You’re Invited to a Morning Seminar with Patheon
Our team of expert pharmaceutical scientists is pleased to invite you to a complimentary morning seminar on Moving from Molecule to Clinical Trial- Overcoming Challenges in the Early Development of Small Molecules. The seminar will be held on Tuesday, December 13th at the Hyatt Regency La Jolla in San Diego. .
About this Seminar
Have you ever encountered regulatory issues and thought “How am I going to get through this?” or heard about a molecule that failed to progress to clinical trials due to solubility issues? If so, then this seminar is for you. Patheon is proud to bring together four scientific leaders who, in a complimentary half-day seminar, will help you navigate through regulatory obstacles, give you tips for getting your molecule to clinical trials more efficiently, and provide practical case studies that demonstrate how others molecules have successfully moved to clinic.
As the global leader in Pharmaceutical Development Services, Patheon is committed to providing effective science-based learning opportunities for local professionals. Through this event, you will get the chance to network, meet with scientists, and learn from presentations with solutions to the challenges you currently or might face in the near future. Breakfast and lunch will be served.
Seating is limited. Please RSVP as soon as possible.
Biographies of Speakers
Leah Appel, Ph.D. has over 20 years experience in the pharmaceutical industry, with extensive experience developing drug delivery technology and products. She has applied her expertise over the entire range of drug product development, both tailoring novel delivery technologies for clinical applications and commercializing products using drug delivery technologies. She is an inventor on over 35 drug delivery patents and patent applications. Her primary area of expertise is in oral solid dosage forms including controlled release and delivery of poorly soluble compounds. Leah obtained her B.S. in Chemical Engineering from UCLA in 1982, and her Ph.D. in Pharmaceutics from the University of Utah in 1988. Prior to founding Green Ridge Consulting in 2007, she worked for 10 years at Bend Research, Inc. as the Director of Controlled Release, and for 7 years at INTERx (a division of Merck) developing controlled release technologies.
Anil Kane, Ph.D., MBA, is presently the Senior Director, Pharmaceutical Technical Affairs, North America in the Pharmaceutical Development Services Group of Patheon Inc. He received his Bachelors, Masters and Ph.D. degrees from the University of Bombay, India and served as a post doctoral fellow at the School of Pharmacy at University of Cincinnati, Ohio. Dr. Kane has experience in the Pharmaceutical Development field for over 22 years, during which time he worked for Ciba Geigy Ltd. and subsequently Novartis. He has extensive knowledge of the entire drug development process, having been involved in taking molecules from early stage development to scale up, technical transfers between various manufacturing sites around the world and drug life cycle management. In his current role as Senior Director, Dr. Kane is leading a talented group of scientists in the development of novel lead compounds in this drug delivery area from early phase product development, clinical manufacturing and tech transfers for commercialization.
John McCarty has held R&D management positions at Key Pharmaceuticals, Schering Plough, and Pharmavene (acquired by Shire Pharmaceuticals) and is the founder of the international consulting firm Pharmaceutical Productions. 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. Until just recently he held the position of VP for Formulation Sciences and Drug Delivery at Azopharma Product Development Group. He earned Bachelors degrees in Microbiology and Chemistry from Florida Atlantic University in Boca Raton, FL.
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.

Date: Tuesday, December 13, 2011
Time: 8:30 am — 2:00 pm
Location: Hyatt Regency La Jolla,
3777
La Jolla Village Dr,
San Diego, CA 92122
RSVP: events@patheon.com
Agenda |
|
8:30-9:00 |
Registration/Breakfast |
9:00-9:15 |
Opening Remarks – Dr. Frank Sorgi, VP Pharmaceutical Science and Development – Patheon |
9:15-10:00 |
Keynote Address: Industry and Consulting Perspective on Early Development |
10:00-10:45 |
Filing an IND for Early Clinical Studies: What You Need to Have for First-in-Human Studies |
10:45-11:00 |
Break with Coffee and Refreshments |
11:00-11:45 |
Drug Substance and Early Formulation Development: Perspectives and Risks |
11:45-12:30 |
Parallel Screening—Speeding Bioavailability Improvement of Poorly Soluble Compounds |
12:30-12:45 |
Closing Remarks, Dr. Frank Sorgi |
12:45-2:00 |
Lunch/Networking |