6th Annual Conference on Global Drug Development and Market Access:

Converging Strategies and Best Practices to Benefit Patients

October 15, 2011 | 9.00 AM-6.00 PM 9.00 AM-12.30 PM Tutorials

1.30 PM-6.00 PM

Conference: Day 1: Inaugural Plenary Session: Panel Discussion: Barriers and Facilitators to Innovation in Bio-pharmaceuticals

October 16, 2011 | 9.00 AM-5.00 PM

9:00 AM-10:00 AM 10:30 AM12:30 PM 1.30 PM5.00 PM

Inaugural Exhibit Hall Open Plenary Session: Meet the Regulators Conference: Day 2

October 17, 2011 | 9.00 AM-5.00 PM

9.00 AM-5.00 PM

Conference: Day 3

October 18, 2011 | 9.00 AM-5.00 PM

9.00 AM-5.00 PM

Conference: Day 4

6th Annual Conference on Global Drug Development and Market Access: Converging Strategies and Best Practices to Benefit Patients
Tutorials: October 15, 2011*Conference: October 15-18, 2011

ID #11659 Hotel Intercontinental The Lalit, Mumbai, India

PROGRAM COMMITTEE Larisa Nagra Singh, MPharm VP Global Functional Resourcing, Asia Quintiles, Singapore Albinus DSa Deputy Country Director USFDA, India Dr Nandini Kumar Former Deputy Director General ICMR Co-investigator NIH Project on Bioethics National Institute of Epidemiology (ICMR) Chennai, India Moin Don Executive Director PVCON Pharmacovigilance Services, India Alberto Grignolo, PhD Corporate Vice President-Global Strategy PAREXEL Consulting Boston, MA, USA Arun Mishra, MSc Director, Global Regulatory Affairs (Emerging Markets and Asia-Pacific) GlaxoSmithKline, Middlesex, UK Vishwanath (Mahesh) Iyer, PhD Head, Oncology Biometrics Novartis Healthcare Pvt Ltd Hyderabad, India Arun Bhatt, MD President Clininvent Research, Mumbai, India Nimita Limaye, PhD Senior VP & Global Head: CDM, Medical Writing and SCEDAM, SIRO Clinpharm Pvt Ltd, India Krathish Bopanna, PhD, DSc President and Executive Director Semler Research Center Bangalore, India Balasubramanian Sankaranarayanan Vice President, Healthcare and Life Sciences Smart Decision Services, GenPact, Mumbai, India The DIA India Conference Program is published by the Drug Information Association for distribution at the 6th Annual Conference on Global Drug Development and Market Access: Converging Strategies and Best Practices to Benefit Patients. Copyright to all material in this publication is held by the Drug Information Association. For more information contact us: Manoj Trivedi at Manoj.Trivedi@diaindia.org

PROGRAM CO-CHAIRS

Munish Mehra, PhD President, Global Alliance of Indian Biomedical Professionals Washington, DC, USA

Mubarak Naqvi, MD CSU Director SANOFI, India

This conference will bring together industry professionals, clinicians, patient representatives, and regulatory agencies from India (CDSCO/DCGI), the United States (FDA), Europe (EMA), and emerging markets to: Facilitate knowledge exchange leading to innovation and ultimately patient care Build upon DIAs breadth and depth of topics from drug discovery through post-marketing safety surveillance Provide an invaluable forum for sharing information and networking for professionals involved in the discovery, development, and life cycle management of pharmaceuticals, medical devices, and related products, including discussion of current issues related to new areas such as regulatory changes, biosimilars, medical devices, and best practices in the design, conduct, and reporting of clinical trials

WHO SHOULD ATTEND

Professionals, researchers, and clinicians involved in drug discovery and development and regulatory affairs, e.g.: Drug Development and Clinical Research Managers and Associates Pharmaceutical Physicians and Medical Directors Drug Safety and Drug Surveillance Personnel Professionals Engaged in Discovery Research Clinical Pharmacology Scientists Pharmacologists Regulatory Affairs Managers Regulators Academic Scientists Biostatisticians Data Managers Medical Writers Outsourcing and Marketing Managers IT Professionals Students

DIA (India) Private Limited A 303, Wellington Business Park I Marol Andheri-Kurla Road Andheri (East), Mumbai - 400059
2 INDIA 2011 | 6th ANNUAL PROGRAM

Excellent opportunity to showcase your products and services. Exhibits and advertising opportunities are available.

SPECIAL GUEST

KEYNOTE SPEAKERS

Poet, Lyricist, and Scriptwriter Mumbai, India

Javed Akhtar

Country President Novartis Ltd Mumbai, India

Ranjit Shahani

David Lepay, MD, PhD

Senior Advisor USFDA USA

D R Kaarthikeyan, IPS
Advisor Law-Human Responsibilities Corporate Affairs India

Surinder Singh (Invited)

Drugs Controller General of India New Delhi, India

PROGRAM COMMITTEE

Larisa Nagra Singh, MPharm

VP Global Functional Resourcing, Asia Quintiles, Singapore

Deputy Country Director USFDA India

Albinus DSa

Former Deputy Director General ICMR Co-investigator NIH Project on Bioethics National Institute of Epidemiology (ICMR), Chennai, India

Dr Nandini Kumar

Executive Director PVCON Pharmacovigilance Services India

Moin Don

Arun Bhatt, MD

President Clininvent Research Mumbai, India

Alberto Grignolo, PhD

Corporate Vice President, Global Strategy, PAREXEL Consulting Boston, MA, USA

Director, Global Regulatory Affairs (Emerging Markets and Asia-Pacific) GlaxoSmithKline Middlesex, UK

Arun Mishra, MSc

Krathish Bopanna, PhD, DSc

Vishwanath (Mahesh) Iyer, PhD

Head, Oncology Biometrics, Novartis Healthcare Pvt Ltd Hyderabad, India

President and Executive Director Semler Research Center Bangalore, India

Senior VP & Global Head: CDM, Medical Writing and SCEDAM SIRO Clinpharm Pvt Ltd, India

Nimita Limaye, PhD

Vice President Healthcare and Life Sciences Smart Decision Services GenPact, Mumbai, India

Balasubramanian Sankaranarayanan

SPEAKERS
Robert M Califf, MD Vice Chancellor of Clinical Research Director, Duke Translational Medicine Institute (DTMI) Durham, NC, USA John S Sundy, MD, PhD Associate Professor of Medicine Director, Duke Global Proof of Concept (POC) Research Network Duke Clinical Research Institute (DCRU), Durham, NC, USA Tal Burt, MD Scientific Director Duke Global Proof-of-Concept (POC) Research Network Duke Clinical Research Unit (DCRU) & Duke Clinical Research Institute (DCRI), Durham, NC, USA Nancy Smerkanich Vice President Global Regulatory Affairs Octagon Research Solutions Philadelphia, PA, USA

Gerald W Heddell, PhD TalBurt,M.D.isapsychiatristandclinicalresearchertrainedinIsrael,Italy,France,andtheUS. Mostofhiscareerhasbeeninclinicalresearch,ofdrugsanddevices,inIndustryandacademia. Director of Inspection AfterbeingonthefacultyatColumbiaUniversityDepartmentofPsychiatryTalmovedtoindustry Enforcement and Standards MHRA firstPfizerandthenEisaiasSeniorMedicalDirectoroverseeingallphasesofclinicalresearchand London, UK development.HethenjoinedDukeNationalUniversityofSingaporeGraduateMedicalSchoolas AssociateProfessorforClinicalResearch.HeservedasthefoundingdirectoroftheSingHealth InvestigationalMedicineUnit(IMUinSingapore)andMedantaDukeResearchInstitute(MDRI inDelhi,India)bothpartofDukesglobalProofofConcept(POC)ResearchNetwork.

Sri Mosur President and CEO Global Drug Discovery and Development Jubilant Biosys Bangalore, India

Professor Falguni Sen, PhD Chair, Management Systems Area and Director Global Healthcare Innovation Management Center (GHIM) Graduate School of Business Fordham University New York, USA Raman Govindarajan, MD, PhD Head India R&D Member Asia Pacific R&D Team SANOFI Bangalore, India

Emily Tan, MSc Executive Director Clinical Research, Asia Pacific PharmaNet Singapore

Emmanuelle M Voisin, PhD Principal and Founder Voisin Consulting Life Sciences Paris, France

Helle-Mai Gawrylewski Senior Director, Head Medical Affairs and Alliance Management in Regulatory Medical Writing Johnson & Johnson PRD USA

Shoibal Mukherjee, MD Vice President, Medical Quintiles India

Lakshmi P Kotra, PhD Director-CMDP, Scientist and Associate Professor University of Toronto and University Health Network Canada

Michael Goedde Director, Clinical Data Management Human Genome Sciences, Inc. Rockville, MD, USA

Dr Surinder Kher CEO Asia Manipal Acunova Limited India

IMAGE NOT PICTURED: Cellia K Habita, MD, PhD, President & CEO, Arianne Corp, San Diego, CA, USA
INDIA 2011 | 6th ANNUAL PROGRAM 3

PLENARY SESSION SATURDAY, OCTOBER 15, 2011 4.00 pm-6.00 pm

Panel Discussion: Barriers and Facilitators to Innovation in Bio-pharmaceuticals
SeSSion Chair paneliStS

Prof Sudip Chaudhuri

Munish Mehra, PhD

Professor Indian Institute of Management Kolkata, India

President, Global Alliance of Indian Biomedical Professionals Washington DC, USA panel DiSCuSSion moDerator SeSSion Chair

Sri Mosur

Professor Falguni Sen, PhD

President and CEO Global Drug Discovery and Development Jubilant Biosys Bangalore, India

Chair, Management Systems Area and Director, Global Healthcare Innovation Management Center (GHIM), Graduate School of Business, Fordham University New York, USA Senior pharma company executives will share their vision for what they see as the key opportunities and impediments for India becoming a major pharma hub and what must be done to overcome the impediments.

Villoo Morawala-Patell, PhD

Founder, Chairperson and Managing Director Avesthagen Bangalore, India

Fabio Thiers, MD, PhD Ranjit Shahani

Founder & CEO, ViS Research Institute New York, USA Country President, Novartis India Ltd Mumbai, India

PLENARY SESSION SUNDAY, OCTOBER 16, 2011 10.30 am-12:30 pm

Meet the Regulators: Global Regulatory Forum Session
SeSSion Chair panel DiSCuSSion partiCipantS

David Lepay, MD, PhD

Senior Advisor USFDA, USA

Manish Kumar Shah, PhD

Head, Clinical Operations Pfizer Mumbai, India

Gerald W Heddell, PhD

moDerator panel DiSCuSSion

Munish Mehra, PhD

Director of Inspection, Enforcement and Standards MHRA London, UK

President, Global Alliance of Indian Biomedical Professionals Washington DC, USA A panel of senior regulators from the US, MhRA, EU, Malaysia, and India are being invited to share strategic initiatives undertaken by their agencies followed by a Q&A session.

Surinder Singh, MD

Drugs Controller General of India New Delhi, India

Stephen E Wilson, DrPH Ram Tiwari, PhD

Director, Division of Biometrics III CDER, USFDA, USA Associate Director for Statistical Science and Policy USFDA, USA Ministry of Health Malaysia Drug Controller Karnataka State

Mazlan Ismail, Sr Pharmacist, PSD MOH

B R Jagashetty H G Koshia
Commissioner FDA Gujarat, India

Dr S Natesh

Senior Advisor, Department of Biotechnology India

Dr K K Tripathi

Advisor Department of Biotechnology Govt of India

INDIA 2011 | 6th ANNUAL PROGRAM

EuroMEEting
C o p E n h agEn 2012
26-28 March 2012 Bella Center | Copenhagen, Denmark

24th annual

INDIA 2011 | 6th ANNUAL PROGRAM

SATURDAY, OCTOBER 15, 2011

9.00 AM-12.30 PM TUTORIAL 1 TUTORIAL 2 TUTORIAL 3 TUTORIAL 4 TUTORIAL 5 12.30 PM-1.30 PM 1.30 PM-2.00 PM LUNCH BREAK

SATURDAY, OCTOBER 15, 2011

Project Management Metrics Advancing Drug Development through Licensing Opportunities between Pharma, Biotechs, Academia, and Investors Adaptive Designs in Clinical Research Building a Drug Safety and Pharmacovigilance Framework in India From Reporting of ADRs to Signal Detection Vendor Selection and Oversight, Quality and Compliance Considerations

OPENING CEREMONY, WELCOME, INTRODUCTION TO CONFERENCE CO-CHAIRS INTRODUCTION TO CONFERENCE PROGRAM COMMITTEE AND CONFERENCE OVERVIEW

2.00 PM-3.30 PM 3.30 PM-4.00 PM 4.00 PM-6.00 PM 6.00 PM

KEYNOTE ADDRESS AND SPECIAL GUEST SPEAKER TEA / COFFEE BREAK PLENARY SESSION Panel Discussion: Barriers and Facilitators to Innovation in Bio-pharmaceuticals DAY 1 ADJOURN

SUNDAY, OCTOBER 16, 2011

9.00 AM-10.00 AM 10.00 AM-10.30 AM 10.30 AM-12.30 PM 12.30 PM-1.30 PM 1.30 PM-3.00 PM EXHIBIT OPENING CEREMONY MORNING TEA / COFFEE BREAK PLENARY SESSION Meet the Regulators: Global Regulatory Forum Session LUNCH BREAK PARALLEL TRACKS
CMC / DRUG STANDARDS & QUALITY /REGULATORY

CLINICAL RESEARCH Session CR1 Conference Room 1 Avoiding Common Mistakes in Clinical Research

DATA MANAGEMENT / BIOSTATISTICS / MEDICAL WRITING Session DM1 Conference Room 3 Current Issues in Medical Writing

DRUG DISCOVERY / MARKET ACCESS Session MA1 Conference Room 4 Pricing, Reimbursement and Market Access to Medicines: Current Global Challenges and Prospects

Session RA1 Conference Room 2 Evolving Global Regulatory Landscape and Clinical Development of Biosimilars Role of India

3.00 PM-3.30 PM 3.30 PM-5.00 PM

CLINICAL RESEARCH

AFTERNOON TEA / COFFEE BREAK PARALLEL TRACKS

CMC / DRUG STANDARDS & QUALITY /REGULATORY

DATA MANAGEMENT / BIOSTATISTICS / MEDICAL WRITING Session DM2 Conference Room 3 Designs in Early Phase Clinical Trials

DRUG DISCOVERY / MARKET ACCESS Session DD1 Conference Room 4 PANEL DISCUSSION Partnership Models for Stimulating Innovations

Session CR2 Conference Room 1 Translational Clinical Research Stakeholders Perspectives

Session RA2 Conference Room 2 Recent FDA, EMA, DCGI Guidelines Regulations in Evolution

5.00 PM

DAY 2 ADJOURN

INDIA 2011 | 6th ANNUAL PROGRAM

MONDAY, OCTOBER 17, 2011

9.00 AM-10.30 AM PARALLEL TRACKS
REGULATORY / CMC / DRUG SAFETY AND PV Session RA3 Conference Room 2 Regulatory Strategy: Pathways to Drug Approvals in Different Countries DATA MANAGEMENT / BIOSTATISTICS / MEDICAL WRITING Session DM3 Conference Room 3 Different Tools to Facilitate Clinical Data Management OUTSOURCING AND PROFESSIONAL DEVELOPMENT Session OS1 Conference Room 4 Consideration in Outsourcing Clinical Trials to Emerging Regions: Are Global or Local CROs the Right Choice?

CLINICAL RESEARCH Session CR3 Conference Room 1 Enhancing Public Confidence in Clinical Research through Robust and Empowered Ethics Committees

10.30 AM-11.00 AM 11.00 AM-12.30 PM

MORNING TEA / COFFEE BREAK PARALLEL TRACKS

REGULATORY / CMC / DRUG SAFETY AND PV Session CMC1 Conference Room 2 Ensuring Quality in GMPs Enhance the Approach of Quality driven by ICH Q8, Q9, Q10 and Q11: Practical Implementation DATA MANAGEMENT / BIOSTATISTICS / MEDICAL WRITING Session MA2 Conference Room 3 Synchronizing Clinical, Regulatory and Commercial Strategies During Drug Development to Accelerate Regulatory Approval and Patient Access to New Medicines OUTSOURCING AND PROFESSIONAL DEVELOPMENT Session OS2 Conference Room 4 Current Trends in Outsourcing: Partnership Models and Best Practices for Data Management and Scientific Programming

CLINICAL RESEARCH Session DD2 Conference Room 1 Current Topics in Phase 0 and Phase 1 Studies

12.30 PM-1.30 PM 1.30 PM-3.00 PM

LUNCH BREAK PARALLEL TRACKS

REGULATORY / CMC / DRUG SAFETY AND PV Session DS1 Conference Room 2 Industrial Pharmacovigilance Practices HOT TOPICS OUTSOURCING AND PROFESSIONAL DEVELOPMENT Session DM4 Conference Room 4 Deeper Look into Health Authority Guidances

CLINICAL RESEARCH Session CR4 Conference Room 1 Drug Development for Pediatric and Geriatric Population

Session HT1 Conference Room 3 Regulation, Media and Public Perception Navigating the Minefield in India

3.00 PM-3.30 PM 3.30 PM-5.00 PM

AFTERNOON TEA / COFFEE BREAK PARALLEL TRACKS

REGULATORY / CMC / DRUG SAFETY AND PV Session DS2 Conference Room 2 International Pharmacovigilance Regulatory Updates HOT TOPICS OUTSOURCING AND PROFESSIONAL DEVELOPMENT Session PD1 Conference Room 4 Career Paths in Drug Discovery Transition from University to Industry, Private / Government / Academic Sector Experiences with Highly Trained Graduates for Innovative Biotech Pharma Industry in India

CLINICAL RESEARCH Session CR5 Conference Room 1 New Electronic Systems in Ensuring Good Clinical Practice Compliance

Session HT2 Conference Room 3 Current Hot Topics

5.00 PM

DAY 3 ADJOURN

INDIA 2011 | 6th ANNUAL PROGRAM

CONFERENCE AT A GLANCE
9.00 AM-10.30 AM PARALLEL TRACKS

TUESDAY, OCTOBER 18, 2011

CLINICAL RESEARCH / HT / REGULATORY AFFAIRS Session HT3 Conference Room 1 Current Updates on Select Hot Topics

CMC / DRUG STANDARD & QUALITY / OUTSOURCING Session CMC2 Conference Room 2 Regulatory and CMC Considerations for Clinical Trials and New Technologies

DATA MANAGEMENT / BIOSTATISTICS / MEDICAL WRITING Session DM5 Conference Room 3 Safety Issues in Drug Development

DRUG SAFETY AND PV

Session DS3 Conference Room 4 National Pharmacovigilance and Regulatory Update

10.30 AM-11.00 AM 11.00 AM-12.30 PM

MORNING TEA / COFFEE BREAK PARALLEL TRACKS

CMC / DRUG STANDARD & QUALITY / OUTSOURCING Session OS3 Conference Room 2 How Offshoring is Impacting the way Clinical Data is Processed and Interpreted DATA MANAGEMENT / BIOSTATISTICS / MEDICAL WRITING Session DM6 Conference Room 3 Qualification of Biomarkers and PROs DRUG SAFETY AND PV

CLINICAL RESEARCH / HT / REGULATORY AFFAIRS Session RA4 Conference Room 1 Update on Current Regulations in India

Session DS4 Conference Room 4 Pharmacovigilance New Horizons

12.30 PM-1.30 PM 1.30 PM-3.00 PM

LUNCH BREAK PARALLEL TRACKS

CMC / DRUG STANDARD & QUALITY / OUTSOURCING Session OS4 Conference Room 2 Medical Writing: Best Practices for Effective Partnering DATA MANAGEMENT / BIOSTATISTICS / MEDICAL WRITING Session DM7 Conference Room 3 Issues in Multi-region Clinical Trials DRUG SAFETY AND PV

CLINICAL RESEARCH / HT / REGULATORY AFFAIRS Session CR6 Conference Room 1 Strategies for Enhancing Effectiveness of Project Managers and Team Members

Session CMC3 Conference Room 4 Impact of Counterfeit Medicines and Evolving Potential Technological Solutions

3.00 PM-3.30 PM 3.30 PM-5.00 PM 5.00 PM

AFTERNOON TEA / COFFEE BREAK VALEDICTORY SESSION DAY 4 ADJOURN

INDIA 2011 | 6th ANNUAL PROGRAM

9.00 am-12.30 pm TUTORIALS | SATURDAY, OCTOBER 15, 2011

DAY 1 | SATURDAY, OCTOBER 15, 2011

Tutorial # 1: Project Management Metrics
Duration: 9:00 AM-12:30 PM
inStruCtorS:

Who Will Benefit:

Clinical Project Managers Clinical Research Leaders Project Managers Study Managers Clinical Research Managers Clinical Research Project Support CRAs / Monitors

Nicole M Lee, PMP, PMI-RMP Donald Thampy

Director of Planning and Analysis, Project Management Office ICON Clinical Research, Singapore Service Delivery Operations Lead, Accenture, Bangalore, India

Tutorial Brief: This tutorial has been designed to provide project managers with a clear understanding of the right project management metrics and its applications in clinical trials. It will provide a clear understanding of project management metrics as tools and techniques to monitor and control projects and how they can be applied to your own pharmaceutical projects in the work place. In a tough economy, knowing if a project is on track can make a difference between profit and loss. Gone are the days of launching projects within a portfolio with unclear objectives, poor scheduling and cost estimates, and no way to track progress. Project Managers must understand their organization KPI and ensure the most effective project metrics for measuring these indications. Through the right project metrics, project managers are equipped with tools and techniques to proactively monitor and control their projects.

Tutorial # 2: Advancing Drug Development through Licensing Opportunities between Pharma, Biotechs, Academia and Investors
Duration: 9:00 AM-12:30 PM
inStruCtorS:

Raman Govindarajan, MD, PhD Shozeb Haider, PhD

Head India R&D; Member Asia Pacific R&D Team SANOFI, Bangalore, India Senior Lecturer, Drug Discovery Center for Cancer Research & Cell Biology Queens University, Belfast, UK

Learning Objectives:
What is Project Management Monitoring and Control Process and why is it important for running clinical trials? Defining the key characteristics of the project management process and its importance to clinical trials Using a project management process for improving the success of your own clinical trials Setting clear objectives and defining the scope of your projects Aligning the project objectives with the strategic and financial business objectives Understanding the importance of having an overall strategy for your research projects Developing a detailed project plan to manage your clinical trials Identifying the key project activities Planning a realistic schedule Budget planning Implementing risk management and contingency planning Project implementation and control What are project metrics? Trouble with metrics Do your metrics pass the test? What are the 4 key projects KPIs? How to apply to your study Project review and learning for clinical trials

Tutorial Brief: Successful programs in Drug Discovery and Development are often a result of close collaboration between pharma, biotechs, academia, and investors. For a country to excel in this field, it is imperative that this relatively complicated machinery is well oiled and the relationships between these stakeholders is well understood and well developed. Experienced professionals from Industry, Academia, Finance and Legal will conduct this unique tutorial to elucidate these relationships, highlighting the critical enablers of licensing opportunities. Successful examples from the West will be described in detail for the Indian players to have a better understanding of this subject

Learning Objectives:
To understand the benefits of partnerships in drug discovery and development To learn the critical elements of drug licensing To learn the key areas where such licensing opportunities exist How and where to find funds for drug discovery and development How to protect your intellectual property and make the most of it Some thoughts on Translational Research: How to convert your ideas to a product

Who Will Benefit:

R&D teams of pharma and biotech companies Indian biotech companies that are exploring licensing opportunities Scientists engaged in basic research Doctors and Scientists who want to conduct Translational Research Scientists and Technologists who wish to be entrepreneurs PhDs and young Scientists who want to conduct product driven research Universities and academic institutions Policy makers in the government

INDIA 2011 | 6th ANNUAL PROGRAM

9.00 am-12.30 pm TUTORIALS CONTINUED | SATURDAY, OCTOBER 15, 2011

Tutorial # 3: Adaptive Designs in Clinical Research

Duration: 9:00 AM-12:30 PM
inStruCtorS:

The key requirements like infrastructure, trained personnel, safety reporting structure, and evaluation tools will be identified and discussed. Finally, some of the key concepts in PV like reporting and processing of ADRs, signal detection etc., will be demonstrated through examples and hands on exercises

Vishwanath (Mahesh) Iyer, PhD

Head, Oncology Biometrics Novartis Healthcare Pvt Ltd Hyderabad, India

Learning Objectives:
To understand the current practice of PV in India To learn about the proposed Pharmacovigilance Program of India To see a comparison of PV practices in India versus the developed markets To understand the gaps in the PV reporting practices To identify the key areas of improvements and how to do so To learn the key concepts in pharmacovigilance and how to implement them in your organizations PV programs.

Instructor Invited
Tutorial Brief: This workshop will explore the fast expanding area of adaptive designs in clinical research focusing on the statistical questions, as well as some of the more clinically relevant questions. Discussions will include the following topics: 1. Guidance from the health authorities EMEA reflection paper, and the more recent FDA draft guidance 2. Adaptive Designs in exploratory settings dose finding studies including Bayesian and CRM designs, and response adaptive randomization 3. Adaptive designs in confirmatory settings sample size re-estimation, multi-stage designs including group sequential designs, adaptive designs with multiple endpoints 4. Seamless designs Phase IIA/IIB or Phase IIB/III studies, adaptive studies with treatment selection, adaptive selection (e.g., biomarker based enrichment designs) 5. Adaptive test procedures based on combination tests, conditional error rate, conditional power, and predictive power

Who Will Benefit:

PV Personnel at Pharma companies (Indian as well as multinational) PV Personnel at CROs Government Regulators Medical Advisors / Medical Monitors Hospitals and Medical Institutes Practicing Doctors Professionals aspiring to work in the areas of PV

Learning Objectives:
Understanding the regulatory guidelines for adaptive clinical trials Reviewing common challenges and benefits of adaptive clinical trials Determining when adaptive clinical trials are applicable Assessing statistical considerations for adaptive design Examining logistical considerations for implementation such as data management, recruitment issues, and analysis tools Managing Global Adaptive Clinical Trials

Tutorial # 5: Vendor Selection and Oversight, Quality and Compliance Considerations

Duration: 9:00 AM-12:30 PM
inStruCtorS:

Jeroze J. Dalal

GM, Clinical Operations GlaxoSmithKline Pharmaceuticals Ltd, Mumbai, India

Munish Mehra, PhD

Washington DC, USA

President, Global Alliance of Indian Biomedical Professionals

Who Will Benefit:

Scientists and Statisticians engaged in designing studies Project Leaders Project Managers Regulatory Personnel at Pharma / Biotech / CROs Regulators engaged in evaluating adaptive studies and their results

Tutorial # 4: Building a Drug Safety and Pharmacovigilance Framework in India - From Reporting of ADRs to Signal Detection
Duration: 9:00 AM-12:30 PM
inStruCtorS:

Tutorial Brief: In recent years, FDA has issued multiple warning letters to pharmaceutical companies for lack of oversight of their CROs. In addition, with increased scrutiny and signal detection techniques being used by FDA to detect potential non-compliance, it is critical for sponsors to have appropriate procedures in place for the selection and oversight of their vendors. This tutorial will go over the procedures to be used in selecting vendors and the use of various study plans, vendor oversight plans, quality management plans, and Key Quality Indicators (KQIs) to ensure compliance to applicable regulations and GCPs.

Learning Objectives:
Understand regulatory requirement for sponsor responsibility of vendor oversight Review recent warning letters where sponsors were cited Review various plans and procedures to oversee vendors Review KQIs to oversee vendors

Moin Don

Executive Director PVCON Pharmacovigilance Services, India, Mumbai, India

Vivek Ahuja, MD

Regional Director, Asia Pacific, Pharmacovigilance Baxter Healthcare, Gurgaon, India

Who Will Benefit:

Sponsor personnel involved in the selection and oversight of vendors CROs and other vendors to create best practices and assist their sponsors in oversight and compliance.

Tutorial Brief: This tutorial will cover the essentials of building a robust pharmacovigilance program in India. The instructors will first evaluate the current structure of PV reporting in the country, including the proposed pharmacovigilance program. Then they will identify the areas where improvements can be made.

12.30 pm-1.30 pm

LUNCH

10

INDIA 2011 | 6th ANNUAL PROGRAM

PROGRAM DETAILS 1.30 am-6.00 pm CONFERENCE DAY 1 | SATURDAY, OCTOBER 15, 2011
1.30 pm-2.00 pm OPENING CEREMONY, WELCOME, INTRODUCTION TO CONFERENCE CO-CHAIRS Larisa Nagra Singh, MPharm
VP Global Functional Resourcing, Asia Quintiles, Singapore

INTRODUCTION TO CONFERENCE PROGRAM COMMITTEE AND CONFERENCE OVERVIEW

Mubarak Naqvi, MD
CSU Director SANOFI, Mumbai, India

Munish Mehra, PhD

President Global Alliance of Indian Biomedical Professionals, Washington, DC, USA

2.00 pm-3.30 pm KEYNOTE ADDRESSES AND SPECIAL GUEST SPEAKER Surinder Singh, MD (Invited)
Drugs Controller General of India New Delhi, India

David Lepay, MD, PhD

Senior Advisor USFDA, USA

D R Kaarthikeyan, IPS Ranjit Shahani Javed Akhtar

Advisor Law-Human Responsibilities Corporate Affairs, India Country President, Novartis India Ltd Mumbai, India Poet, Lyricist, and Scriptwriter Mumbai, India

3.30 pm-4.00 pm 4.00 pm-6.00 pm

TEA / COFFEE BREAK PLENARY SESSION

Panel Discussion: Barriers and Facilitators to Innovation in Bio-pharmaceuticals

SeSSion Chair Munish Mehra, PhD President, Global Alliance of Indian Biomedical Professionals Washington, DC, USA panel DiSCuSSion moDerator Professor Falguni Sen, PhD Chair, Management Systems Area and Director, Global Healthcare Innovation Management Center (GHIM), Graduate School of Business, Fordham University New York, USA

Overview on Key Issues in Becoming Innovative

paneliStS Innovations in Indian Pharmaceuticals Companies since TRIPS

Prof Sudip Chaudhari

Indian Institute of Management Kolkata, India Learning from Alliances from Service Provider to Risk Sharing Becoming Leaders in the Innovative Space

Sri Mosur

President and CEO Global Drug Discovery and Development Jubilant Biosys Bangalore, India Innovating Through Convergence of Industry Boundaries

Villoo Morawala-Patell, PhD

Founder, Chairperson and Managing Director Avesthagen Bangalore, India Global Competitiveness of Indian Clinical Research Centres

Fabio Thiers, MD, PhD

Founder & CEO, ViS Research Institute New York, USA Remarking our Innovation Strategy for a Changing India

Ranjit Shahani

Country President, Novartis India Ltd Mumbai, India

6.00 pm

DAY 1 ADJOURN

INDIA 2011 | 6th ANNUAL PROGRAM

11

PROGRAM DETAILS 9.00 am-12.30 pm CONFERENCE DAY 2 | OCTOBER 16, 2011

9.00 am-10.00 am EXHIBIT OPENING CEREMONY 10.00 am-10.30 am MORNING TEA / COFFEE BREAK 10.30 am-12.30 pm PLENARY SESSION
SeSSion Chair

Meet the Regulators: Global Regulatory Forum Session

Manish Kumar Shah, PhD
Head, Clinical Operations Pfizer Mumbai, India

panel DiSCuSSion partiCipantS ContinueD

Surinder Singh, MD

Drugs Controller General of India New Delhi, India

Stephen E Wilson, DrPH Ram Tiwari, PhD

moDerator panel DiSCuSSion

Director, Division of Biometrics III CDER, USFDA, USA Associate Director for Statistical Science and Policy USFDA, USA

Munish Mehra, PhD

President, Global Alliance of Indian Biomedical Professionals Washington, DC, USA A panel of senior regulators from the US, MhRA, EU, Malaysia, and India are being invited to share strategic initiatives undertaken by their agencies followed by a Q&A session. panel DiSCuSSion partiCipantS

Mazlan Ismail, Sr Pharmacist, PSD MOH

Ministry of Health, Malaysia

B R Jagashetty
Drug Controller Karnataka State

David Lepay, MD, PhD

H G Koshia

Senior Advisor, USFDA, USA

Gerald W Heddell, PhD

Commissioner FDA, Gujarat, India

Director of Inspection, Enforcement and Standards MHRA, London, UK

Dr S Natesh

Senior Advisor, Department of Biotechnology India

Dr K K Tripathi

12.30 pm-1.30 pm

LUNCH

Advisor Department of Biotechnology Govt of India

12

INDIA 2011 | 6th ANNUAL PROGRAM

PROGRAM DETAILS 1.30 pm-5.00 pm CONFERENCE DAY 2 | OCTOBER 16, 2011

TRACK 1 CLINICAL RESEARCH
1.30 PM - 3.00 PM

TRACK 2 CMC / DRUG STANDARDS & QUALITY / REGULATORY

1.30 PM - 3.00 PM

TRACK 3 DATA MANAGEMENT / BIOSTATISTICS / MEDICAL WRITING

1.30 PM - 3.00 PM

TRACK 4 DRUG DISCOVERY / MARKET ACCESS

1.30 PM - 3.00 PM

CR1

Avoiding Common Mistakes in Clinical Research

SESSION CHAIR

RA1

Evolving Global Regulatory Landscape and Clinical Development of Biosimilars Role of India
SESSION CHAIR

DM1

Current Issues in Medical Writing

SESSION CHAIR

MA1

Emily Tan, MSc Executive Director Clinical Research Asia Pacific PharmaNet Singapore

Arun Mishra, MSc Director, Global Regulatory Affairs (Emerging Markets and Asia-Pacific) GlaxoSmithKline, Middlesex, UK

Helle-Mai Gawrylewski, MA Sr Dir Med Affairs & Alliance Management in Reg. MW Johnson & Johnson PRD, USA

Pricing, Reimbursement and Market Access to Medicines: Current Global Challenges and Prospects
SESSION CHAIR

Alberto Grignolo, PhD Corporate Vice President, Global Strategy, PAREXEL Consulting Boston, MA, USA

Introduction Role of the Medical Writer in the Clinical Do we Have a Common Understanding? Avoiding Common Mistakes Project Development Team and Professional Definition of SBPs and Key Principles in Management Perspective Alberto Grignolo, PhD Competencies Corporate Vice President, Roshan Padbidri Evaluating SBPs Global Strategy, PAREXEL Consulting Helle-Mai Gawrylewski, MA SM - Clinical Operations Peter Richardson, PhD Sr Dir Med Affairs & Alliance Management Takeda Global Research & Development Quality of Medicines Sector Boston, MA, USA in Reg. MW Center (Asia Pte Ltd) European Medicines Agency Johnson & Johnson PRD, USA Payer Pressures, Challenges and Singapore London, England Opportunities in Europe Review and Quality Control of CSRs and Avoiding Common Mistakes Medical Do we Have a Common Understanding? Suchita Chaudhari Other Documents Perspective Definition of Biosimilars and Key Consultant - Commercial Strategy Consulting Devjani Dasgupta, PhD Geeta Paulmer, MD Principles in Evaluating Biosmilars: an PAREXEL International Operations(Medical Writing and Document Associate Medical Director EMA Perspective London, UK Publishing, ADMIRe) PharmaNet Frank Scappaticci, MD Cognizant Technologies Market Access to Medicines in Developing Senior Medical Director Singapore Roche Countries USA Guidance and Best Practices for Avoiding Common Mistakes Clinical Hareesh Parandhaman Presentation of Data Strategies / Operational Perspective Assistant Director - Business Development Indian Regulatory Framework and Deepa Raj, PhD Sanjeev Hegde, MD Lupin Ltd (Biotech Division) General Manager, Scientific Writing and Head, Clinical Operations Challenges Pune, India Aggregate Safety Reporting Piramal Healthcare Dr K K Tripathi Accenture Services Pvt Ltd Mumbai, India Advisor Department of Biotechnology Chennai, India Govt of India
3.30 PM - 5.00 PM 3.30 PM - 5.00 PM 3.30 PM - 5.00 PM 3.30 PM - 5.00 PM

CR2

Translational Clinical Research Stakeholders Perspectives

SESSION CHAIR

RA2

Recent FDA, EMA, DCGI Guidelines Regulations in Evolution

SESSION CHAIR

DM2

Designs in Early Phase Clinical Trials

SESSION CHAIR

DD1
PANEL DISCUSSION

Tal Burt, MD Scientific Director Duke Global Proof-of-Concept (POC) Research Network Durham, NC, USA Improving Our Approach to Drug Development Robert M Califf, MD Vice Chancellor of Clinical Research Director Duke Translational Medicine Institute (DTMI) Durham, NC, USA

Bobby George, PhD, CCRA, PGDHHM Assistant Vice President Regulatory Affairs Reliance Life Sciences India

Vishwanath (Mahesh) Iyer, PhD Head, Oncology Biometrics Novartis Healthcare Pvt Ltd Hyderabad, India

Partnership Models for Stimulating Innovations

SESSION CHAIR

Krathish Bopanna, PhD, DSc President and Executive Director Semler Research Center Pvt Ltd Bangalore, India Perspective of Stock Exchange in Stimulating Innovations Ravi Tyagi, SME Project Lead National Stock Exchange of India Mumbai, India Risk Appetite Amongst Investors in Providing Capital Solutions for Stimulating Innovations Kapil Khandelwal Director Makven Capital Bangalore, India Incubator Funding Opportunities and Intra Governmental Initiatives Satya Dash Chief Operating Officer ABLE Bangalore, India Scientist Perspective in Addressing Issues on Capital Solutions Chandrashekar B Director Bigtec Labs

Clinical Development Paradigms in FDAs Process Validation Guidance Albinus DSa Translating Cancer Genomics to Effective Deputy Country Director Treatments with Companion Diagnostics Richard Simon USFDA Chief, Biometric Research Branch India National Cancer Institute Rockville, MD, USA European Guidance Challenges Facing the Biomedical Emmanuelle M Voisin, PhD Industry and the Prospect of Principal and Founder Adaptive Designs for Finding the Optimal Collaborative Solutions Voisin Consulting Life Sciences Dose in Oncology Bayesian Logistic Paris, France Regression Models Dr Surinder Kher Vishwanath (Mahesh) Iyer, PhD CEO Asia Head, Oncology Biometrics Manipal Acunova Limited Indian Guidance Novartis Healthcare Pvt Ltd India Arun Bhatt, MD Hyderabad, India President Rationale for an Academic Global Proof Clininvent Research of Concept Research Network Mumbai, India An Adaptive Two-Stage Dose Finding Trial Design John S Sundy, MD, PhD Arghya Chattopadhyay, PhD Associate Professor of Medicine Director Global Project Lead Duke Global Proof of Concept (POC) IIS/Neuro/Inflammation Research Network Hyderabad, India Duke Clinical Research Institute (DCRU), Durham, NC, USA

INDIA 2011 | 6th ANNUAL PROGRAM

13

PROGRAM DETAILS 9.00 am-12.30 pm CONFERENCE DAY 3 | OCTOBER 17, 2011

TRACK 1 CLINICAL RESEARCH TRACK 2 REGULATORY / CMC / DRUG SAFETY AND PV
9.00 AM - 10.30 AM
DATA MANAGEMENT / DRUG DISCOVERY AND MARKET ACCESS / BIOSTATISTICS / MEDICAL WRITING / HOT TOPIC

TRACK 3

TRACK 4 OUTSOURCING AND PROFESSIONAL DEVELOPMENT

9.00 AM - 10.30 AM

9.00 AM - 10.30 AM

9.00 AM - 10.30 AM

CR3

Enhancing Public Confidence in Clinical Research through Robust and Empowered Ethics Committees
SESSION CHAIR

RA3

Regulatory Strategy: Pathways to Drug Approvals in Different Countries

SESSION CHAIR

DM3

Different Tools to Facilitate Clinical Data Management

SESSION CHAIR

OS1

Consideration in Outsourcing Clinical Trials to Emerging Regions: Are Global or Local CROs the Right Choice?
SESSION CHAIR

Dr Nandini Kumar Former Deputy Director General ICMR Co-investigator NIH Project on Bioethics National Institute of Epidemiology (ICMR) Chennai, India

Alberto Grignolo, PhD Corporate Vice President, Global Strategy, PAREXEL Consulting Boston, MA, USA

Nara Iyer Group Head, Oncology Data Management Novartis Healthcare Pvt Ltd

Ajit Nair, PhD President, Global Operations SIRO Clinpharm Pvt Ltd India
DEBATE

Accreditation of Ethics Committees by Introduction SIDCER Alberto Grignolo, PhD Corporate Vice President, Dr Nandini Kumar Former Deputy Director General ICMR Global Strategy, PAREXEL Consulting Co-investigator NIH Project on Bioethics Boston, MA, USA National Institute of Epidemiology (ICMR) Chennai, India Regulatory Strategy: Pathways to Drug Approvals in Different Countries Central Ethics Committee Role and Joseph Scheeren, PharmD Functioning Senior VP, Head of Global Regulatory Affairs Bayer Healthcare Pharmaceuticals Vijay Kumar Deputy Director Genera New York, USA ICMR and New Delhi, India Arun Mishra, MSc Director, Global Regulatory Affairs Accreditation of Ethics Committees by (Emerging Markets and Asia-Pacific) AAHRPP GlaxoSmithKline, Middlesex, UK Shyamala Sesikaran Medical Advisor Generic Pharmaceutical Industry - An AHERF Overview, Regulatory Challenges in USA New Delhi, India and EU Zoher T Sihorwala Vice President Dr Reddys Laboratory Mumbai, India
11.00 AM - 12.30 PM 11.00 AM - 12.30 PM

Demystifying CDM Part I Michael Goedde Director, Clinical Data Management Human Genome Sciences, Inc. Rockville, MD, USA Demystifying CDM Part II Julian Rimmer VP & GM Clinical Services Comprehensive Clinical Development Philadelphia, PA, USA

Vijay Chauthaiwale, PhD VP, Torrent Pharmaceuticals Ltd Ahmedabad, India Badhri Srinivasan Sr Director Quintiles USA C N Ramchand, President CEO Laila Pharmaceuticals India Arun Bhatt, MD President Clininvent Research Mumbai, India

11.00 AM - 12.30 PM

11.00 AM - 12.30 PM

DD2

Current Topics in Phase 0 and Phase 1 Studies

SESSION CHAIR

CMC1

Ensuring Quality in GMPs Enhance the Approach of Quality driven by ICH Q8, Q9, Q10 and Q11: Practical Implementation
SESSION CHAIR

MA2

Vijay Chauthaiwale, PhD Torrent Pharmaceuticals Ltd Ahmedabad, India

Nandkumar Chodankar, PhD Group CEO, Pharma Business Excel Industries Mumbai, India

Synchronizing Clinical, Regulatory and Commercial Strategies During Drug Development to Accelerate Regulatory Approval and Patient Access to New Medicines
SESSION CHAIR

OS2

Current Trends in Outsourcing: Partnership Models and Best Practices for Data Management and Scientific Programming
SESSION CHAIR

Alberto Grignolo, PhD Corporate Vice President, Global Strategy, PAREXEL Consulting, Boston, MA, USA

Ralph Russo, MS, MBA Director Global Clinical Data Integration Merck Research Labs New York, USA

Application of PK / PD Modeling and Simulation to aid Early Development Ranendra Saha Prof of Pharmacy BITS Pilani, India Strategies to Enable a Smooth Transition to Early Phase Clinical Trials Nimish Vachharajani, PhD Senior Vice President, Advinus Therapeutics Bangalore, India

Quality Management and Product Life Cycle Prasad Kanitkar Director, Plant Operations Pfizer Global Manufacturing India Technology Transfer of Biosimilars: Using ICH Quality Drivers to your Advantage a Pragmatic Approach Richard Dennett, PhD Director Voisin Consulting Life Sciences Rennes, France

Introduction Alberto Grignolo, PhD Aligning Cross-functional Performance Metrics for Market Access Effectiveness Suchita Chaudhari Consultant - Commercial Strategy Consulting PAREXEL International London, UK Integrating Registration Strategy and Commercial Strategy During Drug Development Joseph Scheeren, PharmD Senior VP, Head of Global Regulatory Affairs Bayer Healthcare Pharmaceuticals New York, USA Pharmaceutical Pricing and Reimbursement Policies and Practices in Emerging Markets: Impact on Drug Development and Registration Strategy
(presentation by phone)

PANEL DISCUSSION

Microdosing and Chronotherapeutics: Innovative Technologies and Approaches How to Apply QbD and PAT Principles for in Translational Research Tal Burt, MD Preparing Clinical Supplies Nandkumar Chodankar, PhD Scientific Director Group CEO, Pharma Business Duke Global Proof-of-Concept (POC) Excel Industries Research Network Mumbai, India Duke Clinical Research Unit (DCRU) & Duke Clinical Research Institute (DCRI), Durham, NC, USA

Data Management the Business Model of Choice for Outsourcing CDM the Vendor vs the Sponsor Perspective Anil Golla Head, Oncology Data Management Novartis Healthcare Pvt Ltd Nimita Limaye, PhD Senior VP & Global Head: CDM, Medical Writing and SCEDAM SIRO Clinpharm Pvt Ltd India Balasubramanian Sankaranarayanan Vice President, Healthcare and Life Sciences Smart Decision Services, GenPact Mumbai, India Ralph Russo Director Global Clinical Data Integration Merck Research Labs New York, USA Best Practices in Outsourcing Scientific Programing Presentation Frederic Coppin, MSc Manager, Global Scientific Programming MSD Brussels, Belgium and Nimita Limaye, PhD Senior VP & Global Head: CDM, Medical Writing and SCEDAM SIRO Clinpharm Pvt Ltd India

Raj Long DRA Head, AMAC GEM & LATAM Novartis Pharma AG Basel, Switzerland

14

INDIA 2011 | 6th ANNUAL PROGRAM

PROGRAM DETAILS 1.30 pm-5.00 pm CONFERENCE DAY 3 | OCTOBER 17, 2011

TRACK 1 CLINICAL RESEARCH TRACK 2 REGULATORY / CMC / DRUG SAFETY AND PV
1.30 PM - 3.00 PM
DATA MANAGEMENT / DRUG DISCOVERY AND MARKET ACCESS / BIOSTATISTICS / MEDICAL WRITING / HOT TOPIC

TRACK 3

TRACK 4 OUTSOURCING AND PROFESSIONAL DEVELOPMENT

1.30 PM - 3.00 PM

1.30 PM - 3.00 PM

1.30 PM - 3.00 PM

CR4

Drug Development for Pediatric and Geriatric Population

SESSION CHAIR

DS1

Industrial Pharmacovigilance Practices

SESSION CHAIR

HT1

Regulation, Media and Public Perception Navigating the Minefield in India

SESSION CHAIR

DM4

Deeper Look into Health Authority Guidances

SESSION CHAIR

Adnan Mahmood, MD Clinical Research Physician (Oncology/Hematology) Janssen Pharmaceuticals (J&J) Reading, UK

Ricardo Seminario, MD Director Medical & Safety Services Icon Clinical Research Chennai, India

Dr Shoibal Mukherjee, MD Vice President, Medical Quintiles

Vishwanath (Mahesh) Iyer, PhD Oncology Biometrics Novartis Hyderabad, India

Medical Review of Individual Cases is it EMEA Guidance on the Clinical Trials in a Useful use of Core PV Resources? Pediatric Population Ajay Keshava Adnan Mahmood, MD Clinical Research Physician Senior Consultant (Oncology/Hematology) WCI Consulting, USA Janssen Pharmaceuticals (J&J) Reading, UK The Science and Industrial Practice in Signal Detection FDA and EMEA Guidance on Conducting Sidney Kahn, MBChB, PhD Clinical Trials in Geriatric Population Principal Scientist Emmanuelle M Voisin, PhD Sciformix PV Services Principal and Founder Philadelphia, PA, USA Voisin Consulting Life Sciences Paris, France CROs Challenges in PV Capacity Building Issues with Conducting Clinical Trials in in Meeting Sponsors Expectations Pediatric and Geriatric Population in India Ricardo Seminario, MD Yasmin Shenoy Director Medical & Safety Services Director, Regulatory Affairs Icon Clinical Research SANOFI Chennai, India India Q&A Session
3.30 PM - 5.00 PM 3.30 PM - 5.00 PM

Review and Analysis of Recent Reports on the Clinical Research Practice in India, and how it is Shaping the Public Opinion and Perception Dr Mubarak Naqvi, MD Director, Clinical Study Unit SANOFI Compensation for Clinical Trial Related Injury or Death: the Processes and Regulations Needed to Avoid the Repetition of the Recent Issues in India Dr Shoibal Mukherjee, MD Vice President, Medical Quintiles How Should the Companies Operate in the Current Environment? What Policies Need to be Adopted? Is the Global Policy Framework Applicable in Emerging Counties like India? Suresh Menon, MD Chief Scientific Officer Novartis India Ltd Mumbai, India
3.30 PM - 5.00 PM

Health Authority Guidance for Bridging Studies Ashwini Mathur Development Operations Novartis Healthcare Pvt Ltd FDA Guidances on Adaptive Designs and other Statistical Endpoints Ram Tiwari, PhD Associate Director for Statistical Science and Policy USFDA USA FDA Guidance on ADAM and CDISC Standards Stephen E Wilson, DrPH Director, Division of Biometrics III CDER, USFDA USA

3.30 PM - 5.00 PM

CR5

New Electronic Systems in Ensuring Good Clinical Practice Compliance

SESSION CHAIR

DS2

Nancy Smerkanich Vice President Global Regulatory Affairs Octagon Research Solutions Philadelphia, PA, USA

Current Hot Topics International Pharmacovigilance Regulatory Updates SESSION CHAIR Sidney Kahn, MBChB, PhD Principal Scientist Sciformix PV Services Philadelphia, PA, USA

HT2

PD1
SESSION CHAIR Navaneetha Rao, MD VP Clinical R&D Vicus Therapeutics

Career Paths in Drug Discovery Transition from University to Industry, Private / Government /Academic Sector Experiences with Highly Trained Graduates for Innovative Biotech Pharma Industry in India SESSION CHAIR Lakshmi P Kotra, PhD Director-CMDP, Scientist and Associate Professor University of Toronto and University Health Network Canada

PANEL DISCUSSION Repurposed Generic Combinations as New FDA Final Rule for Safety Reporting one Means of Addressing the Challenges from Clinical Trials Implications and S Natesh Facing the Industry Management Senior Advisor (Scientist-H) and Head International Collaborations Navaneetha Rao, MD Sidney Kahn, MBChB, PhD Department of Biotechnology VP Clinical R&D Principal Scientist Government of India Vicus Therapeutics Sciformix PV Services Philadelphia, PA, USA Achievements of the Clinical Trial Prof N Udupa Transformation Initiative (CTTI) TBA Development Safety Update Reports Principal Alberto Grignolo, PhD Manipal College of Pharmaceutical Sciences Nancy Smerkanich DSURs Corporate Vice President, Manipal University Vice President Ricardo Seminario, MD Global Strategy, PAREXEL Consulting, Global Regulatory Affairs Director Medical & Safety Services Boston, MA, USA Octagon Research Solutions Icon Clinical Research Vijay Moolaveesala Philadelphia, PA, USA Chennai, India Director-Operations The Challenges of Multi Pharmacopoeia (Strategic Alliances) ICH E2E and Risk Management through Compliance in a Global Market i3 Global/InVentiv The Use of Electronic Systems in Early Paul Ellis REMS and RMPs Phase Clinical Trials for Ensuring GCP Director, External Advocacy Rajashree Devarakonda, MBBS, M.Sc, CCRP Compliance Global Manufacturing and Supply Director Vinoth Kumar T GlaxoSmithKline Voisin Consulting Assistant Manager and Delivery Lead UK Life Sciences (E-Clinical Technologies) Bangalore, India Techsol Corporation Q&A Session Role of Public-private Partnerships to Bangalore, India Advance Research and Development for Effective Therapeutics Tobby Simon CEO Synergia

Considerations for a Compliant and Secure Cloud Infrastructure to Facilitate Virtual Research Gunjan Jain Health Sciences Global Business Unit, ORACLE India

INDIA 2011 | 6th ANNUAL PROGRAM

15

PROGRAM DETAILS 9.00 am-12.30 pm CONFERENCE DAY 4 | OCTOBER 18, 2011

TRACK 1 CLINICAL RESEARCH / HT / REGULATORY AFFAIRS
9.00 AM - 10.30 AM

TRACK 2 TRACK 3 CMC /DRUG STANDARD & QUALITY DATA MANAGEMENT / / OUTSOURCING BIOSTATISTICS / MEDICAL WRITING
9.00 AM - 10.30 AM 9.00 AM - 10.30 AM

TRACK 4 DRUG SAFETY AND PV

9.00 AM - 10.30 AM

HT3

Current Updates on Select Hot Topics

SESSION CHAIR

CMC2

Regulatory and CMC Considerations for Clinical Trials and New Technologies
SESSION CHAIR

DM5

Safety Issues in Drug Development

SESSION CHAIR

DS3

National Pharmacovigilance and Regulatory Update

SESSION CHAIR

Albinus DSa Deputy Country Director USFDA India

Mike James GlaxoSmithKline Manager Reg Infl CMC Reg Affairs London, UK The Role of CMC in Investigational New Drugs Sultan Ghani Former Director Health Canada CMC Requirements to Support New Technologies Mike James GlaxoSmithKline Manager Reg Infl CMC Reg Affairs London, UK Preparing your Global Clinical Trials Dossier - Comparing the Indian Draft Guidelines on Approval of Clinical Trials and New Drugs with other Agencies Stuart Wright Regulatory Services Canada

Dr Chitra Lele Chief Scientific Officer Sciformix Corp USA

Usha Sharma Express Pharma/Indian Express Newspapers MS: Business Publications Division Mumbai, India

Current Developments in Translational Research The NCATS NIH Initiative Tal Burt, MD Scientific Director Duke Global Proof-of-Concept (POC) Research Network Duke Clinical Research Unit (DCRU) & Duke Clinical Research Institute (DCRI), Durham, NC, USA An Overview of FDA cGMP Inspections and Compliance in India Albinus DSa Deputy Country Director USFDA India Risk Based Monitoring Arun Bhatt, MD President Clininvent Research Mumbai, India

Resolving the Type I and Type II Error Building up Indian Pharmacovigilance Dilemma for Clinical Safety Analyses Capacity A Regulatory Perspective Devan Mehrotra Dr Y K Gupta Senior Director and Head VP Clinical Development Early Clinical Development Statistics Semler Research Centre Pvt Ltd Biostatistics & Research Decision Sciences India Merck Research Laboratories USA Building up Indian Pharmacovigilance Capacity A Stakeholders Perspective Visual Analytics for Instream Review and Dhananjay Bakle Safety Monitoring in Clinical Trials and PostExecutive Vice President - Medical Research marketing Applications Lupin Pharma Michael OConnell India Sr Director, Analytics TIBCO Schedule Y An Introspection USA Kedar Suvarnapathki Regulatory Affairs Manager Comparison of AE Incidence Between Drugs Amgen Technology Pvt Ltd Dr Chitra Lele Mumbai, India Chief Scientific Officer Sciformix Corp Q&A Session USA

11.00 AM - 12.30 PM

11.00 AM - 12.30 PM

11.00 AM - 12.30 PM

11.00 AM - 12.30 PM

RA4

Update on Current Regulations in India

How Offshoring is Impacting the way Qualification of Biomarkers and PROs SESSION CHAIR SESSION CHAIR Clinical Data is Processed and Interpreted SESSION CHAIR Stephen E Wilson, DrPH Arun Bhatt, MD Nimita Limaye, PhD Director, Division of Biometrics III President Senior VP & Global Head: CDER, USFDA Clininvent Research CDM, Medical Writing and SCEDAM USA Mumbai, India SIRO Clinpharm Pvt Ltd India Offshoring Clinical Research: Implications for Coherent Aggregation of Data Debjit Biswas Sr Director, Clinical Development Head Biostats and Data Management Piramal Life Sciences, India Biomarker Analytics for Assessment of Safety and Efficacy in Clinical Trials Michael OConnell Sr Director, Analytics TIBCO USA

OS3

DM6

DS4

Pharmacovigilance New Horizons

SESSION CHAIR

Dr Urmila Thatte, MD Head of Department of Clinical Pharmacology Seth GS Medical College and KEM Hospital, Mumbai, India PANEL DISCUSSION Empowering ECs / IRBs to Evaluate Safety and Risk During Clinical Trials
MODERATOR

Regulatory Expectations Medical Devices Sumati Randeo Head Regulatory Quality and Compliance Asia Pacific India

Current Regulatory Trends Biologics Bobby George, PhD, CCRA, PGDHHM Outsourcing and the Changes in Clinical Assistant Vice President Regulatory Affairs Data Management Reliance Life Sciences Suresh Ramu India Director - Operations Cytespace Research Pvt Ltd Regulatory Challenges for Stem Cell India Research Umesh Baikunje Sr General Manager Quality and Regulatory Affairs Stempeutics Research Pvt Ltd India

Item Response Theory and Rasch Methodology to Develop Better Measurement Tools for Assessing Efficacy Integration of Pharmacovigilance in Medical of New Medicinal Products and Para Medical Syllabus Munish Mehra, PhD Dr Urmila Thatte President Head of Department of Clinical Pharmacology Global Alliance of Indian Biomedical Seth GS Medical College and KEM Hospital, Professionals Mumbai, India Washington, DC, USA Q&A Session FDA Guidance on Qualification of Biomarkers and PROs Stephen E Wilson, DrPH Director, Division of Biometrics III CDER, USFDA USA

Dr Chitra Lele Chief Scientific Officer Sciformix Corp USA

16

INDIA 2011 | 6th ANNUAL PROGRAM

PROGRAM DETAILS 1.30 pm-5.00 pm CONFERENCE DAY 4 | OCTOBER 18, 2011

TRACK 1 CLINICAL RESEARCH / HT / REGULATORY AFFAIRS
1.30 PM - 3.00 PM

TRACK 3 TRACK 2 DATA MANAGEMENT / CMC /DRUG STANDARD & QUALITY BIOSTATISTICS / MEDICAL WRITING / OUTSOURCING
1.30 PM - 3.00 PM 1.30 PM - 3.00 PM

TRACK 4 DRUG SAFETY AND PV

1.30 PM - 3.00 PM

CR6

Strategies for Enhancing Effectiveness of Project Managers and Team Members

SESSION CHAIR

OS4

Medical Writing: Best Practices for Effective Partnering

SESSION CHAIR

DM7

Issues in Multi-region Clinical Trials

SESSION CHAIR

CMC3

Chirag Trivedi, PhD Associate Director - Project Management & Strategic Initiatives SANOFI Mumbai, India Challenges in Project Management Sudip Sinha Vice President Project Management and Clinical Operations CliniRx Research Pvt Ltd India Understanding Change and how People Deal with it Subashri Shivkumar Hub Unit Director India Regional Clinical Operations Bristol-Myers Squibb India Pvt Ltd Effective Project Mangers Should They Manage OR Lead Dr Aamir Shaikh, MD Founder, Health Care Consultant, Assansa Mumbai, India

Carolyn Smith-Barrett, PhD Global Head, Regulatory Medical Writing Johnson & Johnson Pharma R&D New York, USA
PANEL DISCUSSION

Dr Jayanti Gupta, PhD VP Clinical Development Semler Research Centre Pvt Ltd Mumbai, India

Impact of Counterfeit Medicines and Evolving Potential Technological Solutions

SESSION CHAIR

Neville Broad Anti-counterfeit Manager Abbott Laboratories UK

Best Practices for Effective Partnering in the Field of Medical Writing Focussing on True Partnership vs Outsourcing

Key Regulatory and Clinical Rapid Screening Methods to Detect Considerations when Conduction Counterfeit a Global Clinical Trial in Emerging Neville Broad Economies Anti-counterfeit Manager Dr Cellia K Habita Abbott Laboratories Suhasini Sharma, MD President & CEO UK Director, Medical Writing and Medical Review Arianne Corp SCIFORMIX TECHNOLOGIES PRIVATE San Diego, CA, USA Counterfeit Medicines in Asia Today LIMITED Bejon Misra Case Studies on Quality Laboratory Data Founder and Standardized Processes in MultiPartnership for Safe Medicines (PSM) Nimita Limaye, PhD regional Clinical Trials India Senior VP & Global Head: Dr Neelesh Shah CDM, Medical Writing and SCEDAM COO, Group Head The Malaysian Experience with Medtang SIRO Clinpharm Pvt Ltd Metropolis Group India Mazlan Ismail, Sr Pharmacist, PSD MOH India Ministry of Health Malaysia Jane Dixon, PhD Principal, Medical Communications Scientist Considerations for Design and Analysis of AstraZeneca, LP, Wilmington, DE, USA MRCTs Dr Jayanti Gupta, PhD VP Clinical Development Dr Devjani Dasgupta, DGM Semler Research Centre Pvt Ltd Operations (Medical Writing and Document Mumbai, India Publishing, ADMIRe) Cognizant Technology Solutions
3.30 PM - 5.00 PM 3.30 PM - 5.00 PM

3.30 PM - 5.00 PM

3.30 PM - 5.00 PM

VALEDICTORY SESSION

VALEDICTORY SESSION

VALEDICTORY SESSION

VALEDICTORY SESSION

INDIA 2011 | 6th ANNUAL PROGRAM

17

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DIA 2012
Collaborate to Innovate

June 24-28, 2012 | Philadelphia, PA | Pennsylvania Convention Center