#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

Innovative Strategies for Individualized Health Care - November 1-4 Hyderabad

. Innovative Strategies for Individualized Health Care KEYNOTE SPEAKER Paul Huckle Senior Vice President Global Regulatory Affairs GlaxoSmithKline DIA India’s 7th Annual Conference: "Discovery Through Commercialization - Innovative Strategies for Individualized Health Care" is your only chance this year to interact and network with the largest gathering of International and Indian Regulators and Pharma professionals in India. This year at Hyderabad International Convention Centre (HICC), Hyderabad, this conference and exhibition will bring together over 400 of your key past, present and future patrons. There are over 100 international and Indian industry leaders who will present and discuss pertinent and relevant issues in 25 key sessions on topics related to Drug Discovery, Development, Manufacturing, Commercialization, Regulatory, Ethical, Social, Legal, Technology & Standards, Lean Strategy, Outsourcing Strategy, Pharmacovigilance and Therapeutics. For more information please click here to view the conference brochure or contact Rhean.DSouza@diaindia.org or call +91.98.2058.7798.  Read More Participant Profile of Last Year's Conference Attendees - - - - - - - - - - - - - - - - - Program Highlights Discovery: Bioinformatics, Next Gen Sequencing, Lead optimization – the need for speed Development: Barriers and drivers relevant to clinical development across clinical operations, data management, biostatistics, programming, and medical writing, highlighting systems biology paradigm (e.g. pharmacogenomics, metabolomics) and innovative developmental approaches (e.g. chronotherapeutics, microdosing) Manufacturing: Flexible solutions to adapt to the evolving global regulatory scenario and quality standards Commercialization: Health economics and outcomes research driving product and pricing strategy, patient access, payor challenges, Go-to-investors and financial/partnering strategies for product development Regulatory, ethical, social and legal issues: Data privacy and consent issues in the evolving technologies related to personalized medicine Technology and Standards: Technology – SOA, the Cloud and the future, Data and Semantic Interoperability Technology, GRC (Governance, Regulation and Compliance) all focused on Personalized Medicine.  Lean strategy: The application of Lean in pharmacovigilance, medical writing, clinical operations and site performance. Driving the critical path. The conference will address the strategy for drug discovery and clinical development pipeline and faster time to market in the era of blockbuster patient expiries and issues of integrating and streamlining data flows across the entire life cycle of the molecule, and the standardization and rigor that needs to be implemented. It will also stress upon the ethical, legal, social and regulatory and financial and investments challenges impacting all of the above and how processes and technology will need to be upgraded to support the same. To know more contact Rhean.DSouza@diaindia.org or call +91.98.2058.7798.  Read More Exhibit Details With over 9500 square feet of area the exhibition this year hosted at Hyderabad International Convention Centre (HICC), will help you connect with over 400 patrons. As an exhibitor you will be entitled to: Two complimentary conference passes Two complimentary exhibit booth attendee passes Pre-fitted shell scheme booth structure Fascia board with 25 character company name One electrical connection Three spotlights One table Two chairs One wastebasket Carpet Exhibit Fee: 3m x 2m booth space - INR 168,540/- (inclusive of taxes) Please click here to view the Exhibit Layout and Booking Form. For more details contact Manoj.Trivedi@diaindia.org  or call +91.98.1977.7493.  Read More Email Preferences    |    My DIA    |    Forward to a Friend    |

Flexible Manufacturing Solutions To Adapt To The Evolving Industry Scenario - Hyderabad, India

The 7th Annual Conference offers attendees a numbers of sessions specifically focusing on catering to manufacturing. To help the manufacturing industry DIA is offering a special 2 day registration fee. This can be availed by others as well. Details of these sessions are mentioned below.   Manufacturing - Session 12 - November 3, 2012  This session chaired by SC Singhai, Vice President - Tech Transfer, Dr. Reddy’s will discuss Potent Product Process and Facility Design by SC Singhai,Vice President - Tech Transfer, Dr. Reddy’s Quality Management Process in Faculty Development by Vinay Nayak, President, Alembic Pharmaceuticals World Class Manufacturing- A Challenge and Opportunity for the Indian Pharma Industry by Pushpinder Bindra, 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 by Nicolas Cappuccino, Global Head, Quality,  Dr. Reddy’s   Register Online      Read More Manufacturing - Session 15 - November 3, 2012 This session chaired by Subir Basak, President, Jubilant Biosys will discuss Pharmacogenomics for Personalized Medicine: Optimizing use of Drug and Drug Combinations to Improve Patient Outcome by Jugnu Jain, Director, Saarum Siences Quality Control, a Necessary Paradigm when “Leaning Out” Operations, as Pharmaceuticals Shift from the Blockbuster Model to Personalized Gene Therapies and Gene-specific Small-molecule Treatments by Swapnil Baghel, Quality Lead, Biocon BioManufacturing in India by Subir Basak, President, Jubilant Biosys   Register Online      Read More 7th Annual Conference Registration Fees Reduced Registration fees at the 7th Annual Conference have been reduced by nearly 20% to as low as Rs. 9,000 + taxes to help the industry participate in large numbers and gain immensely through this unique networking opportunity. Click here to view the conference program with over 75 International & India industry leaders. For more information and group registrations please contact Rhean.DSouza@diaindia.org or call +91.98.2058.7798. Follow us and tweet on the 7th Annual Conference with #DIAIndiaAM2012   Register Online      Read More Email Preferences    |    My DIA    |    Forward to a Friend    |