You’re Invited to an afternoon Seminar with Patheon Thursday, June 14, 2012
Time: 12:30 pm-6:30 pm
Location: Hyatt Regency
San Francisco Airport, 1333 Bayshore Highway, Burlingame, CA 94010
Our team of expert pharmaceutical scientists invite you to a complimentary afternoon seminar on Knowing Which Early Development Signs to Follow on the Road to Proof of Concept. The seminar will be held on Thursday, June 14th at the Hyatt Regency San Francisco Airport.
About This Seminar
The road to FTIH trials is a long journey with many decisions along the way, upon which may rest the future of your molecule. The data we generate and how this is interpreted will form our choices on the development path to follow and can be the difference between success and failure.
During this seminar you will hear case studies and analysis from industry leading experts on Regulatory Strategies for IND Submission, API Characterization to achieve optimum performance, Analytical Method Development for preclinical and IND submissions, and Pre-formulation and Formulation Development for IND enablement. This will provide you with insight into which signs to follow and how they can help speed you along the road to Proof of Concept.
Lunch and afternoon refreshments will be served. You are also invited to a networking reception after the event. Seating is limited. Please RSVP as soon as possible. Agenda
12:30-1:30 pm Registration & Lunch
1:30-1:45 pm Opening Remarks
1:45-2:30 pm Filing an IND for Early Clinical Studies: What You Need to Have for First-in-Human Studies
John McCarty, Ph.D., Pharmaceutical Productions, Inc.
2:30-3:15 pm Successful Analytical Method Development for Preclinical Assessment and IND Enablement
Jason M. Vaughn, Ph.D., Scientific Director, Patheon
3:15-3:30 pm Break with Coffee and Refreshments
3:30-4:15 pm Designing Your API for Performance -API Characterization
Gail Strong, Ph.D., Sr Director Pharmaceutical Science – Patheon
4:15-5:00 pm Clinical Success Through Stepwise Preformulation and Formulation Development
John Koleng, R.Ph, Ph.D., Adjunct Assistant Professor at University of Texas at Austin, Partner at AlphaVektor, LLC and Associate at Regulatory Compliance Initiatives
5:00-5:15 pm Closing Remarks
5:15-6:30 pm Networking Reception