2019 BioSafe General Membership Meeting May 7-9, 2019 ...

2019 BioSafe General Membership Meeting May 7-9, 2019

Takeda; Cambridge, MA

Tuesday, May 7th

12:00-1:00 PM

Registration

1:00-1:15 PM

Welcome and Opening Remarks Victoria Dohnal, BIO; TBD, Takeda

1:15-3:15 PM

Session 1: New Frontiers in PKPD Co-chairs: Jay Tibbitts, AbbVie and Amrita Kamath, Genentech

Impact of relative target affinities of T-cell dependent bispecifics on Biodistribution

Andy Boswell, Genentech

Mechanistic aspects of anti-CD19 CAR T Cell

John Rossi, Kite

therapy based on clinical observation in lymphoma

and leukemia

Impact of chemical modifications on the PK-PD relationships for RNAi therapies

Brooke Rock, Amgen

Strategies on PK/PD modeling and first-in-human Kefeng Sun, Takeda dose projection for AAV-based gene therapy

3:15-3:45 PM 3:45-5:45 PM

Coffee Break

Session 2: Therapeutic Cancer Vaccines Co-chairs: Ping Peng, Janssen and Anu Connor, Novartis

Overview of therapeutic cancer vaccines

Nonclinical safety strategy for therapeutic cancer vaccines

Gautham K. Rao, Genentech Rani Sellers, Pfizer

Nonclinical safety strategy for oncolytic virus

mRNA cancer vaccines: toxicology strategy evolution

Christina de Zafra, Amgen Rodrigo Laureano, Moderna

Panel discussion with speakers and Dr. Galaro, FDA Open Night

2019 BioSafe General Membership Meeting May 7-9, 2019

Takeda; Cambridge, MA

Wednesday, May 8th

8:00-8:30 AM

Breakfast

8:30-10:30 AM

Session 3: Cell and Gene Therapy Co-chairs: Sarah Voyetk, bluebird bio and Nicholas Buss, Regenxbio

Impact of CAR T infiltration on the tumor microenvironment

Keith Mansfield, Novartis

Pre-clinical considerations for neoantigen directed Sadik Kassim, Kite T Cell therapies

Preclinical efficacy and safety of Valoctocogene Roxaparvovec (BMN 270), a gene therapy for Hemophilia A

Carlos Fonck, BioMarin

10:30-11:00 AM 11:00-12:30 PM

12:30-1:30 PM 1:30-2:30 PM

Towards a CRISPR medicine for LCA10 Coffee Break Session 4: BioSafe Updates Message from the BioSafe Chair TCR 2.0 survey update Lunch Session 5: Breakout Sessions

Chris Wilson, Editas

Helen Haggerty, BMS Tim MacLachlan, Novartis

2:30-3:00 PM 3:00-4:00 PM 4:00-5:30 PM

Coffee Break

Breakout Session Recap/Discussion

Session 6: Beyond TDAR: Assessing cell-mediated immune responses Co-chairs: Sven Kronenberg, Roche and Marie-Soleil Piche, CRL

Introduction: innate cellular immune function & DTH

Sven Kronenberg, Roche

6:00-8:00 PM

No restrictions!? Implementing CD8 cellular immunity assessments in cyno safety studies

Case example on (CD8) cell-mediated immune function testing with a combination of mAbs

Reception

Rashade Haynes II, BMS Cris Kamperschroer, Pfizer

2019 BioSafe General Membership Meeting May 7-9, 2019

Takeda; Cambridge, MA

Thursday, May 9th

8:00-8:15 AM

Breakfast

8:15-10:15 AM

Session 7: 3Rs and animal (re)use Co-chairs: David Clarke, Lilly and Jessica Lynch, Janssen

Introduction

Fostering a culture of care at Genentech and exploring opportunities for refinements in toxicology studies

David Clarke, Lilly Donna Lee, Genentech

Review of two-species toxicities from short-term Helen Prior, NC3Rs studies highlights opportunities for reducing to one species for chronic studies

WoE approach for developmental toxicity assessment of biopharmaceuticals, a BioSafe white paper

Chris Bowman, Pfizer

Case study: Reducing animal use through early regulatory interactions focused on defining patient risk:benefit

Krishna Allamneni, Jazz

10:15-10:30 AM 10:30-12:30 PM

Panel Discussion

Coffee Break

Session 8: Lack of relevant species Co-chairs: Guenter Blaich, AbbVie and Meghan Flaherty, Takeda

A biology driven approach to the calculation of a first-in-human starting dose

Madeline Fort, Amgen

Case examples of cancer immunotherapy projects with lack of relevant species for nonclinical safety testing

Anneliese Schneider, Roche

Overcoming species challenges for a bispecific safety assessment

Jennifer Brown, MacroGenics

Binding versus pharmacologically relevant species: Sara Santagostino,

1Fab HER2 TDB case study

Genentech

12:30-12:45 PM

Closing Remarks and Feedback from General Membership Jay Tibbitts, AbbVie and Victoria Dohnal, BIO

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