Susan Alters, PhD, is the Principal Consultant and President of Alters Bioscience Consulting. Dr. Alters has over twenty years of experience in the biotechnology industry focusing on drug development of therapeutic agents from basic research through lead selection, optimization, preclinical development, IND-enabling studies, and Phase I clinical trials. Her expertise spans multiple clinical areas, as well as a wide range of therapeutic approaches, and study designs.
Dr. Alters has drug development experience from both the biotech sponsor and CRO provider side. She has held management positions with several biotech companies directing research and development groups, managing cross-functional project teams, initiating collaborations with contract labs, government agencies, and thought leaders in academia and industry, and working with business and legal departments. In addition, Dr. Alters has managed an accredited animal facility responsible for all biotech research and preclinical development activities and served on the Institutional Animal Care and Use Committee (IACUC). She has valuable hands-on expertise in cell biology, pharmacology, and implementing animal models of human disease. Dr. Alters has peer-reviewed publications on preclinical development of therapeutics for oncology, endocrinology, asthma, allergy, diabetes, multiple sclerosis, transplantation and immunotherapy and has been an invited presenter at many prestigious scientific meetings.
Dr. Alters holds a Ph.D. from Stanford University and a B.S. from the University of Rochester. She is located in the San Francisco Bay Area, home to many start-up and successful biotechnology companies.
- Ph.D. Cancer Biology, Stanford University, Stanford, CA.
- B.S. Molecular Genetics with high distinction in research, University of Rochester, NY.
- Strategic planning, due-diligence and project assessment
- Management of project and development team
- Diverse clinical indications including oncology, inflammation, endocrinology, autoimmunity, metabolics, infectious disease, asthma/allergy, pain, transplantation, hematology, and intestinal disease
- Drug development experience from both CRO provider and biotech sponsor side
- Multiple therapeutic strategies including peptides, proteins, small molecules, nanoparticles, antibodies, cell and gene therapy, vaccines, combination therapy, and drug delivery
- Variety of study types including in vivo proof of concept, in vitro activity/MOA, selection of predictive model, efficacy and dose optimization, pharmacokinetics, pharmacodynamics, ADME, toxicology, biomarker assessment, and assay development
- Liaison between industry professionals, CROs, academic thought leaders, business and venture groups and government agencies
- Scientific and corporate writing (study reports, publications, abstracts, grants, patents, INDs, investigator brochures, executive summary))
- Presentations to scientists, management, investors, and professional conferences
Susan E. Alters, Ph.D.
Principal Consultant and President of Alters Bioscience Consulting
6/03 – present
Work with biotech and pharma clients to provide preclinical drug development strategy and implementation on their proprietary compounds. Responsibilities include the design and management of in vitro activity and mechanism of action, as well as in vivo efficacy, pharmacology and pharmacokinetic studies, the evaluation and direction of CROs and academic collaborators, performing due-diligence on new corporate ventures and in-licensing opportunities, and writing study reports, INDs, grants, business plans and other documents.
Senior Director, Preclinical Drug Development, Amunix
12/09 – present
Provide preclinical drug development strategy for Amunix, an early stage biopharma company using its proprietary XTEN technology to create superior pharmaceutical proteins. Responsibilities include the design and implementation of PK/PD studies for protein pharmaceuticals in endocrinology, immunology, hematology, oncology, intestinal disease and other disease indications.
Director Drug Discovery Research, Targesome Inc
9/02 – 6/03
Developed and led pre-clinical R&D program to assess mechanism of action, efficacy, and safety for lead targeted nanoparticle therapeutic for oncology. Led collaborations with pharmaceutical, academic, and government groups. Evaluated new product opportunities including appropriate target and targeting agent selection, technology platform and biological models. Provided in vitro and in vivo pre-clinical support for chemistry and process development groups resulting in selection of next generation candidates. Served as company spokesperson at scientific meetings and investor presentations.
Manager, Cell and Molecular Biology, SurroMed Inc.
1/98 – 8/02
Completed five clinical studies for biomarker identification including those in multiple sclerosis, asthma/allergy, and rheumatoid arthritis. Responsible for target antigen identification and validation, cell and immunoassay development, study design, data analysis and report generation for all clinical studies. Managed the asthma/allergy project team that included contributors from clinical affairs, biology, chemistry, bioinformatics, engineering, clinical operations, and external scientific experts. Recruited and served as scientific liaison to academic and industrial colleagues.
Group Leader, Immunology and Gene Therapy, Applied Immune Sciences/RPR GenCell
5/92 – 1/98
Led group charged with researching and developing new lead therapeutics for oncology. Generated pre-clinical efficacy data in a variety of tumor models to support two IND submissions for antigen specific immunotherapy of cancer. Served as clinical studies project manager coordinating efforts of multidisciplinary team in taking project from research concept through phase I clinical trial.
Manager, Animal Sciences Dept, Applied Immune Sciences/RPR GenCell
7/94 – 1/98
Managed the accredited AIS animal facility charged with performing all animal studies for R&D department. Researched and assisted in implementation of new animal models of cancer, autoimmune disease and transplantation. Served as scientific advisor to Institutional Animal Care and Use Committee (IACUC).
Senior Scientist, Autoimmunity, Applied Immune Sciences/RPR GenCell
5/92 – 5/94
Started autoimmunity department and initiated projects in multiple sclerosis, diabetes, and myasthenia gravis. Established the SCID-Hu Pancreas mouse model to investigate pathogenic subsets of T cells in patients with type I diabetes. Developed a cell selection device to assist in islet cell isolations for transplantation into diabetic
Postdoctoral Fellow, Department of Medicine/Immunology, Stanford University Medical Center
9/89 – 5/92
Identified T cell anergy as the mechanism responsible for anti-CD4 mediated islet transplantation tolerance in murine and rat streptozotocin induced diabetes models and explored the role of IL2 in tolerance induction.
Postdoctoral Fellow, Department of Molecular Immunology, Becton Dickinson
5/89 – 9/89
Expanded thesis studies using the panel of chimeric anti–CD4antibodies in treatment of experimental allergic encephalomyelitis in mice.
Graduate Student, Stanford University Medical Center, Stanford, CA
1/85 – 5/89
Implemented molecular biology and cellular immunology techniques to generate a panel of chimeric anti–CD4 antibodies. Characterized the in vitro and in vivo efficacy of these antibodies in murine experimental allergic encephalomyelitis, a model for multiple sclerosis.
- American Association of Cancer Research
- American Association of Immunologists
- Clinical Immunology Society
- Federation of American Societies of Experimental Biology
- American Association for the Advancement of Science
- Bay Area PK/PD Network
- Preclinical Consulting Resources
- Life Science Professionals
- Association for Women in Science
- Stanford University Alumni