UbiVac Advisory Board
Ashok K. Batra, MD, FRCS, FACS, MBA
Dr. Batra has more than 30 years of international experience in academic medicine, scientific research, medical management, clinical trials and regulatory policy. He holds an MD from Delhi University, India and received general surgery training in the United Kingdom and is a Fellow of the Royal College of Surgeons, Glasgow, Scotland.
Dr. Batra received training in urology and neuro-urology training at UPENN, UCSF and Temple Universities in the US. He is a board certified urologist and a Fellow of the American College of Surgeons. He earned an MBA from Binghampton University, New York.
A Division Director of Clinical Evaluations and Pharmacology Toxicology at OCTGT, CBER, he was part of the Federal Drug Administration (FDA) that regulated cancer vaccines, immunotherapies, stem cell therapies, and gene therapies. Prior to that he was adjunct professor and division director of neuro-urology, female and reconstructive urology at SUNY, Syracuse.
At present Dr. Batra is managing director of USBPC Group LLC that provides consultation services, scientific advice and expert opinion on biotechnology, pharmaceutical and medical device development.
Mark B. Evenstad, BA, MBA
Mark Evenstad is the Chief Executive Officer of Upsher-Smith Laboratories, Inc., Minneapolis, Minnesota, a privately held fully-integrated pharmaceutical company. As Chief Executive Officer of Upsher-Smith, Mark Evenstad brings creativity, business strategy, and operational knowledge to the UbiVac Board.
Mark guides the long-term corporate strategy for Upsher-Smith. He specifically focuses on business development and expanding the company’s R&D successes with high-value, high-quality therapies and partnerships that deliver better health outcomes and enhance life.
Mark started his career with Upsher-Smith at a young age, working his way through many areas of the organization. Learning from his father (former CEO, now Chairman Kenneth Evenstad), he gained extensive, hands-on experience throughout all facets of the company.
Mark holds a B.A. in Business and an MBA in Venture Management from the University of St. Thomas in St. Paul, Minn.
Paul E. Freiman, BS, Honorary Doctorate
Mr. Freiman has extensive pharmaceutical and biotechnology industry operating experience as a board member and chief executive officer of private and publicly traded companies.
He is a pharmacist and is currently an independent pharmaceutical and biotechnology industry consultant. He serves as chairman of Chronix BioMedical and is a member of the NovaBay Pharmaceutical Board of Directors.
Before that Mr. Freiman served on the boards of Otsuka America, Inc. and several biotechnology companies based in the US and Singapore. He also was a partner of Burrill Brasil Investmentos based in Rio de Janiero and president and chief executive officer of Neurobiological Technologies, Inc. and a member of its board of directors.
Mr. Freiman was chairman and chief executive officer of Syntex Corporation that was sold to the Roche Group for $5.3 billion during his tenure. He is credited with much of the marketing success of Syntex’s lead product, Naprosyn, and was responsible for moving the product to over-the-counter status, marketed as Aleve. Aleve currently generates approximately $400 million in annual revenues worldwide.
Mr. Freiman served on the board of the Pharmaceutical Research and Manufacturers Association of America (PhRMA) and was its chairman. He also served on industry task forces, nationally and internationally and was chairman of the University of California Foundation, the United Way of Silicon Valley and a number of not-for-profit organizations through the years.
Mr. Freiman received a BS in pharmacy from Fordham University and an honorary doctorate from the Arnold & Marie Schwartz College of Pharmacy.
Karl-Josef (“Kajo”) Kallen, MD, PhD
Dr. Kallen holds an MD from the RWTH Aachen, Germany, and a PhD in Cell Biology from University College London. He received his education in internal medicine and oncology at the I. Medizinische Klinik of Mainz University and is a board certified internist.
He has a strong basic science background in biophysics, cell biology and molecular immunology, and completed a habilitation in biochemistry at the Christian-Albrechts University in Kiel.
At Merck-Serono, he was involved in the clinical development of Cetuximab in Japan, and after his promotion to senior medical director was responsible for the global clinical development of Merck-Serono’s cancer immunotherapy portfolio.
He is a member of several international working groups that develop new paradigms for the clinical development of cancer vaccines and immunotherapies. He received extensive management education from MIT Sloan School of Management and London Business School.
Samir N. Khleif, MD
Samir N. Khleif, MD, is director of the Georgia Regents University (GRU) Cancer Center in Augusta, Georgia. He is board certified in internal medicine and medical oncology. His BS and MD degrees are from the University of Jordan School of Medicine, Amman, Jordan. He was a post-doctoral research fellow, Hematology-Oncology at Michigan State University and an intern at Case Western Reserve University. His residency was at the Medical College of Ohio, Toledo, Ohio.
Dr. Khleif has diverse and vast experience in clinical and basic cancer research, strategic and programmatic national and institutional development, and research and health care administration and leadership. He has led the development of national strategies and complex health care and research organizations in the US and internationally. He is also a recognized basic and translational scientist and a medical oncologist with more than 25 years experience. His work has led to many pioneering clinical trials in cancer immunotherapy.
Following his training, Dr. Khleif joined the National Cancer Institute (NCI) as a medical oncology fellow and advanced to senior investigator and chief, Cancer Vaccine Section, at the NCI. During his time there, he also served as a special assistant to the commissioner of the Food and Drug Administration and led the Critical Path Initiative for oncology.
In 2002 Dr. Khleif became the director general and CEO of the King Hussein Cancer Center and Biotechnology Institute (KHIBC) as part of an agreement between the NCI and Jordan. He led the development of the center into an internationally recognized center of excellence.
Dr. Khleif’s research interest is in identifying new and improved strategies to enhance specific immune response against cancer for preventive and therapeutic intent. This is conducted through the understanding of immune regulation and tumor-immune system interaction and translating the findings into therapeutic approaches.
Dr. Khleif serves on several local, national, and international committees and as a cancer vaccine expert for a number of national organizations. His recent recognitions include receiving the Medical Trailblazer Award, Augusta City Classic.
Pamela M. Klein, MD
Dr. Klein has more than 15 years of clinical and translational research experience in oncology drug development. She serves as a consultant and advisor on all aspects of clinical and translational research, and has led programs spanning from the pre-clinical stage to approval and beyond.
Klein is principal of PMK BioResearch where she does strategic consulting to all stages of biotech, often serving as advisor to corporate boards, CEOs, the investment community and management teams. Klein was CMO of Intellikine (since acquired by Milleinium/Takeda), where she built the clinical development organization and brought early compounds from lab to investigational new drug (IND) status and finally, to clinic.
Prior to that, she held positions of increasing responsibility at Genentech, advancing to vice president, development. While at Genentech, she led several franchise development programs including the HER family of compounds, the apoptosis franchise and the hematology programs.
Prior to Genentech, she was at the National Cancer Institute (NCI), where she built and ran the NCI-Navy Breast Center, focusing research on developing surrogate markers of cancer risk, disease activity and predictive markers. Klein earned her medical degree from Stritch School of Medicine, Loyola University.
She completed her internal medicine work at Cedar-Sinai receiving the Leo Rigler Award for Resident of the Year and the Ben Newman Award for Most Humanistic Physician. She also did a medical oncology fellowship at the NCI serving as chief fellow and completing an advanced fellowship in Cancer Genetics.
James J. Mulé, PhD
Dr. Mulé is the Associate Center Director for Translational Science, the Michael McGillicuddy Endowed Chair for Melanoma Research and Treatment, and Director of Cell-based Therapies at the Moffitt Cancer Center, Tampa, Florida.
He is recognized for his research and clinical trial contributions to cancer immunotherapy, particularly in solid tumors. His clinical research group is involved in developing and validating genomic signatures of immunotherapy response, as well as vaccine strategies (e.g., with dendritic cells) and other approaches (e.g., with adoptive T cells) to recognize and destroy tumors.
The translational work in these areas has helped to develop new treatments for advanced cancer patients. He has published nearly 200 articles in the areas of cancer vaccines and cancer immunotherapy. Dr. Mulé serves on Advisory Boards of numerous biotechnology and pharma companies (e.g., OncoPep, Lion Biotech, Vault Pharma, Celgene, among others).
Dr. Mulé remains a long-standing special government employee to the FDA (CDER and CBER) and the NCI. He was Chair of the Cellular, Tissue, and Gene Therapy Advisory Committee of CBER, FDA. He currently serves on the advisory boards of several NCI-designated Cancer Centers and was a member of the NCI Director’s Board of Scientific Counselors (BSC-A). Dr. Mulé also serves on the Editorial Boards of several peer-reviewed journals, including Scientific Reports (nature.com), Journal of Immunotherapy, and Cancer Immunology Research (AACR).
Dr. Mulé received a special individual Ph.D. (IPh.D.) degree in Tumor Immunology from the Fred Hutchinson Cancer Research Center and the University of Washington, Seattle, Washington. He then received his formal post-graduate training at the Surgery Branch, Division of Cancer Treatment, National Cancer Institute, NIH, Bethesda, Maryland, where he became a Senior Investigator with tenure. Dr. Mulé moved to Palo Alto, CA, where he helped to launch and scientifically direct two biotechnology companies. He then moved to Ann Arbor, Michigan to become the Director of the Tumor Immunology and Immunotherapy Program at the University of Michigan Comprehensive Cancer Center, the Maude T. Lane Endowed Professor of Surgery with tenure, Department of Surgery, and Professor in the Department of Internal Medicine.
Dr. Jon M. Wigginton, MD
Dr. Wigginton serves as Senior Vice President of Clinical Development at MacroGenics, Inc. and served as its senior vice president of clinical research since August 2013. He served as therapeutic area head of Immuno-Oncology, Early Clinical Research and executive director of Discovery Medicine-Clinical Oncology at Bristol-Myers Squibb (BMS), where he led the early clinical development of the BMS Immuno-Oncology portfolio including anti-PD-1 and anti-PD-L1.
Prior to joining BMS, Dr. Wigginton served as the director of clinical oncology at Merck Research Laboratories, where he led early and late-stage clinical development teams for small molecules and biologics. During his academic career, he held several positions at the National Cancer Institute Center for Cancer Research (NCI-CCR), including head of the Investigational Biologics Section, Pediatric Oncology Branch.
Dr. Wigginton served as president of the International Society for the Biological Therapy of Cancer (iSBTc), which is now the Society for Immunotherapy of Cancer (SITC). He is the author of more than 50 manuscripts and reviews and is the recipient of multiple awards for scientific accomplishment from sources including the NIH, NCI, USPHS, iSBTc, ISICR, Children’s Cancer Foundation, Merck and BMS. He received his MD and a BS in Biology from the University of Michigan.