7th Annual Conference Discovery through Commercialization: Innovative Strategies for Individualized Health Care November 1-4, 2012 ID #12659 | Hyderabad International Convention Center
Over a period of time, there has PROGRAM ADVISOR Keynote SpeakerS been a paradigm shift in the way Narges Mahaluxmivala medicines are being developed. Senior Consultant Therapy is becoming patient- Clinical Development Research centric and technology is driving real-time monitoring of patient CHAIR, ADVISORY COUNCIL OF INDIA responsiveness. This necessitates Larisa Nagra Singh changes in the way every aspect VP Global Functional Resourcing, Asia of the health care industry, from Quintiles, Singapore discovery through development, manufacturing, and finally PROGRAM COMMITTEE commercialization operate. Albinus D’Sa Deputy Country Director This conference will include US FDA, India multiple tracks focusing upon Paul Huckle Adrian McKemey the confluence of discovery, Munish Mehra Senior Vice President, Practice Leader, Product Development President Global Regulatory Affairs & Commercialization development, manufacturing Global Alliance of Indian Biomedical Professionals GlaxoSmithKline Quintiles and commercialization towards USA the development of innovative, path-breaking strategies in the Baljit (Boo) Samra realm of personalised health care. Vice President and Country Manager, India PROGRAM CO-CHAIRS The conference will address the PAREXEL International strategy for drug discovery and V. N. Balaji clinical development pipeline and Consultant, Discovery Research faster time to market in the era of blockbuster patent expiries Nikhil Kumar President and issues of integrating and Applied Technology Solutions, Inc, USA streamlining data flows across the entire life cycle of the molecule, Tal Burt, MD and the standardization and rigor Scientific Director that needs to be implemented. It Duke Global Proof-of-Concept Research Network Duke Clinical Research Unit & will also stress upon the ethical, Duke Clinical Research Institute, USA legal, social and regulatory and financial and investment Carol Isaacson Barash Nimita Limaye, PhD Vishwanath Iyer, PhD challenges impacting all of the Principal, Helix Health Advisors Vice President Head, Oncology Biometrics above and how processes and Adjunct Prof. Personalized Medicine, Regis College Biometrics & Medical Writing Novartis Healthcare technology will need to be Tata Consultancy Services R. B. Smarta upgraded to support the same. Managing Director Interlink Marketing Consulting, India PROGRAM HIGHLIGHTS Kapil Khandelwal Venture Capitalists & Director • Discovery: Bioinformatics, Next Gen payor challenges, Go-to-investors and Equnev Capital Sequencing, Lead optimization – the need financial/partnering strategies for product for speed development Helle Gawrylewski • Development: Barriers and drivers relevant • Regulatory, ethical, social and legal Senior Director, Regulatory Medical Writing to clinical development across clinical issues: data privacy and consent issues Janssen R&D Companies of J&J, USA operations, data management, biostatistics, in the evolving technologies related to programing, and medical writing, personalized medicine Uday Kumar S Head – Project & Alliance Management highlighting systems biology paradigm • Technology and Standards: Technology – Rhizen Pharmaceuticals S A, Switzerland (e.g. pharmacogenomics, metabolomics) SOA, the Cloud and the future, Data and and innovative developmental approaches Semantic Interoperability Technology, GRC SCIENTIFIC ADVISOR - POSTERS (e.g. chronotherapeutics, microdosing) (Governance, Regulation and Compliance) N. Udupa • Manufacturing: Flexible solutions to adapt to all focused on Personalized Medicine. Professor and Principal the evolving global regulatory scenario and • Lean strategy: The application of Lean in College of Pharmaceutical Sciences, Manipal, India quality standards pharmacovigilance, medical writing, clinical • Commercialization: Health economics operations and site performance. Driving the An excellent opportunity to showcase and outcomes research driving product critical path. and pricing strategy, patient access, your products and services through exhibits and advertisements. DIA (India) Private Limited A 303, Wellington Business Park I, Marol, Andheri-Kurla Road, Andheri (East), Mumbai - 400059 tutorials | DAY 1 | THURSDAY, NOVEMBER 1, 2012 2
9.00-12.00am 2.00-5.00pm QbD: A Challenge to the Pharma Industry (MR 1.01) Bioinformatics (MR 1.01) instructors instructor V. Venkateswarlu Sangeeta Sawant Vice President, Functional Head of Formulation Development, Assistant Professor (Reader), Bioequivalence and Clinical Pharmacokinetics Bioinformatics Center, University of Pune Packaging Development - Integrated Product Development, Dr. Reddy’s Laboratories Bioinformatics has evolved as a multidisciplinary area of science over the past few decades. It has become an integral component R. Manikandan of research and education in life sciences. Having originated Associate Director, Formulation Development as a set of computational tools to analyze biological data such Dr. Reddy’s Laboratories as biomolecular sequences and structures, Bioinformatics now deals with computational processing and analysis of large sets Quality by Design is defined as a systematic approach to of complex data being churned out from advanced and high development that begins with predefined objectives and throughput technologies such as DNA micro-arrays, whole emphasizes product and process understanding and process genome sequences, proteomics data, protein-protein interactions control, based on sound science and quality risk management. etc. A large variety of mathematical algorithms and statistical The important stakeholders involved in this process are patients, techniques are employed for data analysis. industry and regulators. For patients, it is quality, efficacy and safety, for industry, it is important to have quality along with Bioinformatics facilitate simple sequence-based or structure- cost saving and efficiency and for regulators, it is more efficient based analyses of genes and proteins to gain insights into their regulatory oversight. Integrating these aspects is a question molecular functions on one hand and provide insights into to industry and regulator and hence it is a challenge to the systems level biology through analysis of voluminous genomic pharma world. The reason for calling it as a challenge because or proteomic data. The paradigm shift from molecular level the twenty-first century began with the pharmaceutical industry studies in life sciences to systems biology, genotype-phenotype using development approach (empirical) and manufacturing correlations, insights into health and disease states, etc. is being technologies that have been employed since the 1940’s. No greatly accelerated by bioinformatics applications. significant changes in manufacturing process is made until it justifies the high costs and long cycle time needed to gain Learning Objectives: approval. This often resulted in inefficient, overly expensive • To understand the scope of Bioinformatics and introduce processes. As a result, the FDA have embrace a new paradigm for sequence-based approaches: What can be achieved by using regulation through Quality by Design. the sequence analysis methods • To introduce structure-based approaches: What can be The FDA belief is that, quality cannot be tested into products, achieved by analyzing structures of biomolecules but should be built-in or by design. The important elements that • An overview of applications of bioinformatics-based methods will enable to institutionalize this includes, quality target product in various life science areas such as drug design, genetics profile, critical quality attribute, design space, risk assessment, and genetic diseases, infectious and parasitic diseases, control strategy and continuous improvement. The detail approach immunology, etc. towards application of these elements is also well enumerated in ICH guidelines Q8, Q9, Q10 and Q11. Therefore, Implementation of 2.00-5.00pm QbD will enable transformation of the chemistry, manufacturing, Personalized Medicine (Organiser’s Suite) and controls (CMC) review of new drug applications (NDA’s) and instructorS Abbreviated new drug applications (ANDAs) into a science-based pharmaceutical quality assessment Carol Isaacson Barash Jeffrey N Gibbs Principal, Helix Health Advisors Director As Janet Woodcock, Officer at FDA, stated at the 2008 PDA Adjunct Prof. Personalized Hyman, Phelps & McNamara P.C. meeting, ‘QbD is an evolution and not a revolution’ – an evolution Medicine, Regis College that is in response to the increasing cost pressures on both the regulatory agencies and industry. QbD will evolve as we continue It is an introduction to the field of personalized medicine and to increase our understanding and control of the manufacturing how and why it is revolutionizing the practice of medicine. processes. Topics include pharmacogenetics/pharmacogenomics, molecular diagnostics used to tailor therapies, companion diagnostics and Learning Objectives: strategies for revitalizing older drugs. An overview of current and • Emphasis on the importance of the Quality Target Product emerging technologies used, therapeutic domains and regulatory Profile in articulating a quantitative performance target for challenges and ethical issues will be discussed. QbD • Identification of critical material attributes that provide a Attendees will: mechanistic link of the product quality to the manufacturing • Understand the FDA regulatory system for in vitro process diagnostics, and what that means for the drug approval • Critical process parameters are operating parameters and process should be combined with critical material attributes to • Learn how to work collaboratively with in vitro diagnostic describe the relation between unit operation inputs and companies during the clinical trial and the application process outputs to obtain approval of drug and the companion diagnostic • Establishing the design space and enable the changes within • Learn how to structure contracts with an in vitro diagnostic design space company developing a companion diagnostic for your drug • The role of the control strategy as the mechanism for • Learn about the pitfalls on the path to getting approval of the implementation of QbD elements into practice companion diagnostic for your drug • Life cycle management – propose post approval changes • Learn about FDA regulation of laboratory developed tests needed through continuous improvement (LDTs) and the role of LDTs in companion diagnostics • Learn stakeholder interests and concerns • Learn ethical issues in clinical trials and informed consent • Learn privacy issues in data collection, storage, use and disclosure DAY 2 | friDAY, NOVEMBER 2, 2012 3
8.15-9.00 am REGISTRATION
9.00-9.15 am Opening Ceremony (Hall 1 & 2)
9.15-9.45 am Key note address by Paul Huckle, Senior Vice President, Global Regulatory Affairs, GlaxoSmithKline (Hall 1 & 2)
9.45-10.15 am Key note address by Adrian McKemey, Practice Leader, Product Development & Commercialization, Quintiles (Hall 1 & 2)
10.30-11.30 am Tea Break, Poster AND Exhibit Visit (Hall 5 & 6)
11.30 am-1.00 pm CONCURRENT SESSIONS
Session 1 - DISCOVERY 1 Session 2 - Commercialization 1 Session 3 - Technology & Standards 1 Target Discovery (G.01) Health Economics and Valuation Technology for Personalized SESSION CHAIR (Hall 1 & 2) Medicine — SOA, the Cloud and the V. N. Balaji SESSION cHAIR Future (G.02) Consultant Shashidhar Rao SESSION CHAIR Discovery Research Head Global Medical Affairs and HEOR Nikhil Kumar Applications of Next Generation India Operations President Sequencing and Genomics—from Target Novartis Healthcare Applied Technology Solutions, Inc. Discovery to Clinical Trials and Beyond New Molecules: Paths to their War on Drug Failure & Key Role of Raja Mugasimangalam Development and Commercialization in Information Technology Founder and CEO India Genotypic Technology Dnyanesh Limaye Nidhi Saxena Professor and HoD - Pharmacology Distilling Omics Data for Drug Discovery Founder and CEO Oriental College of Pharmacy Kalpana Krishnaswamy Karmic Lifesciences Mumbai University Founder and CEO Personalization and Regulatory Pharma and CRO Industries adoption of Metaome Science Informatics Framework SOA, SaaS and Cloud Technologies — Key Homology Modeling of Proteins and Arun Bhatt Success Factors Ligand Docking: How close are we to President Raghu Punnamraju drug discovery? Clininvent Research Director, Clinical Trials Management Systems R. Sowdhamini Approach to Early Phase Health Engineering and PI Technology Perceptive Informatics (A PAREXEL Company) Associate Professor Economics Evaluations National Centre for Biological Sciences Adrian McKemey Technology for Personalized Medicine Practice Leader, Product Development & and the Pharmaceutical Industry Commercialization Nimita Limaye Quintiles Vice President, Biometrics & Medical Writing Tata Consultancy Services Nitin Kumar Intern Applied Technology Solutions, Inc.
1.00-2.00 pm networking Lunch - Poster and Exhibit Visit DAY 2 | friDAY, NOVEMBER 2, 2012 4
2.00-3.30 pm CONCURRENT SESSIONS Session 4 - Development 1 Session 5 - Commercialization 2 Session 6 - Outsourcing 1 Public Knowledge and Perceptions Product and Pricing Strategy and Outsourcing Strategy (Hall 1 & 2) as Drivers or Barriers to the Future Payor Challenges (G.02) SESSION cHAIR of Clinical Research in India (G.01) SESSION cHAIR Baljit (Boo) Samra SESSION CHAIR Ranga Iyer Corporate Vice President & Country Manager, India Larisa Nagra Singh Healthcare Consultant Vice President PAREXEL International Sizing the Opportunity, Market Driven Global Functional Resourcing, Asia Evolution of Outsourcing Models in Commercialization of Products Quintiles, Singapore Clinical Research Dhananjay Bakhle PARTAKE Program and Survey of Public Executive Vice President, Medical Research Joseph C. Avellone Lupin Pharmaceuticals Corporate Senior Vice President Knowledge and Perceptions of Clinical Clinical Research Services, Worldwide Research Pricing and Access Strategies PAREXEL International Larisa Nagra Singh Ranga Iyer Outsourcing Challenges and Ethical Vice President Healthcare Consultant Global Functional Resourcing, Asia Practices Quintiles, Singapore Using Real World Evidence to Drive Raj Sinha Access Strategies Director, Global Functional Resourcing Challenges of Drug Development in India Simu Thomas Quintiles – The Relevance of Public Awareness and Global Head, HE&OR Modeling & Trends in Early Phase Outsourcing Partnership Executive Director, Health Economics & Krathish Bopanna Outcomes Research Mukesh Kumar Director & Clinical Research Lead, President and CEO Novartis Healthcare, USA Semler Research AP Disease Profile Therapeutic Strategy Unit The Role of Stakeholder Collaborations in Asia Pacific R & D the Ethical Conduct of Clinical Research Sanofi Nandini Kumar Former Deputy Director General Senior Grade Investigator NIH project National Institute of Epidemiology
3.30-4.30 pm Tea Break, Poster AND Exhibit Visit
4:30-6:00 pm CONCURRENT SESSIONS Session 7 - Regulatory 1 Session 8 - Lean SIX SIGMA 1 Session 9 - PV 1 Regulatory, Ethical & Social Policy Lean Six Sigma — Patient Safety - A Well Rounded Issues in Personalized Medicine: Pharmacovigilance, Site View from the Stakeholders (G.02) Discovery to Clinic (Hall 1 & 2) Performance and Clinical Operations SESSION cHAIR SESSION CHAIR (G.01) Vivek Ahuja Carol Isaacson Barash SESSION Co-cHAIRs Director, Pharmacovigilance - Asia Pacific Principal, Helix Health Advisors Nimita Limaye Baxter Healthcare Adjunct Prof. Personalized Medicine Vice President Outsourcing Pharmacovigilance Regis College Tata Consultancy Services Services: Why India can/cannot be the Bridging the Gap: Co-Development of World Leader Helle Gawrylewski (TBC) Targeted Therapeutics and Companion Senior Director, Regulatory Medical Writing Diagnostics in the US and Europe Janssen R&D Companies of J&J, USA Pharmacovigilance Challenges and Patrick Larcier Complexities in Global Clinical Trials Clinical Development & PV Applying Lean Methodology in Sanjeev Miglani Voisin Consulting Pharmacovigilance Vice President Dinesh Kasthuril Pharmacovigilance & Medical Writing Ethical Issues: Indian Scenario Director, Safety and Risk Management Accenture Arun Bhatt Sciformix President Understanding the Concept of Clininvent Research Improving Process Efficiencies in Clinical ‘Pharmacovigilance sans Frontières’ Operations — The Lean Approach Personalized Medicine, Data Needs & to Ensure Effective Patient Safety Guy Schiller Bumping Up Against Ethics Vivek Ahuja Vice President, Business Process Excellence Director, Pharmacovigilance - Asia Pacific Carol Isaacson Barash PAREXEL International Baxter Healthcare Principal, Helix Health Advisors Adjunct Prof. Personalized Medicine Lean Sigma: Improving Site Performance Regis College Using Continuous Process Improvement Methods is Key to Sustained Clinical Development Suresh Ramu Co-founder and CEO Cytespace Research
6.00 pm Day End DAY 3 | saturday, NOVEMBER 3, 2012 5
9.00-10.30 am CONCURRENT SESSIONS SESSION 10 - Discovery 2 Session 11 - Commercialization 3 Session 12 - Manufacturing 1 Lead Discovery (G.01 & G.02) Go to Investors (G.03 & G.04) Quality Management in SESSION cHAIR SESSION cHAIR Manufacturing (G.05 & G.06) Raman Govindarajan R. B. Smarta SESSION cHAIR Head R&D Founder and Managing Director Sunil Singhai Sanofi Interlink Marketing Consulting Vice President - Tech Transfer Impact of Structural Biology on Drug Mergers or Partners Dr. Reddy’s Laboratories Discovery D A Prasanna Potent Product Process and Facility Ajith Kamat Chairman and Managing Director Design Head, Strategic Research Partnerships Ecron Acunova Sunil Singhai Pfizer Vice President - Tech Transfer Branding: An Essential Tool to Attract Dr. Reddy’s Laboratories Lead Identification and Optimization in Investment Small Molecular Drug Discovery: SBDD Madeline Ducate Quality Management Process in Facility Case Studies Executive Vice President, Global Operations Development Vellarkad N. Viswanadhan Pharm-Olam International Vinay Nayak Vice President President Jubilant Biosys Funding and Investing in New Product Alembic Pharmaceuticals Application of Parallel Medicinal Development World Class Manufacturing- A Challenge Chemistry Strategies for Rapid and Anil Kamath and Opportunity for the Indian Pharma Founder Chairman Efficient Optimization of Adenosine A1 Industry Esemcee Advisors Receptor Modulators Pushpinder Bindra (TBC) CEO Zenith and Beyond Case Study: Integration of Patient Needs, and Quality Requirements in Recent Times has Enforced Application of “Quality by Design (QbD)” and “Process Analytical Technology (PAT)” to development of Therapeutic Vaccines Nicolas Cappuccino Global Head, Quality Dr. Reddy’s Laboratories
10.30-11.30 am Tea Break AND Exhibit Visit
DIA India Membership DIA is the premier professional member association in the world addressing solutions to issues and challenges across the entire drug development industry. DIA’s professional development opportunities, timely information resources and global network of thought leaders allow you to take control of your career.
• Participate in our neutral, global forum, completely independent from the influence of any one organization or authority • Learn about regulations, best practices and trends from industry thought leaders • Connect with and learn from regulatory, industry, and academic professionals while advancing your career through conferences, networking opportunities and DIA’s knowledge resources • Take advantage of all these member benefits –join DIA today!
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For details, contacts: Manoj Trivedi tel: +91.22.6741.7625 | cell: +91.98.1977.7493 email: [email protected] DAY 3 | saturday, NOVEMBER 3, 2012 6
11.30 am-1.00 pm CONCURRENT SESSIONS Session 13 - Development 2 Session 14 - Lean SIX SIGMA 2 Session 15 Manufacturing 2 Evolving Roles of Personnel Lean Six Sigma — Medical Writing Personalized medicine Involved in Clinical Trials — Panel (G.03 & G.04) and challenges ahead for Discussion (G.01 & G.02) SESSION Co-cHAIRs Biomanufacturing in India (G.05 & SESSION CHAIR Nimita Limaye G.06) Vice President Sam Mathew SESSION cHAIR Tata Consultancy Services Process Lead-Medical Writing Subir Basak Accenture Services Helle Gawrylewski Senior Director, Regulatory Medical Writing President Jubilant Biosys Ajit Nair Janssen R&D Companies of J&J, USA Global Head - Clinical Services Panel Discussion - Thinking Lean in Pharmacogenomics for Personalized Tata Consultancy Services Medical Writing: Driving Change... Medicine: Optimizing use of Drug and Paul Sokol Drug Combinations to Improve Patient Partha Chakraborthy Senior Director Outcome Senior Director & Global Delivery Head, R&D Neuroscience Therapeutic Area Head Reg MW Jugnu Jain Cognizant Technology Solutions Janssen Research & Development PRD Director Shashidhar Rao Saarum Siences Shubhadeep Sinha Head Global Medical Affairs and HEOR, India Quality Control, a Necessary Paradigm Head (Global) & Associate Vice President Operations Clinical Development & Medical Affairs (CD&MA) Novartis HealthCare when ‘Leaning Out’ Operations, Hetero Group as Pharmaceuticals Shift from the Offshoring Medical Writing: Lean Project Blockbuster Model to Personalized Gene Management Strategy Therapies and Gene-specific Small- Paul Sokol molecule Treatments Senior Director Swapnil Ballal Neuroscience Therapeutic Area Head Reg MW Quality Lead Janssen Research & Development Biocon Seema Gurbani Assistant Manager BioManufacturing in India Tata Consultancy Services Subir Basak President Improving the Sigma Level of Medical Jubilant Biosys Writing Shashidhar Rao Head Global Medical Affairs and HEOR, India Operations Novartis Healthcare Murthy Palli Operations Manager Novartis Healthcare
1.00-2.00 pm NETWORKING Lunch And Exhibit Visit DAY 3 | saturday, NOVEMBER 3, 2012 7
2.00-3.30 pm CONCURRENT SESSIONS Session 16 - Discovery 3 Session 17 - Regulatory 2 Session 18 - Technology & Standards 2 Pre-clinical Discovery and Scientific, Regulatory and Data and Semantic Interoperability Development (G.01 & G.02) Ethical Challenges in Advancing in Personalized Medicine (G.05 & SESSION cHAIR Personalized Medicine (G.03 & G.06) Vishwanath Iyer (Mahesh) G.04) SESSION CHAIR Head, Oncology Biometrics SESSION CHAIR Nikhil Kumar Novartis Healthcare Carol Isaacson Barash President Translational Approaches to Target Principal, Helix Health Advisors Applied Technology Solutions, Inc., USA Validation, Drug Action and Patient Adjunct Prof. Personalized Medicine Semantic Interoperability, Data and Response Characterization Regis College Personalized Medicine Raman Govindarajan Realizing the Promise of Personalization Nikhil Kumar Head, R&D India President through Healthcare Mass Sanofi Applied Technology Solutions, Inc., USA Commercialization Imaging as a Biomarker In Early Stage Sagar Kamarthi CDASH Standards Library Development Associate Professor Implementation Across Multiple EDC Smita Pandit Department of Mechanical and Industrial Systems and its Potential Benefits Director, Imaging Operations Engineering Sunish Raj Perceptive Informatics (A PAREXEL Company) Northeastern University, Boston Manager, GRO Pharmacovigilence and Drug Safety Regulatory Challenges for Molecular and PAREXEL International Shwetha Kamath Companion Diagnostics Harmonization of Clinical Data Standards Drug Safety Physician Jeffrey N. Gibbs Senthil Raja Accenture Director Manager, Clinical DB Programming Hyman, Phelps & McNamara, P. C. PAREXEL International Ethical Issues in Individualized Health Care — Seeking Solutions in a Complex World Aamir Shaikh Founder Assansa Personalized Nutrition: Parallels from Personalized Medicine Emanuelle Voisin CEO and Principal Voisin Consulting
3.30- 4.30 pm Tea Break AND Exhibit Visit
4:30-6:00 pm CONCURRENT SESSIONS Session 19 - Development 3 Session 20 - Therapeutics 1 Session 21 - Manufacturing 3 Current Challenges in Clinical Therapeutics — Pharmacology and Panel discussion Development in India (G.01 & G.02) Applications in Personalise Medicine Panel Discussion on Regulatory in SESSION CHAIR (G.03 & G.04) Manufacturing (G.05 & G.06) Vishwanath Iyer (Mahesh) SESSION cHAIR panelists Head, Oncology Biometrics Vishwas Sovani Novartis Healthcare Country Manager Regulators Invited Challenges in conducting Clinical trials in Revogenex, Inc. India: Sponsor’s perspective Personalised Medicine Pharmacological Bobby George basis Asst Vice President & Head Regulatory Affairs Vishwas Sovani Reliance Life Sciences Country Manager Finding New Drugs for the Treatment Revogenex, Inc. of Neglected Diseases: Trials and Therapeutic Applications of Personalized Tribulations Medicine T Balganesh Mangesh Kulkarni Distinguished Scientist Head of OSDD unit Group Head, DS&E Council of Scientific and Industrial Research Novartis Healthcare (CSIR) Ready to use Kits for Personalized Current Ethics related Challenges in Medicine Clinical Development in India Mukesh Agrawal Shoibal Mukherjee Vice President, CRL Vice President and Head Vimta Labs Asia Medical Sciences Group Quintiles
6.00 pm Day End DAY 4 | sUNDAY, NOVEMBER 4, 2012 8
9:00-10:30 am CONCURRENT SESSIONS Session 22 - Development 4 Shifting Paradigms in Clinical Research (G.01 & G.02) SESSION CHAIR Y. K. Gupta Upcoming Meetings 2013 Prof. & HoD, Department of Pharmacology & Nephrology, Through its five flagship Pharmacovigilance AIIMS conferences and exhibitions February | Mumbai Design of Drug Clinical Trials in India, DIA has established 6th Regulatory Incorporating a Companion Diagnostic itself as a neutral platform April | Ahmedabad Rajashree Devarakonda where thought leaders Director Voisin Consulting from the pharmaceutical, 2nd IT Life Sciences July | Bangalore The Prospect of Microdosing Trials in biotechnology, medical device, and related fields, exchange India Generics Y. K. Gupta ideas, network, and engage August | Hyderabad Prof. & HOD, Department of Pharmacology & with industry professionals Nephrology AIIMS across the globe. 8th Annual Meeting October | Mumbai Private-Academic Collaborations in Clinical Research: An Emerging To know more on the upcoming flagship conferences at DIA Paradigm Sanjay Mittal in India write to [email protected] Director - Research and Clinical Cardiology Medanta - The Medicity
10.30- 11.30 am Tea Break AND Exhibit Visit
11.30 am-1.00 pm CONCURRENT SESSIONS Session 23 - Development 5 Session 24 -Technology & standards 3 Current Topics in Biostatistics (G.01 GRC (Governance, Regulation & & G.02) Compliance) and Personalized SESSION CHAIR Medicine (G.03 & G.04) Munish Mehra SESSION CHAIR President Nikhil Kumar Global Alliance of Indian Biomedical President Professionals, USA Applied Technology Solutions, Inc, USA Development and Validation of GRC and Personalized Medicine - The Threshold-based Prognostic and Evolving Impact of HIT and Personalized Predictive Biomarker Signatures for Medicine on GRC and its Implications Personalized Medicine Strategy Nikhil Kumar Arunava Chakravartty President Data Sciences Team Leader, Asia Applied Technology Solutions, Inc., USA Unilever R&D. Complete Outsourced Pharmacovigilance Dealing with Multiplicity Issues When Operations, Database and Reporting Assessing Benefit in Targeted Sub- 24x7 Available Interaction Center populations - A Case Study Femida Gwadry-Sridhar Vishwanath Iyer (Mahesh) Director, Health Informatics Head, Oncology Biometrics Lawson Health Research Institute Novartis Healthcare Technical Challenges in Large Safety Best Practices in Handling of Missing Implementation Data Including Use of Method of Multiple Anjani Kumar Jha Imputations Director Munish Mehra November Research Group President Global Alliance of Indian Biomedical Professionals
1.00-2.00 pm NETWORKING Lunch AND Exhibit Visit DAY 4 | sUNDAY, NOVEMBER 4, 2012 9
2.00-3.30 pm Closing Plenary session Personalized Precision Medicine: Regulatory, Financial and Ethical Challenges to Ensuring its Growth (G.01 to G.04) Thank you to the SESSION CHAIR th Carol Isaacson Barash 7 Annual Conference Principal, Helix Health Advisors Adjunct Prof. Personalized Medicine, Regis College Supporters! Regulatory Pitfalls in Getting IVDs and Companion Diagnostics FDA Approved Communication with the FDA Jeffrey N. Gibbs Director Hyman, Phelps & McNamara, P. C. level 2
Arun Mishra Director, Global Regulatory Affairs Asia-Pacific, Japan, Emerging Markets GlaxoSmithKline
Shoibal Mukherjee Vice President and Head Asia Medical Sciences Group Quintiles
Nandini Kumar Former Deputy Director General Sr. Grade Investigator NIH project National Institute of Epidemiology level 1 Femida Gwadry-Sridhar Director, Health Informatics Lawson Health Research Institute
Sagar Kamarthi Associate Professor Department of Mechanical and Industrial Engineering Northeastern University, Boston
Internet Free Zone PARTNER Registration Form/ INVOICE 7th Annual Conference - Meeting ID #12659 - November 1-4, 2012 - Hyderabad International Convention Center
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