORKSHOP | DAY TWO | DAY THREE |

1:00 Conference Welcome and Business Card Exchange Session
1:05 Chairperson's Opening Remarks
Bharatt M. Chowrira, Ph.D., Vice President, Sirna Therapeutics and Executive Director, Worldwide Licensing & External Research, Merck and Co., Inc., USA
Keynote Presentations
1:10 The Preclinical Development Challenge: Managing Pipeline Flow
With the large increase in number and diversity of pipeline opportunities, R&D organizations are challenged by the need to solve new and complex science problems while increasing speed and efficiency of operations. This presentation will highlight examples of innovation and operations in the Merck Preclinical Development area, emphasizing equal importance and interdependence of these parameters in addressing the challenge of pipeline flow.
Richard Tillyer, Ph.D., Senior Vice President and Head, Worldwide Preclinical Development, Merck & Co., Inc., USA
1:40 Integration of Commercial, Discovery and Development: Medicinal Products of Differentiated Value
Dr. Reddy's Laboratories has focused its expertise in drug research and development on metabolic and cardiovascular disorders with a goal to generate multiple high quality projects in the pipeline with a faster than average time to market for new products. This presentation will discuss our strategy mixing technology, a strong discovery effort, partnering and licensing, inventive clinical programmes and a strong commercial focus to do cost-effective drug development.
Rajinder Kumar, President, Research, Development and Commercialization, Dr. Reddy's
Case Studies of Evolving Partnering and Business Models
2:10 Risk Sharing R&D Alliances: An Evolving Drug Development Business Model in India
In addition to outsourcing and CRO type services a new risk-reward sharing pharma R&D business model is fast emerging in India. Recently several Indian companies including Ranbaxy have established risk sharing R&D partnerships with big western pharma companies. A survey of the current landscape as well as Ranbaxy's experience and opportunities for such alliances will be presented. Shyam Bishen, Ph.D., Vice President, Corporate Development, Ranbaxy, USA
2:35 Case Study of a Risk-Share R&D Collaboration for an Anti-Cancer Compound: NCE Development & Globalization
The pharmaceutical industry is experiencing global pressures on cost, time and scarcity of expertise. ClinTec International and Dr Reddy's Laboratories have developed an innovative business model to combat these pressures. Through leveraging each others core competencies for mutual benefit they aim to fast-track NCE's from India to the global marketplace. Rabinder Buttar, Ph.D., President & Founder, ClinTec International, United Kingdom
3:00 Refreshment Break, Exhibits/Posters & "Meet the Speakers" Session
3:45 Case Study of the Nicholas Piramal/Eli Lilly Risk-Reward Partnership to Accelerate Drug Development
Nicholas' Piramal's recently announced collaboration with Eli Lilly represents a new model of innovative drug development partnership in India. This risk/reward collaboration involves joint development of several pre-clinical drug candidates from Eli Lilly in multiple therapeutic areas. The deal is not a contract-based activity but a synergy between the two companies aiming to speed up drug development. The NPIL-Lilly alliance seeks to increase productivity in drug development by synergizing the unique strengths of both companies and equitably sharing risk and reward. Details of this partnership and other R&D partnerships will be discussed.
Swati A. Piramal, M.D., Ph.D., Director - Strategic Alliances & Communications, Nicholas Piramal India Limited
4:10 Embracing Cross-Border Alliances to Expand and Advance Drug Discovery Activities
Merck is redefining product discovery and development with a focus on novel science. This presentation will describe some of the approaches that Merck is taking, including increasing cross border alliances and collaborations with companies that focus on high quality, novel research. Merck has been very active in establishing alliances with companies worldwide for products in development as well as research technologies. The presentation will also discuss ways for companies to successfully navigate through the deal-making process at Merck, as well as win-win alliance management once the deal is signed.
Bharatt M. Chowrira, Ph.D., Vice President, Sirna Therapeutics and Executive Director, Worldwide Licensing & External Research, Merck and Co., Inc., USA
4:35 The Genesis of an East-West Collaboration between William Harvey Research Institute and Nizam's Institute of Medical Sciences
As R&D activities become more global in nature, research organizations can maximize their impact and efficiencies through partnering and/or through conducting R&D in different geographies. This presentation will discuss the strategy behind this east-west collaboration including how the collaboration came about, and the potential benefits and synergies for each side.
Mark Caulfield, M.D., Director and Professor of Clinical Pharmacology, William Harvey Research Institute, United Kingdom
MUR Naidu, M.D., Dean Faculty of Medicine and Professor of Clinical Pharmacology, Nizam's Institute of Medical Sciences
Panel Discussion
5:00 Partnership Models Based on Innovation: How Are East-West Collaborations Evolving?

Where are the current business models in both preclinical and clinical?
What do Western companies want from a deal? What do Indian companies want?
How widespread is the movement for Indian companies to reinvent themselves from CRO to innovator?
How are hybrid companies (part CRO, part innovator) evolving?
Moderator: Jitendra Patel, Ph.D., Director, Strategic Planning and Business Development, AstraZeneca, USA
Panelists:
Balu Balasubramanian, Head of Preclinical Outsourcing, Bristol-Myers Squibb, USA
Shyam Bishen, Ph.D., Vice President, Corporate Development, Ranbaxy, USA
Swati A. Piramal, M.D., Ph.D., Director - Strategic Alliances & Communications, Nicholas Piramal India Limited

5:45- Opening Night Cocktail Reception in the Exhibit Hall

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Main Conference - Day Two
Thursday, October 11, 2007
| PRE-CONFERENCE WORKSHOP | DAY ONE | DAY THREE |

8:30 Business Card Exchange
8:35 Chairperson's Welcome and Opening Remarks
Bhaskar Venepalli, Ph.D., President and CEO, CiVentiChem, USA
Establishing an R&D Operation in India as Part of a Global Strategy
8:40 India as a Global R&D Hub: A Case Study of the Infrastructure of Hyderabad's Genome Valley
B.P. Acharya, Managing Director, Andhra Pradesh Industrial Infrastructure Corporation, (APIIC)
8:50 A Multi-Pronged Approach for Establishing a Development Operation in India
Genzyme is in the early stages of establishing a development operation in India. There are many factors we considered, including how to seamlessly integrate such an operation as part of a global clinical development strategy. This presentation will describe the motivations behind our interest in India, give an overview of the due diligence that we undertook and provide an overview of experiences gained to date. P.K. Tandon, Ph.D., Senior Vice President, Global BioMedical Operations, Genzyme, Inc., USA
9:15 Innovative Biologics Research in India: Actis Biologics as a Case Study of Offshoring vs. Outsourcing
Actis Biologics is one of the few companies currently conducting innovative biotechnology research (as opposed to biosimilars/biogenerics) in India. We in-license novel technologies from the West and develop them further in India for commercialization worldwide. We were faced with the issue of offshoring vs. outsourcing to India, both of which have their pros and cons. How do you weigh one against the other and determine what makes sense? This presentation will present a case study of why we chose to offshore as opposed to outsource.
Sanjeev Saxena, Chairman and CEO, Actis Biologics, India
9:40 Refreshment Break, Exhibits/Posters & "Meet the Speakers" Session
10:25 Strategy to Accelerate the Drug Development Process
The ongoing challenge in the global pharmaceutical industry is to bring superior medicines to the market place faster and more cost effectively than the competition. Many companies have moved drug manufacturing to India primarily to reduce costs. While cost is a factor, we focused on establishing a Research and Development capability because of the opportunity to rapidly attract highly talented and competent staff. We will review our experiences over the last two years which have been generally very positive.
David Johnston, Ph.D., Senior Vice President, R&D, Nektar Therapeutics, USA
10:50 Case Study of a Major Multinational Phase III Respiratory Study Conducted at a New R&D Centre in India
This case study will report on the successful conduct of a multinational Phase III study in the respiratory area under a US-IND, following placement of a major R&D Centre in Mumbai and six years of experience in the ICH-GCP trial arena in India. The case study will highlight: India as performance driver and contingency country, Timelines and issues with start up and approvals, Comparative study operational performance metrics and costs, Patient numbers and enrolment challenges, Investigator pool and quality measures.
Antal K. Hajos, Ph.D., Managing Director, ALTANA Pharma Private Ltd, a Nycomed company, Germany/India
Panel Discussion
11:15 R&D in India: The Landscape of Opportunities, Challenges and Real-Life Experiences
This panel discussion will highlight the expanding infrastructure in India to accommodate drug discovery and clinical research. It will also provide lessons learned and real-life experiences from companies who have selected India for an R&D site.
Moderator: Bhaskar Venepalli, Ph.D., President and CEO, CiVentiChem, USA
Panelists:
David Johnston, Senior Vice President, R&D, Nektar Therapeutics, USA
Sanjeev Saxena, Chairman and CEO, Actis Biologics, India
B.P. Acharya, Managing Director, Andhra Pradesh Industrial Infrastructure Corporation, (APIIC)
P.K. Tandon, Ph.D., Senior Vice President, Global BioMedical Operations, Genzyme, Inc., USA
P.M. Murali, Managing Director, Evolva Biotech Pvt. Ltd.
12:00 Luncheon, Exhibits/Posters and "Meet the Speakers" Session
Track 1: Discovery to Innovation
1:00 Chairperson's Remarks
Jitendra Patel, Ph.D., Director, Strategic Planning and Business Development, AstraZeneca, USA
Beyond Outsourcing to Collaborative Research
1:05 Taking Outsourcing to the Next Level: Case Study of the GVK/Wyeth Deal
Wyeth and GVK BIO are in the second year of an innovative and productive synthetic organic chemistry partnership. The rationale to establish this large outsourcing arrangement with one partner as opposed to smaller arrangements with many partners will be discussed. The functional synthetic activities and their impact will be described. Operational attributes and strategic objectives of the relationship will be highlighted, focusing on approaches in the management of this long distance partnership.
Jerauld Skotnicki, Ph.D., Senior Director, Chemical and Screening Sciences, Wyeth Research, USA
1:30 Developing a Cell Biology Outsourcing Partnership in India for Cancer Discovery Research
Capabilities in higher-value biology and preclinical services continue to emerge in India. Advances in biological sciences provide molecular targets for diagnosing and treating cancer. Molecular markers can be used for accurate prognosis and predict response, resistance, and toxicity to therapy. This presentation will discuss a cancer discovery research partnership, including the scientific basis for the partnership, experiences conducting research in India and lessons learned from the partnership.
Swati Bhattacharya, Ph.D., Vice President, Biology Solutions, Simbiosys Biowares, Inc., USA
1:55 Is there a Win-Win Partnering Strategy for US Biotech and Indian Pharma?
As the globalization of the pharmaceutical industry continues, more opportunities are emerging for building partnerships between innovation driven US biotechnology companies and the resource rich Indian pharmaceutical sector. This presentation will outline partnering strategies that could be highly attractive for the future development of new medicines while producing phenomenal financial returns.
Vipin K. Garg, Ph.D., President and CEO, Tranzyme Pharma, USA
2:20 Trends in Licensing - Emergence of Regional Licensing
For a product to be rightly leveraged across markets, emergence of regional deals are on the rise . What are the implications for both licensors and licensees? Using examples of recent regional deals executed in Asia- Pacific, this presentation will discuss how we build business development agendas, execute transactions and manage partnerships going ahead.
M. Sridhar Gopal, Associate Director, Asia Pacific, Strategy Planning & Business Development, AstraZeneca, Singapore
2:45 Refreshment Break, Exhibits/Posters & "Meet the Speakers" Session
Innovative Models for Drug Discovery
3:30 Case Study of Evolva's Business Model to Leverage the "India Advantage" and Develop Drugs with Genetic Chemistry
Evolva is a Swiss-based drug discovery company whose Watchmaker technology relies on assembling genes and pathways in the development of small molecules to drug targets. Evolva established an India operation less than two years ago with the support of India's CSIR, IICT and various investors including APIDC-VCL. Evolva may be among the few true stand alone drug discovery companies in India and this presentation will discuss our business model for leveraging India's strengths as part of our global R&D operation.
P.M. Murali, Managing Director, Evolva Biotech Pvt. Ltd., Switzerland/India
3:55 Innovative R&D Partnering Models and a New Approach to Drug Discovery: Translating Innovation into Therapeutics
Research-led universities are well placed to develop new concepts for tackling disease into novel therapeutics, but have found it very difficult to develop therapeutics to a point at which they can be taken up by industry. This presentation describes a major initiative to bridge this innovation gap and develop a new approach to drug discovery and development through innovative models and India partnerships.
Cathy Tralau-Stewart, Ph.D., Head of Drug Discovery Programme, Imperial College London, United Kingdom
4:20 In Silico Platforms for Drug Discovery
Computational tools have become indispensable to the successful discovery of NCEs and drugs. These tools are employed throughout the discovery process starting from target identification all the way through clinical trials analysis. Successful development and use of in silico models to simulate biological systems requires tying together both analytical tools and data sources into an effective R&D platform. In this presentation, I will provide an overview of efforts underway at TCS in building such a platform.
M. Vidyasagar, Ph.D., Executive Vice President, Advanced Technology, Tata Consultancy Services, India
Rapid-Fire Partnering Session: Open to Conference Attendees
4:45 Discovery/Innovation Companies
This partnering session is designed to provide attendees of the conference an opportunity to share with the audience in a short 2-3 minute presentation a summary of your company, partnering goals or business objectives. Advance registration is required and space is limited. For more information, please contact us at info@bharatbook.com
Track 2: Clinical Trials in India
1:00 Chairperson's Remarks
Rabinder Buttar, Ph.D., President & Founder, ClinTec International, United Kingdom
Clinical Trials: Day-to-Day and Practical Experiences in India
1:05 Practical Experiences Conducting a Global Clinical Trial in India: A Case Study
This presentation will discuss experiences of conducting global clinical trials in India. Some of the aspects that will be addressed are: trial logistics, site selection, patient recruitment, interactions with India's regulatory authority and investigators.
Joher Raniwalla, Vice President, Medical and Regulatory, AstraZeneca Pharma India Ltd.
1:30 An Indian Trial of Mecamylamine in Depressed Patients Who Were Poor Responders to Citalopram
This case study presentation will discuss a clinical trial we conducted in India. The rationale for the trial will be explained and the design of the study (which was flexible dose, double-blind, randomized and placebo controlled) given. The very positive results will be presented and the issues we experienced in setting up and running the study will be described.
Geoffrey C. Dunbar, M.D., Vice President, Clinical Development and Regulatory Affairs, Targacept, Inc., USA
1:55 Clinical Research in India: Challenges and Opportunities
What are some of the key advantages and challenges of doing clinical trials in India? How does India compare with other Asian countries and ascending markets in terms of cost, quality and timelines? What is its place in the global market? What are the novel potential opportunities for India to differentiate itself from other countries?
Richa Chandra, M.D., Global Clinical Lead, Malaria Program; Senior Director, Infectious Diseases, Pfizer Global Research & Development, USA
2:20 Case Studies in India: Experiences and Challenges Faced by a CRO
This presentation will focus on ground realities of conducting clinical studies in India and a CRO's perspectives and experiences through case studies. The case studies will also detail the challenges and lessons learned from conducting large and complex clinical studies in India.
Venkatraman Sunder, Vice President, Business Operations, Asian Clinical Trials, a division of Suven Life Sciences Limited
2:45 Refreshment Break, Exhibits/Posters & "Meet the Speakers" Session
3:30 Keeping Up with Demand for Qualified Scientists and Managers in India: The Human Resource Challenge of Rising Wages and Declining Arbitrage
Talent availability is emerging as a major constraint to the aggressive growth plans in the clinical research space in India. Unbridled attrition and poaching of trained resources is affecting all companies and there are emerging client concerns with regard to attrition and salary growth in India. This presentation will address these issues in the short and long term and discuss opportunities for collaboration to benefit the sector.
Chetan Tamhankar, Chief Operation Officer, SIRO Clinpharm Pvt.
3:55 Outsourcing Models for Clinical Research In India
Pfizer India has been engaged in clinical trials in India for over 12 years now. In these years Pfizer has implemented various sourcing models for its clinical research activities. This presentation will focus on case studies and experiences of working with Managed Service providers, Functional Service providers and Full service providers and will include practical experiences working with CROs in India, highlighting what works well and what doesn't.
Mohanish Anand, Ph.D., Senior Manager, Outsourced Clinical Operations, Clinical Research Department, Pfizer Limited
4:20 Phase IV Studies in India: Opportunities and Challenges
Conducting Phase IV studies in India can offer all the same advantages that a registration trial does; plus perhaps a few more. Brisk enrollment, fewer regulatory hurdles; good quality data are some of the many advantages. CROs have the infrastructure and people to manage such trials. However, Phase IV can pose some unique challenges too. Restricted availability of good quality sites, patient compliance on a longer duration study, physician compensation and competing phase III studies could be the major challenges.
Mubarak Naqvi, M.D., Consultant, Odyssey Research/Institute of One World Health
4:45 Overview of the Indian Society for Clinical Research (ISCR)
Chetan Tamhankar, General Secretary, ISCR
Rapid-Fire Partnering Session: Open to Conference Attendees
4:55 Clinical Service Companies/CROs
This partnering session is designed to provide attendees of the conference an opportunity to share with the audience in a short 2-3 minute presentation a summary of your company, partnering goals or business objectives. Advance registration is required and space is limited. For more information, please contact Michael Keenan at info@bharatbook.com
5:15 Cocktail Reception
6:30 Attendee Networking Dinner
A networking dinner featuring local Indian delicacies and entertainment will provide an excellent opportunity to meet other attendees and speakers outside of conference sessions. Space is limited and an additional fee applies.


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Main Conference - Day Three
Friday, October 12, 2007
| PRE-CONFERENCE WORKSHOP | DAY ONE | DAY TWO |

8:15 Business Card Exchange
8:20 Chairperson's Remarks
Vipin K. Garg, Ph.D., President and CEO, Tranzyme Pharma, USA
The Investment Landscape of Pharma/Biotech in India
8:25 VC Perspective on Investing in India's Biopharma Industry
This talk will give an overview of trends in India's biopharma industry, with a focus on those most relevant to venture investing opportunities. It aims to provide businesses and entrepreneurs with a sense of how US-based VCs evaluate investment opportunities, highlighting some of the current hurdles to securing venture capital in India and posing questions about ways to move past those hurdles.
Stephen Knight, M.D., Managing Partner, Fidelity Biosciences, USA
8:50 Reaping What You Have Sown: Finding a Meaningful Exit from Your Investment in India
Recent years have witnessed substantial investment in India's life sciences industries from multinational corporations, financial sponsors, and local Indian companies and entrepreneurs. As the market continues to mature, shareholders may start contemplating a more imminent exit from their investments and how to achieve the best liquidity outcome in today's global marketplace.
Anurag Sharma, Investment Banker, William Blair International
9:15 Investing in the Life Sciences in India: Speaker Q&A and Mini-Panel
9:45 Refreshment Break & "Meet the Speakers" Session
What's Next in Indian Biotechnology?
10:15 Creating Innovative Products Cost-effectively: The Biocon Strategy
We collaborate with selected partners across the world who have innovative ideas, then use Biocon's considerable India-based capability to create a cost-effective fully integrated new-product development pathway. The first of such novel products is a humanized Monoclonal Antibody for the treatment of cancer. This is being followed by several other products in the company's therapeutic focus areas which are cardio-diabetes, inflammation, and oncology.
Shrikumar Suryanarayan, President, R&D, Biocon Limited, India
10:40 Science Innovation at Avesthagen
Avesthagen looks to deliver personalized healthcare through convergence of food, pharma and population genetics. Scientific innovation and early research at Avesthagen are driven by excellence in fully integrating the competencies in bioinformatics with molecular biology across: Genome Analysis, Transcriptome Analysis, Metabolome Analysis and Lead Optimization and Recombinant Protein Expression. This presentation will describe current research activities at Avesthagen including the recently announced Avestagenome™ project.
Villoo Morawala-Patell, Ph.D., Founder and Managing Director, Avesthagen Pvt. Ltd.
11:05 The Emerging Biotech Landscape in India
This presentation will give an overview of the emerging biotechnology landscape in India, including current capabilities and strengths in biologics and therapeutic protein research and production. An overview of the biogenerics market, regulatory landscape and other emerging growth areas of biotechnology will also be discussed.
Dhananjay B. Patankar, Ph.D., Chief Technical Officer, Intas Biopharmaceuticals Ltd., India
Technology Workshop
11:30 Enzyme Therapeutics: Innovative Research at Advanced Enzyme Technologies
Advanced Enzyme Technologies (AET), a pioneer in biotechnology specializing in enzyme research and development, has developed a unique pipeline of enzyme therapeutics in the circulatory, anti-inflammatory and immuno-modulatory market segments. Our vision is to treat and prevent the underlying cause of disease and replace chemicals-based processes, with enzyme solutions. Enzymes are systemic, synergistic and interact positively with other drugs and are being studied to enhance the bioavailability and decrease side-effects of existing drugs. This presentation will highlight our research efforts and partnership objectives.
C.L. Rathi, Managing Director, Advanced Enzyme Technologies (AET)
12:00 Luncheon, Exhibits/Posters & "Meet the Speakers" Session
Track 1: Discovery to Innovation
1:00 Chairperson's Remarks
Kishore Murthy, Ph.D., Chief Scientific and Operating Officer, GangaGen Life Sciences, Inc., Canada
1:05 Ranbaxy's Approach to Become a Research-Based International Pharma Company
Outsourcing of various components of the drug discovery continuum by various international companies to Indian Pharma Companies is a common practice now a days. However, Ranbaxy has a taken a vertically integrated approach to become a research-based international pharma company. It has relied on national and international alliances to build a strong pipeline of clinic-ready new chemical entities (NCEs). In this presentation, I will discuss Ranbaxy's approach to innovative drug discovery and describe the challenges of drug discovery in the Indian Environment.
Pradip K. Bhatnagar, Ph.D., Senior Vice President, New Drug Discovery Research, Ranbaxy Laboratories Ltd., India
1:30 Novel Approach for the Treatment of Diabetic Complications
Abstract to come.
Vijay Chauthaiwale, Ph.D., General Manager, Discovery Research, Torrent Pharmaceuticals Limited, India
1:55 Collaborative Research Partnerships (CRP's): Moving up the Value Chain from Fee-for-service to Fully Integrated R&D and NCE Research
Global pharma is being challenged by losing blockbusters to generic competition, escalating R&D costs and an anemic R&D pipeline. To combat all these issues, opportunities have emerged for global pharma to align themselves with small, innovative pharma in India to save time and money as well as gain access to innovation by those with the capability to do discovery research. This presentation will offer highlights from Suven's innovation efforts and collaborative research partnerships.
Venkat Jasti, CEO, Suven Life Sciences Limited, India
2:20 Antibacterials and Phage-Based Technologies: The Role of India in a Global R&D Strategy
GangaGen is a biopharmaceutical company developing bacteriophage-based technologies for the treatment of antibiotic resistant bacterial infections. Successful interactions between our R&D facilities located in both India and Canada have led to a promising pipeline of new products. This presentation will discuss our scientific approach, technologies and product pipeline, along with our business model and strategy to leverage India's advantages into our R&D efforts.
Kishore Murthy, Ph.D., Chief Scientific and Operating Officer, GangaGen Life Sciences, Inc., Canada
2:45 Development of a Novel Multivalent Therapeutic Vaccine for Treatment of Cancer
We have designed, cloned and expressed a multivalent therapeutic vaccine, which would neutralize the over produced growth factors with the aim to not only retard the growth but also kill cancer cells. The antibody reacted not only with VIP, bombesin, substance P and EGF but also was found to localize to the surface of the cancer cells and were cytotoxic in nature. The protein is being formulated for further development work.
Rama Mukherjee, Ph.D., President, Research and Development, Dabur Research Foundation
3:10 Close of Conference
Track 2: Clinical Trials in India
1:00 Chairperson's Remarks
Outsourcing and Partnering in Clinical Trials
1:05 Partnering with CROs in India
Partnering with CROs can help sponsor companies save time, increase productivity, and reduce financial risk, depending on the type of alliance. Having a good CRO selection process may well ensure the selection of a CRO that has the right capability, capacity, compatibility and cost fit that would enable a mutually beneficial and perhaps long-term association. This presentation will focus on the India story and how MNCs are leveraging the partnering model to their advantage. It will also identify the critical parameters that drive these kind of alliances.
Utkarsh Palnitkar, Partner, Transaction Advisory Services, Industry Leader, Healthsciences, Ernst and Young
1:30 Outsourcing of Clinical Data Management in India
Clinical Data Management in India has been going at over 40% p.a over the past 5 years. Recent announcements by big pharma seem to indicate a strategy of outsourcing a large fraction of the data management function within the organization to a single vendor popularly known as 'Function Service Provider' model, especially with operational capabilities in India. With electronic data capture becoming more popular with clinical investigators and sponsors alike, most of the new data management work embraces this new technology. These new operational models with off shoring and the new technology platforms, require new / modified processes to deliver to the expectations of the sponsor. India with its vast expertise in business process outsourcing is the right destination for this challenge.
Suresh Ramu, Executive Director, Data Management, Quintiles Technologies Pvt Limited, India
1:55 Outsourcing Options and Business Models for Pharmacovigilance in India: Drug Safety Challenges and Solutions
An increase in drug safety concerns and the number of ADRs reported has resulted in an increase in the volume of data handled. Further, high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. Companies are opting for outsourcing to an experienced and capable partner to meet this level of sophistication. Outsourcing options and business models available in India for Pharmacovigilance activities shall be discussed during the presentation along with a case study.
Deepa Arora M.D., Medical Advisor, International Clinical Research, Wockhardt Limited, India
2:20 Spearheading Clinical Trials in India: 15 Years of Practical Experience and Case Studies in Oncology
This presentation will provide a true picture of the current clinical trial environment in India from multiple phase I, II and III case studies in oncology. It will discuss capabilities, strengths and weaknesses of Indian hospitals and clinical trials centers, experiences with regulatory panels, ethics committees, the ICMR and oncology study groups in India. A discussion of performance metrics of clinical trials in India and which therapeutic areas are most amenable to clinical trials in India will also be presented.
Purvish M. Parikh, M.D., Ph.D., Professor and Head of Medical Oncology, Tata Memorial Hospital, India
2:45 INDOX (India -Oxford) Cancer Clinical Trials Network
The INDOX Cancer Clinical Trials Network is a novel collaboration between Oxford University and six large regional cancer centers in India. These centers cover over 80 % of academic oncology in India. Through a unique funding from GSK, Oxford University has trained various staff for carrying out various phase trials including Phase I trials.
Vinod Raina, M.D., Professor and Head of Medical Oncology, All India Institute of Medical Sciences (AAIMS), India
3:10 Close of Conference
3:15 Site Visits to Asian Clinical Trials and ICICI Knowledge Park
Conference attendees may choose to participate in a site visit to Asian Clinical Trials OR ICICI Knowledge Park facilities, both of which will be followed by a reception. Shuttle buses will be provided from the conference venue.
Asian Clinical Trials, a division of Suven Life Sciences Limited (Suven) is a full spectrum CRO, providing total clinical trials solutions encompassing different therapeutic areas. Added to this Suven's capabilities include Contract Research And Manufacturing Services (CRAMS), Drug Discovery and Development Support Services (DDDSS) and Collaborative Research Partnership (CRP) programs, offering seamless transition through every stage in drug development for global Pharma and Biotech companies.

ICICI Knowledge Park, a not-for-profit wet-lab research park in Hyderabad, India, promotes business-driven R&D in life sciences by creating an innovation hub in the region. IKP provides ready-to-use laboratory modules, incubation facility and land on lease to companies for building their own research centers. IKP also has two research centers on public health technologies and agricultural knowledge sharing. Currently there are 19 companies at IKP including Albany Molecular Research, Dupont, GVK Biosciences, Matrix Laboratories, Nektar Therapeutics and US Pharmacopoeia.

For more information, kindly contact us at :

Bharat Book Bureau
207, Hermes Atrium, Sector 11, PO Box.54, CBD Belapur, Navi Mumbai - 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com

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