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CONFERENCE

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Clinical Trials in India and China

Strategies for planning, placing and implementing clinical trials in India & China

22nd - 24th October 2008, BSG Conference Centre, 226 - 236 City Road, London, EC1V 2TT, United Kingdom

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Background Info
Workshop
Day 1
Day 2
Partners
Past Papers

Platinum Sponsor

Associate Sponsors

Marketing Sponsors

Media Partners

Background Info

India and China, two of the world’s most populous countries and once considered difficult markets to enter, have taken significant strides as emerging markets in drug development. It is no coincidence over the last decade or more of economic liberalization, and years of unprecedented growth, that India and China are becoming a preferred clinical research destination for multinational pharmaceutical and biotechnology corporations. Cost-savings are a significant draw card for many pharmaceutical companies when deciding to outsource clinical research to countries in emerging markets such as India and China.

This event focuses on the real issues that matter when setting up trials in nontraditional countries. In today’s ultra-competitive marketplace, companies are pushing the limits for running trials in traditional countries. Learn from successful company stories that have relocated their operations to emerging companies and explore the challenges that are involved.

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:

• Summarise methods to make informed decisions about conducting clinical studies from a biopharmaceutical perspective
• Identify the data management, CMC supply chain, operational requirements and CRO infrastructure in India and China
• Discuss the regulatory requirements and implication of conducting these studies in India and China
• Explain government regulation and legal infrastructure in India and China
• 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 China, India and Latin America, and ways to overcome them?
• Explore innovative strategies for outsourcing, what you should be looking for in a CRO?
• What considerations are involved in writing and managing a sensible contract?
• How can you take advantage of the global market for clinical trials?

Key speakers:
• AstraZeneca
• Pfizer
• Lundbeck
• Excel-China
• Draco Healthcare
• TTC-LLC
• Good Clinical Practice Alliance
• Davies Arnold Cooper
• Excel PharmaStudies
• Fisher Clinical Services
• Lambda Therapeutics Research
• Institute of Clinical Research India

Who Should Attend?
Pharmaceutical, biotech and CROs, Directors and Heads of:
• Clinical Research and 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

Workshop

Pre-Conference Interactive Workshop:
Conducting clinical trials in China

Wednesday 22nd October 2008
Timings: 09:00 - 09:30 Coffee & Registration
09:30 - 15.30 Workshop

Led by: Linda Zhao, CEO, Draco Healthcare

Workshop Agenda
• Current market forces behind the healthcare industry in China
• What has changed and what changes are expected from the SFDA?
• How these changes will affect clinical trial operation efficiency and excellence in China
• The availability of high quality clinical trial sites
• Using epidemiology data strategically to dramatically improve clinical trial efficiency
• The current Good Clinical Practice guidelines in China
• Clinical trial applications for biologics, chemical drugs and natural products
- timeline and documents
- myth and truth

About: Draco Healthcare Consulting LLC
Draco Healthcare Consulting LLC is a California and Beijing dual-based consultancy focusing on the Chinese pharmaceutical industry. With the mission of “Better Medicine for Better Health in China”, Draco’s dedicated professional team of veteran healthcare consultants, experts on Chinese regulation environment of pharmaceutical and medical device, statistician and epidemiologist strives to provide enabling products and services to help clients business in China.

Selected consulting services by Draco include: access to care-marketing strategy of high-cost oncology drugs in China, distribution channels, pricing and reimbursement and sales partner selection as well CRO and clinical trial sites selections.

As a leading consultancy specializing in Chinese pharmaceutical industry, Draco also publishes China-focused multi-client reports. Main reports include the China Epidemiology Reports 2008 and China Hospital System Reports 2008. China Epidemiology Reports have detailed and updated patient population information on cancers (20 key cancers), infectious disease (five key diseases), CNS, cardiovascular diseases and respiratory system disease. China Hospital Systems have detailed information about China’s unique hospital systems, including its ranking by the government, healthcare insurance situation, costs of hospital visit and stays as well as who is (are) paying for the healthcare in China. These reports are marketed through world leading publishers Windhover and Plan A Inc separately. For more information, visit: www.dracohealthcare.com

Day 1

09:00 Registration and refreshments

09:30 Chair’s opening remarks

Francis P. Crawley
Executive Director
Good Clinical Practice Alliance

09:40 Examining the future market for clinical trials
• Identify the significance of the clinical trial in the current industry market
• Will there be a profit from an increase in usage of the new technology services?
• Is there a solid case for investment or is it just a gimmick?

Francis P. Crawley
Executive Director
Good Clinical Practice Alliance

10:20 Optimising return on investment (ROI) of multinational and domestic clinical trials in China
• How to choose the best strategies to ensure early involvement of China?
• How to discover an innovative model to overcome regulatory hurdles?
• How to build a high-performing global medical team to achieve desired objectives and results.
• Can replicating a global protocol for a Chinese clinical trial be a best practice in a rapid growing market?

Mark Engel
Chairman
Excel PharmaStudies

11:00 Morning refreshments & discussion

11:20 Presentation to be announced

Anand Bhogu
VP, Clinical Trial Management
Lambda Therapeutics Research

12:00 Accelerate oncology clinical development in Asia
• Key opportunities and challenges in oncology development in Asia-Pacific regions
• Incorporate Asia-Pacific countries into the global development plan
• Define key success factors in oncology development in Asian countries
• Select the optimal clinical sites for exploratory oncology trials

Alison McAdams
Associate Partner
Davies Arnold Cooper

12:40 Networking luncheon

14:00 Current trends in clinical outsourcing
• What are the current trends affecting growth in the contract drug development industry?
• The size and growth of R&D spending, in- and out-of-house
• Factors driving contract research strategy?
• Is clinical outsourcing more strategic than in previous years?
• Will the current trend to outsource clinical trials to Asia be successful?

Tommy Pedersen
Head of Clinical Data Operations
Lundbeck

14:40 Panel Discussion - Integrated R&D and high-value partnerships in India and China: A new paradigm for drug development
• Can you really outsource an entire project to Asia to extend your R&D capabilities?
• How are the business models changing?
• IP leakage - is this a legitimate concern?
• Risk-sharing deals versus higher value service deals

Moderator:
Francis P. Crawley
Executive Director
Good Clinical Practice Alliance
Panelists:
Tommy Pedersen
Head of Clinical Data Operations
Lundbeck

15:20 Afternoon refreshments

15:40 Grant Budgeting and Negotiating in India & China

Holly Squires
Senior Vice President
TTC- llc

16:20 Panel Discussion - Achieving global standard preclinical capabilities in China to supplement R&D efforts
• What are the current capabilities in efficacy/safety models, DMPK, in vivo pharmacology?
• Access to high quality animals for preclinical studies
• Finding the right talent pool of qualified toxicologists, pathologists, QA and lab animal experts
• Status of GLP compliant testing facilities
• Preparing for the clinic IND-enabling studies, formulation

Panelists:
Francis P. Crawley, Executive Director, Good Clinical Practice Alliance
Jim Worrell, CEO, AmeriStart

17:00 Chairperson’s closing remarks

17:10 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting.

Day 2

09:00 Coffee and registration

09:30 Chair’s opening remarks

Linda Zhao
CEO
Draco Healthcare

09:40 Clinical Trials in India- Bridging the gap between demand and supply of Human Resource
• Need for a trendsetting educational system to take on the load
• Demand and supply situation of human resource in the clinical trials industry in India
• Develop, train and engineer a revolution in the processes and delivery system
• Customised education to satisfy the large requirement of clinical research and healthcare professionals

Shiv Raman Dugal
Chairman
Institute of Clinical Research India

10:20 Conducting Phase III and IV trials in China: Practical considerations
• Regulatory and timing considerations
• Selection and management of sites
• Impact on future sales

Ellen Zhao
Director
Excel-China

11:00 Morning coffee & discussion

11:20 Best practices for managing a global clinical supply chain
• An overview on challenges in different regions
• Shipping directly or contracting with a local depot
• Creating a unified set of SOPs in a global company

Sean Smith
VP and General Manager
Fisher Clinical Services

12:00 Panel Discussion - Recent developments in the regulatory landscape for clinical trials in India
• What are the factors which are likely to affect the clinical trial industry in India.
• Is the government looking at allowing Phase 1 clinical trials in India?
• An analysis on the amendments to Schedule Y.
• Bills are soon to be proposed regarding ethical issues with clinical trials and clinical establishments in India.
• Does the government focus on making India a hub for global clinical trials?

Panelists:
Linda Zhao, CEO, Draco Healthcare
Jim Worrell, CEO, AmeriStart
Nermeen Varawalla, Vice President, PRA International

12:40 Networking luncheon

14:00 The current market forces at work in China
• What happened in 2007 and what changes are expected from the SFDA?
• How will this affect your clinical trial operation excellence?
• How will this affect your clinical trial operation excellence?
• The availability of high quality clinical trial sites and using epidemiological data strategically to dramatically improve trial efficiency
• What is the impact of patient segments (geographic and economic) to efficient clinical trial recruitments?
• Clinical Trial Application for biologics, chemical drugs and natural products timeline, procedure and documents required depending on what category your drug falls into.

Linda Zhao
CEO
Draco Healthcare

14:40 – Reviewing the BA – BE studies in India and an analysis on Phase 2 -3 studies.
• History of BA-BE studies in India
• The FDA in India: Auditing BA-BE CROs
• GCP / GLP by Indian BA-BE CROs
• Cost Advantages of Indian CROs vs American CROs
• The Regulatory Process for conducting BA-BE Studies in India
• Timing of the Studies
• Potential Land Mines to Avoid

Jim Worrell
CEO
AmeriStart

15:20 Afternoon tea

15:40 Current challenges in conducting clinical research in India
• Overall growth of clinical research in India
• Identify key trends
• Identify regulatory, site and ethics challenges
• Case studies

Chandrashekhar Potkar
Director, Medical and Regulatory Affairs
Pfizer

16:20 – Best practice in leveraging China for global development.
• Why China is a "must have" in drug development program?
• Establishing development capabilities in China
• Overview of regulatory process for clinical trial application in China

Joanne Jiang
Vice President
Fountain Medical Development

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 pharmaceutical and healthcare industries. With $1.8 billion in 2005 revenue and more than 50 years of industry experience, IMS offers leading-edge business intelligence products and services that are integral to clients’ day-today operations, including portfolio optimisation capabilities; launch and brand management solutions; sales force effectiveness innovations; managed care and over-the-counter offerings; and consulting and services solutions that improve ROI and the delivery of quality healthcare worldwide. For further information please visit: www.imshealth.com

Associate Sponsors:

Lambda Therapeutic Research Limited
Lambda Therapeutic Research Limited is a leading international private-owned, professionally managed, full-service CRO with state-of-the-art Phase I-IV facilities in INDIA and Warsaw / POLAND. Lambda has over 550 employees. Since its inception in the year 1999 by experienced pharmaceutical professionals, Lambda has grown in various segments over the years. Recently in May 2007 Lambda acquired two Polish CROs in Warsaw.

Services offered by Lambda Therapeutic Research Limited:
• Phase-I Units
• Clinical Trials – Phase II to Phase IV units in India and Poland
• Central Clinical Laboratory services
• Bio-analytical Laboratory services
• Data Management Services
• Drug and Supply Storage and Logistics

Clinical Trials Phase II – IV
Since 2003, Lambda has been performing clinical trials in phases II - IV on behalf of its domestic and international clients. The Clinical Trial Management Department is based at our Head office in Ahmedabad, and has additional staff based in Mumbai, Chennai and in Warsaw (Poland). Lambda has a team of 54 experienced professionals working in Clinical Trials Management, Site Management, Clinical Monitoring and Medical Monitoring. Additionally, to support global clinical trials, Lambda also has Strategic Partnership Agreements in place with experienced CROs in different geographies. Visit us at www.lambda-cro.com

Fountain Medical Development Corp.
Fountain Medical Development Corp. is a contract research organization (CRO) offering a full range of ICH GCP compliant clinical research services for multinational clients conducting clinical research in China. The management team of Fountain has decades of combined experience working with the world’s leading CRO’s and drug developers. In the Chinese CRO market, we fill the void of a service provider that balances high quality with moderate cost. Our extensive global experience in multiple therapeutic areas is unmatched by other local CRO’s, and our lower operational cost allows us to pass significant savings on to our clients. For further information please visit: www.fountainmed.com

D2L Pharma Research Solutions
D2L Pharma Research Solutions is an India based leading Clinical Research & Pharma Consulting service provider to multinational Pharmaceutical/Biotech companies.

D2L's core focus under Clinical Research is Site Management Services (D2L-SMO) & Clinical Data Management (D2L-CDM). D2L-SMO operates on a unique model of ‘Multi-site, Multi-specialty SMO”. D2L-CDM works on fully integrated clinical data management solutions.

Our Consulting Division has more than 50 years of cumulative experience in US, EU and Asia-Pacific markets. Our core expertise areas are Market Research, KOL Identification & Management, Competitive Intelligence, Sales Forecasting, Sales Force Effectiveness, Market Assessment, Epidemiology, Dashboards & Tools, eCME & Promotional Material Development etc.

Get to know more about us at: d2lpharma.com; d2l-smo.com

Marketing Sponsors:

InCROM CHINA
InCROM CHINA, a leading SMO/CRO in China with its head office located in Shanghai and branch offices in Beijing, Guangzhou and Chengdu, was established in 2003 as an owned subsidiary of InCROM Group. Its vast affiliated network consisting of over 30% (64 as of May 2008) of all SFDA approved clinical trial facilities (spread out in 16 provinces) and 9 laboratories, continues to expand rapidly. InCROM CHINA provides comprehensive clinical services as well as consulting services such as marketing research. Since its establishment, InCROM China has completed over 40 projects for various domestic and global companies, including a few top global pharmas. For further information please visit: www.incrom.com

BTG
BTG in-licenses, develops and commercialises pharmaceuticals and has a broad pipeline of development programmes targeting neurological and other disorders including varicose veins. The company also has a substantial and growing revenue stream of milestone payments and royalties from out-licensed products. BTG has expertise in developing novel NCE programmes and repositioned or reprofiled compounds. We are actively seeking to develop long-term relationships with potential partners in order to strengthen our clinical development pipeline. We review and determine the optimum development strategy for each programme we acquire, undertaking the development alone or in collaboration, and are interested in hearing from companies with high quality programmes within, Neurological Disorders, Pain Therapeutics and Sleep Disorders. BTG operates from offices in London, Philadelphia and Osaka. For further information please visit: www.btgplc.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

Pharmalicensing
Pharmalicensing is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting in- and out-licensing activities, Pharmalicensing provides partnering services, business development reports and industry news. For further information please visit pharmalicensing.com

ClinicalTrials.net
ClinicalTrials.net is the new web information portal dedicated to the world of Clinical Trials. With news headlines updated on a daily basis, the unique mix of current trials, events, scientific posters and resources makes this a one-stop-shop for essential information.

If you would like information on the range of sponsorship or exhibition possibilities for this conference, please contact:

Aamir Rana: +44 (0)20 75499934
Sara Mathieson: +44 (0)207 75499948

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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