AAVPT/USP Joint Workshop

Exploration of Developmental Approaches to Companion Animal Antimicrobials: Providing for the Unmet Therapeutic Needs of Dogs and Cats

October 23-24, 2008

Spaulding Auditorium

U.S Pharmacopeia, Inc.

12601 Twinbrook Parkway

Rockville, Maryland

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Issue: Antimicrobials approved for dogs and cats are supported by indications that are often not consistent with the way they are used in companion animal practice.

Objective: The objective of the workshop is to describe alternative approaches to data development supporting new labeling indications consistent with the therapeutic needs of companion animal medicine.

Questions to consider for this workshop:

• Considering how you actually use antimicrobials in practice, do the labels on companion animal antimicrobial products meet your therapeutic needs?
• What information would you like to see on product labels and how would you use this information?
• What criteria go into your selection of an antimicrobial?
• Currently, how do you get the information that you need to support product use?
• How do you determine what dose, dosing interval and duration in actual conditions of use?
• How do you determine what the safety of a product is if you are using it at higher doses or more frequently than the dosing interval on the label?
• What additional safety and effectiveness information would be useful on labeling to help you determine dose, dosing interval, and duration?

How can a study be designed to cover multiple indications?

• What power/number of cases are needed?
• What special considerations would be needed when designing the control group(s) for such a study?
• If different indications require different doses, dosing interval or durations of treatment, how would effectiveness and safety data on the different indication be combined?
• What is the measure of success/effectiveness?
• What are the appropriate endpoints to measure effectiveness?
• If different diseases have different safety issues (extreme case: trial including puppy acne and encephalitis), how would risk benefit be determined with respect to effectiveness and safety?
• What are some the challenges associated with defining clinically relevant measures of success?
• How can PK/PD be used?
• What options are there for supporting the effectiveness of diseases that are associated with low incidence?
• Can universities/referral practices play a larger role in developing studies for a more challenging range of indications?

Program Committee
Anthony Lucas, B.V.M.S., Ph.D., Co-chair
Marilyn N. Martinez, Ph.D., Co-chair
Ian DeVeau, Ph.D., Co-chair
Michael Apley, D.V.M., Ph.D., DACVCP
Melanie Berson, D.V.M.
Ralph Claxton, D.V.M., M.S.
John Donecker, V.M.D., M.S., DABVP
Amy Neal, D.V.M.
Mark Papich, D.V.M., M.S., DACVCP
Michele Sharkey, D.V.M.
Linda Wilmot, D.V.M.
Carol A. Davis, M.S., Ph.D., AAVPT President-elect