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You’re Invited to an afternoon Seminar with Patheon |
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Date: |
Thursday, June 14, 2012
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Time: |
12:30 pm-6:30 pm |
Location: |
Hyatt Regency
San Francisco Airport,
1333 Bayshore Highway,
Burlingame, CA 94010 |
RSVP: |
events@patheon.com |
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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. |
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Agenda |
Time |
Schedule |
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 |
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Biographies of Speakers |
John J. Koleng, Ph.D. co-founded and served as COO/VP Industrial Operations at PharmaForm, a CDMO focused on novel drug delivery systems, before founding AlphaVektor, a drug delivery technology and development consultancy. Over the past 17 years, he has guided and assisted numerous life-science clients in the development of their technology enriched/enabled products, delivery systems, and processes for various indications. John’s drug product development experience ranges from nano-dose tablets and abuse deterrent systems to liquid-filled capsules, hot melt extruded dosage forms, and transdermals. He has published scientific research articles on topics including hot melt extrusion, pressurized meter dose inhalation, and aqueous film coating. John received a B.S. in Pharmacy and a Ph.D. in Pharmaceutics from the University of Texas at Austin where he holds an Adjunct Assistant Professor appointment. |
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Jason M. Vaughn, Ph.D. has 12 years of pharmaceutical development experience. He spent several years at PharmaForm LLC in various positions including Associate Director of Analytical and Formulation Development, Director of Operations and eventually Vice President of Operations. He then joined DPT Laboratories as Director of Formulation Development where he led a team that developed formulations for liquids and semisolids. Following this, he joined Enavail LLC as Director of Research. In 2012, Jason joined Patheon as Director of Scientific Affairs in the Cincinnati facility. He received a B.S. in Pharmacy and a Ph.D. in Pharmaceutics from the University of Texas at Austin.
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John McCarty, Ph.D. has held R&D management positions at Key Pharmaceuticals, Schering Plough, Pharmavene (acquired by Shire Pharmaceuticals) and held the position of VP for Formulation Sciences and Drug Delivery at Azopharma Product Development Group. He is the founder of the international consulting firm McCarty Pharma Consultants Inc. John is known for his broad expertise in the development of all major dosage forms and is a contributor to industrial publications such as Tablet and Capsules and American Pharmaceutical Review. He is an inventor on numerous US and foreign patents. He holds Bachelor degrees in Microbiology and Chemistry from Florida Atlantic University in Boca Raton, FL. |
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Gail L. Strong, Ph.D. has 20 years of pharmaceutical development experience. She spent 11 years at Upjohn/Pharmacia/Pfizer focused on the drug discovery development interface in the pharmaceutics department, eventually as Director of Pharmaceutics for the three U.S. sites. She then joined Theravance as Director of Solid Forms. At Theravance she led the GI-motility team from early development through a successful Phase 2 proof of concept clinical study. In 2011 she joined Patheon as Senior Director of the South San Francisco Early Development lab. She received a B.S. in Chemical Engineering from Colorado State University, a M.S. in Chemical Engineering from the University of Arizona and a Ph.D. in Pharmaceutics from the University of Michigan. |
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