Please Join Us Tuesday, January 25, 2011
The Rice
Alliance – Austin Chapter and UT's Austin Technology Incubator
invite you to
Austin's life sciences networking and educational event – symBIOsis.
If you're
a life sciences entrepreneur, entrepreneur-to-be, faculty, graduate student,
postdoctoral fellow,
or part of the life sciences industry in Austin, then this is for you!
The
mission of symBIOsis is to provide
an Austin-area forum
for the life
sciences community to network, support each other, and
learn about the challenges of starting and growing life sciences technology
companies.
Tuesday, January 25, 2011
5:30
– 7:30PM
AT&T
Executive Education & Conference Center
$5 Students, $15 General
"Regulatory Matters Matter! A Commercialization Discussion for Biotechnology Entrepreneurs"
Enjoy food, drink, & conversation with Austin's life sciences network. Then stay for a panel discussion of regulatory pathway strategy and its importance in early stage companies. The panelists include experts in regulatory affairs with medical device, diagnostic and pharmaceutical experience. Additionally, the panel will include an attorney with insights on supporting regulatory filings and a start-up investor with thoughts on how regulatory strategy influences investment decisions in early stage companies.
Panelists: Dr. Cindy WalkerPeach is the Director of ATI-Bioscience Incubator. She is responsible for developing and expanding ATI’s commercialization effort within the life science, diagnostic and therapeutic sectors and conducting due diligence on early-stage bioscience companies. She also assists ATI member companies in accessing venture capital, angel funders and federal funding sources.
Mr. Meek has served Luminex Corporation as Vice President in the areas of Quality Assurance/Regulatory Affairs and Manufacturing for the last ten years. During the 17 years prior to joining Luminex, Mr. Meek was employed at Abbott Laboratories. While at Abbott, he held various management positions in the area of Technical Product Development, Reagent and Instrument Manufacturing and Quality. Prior to joining Abbott Laboratories, he spent three years as Technical Liaison for AMF Biological and Diagnostics Company. Mr. Meek graduated from The University of Texas at Austin in 1979 with a B.A. degree in Biology and is a Certified Quality Engineer. Jeffrey Lazar offers almost 40 years of clinical research experience across nearly all aspects of medicine and pharmacology. Jeff has had several successful careers -- as a bench scientist (he described the first renin inhibitor), a clinical scientist (he was the first to postulate a kinetic effect of estrogens on the renin reaction as a mechanism for the hypertension associated with oral contraceptives), a university professor (he was tenured at the Uniformed Services University – the Department of Defense Medical School), in the pharmaceutical industry (he was the founding director of the Early Clinical Research Group at Pfizer Central Research), and in the CRO industry (he was a senior executive at Pharmaco in Austin, TX, responsible for Toxicology, Phase I, Regulatory Affairs, and Worldwide Consulting Services). This has provided Jeff with a unique blend of hands-on experience across all aspects of drug, biologics, and device research. While at Pfizer, he was the manager responsible for the amlodipine (Norvasc®) NDA and was a senior member of the teams that developed fluconazole (Diflucan®), sertraline (Zoloft®), doxazosin (Cardura®), and azithromycin (Zithromax®/Z-Pac®). He has been involved with multiple NDAs across nearly all therapeutic areas. Jeff received his MD from the University of Michigan in Ann Arbor and his PhD from The University of Heidelberg (Germany). He trained in Internal Medicine at the University of Michigan Medical Center, and in Clinical Pharmacology at Vanderbilt University. He has over 40 peer-reviewed publications in the Jerry DeVries is a co-founder and managing director of Texo Ventures, an early stage healthcare venture capital company that works alongside entrepreneurs helping them to accelerate the launch of their companies. He has a passion for marketing and business development and enjoys working closely with management teams to help them develop their business strategies and marketing programs. Rebecca Jones McKnight works with clients who develop, make, and distribute FDA-regulated products, and with those who play a part in the investigation and delivery of health care products and services. She co-chairs DLA Piper's Clinical Trials Working Group and Health Care Policy and Regulatory Working Group. She assists clients with matters including analyzing pharmaceutical and medical device company policies, practices and documentation to assess areas of vulnerability under relevant regulatory standards and recommending methods to strengthen compliance efforts and tracking and evaluating emerging regulatory requirements with potential impact on FDA-regulated companies and developing strategies for compliance. She also advises companies on clinical trial registry and results database requirements and assisting with development of internal policies to facilitate compliance and develop strategies and provide advocacy and legal guidance for medical device manufacturers with innovative technologies throughout product development and the clearance/approval process. Ms. McKnight also provides regulatory counsel and strategic litigation assistance for pharmaceutical companies, as relevant to cases involving failure to warn claims, and addressing allegations related to reporting of adverse events and clinical data, and promotional practices. Ms. McKnight began her career as a member of the FDA/Healthcare team at King & Spalding in Washington, DC. |