(Tucson, Arizona) The Arizona Center for Innovation (AzCI) will host a one day workshop geared towards biotechnology companies to teach them how to navigate the U.S. Food and Drug Administration (FDA) regulatory process.

Attendees will receive a general overview of the FDA regulatory process. The session will introduce the different types of approvals or clearances required for new products in the bioscience industry and how and when to start preparing for FDA review. The session will also provide a "Top Ten" list for starting a bio-company that will have to go through FDA review. The workshop will also present the importance of one's demographic market and the due diligence involved such as market research, gaining acceptance by the target market, and building patient support and demand. Attendees will also learn how to move the device or pharmaceutical beyond the United States by discussing the regulatory processes with international regulatory agencies. Biotech companies will explore how to best develop and implement an international strategy.

The workshop, set for September 20, 2011, will be taught by the following experts:

Marlene Haffner, MD, MPH is the CEO of Haffner Associates, LLC., a firm dedicated to the strategy, development and policy of drug development with a special emphasis on rare diseases and the products that treat them. She also spent more than 25 years working for the FDA as the Director of the Office of Health Affairs in the Center for Devices and Radiological Health (CDRH), and Director of the Office of Orphan Products Development

David Feigal, MD, MPH is a Partner NDA Partners. He held senior positions in FDA medical product centers including the Center Director of CDRH, the Deputy Center Director of Center for Biologics Evaluation and Research (CBER) and Director of the Office of Drug Evaluation IV (Anti-infective-Antiviral Drug Products), CDER.

Barbara Wuebbels, RN, MS –is the Manager of Medical Affairs Investigator Relations for BioMarin Pharmaceutical located in Novato, CA. She has worked in the orphan drug arena for the past 12 years. Prior to joining BioMarin, she was Director at Ucycld Pharma a subsidiary of Medicis Pharmaceutical Corp. She is actively involved with national and international rare disease organizations and patient advocacy groups.

Bioscience industry leaders will also discuss regulatory trends in the development of new drugs and devices as well as the regulatory process. The workshop will also be followed by a networking reception co-sponsored by the Bioindustry Organization of Southern Arizona (BIO-SA).

For more information or to register contact Lori Kavanaugh at This email address is being protected from spambots. You need JavaScript enabled to view it. or (520) 382-3260.

The Arizona Center for Innovation (AzCI) provides structured business development for technology companies. It works with University of Arizona students, faculty and staff as well as entrepreneurs in the community in moving technology through the commercialization process to create new companies in Southern Arizona. Founded in 2003, AzCI assists technology companies in the region. Interested companies should visit www.azinnovation.com.

Media Release
September 13, 2011

Media Inquiries
Office of University Research Parks ● Jessa B. Turner ● (520) 382-2485 ●  This email address is being protected from spambots. You need JavaScript enabled to view it.