Thursday, October 31, 2013

Rotation 4: Industry - Catalyst Regulatory Services, LLC, Dexter, MI

Posted by Jennifer at Thursday, October 31, 2013

After having 3 hospital rotations, I was excited to begin my fourth pharmacy rotation in the industry setting at Catalyst Regulatory Services, LLC.  Right from the start, Catalyst welcomed me into their team!

Catalyst is a consulting company that provides regulatory strategy and operational assistance to pharmaceutical companies large and small.  The president of the company is Mark Ammann, Pharm.D., and my preceptor, Anita Fereshetian, R.Ph., MS, is a regulatory director on the management team.  The Catalyst management team consists of a regulatory operations manager and senior consultants, many of whom are pharmacists and have had extensive industry experience at various pharmaceutical companies.  Catalyst also has a widespread consultant staff.

In a nut shell, biotechnology and pharmaceutical companies contract out to Catalyst for guidance with regulatory issues.  Catalyst assists with strategy development, submission of orphan applications, investigational new drug applications, new drug applications, and much more!  Catalyst composes submissions that are sent not only to the FDA but also to the EMA and other international regulatory bodies.  While on rotation, I was considered to be part of the drug development team in two specific pharmaceutical companies for which I was working on projects.

In the beginning of my rotation, I learned about Regulatory Affairs, clinical research, the Prescription Drug User Fee Act (PDUFA), and rare diseases and orphan drugs.  Mark, Anita, and others regularly had didactic discussions with me about these topics and more.  They were glad to have these talks and answered any questions that I had! As various topics arose during my rotation, there were often FDA guidances from which I was able to gather specific information and then discuss with my preceptor Anita.  I became a pro at navigating the FDA and EMA websites as well as to investigate planned, current, or even completed clinical trials.

I worked on some fascinating projects while at Catalyst!  Most notably, I was the lead author for an orphan application and drafted a protocol synopsis for a phase II study.  I learned in depth about a specific disease state and the current treatments for the disease, including current marketed therapies and investigational new therapies.  These were long-term projects that I worked on for the majority of my rotation, and it was rewarding to finish them on time before my rotation ended!

During my time at Catalyst, I observed several skills and attributes that I think are essential when working in Regulatory Affairs, and I was able to improve upon these skills while on rotation:
Ability to work independently and with a team – I worked on projects independently for some of the time, but I regularly discussed these projects with my preceptor Anita.  Even though self-sufficiency for working on projects is needed, it is very important to be able to work well with others.  For example, I worked with several other people from different divisions of a pharmaceutical company as well.
Time management – Many documents are time-sensitive.  Also, if a company has a goal deadline for a submission, a Regulatory Affairs professional needs to do his or her best to complete their work within that timeframe.
Detail-oriented – There are specific pieces of information that should be included in submission documents in order to obtain approval from the FDA or another regulatory body.
Critical thinking – Understanding the FDA guidances and figuring out how to construct submissions is vital.  Also, understanding the clinical data that supports the submission document is important.
Passion – As with any career, it is important to enjoy what you do!

A highlight of my rotation is that I was able to observe and contribute to team development and committee meetings with Catalyst and pharmaceutical companies, most notably preparation meetings for a pre-IND FDA meeting. There are different types of FDA meetings (A, B, C), and I was very fortunate that Catalyst invited me to attend a pre-IND meeting (type B) at the FDA in Silver Spring, Maryland!  It was terrific to learn first-hand how to prepare for and carry out a meeting with officials from the FDA.  It is very important to know exactly what topics to discuss at the meeting since time is limited.  Additionally, clear and effective communication is vital.

I learned so much about pharmaceutical industry while at Catalyst, not only through reading FDA guidances and working on projects but mainly by talking to people at Catalyst and other pharmaceutical companies about their career paths in industry.  They were all more than happy to share their experiences with me.  There are many wonderful career opportunities for pharmacists in the pharmaceutical industry!