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Effective outsourcing: Navigating hurdles and avoiding pitfalls in virtual drug development
All About Science Series
Thursday, April 15, 2010

11:30 AM - 12:00 PM   Registration, Lunch, and Networking
12:00 PM - 1:30 PM     Presentation & Panel Discussion
1:30 PM - 3:00 PM       Networking Dessert & Product Show

Virtual drug development promises savings of time and cost in the development of new drugs and devices. In order to realize this promise, managers and executives may need to learn some new tricks!

In this session a panel of experts with different perspectives on the virtual development experience will discuss some of the advantages and challenges of the virtual model.

The panel will include:
Dr. Kate Hanham, President & Founder, Mentara, Inc.: Mentara is a consulting consortium of highly qualified drug/device discovery and development professionals.
Richard Lin, President, Explora Biolabs, Inc.: Explora BioLabs provides vivarium and pre-clinical in vivo contract research services.
Dr. Fred Aslan, Vice President, Venrock: an investor experienced in starting and running virtual companies.
Dr. Michael Chang, Vice President, Research & Development, Limerick BioPharma: an executive using the virtual development model.
Toni Foster, M.A., formerly Senior Director, Clinical and Project Management, Biovascular: an expert with over 17 years of experience and over 45 clinical drug trials managed.

Immediately following the event, the BioCenter will host a Networking Dessert & Product Show, generously provided by Scientist Solutions Events�. Attendees will be invited to join us to enjoy delicious desserts, fruit smoothies, gourmet coffees and enter the raffle to win a Nintendo Wii!

Cost & Registration
� Regular Price: $30
� Partners' Network: $20
� BioCenter Members: Free (please RSVP to Aur�lie)
� On-site Registration: add $10 to the above
Space is limited for this event, so early pre-registration is recommended to avoid disappointment on the day!

The San Jose BioCenter
5941 Optical Court
San Jose, CA 95138
Click here for venue directions»

This event is produced in partnership with BioCenter Silver Sponsor, Mentara, a consortium of highly experienced professionals dedicated to providing the highest quality consulting services in drug, biologic and device development.

Speakers Bios

Kate Hanham, Ph.D., President & Founder, Mentara, Inc.
Dr. Hanham has consulted for organizations ranging from start-up biotechnology to some of the top ten pharmaceutical companies. She has provided strategic input at all stages of product development, designed and implemented clinical, regulatory and manufacturing strategies from early development through NDA. Dr. Hanham has held lead responsibilities in critical communications with the FDA and international regulatory agencies. She has also provided assessment of technology, product development and clinical operations for financial groups seeking to invest in biotechnology.
Dr. Hanham earned her Ph.D. in biochemistry at the University of Birmingham, England, and was awarded a Wellcome Trust fellowship at Yale University. After receiving a faculty position at Yale, Dr. Hanham moved into private industry where her work experience included Centocor, Repligen and Aviron prior to founding her consulting company in 1996. Dr. Hanham's research career in infectious diseases, applied immunology and vaccine development has provided experience critical to organizations developing a variety of products, including monoclonal antibodies, HIV and other viral vaccines, immune modulating agents and small molecule therapeutics. Dr. Hanham has designed and implemented pre-clinical and clinical research protocols in many therapeutic areas, and with her team at Mentara, established the logistics of data capture and specimen management for complex global clinical trials, designed analytical and test laboratories, established and validated analytical methods; provided project management support at all stages of product development and managed domestic and international manufacturing operations.

Richard Lin, President, Explora Biolabs, Inc.
Dr. Richard Lin has more than 20 years of academic research and industry drug development experience. With extensive knowledge of physiology and research operations, Richard oversees strategic development of Explora's services. Prior to founding Explora BioLabs, Richard was a Research Investigator at Ansata Therapeutics. He headed the group responsible for the preclinical development of Ansata's novel antimicrobial peptides in support of their advancement toward IND filing. In addition, his group studied the in vivo activities and biodistribution of novel peptide and protein therapeutics using a variety of animal models, including cancer and neurodegenerative disease models. Richard also served as head of the Physiology Department at Genset Corporation, where he led the effort to determine the in vivo functions of Genset's leading therapeutic proteins in the areas of obesity and diabetes. Richard's earlier biotech experience included a Group Leader position at Corvas International, where he led the in vivo Pharmacology department, and a Senior Scientist position at Axys Pharmaceuticals, where he created several knockout models for diseases including cancer and asthma. Richard conducted his postdoctoral research at UC San Diego Cancer Center, and received his PhD in Zoology from UC Berkeley.

Fred Aslan, M.D., Vice President, Venrock
Dr. Aslan joined Venrock in 2006 and is focused on healthcare. Prior to Venrock, he was with Atlas Venture assessing investments in medical devices and biotechnology. Earlier in his career, Fred was Director of Business Development and Head of Investor Relations for CuraGen Corporation, an oncology-focused drug development company. In this role, he was responsible for strategic planning, the in-licensing of a clinical stage oncology product, securing sell-side analyst coverage and helping raise over $100 million. Prior to CuraGen, he worked at Boston Consulting Group where he advised biotechnology and pharmaceutical companies. Fred�s medical background combined with his business experience brings practical insights and advice to any healthcare entrepreneur. He received a B.S. in Biology from Duke University, an M.B.A. from Harvard Business School (with distinction) and his M.D. from the Yale University School of Medicine.

Dr. Michael Chang, Vice President, Research & Development, Limerick BioPharma
Michael Chang joined Limerick BioPharma in 2009 and is the Vice President of Research and Development. He brings 17 years of industry experience in small molecule drug development. Prior to joining Limerick, Dr. Chang held a number of senior positions at CV Therapeutics, Inc., where he was responsible for commercial product manufacturing and managing the company�s key partnership to launch Ranexa� overseas. He also held responsibility for portfolio analysis, alliance management, and project management. Before joining CV Therapeutics, Dr. Chang managed R&D; teams at Agouron Pharmaceuticals, Inc., where he managed the drug development and registration of Viracept�. Dr. Chang received his BS and PhD in microbiology and immunology from the University of California at Los Angeles and completed his postdoctoral training at the University of California at San Francisco. He holds an MBA from San Diego State University.

Toni Foster, M.A., formerly Senior Director, Clinical and Project Management, Biovascular
Ms. Foster has over 17 years of clinical development and project management experience including international management of over 45 clinical drug trials from Phase 1 through Phase 3b, including orphan drug populations, as well as pilot studies in Class III medical devices. She has developed and managed all logistics and vendors for global trials, established quality methods and tools, and provided project management at all stages (pre-clinical through launch) of product development. Ms. Foster was recently Senior Director, Clinical and Project Management at BioVascular, Inc. where she led the management of clinical operations, project management (across all departments), data management, contract negotiations, and vendor management. Previously she was Senior Director, Clinical Operations at La Jolla Pharmaceutical and was a key leader in filing the company�s first NDA. Prior, Ms. Foster held positions of increasing responsibility at two of the largest CROs, Quintiles, Inc. and PAREXEL International. Ms. Foster therapeutic areas of experience include anti-infective, autoimmune, cardiovascular, CNS, dermatology, hematology, and urology. She holds her B.S. from Michigan State University, her M.A. in Organizational Management from University of Phoenix, and has U.S. Regulatory Affairs Certification.

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