#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

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

There are only 4 days left to register for India’s most informative and dynamic meeting on the pharmaceutical industry!

DIA India’s 7th Annual Conference Discovery through Commercialization: Innovative Strategies for Individualized Healthcare, being held at the Hyderabad  International Convention Center Novotel & HICC Complex on November 1-4 is shaping up to be a ‘can’t-miss event.’ 

This 2012 conference will focus on the discovery, development, manufacturing and commercialization to generate ground-breaking approaches to personalized health care. We are proud to present Keynote Addresses from Paul Huckle, Senior Vice President, Global Regulatory Affairs, GlaxoSmithKline and Adrian McKemey, Practice Leader, Product Development & Commercialization, Quintiles.

For Rs9000.00 for 3 days you will network with global colleagues, hear from top leaders, and choose from over 26
interactive sessions. Click here to view the conference program with over 75 International & India industry leaders.

There are only a few days left to  for DIA India’s 7th Annual Conference- we are looking forward to seeing you there!

For more information and group registrations please contact Manoj.Trivedi@diaindia.org or call +91.98.2058.7798.

  Register Online     Read More

Follow us and tweet on the 7th Annual Conference with #DIAIndiaAM2012

DIA INDIA 7th Annual Conference - November 1-4 Hyderabad

Listen to Paul Huckle & Adrian McKemey - Keynote Speakers at 7th Annual Conference KEYNOTE SPEAKER 1 Paul Huckle Senior Vice President Global Regulatory Affairs GlaxoSmithKline   KEYNOTE SPEAKER 2 Adrian McKemey Practice Leader, Product Development & Commercialization Quintiles The 7th Annual Conference this year will begin with Keynote Addresses from Paul Huckle, Senior Vice President, Global Regulatory Affairs, GlaxoSmithKline and Adrian McKemey, Practice Leader, Product Development & Commercialization, Quintiles. The three day conference through 25 sessions and 3 tutorials on the theme 'Innovative Strategies for Individualized Health Care' will bring together regulators and pharma professionals working in the discovery, development, manufacturing or commercialization fields, academicians working in the fields related to the healthcare industry, finance professionals working in the healthcare sector and patient advocacy groups. To know more on the conference program here are a few session details.   Scientific, Regulatory and Ethical Challenges in Advancing Personalized Medicine  This session chaired by Carol Isaacson Barash, Principal, Helix Health Advisors, Adjunct Prof. Personalized Medicine, Regis College will discuss Realizing the Promise of Personalization through Healthcare Mass Commercialization by Sagar Kamarthi, Associate Professor, Department of Mechanical and Industrial Engineering, Northeastern University, Boston Regulatory Challenges for Molecular and Companion Diagnostics by Jeffrey N. Gibbs, Director Hyman, Phelps & McNamara, P. C. Ethical Issues in Individualized Health Care — Seeking Solutions in a Complex World by Aamir Shaikh, Founder Assansa Personalized Nutrition: Parallels from Personalized Medicine by Emanuelle Voisin, CEO and Principal, Voisin Consulting   Register Online      Read More Therapeutics — Pharmacology and Applications in Personalise Medicine This session chaired by Vishwas Sovani, Country Manager, Revogenex, Inc. will discuss Personalised Medicine Pharmacological basis by Vishwas Sovani, Country Manager, Revogenex, Inc. Therapeutic Applications of Personalized Medicine by Mangesh Kulkarni, Group Head, DS&E Novartis Healthcare Ready to use Kits for Personalized Medicine by Mukesh Agrawal, Vice President - CRL, Vimta Labs   Register Online      Read More Personalized Precision Medicine: Regulatory, Financial and Ethical Challenges to Ensuring its Growth  This panel chaired by Carol Isaacson Barash, Principal, Helix Health Advisors, Adjunct Prof. Personalized Medicine, Regis College will consist of the following panelists Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, P. C. Arun Mishra, Director, Global Regulatory Affairs, Asia-Pacific, Japan, Emerging Markets, GlaxoSmithKline Shoibal Mukherjee, Vice President and Head, Asia Medical Sciences Group, Quintiles Nandini K. Kumar, Former Deputy Director General, Sr. Grade Investigator NIH project, National Institute of Epidemiology Femida Gwadry-Sridhar, Director, Health Informatics, Lawson Health Research Institute Sagar Kamarthi, Associate Professor, Department of Mechanical and Industrial Engineering Northeastern University, Boston   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 Thank You to our 7th Annual Conference Supporters Level 2 Level 1 Email Preferences    |    My DIA    |    Forward to a Friend    |

Breast Cancer Study Points to Personalized Treatments

Whole genome scanning tested for clinical decision making.

DANIEL S. LEVINE

The Burrill Report

“The French consortium has opened a new door to more personalized treatment of advanced breast cancer.”

A first-of-its-kind, large scale trial of whole genome cancer testing to personalize treatment for patients with metastatic breast cancer finds in 20 percent of the cases uncovered rare and unexpected genomic activity and argues it’s time to make this approach a clinical standard.

A French research consortium presented the findings from their study at the 2012 European Society for Medical Oncology Congress in Vienna. The results were based on biopsies performed in 402 breast cancer patients, including 26 patients for whom analyses are ongoing.

for complete article:
http://www.burrillreport.com/article-breast_cancer_study_points_to_personalized_treatments.html

Innovative Strategies for Individualized Health Care (Hyderabad) - last 3 wks to register

Last 3 Weeks To Register - 7th Annual Conference The 7th Annual Conference this year through 25 sessions and 3 tutorials on the theme 'Innovative Strategies for Individualized Health Care' will bring together regulators and pharma professionals working in the discovery, development, manufacturing or commercialization fields, academicians working in the fields related to the healthcare industry, finance professionals working in the healthcare sector and patient advocacy groups. To know more on the conference program here are a few session details.   Lead Discovery  This session chaired by Raman Govindarajan, Head R&D, Sanofi will discuss Impact of Structural Biology on Drug Discovery by Ajith Kamat, Head, Strategic Research Partnerships, Pfizer Lead Identification and Optimization in Small Molecular Drug Discovery: SBDD Case Studies byVellarkad N. Viswanadhan,  Vice President, Jubilant Biosys Application of Parallel Medicinal Chemistry Strategies for Rapid and Efficient Optimization of Adenosine A1 Receptor Modulators by Venkata Palle, Vice President - Discovery Research Novel Drug Discovery and Development, Lupin   Register Online      Read More Product and Pricing Strategy and Payor Challenges This session chaired by R. B. Smarta, Founder and Managing Director, Interlink Marketing Consulting will discuss Sizing the Opportunity, Market Driven Commercialization of Products by Dhananjay Bhakhle, Executive Vice President, Medical Research, Lupin Pharmaceuticals Pricing Strategy in Indian Context by Anil Kamath, Founder Chairman, Esemcee Advisors Using Real World Evidence to Drive Access Strategies by Simu Thomas, Global Head, Economic Modeling, Global Medical Affairs and HEOR Novartis, USA   Register Online      Read More Evolving Roles of Personnel Involved in Clinical Trials:  Panel Discussion  This panel chaired by Sam Mathew, Process Lead-Medical Writing, Accenture Services will consist of the following panelists Ajit Nair, Global Head - Clinical Services, Tata Consultancy Services Partha Chakraborthy, Senior Director & Global Delivery Head, R&D, Cognizant Technology Solutions Anish Desai, Director Medical Affairs and Clinical Operations, Johnson & Johnson S Sinha, Head (Global) & Associate Vice President, Clinical Development & Medical Affairs (CD&MA), Hetero Group   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

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    |