#diaIndiaAM2012 Saturday, November 3 Pharma sessions in Hyderabad, India

DIA’s 7th Annual Conference Discovery through Commercialization: Innovative Strategies for Individualized Healthcare

Nov 1 2012 8:30AM - Nov 4 2012 5:00PM | Hyderabad International Convention Center Novotel & HICC Complex (Near Hitec City) PO Bag 1101 Cyberabad Post Office Hyderabad 500081 India

Saturday, November 3, 2012

9:00AM - 10:30AM

Session 10: Lead Discovery

Session Chair(s):

chair
• Raman Govindarajan
  Senior Vice President, Development & Translational Medicine
  Jubilant Biosys, India

Speaker(s):

presentation
• Impact of Structural Biology on Drug Discovery Ajith Kamat
  Head, Strategic Research Partnership
  Pfizer Ltd., India
presentation
• Lead Identification and Optimization in Small Molecular Drug Discovery: SBDD Case Studies Vellarkad N. Viswanadhan
  VP
  Jubilant Biosys, India
presentation
• Application of Parallel Medicinal Chemistry Strategies for Rapid and Efficient Optimization of Adenosine A1 Receptor Modulators Representative Invited
  United States

9:00AM - 10:30AM

Session 11: Go to Investors

Session Chair(s):

chair
• R. B. Smarta
  Founder and Managing Director
  Interlink Marketing Consultancy Pvt. Ltd., India

Session 11: Go to Investors

Speaker(s):

presentation
• Mergers or Partners D. A. Prasanna
  Chairman and Managing Director
  Ecron Acunova, Germany
presentation
• Branding: An Essential Tool to Attract Investment Madeline Ducate, MPH,MS
  Exec.VP Global Operations
  Pharm-Olam International, United States
presentation
• Funding and Investing in New Product Development Anil Kamath
  Eli Lilly and Company, United States

9:00AM - 10:00AM

Session 12: Quality Management in Manufacturing

Session Chair(s):

chair
• Sunil Singhai
  Vice President - Tech Transfer
  Dr. Reddy's Laboratories, India

Session 12: Quality Management in Manufacturing

Speaker(s):

presentation
• Potent Product Process and Facility Design Sunil Singhai
  Vice President - Tech Transfer
  Dr. Reddy's Laboratories, India
presentation
• Quality Management Process in Faculty Development Vinay Nayak
  President Technical
  Alembic Pharmaceuticals, India
presentation
• World Class Manufacturing- A Challenge and Opportunity for the India Pharma Industry Pushpinder Bindra
  CEO
  Zenith and Beyond, India
presentation
• 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 Nicholas Cappuccino, PhD,MBA
  Global Head, Quality
  Dr. Reddy's, United States

11:30AM - 1:00PM

Session 13: Evolving Roles of Personnel Involved in Clinical Trials — Panel Discussion

Session Chair(s):

chair
• Sam T Mathew
  Process Lead-Medical Writing
  Accenture Services, India

Speaker(s):

presentation
• Ajit Nair
  Global Head, Clinical Services
  TATA Consultancy Services, India
presentation
• Partha Chakraborty, MBA
  Director/Head, Pharmacovigilance Center of Excellence
  Cognizant, India
presentation
• Shubhadeep Sinha, DrMed,MD
  Medical Doctor
  Clinical Research & Pharmacovigilance Consultant, India

11:30AM - 1:00PM

Session 14: Lean Six Sigma — Medical Writing

Session Chair(s):

chair
• Nimita Limaye, PhD
  Vice President
  Tata Consultancy Services, India
chair
• Helle Gawrylewski, MA
  Senior Director, Regulatory Medical Writing
  Janssen R&D Companies of J&J, United States

Session 14: Lean Six Sigma — Medical Writing

Speaker(s):

presentation
• Panel Discussion: Thinking Lean in Medical Writing: Driving Change Paul P. Sokol, PhD
  Director
  Johnson & Johnson Prd., United States
presentation
• Panel Discussion: Thinking Lean in Medical Writing: Driving Change Shashidhar Rao
  Head Global Medical Affairs and HEOR, India Operations
  Novartis Healthcare Pvt. Ltd., India
presentation
• Offshoring Medical Writing: Lean Project Management Strategy Paul P. Sokol, PhD
  Director
  Johnson & Johnson Prd., United States
presentation
• Offshoring Medical Writing: Lean Project Management Strategy Seema G. Gurbani
  Assistant Manager, Medical Writing
  Tata Consultancy Services, India
presentation
• Improving the Sigma Level of Medical Writing Shashidhar Rao
  Head Global Medical Affairs and HEOR, India Operations
  Novartis Healthcare Pvt. Ltd., India
presentation
• Improving the Sigma Level of Medical Writing Murthy Palli
  Operations Manager
  Novartis Healthcare, India

11:30AM - 1:00PM

Session 15: Personalized Medicine and Challenges ahead for Biomanufacturing in India

Session Chair(s):

chair
• Subir Basak
  President
  Jubilant Biosys, India

Session 15: Personalized Medicine and Challenges ahead for Biomanufacturing in India

Speaker(s):

presentation
• Pharmacogenomics for Personalized Medicine: Optimizing use of Drug and Drug Combinations to Improve Patient Outcome Jugnu Jain
  Director
  Saarum Sciences, India
presentation
• Quality Control, a Necessary Paradigm when 'Leaning Out' Operations, as Pharmaceutials Shift from the Blockbuster Model to Personalized gene Therapies and Gene-specific Small-molecule Treatments Swapnil Ballal
  Quality Lead
  Biocon, India
presentation
• BioManufacturing in India Subir Basak
  President
  Jubilant Biosys, India

2:00PM - 3:30PM

Session 16: Pre-clinical Discovery and Development

Session Chair(s):

chair
• Vishwanath Iyer (Mahesh)
  Head, Oncology Biometrics
  Novartis Healthcare, India

Speaker(s):

presentation
• Translational Approaches to Target Validation, Drug Action and Patient Response Characterization Raman Govindarajan
  Senior Vice President, Development & Translational Medicine
  Jubilant Biosys, India
presentation
• Imaging as a Biomarker in Early Stage Development Smita Pandit
  Director, Imaging Operations
  Perceptive Informatics, India
presentation
• Pharmacovigilence and Drug Safety Shwetha Kamath
  Drug Safety Physician
  Accenture, India

2:00PM - 3:30PM

Session 17: Scientific, Regulatory and Ethical Challenges in Advancing Personalized Medicine

Session Chair(s):

chair
• Carol Isaacson Barash
  Adjunct Prof. Personalized Medicine, Regis College
  Principal, Helix Health Advisors, United States

Session 17: Scientific, Regulatory and Ethical Challenges in Advancing Personalized Medicine

Speaker(s):

presentation
• Realizing the Promise of Personalization through Health Care Mass Commercialization Sagar Kamarthi
  Associate Professor
  Northeastern University, United States
presentation
• Regulatory Challenges for Molecular and Companion Diagnostics Jeffrey N. Gibbs, JD
  Director
  Hyman Phelps & McNamara, PC, United States
presentation
• Ethical Issues in Individualized Health Care — Seeking Solutions in a Complex World Aamir Shaikh, MD
  Founder
  Assansa, India
presentation
• Personalized Nutrition: Parallels from Personalized Medicine Emmanuelle Voisin, PhD
  CEO and Principal
  Voisin Consulting, France

2:00PM - 3:30PM

Session 18: Data and Semantic Interoperability in Personalized Medicine

Session Chair(s):

chair
• Nikhil Kumar
  President
  Applied Technology Solutions, Inc., United States

Session 18: Data and Semantic Interoperability in Personalized Medicine

Speaker(s):

presentation
• Semantic Interoperability, Data and Personalized Medicine Nikhil Kumar
  President
  Applied Technology Solutions, Inc., United States
presentation
• CDASH Standards Library Implementation Across Multiple EDC Systems and its Potential Benefits Sunish Raj
  Manager, GRO
  PAREXEL International, India
presentation
• Harmonization of Clinical Data Standards Senthil Raja
  Manager, Clinical DB Programming
  PAREXEL International, India

4:30PM - 6:00PM

Session 19: Current Challenges in Clinical Development in India

Session Chair(s):

chair
• Viswanath Iyer (Mahesh), PhD
  Head, Oncology Biometrics
  Novartis Healthcare Pvt. Ltd., India

Session 19: Current Challenges in Clinical Development in India

Speaker(s):

presentation
• Challenges in Conducting Clinical Trials in India: Sponsor's Perspective Bobby George, PhD
  Asst. VP, Regulatory Affairs
  Reliance Life Sciences, India
presentation
• T. Balganesh
  Distinguished Scientist Head of OSDD Unit
  Council of Scientific and Industrial Research (CSIR), India
presentation
• Current Ethics Related Challenges in Clinical Development in India Shoibal Mukherjee, MD,MS
  Vice President, Medical
  Quintiles, India

4:30PM - 6:00PM

Session 20: Therapeutics — Pharmacology and Applications in Personalise Medicine

Session Chair(s):

chair
• Vishwas Sovani
  Revogenex, Inc., India

Session 20: Therapeutics — Pharmacology and Applications in Personalise Medicine

Speaker(s):

presentation
• Personalised Medicine Pharmacological basis Vishwas Sovani
  Revogenex, Inc., India
presentation
• Therapeutic Applications of Personalized Medicine Mangesh S. Kulkarni, MD
  Group Head, DS&E
  Novartis Healthcare, India
presentation
• Ready to Use Kits for Personalized Medicine Mukesh Agrawal
  Vice President, CRL
  Vimta Labs, India

4:30PM - 6:00PM

Session 21: Panel Discussion on Regulatory in Manufacturing