kapil Khandelwal : Drug Information Agence (DIA) conference agenda

October 15, 2011 | 9.00 AM-6.00 PM

9.00AM-12.30PM Tutorials

1.30PM-6.00PM Conference:Day1:Inaugural

PlenarySession:PanelDiscussion:Barriers

andFacilitatorstoInnovationin

Bio-pharmaceuticals

October 16, 2011 | 9.00 AM-5.00 PM

9:00AM-10:00AM Inaugural–ExhibitHallOpen

10:30AM–12:30PM PlenarySession:MeettheRegulators

1.30PM–5.00PM Conference:Day2

October 17, 2011 | 9.00 AM-5.00 PM

9.00AM-5.00PM Conference:Day3

October 18, 2011 | 9.00 AM-5.00 PM

9.00AM-5.00PM Conference:Day4

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

BestPracticestoBenefitPatients

INDIA 2011|6thANNUALPROGRAM2

6thAnnualConferenceonGlobalDrugDevelopmentandMarketAccess:ConvergingStrategiesandBestPracticestoBenefitPatientsTutorials:October15,2011* Conference:October15-18,2011 ID#11659HotelIntercontinentalTheLalit,Mumbai,India

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

PROGRAM CO-CHAIRS

Thisconferencewillbringtogether industryprofessionals,clinicians,patientrepresenta-tives,andregulatoryagenciesfromIndia(CDSCO/DCGI),theUnitedStates(FDA),Europe(EMA),andemergingmarketsto:

• Facilitateknowledgeexchangeleadingtoinnovationandultimatelypatientcare

• BuilduponDIA’sbreadthanddepthoftopicsfromdrugdiscoverythroughpost-marketingsafetysurveillance

• Provideaninvaluableforumforsharinginformationandnetworkingforprofessionalsinvolvedinthediscovery,development,andlifecyclemanagementofpharmaceuticals,medicaldevices,andrelatedproducts,includingdiscussionofcurrentissuesrelatedtonewareassuchasregulatorychanges,biosimilars,medicaldevices,andbestpracticesinthedesign,conduct,andreportingofclinicaltrials

WHOSHOULDATTENDProfessionals,researchers,andcliniciansinvolvedindrugdiscoveryanddevelopmentandregulatoryaffairs,e.g.:

• DrugDevelopmentandClinicalResearchManagersandAssociates• PharmaceuticalPhysiciansandMedicalDirectors• DrugSafetyandDrugSurveillancePersonnel• ProfessionalsEngagedinDiscoveryResearch• ClinicalPharmacologyScientists• Pharmacologists• RegulatoryAffairsManagers• Regulators• AcademicScientists• Biostatisticians• DataManagers• MedicalWriters• OutsourcingandMarketingManagers• ITProfessionals• Students

PROGRAM COMMITTEE

Larisa Nagra Singh, MPharmVPGlobalFunctionalResourcing,AsiaQuintiles,Singapore

Albinus D’SaDeputyCountryDirectorUSFDA,India

Dr Nandini KumarFormerDeputyDirectorGeneralICMRCo-investigatorNIHProjectonBioethicsNationalInstituteofEpidemiology(ICMR)Chennai,India

Moin DonExecutiveDirectorPVCONPharmacovigilanceServices,India

Alberto Grignolo, PhDCorporateVicePresident-GlobalStrategyPAREXELConsultingBoston,MA,USA

Arun Mishra, MScDirector,GlobalRegulatoryAffairs(EmergingMarketsandAsia-Pacific)GlaxoSmithKline,Middlesex,UK

Vishwanath (Mahesh) Iyer, PhDHead,OncologyBiometricsNovartisHealthcarePvtLtdHyderabad,India

Arun Bhatt, MDPresidentClininventResearch,Mumbai,India

Nimita Limaye, PhDSeniorVP&GlobalHead:CDM,MedicalWritingandSCEDAM,SIROClinpharmPvtLtd,India

Krathish Bopanna, PhD, DScPresidentandExecutiveDirectorSemlerResearchCenterBangalore,India

Balasubramanian SankaranarayananVicePresident,HealthcareandLifeSciencesSmartDecisionServices,GenPact,Mumbai,India

TheDIAIndiaConferenceProgramispublishedbytheDrugInformationAssociationfordistribu-tionatthe6th Annual Conference on Global Drug Development and Market Access: Converging Strategies and Best Practices to Benefit Patients.CopyrighttoallmaterialinthispublicationisheldbytheDrugInformationAssociation.

Formoreinformationcontactus:Manoj [email protected]

DIA (India) Private LimitedA 303, Wellington Business Park I

Marol Andheri-Kurla RoadAndheri (East), Mumbai - 400059

Munish Mehra, PhDPresident,GlobalAllianceofIndian

BiomedicalProfessionalsWashington,DC,USA

Mubarak Naqvi, MDCSUDirectorSANOFI,India

INDIA 2011|6thANNUALPROGRAM 3

Tal Burt, M.D. is a psychiatrist and clinical researcher trained in Israel, Italy, France, and the US. Most of his career has been in clinical research, of drugs and devices, in Industry and academia. After being on the faculty at Columbia University Department of Psychiatry Tal moved to industry – first Pfizer and then Eisai as Senior Medical Director overseeing all phases of clinical research and development. He then joined Duke‐National University of Singapore Graduate Medical School as Associate Professor for Clinical Research. He served as the founding director of the SingHealth 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.

Ranjit ShahaniCountryPresident

NovartisLtdMumbai,India

D R Kaarthikeyan, IPSAdvisorLaw-Human

ResponsibilitiesCorporateAffairs

India

Surinder Singh (Invited)DrugsControllerGeneralofIndia

NewDelhi,India

Javed Akhtar Poet,Lyricist,

andScriptwriterMumbai,India

Alberto Grignolo, PhDCorporateVicePresident,

GlobalStrategy,PAREXELConsulting

Boston,MA,USA

Moin DonExecutiveDirector

PVCONPharmacovigilanceServices

India

Dr Nandini KumarFormerDeputyDirectorGeneralICMR

Co-investigatorNIHProjectonBioethics

NationalInstituteofEpidemiology(ICMR),Chennai,India

Albinus D’SaDeputyCountryDirector

USFDAIndia

Larisa Nagra Singh, MPharm

VPGlobalFunctionalResourcing,Asia

Quintiles,Singapore

Arun Bhatt, MDPresident

ClininventResearchMumbai,India

Arun Mishra, MScDirector,GlobalRegulatoryAffairs

(EmergingMarketsandAsia-Pacific)GlaxoSmithKlineMiddlesex,UK

Vishwanath (Mahesh) Iyer, PhDHead,OncologyBiometrics,NovartisHealthcarePvtLtd

Hyderabad,India

Balasubramanian Sankaranarayanan

VicePresidentHealthcareandLifeSciences

SmartDecisionServicesGenPact,Mumbai,India

Nimita Limaye, PhDSeniorVP&GlobalHead:

CDM,MedicalWritingandSCEDAMSIROClinpharmPvtLtd,India

Krathish Bopanna, PhD, DSc

PresidentandExecutiveDirector

SemlerResearchCenterBangalore,India

David Lepay, MD, PhDSeniorAdvisor

USFDAUSA

SPEAKERS

PROGRAM COMMITTEE

SPECIAL GUEST KEYNOTE SPEAKERS

IMAGE NOT PICTURED: Cellia K Habita, MD, PhD, President&CEO,ArianneCorp,SanDiego,CA,USA

Nancy SmerkanichVicePresidentGlobalRegulatoryAffairsOctagonResearchSolutionsPhiladelphia,PA,USA

Tal Burt, MDScientificDirectorDukeGlobalProof-of-Concept(POC)ResearchNetworkDukeClinicalResearchUnit(DCRU)&DukeClinicalResearchInstitute(DCRI),Durham,NC,USA

Robert M Califf, MDViceChancellorofClinicalResearchDirector,DukeTranslationalMedicineInstitute(DTMI)Durham,NC,USA

Sri MosurPresidentandCEOGlobalDrugDiscoveryandDevelopmentJubilantBiosysBangalore,India

Gerald W Heddell, PhDDirectorofInspectionEnforcementandStandardsMHRALondon,UK

John S Sundy, MD, PhDAssociateProfessorofMedicineDirector,DukeGlobalProofofConcept(POC)ResearchNetworkDukeClinicalResearchInstitute(DCRU),Durham,NC,USA

Emmanuelle M Voisin, PhD PrincipalandFounderVoisinConsultingLifeSciencesParis,France

Emily Tan, MScExecutiveDirectorClinicalResearch,AsiaPacificPharmaNetSingapore

Professor Falguni Sen, PhD Chair,ManagementSystemsAreaandDirectorGlobalHealthcareInno-vationManagementCenter(GHIM)GraduateSchoolofBusinessFordhamUniversityNewYork,USA

Shoibal Mukherjee, MDVicePresident,MedicalQuintilesIndia

Helle-Mai GawrylewskiSeniorDirector,HeadMedicalAffairsandAllianceManagementinRegulatoryMedicalWritingJohnson&JohnsonPRDUSA

Dr Surinder KherCEOAsiaManipalAcunovaLimitedIndia

Michael Goedde Director,ClinicalDataManagementHumanGenomeSciences,Inc.Rockville,MD,USA

Raman Govindarajan, MD, PhDHeadIndiaR&DMemberAsiaPacificR&DTeamSANOFIBangalore,India

Lakshmi P Kotra, PhDDirector-CMDP,ScientistandAssociateProfessorUniversityofTorontoandUniversityHealthNetworkCanada


PLENARYSESSION—SUNDAY,OCTOBER16,2011—10.30am-12:30pm

PLENARYSESSION—SATURDAY,OCTOBER15,2011—4.00pm-6.00pm

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

Munish Mehra, PhDPresident,GlobalAllianceofIndianBiomedicalProfessionalsWashingtonDC,USA

panel DiSCuSSion moDerator SeSSion Chair

Professor Falguni Sen, PhDChair,ManagementSystemsAreaandDirector,GlobalHealthcareInnovationManagementCenter(GHIM),GraduateSchoolofBusiness,FordhamUniversityNewYork,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.

Meet the Regulators: Global Regulatory Forum SessionSeSSion Chair

Manish Kumar Shah, PhDHead,ClinicalOperationsPfizerMumbai,India

moDerator – panel DiSCuSSion

Munish Mehra, PhDPresident,GlobalAllianceofIndianBiomedicalProfessionalsWashingtonDC,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.

paneliStS

Prof Sudip ChaudhuriProfessorIndianInstituteofManagementKolkata,India


Villoo Morawala-Patell, PhDFounder,ChairpersonandManagingDirectorAvesthagenBangalore,India

Fabio Thiers, MD, PhDFounder&CEO,ViSResearchInstituteNewYork,USA

Ranjit ShahaniCountryPresident,NovartisIndiaLtdMumbai,India

panel DiSCuSSion partiCipantS

David Lepay, MD, PhDSeniorAdvisorUSFDA,USA

Gerald W Heddell, PhDDirectorofInspection,EnforcementandStandardsMHRALondon,UK

Surinder Singh, MDDrugsControllerGeneralofIndiaNewDelhi,India

Stephen E Wilson, DrPHDirector,DivisionofBiometricsIIICDER,USFDA,USA

Ram Tiwari, PhDAssociateDirectorforStatisticalScienceandPolicyUSFDA,USA

Mazlan Ismail, Sr Pharmacist, PSD MOH MinistryofHealthMalaysia

B R JagashettyDrugControllerKarnatakaState

H G KoshiaCommissionerFDAGujarat,India

Dr S NateshSeniorAdvisor,DepartmentofBiotechnologyIndia

Dr K K TripathiAdvisorDepartmentofBiotechnologyGovtofIndia


EuroMEEtingCopEnhagEn 2012

2 4 t h a n n u a l

26-28 March 2012Bella Center | Copenhagen, Denmark


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

CLINICAL RESEARCH

Session CR1Conference Room 1

Avoiding Common Mistakes in Clinical Research

CLINICAL RESEARCH


Translational Clinical Research — Stakeholders’ Perspectives

CMC / DRUG STANDARDS & QUALITY /REGULATORY

Session RA1Conference Room 2

Evolving Global Regulatory Landscape and Clinical

Development of Biosimilars — Role of India

CMC / DRUG STANDARDS & QUALITY /REGULATORY


Recent FDA, EMA, DCGI Guidelines — Regulations in Evolution

DATA MANAGEMENT / BIOSTATISTICS / MEDICAL WRITING

Session DM1Conference Room 3

Current Issues in Medical Writing



Designs in Early Phase Clinical Trials

DRUG DISCOVERY / MARKET ACCESS

Session MA1Conference Room 4

Pricing, Reimbursement and Market Access to Medicines:

Current Global Challenges and Prospects

DRUG DISCOVERY / MARKET ACCESS

Session DD1Conference Room 4PANEL DISCUSSION

Partnership Models for Stimulating Innovations

3.00 PM-3.30 PM AFTERNOON TEA / COFFEE BREAK

3.30 PM-5.00 PM PARALLEL TRACKS

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




SATURDAY,OCTOBER15,2011

SUNDAY,OCTOBER16,2011


5.00 PM DAY 2 ADJOURN5.00 PM DAY 3 ADJOURN

CLINICAL RESEARCH


Enhancing Public Confidence in Clinical Research through

Robust and Empowered Ethics Committees

CLINICAL RESEARCH

Session DD2Conference Room 1

Current Topics in Phase 0 and Phase 1 Studies

CLINICAL RESEARCH


Drug Development for Pediatric and Geriatric Population

CLINICAL RESEARCH


New Electronic Systems in Ensuring Good Clinical Practice

Compliance

REGULATORY / CMC / DRUG SAFETY AND PV


Regulatory Strategy: Pathways to Drug Approvals in Different

Countries


Session CMC1Conference Room 2

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

Implementation


Session DS1Conference Room 2

Industrial Pharmacovigilance Practices



International Pharmacovigilance Regulatory Updates



Different Tools to Facilitate Clinical Data Management


Session MA2Conference 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 OS1Conference Room 4

Consideration in Outsourcing Clinical Trials to Emerging

Regions: Are Global or Local CRO’s the Right Choice?



Current Trends in Outsourcing: Partnership Models and Best

Practices for Data Management and Scientific Programming



Deeper Look into Health Authority Guidances


Session PD1Conference 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


11.00 AM-12.30 PM PARALLEL TRACKS

9.00 AM-10.30 AM PARALLEL TRACKS





MONDAY,OCTOBER17,2011

HOT TOPICS

Session HT1Conference Room 3

Regulation, Media and Public Perception – Navigating the

Minefield in India

HOT TOPICS

Session HT2Conference Room 3Current Hot Topics


CONFERENCE AT A GLANCE

CLINICAL RESEARCH / HT / REGULATORY AFFAIRS

Session HT3Conference Room 1

Current Updates on Select Hot Topics



Update on Current Regulations in India



Strategies for Enhancing Effectiveness of Project

Managers and Team Members

CMC / DRUG STANDARD & QUALITY / OUTSOURCING


Regulatory and CMC Considerations for Clinical Trials and New

Technologies



How Offshoring is Impacting the way Clinical Data is Processed and

Interpreted



Medical Writing: Best Practices for Effective Partnering



Safety Issues in Drug Development



Qualification of Biomarkers and PROs



Issues in Multi-region Clinical Trials

DRUG SAFETY AND PV


National Pharmacovigilance and Regulatory Update

DRUG SAFETY AND PV


Pharmacovigilance New Horizons

DRUG SAFETY AND PV


Impact of Counterfeit Medicines and Evolving Potential

Technological Solutions


3.30 PM-5.00 PM VALEDICTORY SESSION


TUESDAY,OCTOBER18,2011


11.00 AM-12.30 PM PARALLEL TRACKS

9.00 AM-10.30 AM PARALLEL TRACKS




9.00am-12.30pmTUTORIALS|SATURDAY,OCTOBER15,2011

DAY1| SATURDAY, OCTOBER 15, 2011

Tutorial # 1: Project Management MetricsDuration: 9:00 AM-12:30 PM

inStruCtorS:

Nicole M Lee, PMP, PMI-RMPDirectorofPlanningandAnalysis,ProjectManagementOfficeICONClinicalResearch,Singapore

Donald ThampyServiceDeliveryOperationsLead,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 applica-tions in clinical trials. It will provide a clear understanding of project manage-ment 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 be-tween profit and loss. Gone are the days of launching projects within a port-folio 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.

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

Who Will Benefit:• Clinical Project Managers

• Clinical Research Leaders

• Project Managers

• Study Managers

• Clinical Research Managers

• Clinical Research Project Support

• CRAs / Monitors

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

inStruCtorS:

Raman Govindarajan, MD, PhDHeadIndiaR&D;MemberAsiaPacificR&DTeamSANOFI,Bangalore,India

Shozeb Haider, PhDSeniorLecturer,DrugDiscoveryCenterforCancerResearch&CellBiologyQueen’sUniversity,Belfast,UK

Tutorial Brief: Successful programs in Drug Discovery and Development are of-ten 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 stake-holders is well understood and well developed.

Experienced professionals from Industry, Academia, Finance and Legal will con-duct 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


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

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 organization’s PV programs.

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

Tutorial # 5: Vendor Selection and Oversight, Quality and Compliance ConsiderationsDuration: 9:00 AM-12:30 PM

inStruCtorS:

Jeroze J. DalalGM,ClinicalOperationsGlaxoSmithKlinePharmaceuticalsLtd,Mumbai,India

Munish Mehra, PhDPresident,GlobalAllianceofIndianBiomedicalProfessionals

WashingtonDC,USA

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 (KQI’s) 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 KQI’s to oversee vendors

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 # 3: Adaptive Designs in Clinical ResearchDuration: 9:00 AM-12:30 PM

inStruCtorS:

Vishwanath (Mahesh) Iyer, PhDHead,OncologyBiometricsNovartisHealthcarePvtLtdHyderabad,India

Instructor InvitedTutorial 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

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

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 DetectionDuration: 9:00 AM-12:30 PM

inStruCtorS:

Moin DonExecutiveDirectorPVCONPharmacovigilanceServices,India,Mumbai,India

Vivek Ahuja, MDRegionalDirector,AsiaPacific,PharmacovigilanceBaxterHealthcare,Gurgaon,India

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

9.00am-12.30pmTUTORIALSCONTINUED|SATURDAY,OCTOBER15,2011


1.30am-6.00pmCONFERENCEDAY1|SATURDAY,OCTOBER15,2011

1.30 pm-2.00 pm OPENING CEREMONY, WELCOME, INTRODUCTION TO CONFERENCE CO-CHAIRSLarisa Nagra Singh, MPharmVPGlobalFunctionalResourcing,AsiaQuintiles,Singapore

INTRODUCTION TO CONFERENCE PROGRAM COMMITTEE AND CONFERENCE OVERVIEWMubarak Naqvi, MDCSUDirectorSANOFI,Mumbai,India

Munish Mehra, PhDPresidentGlobalAllianceofIndianBiomedicalProfessionals,Washington,DC,USA

2.00 pm-3.30 pm KEYNOTE ADDRESSES AND SPECIAL GUEST SPEAKERSurinder Singh, MD (Invited)DrugsControllerGeneralofIndiaNewDelhi,India

David Lepay, MD, PhDSeniorAdvisorUSFDA,USA

D R Kaarthikeyan, IPSAdvisorLaw-HumanResponsibilitiesCorporateAffairs,India


Javed AkhtarPoet,Lyricist,andScriptwriterMumbai,India

3.30 pm-4.00 pm TEA / COFFEE BREAK

4.00 pm-6.00 pm PLENARY SESSIONPanel Discussion: Barriers and Facilitators to Innovation in Bio-pharmaceuticalsSeSSion Chair

Munish Mehra, PhDPresident,GlobalAllianceofIndianBiomedicalProfessionalsWashington,DC,USA

panel DiSCuSSion moDerator

Professor Falguni Sen, PhDChair,ManagementSystemsAreaandDirector,GlobalHealthcareInnovationManagementCenter(GHIM),GraduateSchoolofBusiness,FordhamUniversityNewYork,USA

PROGRAMDETAILS

Overview on Key Issues in Becoming Innovative paneliStS

Innovations in Indian Pharmaceuticals Companies since TRIPS

Prof Sudip ChaudhariIndianInstituteofManagementKolkata,India

Learning from Alliances — from Service Provider to Risk

Sharing — Becoming Leaders in the Innovative Space


Innovating Through Convergence of Industry Boundaries

Villoo Morawala-Patell, PhDFounder,ChairpersonandManagingDirectorAvesthagenBangalore,India

Global Competitiveness of Indian Clinical Research Centres

Fabio Thiers, MD, PhDFounder&CEO,ViSResearchInstituteNewYork,USA

Remarking our Innovation Strategy for a Changing India


6.00 pm DAY 1 ADJOURN


PROGRAMDETAILS

9.00am-12.30pmCONFERENCEDAY2|OCTOBER16,2011

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 SESSIONMeet the Regulators: Global Regulatory Forum SessionSeSSion Chair

Manish Kumar Shah, PhDHead,ClinicalOperationsPfizerMumbai,India

moDerator – panel DiSCuSSion

Munish Mehra, PhDPresident,GlobalAllianceofIndianBiomedicalProfessionalsWashington,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

David Lepay, MD, PhDSeniorAdvisor,USFDA,USA

Gerald W Heddell, PhDDirectorofInspection,EnforcementandStandardsMHRA,London,UK

panel DiSCuSSion partiCipantS ContinueD

Surinder Singh, MDDrugsControllerGeneralofIndiaNewDelhi,India

Stephen E Wilson, DrPHDirector,DivisionofBiometricsIIICDER,USFDA,USA

Ram Tiwari, PhDAssociateDirectorforStatisticalScienceandPolicyUSFDA,USA

Mazlan Ismail, Sr Pharmacist, PSD MOHMinistryofHealth,Malaysia

B R JagashettyDrugControllerKarnatakaState

H G KoshiaCommissionerFDA,Gujarat,India

Dr S NateshSeniorAdvisor,DepartmentofBiotechnologyIndia

Dr K K TripathiAdvisorDepartmentofBiotechnologyGovtofIndia

12.30 pm-1.30 pm LUNCH


PROGRAMDETAILS

TRACK 1 CLINICAL RESEARCH

1.30 PM - 3.00 PM

CR1Avoiding Common Mistakes in Clinical Research

SESSIONCHAIREmily Tan, MSc

ExecutiveDirectorClinicalResearchAsiaPacificPharmaNet

Singapore

Avoiding Common Mistakes — Project Management Perspective

Roshan PadbidriSM-ClinicalOperations

TakedaGlobalResearch&DevelopmentCenter(AsiaPteLtd)

Singapore

Avoiding Common Mistakes — Medical Perspective

Geeta Paulmer, MDAssociateMedicalDirector

PharmaNetSingapore

Avoiding Common Mistakes — Clinical Strategies / Operational Perspective

Sanjeev Hegde, MDHead,ClinicalOperations

PiramalHealthcareMumbai,India

3.30 PM - 5.00 PM

CR2Translational Clinical Research — Stakeholders’ Perspectives

SESSIONCHAIRTal Burt, MD

ScientificDirectorDukeGlobalProof-of-Concept(POC)

ResearchNetworkDurham,NC,USA

Improving Our Approach to Drug Development

Robert M Califf, MDViceChancellorofClinicalResearchDirectorDukeTranslationalMedicineInstitute(DTMI)

Durham,NC,USA

Challenges Facing the Biomedical Industry and the Prospect of Collaborative Solutions

Dr Surinder KherCEOAsia

ManipalAcunovaLimitedIndia

Rationale for an Academic Global Proof of Concept Research Network

John S Sundy, MD, PhDAssociateProfessorofMedicineDirector

DukeGlobalProofofConcept(POC)ResearchNetwork

DukeClinicalResearchInstitute(DCRU),Durham,NC,USA

TRACK 3 DATA MANAGEMENT /

BIOSTATISTICS / MEDICAL WRITING

1.30 PM - 3.00 PM

DM1Current Issues in Medical Writing

SESSIONCHAIRHelle-Mai Gawrylewski, MA

SrDirMedAffairs&AllianceManagementinReg.MW

Johnson&JohnsonPRD,USA

Role of the Medical Writer in the Clinical Development Team and Professional Competencies

Helle-Mai Gawrylewski, MASrDirMedAffairs&AllianceManagement

inReg.MWJohnson&JohnsonPRD,USA

Review and Quality Control of CSRs and Other Documents

Devjani Dasgupta, PhDOperations(MedicalWritingandDocument

Publishing,ADMIRe)CognizantTechnologies

Guidance and Best Practices for Presentation of Data

Deepa Raj, PhDGeneralManager,ScientificWritingand

AggregateSafetyReportingAccentureServicesPvtLtd

Chennai,India

3.30 PM - 5.00 PM

DM2Designs in Early Phase Clinical Trials

SESSIONCHAIRVishwanath (Mahesh) Iyer, PhD

Head,OncologyBiometricsNovartisHealthcarePvtLtd

Hyderabad,India

Clinical Development Paradigms in Translating Cancer Genomics to Effective Treatments with Companion Diagnostics

Richard SimonChief,BiometricResearchBranch

NationalCancerInstituteRockville,MD,USA

Adaptive Designs for Finding the Optimal Dose in Oncology — Bayesian Logistic Regression Models

Vishwanath (Mahesh) Iyer, PhDHead,OncologyBiometricsNovartisHealthcarePvtLtd

Hyderabad,India

An Adaptive Two-Stage Dose Finding Trial Design

Arghya Chattopadhyay, PhDGlobalProjectLead

IIS/Neuro/InflammationHyderabad,India

TRACK 2 CMC / DRUG STANDARDS & QUALITY

/ REGULATORY

1.30 PM - 3.00 PM

RA1Evolving Global Regulatory Landscape and Clinical Development of Biosimilars — Role of India

SESSIONCHAIRArun Mishra, MSc

Director,GlobalRegulatoryAffairs(EmergingMarketsandAsia-Pacific)

GlaxoSmithKline,Middlesex,UK

Do we Have a Common Understanding? Definition of SBPs and Key Principles in Evaluating SBPs

Peter Richardson, PhDQualityofMedicinesSector

EuropeanMedicinesAgencyLondon,England

Do we Have a Common Understanding? Definition of Biosimilars and Key Principles in Evaluating Biosmilars: an EMA Perspective

Frank Scappaticci, MDSeniorMedicalDirector

RocheUSA

Indian Regulatory Framework and Challenges

Dr K K TripathiAdvisor

DepartmentofBiotechnologyGovtofIndia

3.30 PM - 5.00 PM

RA2Recent FDA, EMA, DCGI Guidelines — Regulations in Evolution

SESSIONCHAIRBobby George, PhD, CCRA, PGDHHM

AssistantVicePresidentRegulatoryAffairsRelianceLifeSciences

India

FDA’s Process Validation GuidanceAlbinus D’Sa

DeputyCountryDirectorUSFDA

India

European GuidanceEmmanuelle M Voisin, PhD

PrincipalandFounderVoisinConsultingLifeSciences

Paris,France

Indian GuidanceArun Bhatt, MD

PresidentClininventResearch

Mumbai,India

1.30pm-5.00 pmCONFERENCEDAY2|OCTOBER16,2011

TRACK 4 DRUG DISCOVERY / MARKET ACCESS

1.30 PM - 3.00 PM

MA1Pricing, Reimbursement and Market Access to Medicines: Current Global Challenges and Prospects

SESSIONCHAIRAlberto Grignolo, PhD

CorporateVicePresident,GlobalStrategy,PAREXELConsulting

Boston,MA,USA

IntroductionAlberto Grignolo, PhD


Boston,MA,USA

Payer Pressures, Challenges and Opportunities in Europe

Suchita ChaudhariConsultant-CommercialStrategyConsulting

PAREXELInternationalLondon,UK

Market Access to Medicines in Developing Countries

Hareesh ParandhamanAssistantDirector-BusinessDevelopment

LupinLtd(BiotechDivision)Pune,India

3.30 PM - 5.00 PM

DD1PANELDISCUSSIONPartnership Models for Stimulating Innovations

SESSIONCHAIRKrathish Bopanna, PhD, DSc

PresidentandExecutiveDirectorSemlerResearchCenterPvtLtd

Bangalore,India

Perspective of Stock Exchange in Stimulating Innovations

Ravi Tyagi, SMEProjectLead

NationalStockExchangeofIndiaMumbai,India

Risk Appetite Amongst Investors in Providing Capital Solutions for Stimulating Innovations

Kapil KhandelwalDirector

MakvenCapitalBangalore,India

Incubator Funding Opportunities and Intra Governmental Initiatives

Satya DashChiefOperatingOfficer

ABLEBangalore,India

Scientist Perspective in Addressing Issues on Capital Solutions

Chandrashekar BDirector

BigtecLabs


PROGRAMDETAILS


9.00 AM - 10.30 AM

CR3Enhancing Public Confidence in Clinical Research through Robust and Empowered Ethics Committees

SESSIONCHAIR Dr Nandini Kumar

FormerDeputyDirectorGeneralICMRCo-investigatorNIHProjectonBioethics

NationalInstituteofEpidemiology(ICMR)Chennai,India

Accreditation of Ethics Committees by SIDCER

Dr Nandini KumarFormerDeputyDirectorGeneralICMR

Co-investigatorNIHProjectonBioethicsNationalInstituteofEpidemiology(ICMR)

Chennai,India

Central Ethics Committee — Role and Functioning

Vijay KumarDeputyDirectorGenera

ICMRNewDelhi,India

Accreditation of Ethics Committees by AAHRPP

Shyamala SesikaranMedicalAdvisor

AHERFNewDelhi,India

11.00 AM - 12.30 PM

DD2Current Topics in Phase 0 and Phase 1 Studies

SESSIONCHAIRVijay Chauthaiwale, PhD

TorrentPharmaceuticalsLtdAhmedabad,India

Application of PK / PD Modeling and Simulation to aid Early Development

Ranendra SahaProfofPharmacy

BITSPilani,India

Strategies to Enable a Smooth Transition to Early Phase Clinical Trials

Nimish Vachharajani, PhDSeniorVicePresident,AdvinusTherapeutics

Bangalore,India

Microdosing and Chronotherapeutics: Innovative Technologies and Approaches in Translational Research

Tal Burt, MDScientificDirector

DukeGlobalProof-of-Concept(POC)ResearchNetwork

DukeClinicalResearchUnit(DCRU)&DukeClinicalResearchInstitute(DCRI),

Durham,NC,USA


DRUG DISCOVERY AND MARKET ACCESS / BIOSTATISTICS / MEDICAL WRITING / HOT TOPIC

9.00 AM - 10.30 AM

DM3Different Tools to Facilitate Clinical Data Management

SESSIONCHAIRNara Iyer

GroupHead,OncologyDataManagementNovartisHealthcarePvtLtd

Demystifying CDM — Part I Michael Goedde

Director,ClinicalDataManagementHumanGenomeSciences,Inc.

Rockville,MD,USA

Demystifying CDM — Part IIJulian Rimmer

VP&GMClinicalServicesComprehensiveClinicalDevelopment

Philadelphia,PA,USA

11.00 AM - 12.30 PM

MA2Synchronizing Clinical, Regulatory and Commercial Strategies During Drug Development to Accelerate Regulatory Approval and Patient Access to New Medicines


CorporateVicePresident,GlobalStrategy,PAREXELConsulting,

Boston,MA,USA


Aligning Cross-functional Performance Metrics for Market Access Effectiveness

Suchita ChaudhariConsultant-CommercialStrategyConsulting

PAREXELInternationalLondon,UK

Integrating Registration Strategy and Commercial Strategy During Drug Development

Joseph Scheeren, PharmDSeniorVP,HeadofGlobalRegulatoryAffairs

BayerHealthcarePharmaceuticalsNewYork,USA

Pharmaceutical Pricing and Reimbursement Policies and Practices in Emerging Markets: Impact on Drug Development and Registration Strategy (presentation by phone)

Raj LongDRAHead,AMACGEM&LATAM

NovartisPharmaAGBasel,Switzerland

TRACK 2 REGULATORY / CMC / DRUG SAFETY AND PV

9.00 AM - 10.30 AM

RA3Regulatory Strategy: Pathways to Drug Approvals in Different Countries



Boston,MA,USA



Boston,MA,USA

Regulatory Strategy: Pathways to Drug Approvals in Different Countries

Joseph Scheeren, PharmDSeniorVP,HeadofGlobalRegulatoryAffairs

BayerHealthcarePharmaceuticalsNewYork,USA

andArun Mishra, MSc

Director,GlobalRegulatoryAffairs(EmergingMarketsandAsia-Pacific)

GlaxoSmithKline,Middlesex,UK

Generic Pharmaceutical Industry - An Overview, Regulatory Challenges in USA and EU

Zoher T SihorwalaVicePresident

DrReddy’sLaboratoryMumbai,India

11.00 AM - 12.30 PM

CMC1Ensuring Quality in GMPs — Enhance the Approach of Quality driven by ICH Q8, Q9, Q10 and Q11: Practical Implementation

SESSIONCHAIR Nandkumar Chodankar, PhD

GroupCEO,PharmaBusinessExcelIndustries

Mumbai,India

Quality Management and Product Life Cycle

Prasad KanitkarDirector,PlantOperations

PfizerGlobalManufacturingIndia

Technology Transfer of Biosimilars: Using ICH Quality Drivers to your Advantage — a Pragmatic Approach

Richard Dennett, PhDDirector

VoisinConsultingLifeSciencesRennes,France

How to Apply QbD and PAT Principles for Preparing Clinical Supplies

Nandkumar Chodankar, PhDGroupCEO,PharmaBusiness

ExcelIndustriesMumbai,India

9.00am-12.30pm CONFERENCEDAY3|OCTOBER17,2011TRACK 4


9.00 AM - 10.30 AM

OS1Consideration in Outsourcing Clinical Trials to Emerging Regions: Are Global or Local CRO’s the Right Choice?

SESSIONCHAIRAjit Nair, PhD

President,GlobalOperationsSIROClinpharmPvtLtd

India

DEBATEVijay Chauthaiwale, PhD

VP,TorrentPharmaceuticalsLtdAhmedabad,India

Badhri SrinivasanSrDirector

QuintilesUSA

C N Ramchand,

PresidentCEOLailaPharmaceuticals

India

Arun Bhatt, MDPresident

ClininventResearchMumbai,India

11.00 AM - 12.30 PM

OS2Current Trends in Outsourcing: Partnership Models and Best Practices for Data Management and Scientific Programming

SESSIONCHAIRRalph Russo, MS, MBA

DirectorGlobalClinicalDataIntegration

MerckResearchLabsNewYork,USA

PANELDISCUSSIONData Management — the Business Model of Choice for Outsourcing CDM — the Vendor vs the Sponsor Perspective

Anil GollaHead,OncologyDataManagement

NovartisHealthcarePvtLtdNimita Limaye, PhD

SeniorVP&GlobalHead:CDM,MedicalWritingandSCEDAM

SIROClinpharmPvtLtdIndia

Balasubramanian SankaranarayananVicePresident,HealthcareandLifeSciences

SmartDecisionServices,GenPactMumbai,India

Ralph RussoDirector

GlobalClinicalDataIntegrationMerckResearchLabs

NewYork,USA

Best Practices in Outsourcing Scientific Programing — Presentation

Frederic Coppin, MScManager,GlobalScientificProgramming

MSDBrussels,Belgium

andNimita Limaye, PhD




PROGRAMDETAILS


1.30 PM - 3.00 PM

CR4Drug Development for Pediatric and Geriatric Population

SESSIONCHAIRAdnan Mahmood, MD

ClinicalResearchPhysician(Oncology/Hematology)

JanssenPharmaceuticals(J&J)Reading,UK

EMEA Guidance on the Clinical Trials in Pediatric Population

Adnan Mahmood, MDClinicalResearchPhysician

(Oncology/Hematology)JanssenPharmaceuticals(J&J)

Reading,UK

FDA and EMEA Guidance on Conducting Clinical Trials in Geriatric Population

Emmanuelle M Voisin, PhDPrincipalandFounder

VoisinConsultingLifeSciencesParis,France

Issues with Conducting Clinical Trials in Pediatric and Geriatric Population in India

Yasmin Shenoy Director,RegulatoryAffairs

SANOFIIndia

3.30 PM - 5.00 PM

CR5New Electronic Systems in Ensuring Good Clinical Practice Compliance

SESSIONCHAIRNancy Smerkanich

VicePresidentGlobalRegulatoryAffairs

OctagonResearchSolutionsPhiladelphia,PA,USA

Considerations for a Compliant and Secure Cloud Infrastructure to Facilitate Virtual Research

Gunjan Jain HealthSciencesGlobalBusinessUnit,ORACLE

India

TBANancy Smerkanich

VicePresidentGlobalRegulatoryAffairs

OctagonResearchSolutionsPhiladelphia,PA,USA

The Use of Electronic Systems in Early Phase Clinical Trials for Ensuring GCP Compliance

Vinoth Kumar TAssistantManagerandDeliveryLead

(E-ClinicalTechnologies)TechsolCorporation

Bangalore,India


DRUG DISCOVERY AND MARKET ACCESS / BIOSTATISTICS / MEDICAL WRITING / HOT TOPIC

1.30 PM - 3.00 PM

HT1Regulation, Media and Public Perception – Navigating the Minefield in India

SESSIONCHAIRDr Shoibal Mukherjee, MD

VicePresident,MedicalQuintiles

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, MDDirector,ClinicalStudyUnit

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, MDVicePresident,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, MDChiefScientificOfficer

NovartisIndiaLtdMumbai,India

3.30 PM - 5.00 PM

HT2Current Hot Topics

SESSIONCHAIRNavaneetha Rao, MD

VPClinicalR&DVicusTherapeutics

Repurposed Generic Combinations as one Means of Addressing the Challenges Facing the Industry

Navaneetha Rao, MDVPClinicalR&D

VicusTherapeutics

Achievements of the Clinical Trial Transformation Initiative (CTTI)

Alberto Grignolo, PhDCorporateVicePresident,

GlobalStrategy,PAREXELConsulting,Boston,MA,USA

The Challenges of Multi Pharmacopoeia Compliance in a Global Market

Paul EllisDirector,ExternalAdvocacy

GlobalManufacturingandSupplyGlaxoSmithKline

UK

Role of Public-private Partnerships to Advance Research and Development for Effective Therapeutics

Tobby SimonCEO

Synergia

TRACK 2 REGULATORY / CMC / DRUG SAFETY AND PV

1.30 PM - 3.00 PM

DS1Industrial Pharmacovigilance Practices

SESSIONCHAIR Ricardo Seminario, MD

DirectorMedical&SafetyServicesIconClinicalResearch

Chennai,India

Medical Review of Individual Cases — is it a Useful use of Core PV Resources?

Ajay KeshavaSeniorConsultant

WCIConsulting,USA

The Science and Industrial Practice in Signal Detection

Sidney Kahn, MBChB, PhDPrincipalScientist

SciformixPVServicesPhiladelphia,PA,USA

CRO’s Challenges in PV Capacity Building in Meeting Sponsors’ Expectations

Ricardo Seminario, MDDirectorMedical&SafetyServices

IconClinicalResearchChennai,India

Q&A Session

3.30 PM - 5.00 PM

DS2International Pharmacovigilance Regulatory Updates

SESSIONCHAIRSidney Kahn, MBChB, PhD

PrincipalScientistSciformixPVServicesPhiladelphia,PA,USA

New FDA Final Rule for Safety Reporting from Clinical Trials — Implications and Management

Sidney Kahn, MBChB, PhDPrincipalScientist

SciformixPVServicesPhiladelphia,PA,USA

Development Safety Update Reports - DSURs

Ricardo Seminario, MDDirectorMedical&SafetyServices

IconClinicalResearchChennai,India

ICH — E2E and Risk Management through REMS and RMPs Rajashree Devarakonda, MBBS, M.Sc, CCRP

DirectorVoisinConsulting

LifeSciencesBangalore,India

Q&A Session

1.30pm-5.00 pmCONFERENCEDAY3|OCTOBER17,2011TRACK 4


1.30 PM - 3.00 PM

DM4Deeper Look into Health Authority Guidances

SESSIONCHAIRVishwanath (Mahesh) Iyer, PhD

OncologyBiometricsNovartis

Hyderabad,India

Health Authority Guidance for Bridging Studies

Ashwini MathurDevelopmentOperations

NovartisHealthcarePvtLtd

FDA Guidances on Adaptive Designs and other Statistical Endpoints

Ram Tiwari, PhDAssociateDirectorforStatistical

ScienceandPolicyUSFDA

USA

FDA Guidance on ADAM and CDISC Standards

Stephen E Wilson, DrPHDirector,DivisionofBiometricsIII

CDER,USFDAUSA

3.30 PM - 5.00 PM

PD1Career 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

SESSIONCHAIRLakshmi P Kotra, PhD

Director-CMDP,ScientistandAssociateProfessorUniversityofTorontoand

UniversityHealthNetworkCanada

PANELDISCUSSIONS Natesh

SeniorAdvisor(Scientist-H)andHeadInternationalCollaborations

DepartmentofBiotechnologyGovernmentofIndia

Prof N UdupaPrincipal

ManipalCollegeofPharmaceuticalSciencesManipalUniversity

Vijay MoolaveesalaDirector-Operations(StrategicAlliances)

i3Global/InVentiv


TRACK 1 CLINICAL RESEARCH / HT /

REGULATORY AFFAIRS

9.00 AM - 10.30 AM

HT3Current Updates on Select Hot Topics

SESSIONCHAIRAlbinus D’Sa

DeputyCountryDirectorUSFDA

India

Current Developments in Translational Research — The NCATS NIH Initiative

Tal Burt, MDScientificDirector

DukeGlobalProof-of-Concept(POC)ResearchNetwork

DukeClinicalResearchUnit(DCRU)&DukeClinicalResearchInstitute(DCRI),

Durham,NC,USA

An Overview of FDA cGMP Inspections and Compliance in India

Albinus D’SaDeputyCountryDirector

USFDAIndia

Risk Based Monitoring Arun Bhatt, MD


Mumbai,India

11.00 AM - 12.30 PM

RA4Update on Current Regulations in India

SESSIONCHAIRArun Bhatt, MD


Mumbai,India

Regulatory Expectations — Medical Devices Sumati RandeoHeadRegulatory

QualityandComplianceAsiaPacificIndia

Current Regulatory Trends — BiologicsBobby George, PhD, CCRA, PGDHHM

AssistantVicePresidentRegulatoryAffairsRelianceLifeSciences

India

Regulatory Challenges for Stem Cell Research

Umesh BaikunjeSrGeneralManager

QualityandRegulatoryAffairsStempeuticsResearchPvtLtd

India



9.00 AM - 10.30 AM

DM5Safety Issues in Drug Development

SESSIONCHAIR Dr Chitra Lele

ChiefScientificOfficerSciformixCorp

USA

Resolving the Type I and Type II Error Dilemma for Clinical Safety Analyses

Devan MehrotraSeniorDirectorandHead

EarlyClinicalDevelopmentStatisticsBiostatistics&ResearchDecisionSciences

MerckResearchLaboratoriesUSA

Visual Analytics for Instream Review and Safety Monitoring in Clinical Trials and Post-marketing Applications

Michael O’ConnellSrDirector,Analytics

TIBCOUSA

Comparison of AE Incidence Between Drugs Dr Chitra Lele


USA

11.00 AM - 12.30 PM

DM6Qualification of Biomarkers and PROs

SESSIONCHAIRStephen E Wilson, DrPH

Director,DivisionofBiometricsIIICDER,USFDA

USA

Biomarker Analytics for Assessment of Safety and Efficacy in Clinical Trials

Michael O’ConnellSrDirector,Analytics

TIBCOUSA

Item Response Theory and Rasch Methodology to Develop Better Measurement Tools for Assessing Efficacy of New Medicinal Products

Munish Mehra, PhDPresident

GlobalAllianceofIndianBiomedicalProfessionals

Washington,DC,USA

FDA Guidance on Qualification of Biomarkers and PROs

Stephen E Wilson, DrPHDirector,DivisionofBiometricsIII

CDER,USFDAUSA

TRACK 2 CMC /DRUG STANDARD & QUALITY

/ OUTSOURCING

9.00 AM - 10.30 AM

CMC2Regulatory and CMC Considerations for Clinical Trials and New Technologies

SESSIONCHAIRMike James

GlaxoSmithKlineManagerRegInflCMCRegAffairs

London,UK

The Role of CMC in Investigational New Drugs

Sultan GhaniFormerDirectorHealth

Canada

CMC Requirements to Support New Technologies

Mike JamesGlaxoSmithKline

ManagerRegInflCMCRegAffairsLondon,UK

Preparing your Global Clinical Trials Dossier - Comparing the Indian Draft Guidelines on Approval of Clinical Trials and New Drugs with other Agencies

Stuart WrightRegulatoryServices

Canada

11.00 AM - 12.30 PM

OS3How Offshoring is Impacting the way Clinical Data is Processed and Interpreted

SESSIONCHAIRNimita Limaye, PhD



Offshoring Clinical Research: Implications for Coherent Aggregation of Data

Debjit BiswasSrDirector,ClinicalDevelopment

HeadBiostatsandDataManagementPiramalLifeSciences,India

Outsourcing and the Changes in Clinical Data Management

Suresh RamuDirector-Operations

CytespaceResearchPvtLtdIndia

TRACK 4DRUG SAFETY AND PV

9.00 AM - 10.30 AM

DS3National Pharmacovigilance and Regulatory Update

SESSIONCHAIRUsha Sharma

ExpressPharma/IndianExpressNewspapersMS:BusinessPublicationsDivision

Mumbai,India

Building up Indian Pharmacovigilance Capacity — A Regulatory Perspective

Dr Y K GuptaVPClinicalDevelopment

SemlerResearchCentrePvtLtdIndia

Building up Indian Pharmacovigilance Capacity — A Stakeholder’s Perspective

Dhananjay Bakle ExecutiveVicePresident-MedicalResearch

LupinPharmaIndia

Schedule Y — An Introspection Kedar Suvarnapathki

RegulatoryAffairsManagerAmgenTechnologyPvtLtd

Mumbai,India

Q&A Session

11.00 AM - 12.30 PM

DS4Pharmacovigilance New Horizons

SESSIONCHAIRDr Urmila Thatte, MD

HeadofDepartmentofClinicalPharmacology

SethGSMedicalCollegeandKEMHospital,Mumbai,India

PANELDISCUSSIONEmpowering ECs / IRBs to Evaluate Safety and Risk During Clinical Trials

MODERATORDr Chitra Lele


USA

Integration of Pharmacovigilance in Medical and Para Medical Syllabus

Dr Urmila ThatteHeadofDepartmentofClinicalPharmacology

SethGSMedicalCollegeandKEMHospital,Mumbai,India

Q&A Session

9.00am-12.30pm CONFERENCEDAY4|OCTOBER18,2011

PROGRAMDETAILS


TRACK 1 CLINICAL RESEARCH / HT /

REGULATORY AFFAIRS

1.30 PM - 3.00 PM

CR6Strategies for Enhancing Effectiveness of Project Managers and Team Members

SESSIONCHAIRChirag Trivedi, PhD

AssociateDirector-ProjectManagement&StrategicInitiatives

SANOFIMumbai,India

Challenges in Project ManagementSudip Sinha

VicePresidentProjectManagementandClinicalOperations

CliniRxResearchPvtLtdIndia

Understanding Change and how People Deal with it

Subashri ShivkumarHubUnitDirector—India

RegionalClinicalOperationsBristol-MyersSquibbIndiaPvtLtd

Effective Project Mangers – Should They Manage OR Lead

Dr Aamir Shaikh, MDFounder,HealthCareConsultant,Assansa

Mumbai,India

3.30 PM - 5.00 PM

VALEDICTORY SESSION



1.30 PM - 3.00 PM

DM7Issues in Multi-region Clinical Trials

SESSIONCHAIRDr Jayanti Gupta, PhDVPClinicalDevelopment

SemlerResearchCentrePvtLtdMumbai,India

Key Regulatory and Clinical Considerations when Conduction a Global Clinical Trial in Emerging Economies

Dr Cellia K HabitaPresident&CEO

ArianneCorpSanDiego,CA,USA

Case Studies on Quality Laboratory Data and Standardized Processes in Multi-regional Clinical Trials

Dr Neelesh ShahCOO,GroupHeadMetropolisGroup

India

Considerations for Design and Analysis of MRCTs

Dr Jayanti Gupta, PhDVPClinicalDevelopment

SemlerResearchCentrePvtLtdMumbai,India

3.30 PM - 5.00 PM

VALEDICTORY SESSION

TRACK 2 CMC /DRUG STANDARD & QUALITY

/ OUTSOURCING

1.30 PM - 3.00 PM

OS4Medical Writing: Best Practices for Effective Partnering

SESSIONCHAIRCarolyn Smith-Barrett, PhD

GlobalHead,RegulatoryMedicalWritingJohnson&JohnsonPharmaR&D

NewYork,USA

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

Suhasini Sharma, MDDirector,MedicalWritingandMedicalReview

SCIFORMIXTECHNOLOGIESPRIVATELIMITED

Nimita Limaye, PhDSeniorVP&GlobalHead:

CDM,MedicalWritingandSCEDAMSIROClinpharmPvtLtd

India

Jane Dixon, PhDPrincipal,MedicalCommunicationsScientist

AstraZeneca,LP,Wilmington,DE,USA

Dr Devjani Dasgupta, DGMOperations(MedicalWritingandDocument

Publishing,ADMIRe)CognizantTechnologySolutions

3.30 PM - 5.00 PM

VALEDICTORY SESSION

TRACK 4DRUG SAFETY AND PV

1.30 PM - 3.00 PM

CMC3Impact of Counterfeit Medicines and Evolving Potential Technological Solutions

SESSIONCHAIRNeville Broad

Anti-counterfeitManagerAbbottLaboratories

UK

Rapid Screening Methods to Detect Counterfeit

Neville BroadAnti-counterfeitManager

AbbottLaboratoriesUK

Counterfeit Medicines in Asia TodayBejon Misra

FounderPartnershipforSafeMedicines(PSM)

India

The Malaysian Experience with MedtangMazlan Ismail, Sr Pharmacist, PSD MOH

MinistryofHealthMalaysia

3.30 PM - 5.00 PM

VALEDICTORY SESSION

1.30pm-5.00 pmCONFERENCEDAY4|OCTOBER18,2011

PROGRAMDETAILS

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6th Annual Conference on Global Drug Development and Market Access: Converging Strategies and Best Practices to Benefit PatientsMeeting I.D. # 11659 – October 15-18, 2011 – Hotel Intercontinental The Lalit, Mumbai, INDIA

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DIA(India)PrivateLimited,A-303,WellingtonBusinessParkI

Andheri-KurlaRoad,Marol,Andheri(East),Mumbai400059India

Phone:+91-22-6765-3226Fax:+91-22-28594762

TUTORIALSIndustry, Academia, and Students

Tutorial 1 Tutorial 2 Tutorial 3 Tutorial 4 Tutorial 5

BASIC RATE 3767 3767 3767 3767 3767

TAXES 233 233 233 233 233

TOTAL q 4000 q 4000 q 4000 q 4000 q 4000

FULL MEETING CANCELLATION (All refunds will be issued in the currency of original payment):Member/NonmemberRegistration=INR3,000 • StudentRegistration=INR500

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

2012Collaborate to Innovate

DIA

kapil Khandelwal : Drug Information Agence (DIA) conference agenda

Health & Medicine

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