Kapil Khandelwal QuoteUnquote with KK www.kapilkhandelwal.com

1. 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 Inaugural – Exhibit Hall Open
10:30 AM–12:30 PM Plenary Session: Meet the Regulators
1.30 PM–5.00 PM 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

2. 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
PROGRAM CO-CHAIRS
Larisa Nagra Singh, MPharm
VP Global Functional Resourcing, Asia
Quintiles, Singapore
Albinus D’Sa
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 Munish Mehra, PhD Mubarak Naqvi, MD
Alberto Grignolo, PhD President, Global Alliance of Indian CSU Director
Corporate Vice President-Global Strategy Biomedical Professionals SANOFI, India
PAREXEL Consulting Washington, DC, USA
Boston, MA, USA
Arun Mishra, MSc
This conference will bring together industry professionals, clinicians, patient representa-
Director, Global Regulatory Affairs
(Emerging Markets and Asia-Pacific) tives, and regulatory agencies from India (CDSCO/DCGI), the United States (FDA), Europe
GlaxoSmithKline, Middlesex, UK (EMA), and emerging markets to:
Vishwanath (Mahesh) Iyer, PhD • Facilitate knowledge exchange leading to innovation and ultimately patient care
Head, Oncology Biometrics
Novartis Healthcare Pvt Ltd • Build upon DIA’s breadth and depth of topics from drug discovery through
Hyderabad, India post-marketing safety surveillance
Arun Bhatt, MD • Provide an invaluable forum for sharing information and networking for professionals
President involved in the discovery, development, and life cycle management of pharmaceuticals,
Clininvent Research, Mumbai, India
medical devices, and related products, including discussion of current issues related to
Nimita Limaye, PhD
Senior VP & Global Head: CDM, Medical Writing
new areas such as regulatory changes, biosimilars, medical devices, and best practices
and SCEDAM, SIRO Clinpharm Pvt Ltd, India in the design, conduct, and reporting of clinical trials
Krathish Bopanna, PhD, DSc
President and Executive Director WHO SHOULD ATTEND
Semler Research Center Professionals, researchers, and clinicians involved in drug discovery and development and
Bangalore, India
regulatory affairs, e.g.:
Balasubramanian Sankaranarayanan • Drug Development and Clinical Research Managers and Associates
Vice President, Healthcare and Life Sciences
Smart Decision Services, GenPact, Mumbai, India • Pharmaceutical Physicians and Medical Directors
• Drug Safety and Drug Surveillance Personnel
The DIA India Conference Program is published • Professionals Engaged in Discovery Research
by the Drug Information Association for distribu-
tion at the 6th Annual Conference on Global Drug • Clinical Pharmacology Scientists
Development and Market Access: Converging • Pharmacologists
Strategies and Best Practices to Benefit Patients. • Regulatory Affairs Managers
Copyright to all material in this publication is held
by the Drug Information Association. • Regulators
• Academic Scientists
For more information contact us:
Manoj Trivedi at Manoj.Trivedi@diaindia.org • Biostatisticians
• Data Managers
• Medical Writers
• Outsourcing and Marketing Managers
DIA (India) Private Limited
• IT Professionals
A 303, Wellington Business Park I • Students
Marol Andheri-Kurla Road
Andheri (East), Mumbai - 400059
Excellent opportunity to showcase your products and
2 INDIA 2011 | 6th ANNUAL PROGRAM services. Exhibits and advertising opportunities are available.

3. SPECIAL GUEST KEYNOTE SPEAKERS
Javed Akhtar Ranjit Shahani David Lepay, MD, PhD D R Kaarthikeyan, IPS Surinder Singh (Invited)
Poet, Lyricist, Country President Senior Advisor Advisor Law-Human Drugs Controller General of India
and Scriptwriter Novartis Ltd USFDA Responsibilities New Delhi, India
Mumbai, India Mumbai, India USA Corporate Affairs
India
PROGRAM COMMITTEE
Larisa Nagra Singh, Albinus D’Sa Dr Nandini Kumar Moin Don Arun Bhatt, MD Alberto Grignolo, PhD
Deputy Country Director Former Deputy Director General ICMR Executive Director President Corporate Vice President,
MPharm Co-investigator NIH Project on
VP Global Functional USFDA PVCON Pharmacovigilance Clininvent Research Global Strategy,
Bioethics
Resourcing, Asia India National Institute of Epidemiology
Services Mumbai, India PAREXEL Consulting
Quintiles, Singapore (ICMR), Chennai, India India Boston, MA, USA
Arun Mishra, MSc Krathish Bopanna, Vishwanath (Mahesh) Iyer, PhD Nimita Limaye, PhD Balasubramanian
Director, Global Regulatory Affairs PhD, DSc Head, Oncology Biometrics, Senior VP & Global Head: Sankaranarayanan
(Emerging Markets and Asia-Pacific) President and Executive Novartis Healthcare Pvt Ltd CDM, Medical Writing and SCEDAM Vice President
GlaxoSmithKline Director Hyderabad, India SIRO Clinpharm Pvt Ltd, India Healthcare and Life Sciences
Middlesex, UK Semler Research Center Smart Decision Services
Bangalore, India GenPact, Mumbai, India
SPEAKERS
Robert M Califf, MD Tal Burt, MD Nancy Smerkanich
Vice Chancellor of Clinical Research Scientific Director Vice President
Director, Duke Global Proof-of-Concept Global Regulatory Affairs
Duke Translational Medicine (POC) Research Network Duke Octagon Research Solutions
Institute (DTMI) Clinical Research Unit (DCRU) & Philadelphia, PA, USA
Durham, NC, USA Duke Clinical Research
Institute (DCRI), Durham, NC, USA
John S Sundy, MD, PhD Gerald W Heddell, PhD
Tal Burt, M.D. is a psychiatrist and clinical researcher trained in Israel, Italy, France, and the US. Sri Mosur
Associate Professor of Medicine Director of Inspection
Most of his career has been in clinical research, of drugs and devices, in Industry and academia. President and CEO Global Drug
Director, Duke Global Proof of After being on the faculty at Columbia University Department of Psychiatry Tal moved to industry –
Enforcement and Standards MHRA Discovery and Development
first Pfizer and then Eisai as Senior Medical Director overseeing all phases of clinical research and
Concept (POC) Research Network London, UK
development. He then joined Duke‐National University of Singapore Graduate Medical School as
Jubilant Biosys
Duke Clinical Research Institute Associate Professor for Clinical Research. He served as the founding director of the SingHealth Bangalore, India
(DCRU), Durham, NC, USA Investigational Medicine Unit (IMU – in Singapore) and Medanta Duke Research Institute (MDRI –
in Delhi, India) – both part of Duke’s global Proof‐of‐Concept (POC) Research Network.
Professor Falguni Sen, PhD Emily Tan, MSc Emmanuelle M Voisin, PhD
Chair, Management Systems Area Executive Director Principal and Founder Voisin
and Director Global Healthcare Inno- Clinical Research, Asia Pacific Consulting Life Sciences
vation Management Center (GHIM) PharmaNet Paris, France
Graduate School of Business Singapore
Fordham University
New York, USA
Raman Govindarajan, MD, PhD Helle-Mai Gawrylewski Shoibal Mukherjee, MD
Head India R&D Senior Director, Head Medical Vice President, Medical
Member Asia Pacific Affairs and Alliance Management in Quintiles
R&D Team SANOFI Regulatory Medical Writing India
Bangalore, India Johnson & Johnson PRD
USA
Lakshmi P Kotra, PhD Michael Goedde Dr Surinder Kher
Director-CMDP, Scientist and Director, Clinical Data CEO Asia
Associate Professor Management Manipal Acunova Limited
University of Toronto and University Human Genome Sciences, Inc. India
Health Network Rockville, MD, USA
Canada
IMAGE NOT PICTURED: Cellia K Habita, MD, PhD, President & CEO, Arianne Corp, San Diego, CA, USA
INDIA 2011 | 6th ANNUAL PROGRAM 3

4. PLENARY SESSION — SATURDAY, OCTOBER 15, 2011 — 4.00 pm-6.00 pm
Panel Discussion: Barriers and Facilitators to paneliStS
Innovation in Bio-pharmaceuticals Prof Sudip Chaudhuri
Professor
SeSSion Chair
Indian Institute of Management
Munish Mehra, PhD Kolkata, India
President, Global Alliance of Indian Biomedical Professionals
Sri Mosur
Washington DC, USA
President and CEO Global Drug Discovery and Development
panel DiSCuSSion moDerator SeSSion Chair Jubilant Biosys
Professor Falguni Sen, PhD Bangalore, India
Chair, Management Systems Area and Director, Villoo Morawala-Patell, PhD
Global Healthcare Innovation Management Center (GHIM), Founder, Chairperson and Managing Director
Graduate School of Business, Fordham University Avesthagen
New York, USA Bangalore, India
Fabio Thiers, MD, PhD
Senior pharma company executives will share their vision for what they see as the key Founder & CEO, ViS Research Institute
opportunities and impediments for India becoming a major pharma hub and what New York, USA
must be done to overcome the impediments. Ranjit Shahani
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 panel DiSCuSSion partiCipantS
SeSSion Chair David Lepay, MD, PhD
Senior Advisor
Manish Kumar Shah, PhD USFDA, USA
Head, Clinical Operations
Pfizer Gerald W Heddell, PhD
Mumbai, India Director of Inspection, Enforcement and Standards
moDerator – panel DiSCuSSion MHRA
London, UK
Munish Mehra, PhD
President, Global Alliance of Indian Biomedical Professionals Surinder Singh, MD
Washington DC, USA Drugs Controller General of India
New Delhi, India
A panel of senior regulators from the US, MhRA, EU, Malaysia, and India are being invited Stephen E Wilson, DrPH
to share strategic initiatives undertaken by their agencies followed by a Q&A session. Director, Division of Biometrics III
CDER, USFDA, USA
Ram Tiwari, PhD
Associate Director for Statistical Science and Policy
USFDA, USA
Mazlan Ismail, Sr Pharmacist, PSD MOH
Ministry of Health
Malaysia
B R Jagashetty
Drug Controller
Karnataka State
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
4 INDIA 2011 | 6th ANNUAL PROGRAM

5. 24th annual
EuroMEEting
C o p E n h agEn 2012
26-28 March 2012
Bella Center | Copenhagen, Denmark
INDIA 2011 | 6th ANNUAL PROGRAM 5

6. SATURDAY, OCTOBER 15, 2011
SATURDAY, OCTOBER 15, 2011
9.00 AM-12.30 PM TUTORIAL 1 Project Management Metrics
TUTORIAL 2 Advancing Drug Development through Licensing Opportunities between Pharma, Biotechs, Academia, and
Investors
TUTORIAL 3 Adaptive Designs in Clinical Research
TUTORIAL 4 Building a Drug Safety and Pharmacovigilance Framework in India — From Reporting of ADRs to Signal Detection
TUTORIAL 5 Vendor Selection and Oversight, Quality and Compliance Considerations
12.30 PM-1.30 PM LUNCH BREAK
1.30 PM-2.00 PM OPENING CEREMONY, WELCOME, INTRODUCTION TO CONFERENCE CO-CHAIRS
INTRODUCTION TO CONFERENCE PROGRAM COMMITTEE AND CONFERENCE OVERVIEW
2.00 PM-3.30 PM KEYNOTE ADDRESS AND SPECIAL GUEST SPEAKER
3.30 PM-4.00 PM TEA / COFFEE BREAK
4.00 PM-6.00 PM PLENARY SESSION — Panel Discussion: Barriers and Facilitators to Innovation in Bio-pharmaceuticals
6.00 PM DAY 1 ADJOURN
SUNDAY, 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 — Meet the Regulators: Global Regulatory Forum Session
12.30 PM-1.30 PM LUNCH BREAK
1.30 PM-3.00 PM PARALLEL TRACKS
CMC / DRUG STANDARDS & DATA MANAGEMENT / DRUG DISCOVERY / MARKET
CLINICAL RESEARCH QUALITY /REGULATORY BIOSTATISTICS / MEDICAL WRITING ACCESS
Session CR1 Session RA1 Session DM1 Session MA1
Conference Room 1 Conference Room 2 Conference Room 3 Conference Room 4
Avoiding Common Mistakes in Evolving Global Regulatory Current Issues in Medical Writing Pricing, Reimbursement and
Clinical Research Landscape and Clinical Market Access to Medicines:
Development of Biosimilars — Role Current Global Challenges and
of India Prospects
3.00 PM-3.30 PM AFTERNOON TEA / COFFEE BREAK
3.30 PM-5.00 PM PARALLEL TRACKS
CMC / DRUG STANDARDS & DATA MANAGEMENT / DRUG DISCOVERY / MARKET
CLINICAL RESEARCH QUALITY /REGULATORY BIOSTATISTICS / MEDICAL WRITING ACCESS
Session CR2 Session RA2 Session DM2 Session DD1
Conference Room 1 Conference Room 2 Conference Room 3 Conference Room 4
Translational Clinical Research — Recent FDA, EMA, DCGI Guidelines Designs in Early Phase Clinical Trials PANEL DISCUSSION
Stakeholders’ Perspectives — Regulations in Evolution Partnership Models for Stimulating
Innovations
5.00 PM DAY 2 ADJOURN
6 INDIA 2011 | 6th ANNUAL PROGRAM

7. MONDAY, OCTOBER 17, 2011
9.00 AM-10.30 AM PARALLEL TRACKS
REGULATORY / CMC / DATA MANAGEMENT / OUTSOURCING AND
CLINICAL RESEARCH DRUG SAFETY AND PV BIOSTATISTICS / MEDICAL WRITING PROFESSIONAL DEVELOPMENT
Session CR3 Session RA3 Session DM3 Session OS1
Conference Room 1 Conference Room 2 Conference Room 3 Conference Room 4
Enhancing Public Confidence Regulatory Strategy: Pathways Different Tools to Facilitate Clinical Consideration in Outsourcing
in Clinical Research through to Drug Approvals in Different Data Management Clinical Trials to Emerging
Robust and Empowered Ethics Countries Regions: Are Global or Local CRO’s
Committees the Right Choice?
10.30 AM-11.00 AM MORNING TEA / COFFEE BREAK
11.00 AM-12.30 PM PARALLEL TRACKS
REGULATORY / CMC / DATA MANAGEMENT / OUTSOURCING AND
CLINICAL RESEARCH DRUG SAFETY AND PV BIOSTATISTICS / MEDICAL WRITING PROFESSIONAL DEVELOPMENT
Session DD2 Session CMC1 Session MA2 Session OS2
Conference Room 1 Conference Room 2 Conference Room 3 Conference Room 4
Current Topics in Phase 0 and Ensuring Quality in GMPs — Enhance Synchronizing Clinical, Regulatory Current Trends in Outsourcing:
Phase 1 Studies the Approach of Quality driven by and Commercial Strategies During Partnership Models and Best
ICH Q8, Q9, Q10 and Q11: Practical Drug Development to Accelerate Practices for Data Management
Implementation Regulatory Approval and Patient and Scientific Programming
Access to New Medicines
12.30 PM-1.30 PM LUNCH BREAK
1.30 PM-3.00 PM PARALLEL TRACKS
REGULATORY / CMC / HOT TOPICS OUTSOURCING AND PROFESSIONAL
CLINICAL RESEARCH DRUG SAFETY AND PV DEVELOPMENT
Session CR4 Session DS1 Session HT1 Session DM4
Conference Room 1 Conference Room 2 Conference Room 3 Conference Room 4
Drug Development for Pediatric Industrial Pharmacovigilance Regulation, Media and Public Deeper Look into Health Authority
and Geriatric Population Practices Perception – Navigating the Guidances
Minefield in India
3.00 PM-3.30 PM AFTERNOON TEA / COFFEE BREAK
3.30 PM-5.00 PM PARALLEL TRACKS
REGULATORY / CMC / HOT TOPICS OUTSOURCING AND PROFESSIONAL
CLINICAL RESEARCH DRUG SAFETY AND PV DEVELOPMENT
Session CR5 Session DS2 Session HT2 Session PD1
Conference Room 1 Conference Room 2 Conference Room 3 Conference Room 4
New Electronic Systems in International Pharmacovigilance Current Hot Topics Career Paths in Drug Discovery —
Ensuring Good Clinical Practice Regulatory Updates Transition from University to Industry,
Compliance Private / Government / Academic
Sector Experiences with Highly
Trained Graduates for Innovative
Biotech Pharma Industry in India
5.00 PM DAY 3 ADJOURN
INDIA 2011 | 6th ANNUAL PROGRAM 7

8. CONFERENCE AT A GLANCE TUESDAY, OCTOBER 18, 2011
9.00 AM-10.30 AM PARALLEL TRACKS
CLINICAL RESEARCH / HT / CMC / DRUG STANDARD & QUALITY DATA MANAGEMENT / DRUG SAFETY AND PV
REGULATORY AFFAIRS / OUTSOURCING BIOSTATISTICS / MEDICAL WRITING
Session HT3 Session CMC2 Session DM5 Session DS3
Conference Room 1 Conference Room 2 Conference Room 3 Conference Room 4
Current Updates on Select Hot Regulatory and CMC Considerations Safety Issues in Drug Development National Pharmacovigilance and
Topics for Clinical Trials and New Regulatory Update
Technologies
10.30 AM-11.00 AM MORNING TEA / COFFEE BREAK
11.00 AM-12.30 PM PARALLEL TRACKS
CLINICAL RESEARCH / HT / CMC / DRUG STANDARD & QUALITY DATA MANAGEMENT / DRUG SAFETY AND PV
REGULATORY AFFAIRS / OUTSOURCING BIOSTATISTICS / MEDICAL WRITING
Session RA4 Session OS3 Session DM6 Session DS4
Conference Room 1 Conference Room 2 Conference Room 3 Conference Room 4
Update on Current Regulations How Offshoring is Impacting the Qualification of Biomarkers and Pharmacovigilance New Horizons
in India way Clinical Data is Processed and PROs
Interpreted
12.30 PM-1.30 PM LUNCH BREAK
1.30 PM-3.00 PM PARALLEL TRACKS
CLINICAL RESEARCH / HT / CMC / DRUG STANDARD & QUALITY DATA MANAGEMENT / DRUG SAFETY AND PV
REGULATORY AFFAIRS / OUTSOURCING BIOSTATISTICS / MEDICAL WRITING
Session CR6 Session OS4 Session DM7 Session CMC3
Conference Room 1 Conference Room 2 Conference Room 3 Conference Room 4
Strategies for Enhancing Medical Writing: Best Practices for Issues in Multi-region Clinical Trials Impact of Counterfeit Medicines
Effectiveness of Project Effective Partnering and Evolving Potential
Managers and Team Members Technological Solutions
3.00 PM-3.30 PM AFTERNOON TEA / COFFEE BREAK
3.30 PM-5.00 PM VALEDICTORY SESSION
5.00 PM DAY 4 ADJOURN
8 INDIA 2011 | 6th ANNUAL PROGRAM

9. 9.00 am-12.30 pm TUTORIALS | SATURDAY, OCTOBER 15, 2011
DAY 1 | SATURDAY, OCTOBER 15, 2011 Who Will Benefit:
• Clinical Project Managers
Tutorial # 1: Project Management Metrics • Clinical Research Leaders
Duration: 9:00 AM-12:30 PM • Project Managers
inStruCtorS: • Study Managers
Nicole M Lee, PMP, PMI-RMP • Clinical Research Managers
Director of Planning and Analysis, Project Management Office • Clinical Research Project Support
ICON Clinical Research, Singapore
• CRAs / Monitors
Donald Thampy
Service Delivery Operations Lead, Accenture, Bangalore, India
Tutorial Brief: This tutorial has been designed to provide project managers with
Tutorial # 2: Advancing Drug Development through
a clear understanding of the right project management metrics and its applica- Licensing Opportunities between Pharma, Biotechs,
tions in clinical trials. It will provide a clear understanding of project manage- Academia and Investors
ment metrics as tools and techniques to monitor and control projects and how Duration: 9:00 AM-12:30 PM
they can be applied to your own pharmaceutical projects in the work place. inStruCtorS:
In a tough economy, knowing if a project is on track can make a difference be- Raman Govindarajan, MD, PhD
tween profit and loss. Gone are the days of launching projects within a port- Head India R&D; Member Asia Pacific R&D Team
folio with unclear objectives, poor scheduling and cost estimates, and no way SANOFI, Bangalore, India
to track progress. Project Managers must understand their organization KPI Shozeb Haider, PhD
and ensure the most effective project metrics for measuring these indications. Senior Lecturer, Drug Discovery
Center for Cancer Research & Cell Biology
Through the right project metrics, project managers are equipped with tools
Queen’s University, Belfast, UK
and techniques to proactively monitor and control their projects.
Tutorial Brief: Successful programs in Drug Discovery and Development are of-
Learning Objectives: ten a result of close collaboration between pharma, biotechs, academia, and
• What is Project Management Monitoring and Control Process and why is it investors. For a country to excel in this field, it is imperative that this relatively
important for running clinical trials? complicated machinery is well oiled and the relationships between these stake-
• Defining the key characteristics of the project management process and its holders is well understood and well developed.
importance to clinical trials Experienced professionals from Industry, Academia, Finance and Legal will con-
• Using a project management process for improving the success of your own duct this unique tutorial to elucidate these relationships, highlighting the critical
clinical trials enablers of licensing opportunities. Successful examples from the “West” will
• Setting clear objectives and defining the scope of your projects be described in detail for the Indian players to have a better understanding of
• Aligning the project objectives with the strategic and financial business this subject
objectives Learning Objectives:
• Understanding the importance of having an overall strategy for your • To understand the benefits of partnerships in drug discovery and
research projects development
• Developing a detailed project plan to manage your clinical trials • To learn the critical elements of drug licensing
• Identifying the key project activities • To learn the key areas where such licensing opportunities exist
• Planning a realistic schedule • How and where to find funds for drug discovery and development
• Budget planning • How to protect your intellectual property and make the most of it
• Implementing risk management and contingency planning • Some thoughts on Translational Research: How to convert your ideas to a
• Project implementation and control product
• What are project metrics?
Who Will Benefit:
• Trouble with metrics
• R&D teams of pharma and biotech companies
• Do your metrics pass the test?
• Indian biotech companies that are exploring licensing opportunities
• What are the 4 key projects KPIs?
• Scientists engaged in basic research
• How to apply to your study
• Doctors and Scientists who want to conduct Translational Research
• Project review and learning for clinical trials
• 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

10. 9.00 am-12.30 pm TUTORIALS CONTINUED | SATURDAY, OCTOBER 15, 2011
Tutorial # 3: Adaptive Designs in Clinical Research The key requirements like infrastructure, trained personnel, safety reporting
structure, and evaluation tools will be identified and discussed.
Duration: 9:00 AM-12:30 PM
inStruCtorS: 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
Vishwanath (Mahesh) Iyer, PhD
Head, Oncology Biometrics exercises
Novartis Healthcare Pvt Ltd
Hyderabad, India Learning Objectives:
Instructor Invited • To understand the current practice of PV in India
Tutorial Brief: This workshop will explore the fast expanding area of adaptive • To learn about the proposed Pharmacovigilance Program of India
designs in clinical research focusing on the statistical questions, as well as some • To see a comparison of PV practices in India versus the developed markets
of the more clinically relevant questions. Discussions will include the following • To understand the gaps in the PV reporting practices
topics: • To identify the key areas of improvements and how to do so
1. Guidance from the health authorities – EMEA reflection paper, and the more • To learn the key concepts in pharmacovigilance and how to implement them
recent FDA draft guidance in your organization’s PV programs.
2. Adaptive Designs in exploratory settings – dose finding studies including
Bayesian and CRM designs, and response adaptive randomization Who Will Benefit:
3. Adaptive designs in confirmatory settings – sample size re-estimation, • PV Personnel at Pharma companies (Indian as well as multinational)
multi-stage designs including group sequential designs, adaptive designs • PV Personnel at CROs
with multiple endpoints
• Government Regulators
4. Seamless designs – Phase IIA/IIB or Phase IIB/III studies,
• Medical Advisors / Medical Monitors
adaptive studies with treatment selection, adaptive selection (e.g., biomarker
• Hospitals and Medical Institutes
based enrichment designs)
• Practicing Doctors
5. Adaptive test procedures based on combination tests, conditional error rate,
conditional power, and predictive power • Professionals aspiring to work in the areas of PV
Tutorial # 5: Vendor Selection and Oversight, Quality
Learning Objectives:
and Compliance Considerations
• Understanding the regulatory guidelines for adaptive clinical trials
Duration: 9:00 AM-12:30 PM
• Reviewing common challenges and benefits of adaptive clinical trials inStruCtorS:
• Determining when adaptive clinical trials are applicable
Jeroze J. Dalal
• Assessing statistical considerations for adaptive design GM, Clinical Operations
• Examining logistical considerations for implementation such as data GlaxoSmithKline Pharmaceuticals Ltd, Mumbai, India
management, recruitment issues, and analysis tools Munish Mehra, PhD
• Managing Global Adaptive Clinical Trials President, Global Alliance of Indian Biomedical Professionals
Washington DC, USA
Who Will Benefit:
Tutorial Brief: In recent years, FDA has issued multiple warning letters to
• Scientists and Statisticians engaged in designing studies pharmaceutical companies for lack of oversight of their CROs. In addition,
• Project Leaders with increased scrutiny and signal detection techniques being used by FDA to
• Project Managers detect potential non-compliance, it is critical for sponsors to have appropriate
• Regulatory Personnel at Pharma / Biotech / CROs 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
• Regulators engaged in evaluating adaptive studies and their results
various study plans, vendor oversight plans, quality management plans, and
Key Quality Indicators (KQI’s) to ensure compliance to applicable regulations
Tutorial # 4: Building a Drug Safety and and GCPs.
Pharmacovigilance Framework in India - From
Learning Objectives:
Reporting of ADRs to Signal Detection
• Understand regulatory requirement for sponsor responsibility of vendor
Duration: 9:00 AM-12:30 PM oversight
inStruCtorS:
• Review recent warning letters where sponsors were cited
Moin Don
Executive Director • Review various plans and procedures to oversee vendors
PVCON Pharmacovigilance Services, India, Mumbai, India • Review KQI’s to oversee vendors
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
Tutorial Brief: This tutorial will cover the essentials of building a robust
pharmacovigilance program in India. The instructors will first evaluate the • CROs and other vendors to create best practices and assist their sponsors in
oversight and compliance.
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

11. 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
Advisor Law-Human Responsibilities
Corporate Affairs, India
Ranjit Shahani
Country President, Novartis India Ltd
Mumbai, India
Javed Akhtar
Poet, Lyricist, and Scriptwriter
Mumbai, India
3.30 pm-4.00 pm TEA / COFFEE BREAK
4.00 pm-6.00 pm PLENARY SESSION
Panel Discussion: Barriers and Facilitators to
Innovation in Bio-pharmaceuticals
SeSSion Chair Overview on Key Issues in Becoming Innovative
Munish Mehra, PhD paneliStS
President, Global Alliance of Indian Biomedical Professionals Innovations in Indian Pharmaceuticals Companies since TRIPS
Washington, DC, USA
Prof Sudip Chaudhari
panel DiSCuSSion moDerator
Indian Institute of Management
Professor Falguni Sen, PhD
Kolkata, India
Chair, Management Systems Area and Director,
Global Healthcare Innovation Management Center (GHIM), Learning from Alliances — from Service Provider to Risk
Graduate School of Business, Fordham University Sharing — Becoming Leaders in the Innovative Space
New York, USA
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

12. 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
Meet the Regulators: Global Regulatory Forum Session panel DiSCuSSion partiCipantS ContinueD
SeSSion Chair Surinder Singh, MD
Manish Kumar Shah, PhD Drugs Controller General of India
Head, Clinical Operations New Delhi, India
Pfizer Stephen E Wilson, DrPH
Mumbai, India Director, Division of Biometrics III
moDerator – panel DiSCuSSion CDER, USFDA, USA
Munish Mehra, PhD Ram Tiwari, PhD
President, Global Alliance of Indian Biomedical Professionals Associate Director for Statistical Science and Policy
Washington, DC, USA USFDA, USA
Mazlan Ismail, Sr Pharmacist, PSD MOH
A panel of senior regulators from the US, MhRA, EU, Malaysia, and India are being invited to Ministry of Health, Malaysia
share strategic initiatives undertaken by their agencies followed by a Q&A session. B R Jagashetty
Drug Controller
panel DiSCuSSion partiCipantS Karnataka State
David Lepay, MD, PhD H G Koshia
Senior Advisor, USFDA, USA Commissioner
FDA, Gujarat, India
Gerald W Heddell, PhD
Director of Inspection, Enforcement and Standards Dr S Natesh
MHRA, London, UK Senior Advisor, Department of Biotechnology
India
Dr K K Tripathi
Advisor
Department of Biotechnology
Govt of India
12.30 pm-1.30 pm LUNCH
12 INDIA 2011 | 6th ANNUAL PROGRAM

13. PROGRAM DETAILS
1.30 pm-5.00 pm CONFERENCE DAY 2 | OCTOBER 16, 2011
TRACK 1 TRACK 2 TRACK 3 TRACK 4
CLINICAL RESEARCH CMC / DRUG STANDARDS & QUALITY DATA MANAGEMENT / DRUG DISCOVERY / MARKET ACCESS
/ REGULATORY BIOSTATISTICS / MEDICAL WRITING
1.30 PM - 3.00 PM 1.30 PM - 3.00 PM 1.30 PM - 3.00 PM 1.30 PM - 3.00 PM
CR1 RA1 DM1 MA1
Avoiding Common Mistakes in Clinical Evolving Global Regulatory Landscape Current Issues in Medical Writing Pricing, Reimbursement and Market Access
Research and Clinical Development of Biosimilars SESSION CHAIR to Medicines: Current Global Challenges and
SESSION CHAIR — Role of India Helle-Mai Gawrylewski, MA Prospects
Emily Tan, MSc SESSION CHAIR Sr Dir Med Affairs & Alliance Management SESSION CHAIR
Executive Director Clinical Research Arun Mishra, MSc in Reg. MW Alberto Grignolo, PhD
Asia Pacific PharmaNet Director, Global Regulatory Affairs Johnson & Johnson PRD, USA Corporate Vice President,
Singapore (Emerging Markets and Asia-Pacific) Global Strategy, PAREXEL Consulting
GlaxoSmithKline, Middlesex, UK Boston, MA, USA
Avoiding Common Mistakes — Project Do we Have a Common Understanding? Role of the Medical Writer in the Clinical Introduction
Management Perspective Definition of SBPs and Key Principles in Development Team and Professional Alberto Grignolo, PhD
Roshan Padbidri Evaluating SBPs Competencies Corporate Vice President,
SM - Clinical Operations Peter Richardson, PhD Helle-Mai Gawrylewski, MA Global Strategy, PAREXEL Consulting
Takeda Global Research & Development Quality of Medicines Sector Sr Dir Med Affairs & Alliance Management Boston, MA, USA
Center (Asia Pte Ltd) European Medicines Agency in Reg. MW
Singapore London, England Johnson & Johnson PRD, USA Payer Pressures, Challenges and
Opportunities in Europe
Avoiding Common Mistakes — Medical Do we Have a Common Understanding? Review and Quality Control of CSRs and Suchita Chaudhari
Perspective Definition of Biosimilars and Key Other Documents Consultant - Commercial Strategy Consulting
Geeta Paulmer, MD Principles in Evaluating Biosmilars: an Devjani Dasgupta, PhD PAREXEL International
Associate Medical Director EMA Perspective Operations(Medical Writing and Document London, UK
PharmaNet Frank Scappaticci, MD Publishing, ADMIRe)
Singapore Senior Medical Director Cognizant Technologies Market Access to Medicines in Developing
Roche Countries
Avoiding Common Mistakes — Clinical USA Guidance and Best Practices for Hareesh Parandhaman
Strategies / Operational Perspective Presentation of Data Assistant Director - Business Development
Sanjeev Hegde, MD Indian Regulatory Framework and Deepa Raj, PhD Lupin Ltd (Biotech Division)
Head, Clinical Operations Challenges General Manager, Scientific Writing and Pune, India
Piramal Healthcare Dr K K Tripathi Aggregate Safety Reporting
Mumbai, India Advisor Accenture Services Pvt Ltd
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 RA2 DM2 DD1
Translational Clinical Research — Recent FDA, EMA, DCGI Guidelines — Designs in Early Phase Clinical Trials PANEL DISCUSSION
Stakeholders’ Perspectives Regulations in Evolution SESSION CHAIR Partnership Models for Stimulating
SESSION CHAIR SESSION CHAIR Vishwanath (Mahesh) Iyer, PhD Innovations
Tal Burt, MD Bobby George, PhD, CCRA, PGDHHM Head, Oncology Biometrics SESSION CHAIR
Scientific Director Assistant Vice President Regulatory Affairs Novartis Healthcare Pvt Ltd Krathish Bopanna, PhD, DSc
Duke Global Proof-of-Concept (POC) Reliance Life Sciences Hyderabad, India President and Executive Director
Research Network India Semler Research Center Pvt Ltd
Durham, NC, USA Bangalore, India
Improving Our Approach to Drug FDA’s Process Validation Guidance Clinical Development Paradigms in Perspective of Stock Exchange in
Development Albinus D’Sa Translating Cancer Genomics to Effective Stimulating Innovations
Robert M Califf, MD Deputy Country Director Treatments with Companion Diagnostics Ravi Tyagi, SME
Vice Chancellor of Clinical Research Director USFDA Richard Simon Project Lead
Duke Translational Medicine Institute (DTMI) India Chief, Biometric Research Branch National Stock Exchange of India
Durham, NC, USA National Cancer Institute Mumbai, India
European Guidance Rockville, MD, USA
Challenges Facing the Biomedical Emmanuelle M Voisin, PhD Risk Appetite Amongst Investors
Industry and the Prospect of Principal and Founder Adaptive Designs for Finding the Optimal in Providing Capital Solutions for
Collaborative Solutions Voisin Consulting Life Sciences Dose in Oncology — Bayesian Logistic Stimulating Innovations
Dr Surinder Kher Paris, France Regression Models Kapil Khandelwal
CEO Asia Vishwanath (Mahesh) Iyer, PhD Director
Manipal Acunova Limited Indian Guidance Head, Oncology Biometrics Makven Capital
India Arun Bhatt, MD Novartis Healthcare Pvt Ltd Bangalore, India
President Hyderabad, India
Rationale for an Academic Global Proof Clininvent Research Incubator Funding Opportunities and
of Concept Research Network Mumbai, India An Adaptive Two-Stage Dose Finding Intra Governmental Initiatives
John S Sundy, MD, PhD Trial Design Satya Dash
Associate Professor of Medicine Director Arghya Chattopadhyay, PhD Chief Operating Officer
Duke Global Proof of Concept (POC) Global Project Lead ABLE
Research Network IIS/Neuro/Inflammation Bangalore, India
Duke Clinical Research Institute (DCRU), Hyderabad, India
Durham, NC, USA Scientist Perspective in Addressing Issues
on Capital Solutions
Chandrashekar B
Director
Bigtec Labs
INDIA 2011 | 6th ANNUAL PROGRAM 13

14. PROGRAM DETAILS
9.00 am-12.30 pm CONFERENCE DAY 3 | OCTOBER 17, 2011
TRACK 1 TRACK 2 TRACK 3 TRACK 4
CLINICAL RESEARCH REGULATORY / CMC / DATA MANAGEMENT / OUTSOURCING AND PROFESSIONAL
DRUG SAFETY AND PV DRUG DISCOVERY AND MARKET ACCESS / DEVELOPMENT
BIOSTATISTICS / MEDICAL WRITING / HOT TOPIC
9.00 AM - 10.30 AM 9.00 AM - 10.30 AM 9.00 AM - 10.30 AM 9.00 AM - 10.30 AM
CR3 RA3 DM3 OS1
Enhancing Public Confidence in Regulatory Strategy: Pathways to Drug Different Tools to Facilitate Clinical Data Consideration in Outsourcing Clinical
Clinical Research through Robust and Approvals in Different Countries Management Trials to Emerging Regions: Are Global or
Empowered Ethics Committees SESSION CHAIR SESSION CHAIR Local CRO’s the Right Choice?
SESSION CHAIR Alberto Grignolo, PhD Nara Iyer SESSION CHAIR
Dr Nandini Kumar Corporate Vice President, Group Head, Oncology Data Management Ajit Nair, PhD
Former Deputy Director General ICMR Global Strategy, PAREXEL Consulting Novartis Healthcare Pvt Ltd President, Global Operations
Co-investigator NIH Project on Bioethics Boston, MA, USA SIRO Clinpharm Pvt Ltd
National Institute of Epidemiology (ICMR) India
Chennai, India
Accreditation of Ethics Committees by Introduction Demystifying CDM — Part I DEBATE
SIDCER Alberto Grignolo, PhD Michael Goedde Vijay Chauthaiwale, PhD
Dr Nandini Kumar Corporate Vice President, Director, Clinical Data Management VP, Torrent Pharmaceuticals Ltd
Former Deputy Director General ICMR Global Strategy, PAREXEL Consulting Human Genome Sciences, Inc. Ahmedabad, India
Co-investigator NIH Project on Bioethics Boston, MA, USA Rockville, MD, USA
National Institute of Epidemiology (ICMR) Badhri Srinivasan
Chennai, India Regulatory Strategy: Pathways to Drug Demystifying CDM — Part II Sr Director
Approvals in Different Countries Julian Rimmer Quintiles
Central Ethics Committee — Role and Joseph Scheeren, PharmD VP & GM Clinical Services USA
Functioning Senior VP, Head of Global Regulatory Affairs Comprehensive Clinical Development
Vijay Kumar Bayer Healthcare Pharmaceuticals Philadelphia, PA, USA C N Ramchand,
Deputy Director Genera New York, USA President CEO
ICMR and Laila Pharmaceuticals
New Delhi, India Arun Mishra, MSc India
Director, Global Regulatory Affairs
Accreditation of Ethics Committees by (Emerging Markets and Asia-Pacific) Arun Bhatt, MD
AAHRPP GlaxoSmithKline, Middlesex, UK President
Shyamala Sesikaran Clininvent Research
Medical Advisor Generic Pharmaceutical Industry - An Mumbai, India
AHERF Overview, Regulatory Challenges in USA
New Delhi, India and EU
Zoher T Sihorwala
Vice President
Dr Reddy’s Laboratory
Mumbai, India
11.00 AM - 12.30 PM 11.00 AM - 12.30 PM 11.00 AM - 12.30 PM 11.00 AM - 12.30 PM
DD2 CMC1 MA2 OS2
Current Topics in Phase 0 and Phase 1 Ensuring Quality in GMPs — Enhance the Synchronizing Clinical, Regulatory and Current Trends in Outsourcing: Partnership
Studies Approach of Quality driven by ICH Q8, Q9, Commercial Strategies During Drug Models and Best Practices for Data
SESSION CHAIR Q10 and Q11: Practical Implementation Development to Accelerate Regulatory Management and Scientific Programming
Vijay Chauthaiwale, PhD SESSION CHAIR Approval and Patient Access to New SESSION CHAIR
Torrent Pharmaceuticals Ltd Nandkumar Chodankar, PhD Medicines Ralph Russo, MS, MBA
Ahmedabad, India Group CEO, Pharma Business SESSION CHAIR Director
Excel Industries Alberto Grignolo, PhD Global Clinical Data Integration
Mumbai, India Corporate Vice President, Merck Research Labs
Global Strategy, PAREXEL Consulting, New York, USA
Boston, MA, USA
Application of PK / PD Modeling and Quality Management and Product Life Introduction PANEL DISCUSSION
Simulation to aid Early Development Cycle Alberto Grignolo, PhD Data Management — the Business Model
Ranendra Saha Prasad Kanitkar of Choice for Outsourcing CDM — the
Prof of Pharmacy Director, Plant Operations Aligning Cross-functional Performance Vendor vs the Sponsor Perspective
BITS Pfizer Global Manufacturing Metrics for Market Access Effectiveness
Anil Golla
Pilani, India India Suchita Chaudhari Head, Oncology Data Management
Consultant - Commercial Strategy Consulting Novartis Healthcare Pvt Ltd
Strategies to Enable a Smooth Transition Technology Transfer of Biosimilars: Using PAREXEL International
Nimita Limaye, PhD
to Early Phase Clinical Trials ICH Quality Drivers to your Advantage — London, UK
Senior VP & Global Head:
Nimish Vachharajani, PhD a Pragmatic Approach CDM, Medical Writing and SCEDAM
Senior Vice President, Advinus Therapeutics Richard Dennett, PhD Integrating Registration Strategy and
SIRO Clinpharm Pvt Ltd
Bangalore, India Director Commercial Strategy During Drug
India
Voisin Consulting Life Sciences Development
Balasubramanian Sankaranarayanan
Microdosing and Chronotherapeutics: Rennes, France Joseph Scheeren, PharmD
Vice President, Healthcare and Life Sciences
Innovative Technologies and Approaches Senior VP, Head of Global Regulatory Affairs
Smart Decision Services, GenPact
in Translational Research How to Apply QbD and PAT Principles for Bayer Healthcare Pharmaceuticals
Mumbai, India
Tal Burt, MD Preparing Clinical Supplies New York, USA
Ralph Russo
Scientific Director Nandkumar Chodankar, PhD Pharmaceutical Pricing and Director
Duke Global Proof-of-Concept (POC) Group CEO, Pharma Business Reimbursement Policies and Practices Global Clinical Data Integration
Research Network Excel Industries in Emerging Markets: Impact on Drug Merck Research Labs
Duke Clinical Research Unit (DCRU) & Mumbai, India Development and Registration Strategy New York, USA
Duke Clinical Research Institute (DCRI), (presentation by phone)
Durham, NC, USA Raj Long Best Practices in Outsourcing Scientific
DRA Head, AMAC GEM & LATAM Programing — Presentation
Novartis Pharma AG Frederic Coppin, MSc
Basel, Switzerland Manager, Global Scientific Programming
MSD
Brussels, Belgium
and
Nimita Limaye, PhD
Senior VP & Global Head:
CDM, Medical Writing and SCEDAM
SIRO Clinpharm Pvt Ltd
14 INDIA 2011 | 6th ANNUAL PROGRAM India