Agenda (All times in Eastern Standard Time)
11:00 – 11:05 AM
Welcome and Opening Remarks
Tracey Papenfuss, Charles River Laboratories, ITC Education & Outreach Workgroup Co-Lead
E’Lissa Flores, HESI Scientific Program Manager
11:05 – 11:15 AM
Immuno-Safety Field Overview
Tracey Papenfuss, Charles River Laboratories, ITC Education & Outreach Workgroup Co-Lead
11:15 – 11:30 AM
Career Speaker Introductions
Wendy Freebern, Janssen, ITC Education & Outreach Workgroup Co-Lead
David McMillan, US Food and Drug Administration (FDA), ITC Member
Cheryl Rockwell, Michigan State University
11:30 – 11:55 AM
Open Discussion and Q&A with Attendees & Speakers
Open to all
11:55 AM – 12:00 PM
Closing Remarks
Danice Wilkins, Charles River Laboratories, ITC Science Outreach Group Lead
StageBio
Dr. Tracey Papenfuss has over 20 years of specialized experience in immunology, pathology, and related disciplines in both industry and academia. She previously worked as a pathologist (immunopathology specialization) in preclinical safety assessment at Charles River Laboratories. She previously directed an academic research laboratory in early discovery immunotherapeutics for inflammatory and autoimmune diseases and cancer at The Ohio State University. In addition to her current position in safety assessment in industry, she continues to serve as an adjunct faculty member in the College of Veterinary Medicine and College of Pharmacy where she collaborates with colleagues and continues to support the training and education of professional students, residents, and graduate students in translational pharmacology, comparative medicine, and drug development.
She has been a member of the HESI Immunosafety Committee since 2016. During that time she has actively participated in, contributed to, and led activities and projects within multiple working groups that support all of the key objectives in the Immunosafety Committee’s mission statement.
In addition, she maintains professional affiliations, gives scientific presentations, publishes peer-reviewed manuscripts and book chapters, and dialogs with scientists within the multiple disciplines (immunology, toxicology, pathology, regulatory science, etc.) that relate to immune safety and its translation to human health risk assessment. Immunosafety is a vibrant and rapidly advancing field which benefits from active collaborations and communications between scientists from academia, government, and industry.
Janssen
Wendy has worked in the pharmaceutical industry for 18 years and currently is the Global Leader of Hematological and Immunological Toxicology at Janssen. Wendy earned her PhD in Microbiology and Immunology from the University at Buffalo where her projects focused on molecular parasitology and she became enamored with complex signal transduction. Widening her breadth of expertise, yet keeping in mind her interest for molecular signaling, Wendy moved from parasitology to T-cell biology during her post-doctoral fellowship at the National Cancer Institute where she enhanced her previous textbook learnings of immunology and cemented her dedication to studying the effects of therapeutics on the immune system. Wendy started her career in the pharmaceutical industry at Bristol Myers Squibb at the bench as an Immunotoxicologist and 17 years later continued to have a deep interest in the subject matter expertise of immunotoxicology while learning and growing as a matrix leader across Research and Development. In 2021, Wendy started a new adventure at Janssen to establish an immunotoxicology expert group in the Nonclinical Safety Organization.
US Food and Drug Administration
Dr. McMillan is a board-certified toxicologist specializing in immunotoxicology with extensive experience in multiple fields, including immunology, pharmacology, chemistry and drug discovery. He received his Ph.D. from the University of Rochester School of Medicine and Dentistry in 2013 under the supervision of Drs. Richard Phipps and Patricia Sime, and completed a postdoctoral fellowship at the University of Vermont College of Medicine in the laboratory of Dr. Yvonne Janssen-Heininger in 2015.
Dr. McMillan joined the U.S. Food & Drug Administration in January 2016, and is currently a nonclinical reviewer in the Division of Pharmacology/Toxicology for Infectious Diseases assigned to the Division of Antivirals. In his current position, he reviews, evaluates and interprets GLP and non-GLP nonclinical safety studies for INDs and pre-INDs, and provides feedback on additional studies that may be needed, prior to clinical trial initiation. He also reviews NDAs, BLAs, supplements and any associated labeling prior to marketplace approval or licensing for new drugs. In addition, Dr. McMillan is the current chair of the FDA/CDER Immunotoxicology Subcommittee and is regularly involved in the American College of Toxicology.
Michigan State University
Dr. Rockwell is an associate professor in the department of Pharmacology & Toxicology at Michigan State University. She is also currently serving as the acting director of the Applied Immunology Center for Education and Research at Michigan State University. She received her Ph.D. in 2005 in Pharmacology and Toxicology from Michigan State University. She conducted her postdoctoral research at the University of Missouri Kansas City and the University of Kansas Medical Center. In 2010, Dr. Rockwell received a K99/R00 transitional grant from NIEHS, which allowed her to transition into an independent tenure-track position at Michigan State University.
Her current research focuses on the mechanisms that regulate immune cell differentiation as well as the effects of xenobiotics on those processes. She is currently investigating the role of Nrf2 in immune cell differentiation and function in the context of food allergy and infectious disease. She has mentored 6 doctoral students, 1 master’s student, 2 postdoctoral fellows, 1 post-baccalaureate and many undergraduate students thus far.
In 2016, Dr. Rockwell received an Outstanding New Environmental Scientist (ONES) grant, awarded by NIEHS. She has received several awards from the Society of Toxicology (SOT), including presentation awards, travel awards and the Outstanding Young Immunotoxicologist of the Year award. In 2020, she was honored to receive the Early Career award by the Toxicology Division of the American Society of Pharmacology and Experimental Therapeutics. Last year, she was the recipient of the Kenneth Moore award from the department of Pharmacology & Toxicology at MSU. The students in her laboratory have also received a number of awards from Society of Toxicology, including the Carl C. Smith award from the Mechanisms specialty section, the Frank C. Lu award from the Food Safety specialty section as well as presentation awards from the Immunotoxicology specialty section. She has served on numerous SOT committees, including the Continuing Education and Membership committees as well as numerous committees of the Immunotoxicology specialty section. She has served as Councilor for both the Michigan regional chapter and the Immunotoxicology Specialty Section of the Society of Toxicology. She currently serves as the President of Michigan Society of Toxicology and Vice President of the Mechanisms Specialty section of SOT. She is also Secretary-Treasurer of the Toxicology Division of the American Society of Experimental Pharmacology and Therapeutics.
Charles River Laboratories
Danice Wilkins, Scientific Director for Immunology and Biomarkers at Charles River Massachusetts, is an immunologist with over 18 years of combined academic, CRO and biopharmaceutical drug development experience. Danice earned her MS and PhD in Cellular and Molecular Biology from the University of Nevada School of Medicine in Reno, Nevada, where her projects focused on the effects of agonist anti-CD40 antibodies on renal cell carcinomas and antigen-independent T cell responses to cancer immunotherapy.
After completing her PhD, Danice joined the Laboratory Sciences group at Charles River Nevada where she served as the Program Director for Immunology and the lead scientist for flow cytometry and pharmacodynamic assays. More recently, she held industry positions at Momenta Pharmaceuticals where she served as the Associate Director of Preclinical and Developmental Sciences, and Elstar Therapeutics where she served as the Director of Immunotoxicology. Her combined CRO and drug development experience includes the strategic design and outsourcing of preclinical in vivo pharmacodynamic and immunotoxicology studies, as well as the development and validation of flow cytometry and cell-based functional bioassays and immunology biomarkers.
E’Lissa Flores joined HESI in 2020 as a Scientific Program Manager. She currently co-manages several HESI committees, including the Cardiac Safety Committee, the Genetic Toxicology Technical Committee (GTTC), and the Immuno-Safety Technical Committee (ITC). Prior to joining HESI, she worked at the Milken Institute’s Center for Strategic Philanthropy where she advised philanthropists and non-profit foundations to help manage several neurology-related disease projects, including overseeing a $12 million grant program and developing a novel fellowship award. Dr. Flores received her BS in Biology from Stony Brook University and her PhD in Translational Biomedical Science from the University of Rochester School of Medicine and Dentistry. Her thesis work focused on immunotoxicology, investigating the mechanism(s) of how environmental chemicals alter the human immune system and how they contribute to the obesity epidemic. While at the University of Rochester Medical Center, Dr. Flores was a Science Outreach Coordinator funded by the National Science Foundation (NSF) and served on the Executive Diversity and Inclusion Committee. She is also an advocate for women and underrepresented minorities in the STEM fields.
hesi@hesiglobal.org
Phone: +1-202-659-8404
Fax: +1-202-659-3859
740 15th Street NW, Suite 600
Washington, DC 20005
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