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7th Annual Conference  Discovery through Commercialization:  Innovative Strategies for Individualized Health Care  Novembe...
tutorials | DAY 1 | THURSDAY, NOVEMBER 1, 2012                                                                            ...
DAY 2 | friDAY, NOVEMBER 2, 2012                                                                                          ...
DAY 2 | friDAY, NOVEMBER 2, 2012                                                                                          ...
DAY 3 | saturday, NOVEMBER 3, 2012                                                                                        ...
DAY 3 | saturday, NOVEMBER 3, 2012                                                                                        ...
DAY 3 | saturday, NOVEMBER 3, 2012                                                                                        ...
DAY 4 | sUNDAY, NOVEMBER 4, 2012                                                                                        89...
DAY 4 | sUNDAY, NOVEMBER 4, 2012                                                                                92.00-3.30...
Registration Form/ INVOICE                        7th Annual Conference - Meeting ID #12659 - November 1-4, 2012 - Hyderab...
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Drug Information Agency (dia) 7th annual conference: Kapil Khandelwal, EquNev Capital,


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Kapil Khandelwal
EquNev Capital

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Drug Information Agency (dia) 7th annual conference: Kapil Khandelwal, EquNev Capital,

  1. 1. 7th Annual Conference Discovery through Commercialization: Innovative Strategies for Individualized Health Care November 1-4, 2012  ID #12659 | Hyderabad International Convention CenterPROGRAM ADVISOR Keynote Speaker PROGRAM CO-CHAIRSNarges MahaluxmivalaSenior ConsultantClinical Development ResearchCHAIR ADVISORY COUNCIL OF INDIALarisa Nagra SinghVP Global Functional Resourcing, AsiaQuintiles, SingaporePROGRAM COMMITTEEAlbinus D’SaDeputy Country DirectorUS FDA, IndiaMunish Mehra Paul Huckle Nimita Limaye, PhD Vishwanath Iyer, PhDPresident Senior Vice President, Vice President Head, Oncology Biometrics Global Regulatory Affairs Tata Consultancy Services Novartis Health Care Pvt LtdGlobal Alliance of Indian Biomedical Professionals GlaxoSmithKlineUSABaljit (Boo) SamraVice President and Country Manager Over a period of time there has been a paradigm shift in the way medicines are being developed.PAREXEL International Therapy is becoming patient-centric and technology is driving real-time monitoring of patientV. N. Balaji responsiveness. This necessitates changes in the way every aspect of the health care industry, fromConsultant, Discovery Research discovery through development, manufacturing, and finally commercialization operate.Nikhil KumarPresident This conference will include multiple tracks focusing upon the confluence of discovery, development,Applied Technology Solutions, Inc, USA manufacturing and commercialization towards the development of innovative, path-breaking strategies in the realm of personalised health care. The conference will address the strategy forTal Burt, MD drug discovery and clinical development pipeline and faster time to market in the era of blockbusterScientific DirectorDuke Global Proof-of-Concept (POC) Research patient expiries and issues of integrating and streamlining data flows across the entire life cycle ofNetwork the molecule, and the standardization and rigor that needs to be implemented. It will also stress uponDuke Clinical Research Unit (DCRU) & the ethical, legal, social and regulatory and financial and investments challenges impacting all of theDuke Clinical Research Institute (DCRI), USA above and how processes and technology will need to be upgraded to support the same.Carol Isaacson BarashPrincipal, Helix Health Advisors PROGRAM HIGHLIGHTSAdjunct Prof. Personalized Medicine, Regis College • Discovery: Bioinformatics, Next Gen payor challenges, Go-to-investors andR. B. SmartaFounder and Managing Director Sequencing, Lead optimization – the need financial/partnering strategies for productInterlink Marketing Consulting Private Limited, India for speed development • Development: Barriers and drivers relevant • Regulatory, ethical, social and legalKapil Khandelwal to clinical development across clinical issues: data privacy and consent issuesVenture Capitalists & Independent Board Member operations, data management, biostatistics, in the evolving technologies related to programming, and medical writing, personalized medicineHelle Gawrylewski highlighting systems biology paradigm • Technology and Standards: Technology –Senior Director, Regulatory Medical WritingJanssen R&D Companies of J&J, USA (e.g. pharmacogenomics, metabolomics) SOA, the Cloud and the future, Data and and innovative developmental approaches Semantic Interoperability Technology, GRCUday Kumar S (e.g. chronotherapeutics, microdosing) (Governance, Regulation and Compliance)Head – Project & Alliance Management • Manufacturing: Flexible solutions to adapt to all focused on Personalized Medicine.Rhizen Pharmaceuticals S A, Switzerland the evolving global regulatory scenario and • Lean strategy: The application of Lean in quality standards pharmacovigilance, medical writing, clinicalSCIENTIFIC ADVISOR - POSTERS • Commercialization: Health economics operations and site performance. Driving theN. Udupa and outcomes research driving product critical path.Professor and Principal and pricing strategy, patient access,College of Pharmaceutical Sciences, Manipal, India Excellent opportunity to showcase your products and services through exhibits and advertisements. DIA (India) Private Limited A 303, Wellington Business Park I, Marol Andheri-Kurla Road Andheri (East), Mumbai - 400059
  2. 2. tutorials | DAY 1 | THURSDAY, NOVEMBER 1, 2012 29.00-12.00am 2.00-5.00pmQbD: A Challenge to the Pharma Industry (MR 1.01) Bioinformatics (MR 1.01)instructors instructorV. Venkateswarlu Sangeeta SawantVice President, Functional Head of Formulation Development, Assistant Professor (Reader),Bioequivalence and Clinical Pharmacokinetics Bioinformatics Center, University of PunePackaging Development - Integrated Product Development,Dr. Reddy’s Laboratories Bioinformatics has evolved as a multidisciplinary area of science over the past few decades. It has become an integral componentR. Manikandan of research and education in life sciences. Having originatedAssociate Director, Formulation Development as a set of computational tools to analyze biological data suchDr. Reddy’s Laboratories as biomolecular sequences and structures, Bioinformatics now deals with computational processing and analysis of large setsQuality by Design is defined as a systematic approach to of complex data being churned out from advanced and highdevelopment that begins with predefined objectives and throughput technologies such as DNA micro-arrays, wholeemphasizes product and process understanding and process genome sequences, proteomics data, protein-protein interactionscontrol, based on sound science and quality risk management. etc. A large variety of mathematical algorithms and statisticalThe important stake holders involved in this process are Patients, techniques are employed for data analysis.industry and regulators. For Patients it is quality, efficacy andsafety, for industry it is important to have quality along with Bioinformatics facilitate simple sequence-based or structure-cost saving and efficiency and for regulators it is more efficient based analyses of genes and proteins to gain insights into theirregulatory oversight. Integrating these aspects is a question molecular functions on one hand and provide insights intoto industry and regulator and hence it is a challenge to the systems level biology through analysis of voluminous genomicpharm world. The reason for calling it as challenge because the or proteomic data. The paradigm shift from molecular leveltwenty-first century began with the pharmaceutical industry studies in life sciences to systems biology, genotype-phenotypeusing development approach (empirical) and manufacturing correlations, insights into health and disease states, etc. is beingtechnologies that have been employed since the 1940’s. No greatly accelerated by bioinformatics applicationssignificant changes in manufacturing process is made until itjustify the high costs and long cycle time needed to gain approval. Learning Objectives:This often resulted in inefficient, overly expensive processes. As a • To understand the scope of Bioinformatics and introduceresult, the FDA (Food and Drug Administration) have embrace a sequence-based approaches: What can be achieved by usingnew paradigm for regulation through Quality by Design. the sequence analysis methods • To introduce structure-based approaches: What can beThe FDA belief is that, quality cannot be tested into products, achieved by analyzing structures of biomoleculesbut should be built-in or by design. The important elements • An overview of applications of bioinformatics-based methodsthat will enable to institutionalize this includes, Quality target in various life science areas such as drug design, geneticsproduct profile, critical quality attribute, design space, risk and genetic diseases, infectious and parasitic diseases,assessment, control strategy and Continuous Improvement. immunology, etc.The detail approach towards application of these elements isalso well enumerated in ICH guidelines Q8, Q9, Q10 and Q11. 2.00-5.00pmTherefore Implementation of QbD will enable transformation of Personalized Medicine (MR 1.02)the chemistry, manufacturing, and controls (CMC) review of new instructorSdrug applications (NDA’s) and Abbreviated new drug applications(ANDAs) into a science-based pharmaceutical quality assessment Carol Isaacson Barash Jeffrey N Gibbs Principal, Helix Health Advisors DirectorAs Janet Woodcock, Officer at FDA, stated at the 2008 PDA Adjunct Prof. Personalized Hyman, Phelps & McNamara P.C.meeting, ‘‘QbD is an evolution and not a revolution’’ – an evolution Medicine, Regis Collegethat is in response to the increasing cost pressures on both theregulatory agencies and industry. QbD will evolve as we continue It is an introduction to the field of personalized medicine andto increase our understanding and control of the manufacturing how and why it is revolutionizing the practice of medicine.processes. Topics include pharmacogenetics/pharmacogenomics, molecular diagnostics used to tailor therapies, companion diagnostics andLearning Objectives: strategies for revitalizing older drugs. An overview of current and• Emphasis on the importance of the Quality Target Product emerging technologies used, therapeutic domains and regulatory Profile in articulating a quantitative performance target for challenges and ethical issues will be discussed QbD.• Identification of critical material attributes that provide a Attendees will: mechanistic link of the product quality to the manufacturing • Understand the FDA regulatory system for in vitro process. diagnostics, and what that means for the drug approval• Critical process parameters are operating parameters and process should be combined with critical material attributes to • Learn how to work collaboratively with in vitro diagnostic describe the relation between unit operation inputs and companies during the clinical trial and the application process outputs. to obtain approval of drug and the companion diagnostic• Establishing the design space and enable changes within • Learn how to structure contracts with an in vitro diagnostic design space company developing a companion diagnostic for your drug• The role of the control strategy as the mechanism for • Learn about the pitfalls on the path to getting approval of the implementation of QbD elements into practice companion diagnostic for your drug• Lifecycle management – propose post approval changes • Learn about FDA regulation of laboratory developed tests needed through continuous improvement (LDTs) and the role of LDTs in companion diagnostics • Learn stakeholder interests and concerns • Learn ethical issues in clinical trials and informed consent • Learn privacy issues in data collection, storage, use and disclosure
  3. 3. DAY 2 | friDAY, NOVEMBER 2, 2012 38.15-9.00 am REGISTRATION9.00-9.15 am Opening Ceremony (Hall 1 & 2)9.15-9.45 am Key note address 1 (Hall 1 & 2)9.45-10.15 am Key note address 2 (Hall 1 & 2)10.30-11.30 am Tea Break, Poster & Exhibit Visit (Hall 5 & 6)11.30 am-1.00 pm CONCURRENT SESSIONSSession 1 - DISCOVERY 1 Session 2 - Commercialization 1 Session 3 - Technology & Standards 1Target Discovery (G.01) Health Economics and Valuation Technology for PersonalizedSESSION CHAIR (Hall 1 & 2) Medicine — SOA, the Cloud and theV. N. Balaji SESSION cHAIR Future (G.02)Consultant Shashidhar Rao SESSION CHAIRDiscovery Research Head Global Medical Affairs and HEOR Nikhil Kumar Applications of Next Generation India Operations President Sequencing and Genomics—from Target Novartis Healthcare Applied Technology Solutions, Inc. Discovery to Clinical Trials and Beyond New Molecules: Paths to their War on Drug Failure & Key Role of Raja Mugasimangalam Development and Commercialization in Information Technology CEO India Dnyanesh Limaye Genotypic Technology Nidhi Saxena Professor and Head of Department Distilling Omics Data for Drug Discovery Founder and CEO Pharmacology Kalpana Krishnaswamy Karmic Lifesciences Pharma and CRO Industries adoption of CEO Personalization and Regulatory SOA, SaaS and Cloud Technologies — Key Metaome Science Informatics Framework Success Factors Homology Modeling of Proteins and Arun Bhatt Raghu Punnamraju Ligand Docking: How close are we to President Director, Clinical Trials Management Systems drug discovery? Clininvent Research Engineering and PI Technology R. Sowdhamini Approach to Early Phase Health Perceptive Informatics (A PAREXEL Company) Associate Professor Economics Evaluations Technology for Personalized Medicine National Centre for Biological Sciences Adrian McKemey and the Pharmaceutical Industry Practice Leader, Product Development & Nimita Limaye Commercialization Vice President Quintiles Tata Consultancy Services Nitin Kumar Intern Applied Technology Solutions, Inc.1.00-2.00 pm Lunch - Poster & Exhibit Visit Exhibiting Opportunities Exhibit your business to a targeted group of key decision makers with an explicit interest in your products and services built specifically for pharmaceutical, biotechnology, clinical, and medical device enterprises. With over 9,500 square feet of area the exhibition this year hosted at Hyderabad International Convention Centre (HICC), will help you connect with over 400 patrons. Exhibit Fee: 3m x 2m booth space - INR 150,000/- (No taxes involved) For more details on the Exhibit Layout and Booking Form please click here or contact or call +91.98.1977.7493.
  4. 4. DAY 2 | friDAY, NOVEMBER 2, 2012 42.00-3.30 pm CONCURRENT SESSIONSSession 4 - Development 1 Session 5 - Commercialization 2 Session 6 - Outsourcing 1Public Knowledge and Perceptions Product and Pricing Strategy and Outsourcing Strategy (Hall 1 & 2)as Drivers or Barriers to the Future Payor Challenges (G.02) SESSION cHAIRof Clinical Research in India (G.01) SESSION cHAIR Baljit (Boo) SamraSESSION CHAIR Ranga Iyer Corporate Vice President & Country Manager, IndiaTal Burt Healthcare Consultant PAREXEL InternationalScientific Director Sizing the Opportunity, Market DrivenDuke Global Proof-of-Concept (POC) Evolution of Outsourcing Models in Commercialization of ProductsResearch Network Clinical Research Dhananjay Bhakhle Executive Vice President, Medical Research Joseph C. Avellone PARTAKE Program and Survey of Public Lupin Pharmaceuticals Corporate Senior Vice President Knowledge and Perceptions of Clinical Clinical Research Services, Worldwide Research Financing for Clinical Development, Cost PAREXEL International Tal Burt for Transition, Drug Diagnostics Core Scientific Director Outsourcing Challenges and Ethical Development Duke Global Proof-of-Concept (POC) Research Practices Ranga Iyer Network Raj Sinha Healthcare Consultant Director, Global Functional Resourcing Challenges of Drug Development in India Using Real World Evidence to Drive Quintiles – The Relevance of Public Awareness and Access Strategies Trends in Early Phase Outsourcing Partnership Simu Thomas Mukesh Kumar Krathish Bopanna Global Head, Economic Modeling, Global Director & Clinical Research Lead, President and CEO Medical Affairs and HEOR AP Disease Profile Semler Research Novartis , USA Therapeutic Strategy Unit The Role of Stakeholder Collaborations in Asia Pacific R & D the Ethical Conduct of Clinical Research Sanofi Nandini Kumar Former Deputy Director General Senior Grade Investigator NIH project National Institute of Epidemiology3.30-4.30 pm Tea Break, Poster & Exhibit Visit4:30-6:00 pm CONCURRENT SESSIONSSession 7 - Regulatory 1 Session 8 - Lean SIX SIGMA 1 Session 9 - PV 1Regulatory, Ethical & Social Policy Lean Six Sigma — Patient Safety - A Well RoundedIssues in Personalized Medicine: Pharmacovigilance, Site View from the Stakeholders (G.02)Discovery to Clinic (Hall 1 & 2) Performance and Clinical Operations SESSION cHAIRSESSION CHAIR (G.01) Vivek AhujaCarol Isaacson Barash SESSION Co-cHAIRs Director, Pharmacovigilance - Asia PacificPrincipal, Helix Health Advisors Baxter Healthcare Nimita LimayeAdjunct Prof. Personalized Medicine Vice President Outsourcing PharmacovigilanceRegis College Tata Consultancy Services Services: Why India can/cannot be the Bridging the Gap: Co-evelopment of World Leader Helle Gawrylewski Manni Kuthiala Targeted Therapeutics and Companion Senior Director, Regulatory Medical Writing Delivery Manager Diagnostics in the US and Europe Janssen R&D Companies of J&J, USA Tata Consultancy Services Patrick Larcier Clinical Development & PV Applying Lean Methodology in Pharmacovigilance Challenges and Voisin Consulting Pharmacovigilance Complexities in Global Clinical Trials Dinesh Kasthuril Sanjeev Miglani Ethical Issues: Indian Scenario Director, Safety and Risk Management Vice President Arun Bhatt Sciformix Pharmacovigilance & Medical Writing President Accenture Clininvent Research Improving Process Efficiencies in Clinical Operations — The Lean Approach Understanding the Concept of Personalized Medicine, Data Needs & Guy Schiller ‘Pharmacovigilance sans Frontières’ Bumping Up Against Ethics Vice President, Business Process Excellence to Ensure Effective Patient Safety Carol Isaacson Barash PAREXEL International Vivek Ahuja Principal, Helix Health Advisors Director, Pharmacovigilance - Asia Pacific Adjunct Prof. Personalized Medicine Lean Sigma: Improving Site Performance Baxter Healthcare Regis College Using Continuous Process Improvement Methods is Key to Sustained Clinical Development Suresh Ramu Co-founder and CEO Cytespace Research6.00 pm Day End
  5. 5. DAY 3 | saturday, NOVEMBER 3, 2012 59.00-10.30 am CONCURRENT SESSIONSSESSION 10 - Discovery 2 Session 11 - Commercialization 3 Session 12 - Manufacturing 1Lead Discovery (G.01 & G.02) Go to Investors (G.03 & G.04) Manufacturing (G.05 & G.06)SESSION cHAIR SESSION cHAIR SESSION cHAIRRaman Govindarajan R. B. Smarta SC SinghaiHead R&D Founder and Managing Director Vice President - Tech TransferSanofi Interlink Marketing Consulting Dr. Reddy’s Impact of Structural Biology on Drug Mergers or Partners Potent Product Process and Facility Discovery D A Prasanna Design Ajith Kamat Chairman and Managing Director SC Singhai Head, Strategic Research Partnerships Ecron Acunova Vice President - Tech Transfer Pfizer Dr. Reddy’s Branding an Essential Tool to Attract Lead Identification and Optimization in Investment Quality Management Process in Facility Small Molecular Drug Discovery: SBDD Madeline Ducate Development Case Studies Executive Vice President, Global Operations Vinay Nayak Vellarkad N. Viswanadhan Pharm-Olam International President Vice President Alembic Pharmaceuticals Jubilant Biosys Funding & Investing in New Product World Class Manufacturing- A Challenge Application of Parallel Medicinal Development and Opportunity for the Indian Pharma Chemistry Strategies for Rapid and Anil Kamath Industry Efficient Optimization of Adenosine A1 Founder Chairman Pushpinder Bindra Receptor Modulators Esemcee Advisors CEO Venkata Palle Zenith and Beyond Vice President - Discovery Research Case Study: Integration of Patient Novel Drug Discovery and Development Needs, and Quality Requirements in Lupin Recent Times has Enforced Application of “Quality by Design (QbD)” and “Process Analytical Technology (PAT)” to development of Therapeutic Vaccines Nicolas Cappuccino Global Head, Quality Dr. Reddy’s10.30-11.30 am Tea Break AND Exhibit Visit DIA India Membership DIA is the premier professional member association in the world addressing solutions to issues and challenges across the entire drug development industry. DIA’s professional development opportunities, timely information resources and global network of thought leaders allow you to take control of your career. • Participate in our neutral, global forum, completely independent from the influence of any one organization or authority • Learn about regulations, best practices and trends from industry thought leaders • Connect with and learn from regulatory, industry, and academic professionals while advancing your career through conferences, networking opportunities and DIA’s knowledge resources • Take advantage of all these member benefits – join DIA today! Standard Membership Student Membership Annual Fee: Rs. 1,950 (inclusive of taxes) Annual Fee: Rs. 500 (inclusive of taxes) For details, contacts: Rhean D’Souza tel: +91.22.2859.4762 | cell: +91.98.2058.7798 email:
  6. 6. DAY 3 | saturday, NOVEMBER 3, 2012 611.30 am-1.00 pm CONCURRENT SESSIONSSession 13 - Development 2 Session 14 - Lean SIX SIGMA 2 Session 15 Manufacturing 2Evolving Roles of Personnel Lean Six Sigma — Medical Writing Manufacturing (G.05 & G.06)Involved in Clinical Trials — Panel (G.03 & G.04) SESSION cHAIRDiscussion (G.01 & G.02) SESSION Co-cHAIRs Subir BasakSESSION CHAIR Nimita Limaye President Vice President Jubilant BiosysSam Mathew Tata Consultancy ServicesProcess Lead-Medical Writing Pharmacogenomics for PersonalizedAccenture Services Helle Gawrylewski Senior Director, Regulatory Medical Writing Medicine: Optimizing use of Drug and Janssen R&D Companies of J&J, USA Drug Combinations to Improve Patient Ajit Nair Outcome Global Head - Clinical Services Panel Discussion - Thinking Lean in Jugnu Jain Tata Consultancy Services Medical Writing: Driving Change... Director Paul Sokol Saarum Siences Partha Chakraborthy Senior Director Senior Director & Global Delivery Head, R&D Neuroscience Therapeutic Area Head Reg MW Quality Control, a Necessary Paradigm Cognizant Technology Solutions Janssen Research & Development PRD when “Leaning Out” Operations, Shashidhar Rao as Pharmaceuticals Shift from the Anish Desai Head Global Medical Affairs and HEOR, India Blockbuster Model to Personalized Gene Director Medical Affairs and Clinical Operations Operations Therapies and Gene-specific Small- Johnson & Johnson Novartis Health Care molecule Treatments Swapnil Ballal S Sinha Offshoring Medical Writing: Lean Project Quality Lead Head (Global) & Associate Vice President Management Strategy Biocon Clinical Development & Medical Affairs (CD&MA) P. Sokol Hetero Group Senior Director, Neuroscience Therapeutic BioManufacturing in India Area Head Reg MW Subir Basak Janssen Research & Development President Seema Gurbani Jubilant Biosys Assistant Manager Tata Consultancy Services Improving the Sigma Level of Medical Writing Shashidhar Rao Head Global Medical Affairs and HEOR, India Operations Novartis Health Care Pvt. Ltd Palli, M Operations Manager Novartis1.00-2.00 pm Lunch And Exhibit Visit Marketing and Industry Support Opportunities Whether your primary marketing objective is to maximize exposure of your brand, secure new business or demonstrate your expertise, the 7th Annual Conference offers you the perfect platform. DIA offers 2 levels of support categories. Level 2 includes booth space, eight delegate passes, pre-conference branding in meeting flyer, DIA promotional mailing & DIA event website, exclusive ‘Thank You’ signage, and more. (Only 1 available) Level 1 includes booth space, six delegate passes, pre-conference branding in meeting flyer, DIA promotional mailing & DIA event website, and more. (2 available) Partnering opportunites such as Speaker Dinner Partner, Lunch Partners, Delegate Kit Partner and Internet Free Zone Partner are also available. To read more click here or contact Manoj Trivedi at or call +91.98.1977.7493
  7. 7. DAY 3 | saturday, NOVEMBER 3, 2012 72.00-3.30 pm CONCURRENT SESSIONSSession 16 - Discovery 3 Session 17 - Regulatory 2 Session 18 - Technology & Standards 2Pre-clinical Discovery and Scientific, Regulatory and Data and Semantic InteroperabilityDevelopment (G.01 & G.02) Ethical Challenges in Advancing in Personalized Medicine (G.05 &SESSION cHAIR Personalized Medicine (G.03 & G.06)Dr. Vishwanath Iyer (Mahesh) G.04) SESSION CHAIRHead, Oncology Biometrics SESSION CHAIR Nikhil KumarNovartis Healthcare President Carol Isaacson Barash Translational Approaches to Target Principal, Helix Health Advisors Applied Technology Solutions, Inc., USA Validation, Drug Action and Patient Adjunct Prof. Personalized Medicine Semantic Interoperability, Data and Response Characterization Regis College Personalized Medicine Raman Govindarajan Nikhil Kumar Realizing the Promise of Personalization Head, R&D India President through Health Care Mass Sanofi Applied Technology Solutions, Inc., USA Commercialization Imaging as a Biomarker In Early Stage Sagar Kamarthi CDASH Standards Library Development Associate Professor Implementation Across Multiple EDC Smita Pandit Department of Mechanical and Industrial Systems and its Potential Benefits Director, Imaging Operations Engineering Sunish Raj Perceptive Informatics (A PAREXEL Company) Northeastern University, Boston Manager, Clinical DB Programming Pharmacovigilence and Drug Safety Regulatory Challenges for Molecular and PAREXEL International Shwetha Kamath Companion Diagnostics Harmonization of Clinical Data Standards Drug Safety Physician Jeffrey N. Gibbs Senthil Raja Accenture Director Manager, Clinical DB Programming Hyman, Phelps & McNamara, P. C. PAREXEL International Ethical Issues in Individualized Health Care — Seeking Solutions in a Complex World Aamir Shaikh Founder Assansa Personalized Nutrition: Parallels from Personalized Medicine Emanuelle Voisin CEO and Principal Voisin Consulting3.30- 4.30 pm Tea Break AND Exhibit Visit4:30-6:00 pm CONCURRENT SESSIONSSession 19 - Development 3 Session 20 - Therapeutics 1 Session 21 - Manufacturing 3Current Challenges in Clinical Therapeutics — Pharmacology and Panel discussionDevelopment in India (G.01 & G.02) Applications in Personalise Medicine Panel Discussion on Regulatory inSESSION CHAIR (G.03 & G.04) Manufacturing (G.05 & G.06)Vishwanath Iyer (Mahesh) SESSION cHAIR panelistsHead, Oncology Biometrics Vishwas SovaniNovartis Healthcare Regulators Invited Country Manager Challenges in conducting Clinical trials in Revogenex, Inc. India: Sponsor’s perspective Personalised Medicine Pharmacological Bobby George basis Asst Vice President & Head Regulatory Affairs Vishwas Sovani Reliance Life Sciences Country Manager Finding New Drugs for the Treatment Revogenex, Inc. of Neglected Diseases: Trials and Therapeutic Applications of Personalized Tribulations Medicine Bal Ganesh Mangesh Kulkarni Distinguished Scientist Head of OSDD unit Group Head, DS&E Council of Scientific and Industrial Research Novartis Healthcare (CSIR) Ready to use Kits for Personalized Current Ethics-related Challenges in Medicine Clinical Development in India Mukesh Agrawal Shoibal Mukherjee Vice President, CRL Vice President and Head Vimta Labs Asia Medical Sciences Group Quintiles6.00 pm Day End
  8. 8. DAY 4 | sUNDAY, NOVEMBER 4, 2012 89:00-10:30 am CONCURRENT SESSIONS Session 22 - Development 4 Shifting Paradigms in Clinical Research (G.01 & G.02) Upcoming Meetings 2013 SESSION CHAIR Y. K. Gupta Prof. & HoD, Department of Pharmacology & Nephrology, Through its five flagship Pharmacovigilance AIIMS conferences and exhibitions February | Mumbai Design of Drug Clinical Trials in India, DIA has established Incorporating a Companion Diagnostic 6th Regulatory itself as a neutral platform Rajashree Devarakonda April | Ahmedabad Director where thought leaders Voisin Consulting from the pharmaceutical, 2nd IT Life Sciences The Prospect of Microdosing Trials in biotechnology, medical device, July | Bangalore India and related fields, exchange Generics Y. K. Gupta ideas, network, and engage August | Hyderabad Prof. & HOD, Department of Pharmacology & with industry professionals Nephrology AIIMS across the globe. 8th Annual Meeting October | Mumbai Private-Academic Collaborations in Clinical Research: An Emerging Paradigm To know more on the upcoming flagship conferences at DIA Naresh Trehan in India write to Chairman & Managing Director Medanta- The Medicity10.30- 11.30 am Tea Break AND Exhibit Visit11.30 am-1.00 pm CONCURRENT SESSIONS Session 23 - Development 5 Session 24 -Technology & standards 3 Current Topics in Biostatistics (G.01 GRC (Governance, Regulation and & G.02) Compliance) and Personalized SESSION CHAIR Medicine (G.03 & G.04) Munish Mehra SESSION CHAIR President Nikhil Kumar Global Alliance of Indian Biomedical President Professionals Applied Technology Solutions, Inc, USA Development and Validation of Strengthening of Safety Monitoring Threshold-based Prognostic and Vaccines in Albania Predictive Biomarker Signatures for Merita KUÇUKU Personalized Medicine Strategy Head, National Regulatory Authority of Vaccines Arunava Chakravartty & Immunobiological Products of Albania Data Sciences Team Leader, Asia National Center Drugs Control, Albania Unilever R&D. Complete Outsourced Pharmacovigilance Dealing with Multiplicity Issues When Operations, Database and Reporting Assessing Benefit in Targeted Sub- 24x7 Available Interaction Center populations - A Case-Study Femida Gwadry-Sridhar Vishwanath Iyer (Mahesh) Director, Health Informatics Head, Oncology Biometrics Lawson Health Research Institute Novartis Healthcare Technical Challenges in Large Safety Best Practices in Handling of Missing Implementation Data Including Use of Method of Multiple Anjani Kumar Jha Imputations Director Munish Mehra November Research Group President Global Alliance of Indian Biomedical Professionals1.00-2.00 pm Lunch AND Exhibit Visit
  9. 9. DAY 4 | sUNDAY, NOVEMBER 4, 2012 92.00-3.30 pm Closing Plenary sessionPersonalized Precision Medicine: Regulatory, Financialand Ethical Challenges to Ensuring its Growth (G.01 toG.04)SESSION CHAIR Student and IndustryCarol Isaacson BarashPrincipal, Helix Health Advisors Poster PresentationAdjunct Prof. Personalized Medicine, Regis College Regulatory Pitfalls in Getting IVDs and Companion Diagnostics FDA Approved Communication w the FDA This year for the first time under the Jeffrey N. Gibbs guidance of our Scientific Advisor – Posters, Director Dr. N. Udupa, Professor and Principal, Hyman, Phelps & McNamara, P. C. College of Pharmaceutical Sciences, Manipal, India, and Program Co-chairs Arun Mishra Nimita Limaye, PhD, Vice President, Tata Director, Global Regulatory Affairs Asia-Pacific, Japan, Emerging Markets Consultancy Services and Vishwanath GlaxoSmithKline Iyer, PhD, Head, Oncology Biometrics, Novartis Health Care, 15 selected students Shoibal Mukherjee from colleges and 15 selected Industry Vice President and Head professionals across India will get a once- Asia Medical Sciences Group Quintiles in-a life-time opportunity to present their research work to a diverse group of Nandini K. Kumar professionals who are actively involved Former Deputy Director General in the discovery, development, and life Sr. Grade Investigator NIH project cycle management of pharmaceuticals, National Institute of Epidemiology biotechnology, and health care related Femida Gwadry-Sridhar products. Director, Health Informatics Lawson Health Research Institute POSTERS Topics Sagar Kamarthi Posters will be presented on topics related Associate Professor Department of Mechanical and Industrial Engineering to: Northeastern University, Boston • Drug Discovery • Clinical Trials • Clinical Data Management • Medical Writing Thank you to our Supporters • Pharmacovigilance • Biostatistics • Bioinformatics • Regulatory Affairs level 2 To know more contact level 1
  10. 10. Registration Form/ INVOICE 7th Annual Conference - Meeting ID #12659 - November 1-4, 2012 - Hyderabad International Convention Center REGISTRATION FEES (Please tick the applicable fee) FOR dia members only FOR non members only basic rate taxes total basic rate taxes total Industry 9000 1112 q INR 10112 Industry 10000 1226 q INR 11236 Academia 4500 556 q INR 5056 Academia 6000 742 q INR 6742 Student 4000 494 q INR 4494 Student 4500 556 q INR 5056 FOR two day registration only tutorial basic rate taxes total basic rate taxes total Industry 8000 989 q INR 8989 Industry 3000 371 q INR 3371 Academia 4500 556 q INR 5056 Academia 3000 371 q INR 3371 Student 3000 371 q INR 3371 Student 3000 371 q INR 3371 Register 10 from your company and receive the 11th FREE! Contact Rhean D’Souza for details on or call +91.98.2058.7798Registration fee includes refreshment breaks, luncheons, and conference material. *Includes Membership. **A limited number of student registrations are available. A student is an undergraduate/ graduate who can document enrollment in a Signature accredited, degree granting, academic program. Please send completed registration form, copy of student identification, and payment.CANCELLATION POLICY:  Cancellations must be in writing and received on or before september 30, 2012.Registrants who do not cancel in writing by that date and do not attend the event will be responsible for the full registration fee paid. Registrants are responsible for cancel-ling their own hotel and airline reservations. If the event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants. Upon cancellation, theadministrative fee that will be withheld is: Industry - INR 6,000 | Academia/ Student - INR 3,500 | Tutorial - INR 3,371.(All refunds will be issued in the currency of original payment.) SUPPORTING & EXHIBITING OPPORTUNITIES Excellent opportunity to interact and network with the largest gathering of International and Indian Regulators and Pharma professionals in India. To know more on the this exhibit & showcase your products and services contact or call +91.98.1977.7493 REGISTRATION PROCESS Registration form should be duly filled and signed by the authorized person. You are requested to email the duly filled and signed registration form to first and then courier it along with registration fees within 5 working days. All registrations alongs with the registraion fees should reach DIA (Mumbai office) before the conference. For clarifications call Rhean D’Souza on +91.98205.87798 DELEGATE DETAILS (Please write all details in full caps)Please check the applicable category:    q 3 Days | q 2 Days - q Nov 2nd q Nov 3rd q Nov 4thq Academia  q Government  q Industry  q CRO q Non-Member   q Member : Customer ID No.: _______________ q Dr.  q Mr.  q Ms. First Name Last Name (Family Name) . Job Title Organisation/ Company/ Institute Name Address (Please write your address in the format required for delivery to your country.) q Business Address q Home AddressPostal Code City State Country Telephone Number Fax Number Mobile Numberemail (Required for confirmation) Authorised SignatoryPayment contact person’s Full Name Telephone Number Email Organisation PAN no. total payable amount Payment information MEETING CONTACTS Bank Details: MEETING MANAGER: Manoj Trivedi, Senior Manager Marketing and Program Development, DIA (India) Private Limited Beneficiary Account Number : 061010200024611 Cell: +91.98.1977.7493, Tel: +91.22.6765.3226, mail: Name of Account : DIA (India) Pvt Ltd Bank Name: AXIS BANK LTD. HOTEL RESERVATIONS Bank Address: Dhiraj Baug Near Hari Niwas Circle, LBS Marg, Thane (West) – 400602, Maharashtra, INDIA Attendees are responsible for their hotel & airline reservations. Novotel & HICC Complex is Swift Code: AXISINBB061 holding a block of rooms at the reduced rate mentioned below until September 30, 2012, for IFSC CODE : UTIB0000061 the DIA event attendees. Room availability at this rate is guaranteed only until this date or until Service Tax Registration #: AACCD8624N ST001 the block is filled. Permanent Account (PAN) # : AACCD8624N Single INR 7500 (Inclusive of taxes and breakfast) Cheque Details: contact: Burzin Patel email: Please send the completed form, along with draft/cheque made payable to Tel: +91.40.6613.4422; Fax: +91.40.6613.4322 DIA (India) Private Limited to: Rhean D’Souza, DIA (India) Private Limited Add: Novotel & HICC Complex (near Hitec City), PO Bag 1101, Cyberabad Post Office, A-303, Wellington Business Park, Andheri-Kurla Road, Marol, Andheri (East), Hyderabad - 500 081 Mumbai 400 059 India. Phone: +91.22.6765.3226