Second Regulatory Education Seminar:
All about Investigtional New Drug Applications (IND’s)

October 10, 2007, 1 - 5 PM

Location: Genentech Hall Auditorium, GH-N106, Mission Bay, UCSF

• We are about to submit an IND to FDA. What are the rules and regulations we will be subject to?
• My lab has synthesized a new promising chemical entity to treat disease X. Can we use the laboratory grade material to test the toxicity of the chemical entity in animals? What are the manufacturing requirements for human testing?
• How much animal data are required before we move onto clinical studies? Do we have any guidelines to decide an initial dose for human testing?

Pre-seminar consulting

Before the seminar, one-on-one complimentary consultation sessions will be provided on a reservation basis, 9 AM - 12 PM. If you have a development project that you would like to discuss with these experts, please request a DTRCS consultation.

For more information

Contact Julie Nelson or Marlene Berro.

Learn More: Regulatory Knowledge & Support

Have you been in any of the above situations or similar; not know what your best option was; have no resources to go to for help? You now have a resource right here at UCSF. Here is the answer for you.

The Clinical and Translational Science Institute (CTSI) is pleased to announce the Second Regulatory Education Seminar Series, in association with the Diagnostic Therapeutic Regulatory Consulting Service (DTRCS) and Regulatory Knowledge and Support (RKS), provided by the UCSF Washington, DC-based Center for Drug Development Science (CDDS), a world-renowned center in drug development and regulatory sciences, affiliated with the Department of Biopharmaceutical Sciences, School of Pharmacy.

The topics are:

• Preclinical Data Package for IND Submission (Carl Peck, MD, former Director, Center for Drug Evaluation and Research, FDA) Slides
• Chemistry, Manufacturing, and Quality Control 101 for New Drug Candidates (David Savello, PhD, Senior Vice President, Development, Xenoport, Inc.) Slides
• Animal Data for Human Testing: Where to Start and Stop? (Hilary V. Sheevers, PhD, former Pharmacology/Toxicology Team Leader, Center for Drug Evaluation and Research, FDA) Slides
• Choosing a Dose for the First-Time-In-Human Study (Howard Lee, MD, PhD, Director, Center for Drug Development Science) Slides

Come learn and enjoy. Bring your colleagues and take advantage of this very special opportunity.