Dr. A. Jay Gandolfi is a professor emeritus in the University of Arizona College of Pharmacy, former associate dean for Research and Graduate Studies at the University of Arizona, former director of the Center for Toxicology, former director of the National Institutes of Health Superfund Hazardous Waste Research Program, and former co-director of the Dean Carter Binational Center for Environmental Health Sciences.
Dr. Gandolfi received a BA in chemistry from the University of California, Davis (1968); PhD in biochemistry from Oregon State University (1972); and postdoctoral training in anesthesiology research at the Mayo Clinic. In 1978, Dr. Gandolfi joined the faculty of the University of Arizona with appointments in the Departments of Anesthesiology (Medicine), Pharmacology (Medicine), and Pharmacology-Toxicology (Pharmacy). For his service and research, Dr. Gandolfi received the top award from the College of Medicine—the Founders Day Award (1998). In 1999, he was appointed associate dean for Research and Graduate Studies in the College of Pharmacy.
Dr. Gandolfi was very active with the Society of Toxicology (SOT), holding numerous elected and appointed offices. In 2004, he received the Society’s Education Award for his longtime excellence in teaching and mentoring graduate students. In 2013, his research in the toxicology of metals was honored with the Career Achievement Award from the Metals Specialty Section of SOT. In 2007, he received the Findlay E. Russell, MD, PhD, Distinguished Citizen Award for his years of service to the College of Pharmacy.
Dr. Gandolfi taught drug disposition and toxicology to undergraduates, graduate students, and professional students in the Colleges of Medicine and Pharmacy at the University of Arizona. He was a co-editor of the 14-volume Comprehensive Toxicology series (1997). Dr. Gandolfi’s research interests were in the disposition and toxicology of drugs (e.g., anesthetics) and environmental chemicals (e.g., halocarbons and arsenicals) and the development of in vivo and in vitro models for studying mechanisms of toxicity. Dr. Gandolfi’s research was continuously funded by federal sources, foundations, and industry throughout his career, resulting in almost 300 peerreviewed publications and multiple book chapters. He served on numerous federal research review committees and advisory boards to colleges and centers across the nation.
Dr. Mary Ellen Cosenza is a regulatory consultant with over 35 years of senior leadership experience in the biopharmaceutical industry in the US, Europe, and emerging markets. During her 20-year tenure at Amgen, she led the US Regulatory Department and the International Emerging Markets Regulatory Department and served as an executive director of global regulatory affairs and safety, focusing on early development and inflammation. In addition to her leadership roles in regulatory affairs, she also served as the senior director of toxicology at Amgen. Before joining Amgen, she served as a principal scientist in toxicology for the Medical Research Division of American Cyanamid Company (now Pfizer).
While at Amgen, Dr. Cosenza was responsible for both early- and late-stage development programs resulting in numerous successful IND, CTA, NDA, MAA, and BLA submissions in a broad variety of therapeutic areas and modalities. In addition, she played a key leadership role in preparing teams for global health authority meetings with US FDA, EMA, and regional country health authorities, including several US FDA Advisory Committee meetings.
Dr. Cosenza is recognized as an expert in preclinical biologic drug development and is a founding member of BIO’s BioSafe Preclinical Expert group. She was also a member of an Expert Working Group, operating under the auspices of the International Conference on Harmonization (ICH), for ICH M3(R2). Dr. Cosenza is well published in the field of biological drug development and has authored several chapters on this topic as well.
Dr. Cosenza is a Diplomate of the American Board of Toxicology, a Fellow of the Academy of Toxicological Sciences, and a member of the Society of Toxicology (SOT), Drug Information Association (DIA), and Regulatory Affairs Professional Society (RAPS). She also holds a Regulatory Affairs Certification for both the US and EU. Dr. Cosenza has been a member of ACT since 1988, serving as an active speaker and session Chair. Most notably, she developed the first Study Director Training Course in 2001, has served as a member of the ACT Education Committee, and has served ACT as Councilor, Treasurer, and President. Dr. Cosenza remains active in ACT and is currently a member of the Outreach Committee. She is also an instructor at the University of Southern California, where she teaches a graduate-level course on food and drug toxicology
Dr. Cosenza received her PhD from St. John’s University, New York, and her MS in regulatory science from the University of Southern California, Los Angeles.
Dr. Kenneth L. Hastings received his Doctor of Public Health from the University of North Carolina at Chapel Hill School of Public Health in 1987. He completed his doctoral research at the Chemical Industry Institute of Toxicology under the direction of Dr. Jack Dean. Dr. Hastings then served as a US Peace Corps volunteer in Fiji under the Permanent Secretary for Health. From 1988 to 1991, Dr. Hastings completed a postdoctoral fellowship and was then appointed research associate in the Pharmacology/Toxicology Research Laboratory of the Department of Anesthesiology within the University of Arizona College of Medicine, under the direction of Dr. A. Jay Gandolfi.
From 1991 to 2007, Dr. Hastings worked in the US FDA Center for Drug Evaluation and Research (US FDA/CDER) in various positions: pharmacology/toxicology reviewer in the Division of Anti-viral Drug Products (1991–1997), pharmacology/toxicology supervisor in the Division of Special Pathogen and Immunologic Drug Products (1997–2003), and associate director in the Office of New Drugs (2003–2007). Dr. Hastings served on numerous committees and working groups while at US FDA, including lead representative for US FDA/CDER on the ICCVAM validation of the murine local lymph node assay and as lead negotiator on ICH S8 (Immunotoxicology Evaluation of New Drugs). From 2007 to 2014, Dr. Hastings was associate vice president for regulatory policy at Sanofi US, serving as corporate representative on numerous industry working groups dealing with regulatory science and policy.
Dr. Hastings has served in many professional societies (President, American College of Toxicology; President, Society of Toxicology [SOT] Immunotoxicology Specialty Section; President, SOT Regulatory and Safety Evaluation Specialty Section; chairperson of the Scientific Liaison Coalition). Dr. Hastings served as President of the American Board of Toxicology and has numerous publications, including editing books on the use of minipigs in biomedical research and international standards for nonclinical safety evaluation of medical products. Dr. Hastings is currently an independent consultant specializing in toxicology studies in drug development.
Dr. John E. Atkinson has over 30 years of active practice in the field of toxicology, with experience in the CRO and biopharmaceutical industries. He started his career at Bio/ dynamics, Inc, and then joined Southern Research Institute to build the scientific capabilities and toxicology business at its newly established Frederick Research Center site in Frederick, Maryland. Dr. Atkinson then joined Amgen and worked in the Comparative Biology and Safety Sciences Group for 10 years. As a scientific director, he provided expertise in toxicology and safety assessment programs to project teams. He also served as an early development leader, and his group was responsible for scientific and operational oversight for Amgen-CRO outsourcing relationships. Most recently, he was senior director, toxicology, at the former Agensys Inc., developing ADCs and other hybrid carrier platforms for oncology indications. Dr. Atkinson has been an ACT member for over 25 years and has served the College in many capacities. He has served on many committees over the years, as well as on Council (1996–1999) and as Vice President-Elect, Vice President, President, and Past President (2000–2004). In addition to his role in the leadership of the College, he has worked behind the scenes of the Annual Meeting for the past 15 years to organize a golf outing for those attending the meeting. In addition to ACT, Dr. Atkinson has been a longtime member of the Society of Toxicology (SOT; 30+ years) and has served on several SOT committees. He is a member of numerous other scientific and professional organizations.
Dr. Atkinson received his BS in biology from the University of Richmond and his MS and PhD in toxicology from the Graduate Center for Toxicology at the University of Kentucky. He conducted postdoctoral research at the Tobacco and Health Research Institute at the University of Kentucky. Dr. Atkinson received his board certification as a Diplomate of the American Board of Toxicology in 1991.
Dr. Francis Wolenski is responsible for the nonclinical safety evaluation of small molecules and biologics for oncology, gastrointestinal disorders, and targeted therapies as a senior toxicologist at Takeda Pharmaceuticals Company Limited. He attended undergrad at the Massachusetts Institute of Technology and received his PhD from Boston University. In 2012, Dr. Wolenski joined Takeda as a postdoctoral researcher under Dr. Joe Senn. He is a Diplomate of the American Board of Toxicology (2017). Dr. Wolenski has attended the ACT annual meetings since 2014. He was an inaugural member of the ACT Early Career Professional Outreach Subcommittee, which he co-chaired in 2018, and currently serves on the Communications Committee. At the 2016 Annual Meeting he organized a speed networking event, in 2017 he co-chaired a Symposium, and in 2019 he is speaking at a Symposium and a Continuing Education course
Dr. Wolenski also encourages any early career person reading this who, like he was five years ago, may be unsure of their place within ACT to meet their peers, build those connections, and make this community their own.
A. Emami, J. Tepper, B. Short, T. L. Yaksh, A. M. Bendele, T. Ramani, A. F. Cisternas, J. H. Chang, and R. D. Mellon “Toxicology Evaluation of Drugs Administered via Uncommon Routes:Intranasal, Intraocular, Intrathecal/Intraspinal, and Intra-Articular” International Journal of Toxicology: Volume 37 (1): 4–27, 2018
Kelsey Behrens, University of North Carolina at Chapel Hill
Tetyana Kobets, New York Medical College
Nataliia Kovalchuk, University of Arizona
Lauren Lewis, Texas A&M University
Sireesha Manne, Iowa State University
Caroline Moore, University of California, Los Angeles
Dharmin Rokad, Iowa State University
Songyeon Ahn, University of Texas at Austin
Asha Rizor, Florida A&M University
Benjamin Elser, University of Iowa
Timur Khaliullin, West Virginia University
Matthew Ruis, Duke University
Rashidat Jimoh, University of Lagos, Nigeria
Kpobari Nkpaa, University of Port Harcourt, Nigeria
Kamakshi Mehta, All India Institute of Medical Sciences, India
Ganna Shayakhmetova, SI Institute of Pharmacology and Toxicology NMA of Ukraine, Ukraine
Abdalla Moursi Wedn, Alexandria University, Egypt
To apply or nominate for a 2020 ACT Award visit the Awards website.