
Antibody-Drug Conjugates: An Emerging Modality for the Treatment of Cancer
Tuesday, January 28, 2014
Conventional anticancer therapeutics often suffer from lack of specificity, resulting in toxicities to normal healthy tissues and poor therapeutic index. Antibody-drug conjugates (ADCs) constitute a therapeutic modality in which a cytotoxic agent is chemically linked to an antibody (Ab) that recognizes a tumor-associated antigen. The basic strategy underlying ADC technology is to combine the target selectivity of mAbs with the potency of cytotoxic agents, such as certain natural products and synthetic molecules, with the goal of generating therapeutic drugs that are highly efficacious but also safe. The ADC platform currently includes a growing repertoire of cytotoxic payloads, linker technologies and conjugation methods. Two ADCs have recently received FDA approval and more than 30 are in clinical development. This symposium aims to highlight advances in ADC research, clinical development and regulatory perspectives. Topics will range from early phase research focused on development of novel linker-payload and conjugation chemistries to clinical concepts and development of biomarkers and patient selection strategies.
*Reception to follow.
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Student/Postdoc Member | $15 |
Nonmember (Academia) | $65 |
Nonmember (Corporate) | $85 |
Nonmember (Non-profit) | $65 |
Nonmember (Student / Postdoc / Resident / Fellow) | $45 |
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Agenda
* Presentation titles and times are subject to change.
Tuesday, January 28, 2014 | |
8:30 AM | Registration and continental breakfast |
9:00 AM | Welcome and Introduction: |
9:10 AM | Antibody-drug conjugates: Achievements, Challenges and Future |
9:50 AM | Clinical Development of Antibody-Drug Conjugates with a Focus on TDM1 in Breast Cancer |
10:30 AM | Networking coffee break |
11:00 AM | Potent Immunoconjugates for Cancer Therapy |
11:40 AM | Improved Efficacy of Antibody Drug Conjugates via Site-Specific Incorporation of Linkable Amino Acids |
12:20 PM | Networking lunch break |
1:20 PM | Nonclinical Safety Assessment of ADCS: Challenges of the Next Generation |
2:00 PM | Bench to Bedside Translation of ADC Efficacy |
2:40 PM | Networking coffee break |
3:10 PM | Regulatory Considerations for Antibody-Drug Conjugates: A Clinical Pharmacology Perspective |
3:50 PM | Diagnostic Approaches In Antibody-Drug Conjugate Development |
4:30 PM | Closing remarks Networking reception |
5:30 PM | Close |
Speakers
Organizers
Mercedes Beyna, MS
Pfizer
Mercedes Beyna is a scientist in the Neuroscience Research Unit at Pfizer. Her research focuses on target identification and assay development in the areas of psychiatric as well as neurodegenerative disorders. Captivated by neuroscience, she has worked in the field for over 10 years, in both academic and industrial laboratory settings. Before joining pharmaceutical R&D, Mercedes held lab manager and senior lab technician positions at New York University (NYU). Mercedes attended Binghamton University, earning her undergraduate degree in Biology, and subsequently received her Master's Degree in Biology from NYU. As the Pfizer lead in the Biochemical Pharmacology Discussion Group at the New York Academy of Sciences, she enjoys developing interesting and educational symposia.
Jennifer Henry, PhD
The New York Academy of Sciences
Puja Sapra, PhD
Pfizer
Nahor Haddish-Berhane, PhD
Pfizer
Dr. Nahor Haddish-Berhane is a Senior Principal Scientist working at Pfizer. He works in the area of oncology specifically ADC efficacy and toxicology translational research. Dr. Haddish-Berhane has over 8 years of research experience in PK/PD and systems pharmacology modeling and simulation of biological systems in disease areas such as cardiovascular and metabolic, antibacterial and intestinal inflammation. Dr. Haddish-Berhane received his PhD in Bioscience Engineering from Catholic University of Leuven, Belgium.
Mauricio Leal, PhD
Pfizer
Dr. Leal is currently an Associate Research Fellow in the Pharmacokinetics, Dynamics & Metabolism (PDM) department within the Biotherapeutics R&D at Pfizer. He is responsible for providing PDM support for the Oncology Research Unit at the Pearl River, NY site with primary focus on supporting the Antibody Drug Conjugate (ADC) research programs. Prior to that, he was a Senior Director, Pharmacokinetics, at Wyeth and he started his career at Lederle laboratories. He is a member of the AAPS, ISSX, AACR and the New York Academy of Sciences. Dr. Leal received his BS in toxicology and PhD in toxicology / pharmacology from St. Johns University, NY.
Dhaval K. Shah, PhD
The State University of New York at Buffalo
Dr. Dhaval Shah is an Assistant Professor in the Department of Pharmaceutical Sciences at the State University of New York at Buffalo. After his graduation from the same department, he joined Pfizer, and after 3 years he left Pfizer to pursue his academic career. Dr. Shah's research interests include discovery and development of novel biological drugs like ADCs for the treatment of cancer, obesity. His work integrates the principles of PK/PD and mathematical modeling to quantify the efficacy and toxicity of drugs, which in turn provides a predictive systems framework for successful preclinical-to-clinical translation of drugs.
Speakers
Alan Wahl, PhD
Ambrx, Inc.
Dr. Alan Wahl is Vice President, at Ambrx, Inc. in La Jolla, CA, and is responsible for discovery and pre-clinical development of their protein and drug-conjugate therapeutics. Dr. Wahl received his MS and PhD in Biochemistry / Biophysics from the University of Rochester, and completed post-doctoral work in Experimental Oncology at Stanford University. Over the past 25 years he has held senior drug discovery positions at Bristol-Myers Squibb, Seattle Genetics, Biogen Idec and Abbott Labs, and during this time has led the discovery and pre-clinical development of numerous antibody drug conjugates.
Nahor Haddish-Berhane, PhD
Pfizer
Sara Hurvitz, MD
UCLA Medical Center
Sara Hurvitz, MD, is an Assistant Professor of Medicine at the University of California, Los Angeles (UCLA); Co-Director of the Santa Monica-UCLA Outpatient Oncology Practice; Medical Director of the Clinical Research Unit of the Jonsson Comprehensive Cancer Center of UCLA; and Director of the Breast Oncology Program, Division of Hematology-Oncology, at UCLA. Dr. Hurvitz received her medical degree from the University of Southern California School of Medicine. She served her internship and residency at UCLA, and was selected Chief Resident of Internal Medicine for 2002-2003. She then completed a Hematology-Oncology Fellowship at UCLA in 2006. Dr. Hurvitz is board-certified in Internal Medicine, Hematology, and Medical Oncology. Dr. Hurvitz is a member of numerous professional organizations including the American Society of Clinical Oncology and the American Association of Cancer Research and is a Fellow of the American College of Physicians. Her research interests include the preclinical and clinical evaluation of cutting-edge targeted therapies for breast cancer including novel therapeutic combinations. She has served as Principal Investigator for over 25 phase I, II and III international breast cancer clinical trials including studies evaluating T-DM1 and has presented the results of her breast cancer research at multiple national and international symposiums. She has also been active in community service, breast cancer advocacy, and patient education. Dr. Hurvitz has received numerous honors, including in 2007 a Young Investigator Award from the American Society of Clinical Oncology as well as the Marni Levine Breast Cancer Research Award in 2008-2011, the Andrea Dembrowsky Breast Cancer Research Award in 2009-2010 and the Diana Gordon Jonsson Award for Clinical Excellence in 2011.
Omar Kabbarah, PhD
Genentech Inc.
At Genentech, Dr. Kabbarah leads three clinical-stage Oncology programs, including two Antibody-Drug Conjugates (ADCs), and is driving a Biomarker Disease Strategy focused on Colorectal Cancer. Prior to joining Genentech, he was Principal Scientist at AstraZeneca in Boston, where he established an Oncology Target Discovery group and actively contributed to a Breast Cancer Strategy as a member of a Global Disease Area Team. He also headed an Oncology Target Identification and Validation group at AVEO Pharmaceuticals that delivered tens of well-validated oncology targets.
His educational background encompasses a variety of areas, including CNS development for an MS degree at the NIH, establishment and characterization of mouse models of cancer as part of a PhD from Washington University School of Medicine, and melanoma genomics and disease biomarker discovery as a post-doc at the Dana-Farber/Harvard Cancer Institute, where he discovered the first-in-class Golgi oncoprotein GOLPH3.
Puja Sapra, PhD
Pfizer
Puja Sapra is Senior Director at the Oncology Research Unit, Pfizer where she oversees all antibody drug conjugate therapeutic programs. Prior to joining Pfizer, she led Pharmacology groups at Enzon Pharmaceuticals and Immunomedics Inc. and developed oncology-based drugs that are undergoing clinical evaluation. She received a Bachelor's degree from All India Institute of Medical Sciences, MS from UK and a PhD in Pharmacology from University of Alberta, Canada. Since PhD she has developed various therapeutic modalities including antibodies, antibody-drug conjugates, pegylated drugs, nanoparticles and antisense oligonucleotides. She is an author of >50 scientific publications, book chapters and co-inventor on several issued patents. She has received numerous honors and grants some of which include British Chevening scholarship, Alberta Heritage foundation fellowship, NIH SBIR grant and EHA young investigator award.
Peter D. Senter, PhD
Seattle Genetics, Inc.
Peter Senter joined Seattle Genetics in August 1998 and has served as Vice President, Chemistry since September 2002. In February 2009, Dr. Senter was recognized as the company's first Distinguished Fellow. He leads Seattle Genetics' chemistry department, which carries out research in antibody-drug conjugate technologies, including the development of potent drug payloads, novel linker systems, conjugation methodology and mechanism of action studies. The work from his group at Seattle Genetics provided the basis for Adcetris, an approved antibody drug conjugate for the treatment of relapsed Hodgkin lymphoma and anaplastic large cell lymphoma. Prior to joining the company, Dr. Senter was with Cytokine Networks, Inc., the Bristol-Myers Squibb Pharmaceutical Research Institute and the Dana-Farber Cancer Institute, Harvard Medical School. While at Bristol Myers Squibb, Dr. Senter and his colleagues developed Etopofos, a water soluble anticancer prodrug approved for solid tumor therapy. Dr. Senter received an AB in Biochemistry from the University of California, Berkeley, a PhD in Chemistry from the University of Illinois, and did postdoctoral research at the Max Planck Institute of Experimental Medicine in Göttingen, Germany. He is the Senior Editor of Bioconjugate Chemistry and serves as an Affiliate Professor of Bioengineering at the University of Washington. His research interests include targeted drug delivery, protein chemistry and biochemistry, and anti-cancer drug design. Dr. Senter has authored more than 130 scientific publications and holds more than 40 patents.
Melissa M. Schutten, DVM, PhD, DACVP
Genentech Inc.
Dhaval K. Shah , PhD
The State University of New York at Buffalo
Dr. Dhaval Shah is an Assistant Professor in the Department of Pharmaceutical Sciences at the State University of New York at Buffalo. After his graduation from the same department, he joined Pfizer, and after 3 years he left Pfizer to pursue his academic career. Dr. Shah's research interests include discovery and development of novel biological drugs like ADCs for the treatment of cancer, obesity. His work integrates the principles of PK/PD and mathematical modeling to quantify the efficacy and toxicity of drugs, which in turn provides a predictive systems framework for successful preclinical-to-clinical translation of drugs.
Stacey S. Shord, PharmD, BCOP, FCCP
Food and Drug Administration: Silver Spring, MD
Dr. Shord is a reviewer for the Office of Clinical Pharmacology in the US Food and Drug Administration. She received her Doctorate in Pharmacy from the University of Maryland at Baltimore in 1997. Dr. Shord then completed a Pharmacy Practice residency at the University of Pittsburgh Medical Center and an Oncology Pharmacy Practice residency at the UNC Hospitals. She next completed a fellowship in Oncology Pharmacotherapy at the School of Pharmacy, University of North Carolina in 2001. Dr. Shord joined the faculty at the College of Pharmacy, University of Illinois at Chicago in 2001 as assistant professor where her research focused on drug metabolism in patients with cancer and hematological diseases. She joined the Food and Drug Administration in 2009 as a reviewer of oncology drug products. Special interests include the clinical development of antibody-drug conjugates and epigenome targeted drugs. Dr. Shord earned her Board Certification in Oncology Pharmacy in 2000. She has authored 44 peer reviewed papers and 9 book chapters. She is an active member of the American Society for Clinical Pharmacology and Therapeutics and the American College of Clinical Pharmacy.
Abstracts
ADCs: Achievements, Challenges and Future
Puja Sapra, PhD, Pfizer
Clinical development of Antibody-drug conjugates with a focus on TDM1 in breast cancer
Sara Hurvitz, MD, UCLA Medical Center
Potent Immunoconjugates for Cancer Therapy
Peter D. Senter, PhD, Seattle Genetics, Inc.
Improved Efficacy of Antibody Drug Conjugates via Site-Specific Incorporation of Linkable Amino Acids
Dr. Alan Wahl, Vice President of Discovery & Pre-Clinical Development, Ambrx, Inc. La Jolla, CA
Nonclinical Safety Assessment of ADCS: Challenges of the Next Generation
Melissa M. Schutten, DVM, PhD, DACVP, Genentech, Inc., Safety Assessment
Bench to Bedside Translation of ADC Efficacy
Dhaval K. Shah, PhD, The State University of New York at Buffalo
Nahor Haddish-Berhane, PhD, Pfizer
Regulatory Considerations for Antibody-drug Conjugates: A Clinical Pharmacology Perspective
Stacey S. Shord, PharmD, BCOP, FCCP, Food and Drug Administration
Diagnostic Approaches in Antibody-Drug Conjugate Development
Omar Kabbarah, PhD, Genentech Inc.
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