Joy A. Cavagnaro, PhD, DABT, ATS, RAC, FRAPS, earned her PhD in biochemistry at the University of North Carolina at Chapel Hill. Currently, she is the president of Access BIO, L.C., a consultancy she founded, on September 9, 1999, focusing on science-based regulatory strategies and preclinical development services for translation of novel drug, biologics, and device combinations to the clinic. Dr. Cavagnaro’s career spans academia, the CRO and biotechnology industries, and government. During her tenure at CBER/FDA, she was appointed to the SBRS and served as the FDA safety topic lead and as rapporteur for ICH S6. She was the first to advocate the “case-by-case,” rational, science-based approach to preclinical safety evaluation, furthering the 3Rs principle of animal welfare. The principles of ICH S6 have supported the progression and evolution of biologics as a field, including the translation of novel cell- and gene-based therapies into the clinic. Dr. Cavagnaro is past Chair of the Translational Science & Product Development Committee and the Clinical and Regulatory Affairs Committee and of the ASGCT. She is also past Chair of the board of the Regulatory Affairs Professional Society. She was a member of the NTP Scientific Advisory Committee on Alternative Toxicological Methods and is an advisor and current member of the Grants Working Group of the California Institute of Regenerative Medicine. She is the founder and past Chair of BioSafe, an international expert preclinical science committee within BIO. She is a past member of the ACT Education and Animals in Research Committees and Past President of the NCAC-SOT. She is a past Chair of CRRI, an independent investigational review board, and is currently a member of Advarra’s IRB. Dr. Cavagnaro is a recipient of the FDA Award of Merit individual and group awards. In 2011, Dr. Cavagnaro received the Society of Toxicology Biotechnology Specialty Section First Career Achievement Award and in 2019 the Society’s Arnold J. Lehman Award. Dr. Cavagnaro’s work on the preclinical safety and development strategies for biopharmaceuticals has been widely published, in the form of both peer-reviewed articles and book chapters. She is the editor of this subject’s foremost book, Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials,commonly referred to as the “BioBible.” The “New Testament,” Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals (Joy A. Cavagnaro and Mary Ellen Cosenza, eds., CRC Press, 1st Edition), published in 2021. Dr. Cavagnaro currently serves on multiple scientific advisory boards for biopharmaceutical companies and nonprofits and consults and lectures internationally on translation and risk assessment of novel biological therapies.
Mildred Christian Women’s Leadership in Toxicology Award
Grace M. Furman, PhD, DABT
As CEO/president of Paracelsus, Inc., Grace M. Furman, PhD, DABT, provides professional toxicology services to the pharmaceutical industry as an independent consultant. Dr. Furman made the decision to become independent in mid-2006, at which time she was senior director of Regulatory Safety Assessment in Pfizer’s Drug Safety Research and Development department.
Dr. Furman began her professional career in Cincinnati as a divisional toxicologist in Procter & Gamble’s Health Care Sector (1992–1994). After a brief experience in the consumer products sector, Dr. Furman opted to further her professional career in the pharmaceutical industry and migrated to San Diego to accept a position as sole toxicologist with DepoTech Corporation (now Pacira Pharmaceuticals, Inc.), where she was instrumental in building the preclinical development group (1994–1999). Dr. Furman’s first opportunity to explore independent consulting came unexpectedly in early 1999 as a result of corporate restructuring and a concurrent lack of professional prospects within the San Diego area. Later that same year, an attractive position within Agouron Pharmaceuticals, Inc., lured Dr. Furman back into industry. Through a subsequent series of mergers and acquisition, the Agouron opportunity developed into the position Dr. Furman held within Pfizer’s Global R&D division through 2006. In late 2006, Dr. Furman founded Paracelsus, Inc., and became its first employee. Paracelsus commenced conducting business as a corporate entity in January 2007. Dr. Furman’s area of professional expertise relates to regulatory toxicology as applied to development of novel small molecule therapeutics across a wide range of therapeutic areas.
Dr. Furman received her PhD in biomedical sciences with a specialization in toxicology from Northeastern University in Boston, Massachusetts (1992). She also holds a BS in toxicology (1986) and has been a Diplomate of the American Board of Toxicology since 2000. Dr. Furman is an active member of ACT and has served ACT as a two-term Council member (2009–2011 and 2017–2019), as a member of the Nominating Committee (2008), as Secretary (2013–2014), and as Co-Chair (2017/2018) and Chair (2018/2019) of the Education Committee. Dr. Furman is also a member of the Society of Toxicology and the Southern California Regional Chapter of the Society of Toxicology and has held several Executive Council positions, including President, within the Regional Chapter. In addition, Dr. Furman is an active member of the Roundtable of Toxicology Consultants, serving as President-Elect (2020), President (2021), and Past President (2022).
Dr. Furman is Chair Emeritus of the San Diego Biotechnology Discussion Group and a founding member of San Diego’s Women in Biosciences. Additionally, Dr. Furman designed and instructed the “Toxicology” classroom and distance-learning courses offered through the University of California/San Diego Extension’s Drug Discovery and Development and AMDET Process Certificate Programs (2005–2014).
Debie Hoivik, PhD, DABT
Dr. Hoivik received her PhD from the University of Connecticut under the mentorship of Dr. Steven Cohen and conducted her post-doctoral research with Dr. Stephen Safe’s team at Texas A&M University. Debie began her career as a toxicologist in the pharmaceutical industry when she joined GlaxoWellcome where, over the course of the next 8 years she would focus on the nonclinical safety aspects of drug development, primarily in the areas of metabolic diseases and antivirals. Debie then worked for the next 15 years at Boehringer-Ingelheim Pharmaceuticals in a variety of capacities where she continued to contribute to the development of therapeutic candidates from early discovery through post marketing. In 2019 she joined Akebia Therapeutics and in her current role as VP, Early Development she provides oversight and strategic planning for early pipeline programs from Discovery through clinical Proof of Concept. Over the course of her career, she has published over 25 manuscripts and 5 invited book chapters. Dr. Hoivik has also participated in various consortium (e.g., ILSI/HESI, PhRMA subgroups) and outreach (e.g., SOT ToxScholar) efforts. Debie is a Diplomate of the American Board of Toxicology; and she is a member of the editorial review board for the International Journal of Toxicology. In addition, she is an active member of American College of Toxicology (ACT), and the Society of Toxicology (SOT), including chapters in North Carolina, and the Northeast. Dr. Hoivik started her work with ACT in 2002 when she served as a Councilor. She has continued serving the college over the years in a variety of capacities including Chair, Continuing Education Committee (2003–2004), Secretary (2004-2006), Nominating Committee (2007–2008), Program Committee (2016), and Awards Committee (2018–2020). Dr. Hoivik was part of the original team that crafted ACT’s Pathology for Nonpathologists Course in 2003. In addition, she has been a lecturer for two ACT Courses (Toxicology for Pharmaceutical and Regulatory Scientists and Advanced Comprehensive Toxicology) She has also served the SOT as a member of the Communication Committee (2009–2010) and Education Committee (2016– Chair 2018). At a regional level, Debie has supported the Northeast Chapter of the Society of Toxicology as President Elect (2016), President (2017) and Past President (2018). Dr. Hoivik is a regular ACT Annual Meeting attendee, and she has contributed to the Annual Meeting content as either a Session Chair or Continuing Education Course speaker.
Carol C. Lemire Unsung Hero Award
Douglas A. Donahue, MS, DABT, ERT
Douglas A. Donahue, MS, DABT, ERT, obtained his MS in biological sciences from Bowling Green State University in 2004, with emphasis on general toxicology, endocrinology, and environmental pollutants. He holds both a DABT and an ERT certification. Mr. Donahue currently serves as the head of Preclinical Toxicology for GSK Vaccines, supporting key mRNA-based vaccines. For the past 18 years, Mr. Donahue’s career has focused on practical applications for industrial, cosmetic, device, pharma, and vaccine product development. Positions held at GSK, WIL Research, KAO, Covance, and Becton-Dickenson have allowed Mr. Donahue to shepherd more than 300 successful global product registrations/approvals with major regulatory agencies, including REACH, TSCA, EPA, FDA, and EMA. Significant areas of expertise include DART, medical device registrations, and rare disease treatments. Although he has worked primarily in an industry setting, Mr. Donahue actively contributes to the academic community through peer-reviewed journal publications and serves as a guest lecturer for University of Texas Medical Branch at Galveston. He is also grant reviewer for the Alternatives Research & Development Foundation (ARDF), which supports novel, viable strategies for in vivo animal testing. Mr. Donahue mentored many early career toxicologists at Covance, at Becton-Dickinson, and now at GSK, helping train the next generation of toxicology professionals. Mr. Donahue also formally participates in the ACT Mentorship program, meeting with his Mentee quarterly. Mr. Donahue is an active member of ACT (since 2008), serving as an elected member of the ACT Membership Committee (2020–2023) and an appointed member of the ACT Program Committee (2018–2020), as well as co-chairing sessions and Continuing Education courses. He remains a Full member of the Society of Toxicology (SOT) and the British Toxicology Society (BTS). Mr. Donahue was blessed with amazing role models early in his toxicology career, and he embraces the need to educate, lead, and serve the toxicology community. He is, therefore, thankful to the ACT Awards Committee and Council to be selected for the Carol C. Lemire Unsung Hero Award.
Early Career Professional Award
David McMillan, PhD, DABT
David McMillan, PhD, DABT, is a senior toxicologist in the Division of Pharmacology/Toxicology for Infectious Disease at FDA and is assigned to the Division of Antivirals. Before joining FDA, Dr. McMillan received his PhD in toxicology from the University of Rochester in 2013 and completed a postdoctoral fellowship at the University of Vermont in 2015. His expertise lies primarily in immunology and immunotoxicology. Dr. McMillan has participated in multiple subcommittees and working groups at FDA and is the current Chair of the CDER Immunotoxicology Subcommittee. Within ACT, Dr. McMillan served on the Early Career Professional (ECP) Subcommittee from 2016 to 2020, serving as ECP Subcommittee Chair in his final year, and is a current member of the ACT Education Committee. He has also given multiple presentations and chaired multiple sessions at the ACT Annual Meeting and was invited to give the Hematopoietic and Immune Systems Toxicology” presentation for the ACT Advanced Comprehensive Toxicology course.
Award for Best Paper Published in International Journal of Toxicology
Welsh BT, Faucette R, Bilic S, Martin CJ, Schürpf T, Chen D, Nicholls S, Lansita J, Kalra A.
“Nonclinical Development of SRK-181: An Anti-Latent TGFβ1 Monoclonal Antibody for the Treatment of Locally Advanced or Metastatic Solid Tumors.” Int J Toxicol.: 2021 May/Jun; Volume 40(3):226-241.
2022 North American Graduate Fellowships
Richa Lamichhane, Louisiana State University
Chiquita Price, Mississippi State University
Brittany Rickard, University of North Carolina—Chapel Hill
2021 North American Graduate Fellowship
Kayla Frost, University of Arizona
Moses New-Aaron, University of Nebraska Medical Center
Neha Paranjape, University of Iowa
2022 North American Travel Grants
Sabrina Rahman Archie, Texas Tech University Health Sciences Center
Olatunbosun Arowolo, University of Massachusetts, Amherst
Rebekah Kendall, The University of Montana
Rahul Kumar, Louisiana State University
Courtney McClure, University of California—Los Angeles
Vasiliki Mourikes, University of Illinois
Janet Olugbodi, Bingham University
Faizan Rashid, University of Illinois at Urbana Champaign
JT Toebbe, University of Cincinnati
Yewei Wang, Yale University
2022 International Travel Grants
Funmilayo Doherty, Yaba College of Technology, Nigeria
Adeleye Edema, University of Ibadan Oyo, Ibadan, Nigeria
Goran Gajski, Institute for Medical Research and Occupational Health, Croatia
Onakpa Monday, University of Abuja, Nigeria
Jackson Kenya Njoka, Jomo Kenyatta University of Agriculture and Technology, Kenya
A Special Thank You to Our Platinum and Gold Supporters