Seminar 2: Regulatory Challenges
Regulatory Challenges Associated with New Technology Implementation
Offered Dec. 7, 2017
About the session
As new technology enters the animal health market, one of the biggest challenges of adaptation is achieving a registration, particularly when some features of the new technology may not clearly fit into the current regulatory processes.
Seminar documents
Innovating in Food Producing Animals in the New Age of
"Clean Food"
Scott Holmstrom, Ph.D., senior director, Food and Animal Product Development, Elanco Animal Health
Regulatory Challenges in Food Animal Drug Development
Michael Apley, D.V.M., Ph.D., DACVCP, Frick Professor of Clinical Sciences, College of Veterinary Medicine, Kansas State University
Modern Approaches to Provide Data to Regulatory Agencies
Butch KuKanich, D.V.M., Ph.D., Diplomat ACVCP, professor and assistant department head, College of Veterinary Medicine, Kansas State University
Regulation of Novel New Animal Drugs
Heather Lombardi, Ph.D., Animal Bioengineering and Cellular Therapies team leader, Office of New Animal Drug Evaluation, Food and Drug Administration's Center for Veterinary Medicine
Speakers
Ernst Heinen Chief Development Officer
Aratana Therapeutics Inc.
Ernst Heinen, D.V.M., Ph.D., has served as chief development officer for Aratana Therapeutics Inc. since March 2014. In addition, he served as our the head of Drug Evaluation and Development from June 2012 until March 5, 2014.
From 1990 to 2012, Dr. Heinen held positions of increasing responsibility at Bayer Animal Health, the animal health division of Bayer AG, where he ultimately served as vice president of Research and Development and Veterinary Technical Services, Pets.
Dr. Heinen currently serves on the Kansas State University Olathe Advisory Board and previously served on the boards of the Kansas City Area Development Council and the Center for Animal Health Innovation. He is the author of dozens of scientific articles and presentations focused on the animal health industry.
Dr. Heinen received a veterinary degree and a D.V.M. in veterinary microbiology from the Justus-Liebig-University of Giessen Veterinary School in Giessen, Germany, and is a certified specialist in veterinary microbiology.
Heather Lombardi Leader, Animal Bioengineering and Cellular Therapies Team
Office of New Animal Drug Evaluation
FDA Center for Veterinary Medicine
Dr. Heather Lombardi is the Leader of the newly formed Animal Bioengineering and Cellular Therapies Team in the Office of New Animal Drug Evaluation at the Food and Drug Administration’s Center for Veterinary Medicine (CVM).
Dr. Lombardi previously served as a master reviewer with expertise in the review of innovative products such as proteins, peptides, and cell-based products in the Division of Manufacturing Technologies at CVM.
Dr. Lombardi joined CVM in 2008, and throughout her tenure has participated in many efforts put in place by the Center in order to bring innovative new animal drugs to market in a more predictable and seamless fashion, such as the Innovation Exploration Team (IVET), and numerous technology teams and working groups.
Dr. Lombardi has led efforts to provide guidance and policy to stakeholders specific to the regulation of new technologies.
Dr. Lombardi holds a doctor of philosophy in biological chemistry from the University of Pennsylvania and a bachelor of science in chemistry (biochemistry track) from the University of North Carolina at Chapel Hill.
Senior Director of Food and Animal Product Development
Elanco Animal Health
Scott D. Holmstrom, Ph.D., received his doctorate in analytical chemistry from Miami University in 2000 and joined Elanco Animal Health the same year.
As a research scientist from 2000 through 2006, Dr. Holmstrom has provided chemistry and drug disposition expertise and significant contributions toward the development and commercialization of drug products for Elanco, including global approvals for Comfortis and Trifexis. His work has influenced numerous companion animal and food animal programs targeting ectoparasites, endoparasites, coccidiosis, ketosis and feed efficiency. In these assignments, Dr. Holmstrom has developed and validated analytical and bioanalytical methods, and led technical teams to elucidate the metabolism, pharmacokinetics, and pharmacodynamics of existing products and new compounds.
From 2006 - 2012, Dr. Holmstrom led cross-functional product development teams to obtain global registration of new chemical entities for companion animals, targeting parasiticides. Additionally, from 2011 – 2013, he served to integrate the Jannsen Animal Health research and development efforts with those of Elanco.
From 2013-2016, Dr. Holmstrom led global regulatory affairs for Elanco. In this role, he was responsible for shaping the regulatory landscape to enable outcomes for Elanco, their customers, as well as ensure that Elanco deliverables are completed in accordance with appropriate regulations and commitments to global regulatory authorities. This position provides direction for activities according to the company objectives and plays a key role in the development of short term and long-term company strategy.
In 2016, Dr. Holmstrom led Elanco’s efforts for development and execution on late stage external innovation strategies. In this role, he developed specific strategies and execution plans to collaborate with external companies to commercialize products will support near and mid-term growth objectives for Elanco.
Currently, Dr. Holmstrom leads Elanco’s global food animal product development efforts for pharmaceutical and vaccine products for swine, poultry, beef, dairy, and aqua. In this role, he provides the strategic direction for the global development of products through external and internal coordination, governance, and resourcing.
Butch KuKanichProfessor and Assistant Department Head
Anatomy and Physiology
Kansas State University College of Veterinary Medicine
Dr. Butch KuKanich is a professor of pharmacology and assistant department head at Kansas State University, College of Veterinary Medicine.
He earned his D.V.M. from Virginia Tech in 1997 and his Ph.D. in 2005 from North Carolina State University.
Dr. KuKanich earned Diplomate status in the American College of Veterinary Clinical Pharmacology in 2004.
He has seven years clinical experience in emergency medicine and small animal private practice.
Dr. KuKanich’s research interests focus on companion animal pharmacology, drug interactions, drug metabolism and analgesia.
Michael ApleyFrick Professor of Production Medicine and
Clinical Pharmacology
Kansas State University College of Veterinary Medicine
Dr. Michael Apley is a veterinarian with a Ph.D. in physiology (pharmacology). He is a Diplomate of the American College of Veterinary Clinical Pharmacology. His practice background includes general practice in central Kansas and a feedlot consulting/contract research practice based in Colorado.
Dr. Apley was on the College of Veterinary Medicine faculty at Iowa State University for nine years through 2005. He is currently a professor in the department of veterinary clinical sciences at Kansas State University. Dr. Apley works with veterinarians and producers throughout the United States concerning the use of drugs in food animals and also in the area of beef cattle health with an emphasis on feedlots.
Dr. Apley teaches in the beef production medicine, large animal medicine, and pharmacology courses. His research interests include infectious disease, antibiotic efficacy and resistance, drug residues, and applications of drugs in food animals. In 2016, he and collaborators started a five-year study funded by the FDA which focuses on quantifying antibiotic use in feedlots and dairies.
Dr. Apley is a past president of the Academy of Veterinary Consultants and the American College of Veterinary Clinical Pharmacology. He is currently president of the American Association of Bovine Practitioners. In 2015, Dr. Apley was appointed as a voting member of the Presidential Advisory Council on Combating Antibiotic Resistant Bacteria.