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Drug Discovery & Development of Innovative Therapeutics India
October 20 - 22, 2008 Grand Hyatt Hotel Mumbai, India
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第1天
Monday, October 20, 2008
| DAY ONE | DAY TWO | DAY THREE | | | 8:30 | Chairperson's Welcome and Opening Remarks
Sri(dhar) Mosur, CEO and President, Jubilant Biosys, Ltd. and Managing Director, Jubilant Chemsys, Ltd., India | Accelerating Global Drug Development: The Landscape of India's Transforming Role
全球药物发现进展加快： 印度不断转变中的角色 | | 8:35 | Tools to Therapeutics: Building a Pipeline through "India-Grown Therapeutics" and Partnering
As the transformation of the Indian pharmaceutical landscape, from a manufacturing environment to an intellectually driven R&D environment continues, Indian companies (pharma and CRO's) embrace new technologies and develop integrated capabilities that offer the opportunity to create a new paradigm in global R&D partnering. The emergence of "discovery and translational biology" is quite evident in India as CRO's and pharmaceutical companies build upon the already established tools around chemistry and IT. This ongoing transformation offers the global pharmaceutical industry an opportunity to develop therapeutics of value from India going beyond traditional functional outsourcing models.
Sri(dhar) Mosur, CEO and President, Jubilant Biosys, Ltd. and Managing Director, Jubilant Chemsys, Ltd., India | | 9:00 | What Will it Take to Develop NCEs and Novel Biologics in India for the World Market? A Case Study of Aurigene
This presentation will discuss the drug development infrastructure and process in India by providing a general overview of the capabilities of Indian companies and academic/government institutes, the economic implications of innovative R&D, the regulatory system for pharmaceuticals and the intellectual property environment in India. It will attempt to answer the question of what it will take to develop drugs in India for the world market. As an example of one approach, this presentation will also discuss Aurigene's drug discovery and development capabilities, therapeutic areas of focus (oncology, metabolic disease), scientific programs and pipeline.
CSN Murthy, Chief Executive Officer, Aurigene Discovery Technologies, India | | 9:30 | Is India's Regulatory Framework Supportive of Drug Development?
This session will discuss India's emerging regulatory framework compared to that of the US and Europe, its current and future impact on R&D activities in India and how India is positioning itself globally as a destination for drug development activities. Can phase 1 trials on foreign molecules be conducted in India? What are the current regulatory hurdles in India that impede drug developers and what is being done to improve the environment for R&D?
Dr. N.K. Ganguly, Advisor to Honorable Health Minister India and Distinguished Biotechnology Fellow & Advisor, Translational Health Science & Technology Institute | | 10:00 | Indian CRO Industry Update – Financial Investors' Perspective
Having witnessed a turbulent year in the markets, industry experts pause to review how the public CRO universe has performed compared to the global stock markets. We also discuss how financial investors view early-stage versus late-stage public CRO players and the key operational metrics that drive their valuations. Finally, this session provides a recap on the merger-and-acquisition activity that has shaped the CRO industry in 2008, and discuss key trends specific to the Indian CRO industry.
Anurag Sharma M.D., Investment Banker, William Blair International, United Kingdom | | 10:30 | Networking Refreshment Break | | | Keynote Presentations | | 11:00 | R&D Advantages/ Synergies Available to Ranbaxy through Transformational Deal with Innovator Giant Daiichi Sankyo
This presentation will discuss Ranbaxy's decision to de-merge the company's new drug discovery research (NDDR) unit into a subsidiary, Ranbaxy Life Science Research Ltd. (RLSRL). We feel this decision will accelerate our discovery efforts by creating an independent pathway for new drug discovery research and provide more operational freedom and flexibility to open up new growth opportunities while providing a platform for increased collaboration. It will also enable RLSRL to create intellectual property at a faster pace while positioning it for the future to carry out path breaking research at the cutting edge of modern medicine.
Malvinder Singh, Managing Director and CEO, Ranbaxy Laboratories Limited, India | | 11:35 | Zydus' Drug Discovery Strategy and Development Pipeline - An Example of India's Move to Innovation in Drug Development
This presentation will highlight Zydus' distinctive strategies in employing an integrated R & D approach towards drug discovery and development of both small molecule NCE's and biologicals. The key therapeutic focus areas for research at Zydus Research Centre are in diabetes, obesity, cardiovascular, inflammation and pain. We will also talk about our infrastructure and capabilities at Zydus Research Centre, that helps accelerate our efforts and develop molecules from concept to pre-clinical development and human proof-of-concept.
Pankaj Patel, Chairman & Managing Director, Zydus Cadila, India | | 12:10 | Accelerating Drug Development in Pain and Oncology By Leveraging the India Advantage
Nektar Therapeutics is developing a robust pipeline of high-value therapeutics to address unmet medical needs by leveraging and expanding our industry-leading PEGylation and pulmonary drug development platforms to improve known molecules. In our ongoing efforts to accelerate drug discovery and development activities and to leverage the India advantage (speed-cost-quality), we established an R&D facility in India in 2005. The India operations provide us access to excellent chemistry, analytical development, formulations, pharmacokinetics and toxicology expertise and capabilities that enabled us to rapidly advance into development our proprietary lead product candidates in the areas of pain (NKTR-118) and oncology (NKTR-102 and NKTR-105). The presentation will focus on Nektar's experience and challenges in establishing and managing R&D operations in India.
Bharatt M. Chowrira, Ph.D., Chief Operating Officer & Head, PEGylation Business Unit, Nektar Therapeutics | | 12:30 | Opening of Exhibit & Poster Hall with Networking Luncheon | | 2:00 | Chairperson's Welcome and Opening Remarks
Venkat Jasti, Vice Chairman & CEO, Suven Life Sciences Limited, India | Investment Opportunities In India and Funding Models for Emerging R&D Innovation
印度的投资机会・针对新的R&D的资金筹措模式 | | | Panel Discussion | | 2:05 | Investing into R&D Ventures in India: The Challenges, Promise and Progress
- How does the venture capital and private equity community view investment opportunities in India?
- What are the challenges of raising capital in the India?
- How to measure the "value" of companies involved in pharmaceutical R&D?
- What exit strategies exist for investments in India?
- How should R&D ventures think about raising capital and selecting investor partners?
Panelists:
Jasmin Patel, Ph.D., Managing Director, FIL Capital Management, India
Krishna Kanumuri, Chief Operating Officer, Sai Life Sciences, India
Alok Gupta, Executive Vice President & Country Head, Life Sciences and Technology, YES BANK, Ltd., India
Sunny Sharma, M.B.B.S., Private Equity Partner, Asia, OrbiMed Advisors LLC, USA | | 2:45 | Supporting R&D for Affordable Healthcare: A New Funding Initiative in India from the Wellcome Trust
The Wellcome Trust supports R&D across a diverse range of technologies, including biologics, vaccination, diagnostics, therapeutics, regenerative medicine and small molecule drug discovery. We have enjoyed a productive relationship with Indian scientists going back more than 50 years. An area of growth is our research funding of product R&D via our India-specific funding scheme. Recently funded projects will be used to illustrate how the Wellcome Trust is seeking to catalyze innovations in healthcare through engagement with the pharmaceutical sector and with academic institutions.
Fiona MacLaughlin, Ph.D., Senior Business Analyst, Technology Transfer Division, The Wellcome Trust, United Kingdom | Implementing the FDA's Critical Path Initiative to Accelerate Drug Development
FDA针对促进药物开发的Critical Path Initiative | | 3:15 | Accelerating the Path from Discovery to Proof-of-Concept
The current business model of drug development is not sustainable: R&D costs are spiraling out of control, whilst the number of newly approved pharmacological treatments is shrinking. The FDA provided a thorough root-cause analysis in its Critical Path Initiative. "Biomarker development", "Streamlining clinical trials" and the "Application of mathematical, statistical and computational analysis to biological information" were identified as key areas with the potential to substantially improve the development of new medical treatments. This talk will describe how we are implementing Critical Path philosophy into an R&D organization on a day-by-day basis. We will discuss in general terms how biomarker development, simulation guided clinical trial design and model based drug development approaches can facilitate earlier and better decision-making, from the selection of a candidate to Proof-of-Concept. We then will illustrate the application of this framework on a virtual case study.
Michael Krams, M.D., Assistant Vice President, Clinical Development, Wyeth Research, USA
Amarnath Sharma, Ph.D., Assistant Vice President, Clinical Development, Wyeth Research, USA | | 3:45 | Networking Refreshment Break in Exhibit & Poster Hall | Biomarker Discovery and Novel Molecules in CNS: Accelerating Discovery to the Clinic
CNS的生物标记发现及新分子： 加快从药物研发到临床的速度 | | 4:15 | Suven's Discovery Infrastructure, Scientific Approach and CNS Pipeline
At Suven, we have successfully integrated several new technologies and novel strategies to design and develop a series of molecules in CNS discovery leading to a portfolio of potential candidates for Alzheimer's, Parkinson 's, Schizophrenia and Mild cognitive impairment diseases. Integration of multiple in vivo models, PK-PD correlations, and safety data early-on in the discovery is a key success factor. The first molecule SUVN-502 completed GLP TOX studies and has been approved for the Phase-I Clinical Trails in Switzerland. This talk will outline Suven's discovery infrastructure, scientific approach, how Suven successfully adopted multidimensional optimization of challenges leading to a candidate selection – clinical trails in a tough CNS project.
Venkat Jasti, Vice Chairman & CEO, Suven Life Sciences Limited, India | | 4:45 | Biomarker Discovery in Parkinson's Disease: Gene Expression Comparison of De Novo Blood and Post Mortem Brain
Our research program is focused on the validation of biomarkers for Parkinson's disease. To identify candidate markers, we have conducted gene expression profiling on 21 postmortem brain regions from end-stage Parkinson's disease patients and matched aged control patients with no history or pathological diagnosis of neurologic or psychiatric disease. Results of this study will be presented. Preliminary gene expression analysis of blood samples from de novo mid-stage PD patients will also be presented, identifying common disregulated genes in blood and brain from PD patients.
Jarlath M H ffrench-Mullen, Ph.D., Scientific Director, Gene Logic/Ocimum Biosolutions, USA | | 5:15 | Predictive Validity of the Chakragati Mouse Model in Antipsychotic Drug Screening
The chakragati (ckr) mouse, which was serendipitously created as a result of a transgenic insertional mutation, has been proposed as a model of schizophrenia. The mice exhibit phenotypes which parallel aspects of the pathophysiology of schizophrenia. To investigate the predictive validity of the model, we studied the dose-dependent suppression of spontaneous motor activity in ckr mice on treatment with a range of typical and atypical antipsychotic drugs. Suppression of spontaneous motor activity in the ckr model correlated with clinically equivalent doses of these drugs, suggesting that the ckr model has predictive validity for screening of antipsychotic drugs.
Anil K. Ratty, Ph.D, Chief Scientific Architect, Chakra Biotech, Malaysia | | 5:45 | Opening Night Cocktail Reception in Exhibit & Poster Hall
Sponsored by:
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第2天
Tuesday, October 21, 2008
| DAY ONE | DAY TWO | DAY THREE | | | 8:30 | Chairperson's Welcome and Opening Remarks
Yetunde Taiwo, Ph.D., Director, Global External R&D, Eli Lilly & Co., USA | Accelerating Innovation and Building Your Portfolio through Partnerships
技术创新速度加快及透过夥伴关系建构治疗技术档案 | | 8:35 | The Emergence of Asia as Source for Biopharmaceutical Innovation: Perspectives from a European Pharmaceutical Company
During the past few years we have witnessed the emergence of a vibrant innovation-based biopharmaceutical industry in Asia. Recently, global pharmaceutical companies have entered into a broad range of collaborations with smaller-sized R&D based companies in countries such as India and China. The underlying business models of these collaborations vary broadly, ranging from mere outsourcing / fee-for-service type of agreements to broad collaboration and license agreements on clinical stage assets. This presentation will discuss Boehringer Ingelheim's cultural experiences, business activities and R&D collaborations in Asia (India, China, Taiwan, Korea).
Klaus K. Wilgenbus, M.D., Corporate Senior Vice President, Global Licensing, Boehringer Ingelheim Pharma GmbH, Germany | | 9:05 | Global Partnerships and Strategies to Bring Innovative Therapeutics to Market
The changes in global pharmaceutical industry continue to put pressure on developing new and different methods of bringing innovative therapeutics to market. In addition to traditional partnership structures, we are actively exploring novel shared risk: shared reward partnership structures by which clinically differentiated Lilly and external partner assets can be expediently developed. This presentation will discuss Lilly's approach to identify scientific innovation and capabilities with an emphasis on current activities and opportunities in India.
Yetunde Taiwo, Ph.D., Director, Global External R&D, Eli Lilly & Co., USA | | 9:35 | Building a Global, Clinical-Stage, Biopharmaceutical Company Based Out of India
Avaan Therapeutics accelerates new drug candidates to clinical proof of concept in India and US. Avaan deploys risk-capital on early-stage clinical assets addressing substantial unmet clinical need. The founding team (former Pfizer executives and researchers) has a successful track record of identifying and developing blockbuster new drugs in regulated markets. This team brings to Avaan a potent combination of molecule selection/protocol design capabilities and integrated clinical operations. This presentation will focus on a partnering case study involving innovative approaches to molecule evaluation and cross-border clinical trials execution.
Rajnish Mishra, Ph.D., President and CEO, Avaan Therapeutics, Inc., India | | | Keynote Presentation | | 10:00 | Glenmark's Infrastructure for Innovation in Drug Development and the Role of International Partnerships
Glenmark is a leader in India in the discovery of new molecules (both NCE's and Biologics) and is focused in the areas of inflammation (Asthma/COPD, etc.) and metabolic disorders (Diabetes, Obesity, etc.) This presentation will discuss the infrastructure that has been put in place to accelerate the drug development process at Glenmark Pharmaceuticals. It will also highlight the important role of international partnerships in building a global pharmaceutical company.
Glenn Saldanha, Managing Director and CEO, Glenmark Pharmaceuticals, India | | 10:30 | Networking Refreshment Break in Exhibit & Poster Hall | Building a Portfolio in Oncology: Novel Approaches, Technologies and Molecules from Discovery to POC
癌症治疗的档案建构： 从药物发现到POC的创新方法、技术、分子 | | 11:00 | Translating Biology to Clinical Development; Multiple Myeloma as a Prototype for Drug Development
Preclinical models in multiple myeloma (MM) have allowed for delineation of mechanisms of tumor cell homing to bone marrow (BM); adhesion to extracellular matrix proteins and BM stromal cells; and cytokine-mediated growth, survival, drug resistance, and migration within the BM milieu. Delineation of the signaling cascades mediating these sequelae has identified multiple novel therapeutic targets in the tumor cell and its BM microenvironment. This understanding of biology has allowed the rapid translation of novel therapeutics either alone or in combination and has led to the US FDA approval of 4 different drug combinations in the treatment of MM in the last 5 years. An overview of this rapid translation will be provided with emphasis on novel agents currently in early and late stage clinical development.
Noopur Raje, M.D., Director, Multiple Myeloma Program, Massachusetts General Hospital and Assistant Professor of Medicine, Harvard Medical School, USA | | 11:25 | Banking on Technology to Build a Valuable Drug Pipeline in Cancer and Other Indications
NovaLead Pharma discovers and develops small molecule therapeutic agents capable of multiple mechanism of action for unmet needs and diseases with limited drug options. Advancements in computing technologies have been leveraged in developing VLifeAmadeus – a versatile virtual screening platform and VLifeBiblica – a cross domain knowledge compendium to improve the quality of preclinical candidates and increase productivity, as evidenced by Novalead's rapidly growing pipeline. The pipeline includes indications as diverse as pancreatic cancer to anti-fungals, diabetes and wound healing. VLI27, the lead compound in pancreatic cancer has achieved proof of concept in animals and is progressing rapidly towards IND filing. This presentation will discuss our technology, discovery/development infrastructure, pipeline and business strategy.
Supreet Deshpande, CEO, Novalead Pharma Pvt. Ltd, India | | 11:50 | From Discovery to Proof-of-Concept in Oncology and Metabolic Disease
This presentation will discuss the scientific advances and R&D strategies that have led to NPIL's filing of an Investigational New Drug (IND) application for its lead molecule P-276 in oncology, as well as NPIL's scientific capabilities and NCE pipeline in various therapeutic areas including oncology and metabolic disease. NPIL's vision for leveraging the strengths of R&D in India with global partnerships, to accelerate the discovery of drugs for worldwide markets will also be presented.
Somesh Sharma, Ph.D., Chief Executive Officer, Piramal Life Sciences, Ltd., India | | 12:15 | Preclinical Strategies to Improve Compound Selection and Clinical Outcomes in Cancer Drug Discovery Using New, Mini, Human-Tissue Models
New 3-D or mini-tumor bioassay systems are developed which allow robust drug screening, precise functional analysis and better preclinical prediction. Using a patented HuBiogel culture technology, mini-tumor bioassay platform is established with NCI-60 tumor panel. Real-time analysis of tumor growth, invasion and angiogenesis is accomplished. Validation studies include reporting of new drug candidates, why a lead cancer drug failed in clinical trials and chemo-response profiling in patients. High-value utility of 3-D tumor model is demonstrated through R&D and alpha site collaborations.
Raj K. Singh, Ph.D., President and CEO, Vivo Biosciences, Inc., USA | | 12:40 | Thomson Reuters: Supporting Critical Decisions from Bench to Launch
As India's pharmaceutical industry moves from an outsourcing, manufacturing model towards engaging in new drug discovery research, there is a growing need for companies to stay ahead of the competition, innovate and identify niche opportunities in R&D. Using examples in the oncology therapeutic area, this presentation will demonstrate how researchers, professionals and CEOs can boost their companies' competitive advantage and support their critical decision making throughout the drug development process with integrated, comprehensive and relevant industry and scientific content from the Scientific business of Thomson Reuters.
Michaela White, Principal Consultant, Pharma & Life Sciences Solutions, Asia Pacific, Thomson Reuters, Singapore | | 1:05 | Networking Luncheon in Exhibit & Poster Hall | | 2:00 | Chairperson's Remarks
Pradip K. Bhatnagar, Ph.D., Senior Vice President, Drug Discovery Research, Ranbaxy Laboratories Limited, India | Building a Portfolio in Inflammation: Novel Approaches, Technologies and Molecules from Discovery to POC
炎症性疾病的档案建构：从药物发现到POC的创新方法、技术、分子 | | 2:05 | A Novel Series of CCR1 Antagonists. Part 1: From Library Hit to Optimized Lead; Part 2: Asian CRO Partnering for Early Discovery Efforts
Monocyte infiltration is implicated in a variety of diseases including multiple myeloma, rheumatoid arthritis and multiple sclerosis. CCR1 is a chemokine receptor that upon activation, particularly by MIP1- and RANTES, mediates monocyte trafficking to sites of inflammation. High through-put screening of our combinatorial collection identified potent CCR1 antagonists. Part 1 of this presentation details the optimization of this compound series to a potent, orally bioavailable lead. Part 2 describes how partnering with CROs in China and India in support of chemistry efforts expedited nomination of a CCR1 development candidate.
J. Robert Merritt, Ph.D., Senior Principal Scientist, Medicinal Chemistry, Pharmacopeia, Inc., USA | | 2:35 | Discovery of a Subtype Selective Phosphodiesterase 4 Inhibitor for Inflammatory Airway Disease
Phosphodiesterase type IV (PDE4) was projected as a highly druggable target in the area of inflammatory/autoimmune diseases. Inhibitors of PDE4 enzyme exhibit broad anti-inflammatory effect and exhibit efficacy in human asthma and COPD. However, efforts to develop nonselective PDE4 inhibitors have been complicated by problems of emesis and vasculitis. In this study we report discovery of a novel PDE4B inhibitor that exhibits efficacy by the intratracheal route in different experimental models of airway inflammation and airway reactivity, synergy with bronchodilators and anti-inflammatory agents, and much reduced emetic and vasculitis liabilities.
Pradip K. Bhatnagar, Ph.D., Senior Vice President, Drug Discovery Research, Ranbaxy Laboratories Limited, India | | 3:05 | From Target to Novel Mode of Action in Inflammatory Bone & Joint Disease
Galapagos identified novel targets in bone and joint diseases using its adenoviral discovery platform. It is building a broad pipeline of disease modifying molecules that are progressing towards the clinic. Through alliances with GSK, Lilly and Janssen Pharmaceutica, Galapagos has built one of the largest portfolios in bone and joint, with over 30 target programs in drug discovery. With the first compound in the clinic early 2009, Galapagos is transforming from discovery to development.
Onno van de Stolpe, Chief Executive Officer, Galapagos NV, Belgium | | 3:35 | Networking Refreshment Break in Exhibit & Poster Hall | | 4:05 | Accelerating Inflammation Research through a Systems Biology Approach: Orchid's Experience
Orchid's unique inflammation research is to work on a systems biology approach using clinically relevant anti-inflammatory drugs on various human tissues with the aim of identifying potential and safe human relevant inflammation targets. Developments of in-vitro target based functional assays with classical in vivo pharmacology models have enabled us to effectively screen potential inflammatory NCEs. This presentation details the innovative inflammatory drug discovery approaches at Orchid Research Laboratories Limited.
Sriram Rajagopal, Ph.D., Senior Vice President, Orchid Research Laboratories Ltd., India | | 4:35 | Anti-Inflammatory Activity of Human IgG4 Antibodies and the development of a Novel Antibody Format: UniBody®
Most therapeutic antibodies currently used in the clinic are based on the human IgG1 format, which is a bivalent molecule that efficiently interacts with the immune system's effector functions. This presentation will discuss GenMab's scientific approach to develop a new antibody format: UniBody®, a monovalent and non-activating format with long in vivo half life. The development of this format is based on the knowledge obtained studying the mechanism of IgG4 Fab arm exchange. UniBody® will create opportunities for therapies in indications such as asthma, inflammation and some types of cancer. The development of this format will be discussed and placed in the context of format selection for drug development.
Janine Schuurman, Ph.D., Associate Director, Research, Genmab B.V., The Netherlands | | 5:05 | Case Study – Design of Novel Biological Mechanism of Action for an Anti-Inflammatory Molecule using Virtual Prototyping Technology
Criteria for an effective anti-inflammatory molecule at the bio-molecular level would be the reduction of pro-inflammatory cytokines, chemokines and prostanoids such as PGE2 and enhancement of the pro-resolving lipid mediators such as lipoxins. Key toxicity endpoints for monitoring include maintenance of the ratio of vasoconstrictory to vasodilatory factors (cardiotoxicity related markers) and reduction in CRP levels. Using the Cellworks virtual prototyping macrophage platform enabled identification of a novel physiological mechanism of action which satisfied the above criteria and attenuated the LPS induced inflammation using a virtual macrophage system. This presentation will highlight the methodology used to identify the novel biological mechanism of action.
Shireen Vali, Ph.D. Chief Scientific Officer, Cellworks Group, India | | 5:35 | Close of Day Two
| | 6:00 | Networking Dinner in Mumbai
Join fellow attendees and speakers for an evening out in Mumbai. Space is limited and an additional fee applies. |
第3天
Wednesday, October 22, 2008
| DAY ONE | DAY TWO | DAY THREE | | | 8:30 | Chairperson's Opening Remarks
Greg Wiederrecht, Ph.D., Vice President & Head, External Scientific Affairs, Worldwide Licensing and External Research, Merck & Co., Inc, USA | Session Sponsor:
| Risk-Sharing, Collaborative R&D and Licensing: The Role of Global Partnerships in Building a Pipeline
风险分担、合作R&D・授权： 全球夥伴关系在建构药物产品线中扮演的角色 | | 8:35 | Emerging Collaboration and Partnership Models in India: Virtualization of Drug Discovery in GSK
GlaxoSmithKline's Centre of Excellence for External Drug Discovery (CEEDD) is accountable forsetting up alliances with companies throughout the global biotech sector, with the intent of delivering clinical-stage molecules back into GSK's development organization. We have created winning alliances where the company retains the independence to develop their compounds through to clinical proof-of-concept, calling on our team as needed.
We are now specifically looking to develop such alliances with innovative biotech companies in India who have leading positions in technologies or therapeutic areas.
Shelagh Wilson, Ph.D., Vice President, Biology, Center of Excellence for External Drug Discovery, GlaxoSmithKline, United Kingdom | | 9:15 | Building a Portfolio through Drug Development Partnerships and Licensing
Debiopharm is a NRDO (no research development only) organization specializing in the drug development process to successfully bring novel biopharmaceuticals to market. This presentation will highlight different types of potential deal structures to build a portfolio, taking into account objectives of the companies. It will discuss the importance of being creative to achieve each partner's objectives, how to add value to deals, pitfalls to look out for in deals and the benchmarking of pharma/biotech deals. An overview of our therapeutic interests (oncology, autoimmune diseases and certain opportunistic niches) and experiences in India and globally will be presented.
Kim Bill, Vice-President, Corporate Development, Debiopharm S.A., Switzerland | | 9:45 | Advinus/Merck: Case Study of an Innovative Metabolic Disease Research Collaboration in India
This case study will highlight Merck's research collaboration with Advinus Therapeutics in the area of metabolic diseases. Perspectives from both companies will include: the motivations to participate in the deal, the added-value each party brought to the table, structure of the deal, how the alliance is being managed and the current status of the partnership.
Greg Wiederrecht, Ph.D., Vice President & Head, External Scientific Affairs, Worldwide Licensing and External Research, Merck & Co., Inc, USA
Kasim A. Mookhtiar, Ph.D., Chief Scientific Officer and SVP, Drug Discovery, Advinus Therapeutics Pvt. Ltd., India | | 10:15 | Networking Refreshment Break | | 10:45 | Drug Discovery: Lessons Learned from the Past
This talk will provide highlights of key elements, i.e. infrastructure, skill set, strategy etc. required for a successful discovery program to identify therapeutically useful NCEs. An overview of what have we learned from the past experience globally, particularly from MNCs, and what will it take for Indian pharma to be successful in drug discovery will also be presented. The talk will also provide highlights of our antibiotic program.
Bharat Trivedi, Ph.D., Chief Scientific Officer, Medicinal Chemistry, Drug Discovery, Wockhardt R & D, India | Building a Portfolio in Metabolic Disorders: Novel Approaches, Technologies and Molecules from Discovery to POC
代谢性障碍的档案建构：从药物发现到POC的创新方法、技术、分子 | | 11:15 | Chairperson's Remarks
Michael Mark, Ph.D., Vice President, Metabolic Diseases Research, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany | | 11:20 | Scientific Innovation and Strategies in Metabolic Disease: Opportunities and Issues
This presentation will examine the controversy surrounding metabolic syndrome, the current drug development landscape and Pfizer's approach to building a portfolio in metabolic disease. Pharma/biotech collaborations and licensing play in important role in bringing new medicines forward in this area. This presentation will discuss the types of experimental data Pfizer looks for from a potential biotech partner in order to evaluate an opportunity. It will also cite examples of the innovative and emerging metabolic disease research and opportunities we have found in Asia, particularly in India and China.
John H. "Wick" Johnson, Ph.D., Senior Director, Worldwide Business Development, Pfizer Inc., USA | | 11:55 | The Science and Strategy Behind Building a Portfolio in Metabolic Disease: Novel Opportunities for the Treatment of Diabetes
The prevalence of type 2 diabetes is steadily increasing worldwide. Despite all the efforts in preclinical and clinical research diabetes remains to be a progressive disease with most of the patients not reaching their treatment goal. Novel treatment opportunities will be presented - amongst those the class of GLP-1 analogs, DPP-4 inhibitors, SGLT2 inhibitors or new trends for the treatment of the metabolic syndrome.
Michael Mark, Ph.D., Vice President, Metabolic Diseases Research, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany | | 12:30 | Networking Luncheon | | 1:30 | Technology Presentation Available
Do you have a technology platform or product that accelerates the drug discovery and development process? Are you interested in finding partners or licensing opportunities for your technology or product? For more information on presenting in this space, please contact Kristen Schott at kschott@ibcusa.com | | 2:00 | Use of Computer Aided Drug Design Methods and Structural Biology in the Discovery of a New Class of Clinical Candidates for Diabetes
Fructose 1,6-bisphosphatase (FBPase) is a key regulatory enzyme in the gluconeogenesis pathway and is responsible for the hyperglycemia associated with type- 2 diabetes. Discovery of potent and selective inhibitors of FBPase represents a significant challenge for medicinal chemists. This presentation will discuss the use of structural biology, structural bioinformatics, cheminformatics, computer aided drug design methods, medicinal chemistry and biology for the discovery of a new class of clinical candidates for type-2 diabetes using FBPase as a target enzyme.
M. Rami Reddy, Ph.D., Executive Director, Computer Aided Drug Design, Structural, Biology and Cheminformatics, Metabasis Therapeutics, Inc, USA | | 2:30 | Building an Engine for Innovative Drug Development in India: A Case Study of Novel Discovery Programs in Metabolic Disorders
Connexios Life Sciences is a therapeutics and diagnostics company that is leveraging a unique discovery approach (which we call Translational Network Biology) and combining it with the power of the Indian Clinic to develop a strong portfolio of NCE's, novel fixed dose formulations and novel multiplexed biomarkers based diagnostics in the area of metabolic disorders.
Suri Venkatachalam, Ph.D., Managing Director and CEO, Connexios Life Sciences Private Ltd., India | | 3:00 | Networking Refreshment Break | | 3:30 | Strategies for the Successful Global Development of Antiobesity Drugs and the Role of Animal Models in Defining Efficacy and Safety
Obesity and its comorbidities, Type 2 diabetes and dyslipidaemia, are fast becoming a global epidemic. Yet in spite of enormous unmet clinical need, it is widely believed that the hurdles to achieving the global registration of a new antiobesity drug are becoming more not less onerous. This presentation will provide insights into what are the attitudes of the European and US regulatory authorities to novel antiobesity drugs and what efficacy and safety characteristics are required to achieve a successful product approval. In a second aspect of the talk, examples will be provided to show how the innovative use of animal models can help to address some of the key questions of greater efficacy and safety that are essential prerequisites for the global registration of the next generation of antiobesity drugs.
David Heal, Ph.D., Executive Board Director, RenaSci Consultancy Ltd, United Kingdom | | 4:00 | A Novel AGE Breaker Molecule (TRC 4186) for Diabetic Complications: Case Study of Torrent's R&D Capabilities and Infrastructure in Metabolic Diseases
Therapy for metabolic diseases is no longer mainly about glucose or weight reduction per se, but about an overall reduction in the associated comorbidities. Torrent's drug discovery programs are focused on therapies that address underlying pathology associated with the comorbidities of diabetes and obesity including insulin resistance, dyslipidaemia and microvascular and macrovascular CV risk factors. Accordingly, we have developed significant preclinical and clinical capabilities for treatment of metabolic diseases and associated complications. As an example of these capabilities, a case study of TRC4186 for the treatment of diabetic complications will be discussed.
Vijay Chauthaiwale, Ph.D., Vice President, Discovery Research, Torrent Pharmaceuticals, Ltd., India | | 4:30 | AGE-Breaker TRC4186: Translational Medicine and POC Studies from in-vivo Data to a Clinical Development Concept in CHF Patients
"Translational medicine" and "Proof of Concept" studies are growing in importance in the pharmaceutical industry. Whereas "translational medicine" typically refers to the translation of basic research into real therapies, "proof of concept" studies are carried out to determine if there is early evidence of clinical efficacy using a targeted number of patients. Both have become important instruments to increase likelihood of success for drug development or to increase the early failure rate. Some of these aspects will be discussed in the light of the clinical development concept of TRC4186 for the treatment of CHF.
Markus Meyer, M.D., CEO, Focus IP GmbH, Germany | | 5:00 | Close of Conference |
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