Drug Information Agency (DIA) Kapil Khandelwal QuoteUnquote with KK www.kapilkhandelwal.com

1. 7th Annual Conference
Discovery through Commercialization:
Innovative Strategies for Individualized Health Care
November 1-4, 2012
ID #12659 | Hyderabad International Convention Center
PROGRAM ADVISOR Keynote Speaker PROGRAM CO-CHAIRS
Narges Mahaluxmivala
Senior Consultant
Clinical Development Research
CHAIR ADVISORY COUNCIL OF INDIA
Larisa Nagra Singh
VP Global Functional Resourcing, Asia
Quintiles, Singapore
PROGRAM COMMITTEE
Albinus D’Sa
Deputy Country Director
US FDA, India
Munish Mehra Paul Huckle Nimita Limaye, PhD Vishwanath Iyer, PhD
President Senior Vice President, Vice President Head, Oncology Biometrics
Global Regulatory Affairs Tata Consultancy Services Novartis Health Care Pvt Ltd
Global Alliance of Indian Biomedical Professionals
GlaxoSmithKline
USA
Baljit (Boo) Samra
Vice 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 patient
V. N. Balaji responsiveness. This necessitates changes in the way every aspect of the health care industry, from
Consultant, Discovery Research discovery through development, manufacturing, and finally commercialization operate.
Nikhil Kumar
President 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 for
Tal Burt, MD
drug discovery and clinical development pipeline and faster time to market in the era of blockbuster
Scientific Director
Duke Global Proof-of-Concept (POC) Research patient expiries and issues of integrating and streamlining data flows across the entire life cycle of
Network the molecule, and the standardization and rigor that needs to be implemented. It will also stress upon
Duke Clinical Research Unit (DCRU) & the ethical, legal, social and regulatory and financial and investments challenges impacting all of the
Duke Clinical Research Institute (DCRI), USA above and how processes and technology will need to be upgraded to support the same.
Carol Isaacson Barash
Principal, Helix Health Advisors PROGRAM HIGHLIGHTS
Adjunct Prof. Personalized Medicine, Regis College
• Discovery: Bioinformatics, Next Gen payor challenges, Go-to-investors and
R. B. Smarta
Founder and Managing Director Sequencing, Lead optimization – the need financial/partnering strategies for product
Interlink Marketing Consulting Private Limited, India for speed development
• Development: Barriers and drivers relevant • Regulatory, ethical, social and legal
Kapil Khandelwal to clinical development across clinical issues: data privacy and consent issues
Venture Capitalists & Independent Board Member operations, data management, biostatistics, in the evolving technologies related to
programming, and medical writing, personalized medicine
Helle Gawrylewski
highlighting systems biology paradigm • Technology and Standards: Technology –
Senior Director, Regulatory Medical Writing
Janssen 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, GRC
Uday 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, clinical
SCIENTIFIC ADVISOR - POSTERS • Commercialization: Health economics operations and site performance. Driving the
N. 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. tutorials | DAY 1 | THURSDAY, NOVEMBER 1, 2012 2
9.00-12.00am 2.00-5.00pm
QbD: A Challenge to the Pharma Industry (MR 1.01) Bioinformatics (MR 1.01)
instructors instructor
V. Venkateswarlu Sangeeta Sawant
Vice President, Functional Head of Formulation Development, Assistant Professor (Reader),
Bioequivalence and Clinical Pharmacokinetics Bioinformatics Center, University of Pune
Packaging 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 component
R. Manikandan of research and education in life sciences. Having originated
Associate Director, Formulation Development as a set of computational tools to analyze biological data such
Dr. Reddy’s Laboratories as biomolecular sequences and structures, Bioinformatics now
deals with computational processing and analysis of large sets
Quality by Design is defined as a systematic approach to of complex data being churned out from advanced and high
development that begins with predefined objectives and throughput technologies such as DNA micro-arrays, whole
emphasizes product and process understanding and process genome sequences, proteomics data, protein-protein interactions
control, based on sound science and quality risk management. etc. A large variety of mathematical algorithms and statistical
The important stake holders involved in this process are Patients, techniques are employed for data analysis.
industry and regulators. For Patients it is quality, efficacy and
safety, 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 their
regulatory oversight. Integrating these aspects is a question molecular functions on one hand and provide insights into
to industry and regulator and hence it is a challenge to the systems level biology through analysis of voluminous genomic
pharm world. The reason for calling it as challenge because the or proteomic data. The paradigm shift from molecular level
twenty-first century began with the pharmaceutical industry studies in life sciences to systems biology, genotype-phenotype
using development approach (empirical) and manufacturing correlations, insights into health and disease states, etc. is being
technologies that have been employed since the 1940’s. No greatly accelerated by bioinformatics applications
significant changes in manufacturing process is made until it
justify 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 introduce
result, the FDA (Food and Drug Administration) have embrace a sequence-based approaches: What can be achieved by using
new paradigm for regulation through Quality by Design. the sequence analysis methods
• To introduce structure-based approaches: What can be
The FDA belief is that, quality cannot be tested into products, achieved by analyzing structures of biomolecules
but should be built-in or by design. The important elements • An overview of applications of bioinformatics-based methods
that will enable to institutionalize this includes, Quality target in various life science areas such as drug design, genetics
product 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 is
also well enumerated in ICH guidelines Q8, Q9, Q10 and Q11. 2.00-5.00pm
Therefore Implementation of QbD will enable transformation of Personalized Medicine (MR 1.02)
the chemistry, manufacturing, and controls (CMC) review of new
instructorS
drug 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 Director
As 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 College
that is in response to the increasing cost pressures on both the
regulatory agencies and industry. QbD will evolve as we continue It is an introduction to the field of personalized medicine and
to 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 and
Learning 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. DAY 2 | friDAY, NOVEMBER 2, 2012 3
8.15-9.00 am REGISTRATION
9.00-9.15 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 SESSIONS
Session 1 - DISCOVERY 1 Session 2 - Commercialization 1 Session 3 - Technology & Standards 1
Target Discovery (G.01) Health Economics and Valuation Technology for Personalized
SESSION CHAIR (Hall 1 & 2) Medicine — SOA, the Cloud and the
V. N. Balaji SESSION cHAIR Future (G.02)
Consultant Shashidhar Rao SESSION CHAIR
Discovery 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 Manoj.Trivedi@diaindia.org or call +91.98.1977.7493.

4. DAY 2 | friDAY, NOVEMBER 2, 2012 4
2.00-3.30 pm CONCURRENT SESSIONS
Session 4 - Development 1 Session 5 - Commercialization 2 Session 6 - Outsourcing 1
Public 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 cHAIR
of Clinical Research in India (G.01) SESSION cHAIR Baljit (Boo) Samra
SESSION CHAIR Ranga Iyer Corporate Vice President &
Country Manager, India
Tal Burt Healthcare Consultant
PAREXEL International
Scientific Director
Sizing the Opportunity, Market Driven
Duke Global Proof-of-Concept (POC) Evolution of Outsourcing Models in
Commercialization of Products
Research 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 Epidemiology
3.30-4.30 pm Tea Break, Poster & Exhibit Visit
4:30-6:00 pm CONCURRENT SESSIONS
Session 7 - Regulatory 1 Session 8 - Lean SIX SIGMA 1 Session 9 - PV 1
Regulatory, Ethical & Social Policy Lean Six Sigma — Patient Safety - A Well Rounded
Issues in Personalized Medicine: Pharmacovigilance, Site View from the Stakeholders (G.02)
Discovery to Clinic (Hall 1 & 2) Performance and Clinical Operations SESSION cHAIR
SESSION CHAIR (G.01) Vivek Ahuja
Carol Isaacson Barash SESSION Co-cHAIRs Director, Pharmacovigilance - Asia Pacific
Principal, Helix Health Advisors Baxter Healthcare
Nimita Limaye
Adjunct Prof. Personalized Medicine Vice President Outsourcing Pharmacovigilance
Regis 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 Research
6.00 pm Day End

5. DAY 3 | saturday, NOVEMBER 3, 2012 5
9.00-10.30 am CONCURRENT SESSIONS
SESSION 10 - Discovery 2 Session 11 - Commercialization 3 Session 12 - Manufacturing 1
Lead Discovery (G.01 & G.02) Go to Investors (G.03 & G.04) Manufacturing (G.05 & G.06)
SESSION cHAIR SESSION cHAIR SESSION cHAIR
Raman Govindarajan R. B. Smarta SC Singhai
Head R&D Founder and Managing Director Vice President - Tech Transfer
Sanofi 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’s
10.30-11.30 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: Rhean.Dsouza@diaindia.org

6. DAY 3 | saturday, NOVEMBER 3, 2012 6
11.30 am-1.00 pm CONCURRENT SESSIONS
Session 13 - Development 2 Session 14 - Lean SIX SIGMA 2 Session 15 Manufacturing 2
Evolving Roles of Personnel Lean Six Sigma — Medical Writing Manufacturing (G.05 & G.06)
Involved in Clinical Trials — Panel (G.03 & G.04) SESSION cHAIR
Discussion (G.01 & G.02) SESSION Co-cHAIRs Subir Basak
SESSION CHAIR Nimita Limaye President
Vice President Jubilant Biosys
Sam Mathew
Tata Consultancy Services
Process Lead-Medical Writing Pharmacogenomics for Personalized
Accenture 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
Novartis
1.00-2.00 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
Manoj.Trivedi@diaindia.org or call +91.98.1977.7493

7. DAY 3 | saturday, NOVEMBER 3, 2012 7
2.00-3.30 pm CONCURRENT SESSIONS
Session 16 - Discovery 3 Session 17 - Regulatory 2 Session 18 - Technology & Standards 2
Pre-clinical Discovery and Scientific, Regulatory and Data and Semantic Interoperability
Development (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 CHAIR
Head, Oncology Biometrics SESSION CHAIR Nikhil Kumar
Novartis 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 Consulting
3.30- 4.30 pm Tea Break AND Exhibit Visit
4:30-6:00 pm CONCURRENT SESSIONS
Session 19 - Development 3 Session 20 - Therapeutics 1 Session 21 - Manufacturing 3
Current Challenges in Clinical Therapeutics — Pharmacology and Panel discussion
Development in India (G.01 & G.02) Applications in Personalise Medicine Panel Discussion on Regulatory in
SESSION CHAIR (G.03 & G.04) Manufacturing (G.05 & G.06)
Vishwanath Iyer (Mahesh) SESSION cHAIR panelists
Head, Oncology Biometrics Vishwas Sovani
Novartis 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
Quintiles
6.00 pm Day End

8. DAY 4 | sUNDAY, NOVEMBER 4, 2012 8
9:00-10:30 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 Rhean.DSouza@diaindia.org
Chairman & Managing Director
Medanta- The Medicity
10.30- 11.30 am Tea Break AND Exhibit Visit
11.30 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
Professionals
1.00-2.00 pm Lunch AND Exhibit Visit

9. DAY 4 | sUNDAY, NOVEMBER 4, 2012 9
2.00-3.30 pm Closing Plenary session
Personalized Precision Medicine: Regulatory, Financial
and Ethical Challenges to Ensuring its Growth (G.01 to
G.04)
SESSION CHAIR Student and Industry
Carol Isaacson Barash
Principal, Helix Health Advisors Poster Presentation
Adjunct 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
Rhean.Dsouza@diaindia.org
level 1

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 Rhean.Dsouza@diaindia.org or call +91.98.2058.7798
Registration 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, the
administrative 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 Manoj.Trivedi@DIAIndia.org 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
rhean.dsouza@diaindia.org 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 4th
q 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 Address
Postal Code City State Country
Telephone Number Fax Number Mobile Number
email (Required for confirmation) Authorised Signatory
Payment 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: Manoj.Trivedi@diaindia.org
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: bkpatel@hicc.com
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