Society of Toxicology (MASOT) Fall 2015 Scientific Meeting Sheraton Edison Hotel, Raritan Center, Edison, NJ The Mid-Atlantic Chapter of the Society of Toxicology (MASOT) was formed to: (1) serve as a focal point for toxicological interests within the region; (2) encourage interactions among toxicologists in government, industry, and academia; and, (3) sponsor scientific and educational programs in toxicology. The Chapter and its bylaws were officially approved by the Council of the Society of Toxicology at the March 1982 Annual Meeting. The bylaws were last revised and approved in September 2012.
Transcript
Society of Toxicology (MASOT)
Fall 2015 Scientific Meeting
Sheraton Edison Hotel, Raritan Center, Edison, NJ The Mid-Atlantic Chapter of the Society of Toxicology (MASOT) was formed to: (1) serve as a focal point for toxicological interests within the region; (2) encourage interactions among toxicologists in government, industry, and academia; and, (3) sponsor scientific and educational programs in toxicology. The Chapter and its bylaws were officially approved by the Council of the Society of Toxicology at the March 1982 Annual Meeting. The bylaws were last revised and approved in September 2012.
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Program Committee (2015-2016)
Norman Barlow Kyle Kolaja Eric Beier John Kozlosky Conney Berger, Jr. John Mitchell Kristin Bircsak Gloria Post Sandra Chang Ric Stanulis Todd Davidson Pamella Tijerina George DeGeorge Puneet Vij Shayne Gad Arlene Weiss Richard Hutchinson (Chair) Helmut Zarbl
Officers (2015-2016)
President: George DeGeorge Vice-President: Richard Hutchinson Vice-President Elect: Norman Barlow Secretary: Kathryn Ang Treasurer: Jennifer Ingram-Ross Councilors: Lauren Aleksunes Todd Davidson John Kozlosky Past President: Conney Berger, Jr. Post-Doctoral Representative: Eric Beier Senior Student Representative: Kristin Bircsak Junior Student Representative: Pamella Tijerina
Device and Drug Combination Product Toxicology, Past Present and Future
9:00 – 9:30 Continental Breakfast/Registration/Networking 9:30 – 10:00 Introduction and MASOT Update – Dr. George DeGeorge
Education and Outreach Committee Update – Dr. Diane Hardej 10:00 – 11:00 Student Poster Session 11:00 – 12:00 Dave Anderson (Astra Zeneca/MedImmune)
Title: Development considerations for emerging and novel combination therapies as combination products
12:00 – 1:30 Lunch/Ambassador Award Dr. Lois Lehman-Mckeeman (Bristol-Myers Squibb) Title: Toxicology as a Translational Science
1:30 – 2:00 Student Poster Session
2:00 – 3:00 Dr. Tim Muench (Johnson & Johnson) Title: The marriage of standard and non-standard biocompatibility and wound healing studies in the successful submission of the combination product EVARREST® Fibrin Sealant
3:00 – 3:30 Student Poster Session 3:30 – 4:30 Jennifer Goode (USFDA, Center for Devices and Radiologic Health)
Title: FDA Reviewer Perspective: Considerations for Bench, Biocompatibility, & Animal Testing of Absorbable Drug-Eluting Stents
4:30 – 5:00 Awards/Closing Remarks – Dr. George DeGeorge
5:00 – 6:00 Melissa Marshall, M.A. (Melissa Marshall Consulting LLC) Special Session - “Bullets Kill: Transforming Slide Design”
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Development Considerations for Emerging and Novel Combination Therapies as Combination Products David Anderson (Astra Zeneca/MedImmune) David is Associate Director, Combination Products Quality at AstraZeneca (MedImmune) where he leads a team of Quality Engineers focused on Design Controls for combination products. Previously, he spent time developing/manufacturing antibody-drug conjugates and vaccines, as well as organizing quality systems. David received his B.S. in Chemical Engineering from the University of Delaware. Abstract: Treatment of a disease or condition with combinations of drugs, biologics, and devices together continues to evolve and become more important. Because biological agents are highly complex and expensive molecules, generic versions of biologics, termed “biosimilars” are becoming more prominent in combination therapy. For biosimilars, some design differences in a delivery device or container closure system, compared to the originator, are potentially acceptable by FDA. Accordingly, an emerging and evolving area is biosimilars as combination products. Potentially very novel combination therapies, and combination products, include use of biosimilars in products like antibody-drug conjugates (ADC). The talk will provide an overview of development considerations and highlight potential areas of special focus in quality attributes and preclinical aspects for biosimilars as combination products.
Ambassador Award Lecture – Toxicology as a Translational Science Lois Lehman-Mckeeman, Ph.D. (Bristol-Myers Squibb)
Dr. Lois Lehman-McKeeman is Distinguished Research Fellow in Discovery Toxicology at Bristol-Myers Squibb (BMS) in Princeton, NJ, where she has worked since 2001. Dr. Lehman-McKeeman leads the Discovery Toxicology department and has active research interests broadly in biochemical mechanisms of toxicity. Her research also includes emphasis on the application and integration of metabolomic and transcriptomic technologies in mechanistic toxicology. She has published extensively in these fields. Prior to joining BMS, she was employed in the Human and Environmental Safety Division of the Procter and Gamble. Dr Lehman-McKeeman received a BS degree in Toxicology from the University of the Sciences in Philadelphia and holds a Ph.D. in Toxicology from the University of Kansas Medical Center. She has been active professionally in the Society of Toxicology (SOT) serving on numerous SOT committees, and she has held elective office in the SOT as Councilor from 2000-2002 and the SOT Awards Committee (2008-2010). She was elected as Vice-President elect of the SOT in 2011, serving as President of the SOT in 2013-2014. In 2003, she was appointed Editor of Toxicological Sciences, a position she held through completion of the 2011 journal year. She has also served on a number of other editorial boards. Dr. Lehman-McKeeman has served on numerous national and international advisory committees for USEPA, NIH and IARC and the International Life Sciences
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Institute (ILSI). She was elected as a Fellow of the American Association for the Advancement of Science (AAAS) in 2008, and she is a fellow in the Academy of Toxicological Sciences. She was also the recipient of the Robert Scala Award in Toxicology for research excellence in an industrial laboratory (1994), the Society of Toxicology Achievement Award (2003) and the George H. Scott Award for scientific excellence from the Toxicology Forum (2006). Abstract: Translational science is defined as the process of turning observations in the lab, clinic and community into interventions that improve the health of individuals and the public (National Center for Advancing Translational Sciences; www.ncats.nih.gov). The translational aspects of toxicology are recognized in the definition of our science as the study of the adverse effects of chemical, physical, or biological agents on living organisms and the ecosystem, including the prevention and amelioration of such adverse effects to enhance human and environmental health (www.toxicology.org). This talk will feature examples of translating toxicology research, with emphasis on mechanisms of toxicity, into risk assessments and regulatory decisions. The Marriage of Standard and Non-standard Biocompatibility and Wound Healing Studies in the Successful Submission of the Combination Product EVARREST® Fibrin Sealant Tim Muench, D.V.M., Ph.D. (Johnson & Johnson) Tim is currently a Research Fellow (Johnson & Johnson Medical Devices, Somerville, NJ) serving as an implant pathology expert supporting projects of diverse scope across all of the Johnson & Johnson Medical Devices businesses and other Johnson & Johnson companies as needed. He received his D.V.M. from The Ohio State University, College of Veterinary Medicine and practiced small and large animal medicine and surgery for several years. He began his graduate work in environmental toxicology/aquaculture while fulfilling the requirements for a residency in veterinary pathology at Purdue University, College of Veterinary Medicine where he also completed a PhD in pathobiology. Following completion of his PhD, Tim spent a short time at a state diagnostic laboratory and then joined a medical device testing contract research organization (NAMSA, Toledo, OH). Prior to joining Johnson & Johnson, Tim worked for W.L. GORE and Associates as a research pathologist to focusing upon medical device research and development, project management, and human device explants analysis. Abstract: Many surgical methods and hemostatic agents can be used to achieve and maintain hemostasis in surgical fields. However, numerous clinical situations exist where current treatment modalities are neither effective nor practical. The assessment of new hemostats to address these clinical scenarios primarily target efficacy. However, the biocompatibility and healing properties associated with the new hemostats are crucial for regulatory approval and product acceptance. Standard biocompatibility and healing studies are not appropriate for new hemostats that containing active biologics. This presentation discusses how some of these issues surrounding the biocompatibility and healing were successfully addressed for a combination product.
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FDA Reviewer Perspective: Considerations for Bench, Biocompatibility, & Animal Testing of Absorbable Drug-Eluting Stents Jennifer Goode (USFDA, Center for Devices and Radiologic Health)
Jennifer L. Goode, BS, Biomedical Engineer is currently a scientific reviewer in the Peripheral Interventional Devices Branch, in the Office of Device Evaluation at FDA. Ms. Goode has been a premarket reviewer for over 21 years, with experience reviewing devices and combination products for surgical and interventional treatment of the peripheral vasculature, as well as cardiac monitoring, pacing, neurology and obstetrics and gynecology devices. For the past eight years, Ms. Goode has served as an FDA primary liaison to several ISO Working Groups responsible for the development of international standards for the biocompatibility evaluations of medical devices, including ISO 10993-1 and ISO 10993-4. Since 2008, Ms. Goode has been one of two Office of Device Evaluation representatives to the Biocompatibility Standards Task Group (STG) at the Center for Devices and Radiologic Health. This Biocompatibility STG is responsible for coordinating FDA input to, and scientific review and recognition of all biocompatibility standards used by CDRH. In addition, Ms. Goode was one of two primary authors for the FDA Draft Guidance “Use of International Standard ISO -10993, ‘Biological Evaluation of Medical Devices Part 1’”. Abstract: Therapeutic and diagnostic products that combine drugs, devices, and/or biological elements are termed, and regulated by the US FDA, as combination products. Technological advances continue to merge product types and blur the historical lines of separation between traditional drugs, biologics, and medical devices. Further, the increasing use of absorbable platforms adds another level of complexity to the development and regulation of certain combination products. US FDA’s medical product centers, the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH), are utilizing evolving collaborative efforts in order to address the regulatory challenges of combination products. Because combination products involve components that would normally be developed and regulated under different types of processes and policies, and frequently submitted to different US FDA Centers, these products raise challenging development, regulatory, and review management questions. Differences in these pathways for each combination product type can impact the processes for all aspects of product development and management, especially preclinical testing.
Special Session - “Bullets Kill: Transforming Slide Design” Melissa Marshall, M.A (Melissa Marshall Consulting LLC) Abstract: Using a slide design strategy proven to make technical presentations more understandable, memorable, and persuasive, your team will learn to create better presentation slides using an engaging, assertion-evidence design structure. Through a series of exercises and critiques using their own material, participants will learn the theory behind the structure and how to make immediate improvements.
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Dr. Geoffrey K. Hogan, Ph.D., DABT
Memorial Scholarship / Travel Award
The Dr. Geoffrey K. Hogan, Ph.D., DABT Memorial Scholarship/Travel Award is a $1000 award that will be given to a Ph.D. student annually in memory of Dr. Geoffrey Hogan (June 09, 1940 - February 23, 2011). The award was initiated in 2011 through the generosity of Huntingdon Life Sciences. Mrs. Barbara Hogan and MASOT have graciously agreed to continue this tribute.
Dr. Hogan earned his M.A. in Public Health and later a Ph.D. in Toxicology from the University of Michigan. Among his many accomplishments, Dr. Hogan was the President of Bio/dynamics (currently Huntingdon Life Sciences), and later was Director of Applied Bioscience International. Dr. Hogan had a great interest in the application of toxicology to the protection of human health. This award is a tribute to his efforts towards this goal.
Student Poster Awards Most Outstanding
Outstanding
Honorable Mention
Membership Choice
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MASOT Meeting Sponsors
Gold
($1000 - $2000)
Breakfast sponsored by donation from EPL, Inc.
Lunch sponsored by donation from Calvert Laboratories
