Hot Technologies for Developing Next-Gen Biologics

Speakers

Organizers

Robert Martone

St. Jude Children’s Research Hospital

Robert Martone recently joined the Pathology Department at St. Jude Children's Research Hospital to conduct biomarker research and development with a focus on neuro-oncology. He was previously Neuroscience Therapeutic Area Lead for the Covance Biomarker Center of Excellence. He has extensive experience in the pharmaceutical industry leading neuroscience drug discovery and technology teams through all phases of discovery from target identification through clinical trials with expertise in both small molecule and protein therapeutics. He also has several years of academic research experience in molecular neurobiology, with a focus on the molecular genetics of familial neuropathies, and CNS tumor biomarker development. Since the year 2000, he has helped organize 12 BPDG symposia.

Heather Shih, PhD

Pfizer Centers for Therapeutic Innovation

Heather received her BS in Chemistry from the University of Massachusetts at Lowell and PhD in Biochemistry from Tufts University School of Medicine. She received her postdoctoral trainings at Harvard Medical School and Genetics Institute/Wyeth. During her 12 years of drug discovery career at Pfizer, Heather was involved in developing and applying new technologies to biotherapeutic discovery, which included recombinant protein and phage display technologies. She also co-led a number of drug discovery projects in collaboration with scientists in Neuroscience and Cardiovascular Diseases departments. Currently as a biotherapeutic sourcing lead for Pfizer's External Research Solutions (ERS) group, Heather functions as an alliance manager in several major collaborations between Pfizer's research units and global contract research organizations (CROs). Throughout her career, Heather authored 20 peer-reviewed papers, two book chapters on therapeutic antibody discovery process, and was a co-inventor on three patents. She was instrumental in initiating a new Gordon Research Conference series on Antibody Biology and Engineering in 2010, and co-chaired the 2011 NYAS symposium "Are Neurodegenerative Diseases Spreading? Disease Propagation in Protein Misfolding" and the 2012 NYAS symposium "The New Age of Antibody Therapeutics".

Jennifer Henry, PhD

The New York Academy of Sciences

Speakers

Timothy Charlebois, PhD

Pfizer

Timothy Charlebois, PhD is Vice President of Technology and Innovation Strategy for BioTherapeutics Pharmaceutical Sciences at Pfizer. In this role, he is responsible for developing, integrating and maintaining strategy for process, product and analytical technologies in support of the BioTherapeutics portfolio at Pfizer. He is also responsible for supporting biologics in-licensing and out-licensing activities. He has 20 years’ experience in mammalian and microbial process development, including expression vector design, cell line selection and screening, GMP cell banking and characterization, genetic stability and viral safety testing, cell culture and purification process design and validation, as well as biochemical and microbial assay development and quality control. Dr. Charlebois began his career in 1990 at Genetics Institute and has contributed to the development and registration of drug substance manufacturing for Recombinate®, BeneFIX®, Neumega®, ReFacto®, Infuse™ Bone Graft and Enbrel®.

David J. King

Chief Scientific Officer, AnaptysBio, Inc.

David King is currently Chief Scientific Officer for AnaptysBio, where he leads a group developing antibody therapeutics using a novel technology based on somatic hypermutation and mammalian cell display. Dr. King is an established expert in antibody engineering and antibody therapeutics and has been involved in the design and development of three FDA-approved antibody therapeutics and numerous other clinical stage antibodies. At Celltech in the UK, he was involved in the design and development of Mylotarg®, an antibody-drug conjugate for therapy of acute myeloid leukemia, and was the lead inventor of Cimzia®, a PEGylated antibody fragment for therapy of autoimmune diseases. Prior to AnaptysBio, Dr. King was at Medarex where he was involved in the design and selection of therapeutic antibodies, and he led the development of a new class of antibody-drug conjugates.

William M. Pardridge, MD

Brain Research Institute, UCLA

William M. Pardridge, MD, is Distinguished Professor Emeritus, University of California. Dr. Pardridge has worked on the blood-brain barrier (BBB) since 1970, and has published over 500 publications in the field. He is the inventor of the BBB molecular Trojan horse technology, the field of Trojan horse liposomes for non-invasive, non-viral gene therapy of the brain, and the field of BBB genomics. Dr. Pardridge is Founder and Chief Scientific Officer of ArmaGen Technologies, Inc. He founded ArmaGen in 2004 to develop the BBB Trojan horse technology. At ArmaGen, biologic drugs, which normally do not cross the BBB, are re-engineered to enable BBB penetration. This is possible by re-engineering the biologic drug as a BBB-penetrating IgG fusion protein. Dr. Pardridge and colleagues developed genetically engineered monoclonal antibodies (MAb) against endogenous human BBB receptors, such as the insulin receptor or transferrin receptor. Such receptor-specific MAbs cross the BBB via receptor-mediated transport. The development of such molecular Trojan horses enabled the re-engineering of multiple classes of biologics for penetration of the human BBB, including lysosomal enzyme drugs, therapeutic antibody drugs, neurotrophins, and decoy receptor drugs for brain. First In Human clinical trials are scheduled for 2014 with an IgG-lysosomal enzyme fusion protein.

Steve Projan, PhD, FAAM

iMED Head: Infectious Diseases & Vaccines

Dr. Steve Projan is the Head of Infectious Diseases & Vaccines Innovative Medicines unit (iMED) at MedImmune, leading a cross-functional team dedicated to the therapeutic area strategy, prioritization and advancement of the company's infectious disease and vaccine portfolio.

Dr. Projan joined MedImmune in 2010 as senior vice president of research and development and head of the Infectious Diseases & Vaccines iMED.

Prior to joining MedImmune, Dr. Projan served as vice president and global head of Infectious Diseases at Novartis. He previously spent 15 years at Wyeth in roles of increasing responsibility with his last post as vice president and head of Biological Technologies. During his time at Wyeth, Dr. Projan started the Biologics Discovery Group (covering all therapeutic areas) and initiated multiple collaborations and partnerships, most notably with Cambridge Antibody Technology (now a part of MedImmune/AZ). Prior to Dr. Projan's work in the industry, he spent 14 years at the Public Health Research Institute and presently has over 110 publications to his credit.

Dr. Projan received a bachelor of science from the Massachusetts Institute of Technology and masters of arts and philosophy in biological sciences and a doctorate in molecular genetics from Columbia University.

Sachdev Siddhu, PhD

University of Toronto

Sachdev Sidhu studied chemistry at Simon Fraser University and obtained his B.Sc. with honors in 1991. He then continued his graduate work at Simon Fraser University where he investigated enzyme function, and obtained his Ph.D. in 1996. Following a postdoctoral research fellowship with James Wells at Genentech, Dr. Sidhu joined the Protein Engineering department as a principal investigator in 1998. In 2008, Dr. Sidhu moved to the University of Toronto, where he is a professor in the Banting and Best Department of Medical Research and the Department of Molecular Genetics. He has published more than 100 scientific papers and is a co-inventor on more than 30 patents filed with the US patent office. Dr. Sidhu's research interests focus on the use of combinatorial biology methods to explore protein structure and function, and his group is currently developing synthetic antibody libraries and other scaffolds as sources of potential therapeutics.

E. Sally Ward, PhD

UT Southwestern

Sally Ward received the PhD degree from the Department of Biochemistry, Cambridge University in 1985. From 1985-1988 she was a Research Fellow at Gonville and Caius College whilst working at the Department of Biochemistry at Cambridge University. She held the Stanley Elmore Senior Research Fellowship from 1988-1990, whilst carrying out research in Sir Greg Winter’s laboratory at the MRC Laboratory of Molecular Biology in Cambridge.

In 1990 she joined the University of Texas Southwestern Medical Center as an Assistant Professor. She currently holds the Paul and Betty Meek-FINA Professorship in Molecular Immunology. Her current research interests include understanding FcRn function in mouse and man, using a combination of fluorescence imaging, protein engineering and in vivo studies to understand the factors that regulate the distribution and transport of antibodies. A second area of interest is to characterize the behavior, at the subcellular level, of molecular targets in cancer. Her work includes the development of antibody-based therapies in mouse models of multiple sclerosis, arthritis and cancer. She is a member of the Board of Distinguished Advisors in the Antibody Society and serves on the editorial boards of MAbs and Protein Engineering, Design and Selection.

Patrick C. Wilson, PhD

The University of Chicago

K. Dane Wittrup, PhD

Massachusetts Institute of Technology

Professor K. Dane Wittrup is the Joseph R. Mares Professor of Chemical Engineering and Biological Engineering at the Massachusetts Institute of Technology, a position he has held since 1999. From 1989–1999 he was Assistant Professor, Associate Professor, and then J. W. Westwater Professor of Chemical Engineering, Bioengineering, and Biophysics at the University of Illinois in Champaign/Urbana.

Professor Wittrup received a BS in Chemical Engineering Summa cum Laude in 1984 from the University of New Mexico, and a PhD in Chemical Engineering from the California Institute of Technology in 1988 under the thesis direction of Professor James Bailey. Following a year of postdoctoral research at Amgen (Thousand Oaks, CA), Dr. Wittrup joined the faculty at the University of Illinois.

Wittrup's research program is focused on protein engineering of biopharmaceutical proteins by directed evolution. Areas of interest include: pretargeted radioimmunotherapy; biological response modification of EGFR; and immunotherapy of cancer via engineered cytokines and vaccines.

Professor Wittrup has received the following awards and honors recognizing his scholarship: the A. McLaren White Award, for First Prize in the National American Institute of Chemical Engineers Student Design Contest (1984); the Presidential Young Investigator Award of the National Science Foundation (1990–1995); the Allan P. Colburn Award of the American Institute of Chemical Engineers, for excellence in publications for an individual under the age of 35 (1998); the University of New Mexico College of Engineering Distinguished Young Alumnus Award (2000); the Dow Chemical Company Teaching Award (1989); the UIUC School of Chemical Sciences Award for Excellence in Teaching (1993); the UIUC College of Engineering Anderson Award for Undergraduate Advising (1991, 1994); the J.R. Mares Professorship (1999); and induction as a Fellow of the American Institute of Medical and Biological Engineers (1999).

Professor Wittrup has mentored the following PhD students and postdoctoral fellows who are now faculty members: Jennifer Cochran (Bioengineering, Stanford University); Anne Robinson (Chemical Engineering, University of Delaware); Eric Boder (Chemical Engineering, University of Pennsylvania); Eric Shusta (Chemical Engineering, University of Wisconsin, Madison); Jennifer van Antwerp (Chemical Engineering, Calvin College); Balaji Rao (Chemical Engineering, North Carolina State University); Yong-Sung Kim (Biotechnology, Ajou University, Korea); Mark Olsen (Biochemistry, Texas A&M, Amarillo).