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CONFERENCE

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Clinical Trials in Asia Summit 2009

Determining the prospective strategies for Implementing Clinical trials in India & South Asia - Today's Hottest Market

18th - 20th May 2009, The Park, New Delhi, India

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Background Info
Workshop
Day 1
Day 2
Partners
Past Papers

Platinum Sponsor

Silver Sponsor

Associate Sponsor

Media Partners

Background Info

India has all the competitive advantages for conducting clinical trials. As the country is increasingly becoming a favored destination for clinical trials, a gap analysis needs to be done to scale up all resources for clinical trials. This scale up is essential for India to cope with the large global clinical trial projects. It is no coincidence over the last decade or more of economic liberalization, and years of unprecedented growth, that India and parts of South Asia are becoming a preferred clinical research destination for multinational pharmaceutical and biotechnology corporations.

Clinical Trials Summit 2009 will discuss the on-going pressing concerns faced in clinical trials operations, addressing the risks, timeline and budget constraint, whilst effectively tackling key challenges in overcoming trials agreement and site contract negotiation hurdles. This year, the operational element of trial site management, strategic partnership with CROs and SMOs, patient, talent & investigators management will be discussed in order to improve and optimize the overall drug development effectiveness and ROI. Find out how to implement and benefit from electronic data management & monitoring cost effectively. This event will be shared by leading industrial practitioners across the region to promote practical discussions; especially on the know-how to manage needs, variability of different countries and institutions to enhance clinical operational excellence and vigilance. Delegates will have the opportunity to learn, network and benchmark against the global top pharmas and local industry leaders on the best practices in talent, site, budget and performance management in clinical trials. The conference aims to provide a detailed analysis of what it takes to conduct clinical trials from a biopharmaceuticals and vaccines perspective in India and China and also addressing risk/benefit balance, anecdotal experiences of the multinational pharmaceutical industry in India and China, selection and role of CROs, logistics of operations, clinical trials management, government policies (including IPR issues) and pharmacovigilance.

Reasons to register today:
• How can you take advantage of the global market for clinical trials?
• Improving and optimizing site management and overall productivity of clinical operations
• Optimising clinical trials operation effectiveness and ROI through strategic site, patient, data and risk management in the regulated markets
• Identify the data management, CMC supply chain, operational requirements and CRO infrastructure in India and South Asia
• Gaining insights on future forwards of clinical trials and valuing its potential
• Discover how to improve your supplier-client relationships
• Complete trials on schedule and budget by learning to overcome hurdles in investigator/patient recruitment
• What are the issues with off-shoring trials to countries such as India & South Asia? What are the ways to overcome them?
• Explore innovative strategies for outsourcing, what you should be looking for in a CRO?
• Working with limited budget to ensure on time study completion
• Escalating patient recruitment and improving patient retention to save cost and reduce lead-time
• Maximizing trials results through overseas multinational/multi-centric trials
• Avoiding potential pitfalls of trials agreement
• Motivating and managing clinical project teams to improve timeline and progress

Key Speakers
• Chandrashekhar Potkar, Director, Medical and Regulatory Affairs, Pfizer, India
• Viraj Rajadhyaksha, Senior Manager, Operations, Planning & Mgmt Clinical Research, Pfizer, India
• Rajesh Karan, Regional Head of Translational Medicine & Scientific Operations, Novartis, India
• Anirban Roy Chowdhury, Clinical Research Manager, AstraZeneca, India
• Subbaraju Sagi, Senior Sales Consultant,Oracle Health Sciences
• Cheryl Townsend, Director, Regional Operations, George Institute for International Health
• Celestine Juliet, Project Manager, Cipla
• B. Priya, Clinical Operations Manager, Novotech Clinical Research India
• Krathish Bopanna, Senior Vice President, Acunova
• Paula Mumby, Director, i3 Pharma Resourcing
• Guljit Chaudhri, Sr. Advisor, i3 Research
• Milind Antani, Head-Pharma LifeSciences group, Nishith Desai
• Arun Bhatt, President, Clininvent Research
• Arani Chatterjee, Vice President, Clinical Research, Panacea Biotec

Who should attend?
From pharmaceutical, biotech and CRO’s: Directors and Heads of:
• Clinical Research & Development
• Clinical Research Services
• Clinical Operations
• Clinical Data Management
• Clinical IT
• Clinical Trials
• Medical Affairs
• Regulatory Affairs
• Compliance
• Quality Control/Assurance/GCP
• Clinical Study Design
• Safety Surveillance
• Subject Recruitment
• E-Clinical Systems

Location
The Park, New Delhi
15 Parliament Street, New Delhi, 110001
Tel: +91 011 2374 3000 Ext 1902, Fax: +91 11 233629320

Workshop

Pre-Conference Interactive Workshop
Conducting Clinical Trials in India: Achieving Evolving Sponsor Expectations

Monday 18th May 2009

Workshop leader - Senior representative, GVK BIO

Timings: 09:30 - 10:00 Registration & refreshments
10:00 - 16:00 Workshop
Timing includes lunch and refreshment breaks

Morning Session:
Conducting Clinical Trials in China
• Regulatory process in China
• Conducting clinical studies in China: global studies vs. local registration trial
• China and India: collaboration and competition

Afternoon Session:
Conducting Clinical Trials in India: Achieving Evolving Sponsor Expectations
• Protocol and study design customized for the Indian healthcare environment
• Investigator and site selection
• Smooth study start up
• Site support
• Delivering value beyond cost and time savings

Day 1

Day 1, Tuesday 19th May 2009

09:00 Registration and refreshments

09:30 Chair’s opening remarks

Chandrashekhar Potkar
Director, Medical and Regulatory Affairs
Pfizer, India

09:40 Examining the future market for clinical trials
• How can you take advantage of the global market for clinical trials?
• Identify the significance of the clinical trial in India and South Asia market
• Emerging technologies that can be deployed to generate revenue
• How to build a high-performing global medical team to achieve desired objectives and results.

Nermeen Varawalla
Vice President, Scientific & Medical Affairs
PRA International

10:20 Evaluating key emerging markets for improved strategy
• Which emerging markets are hottest today?
• Which markets are next?
• What makes each market unique and how do markets compare?
• What are the challenges and risks of each market?
• Who is operating in each market?

Krathish Bopanna
Senior Vice President
Acunova

11:00 Morning refreshments & discussion

11:20 Clinical trial management: enabling operational efficiency
• New challenges call for new approaches
• Technology as the Enabler of High Performance - The Place of Clinical Trial Management Systems
• Implementation of a Clinical Trial Management System
• Clinical Trials Management of the Future
• Clinical Trial Management Systems in the Wild

Subbaraju Sagi
Senior Sales Consultant
Oracle Health Sciences

12:00 Enhancing staff performance in multinational/multi-centered trials
• Structure of existing system for training and monitoring staff performance
• What are the common problems of staff monitoring and effective solutions
• Strategies to cope with high staff turnover rate to minimise cost for your trials

Paula Mumby, Director, i3 Pharma Resourcing
Cheryl Townsend, Director, Regional Operations
George Institute for International Health

12:40 Networking luncheon

14:00 Clinical Trial Registry - India (CTRI)

Pandey Arvind
Director
Institute of Research In Medical Statistics

14:40 Exploring collaborative opportunities and clinical trial partnership
• Identifying the anticipated advantages of a collaborative clinical trial alliance for greater efficiency
and cost reduction
• Developing programs for successful partnership
• Utilising thought leader networking

Viraj Rajadhyaksha
Senior Manager, Operations, Planning & Management Clinical Research
Pfizer, India

15:20 Afternoon refreshments

15:40 Country and site selection for global clinical trials
• When does patience recruitment get difficult and how can this issue be overcome?
• Determine the challenges in determining where, when and how to expand clinical operations
• How should you make your decision and implement your global expansion plans successfully?

Anirban Roy Chowdhury
Clinical Research Manager
AstraZeneca, India

16:20 Panel Discussion: Overcoming regulatory challenges in Asian clinical trials
In this session, country representatives will gather to share various challenges experienced when conducting clinical trials in their respective countries. The audience will be given an opportunity to address pressing concerns they have with their existing and/or prospective trials
in these countries.

Moderator:
Chandrashekhar Potkar, Director, Medical and Regulatory Affairs, Pfizer, India
Panellists:
Milind Antani, Head-Pharma LifeSciences group, Nishith Desai
Viraj Rajadhyaksha, Senior Manager, Operations, Planning & Management Clinical Research, Pfizer, India

17:00 Offshoring - Balancing the right opportunities and risks
• Exploring potential operational challenges and strategies for managing offshore trials
• Outsourcing an entire project to Asia to extend your R&D capabilities?
• Risk-sharing deals versus higher value service deals

Celestine Juliet
Project Manager
Cipla

17:40 Chairperson’s closing remarks

17:50 Networking drinks reception
Take your discussions further and build new relationships in a relaxed and informal setting.

Day 2

Day 2, Wednesday 20th May 2009

09:00 Registration and refreshments

09:30 Chair’s opening remarks

Arani Chatterjee
Vice President
Clinical Research Panacea Biotec

09:40 Opportunity trials of clinical research in India: focusing on phase I and phase II
• A review of the clinical research environment in India
• A focus on existing business models conduct clinical trials in India
• An evaluation of the opportunities of potential collaborations

Rajesh Karan
Regional Head of Translational Medicine & Scientific Operations
Novartis, India

10:20 Conducting phase III and IV trials in China: practical considerations
• Discuss the common misconceptions and pitfalls
• Regulatory and timing considerations
• Selection and management of sites
• Impact on future sales

11:00 Morning refreshments & discussion

11:20 Avoiding mistakes in selecting an outsourcing partner to conduct clinical trials
• What is the range of opportunities?
• Cut through the hype and learn how to evaluate service providers to avoid choosing the wrong one.
• How is India a host to reputable, reliable suppliers?
• What to look for in order to make the right decision and avoid major, costly mistakes?
• Will the current trend to outsource clinical trials to Asia be successful?

12:00 Rising cost of clinical trials in Asia
• Diverse socio-economic situation in Asia
• Drivers of cost competitiveness in Asia
• Challenges linked to the increase of clinical research activity in Asia and consequences on cost
• Effective Planning and Negotiating your Budgets with Partners

Guljit Chaudhri
Sr. Advisor
i3 Research

12:40 Networking luncheon

14:00 Conducting global clinical trial in government infrastructure

B. Priya
Clinical Operations Manager
Novotech Clinical Research India

14:40 Best practices for engaging regulatory authorities in Asia
• What are the recent regulatory changes and the changes in the pipeline?
• Reporting issues ( Adverse reactions/SUSARS etc)
• What are liabilities in clinical research?
• Reviewing the general regulatory issue (POA etc)
• An analysis on advertisement/marketing issues

Milind Antani
Head-Pharma LifeSciences group
Nishith Desai

15:20 Afternoon refreshments

15:40 Challenges of Project Management in India

Arun Bhatt
President
Clininvent Research

16:20 Panel Discussion – SWOT Analysis
• Strength, Weakness, Opportunities & Threats of the clinical trials in the India & South Asia. (An overall analysis of this three day event)

Moderator:
Arani Chatterjee, Vice President, Clinical Research Panacea Biotec
Panelists:
Krathish Bopanna, Senior Vice President, Acunova
Subbaraju Sagi, Senior Sales Consultant, Oracle Health Sciences

17:00 Chairperson’s closing remarks and end of conference

Partners

Platinum Sponsor

IMS Health
Operating in more than 100 countries, IMS Health is the world’s leading provider of market intelligence to the pharmaceutical and healthcare industries. With $2.2 billion in 2007 revenue and more than 50 years of industry experience, IMS offers leading-edge market intelligence products and services that are integral to clients’ day-to-day operations, including portfolio optimization capabilities; launch and brand management solutions; sales force effectiveness innovations; managed care and consumer health offerings; and consulting and services solutions that improve ROI and the delivery of quality healthcare worldwide. For further information please visit: www.imshealth.com

Silver Sponsor:

Oracle
Oracle is a leading strategic software solutions provider to the health sciences industry. Oracle Health Sciences helps pharmaceutical, biotechnology, medical device, and healthcare organizations become the most successful in the world by offering the most innovative products and services that deliver the most compelling customer and shareholder value. Addressing industry requirements, Oracle provides comprehensive solutions including clinical trial management and analysis, electronic data capture, adverse event reporting and pharmacovigilance applications. Oracle partners with health sciences industry leaders – including the top 20 life sciences companies – to prevent and cure disease and enhance quality of life and accelerate insights for better health. For further information please visit: www.oracle.com

Associate Sponsor:

i3 Pharma Resourcing India
i3 is a pharmaceutical services company, providing integrated scientific strategies and solutions throughout the pharmaceutical product lifecycle. It is composed of i3 Pharma Resourcing, a world-class staffing partner; i3 Research, a therapeutically specialized contract research organization; i3 Drug Safety, engaged in pharmacovigilance and epidemiology; i3 Pharma Informatics, a data, science and technology provider of market analytics; i3 Statprobe, a leader in comprehensive data services; and i3 Innovus, delivering the science and solutions to achieve marketplace success. i3 helps companies gain sharper insights that lead to better patient care. For further information, please visit www.i3global.com

Media Partners:

PharmiWeb.com
PharmiWeb.com is the leading industry-sponsored portal for the pharmaceutical sector. Supported by most of the leading pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features, events listings and international jobs to industry professionals across Europe and the US. For further information please email: corporate@pharmiweb.com

BIOTECHNOLOGY EUROPE
BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. It is based and located in Warsaw, Poland. Biotechnology World was founded in 2007 to provide the world’s biotech and pharma information and market to make it universally accessible and useful for scientific and business processes. Its first step to fulfilling that mission was building the BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers companies completed internet public relations, publication and marketing solutions. One of the main goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector in Europe to global biotechnology, pharmaceutical and life science activities. For further information please visit www.biotechnology-europe.com

Future Pharmaceuticals
Future Pharmaceuticals has forged powerful relationships with key industry leaders to provide a platform for successful brand recognition, and for senior decision-makers to have the means to procure and plan implementation strategies based on the topics covered. Positioned to be an authoritative resource within top pharma companies as well as small, specialty, and biotech, Future Pharmaceuticals magazine is geared to create a deep penetration into a highly targeted and responsive audience, bridging the gap between the industries' top issues and the solutions top-tier vendors can provide. For further information, please visit www.futurepharmaus.com

InPharm
InPharm is the online platform for exclusive pharmaceutical news, comment, contracts, services, jobs and events and is home to InPharmjobs.com, Pharmafile and Pharmafocus. For further information please visit: www.In-Pharm.com

Espicom
Espicom has been a respected provider of pharmaceutical information for over 25 years. Over twenty titles/services span the industry from comprehensive newsletters in key areas such as cancer drugs, drug delivery and generics to in-depth company/ market reports. Espicom’s specialist online services are used daily by leading manufacturers and service companies. For further information please visit: www.espicom.com

Outsourcing-Pharma.com
Outsourcing-Pharma.com is the only free online news source covering the full spectrum of contract services to the pharmaceutical and biotechnology industries, from contract research and development through to manufacturing and commercial services. The emphasis of the publication is on practical news and information, which can be used by senior managers in the day-to-day running of their businesses. For more information, please visit www.outsourcing-pharma.com

If you would like more information on the range of sponsorship or exhibition possibilities for this conference, please contact:
Patricia Gallegos, +44 (0)20 7549 9952

Past Papers

Past papers are free to delegates. If you are unable to attend the event, Past Papers are published two weeks after the event and are available to purchase.

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