MichBio

BioArbor - New Strategies in a Challenging Regulatory Environment

Wednesday, March 21, 2012 (5:00 PM - 7:00 PM)

About BioArbor

BioArbor hosts educational networking events for the life sciences industry in the greater Ann Arbor area. BioArbor’s focus covers technology commercialization, financing strategies, business development, regulatory affairs and marketing. Each meeting features a networking session and an invited speaker, followed by a Q&A period. Invited speakers share experience on topics such as drug discovery & development, medical devices, diagnostics and tools. BioArbor events are open to the public and are especially suited for those interested in starting or growing life science businesses.

In the life sciences space, its hard to avoid dealing with regulators. Yet, getting your product developed and marketed depends on successful regulatory interactions. Right now, many accuse the FDA of being particularly conservative. Come to BioArbor to learn about the current FDA environment and what different companies, both within the biopharma and device space are doing to advance their programs, in some cases with unique approaches
which may minimize the impact of the FDA. This is up to date information
you should not miss!

Networking:  5 pm

Program:  6 pm

Mark Ammann (Moderator)
Owner and President, Catalyst Regulatory Services

Mark Ammann is the owner and President of Catalyst Regulatory Services. Prior to founding Catalyst, Mark established and built a successful Regulatory Affairs consulting practice at United BioSource Corporation where he served as Vice President of Regulatory Affairs and provided strategic regulatory consulting to a range of clients from start-up pharmaceutical companies to large multinational corporations. Prior to starting his consulting career, Mark held positions with increasing levels of responsibility within Regulatory Affairs at three
major pharmaceutical companies (Novartis, Pharmacia and Pfizer). Mark is a recognized leader in the regulatory affairs community with an extensive knowledge of regulatory issues and the overall pharmaceutical development process. His excellent analytical, commun-ication and negotiation skills have been used to effectively prepare and lead teams through many challenging health authority interactions. Mark received his Doctor of Pharmacy
degree from the University of Michigan.

Brian Krausse, PhD, FAHA
Chief Scientific Officer

AlphaCore Pharma
Brian attended graduate school at the University of Illinois Medical Center in Chicago, and later at LSU Medical Center in New Orleans, where he received a Ph.D. in Physiology.  After completing an NIH-sponsored postdoctoral training program under the guidance of Paul Roheim, M.D. he joined Parke-Davis/Pfizer where he became the lead pharmacologist on the team that discovered Lipitor, and head of the ACAT team that discovered avasimibe.  In 2001 he left Pfizer and joined Esperion as VP of Development Pharmacology, and later as Head of Research.  He was the preclinical pharmacologist on the Clinical development Team for apoAIMilano (ETC-216).  His major research focus since 1973 has been cardiovascular therapeutics, in particular, cholesterol-lowering and anti-atherosclerotic drugs.  Brian has authored or co-authored more than 100 peer reviewed scientific papers and book chapters in the field of lipoprotein metabolism and atherosclerosis.

Jim O'Connell
Director, Venture Center

University of Michigan Office of Technology Transfer

Jim leads the Venture Center within the University of Michigan Office of Technology Transfer, focused on creating high quality startup companies based on U M intellectual property.  He has extensive corporate experience from Stryker Instruments, as well as local Ann Arbor startup experience from Xoran Technologies and Sensicore. In his more than 13 years of industry experience, Jim’s roles have always focused on product commercialization and business development, as well as operations and engineering responsibilities. He has helped commercialize over 30 different products including biomaterials, RF Ablation devices, infusion pumps, surgical power tools, high volume sterile disposables, CT Scanners, surgical navigation systems, resorbable plates and screws, and amperometric electrochemical sensors.  He has a BS in Aeronautical Engineering from Rensselaer and an MS in Engineering Management from the University of Maryland.  Prior to industry, Jim was a helicopter pilot in the U.S. Air Force.


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  Pfizer

  

 

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Contact:

Mailing Address:
P.O. Box 130199
Ann Arbor, MI 48113-0199

 

Physical Address:
3520 Green Ct.
Suite 175
Ann Arbor, MI 48105-1579
Google Map

 

Phone: (734) 527-9150
Fax: (734) 302-4933

Email: info@michbio.org

 

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