Agenda
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Pre-Conference Workshop
Animal Health Boot Camp: An Intense Guide to the Laws and Regulations Governing Medicines, Therapeutics, Food and Feed for Companion Animals and Livestock
Sep 13, 2016 2:00pm – 5:30pm
Speakers
Joseph W. Cormier
Attorney
Hyman, Phelps & McNamara, P.C. (Washington, DC)
Diane J. Romza-Kutz
Partner
Thompson Coburn LLP (Chicago, IL)
Day 1 - Wednesday, September 14, 2016
Day 2 - Thursday, September 15, 2016
7:15 |
Continental Breakfast |
8:15 |
Co-Chair’s Opening Remarks and Recap of Day One |
8:30 |
Pet Prescription Portability: An In-Depth Look at the Proposed Fairness to Pet Owner Act |
9:15 |
Revisiting the Animal Drug Compounding Debate |
10:00 |
Morning Coffee Break |
10:30 |
Exploring New Controversies in Bioequivalency Studies for Animal Drugs |
11:15 |
Safe Guards for Third Party Clinical Studies in the Animal Health Arena |
12:00 |
Conference Ends (Luncheon will be served immediately following the conference for Post-conference Workshop Attendees only.) |
Day 1 - Wednesday, September 14, 2016
7:00 |
Registration and Continental Breakfast |
8:00 |
Co-Chairs’ Opening RemarksJudith Weinstein Jeannie M. Perron |
8:15 |
Analyzing the NOOH Process and Its Importance in the Animal Drug ArenaJudith Weinstein Jeannie M. Perron An FDA Notice of Opportunity for Hearing “provides an individual with the opportunity for a hearing on a regulatory action, including a proposed action…before a presiding officer designated by the Commissioner.” The panelists will discuss the FDA Notice of Opportunity for Hearing (NOOH) process and procedures in the context of Animal Health. |
8:45 |
FDA Enforcement Activity in the Animal Health Industry: A Year In ReviewAshish Talati J.D., M.S., RAC CVM’s Office of Surveillance and Compliance has responsibility for and “monitors marketed animal drugs, and veterinary devices to assure their safety and effectiveness…[and] is also is responsible for animal food safety programs including the approval of food additives, monitoring the safety of animal feed and administering the medicated feed program.” This panel will explore this office’s enforcement activity and hotspots for industry in the last year. Points of discussion will include:
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9:30 |
From Glofish to Frankenfish: Understanding How the Approval of Transgenic Animals May Impact Animal and Human Food and DrugsJoseph W. Cormier GMO Salmon was approved for human consumption last fall via a New Animal Drug Application. This panel will explore the controversial nature of this approval as well as its wider implication for animal and human food and drugs.
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10:15 |
Morning Coffee Break |
10:30 |
Exploring the Continuing Controversy of Antibiotic Use in LivestockJohn F. Kuckelman In June 2015, the FDA issued its Veterinary Feed Directive (VFD) final rule which together with Directives 209 and 213 call for tighter controls of antibiotic use in livestock, effective January 2017. This session will explore these Directives and their controversial implications for animal feed and drug manufacturers as well as the public.
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11:15 |
Establishing Protocols for The Next Wave of FSMA Rule Implementation for Animal Feed, Pet Food and Animal Drug ManufacturersJason W. Sapsin Diane J. Romza-Kutz
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12:00 |
Networking Luncheon |
1:00 |
Non-Economic Damages for Animal Loss: Assessing the Legalities, Realities as well as Economic Consequences of Such Awards for the Animal Health IndustryPhil S. Goldberg Dr. Kent McClure Bonnie Lutz At time of press, an appeals court in Georgia is reviewing a matter in which a pet owner is seeking non-economic damages for the loss of a pet. This is an area replete with controversy. While some argue that contrary to established law, pets are more than property and chattel, other argue that should that classification change, the social and economic consequences of such an award would do more harm than good to animal care. This panel will explore this issue and line of cases which seek to compensate for loss of animal companionship. Points of discussion will include:
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1:45 |
Animal Biologic Development: The Continuing Debate Between Cure and CostBrian J. Malkin Hans Draayer MS We live in an age, where biologics for humans have brought tremendous advancements in the cure for disease. This in turn leads to the question about the development of such therapies for animals and the cost effectiveness debate. There are also questions of ethics coupled in this debate concerning animal testing in the development of these products. This panel will explore these controversies. Points of discussion will include:
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2:30 |
Afternoon Refreshment Break |
2:45 |
Dietary Supplements for Animals: Cause and ControversyMichael Uckele
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3:30 |
Creative Leveraging of IP to Ensure Protection of Animal Drugs and TherapeuticsElizabeth A. McGraw
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4:15 |
New Considerations for Advertising and Promotion of Animal Drugs and Animal FoodsKS Reagan Evangelia C. Pelonis
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5:30 |
Conference Adjourns to Day Two |
Day 2 - Thursday, September 15, 2016
7:15 |
Continental Breakfast |
8:15 |
Co-Chair’s Opening Remarks and Recap of Day OneJudith Weinstein Jeannie M. Perron |
8:30 |
Pet Prescription Portability: An In-Depth Look at the Proposed Fairness to Pet Owner ActClint Vranian Eric J. Steiner This past April, a Congressional hearing took place on the merits of the proposed Fairness to Pet Owners Act which in the eyes of its advocates would allow for prescription portability — as well as more economical option for pet owners to purchase pet medicines outside the traditional means of obtaining such medicines through a veterinarian’s office. The Act’s opponents believe that choice already exists at the state level and that this legislation would interfere with the veterinarian’s role in pet care. This panel will discuss this potential legislation and the views of both sides of the debate. Points of discussion will include:
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9:15 |
Revisiting the Animal Drug Compounding DebateTheodore M. Sullivan Rachael G. Pontikes Moderator:Brian J. Malkin The animal drug compounding controversy continues. While, FDA issued a draft guidance on the matter last year. There still is no specific Federal law or Amendment to the Food Drug and Cosmetic Act regulating the practice. In this federal vacuum, various states are now chiming in with their own proposed legislation. In this session, our panelists will continue the discussion from last year and revisit the pros and cons of compounding as well as new compounding controversies. Points of discussion will include:
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10:00 |
Morning Coffee Break |
10:30 |
Exploring New Controversies in Bioequivalency Studies for Animal DrugsBrian J. Malkin Elizabeth A. McGraw Bioequivalency studies are a key requirement of the Generic Animal Drug and Patent Term Restoration Act (GADPTRA), the animal drug equivalent to the Hatch Waxman Act governing human drug brand and generic market access. This panel will explore new concerns relative to bioequivalency in animal drugs and therapeutics.
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11:15 |
Safe Guards for Third Party Clinical Studies in the Animal Health ArenaAnn R. Donoghue DVM, MS Gary Yingling
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12:00 |
Conference Ends (Luncheon will be served immediately following the conference for Post-conference Workshop Attendees only.) |