SUNDAY, APRIL 29

Part I (Morning, 10:00 am – 1:00 pm):
Translational Considerations for Development of Monoclonal Antibodies and Emerging Constructs: Focus on Construct Design

Part 2 (Afternoon, 2:00 pm – 5:00 pm):
Translational Considerations for Development of Monoclonal Antibodies and Emerging Constructs: Focus on Preclinical Development

The class is designed as a full-day; it is recommended that attendees register for both Part 1 and Part 2 to receive the full benefit of the course

Biologics are one of the fastest growing subsets of pharmaceuticals today. In 2016, various monoclonal antibodies were approved by the FDA for diverse conditions such as psoriasis and cancer. This approval trend for monoclonal antibodies was also observed in 2015. Such high approval rate for biologics is a testament to advances in antibody technology and the unique advantage that this class of therapeutics offers. In addition to monoclonal antibodies, other biologics such as antibody drug-conjugates, multi-specific constructs, and antibody-derived modalities are also being considered as viable drug candidates for development. With so many players in the market, it becomes imperative to have an efficient and effective translational approach early on in the drug development process. Clarity on patient-related variables, construct manufacturing considerations, underlying pharmacology and pathophysiology, as well as integration of key translational considerations can accelerate drug development processes, ultimately benefiting patients in need of such therapies. This full-day course, addresses topics related to preclinical development related to novel and complex modalities.

Attendees will learn:

Part 1 (Morning): Focus on Early Discovery and Construct Design:

• Critical considerations for development of biologics
• Antibody affinity and biophysical characterization: Biacore and Kinexa
• Evaluation of factors that govern construct’s design and affinity design goals

Part 2 (Afternoon): Focus on Preclinical Development:

• Considerations for target selection, antibody screening and mAb preclinical development
• Application of antibody engineering in the development of next generation antibody-based therapeutics
• Critical translational considerations

Instructors:

Glareh Azadi, PhD, Senior Scientist, Translational PKPD, Merck Research Laboratories

Gadi Bornstein, PhD, Senior Director, Biologics Discovery, TESARO, Inc.

Veronica Juan, PhD, Principal Scientist, Protein Sciences, Merck Research Labs

Scott L. Klakamp, PhD, Senior Director, Head of Biophysics, Janssen R&D, LLC

Mohammad Tabrizi, PhD, Director Biologics Discovery, Merck Research Laboratories Palo Alto

PART 1
SUNDAY, APRIL 29 Morning, 10:00 am – 1:00 pm

Translational Considerations for Development of Monoclonal Antibodies and Emerging Constructs: Part I: Focus on Construct Design

It is recommended that attendees register for both Part 1 and Part 2 to receive the full benefit of the course.

10:00 Introduction and Overview

Mohammad Tabrizi, PhD, Director, Biologics Discovery, Merck Research Laboratories Palo Alto

10:15 Translational Considerations and Challenges: An Overview

Glareh Azadi, PhD, Senior Scientist, Translational PKPD, Merck Research Laboratories

11:00 Networking Coffee Break

11:15 Antibody Affinity and Biophysical Characterization

Scott L. Klakamp, PhD, Senior Director, Head of Biophysics, Janssen R&D, LLC

12:00 Considerations for Construct Design and Affinity Design Goals

Mohammad Tabrizi, PhD, Director, Biologics Discovery, Merck Research Laboratories Palo Alto

12:45 Interactive Q&A with Faculty

1:00 Close of Morning Session, End of Part 1

Part 2
SUNDAY, APRIL 29 Afternoon, 2:00 pm – 5:00 pm

Translational Considerations for Development of Monoclonal Antibodies and Emerging Constructs: Part 2: Focus on Preclinical Development

It is recommended that attendees register for both Part 1 and Part 2 to receive the full benefit of the course.

2:00 Considerations for Target Selection, Antibody Preclinical Screening & Development

Gadi Bornstein, PhD, Senior Director, Biologics Discovery, TESARO, Inc.

2:45 Antibody Engineering and Technologies

Veronica Juan, PhD, Principal Scientist, Protein Sciences, Merck Research Labs

3:30 Networking Coffee Break

3:45 Considerations for Development of Novel Constructs (ADC & multi-specific)

Mohammad Tabrizi, PhD, Director, Biologics Discovery, Merck Research Laboratories Palo Alto

4:45 Interactive Q&A with Faculty

5:00 End of Part 2

Speaker Biographies

Glareh Azadi, PhD, Senior Scientist, Translational PKPD, Merck Research Laboratories

Glareh Azadi, Ph.D is a senior scientist in PPDM ADME Biologics group at MRL, Palo Alto. She joined MRL in 2016 and works in various projects in early discovery of therapeutic antibodies. She holds a Ph.D in Biomedical Engineering from Brown University.

Gadi Bornstein, PhD, Senior Director, Biologics Discovery, TESARO, Inc.

Dr. Bornstein has over fifteen years of experience in Oncology R&D with an emphasis in preclinical antibody discovery and development. Dr. Bornstein currently leads biologics discovery efforts at TESARO. He received his B.S. in biochemistry at the University of California, Davis and his doctoral degree in biochemistry at the University of Southern California Keck School of Medicine. Dr. Bornstein completed his postdoctoral training at Stanford University in the Division of Immunology and Rheumatology.

Following his postdoctoral training, Dr. Bornstein joined Amgen Fremont, Inc. (formerly Abgenix, Inc.) as a Staff Scientist in the Preclinical Oncology department. Dr. Bornstein has held roles of increasing responsibility at AstraZeneca, Pfizer, and Novartis, where he was a project team leader, lead biologist, and key contributor to scientific strategies for multiple oncology programs.

Veronica Juan, PhD, Principal Scientist, Protein Sciences, Merck Research Labs

Since completing her graduate studies at the University of California, Santa Cruz, Veronica Juan has worked in computational biology and antibody engineering at several biotechnology companies in the San Francisco Bay Area for the past fifteen years. These include Eos Biotechnology, Protein Design Labs (PDL), Abbott (now Abbvie), and Full Spectrum Genetics, Inc. She is currently a Principal Research Scientist at Merck, Discovery Biologics, in the engineering group within Protein Sciences, focusing on in silico assessment and engineering of antibody candidates for developability and lead selection.

Scott L. Klakamp, PhD, Senior Director, Head of Biophysics, Janssen R&D, LLC

Dr. Scott Klakamp is the Sr. Director and Head of Biophysics at Janssen R&D, LLC.  Dr. Klakamp is one of the leading scientists in utilizing Biacore® and KinExA® to measure the binding kinetics and equilibrium dissociation constants of human monoclonal antibody/antigen complexes. Prior to Janssen, Dr. Klakamp was the Founder and Principal Consultant of SKD Consulting LLC. Before SKD Consulting, he was the Vice President of Chemistry and Biochemistry at BiOptix Inc. Dr. Klakamp has also held positions of increasing responsibility in the areas of analytical and biophysical characterization at Chiron, Amgen/Abgenix, AstraZeneca/MedIummune, and Takeda Pharmaceuticals. 

Mohammad Tabrizi, PhD, Director and Head, Biologics Discovery, Merck Research Laboratories Palo Alto

Mohammad Tabrizi, PhD is a leader in translational sciences as related to development of antibody-based therapeutics. His product development experience spans many therapeutic areas including oncology and inflammatory disease, and his technical expertise includes preclinical pharmacology and safety, preclinical and clinical pharmacokinetics, pharmacodynamics, GLP-compliant bioanalytics, and clinical pharmacology of therapeutic monoclonal antibodies.