Stephen Amato

Teaching Professor

Q. How did you get into the field of Regulatory Affairs, Pharmaceutical, Biotechnology and Medical Device?

A. I started my professional career in the field of R&D, and earned a PhD in Molecular and Cellular Biology, studying the genetic mechanisms that convert B lymphocytes into lymphomas.  From there I spent some time (in Toronto) in the field of genomics, and the utilization of next-generation DNA sequencing to assist clinicians in treating infectious diseases, including HIV, HPV and HCV.  I then went to business school, and from there entered the medical device market on the commercial side of the business, specifically in the fields of marketing and reimbursement, where I spent the next ten years.  Along the way, and out of necessity given one of the manufacturers I was working for I started working on global regulatory affairs challenges, specifically in the US, EU, Brazilian, Indian and Chinese markets.  After joining the Adjunct Faculty at Northeastern University and working concurrently for three years I joined the Faculty at Northeastern University full time in 2010 as Program Director for our Global Regulatory Affairs Programs.  Since that time, I have also maintained an active consulting business in the fields of global regulatory affairs, reimbursement and pricing.

Q. What do you enjoy about teaching at Northeastern University?

A. Northeastern University is the world’s pioneer in the use of experiential learning to educate its students.  There is an expectation for Faculty to embody a ‘scholar/practitioner’ model, in which we are expected to not only participate actively in the academic evolution of our fields but also to be active participants within it.  Through teaching at the University I am able to remain current in the rapidly evolving fields of global regulatory affairs and reimbursement, and also concurrently utilize that currency in practising professionally within the field

Q. What courses do you enjoy teaching within the Regulatory Affairs program and why?

A. I enjoy teaching RGA6101 Therapeutics Product Development since it enables me to utilize my background in molecular and cellular biology.  I also enjoy teaching RGA6207 and RGA6235, which are courses that teach students how to deal with emerging topics of interest within the field of regulatory affairs.  These premise underlying these courses is that rapid advances in technology, and utilization of ‘big data’ approaches to developing new pharmaceutical, biologic and medical device topics necessarily requires that regulation of products based on these technologies needs to continuously evolve in order to ensure that they are safe and effective to use in clinical populations.

Q. Why is this a good time to get into the field of Regulatory Affairs?

A. As I mentioned, technology continues to advance rapidly in all biomedical product fields, including pharmaceuticals, biologics, medical devices, as well as combination products like drug delivery therapies.  In addition, we are learning to more effectively utilize analytics, big data and AI to enable more efficient pharmaceutical product development.  While these types of products offer much promise in terms of treatment of many clinical populations, including oncology patients, and also offer the capability to deliver a more ‘precision-based’ approach to medicine, their novelty also means that their clinical utilization is associated with a relatively higher level of risk.  Regulatory affairs professionals are responsible for evaluating the efficacy of these new types of products and determining what populations are best suited to receive them in the clinic.  They are also responsible for assessing the safety of their use in these populations, identifying the potential risks involved, and developing strategies to mitigate these risks.

Q. What are your main interests outside of Regulatory Affairs, Pharmaceutical, Biotechnology and Medical Device?

A. I consult with and advise various stakeholders in the life sciences industry on current challenges in biomedical product commercialization.   I also read quite a bit, but also take time to enjoy family, including spending time with my 3-year-old daughter Francesca.  When I can find the time, I am a Private Pilot and do some flying, as well as motorcycle riding when the weather permits.

Click here to read more about Stephen Amato.