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Drug Information Agence (DIA) conference agenda : Kapil Khandelwal, EquNev Capital, www.equnev.com
6th Annual Conferenceon Global DrugDevelopment andMarket Access: Converging Strategies and Best Practices to Benefit PatientsOctober 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-pharmaceuticalsOctober 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 2October 17, 2011 | 9.00 AM-5.00 PM 9.00 AM-5.00 PM Conference: Day 3October 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, IndiaPROGRAM COMMITTEE PROGRAM CO-CHAIRSLarisa Nagra Singh, MPharmVP Global Functional Resourcing, Asia Quintiles, SingaporeAlbinus D’SaDeputy Country Director USFDA, India Dr Nandini KumarFormer Deputy Director General ICMRCo-investigator NIH Project on BioethicsNational Institute of Epidemiology (ICMR)Chennai, IndiaMoin DonExecutive DirectorPVCON Pharmacovigilance Services, India Munish Mehra, PhD Mubarak Naqvi, MDAlberto Grignolo, PhD President, Global Alliance of Indian CSU DirectorCorporate Vice President-Global Strategy Biomedical Professionals SANOFI, IndiaPAREXEL Consulting Washington, DC, USABoston, MA, USAArun 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 careHead, Oncology Biometrics Novartis Healthcare Pvt Ltd • Build upon DIA’s breadth and depth of topics from drug discovery through Hyderabad, India post-marketing safety surveillanceArun 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, PhDSenior 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 trialsKrathish Bopanna, PhD, DScPresident and Executive Director WHO SHOULD ATTENDSemler 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 AssociatesVice President, Healthcare and Life SciencesSmart Decision Services, GenPact, Mumbai, India • Pharmaceutical Physicians and Medical Directors • Drug Safety and Drug Surveillance PersonnelThe DIA India Conference Program is published • Professionals Engaged in Discovery Researchby the Drug Information Association for distribu-tion at the 6th Annual Conference on Global Drug • Clinical Pharmacology ScientistsDevelopment and Market Access: Converging • PharmacologistsStrategies and Best Practices to Benefit Patients. • Regulatory Affairs ManagersCopyright to all material in this publication is held by the Drug Information Association. • Regulators • Academic ScientistsFor 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 and2 INDIA 2011 | 6th ANNUAL PROGRAM services. Exhibits and advertising opportunities are available.
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 COMMITTEELarisa 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
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 India4 INDIA 2011 | 6th ANNUAL PROGRAM
24th annualEuroMEEtingC o p E n h agEn 201226-28 March 2012Bella Center | Copenhagen, Denmark INDIA 2011 | 6th ANNUAL PROGRAM 5
SATURDAY, OCTOBER 15, 2011SATURDAY, OCTOBER 15, 20119.00 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 Considerations12.30 PM-1.30 PM LUNCH BREAK1.30 PM-2.00 PM OPENING CEREMONY, WELCOME, INTRODUCTION TO CONFERENCE CO-CHAIRS INTRODUCTION TO CONFERENCE PROGRAM COMMITTEE AND CONFERENCE OVERVIEW2.00 PM-3.30 PM KEYNOTE ADDRESS AND SPECIAL GUEST SPEAKER3.30 PM-4.00 PM TEA / COFFEE BREAK4.00 PM-6.00 PM PLENARY SESSION — Panel Discussion: Barriers and Facilitators to Innovation in Bio-pharmaceuticals6.00 PM DAY 1 ADJOURN SUNDAY, OCTOBER 16, 20119.00 AM-10.00 AM EXHIBIT OPENING CEREMONY10.00 AM-10.30 AM MORNING TEA / COFFEE BREAK10.30 AM-12.30 PM PLENARY SESSION — Meet the Regulators: Global Regulatory Forum Session12.30 PM-1.30 PM LUNCH BREAK1.30 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 Prospects3.00 PM-3.30 PM AFTERNOON TEA / COFFEE BREAK3.30 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 4Translational Clinical Research — Recent FDA, EMA, DCGI Guidelines Designs in Early Phase Clinical Trials PANEL DISCUSSION Stakeholders’ Perspectives — Regulations in Evolution Partnership Models for Stimulating Innovations5.00 PM DAY 2 ADJOURN6 INDIA 2011 | 6th ANNUAL PROGRAM
MONDAY, OCTOBER 17, 20119.00 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 BREAK11.00 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 Medicines12.30 PM-1.30 PM LUNCH BREAK1.30 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 India3.00 PM-3.30 PM AFTERNOON TEA / COFFEE BREAK3.30 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 India5.00 PM DAY 3 ADJOURN INDIA 2011 | 6th ANNUAL PROGRAM 7
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
9.00 am-12.30 pm TUTORIALS | SATURDAY, OCTOBER 15, 2011DAY 1 | SATURDAY, OCTOBER 15, 2011 Who Will Benefit: • Clinical Project ManagersTutorial # 1: Project Management Metrics • Clinical Research LeadersDuration: 9:00 AM-12:30 PM • Project ManagersinStruCtorS: • Study ManagersNicole M Lee, PMP, PMI-RMP • Clinical Research ManagersDirector of Planning and Analysis, Project Management Office • Clinical Research Project SupportICON Clinical Research, Singapore • CRAs / MonitorsDonald ThampyService Delivery Operations Lead, Accenture, Bangalore, IndiaTutorial Brief: This tutorial has been designed to provide project managers with Tutorial # 2: Advancing Drug Development througha 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 Investorsment metrics as tools and techniques to monitor and control projects and how Duration: 9:00 AM-12:30 PMthey 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, PhDtween profit and loss. Gone are the days of launching projects within a port- Head India R&D; Member Asia Pacific R&D Teamfolio with unclear objectives, poor scheduling and cost estimates, and no way SANOFI, Bangalore, Indiato track progress. Project Managers must understand their organization KPI Shozeb Haider, PhDand ensure the most effective project metrics for measuring these indications. Senior Lecturer, Drug Discovery Center for Cancer Research & Cell BiologyThrough the right project metrics, project managers are equipped with tools Queen’s University, Belfast, UKand 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
9.00 am-12.30 pm TUTORIALS CONTINUED | SATURDAY, OCTOBER 15, 2011Tutorial # 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 PMinStruCtorS: Finally, some of the key concepts in PV like reporting and processing of ADRs, signal detection etc., will be demonstrated through examples and hands onVishwanath (Mahesh) Iyer, PhDHead, Oncology Biometrics exercisesNovartis Healthcare Pvt LtdHyderabad, India Learning Objectives:Instructor Invited • To understand the current practice of PV in IndiaTutorial Brief: This workshop will explore the fast expanding area of adaptive • To learn about the proposed Pharmacovigilance Program of Indiadesigns in clinical research focusing on the statistical questions, as well as some • To see a comparison of PV practices in India versus the developed marketsof the more clinically relevant questions. Discussions will include the following • To understand the gaps in the PV reporting practicestopics: • To identify the key areas of improvements and how to do so1. 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 Regulators4. 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 Doctors5. 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, QualityLearning 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 regulationsTutorial # 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 vendorDuration: 9:00 AM-12:30 PM oversightinStruCtorS: • Review recent warning letters where sponsors were citedMoin DonExecutive Director • Review various plans and procedures to oversee vendorsPVCON Pharmacovigilance Services, India, Mumbai, India • Review KQI’s to oversee vendorsVivek Ahuja, MDRegional Director, Asia Pacific, PharmacovigilanceBaxter Healthcare, Gurgaon, India Who Will Benefit: • Sponsor personnel involved in the selection and oversight of vendorsTutorial Brief: This tutorial will cover the essentials of building a robustpharmacovigilance 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 proposedpharmacovigilance program. Then they will identify the areas whereimprovements 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-CHAIRSLarisa Nagra Singh, MPharmVP Global Functional Resourcing, Asia Quintiles, SingaporeINTRODUCTION TO CONFERENCE PROGRAM COMMITTEE AND CONFERENCE OVERVIEWMubarak Naqvi, MDCSU DirectorSANOFI, Mumbai, IndiaMunish Mehra, PhDPresident Global Alliance of Indian Biomedical Professionals, Washington, DC, USA2.00 pm-3.30 pm KEYNOTE ADDRESSES AND SPECIAL GUEST SPEAKERSurinder Singh, MD (Invited)Drugs Controller General of IndiaNew Delhi, IndiaDavid Lepay, MD, PhDSenior AdvisorUSFDA, USAD R Kaarthikeyan, IPSAdvisor Law-Human ResponsibilitiesCorporate Affairs, IndiaRanjit ShahaniCountry President, Novartis India LtdMumbai, IndiaJaved AkhtarPoet, Lyricist, and ScriptwriterMumbai, India 3.30 pm-4.00 pm TEA / COFFEE BREAK4.00 pm-6.00 pm PLENARY SESSIONPanel Discussion: Barriers and Facilitators toInnovation in Bio-pharmaceuticalsSeSSion Chair Overview on Key Issues in Becoming InnovativeMunish Mehra, PhD paneliStSPresident, Global Alliance of Indian Biomedical Professionals Innovations in Indian Pharmaceuticals Companies since TRIPSWashington, DC, USA Prof Sudip Chaudharipanel DiSCuSSion moDerator Indian Institute of ManagementProfessor Falguni Sen, PhD Kolkata, IndiaChair, Management Systems Area and Director,Global Healthcare Innovation Management Center (GHIM), Learning from Alliances — from Service Provider to RiskGraduate School of Business, Fordham University Sharing — Becoming Leaders in the Innovative SpaceNew 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, India6.00 pm DAY 1 ADJOURN INDIA 2011 | 6th ANNUAL PROGRAM 11
PROGRAM DETAILS 9.00 am-12.30 pm CONFERENCE DAY 2 | OCTOBER 16, 20119.00 am-10.00 am EXHIBIT OPENING CEREMONY10.00 am-10.30 am MORNING TEA / COFFEE BREAK10.30 am-12.30 pm PLENARY SESSIONMeet the Regulators: Global Regulatory Forum Session panel DiSCuSSion partiCipantS ContinueDSeSSion Chair Surinder Singh, MDManish Kumar Shah, PhD Drugs Controller General of IndiaHead, Clinical Operations New Delhi, IndiaPfizer Stephen E Wilson, DrPHMumbai, India Director, Division of Biometrics IIImoDerator – panel DiSCuSSion CDER, USFDA, USAMunish Mehra, PhD Ram Tiwari, PhDPresident, Global Alliance of Indian Biomedical Professionals Associate Director for Statistical Science and PolicyWashington, DC, USA USFDA, USA Mazlan Ismail, Sr Pharmacist, PSD MOHA panel of senior regulators from the US, MhRA, EU, Malaysia, and India are being invited to Ministry of Health, Malaysiashare strategic initiatives undertaken by their agencies followed by a Q&A session. B R Jagashetty Drug Controller panel DiSCuSSion partiCipantS Karnataka StateDavid Lepay, MD, PhD H G KoshiaSenior Advisor, USFDA, USA Commissioner FDA, Gujarat, IndiaGerald W Heddell, PhDDirector of Inspection, Enforcement and Standards Dr S NateshMHRA, London, UK Senior Advisor, Department of Biotechnology India Dr K K Tripathi Advisor Department of Biotechnology Govt of India12.30 pm-1.30 pm LUNCH 12 INDIA 2011 | 6th ANNUAL PROGRAM
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 WRITING1.30 PM - 3.00 PM 1.30 PM - 3.00 PM 1.30 PM - 3.00 PM 1.30 PM - 3.00 PMCR1 RA1 DM1 MA1Avoiding Common Mistakes in Clinical Evolving Global Regulatory Landscape Current Issues in Medical Writing Pricing, Reimbursement and Market AccessResearch 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, USAAvoiding Common Mistakes — Project Do we Have a Common Understanding? Role of the Medical Writer in the Clinical IntroductionManagement 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 EuropeAvoiding Common Mistakes — Medical Do we Have a Common Understanding? Review and Quality Control of CSRs and Suchita ChaudhariPerspective 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 CountriesAvoiding Common Mistakes — Clinical USA Guidance and Best Practices for Hareesh ParandhamanStrategies / 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 India3.30 PM - 5.00 PM 3.30 PM - 5.00 PM 3.30 PM - 5.00 PM 3.30 PM - 5.00 PMCR2 RA2 DM2 DD1Translational 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, IndiaImproving Our Approach to Drug FDA’s Process Validation Guidance Clinical Development Paradigms in Perspective of Stock Exchange inDevelopment 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, USAChallenges Facing the Biomedical Emmanuelle M Voisin, PhD Risk Appetite Amongst InvestorsIndustry and the Prospect of Principal and Founder Adaptive Designs for Finding the Optimal in Providing Capital Solutions forCollaborative 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, IndiaRationale for an Academic Global Proof Clininvent Research Incubator Funding Opportunities andof 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
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 TOPIC9.00 AM - 10.30 AM 9.00 AM - 10.30 AM 9.00 AM - 10.30 AM 9.00 AM - 10.30 AMCR3 RA3 DM3 OS1Enhancing Public Confidence in Regulatory Strategy: Pathways to Drug Different Tools to Facilitate Clinical Data Consideration in Outsourcing ClinicalClinical Research through Robust and Approvals in Different Countries Management Trials to Emerging Regions: Are Global orEmpowered 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, IndiaAccreditation 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 QuintilesCentral 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 AffairsAccreditation of Ethics Committees by (Emerging Markets and Asia-Pacific) Arun Bhatt, MDAAHRPP 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, India11.00 AM - 12.30 PM 11.00 AM - 12.30 PM 11.00 AM - 12.30 PM 11.00 AM - 12.30 PMDD2 CMC1 MA2 OS2Current Topics in Phase 0 and Phase 1 Ensuring Quality in GMPs — Enhance the Synchronizing Clinical, Regulatory and Current Trends in Outsourcing: PartnershipStudies 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, USAApplication of PK / PD Modeling and Quality Management and Product Life Introduction PANEL DISCUSSIONSimulation 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 LtdStrategies to Enable a Smooth Transition Technology Transfer of Biosimilars: Using PAREXEL International Nimita Limaye, PhDto 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 SankaranarayananMicrodosing and Chronotherapeutics: Rennes, France Joseph Scheeren, PharmD Vice President, Healthcare and Life SciencesInnovative Technologies and Approaches Senior VP, Head of Global Regulatory Affairs Smart Decision Services, GenPactin 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 Ltd14 INDIA 2011 | 6th ANNUAL PROGRAM India