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
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. conducted clinical studies for six
years at NIH. His research at the Laboratory of Infectious Diseases
included human respiratory viruses and clinical viral vaccine
trials.
He is a Board Certified Internist with training in Infectious
Diseases. He continues to be a clinical investigator in private
practice. He received his under-graduate and medical degrees
at Harvard.