CVM has initiated a new program to foster continuing education of review scientists in the development, production, and evaluation of animal drugs by facilitating communication among regulatory and drug sponsor scientists. This new initiative, titled, the "CVM Extern Program," involves direct interaction between CVM and drug sponsor scientists. Time is split between the sponsor's headquarters and visits to external Study Investigators at study sites.

Broad areas of interest to CVM include animal drug feasibility studies, new animal drug discovery, animal drug development, efficacy evaluation, safety evaluation, and animal drug manufacturing.

The first Extern Program was successfully completed in Animal Health Product Development with Pfizer Central Research in Groton, CT. Drs. M. E. Reese (Division of Therapeutic Drugs for Non-Food Animals, Equine and Antimicrobial Drugs Branch, HFV-114) and Thomas Letonja (Division of Therapeutic Drugs for Food Animals, Antiparasitic and Physiologic Drugs Branch, HFV-135) participated in a two-week program (April 8 - 19, 1996).

The first week, Drs. Reese and Letonja visited Pfizer's research headquarters in Groton, CT. During this time, Drs. Reese and Letonja participated in an orientation tour of the facilities and an introduction of the animal health development organization and personnel. They also participated in ongoing Project Team activities and attended several meetings and discussions. Drs. Reese and Letonja presented a seminar to explain CVM's organization, the review process of a typical submission and our interactions with other Federal and State regulatory organizations. The seminar was well attended by Animal Health Product Development personnel and generated an animated exchange between CVM representatives and Pfizer's personnel.

The second week of the Program focused on the monitor visits of clinical trial sites. Time was arranged by each Project Team based on ongoing activities. The externs traveled to clinical investigator sites accompanied by Pfizer's monitors. Dr. Reese visited sites located in Louisiana and Texas, and Dr. Letonja interacted with external collaborators in Texas and Wisconsin. Back in Groton, the final day of the second week was reserved for discussion of the visit, the mutual benefits derived, and the future direction of the extern program.

Both the Pfizer participants and the CVM Externs were enlightened by all the issues discussed and enjoyed the free exchange of information between the two organizations.