NorCal SOT & PBSS Spring Symposium 2017 Combination Therapy: Fundamentals, Advances & Case Studies May 16th, 2017 South San Francisco Conference Center, 255 South Airport Boulevard, South San Francisco, CA 94080 Morning Session 7:30 am 8:30 am Registration & Breakfast – Opening message from The NorCal & PBSS Presidents 8:30 am 8:45 am Toufan Parman, PhD, DABT, Director, General Toxicology, SRI – Shichang Miao, PhD, VP, Preclinical Development & Clinical DMPK, ChemoCentryx Introduction to the Preclinical Development of Combination Therapies 8:45 am 9:20 am – Joseph Francisco, CRL Safety Assessment of Combination Therapeutic Agents: Regulatory Guidance 9:20 am 9:55 am and Expectations – Philip Gatti, PhD, FDA Addressing The Challenges With The Discovery of Combination Peptide 9:55 am 10:30 am – Paul Feldman, PhD, Intarcia 10:30 am 10:45 am Coffee Break – 10:45 am 10:55 am Sponsor Platform AM: Envigo – Challenges and solutions in the development of multi-analyte bioanalytical 10:55 am 11:30 am methods – Jonathan Wang, PhD, Genentech Manufacturing and Patient Administration Considerations for the Development 11:30 am 12:05 am of an Ocular Combination Therapy – Lynn Genarro, Genentech 12:05 pm 1:30 pm Lunch Break: Lunch with Experts, Posters – Afternoon Session 1:30 pm 1:45 pm Chapter announcements and acknowledgements – NorCal Student Award presentation: Evaluation of DILI Predictive Hypotheses in 1:45 am 2:05 am Early Drug Development – Rosa Chan, BS, UCSF Combination Toxicity Study of 2 Approved Cardiovascular Drugs 2:05 pm 2:40 pm – Anne Chester PhD DABT, Gilead 2:40 pm 3:00 pm Coffee – 3:00 pm 3:10 pm Sponsor Platform PM: Lovelace – Combination Drug Applications: Nonclinical Reviewer Perspectives 3:10 pm 3:45 pm – Jessica Hawes, PhD, FDA Antibody-Drug Conjugates for the Treatment of Cancer 3:45 pm 4:20 pm – Thomas Pillow, PhD, Genentech 4:20 pm 4:35 pm Closing Remarks – 4:35 pm 5:50 pm Reception & Networking –
NorCal SOT & PBSS Spring Symposium 2017 Combination Therapy: Fundamentals, Advances & Case Studies May 16th, 2017 South San Francisco Conference Center, 255 South Airport Boulevard, South San Francisco, CA 94080 Morning Session 7:30 am – 8:30 am Registration & Breakfast 8:30 am – 8:45 am Opening message from The NorCal & PBSS Presidents Toufan Parman, PhD, DABT, Director, General Toxicology, SRI Shichang Miao, PhD, VP, Preclinical Development & Clinical DMPK, ChemoCentryx 8:45 am – 9:20 am Introduction to the Preclinical Development of Combination Therapies Joseph Francisco, CRL 9:20 am – 9:55 am Safety Assessment of Combination Therapeutic Agents: Regulatory Guidance and Expectations Philip Gatti, PhD, FDA 9:55 am – 10:30 am Addressing The Challenges With The Discovery of Combination Peptide Paul Feldman, PhD, Intarcia 10:30 am – 10:45 am Coffee Break 10:45 am – 10:55 am Sponsor Platform AM: Envigo 10:55 am – 11:30 am Challenges and solutions in the development of multi-analyte bioanalytical methods Jonathan Wang, PhD, Genentech 11:30 am – 12:05 am Manufacturing and Patient Administration Considerations for the Development of an Ocular Combination Therapy Lynn Genarro, Genentech 12:05 pm – 1:30 pm Lunch Break: Lunch with Experts, Posters Afternoon Session 1:30 pm – 1:45 pm Chapter announcements and acknowledgements 1:45 am – 2:05 am NorCal Student Award presentation: Evaluation of DILI Predictive Hypotheses in Early Drug Development Rosa Chan, BS, UCSF 2:05 pm – 2:40 pm Combination Toxicity Study of 2 Approved Cardiovascular Drugs Anne Chester PhD DABT, Gilead 2:40 pm – 3:00 pm Coffee 3:00 pm – 3:10 pm Sponsor Platform PM: Lovelace 3:10 pm – 3:45 pm Combination Drug Applications: Nonclinical Reviewer Perspectives Jessica Hawes, PhD, FDA 3:45 pm – 4:20 pm Antibody-Drug Conjugates for the Treatment of Cancer Thomas Pillow, PhD, Genentech 4:20 pm – 4:35 pm Closing Remarks 4:35 pm – 5:50 pm Reception & Networking
NorCal-Spring-Symposium-2017-Agenda.docx