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Register by September
29th and Save up to $200!
Day Two: Tuesday, October 31
7:45 am Morning Coffee (Breakfast Workshop
Sponsorship Available)
8:00 am Chairperson’s Remarks
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Featured
Presentation
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8:15 am Accessing Talent & Leveraging
Resources
Thomas Hooker Bliss, Jr., Director of Licensing, Amgen Inc.
Although China’s emergence as a life sciences center is thought of
as a recent phenomenon, it is actually the culmination of more than 25
years of events. International companies are just beginning to realize the
potential value from incorporating China into their global operating
models. The audience will learn how to appreciate China’s emergence in a
broader context in terms of time and a more specific context in terms of life sciences. Building on macro numbers and conventional wisdom, I will look at the talent trends that help explain the current status and help forecast China’s future role in life sciences.
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8:45 am
Charles Hsu, Ph.D., MBA, Venture Partner, Pappas Ventures; CEO,
Eureka! Pharmaceuticals
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9:15 am
Building an Integrative R&D Service Company in China
Angela Wong, Ph.D., Vice President, Service Biology, WuXi PharmaTech
WuXi PharmaTech located in Shanghai is the largest supplier of chemistry services in China. Recent expansion of PharmaTech’s services is in the biological sector including DMPK, ADME/tox and bioanalytical analyses. The company’s goal is to become a strategic, long term partner for its clients where it can be counted on to complement their drug discovery whether it is in chemistry, biology preclinical development or large scale API/intermediate production.
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Reasons and strategies to become a fully integrated R&D service company
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What are the challenges?
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How to balance risk and opportunities?
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9:45 am Networking Coffee Break (Sponsorship
Available)
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10:15 am Preclinical Testing in Lab Animals: Lab Animal Welfare, Facility, Accreditations and Information on Achieving all these in the Best Possible Time with Limited Resources
Suresh Poosala D.V.M., M.S. Ph.D., Chief of Comparative Medicine and Animal Program Director, NIA/NIH
This talk will bring forth the requirements to be met by a lab animal facility that undertakes preclinical pathology and toxicology trials. For a potential drug to be tested and submitted for a regulatory agency's approval, animal testing is critical and involves time and money. Lab animal facilities have to pass several standards of testing during the course of the initial set-up and have to maintain these standards to continue to get accredited. There are numerous ways to achieve this in a timely manner. Also, the notion that the best lab animal facilities cost the most is wrong. In this regard, there are ways to minimize the expenses to run a lab animal facility without compromising on the standards. State-of-the-art methods, which include novel and innovative ideas, will be presented along the lines of what is expected of a good animal facility to meet the preclinical testing standards.
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Lab animal accreditations and regulations - meeting the standards for animal welfare
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Animal Care and Use Committee - establishing and approving ASPs - What the USA expects
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Simple ways to establish animal facilities and associated laboratories for preclinical testing
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10:45 am Establishing Preclinical Development Operations in China
John B. Stoudemire, Ph.D., Vice President, Preclinical Development, Ascenta Therapeutics, Inc.
Outsourcing preclinical development can confer significant cost savings while minimizing risk. China has the potential to become a major outsourcing center with a large, technically competent work force, quality facilities, and low costs. These potential advantages are offset by a lack of GLP compliance, quality assurance, and the need for updated electronic data acquisition and management. One approach to maximize productivity and to reduce costs is to establish a site in China.
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The advantages of preclinical outsourcing in China
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The challenges and liabilities of outsourcing
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Establishing a preclinical operations group in China
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11:15 am FDA Compliant Preclinical Drug Development in China
Glenn Rice, Ph.D., CEO, Bridge Pharmaceuticals, Inc.
Contract services in China are rapidly being upgraded to Western standards. This talk will provide a critical review of the state-of-the-art preclinical biopharmaceutical drug development capabilities in China, including infrastructure, animal supply, validation, standard operating issues, bioanalytic capabilities, language and cultural differences, quality assurance issues, husbandry practices, costs, logistics, and professional expertise and recruitment. A comparison of FDA GLP versus SFDA GLP practices will also be made. Overall, China is surprisingly well positioned to become a dominant force in this sector relatively rapidly.
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| Special Inclusive Luncheon Workshop
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Hosted by
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11:45 pm China: The Next Great Opportunity
Matthew Levy, M.S., M.B.A., Director, Global Market Development, Applied Biosystems
This will be an interactive discussion that will focus on the different facets of China as an opportunity within a number of areas, including research & development, market growth, collaboration opportunities, etc. The objective of the workshop is to review data that suggests why there is so much focus on China and how pharma companies can capitalize on this opportunity, as well as pitfalls to avoid. Some of the questions that will be discussed during the workshop include:
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Will China will be the economic leader in the future?
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How can a pharma company take advantage of this opportunity with minimal risk?
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What potential issues exist when exploring China?
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How can a pharma company gain process efficiencies and lower its operational cost structure by leveraging China?
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Does China have unique advantages besides lower costs?
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Applied Biosystems Group, an Applera Corporation
business, develops and markets instrument-based systems, consumables, software, and services to the life science
industry and research community |
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1:00 pm Building an Integrated Drug Discovery Platform in China
Ying Luo, Ph.D., President and CEO, Shanghai Genomics, Inc., President and COO, GNI Ltd.
In the next five to twenty years, China will emphasize discovery research to generate more IP in the fragmented pharmaceutical industry. A weak connection between Chinese academia and biopharmaceutical companies has forced local companies to either focus on the downstream of the value chain or build up a complete gene-to-drug platform independently. In the last five years, Shanghai Genomics has transformed from a target discovery company to a full-fledged biopharmaceutical company with sales and marketing force in China. Our experience proves that a balanced product portfolio combined with extensive international collaboration is the key to success for start-up in China.
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1:30 pm Taking Advantage of the China Clinical Opportunity: Lessons Learned
Mark Engel, Chairman, Excel PharmaStudies
Due to a convergence on trends the number of global trials coming to China has increased rapidly in the last several years (most estimates are around 50% per annum). Despite this rapid increase, there remain a lot of misconceptions about doing clinical trials in China. This session will address these points and also show specific examples of some creative ways to take advantage of the China market.
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Drivers for rapid growth of clinical trials coming to China
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Myth vs. Reality: Clarifying common misconceptions related to timelines and cost
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Examples of unusual ways to take advantage of the China opportunity
- ROI driven trials including proof of concept trials
- Dual development trials
- Additional labeling trials
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2:00 pm Afternoon Refreshment Break (Sponsorship
Available)
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2:30 pm Hong Kong: A Unique Gateway to Mainland China
Carlos Genardini, CEO, Hong Kong Science and Technology Parks Corporation
China is becoming a more attractive place, but patent rules and IP protection standards remain the foremost obstacles for international businesses. Clearly, in biotechnology, trust must be gained before any deal or collaboration can be made. In this context, Hong Kong could become an important biotechnology bridge between the West and mainland China.
Hong Kong offers:
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Western business and regulatory practices: Hong Kong is recognized for adhering to IP laws, a crucial ingredient to building a sound IP infrastructure in today's developing markets.
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A rapidly growing biotechnology infrastructure, as well as a strong clinical research infrastructure: Clinical trials in HK using patients from mainland China can take advantage of the benefits of both worlds (good IP protection and a huge patient population), and they can include parallel trials in HK and mainland China
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Hybrid of the West & the East: Hong Kong has closer access to the vast human resources and the huge mainland Chinese market than Taiwan, Singapore, and several other Asian countries. Thus, with Hong Kong on one end and the whole of mainland China on the other, the Pearl River Delta is uniquely situated to become a vibrant center of the global biotechnology and pharmaceutical industries.
This presentation will offer:
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Summary examples of real-world challenges and opportunities encountered in Hong Kong by global biopharmaceutical companies
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Strategies and tactics to overcome the pitfalls of setting up drug discovery and development operations in Hong Kong
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Ideas on how to overcome the challenges and take advantage of the benefits offered by both Hong Kong and mainland China
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Manufacturing on the mainland and quality control in Hong Kong is an advantageous model for global biotech or pharma companies.
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3:00pm
On the Conduct of Registration Clinical Trials in Chinese Populations in China, Hong Kong, and Taiwan
Johan PE Karlberg, M.D., Ph.D., Director, Clinical Trials Centre, The University of Hong Kong
A significant amount of clinical trial data are
today collected in Asia with the purpose of supporting NDA submissions to the US
FDA. However, due to the recent rapid expansion of the potential market in Asia,
the industry aims to get an earlier approval in such regions, i.e. in parallel
with the US approval. This presentation will be focused on conducting
registration clinical trials in China, Taiwan and Hong Kong, i.e. three Chinese
regions each with their own legal framework, infrastructure, experiences and
potentials. Real case examples will be taken from our recent experience in
establishing a spinal cord injury clinical trial network in 20 hospitals in
China, Taiwan and Hong Kong, a large network for testing cell therapy and drugs
in acute and chronic spinal cord injury patients. The following “how to”
topics all fundamental to success will be addressed:
- How to tackle differences between the US FDA
regulations and the local drug regulations
- How to reduce the impact of
cultural/language differences
- How to screen and accept suitable sites
- How to understand missconceptions related to
site contract/budget issues • How to address sub-normal research ethics
standards
- How to deal with clinical laboratory tests
- How to improve the competence of clinical
trial research staff
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3:30 pm Close of Executive Forum
For more information, please contact:
Micah Lieberman, Conference Director, Cambridge Healthtech Institute
E-mail: mlieberman@pharmaseries.com
For exhibit and sponsorship information, please contact:
Laura Ames, Sales Manager, at 781-972-5483
lames@healthtech.com
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