Perkins & Perkins, INC. Who are We?

In 1984, after eight years as a medical officer at the Food and Drug Administration (FDA), Dr. Jerri Perkins established Perkins & Perkins, Inc. (PPI). PPI offers medical and regulatory assistance to the pharmaceutical and medical device industries. As president of PPI, she has written protocols, prepared companies to meet with FDA staff, participated in FDA meetings with companies, served on Data Safety Monitoring Boards, and assisted companies in preparing IND, NDA, ANDA, IDE, PMA and 510(k) submissions. These submissions have included both drug/device and biologic/device products. She has actively participated in regulatory issues involving AIDS, helped companies get their first patient into clinical trials, identified regulatory issues needing attention in submissions prior to FDA submission, and developed strategy for propelling a product from non-approval to approval without additional data. In addition, Dr. Perkins has conducted pre-FDA audit inspections in the US and Europe. Her audit reports have been used successfully to prepare sites for FDA inspections.

John Calvin Perkins, M.D.
VICE PRESIDENT, CLINICAL AFFAIRS

Dr. John Perkins offers clinical expertise to FDA regulated studies as a Board Certified Internist with training in Infectious Disease. He received his under graduate and medical degrees at Harvard.

In addition, he has conducted clinical studies while in private practice for 25 years and while at the National Institutes of Health, NIH. While at the NIH in the Laboratory of Infectious Diseases his research included human respiratory viruses and clinical viral vaccine trials.

Dr. John Perkins continues to see HIV and internal medicine patients and offers the balance needed between clinical practice and clinical trials required for FDA approval.