September 22-24, 2015 | Boston, MA

Day One

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Wednesday September 23rd

08:30
Registration & Networking

08:50
Chair’s Opening Remarks

Rakesh Dixit, VP, R&D, MedImmune

Rakesh Dixit

Rakesh’s areas of expertise are mainly in the area of pharmaceuticals and biologics drug development, safety assessment of small molecule drugs, biologics, vaccines and in exploring mechanisms of toxicity and biologics pharmacological activity.  Rakesh has helped to bring several blockbuster pharmaceuticals to the market while working at Merck. Rakesh a recognized expert in safety and pharmacology biomarkers and their applications..  Rakesh is the Editor-in-chief of Toxicology Mechanisms and Methods and Associate Editor for Toxicology Applied Pharmacology, and Journal of Toxicology and Environmental Health. Rakesh also serves as an expert reviewer and in appointed committee for many programs managed by the prestigious U.S. National Academy of Sciences and US National Institutes of Health, including National Cancer Institute.

09:00
Landscape Overview Highlighting Optimization Of Bispecific Development

 

  • Highlights from late stage preclinical and clinical bispecifics
  • Lessons learned so far on the development of bispecifics
  • Critical considerations for successful future bispecific development

Rakesh Dixit, VP, R&D, MedImmune

Rakesh Dixit

Rakesh’s areas of expertise are mainly in the area of pharmaceuticals and biologics drug development, safety assessment of small molecule drugs, biologics, vaccines and in exploring mechanisms of toxicity and biologics pharmacological activity.  Rakesh has helped to bring several blockbuster pharmaceuticals to the market while working at Merck. Rakesh a recognized expert in safety and pharmacology biomarkers and their applications..  Rakesh is the Editor-in-chief of Toxicology Mechanisms and Methods and Associate Editor for Toxicology Applied Pharmacology, and Journal of Toxicology and Environmental Health. Rakesh also serves as an expert reviewer and in appointed committee for many programs managed by the prestigious U.S. National Academy of Sciences and US National Institutes of Health, including National Cancer Institute.

09:30
KEYNOTE: Bispecific T Cell Engager (BiTE®) Antibodies: Blinatumomab & Beyond

  • Cellular mechanism of action of the BiTE®
  • Successful development of Blinatumomab
  • Considerations for future development of BiTE® antibodies

Julie Bailis, Principal Scientist, Amgen

Julie Bailis1

Julie Bailis is a Principal Scientist in Oncology Research at Amgen, South San Francisco. Julie received her Ph.D. in Molecular and Cellular Biology from Yale University and then was a Damon Runyon postdoctoral fellow at the Salk Institute for Biological Studies. Her research has primarily focused on targeting DNA repair pathways in cancer, but in the last few years has expanded to include T cell targeted cancer therapy. Since joining Amgen in 2006, Julie has led teams for small molecule and large molecule programs from target identification and validation through pre-clinical development.

10:00
Speed Networking & Morning Refreshments

The Speed Networking session is the most valuable hour you’ll spend at the conference and a great opportunity to introduce yourself to the attendees that you would like to have more in-depth conversations with. This session is the ideal opportunity to get face-to-face time with many of the brightest minds working in the field and establish meaningful business relationships.

DISCOVERY STREAM: Broadening The Target Pool For Bispecifics

11:30 - Gbr1302-Beat® Bispecific Antibody For The Treatment Of HER2 Positive Cancers

  • High yield and purity manufacturability (GMP) using standard mAb process
  • GBR1302 potently redirects T cell cytotoxicity to HER2 positive cancer cells both in vitro and in vivo
  • Potential to overcome most of the pitfalls of current HER2- targeting therapies
  • Large therapeutic window and absence of non-specific T cell activation

Jonathan Back, Head, Glenmark Pharmaceuticals

12:00 - A Bispecific Antibody (mAb2) Targeting CTLA-4 & EGFR Shows Superior Efficacy In A Syngeneic Mouse Tumor Model

  • A bispecific antibody was generated by introducing an EGFR binding site into the Fc region of a CTLA-4 mAb using F-Star’s proprietary Modular Antibody Technology
  • EGFR/CTLA-4 bispecific showed superior efficacy in an in vivo model compared to anti-EGFR and anti-CTLA-4 mAb
  • Efficacy of the bispecific in the mouse model did not correlate with Treg depletion, suggestive of novel biology derived from the bifunctionality

Haijun Sun, VP, F-Star

DEVELOPMENT STREAM: Improving Preclinical Development

11:30 - Anti-CD20/CD3 T Cell Dependent Bispecific Antibody (TDB) As Potential Therapy For B Cell Malignancies

  • Development of a preclinical candidate based on the “knobs-into-holes” technology
  • CD20-TDB shows activity in primary patient leukemia and lymphoma cells both in vitro and in vivo
  • PK and PD results from cyno studies will be shared

Laura Sun, Senior Research Associate, Genentech

12:00 - Novel, Potent CEA Targeting T Cell Bispecific Antibody For The Treatment Of Solid Tumors

  • Development and optimization of a new T cell bispecific antibody format
  • Better differentiation between cells with high vs. low antigen expression levels
  • Molecules with extended half-life and superior potency
  • Convenient production in standard CHO process

Peter Bruenker, Head, Roche

12:30
Lunch & Networking

DISCOVERY STREAM: Optimization Of Bispecifics

13:30 - Explore Optimization Of Bi-functional T Cell Targeting Platform

  • Discover optimization strategy of binding domain
  • Evaluate development and optimization experiences of a bi-functional T cell engaging platform
  • Consider manufacturability properties during design

Lioudmila Tchistiakova, Senior Director, Pfizer

14:00 - Engineering Of A Novel Bispecific Format For Bioactivity & Developability

  • Engineering bispecifics using rapid prototyping and characterization cycles
  • Effectively using high-throughput assays to predict the developability profile of bispecifics

Melissa Geddie, Principal Scientist, Merrimack Pharmaceuticals

14:30 - Panel: How Do We Overcome Optimization Challenges?

This audience participation panel discussion will give you multiple perspectives, ideas and insight on overcoming the complexities of optimizing a bispecific. Leave with a toolbox of solutions to accelerate the robust optimization of your bispecific.

  • Effectively validate synergistic target pairs
  • Evidence-based approach for bispecific optimization
  • What parameters to consider when developing a bispecific

Chair: Rakesh Dixit, VP, R&D, MedImmune

Panellists: To come from audience and speaker faculty

DEVELOPMENT STREAM: Improving Preclinical Development

1:30 - Bispecific Nanobodies With Enhanced Cell Specificity

  • Examples of bispecifics targeting multiple pathways
  • Understand how to enhance specificity of therapeutics
  • Improvements of 10-1700-fold in targeting cells of interest vs. normal cells through engineering of bispecifics

Tony De Fougerolles, CSO, Ablynx

14:00 - Challenges Of FIH Dose Escalation Studies For Novel Therapeutic Antibodies

  • Overcome clinical challenge of dose escalation studies for bispecifics

Setareh Van Driel Shamsili, CMO, Merus

14:30 - Panel: How Do We Overcome Preclinical Development Challenges?

During this session you will engage in an important debate on how to improve bispecific development. Leave the room with comprehensive knowledge of how to effectively translate into the clinic. Quickly identify the signs for clinical success and failure.

  • How are drug developers effectively screening bispecifics?
  • Lessons learned from preclinical development can help us predict clinical efficacy
  • What else do we need?

Chair: Patrick Baeuerle, Managing Director, MPM Capital

Panellists: To come from audience and speaker faculty

15:00
Afternoon Refreshments & Networking

Maximize Developability & Manufacturability of Bispecifics

15:30
To Be Confirmed

TBC, TBC, Pall ForteBio LLC

ForteBio

16:00
Developability Considerations For Bispecifics – Do Not Be Deceived

  • Challenges associated with asymmetric constructs
  • Confirmation of serum compatibility of bispecifics

Mark Chiu, Associate Director, Janssen

Mark Chiu

Mark received his PhD from University of Illinois, before taking post doctoral positions at ETH Zurich and University of Basel Biozentrum. Mark focuses on biophysics, developability and multispecific biologics at Janssen.

16:30
Rapid, Scalable Expression of Bispecific Drugs In CHO Cells

 

  • A streamlined approach to producing bispecific antibodies in CHO cells.
  • Functional assay results of transiently produced bispecific antibodies.
  • Scaling up or scaling down to align yields and resource usage with the stage of candidate development.

James Brady, Vice President, Technical Applications & Customer Support, MaxCyte

James Brady Speaker

James Brady, Ph.D., is Vice President of Technical Applications and Customer Support at MaxCyte, Inc, where he has worked since 2004. Prior to joining MaxCyte, Dr, Brady was a Senior Scientist at Genetic Therapy, Inc. (a Novartis subsidiary) and a Group Leader at MetaMorhpix, Inc. Dr. Brady earned a B.S. in Biology from the College of William and Mary and a Ph.D. in Genetics from Indiana University. He also received postdoctoral training in the National Eye Institute of the National Institutes of Health.

17:00
Addressing Purification Challenges of Bispecific Antibodies Using Alkaline Cation-Exchange Chromatography

  • Unique challenges associated with bispecific antibodies
  • Utilizing alkaline cation-exchange chromatography for impurity reduction
  • Developing scalable manufacturing process for bispecific antibodies

Troii Hall, Research Scientist, Eli Lilly

Troii Hall

Troii Hall, M.S., Associate Consultant Chemist, Bioprocess Research and Development, Eli Lilly and Company, Indianapolis, Indiana.

17:30
Chair’s Stream Summaries & Chair’s Closing Remarks

Rakesh Dixit, VP, R&D, MedImmune

Rakesh Dixit

Rakesh’s areas of expertise are mainly in the area of pharmaceuticals and biologics drug development, safety assessment of small molecule drugs, biologics, vaccines and in exploring mechanisms of toxicity and biologics pharmacological activity.  Rakesh has helped to bring several blockbuster pharmaceuticals to the market while working at Merck. Rakesh a recognized expert in safety and pharmacology biomarkers and their applications..  Rakesh is the Editor-in-chief of Toxicology Mechanisms and Methods and Associate Editor for Toxicology Applied Pharmacology, and Journal of Toxicology and Environmental Health. Rakesh also serves as an expert reviewer and in appointed committee for many programs managed by the prestigious U.S. National Academy of Sciences and US National Institutes of Health, including National Cancer Institute.

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