A Senior Research Scientist with almost a decade of experience in clinical research, Dr. Theresa Scocca currently serves as Program and Regulatory Lead on programs at various stages of development. From Pre-IND interactions and IND submissions through marketing application submissions, Dr. Scocca has worked on a variety of products including drugs, biologics, medical devices, and combination products.

In addition to leading regulatory submissions, Dr. Scocca has participated in FDA meetings and authored her share of protocols, various clinical summaries for marketing applications, briefing packages, and approved product labels. Her experience encompasses a variety of therapeutic areas, including multiple infectious disease programs focused on the development of vaccines, as well as the development of a treatment and a device as well. Dr. Scocca has also served as lead author for the US Package Insert for a complex, multidrug treatment regimen for patients with a life-threatening infectious disease.

Dr. Scocca has served as the Regulatory and Medical Writing Lead for three vaccine development programs funded by the Biomedical Advanced Research and Development Authority (BARDA). Her responsibilities included protocol development, clinical study report development, and the management of IND and associated maintenance submissions. She has also participated in program development for a novel vaccine injection device.

Dr. Scocca holds a Ph.D. in Genetics from the University of Iowa.

Why Clinical Research?

“I wanted to be continually challenged intellectually, and I have found that to be true both scientifically and in the area of regulatory strategy. I also wanted to use my scientific training to contribute to the improvement of human health.”

Why Infectious Disease?

“As the child of a polio survivor who became ill only a few years before a vaccine was available and has suffered life-long disability as a result, I know the value of vaccinations. Treatments are wonderful, but it is most ideal to prevent someone contracting a disease when possible. And the recent treatment I worked on was challenging because of the complex treatment and patient group, but it is exciting to know that these patients now have hope for long-term survival.”

This is what drives Dr. Scocca:

“One of the things that drives me most is the conduct of good science. I feel strongly that every clinical study subject’s contribution is valuable, so we should strive to assure that studies are optimally designed to protect the subject and gather useful data that contribute to a product’s development; design development programs that have a strong possibility for success; and present the data gathered accurately and completely to the regulatory agency in a submission.

I am also driven by the ability to improve human health. At Rho, I have been fortunate to be involved in numerous programs for the treatment of serious and rare diseases, allowing me to contribute to products that can drastically improve quality of life and survival.

And seeing treatments and preventatives available for patients who need them is rewarding. Every product we work on is not successful, but when one is, it is gratifying knowing that you contributed to that product being available for those who need it.”