The discovery and identification of a new molecular entity (NME) and the application of research required to show a proof-of-principle for a therapeutic agent can be rife with pitfalls and it is extremely difficult to qualify a new prospect for venture funding or partnering with another pharmaceutical company. Many times, companies in the early stages of a concept or principle identification fall into the trap of focusing on only the efficacy segment of their prospective therapeutic agent�s potential but have little or no safety data to provide for the initial funding considerations. This often missing safety data is considered to be a critical component by individuals who are responsible for making key venture capital funding and pharmaceutical venture decisions.

To this end, this presentation will take the audience from early discovery, the demonstration of efficacy, drug/biologic agent exposure, early candidate selection, and the preclinical safety aspects which are often missed by startups. In addition, we will discuss scale-up and impurity issue considerations for the Active Pharmaceutical Ingredient (API) during the development phases through late stage drug/biologic development, selection of a preclinical safety evaluation partner, API supply, and regulatory filings.

The session will conclude with a panel discussion to provide attendees with the opportunity for valuable exchanges with experts in the fields of drug development and regulatory toxicology.

Who Should Attend
Discovery scientists, pharmacologists, toxicologists, molecular biologists, business development directors, regulatory directors/officers, Chief Science or Technical Officers, Chief Financial Officers, and Chief Executive Officers in early incubator and small to medium-sized small pharmaceutical/biopharmaceutical start-ups and early development companies.

Speakers
� Dr. Richard Slauter, Senior Director of Drug Metabolism and Pharmacokinetics, MPI Research, Inc.
� Dr. Brian Rogers, VP of Toxicology, Pacific BioDevelopment
� Dr. Stephen Frantz, Senior Director of Business Development, Pacific Northwest, MPI Research, Inc.
� Dr. David Brewster, VP and Sr. Safety Expert for Global NonClinical Safety, F. Hoffman-La Roche

This event is produced in partnership with MPI Research, a full-service toxicology contract research organization that serves the pharmaceutical, consumer product, chemical, and medical device industries, as well as government agencies.

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

Speakers Bios

Dr. Richard Slauter, Senior Director of Drug Metabolism and Pharmacokinetics, MPI Research, Inc.
Ric Slauter, Ph.D. D.A.B.T., is currently the Senior Director of Drug Metabolism and Pharmacokinetics for MPI Research, Inc. in Mattawan, MI. Prior to joining MPI Research, Dr. Slauter was a co-founder and Principal at Bay Therapeutic Development Solutions, a San Jose based consulting firm. Previously, Dr. Slauter was a co-founder of REPAIR Technologies, a regenerative medicine and cell-based therapeutics start-up now located in Austin, TX. Dr. Slauter has held senior positions at Exelixis, Oncocidex, Battelle Biomedical Therapeutics, International Research and Development Corporation, and Research Triangle Institute. He has designed and managed programs in late discovery and lead optimization all the way through non-clinical and early clinical development of new therapeutic products, and interfaced with the FDA for IND, BLA, and 510(k) submissions. He received his PhD in Biochemical Pharmacology from Wayne State University School of Medicine, and completed his post-doctoral studies in Biological Chemistry at University of Michigan.

Brian C. Rogers, Ph.D., D.A.B.T., M.B.A., VP of Toxicology, Pacific BioDevelopment
Brian is a co-founder of the company and serves as our VP of Toxicology. He has nearly 20 years of industrial toxicology experience primarily in biotechnology and pharmaceuticals, including five years at Genentech. During this time he has extensively interacted with the FDA and authored approximately 40 IND and several NDA and BLA nonclinical sections on behalf of clients. His experience enables him to design strategic pharmacology and toxicology programs for our clients. He holds a Ph.D. in Toxicology from the University of North Carolina, Chapel Hill, NC and a B.S. in Environmental Toxicology, University of California, Davis, CA (UCD). He is a Diplomate of the American Board of Toxicology (since 1993) and also holds an MBA from and was an adjunct professor at the UCD School of Management.

Stephen W. Frantz, Ph.D., D.A.B.T., Senior Director of Business Development, Pacific Northwest, MPI Research, Inc.
Stephen W. Frantz, Ph.D., D.A.B.T., as the Director of Business Development for the Pacific Northwest for MPI Research, is responsible for recruitment of preclinical safety and efficacy studies for pharmaceutical industry companies and also serves as a Senior Principal Study Director, a position that is responsible for all aspects of GLP-compliant study conduct, data interpretation, and report finalization for multiple species and study types. Dr. Frantz has worked in the pharmaceutical industry for Bristol-Myers Squibb (1996-2002), ConvaTec/Bristol-Myers Squibb (1995-1996), and Merck & Co. (1993-1995), in the CRO industry at Bushy Run Research Center/Union Carbide Corp. (1985-1993), and the chemical industry for Dow Chemical Company (1981-1985) where he held various research and safety toxicology positions. Dr. Frantz joined MPI Research in 2002 as a Senior Study Director and became a Senior Principal Study Director in 2006. Dr. Frantz has published in the toxicology literature regularly over his career, principally on aspects of cutaneous toxicology, and his CV lists 32 manuscripts and book chapters. Dr. Frantz earned his Bachelor of Science in Physiology from Michigan State University in 1974 and a Masters in Medicinal Chemistry in 1978 and his Ph.D. in Toxicology in 1981 from the University of Michigan. He became a Diplomate of the American Board of Toxicology (A.B.T.) in 1986, receiving his 4th recertification from A.B.T. in 2006, has been an active member of the Society of Toxicology since 1994 (including Nominating Committee service from 2006-2008), and has served as the President-Elect (2003/2004), President (2004/2005), and Past President (2005/2006) of the Michigan Regional Chapter of the Society of Toxicology.

Dr. David Brewster, VP and Sr. Safety Expert for Global NonClinical Safety and Head External Relations, US, F. Hoffman-La Roche
Dr. David Brewster is a Board certified toxicologist with more than 25 years of research experience in toxicology and nearly 19 years experience in the pharmaceutical industry. Dr. Brewster has extensive experience in the development of new molecular entities (small molecules), medical devices, and large molecules, reformulations of marketed products and global product registration and support. At Monsanto he developed and led the thyroid biochemical toxicology and cell proliferation programs. During his tenure at Aventis and its predecessor companies he built and staffed an investigative toxicology group and assumed increasing responsibilities up to the Director of Toxicology and Head of US projects. At Purdue he reorganized and re-energized the organization and integrated the toxicology, pathology, bioanalytical, drug metabolism and toxicokinetic groups into a high performing team. At Roche he was responsible for preclinical safety assessment at Roche Pharmaceuticals, Nutley, NJ with oversight of the toxicology, pathology, drug metabolism, bioanalytics, and pharmacokinetics/toxicokinetics groups and for setting policy and directing strategic planning for non-clinical safety testing. He is currently Sr. Safety Expert for Global NonClinical Safety and Head External Relations, US. Responsibilities include oversight of project strategy and establishing scientific strategic partnering as well as representing the company externally.


About MPI Research

Sound science and complete customer service, along with accelerated program development, are all certainties at MPI Research. We take great pride in assuring thorough and timely support of all your research programs by providing:

� Top-quality studies, with careful attention to detail and accuracy
� Extensive GLP experience
� The most experienced scientific research team in the industry
� Unprecedented responsiveness to Sponsors
� Multiple specialty scientific teams
� Known for our substantial in vivo animal capacity
� The most comprehensive historical control database in the industry
� Consultative approaches to study designs and preclinical programs, especially in terms of our ability to work as extensions of the staff and facilities of our Sponsors
� Capacity, expertise, and technology allow for fast study starts
� On-time, accurate reporting
� Open communication throughout the organization
� Individualized program management services to Sponsors with complex, multi-discipline and/or multi-compound drug development programs

Fore more information about MPI Research, please visit www.mpiresearch.com.