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March 2005 Events

March 21: The Global BioExecutive Program Elective - Pre-Program Course
This class covers basics of biology and pharmacology, important terminology, acronyms, and regulatory framework. Module 1 provides an understanding of the forces of innovation within the industry, the players involved and the interplay of issues and stakeholders. Module 2 covers the dynamics of bringing market and operations optimization strategies to innovation in product development, brand management, pricing, reimbursement and partnerships. Module 3 addresses the challenge of containing costs while maintaining safety and efficacy. Additional information: 415.637.4913 or http://execdev.haas.berkeley.edu/ApplicationFiles/web/WebFrame.cfm?web_id=457

March 22, 2005: Developing a Social Responsibility Strategy
An interactive workshop with tools provided to map stakeholders, understand your organization's social responsible drivers and ways to involve your organization. Presented by Marta Hillescheim Schmal, an Organization Development Specialist currently working as both Director of People and Organization with Novozymes, and as a business partner with Novozymes' Sustainability Development Center in Denmark. To register please call: Rosie Balcunas 408-626-7626.

March 22-24, 2005: RAPS 2005 West Coast Conference & Exhibition
Participants will learn the latest in regulatory strategy and developments from regulatory experts from around the world. Sessions will address the topical and relevant issues relating to drugs, biologics, medical devices and international affairs. Lester M. Crawford, DVM, PhD, Acting Commissioner of the US Food and Drug Administration, will speak at the RAPS 2005 West Coast Conference & Exhibition! Dr. Crawford will give the opening plenary keynote address on "Direction & Future of FDA." Additional information: a href="http://www.raps.org/s_raps/event.asp?TRACKID=&CID=1851&DID=23819">http://www.raps.org/s_raps/event.asp?TRACKID=&CID=1851&DID=23819

March 22th, 2005 Speaker: Jane S. Lebkowski, PhD Topic: 'Development of Human Embryonic Stem Cell Therapies for the Treatment of Human Degenerative Diseases'
March MEETING - Palo Alto AWIS
Dr. Lebkowski will give an industry perspective on the exciting topic of current progress in innovative applications of stem cells. Her talk will include significant achievements that Geron has made in preclinical stem cell research and subsequent product development.
Dr. Lebkowski received her Ph.D. in Biochemistry from Princeton University in 1982. In 1998, Dr. Lebkowski joined Geron as Senior Director of Cell and Gene Therapies, and now heads the human embryonic stem cell program.
PARC , 3333 Coyote Hill Road, Palo Alto, CA 94304,
Directions: www.parc.com/company/directions.html 7:00-7:30 pm Networking and light Supper 7:30-7:45 pm Announcements 7:45-8:45 pm Program 8:45-9:00 pm Discussion
Welcome!! The Meeting is free. You don't need to be a Member to attend. All scientists, students, and their friends are welcome. Men too!
A $5 donation is requested at the door to help cover the cost of refreshments.
For more information about AWIS Palo Alto, visit our website at www.pa-awis.org.

March 23 Saving Your Skin
"Women's Health at Twelve" (WHAT)
What are the changes that occur when skin ages? How can you protect your skin and keep it youthful? What topical creams really help and which are snake oil? In this presentation, the science or lack of science supporting many of the commonly used antiaging products will be explored. Ruby Ghadially, MD, is an Associate Professor in Residence in the UCSF Department of Dermatology. Her interests include skin disorders of pregnancy, aging skin, and stem cells of the epidermis. Speaker: Ruby Ghadially , MD
Cole Hall, 513 Parnassus
12:00-1:00pm
FREE http://www.ucsf.edu/cge/wg/programs/what/current.html#saving
To access the live streaming video of the talks, visit: http://www.uctv.tv/what/

3/23/2005 The Value of Intellectual Property: Spinout to Acquisition
Nanobioconvergence event: John Wetherell, Mark Menna, TBA
Join us for an evening discussion of IP convergence between nanotech and biotechnolgy. Intellectual property plays an important role in the development of new technologies. Along the path to commercialization, IP value changes in relation to market value. Our panelists will discuss the value of intellectual property from spin-out to acquisition.
6:00:00 PM
Pillsbury Winthrop LLP, 2475 Hanover Street ( just off Page Mill Road ), Palo Alto, CA
94304-4304 Tel:(650) 2334500 Fax:(650) 2334545
http://www.nanobioconvergence.com/events.aspx

March 23, 2005: The FDA in the 21st Century: Maneuvering the Socioeconomic Tradeoff
Please join the Professional Women s Healthcare Alliance on Wednesday, March 23rd for an exciting discussion on the Future of the FDA. You will hear leading experts from the drug, tool, and medical device fields discuss how the inherent tradeoff between efficiency for affordable access and safety for societal protection can impact both the FDA and your company. Don t miss this opportunity to network with your industry peers while learning the keys to actively managing successful development with the institution!
Our panel will be moderated by Judith Ann Hasko, a partner in Cooley Godward s Life Sciences practice group and a member of their Business department.
Our panelists include:
Elizabeth M. Tillson, PhD, Vice President of Regulatory Affairs and Quality at Cerus Corporation
Elizabeth Mansfield, PhD, Director, Regulatory Affairs at Affymetrix
Kevin Dwyer, Co-founder and Vice President of Regulatory Affairs at Pacific BioDevelopment, LLC.
Our program will open with networking and light refreshments at 5:30 p.m., followed by our panel discussion at 6:30.
Registration Fees:
Sign up for PWHA Membership today and receive the Member registration rate for the program!
Member Registration.$35, Non Member Registration $55, Program Registration + 2005 PWHA Membership $160. Questions? Please contact the PWHA office at 415.243.2117 for more information.
Wednesday, March 23, 2005 5:30 PM - 8:30 PM; Cooley Godward, Palo Alto Campus, 3175 Hanover Street, Palo Alto, 94304 – ERSVP: March 22nd, 2005
http://pwha.org/Events.html

March 24, 2005: Health & Biosciences Forum 2005
Stem cell research holds the promise of breakthroughs in the treatment of diabetes and Parkinson's disease, among other ailments. It is the new frontier of medicine. But what will it mean to Silicon Valley? It could be months or more before the California Institute for Regenerative Medicine issues the first of $3 billion in grants for stem-cell research, but already there are signs of a coming "California stem cell gold rush". The impact on the local economy will prove measurable. New exploration means new joint ventures and start-ups, all of which need employees, space, equipment and business services. And that new spending can further fuel a recovering economy. The Business Journal will lead a discussion of industry leaders and business leaders as we examine the impact of the new frontier of medicine on business and our economy in Silicon Valley. The Tech Museum, San Jose CA. Registration - 7:30 a.m., Program - 8:00 a.m. to 10:00 a.m. $50 per individual/$500 for a table of 10. BayBio members receive a $10 discount by emailing your RSVP to asouza@bizjournals.com. Additional information and to register: http://sanjose.bizjournals.com/sanjose/event/1306

Recorded FDA Regulations for Medical Device Product Promotion
Date: 03/22/05 - 04/22/05 Location: Recorded Web-Cast
Deborah Wolf, JD, Regulatory Counsel, Acting Coordinator, Promotion and Advertising Policy Center for Devices and Radiological Health, of the FDA will lead a workshop on the regulation of the promotion of medical device products. Learn to foster an understanding of the current FDA regulations for medical device product promotion. This presentation will address updates on pending decisions and future rules that will affect promotion of medical device products. Case studies will be used to illustrate real examples of dilemmas faced by marketers and appropriate actions in marketing within the law.
This session is a recorded version of the live Web-Cast held March 16, 2005 from 2:00pm-4:00pm EST.
This program will be available five business days after the live webcast. There is a separate charge to view the live session. Please register for that portion of the event via the live webcast event listing.
The cost for the recorded session is $39.00 for members and 69.00 for non-members. Once registered you will recieve a confirmation and log-in instructions for the link to the recorded webcast along with a hard copy of the presentation slides. Please allow one business day to process your registration.
http://mmanet.org/program_events/events_detail.cfm?key=35

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