Focus on: Linda Bowen

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| 25 July 2019 | By Zachary Brousseau 

Linda Bowen has more than 35 years of experience in the pharmaceutical industry, including 25 in regulatory and the last 12 specifically focusing on regulatory policy and intelligence. She has been an active volunteer with RAPS at both the global and local levels, having served on RAPS’ board of directors, as a chapter chair, and as an expert author, presenter and speaker. She is currently the chair of the planning committee for the 2019 Regulatory Convergence. Linda is a RAPS Fellow and holds Regulatory Affairs Certification (RAC) for the US, EU, and Canada. She also has been an adjunct professor for the regulatory affairs and quality assurance master’s program at Temple University for more than 18 years.

Linda was kind enough to answer questions for this latest installment of the Regulatory Focus series, ‘Focus on…,’ where we talk with regulatory leaders, thinkers and influencers about their work, experiences, personal philosophies and advice for less experienced professionals. She shared her perspective on how regulatory professionals’ contributions are valued today, giving back to the profession, what it takes to succeed in regulatory intelligence and more.

Following is an edited transcript of our interview:
How do you explain what you do as a regulatory professional to someone unfamiliar with the profession?
I can remember my mother trying to explain to her friends what I did. It went something like, 'she helps get drugs to the people that need them.' To her, that was the most important takeaway from what I did. Now that I am in regulatory policy, it is a bit easier to explain what I do. I help shape the regulatory environment—there’s a lot more to that definition but that’s the main deliverable.
Do you think regulatory professionals are adequately recognized for their important contributions?
If you had asked me that question 25 years ago, I would have probably said no. But I do feel that the regulatory professional of today is considered a critical and strategic part of the industry.
How has the perception of the profession changed since you began your career?
When I first started in the regulatory profession (1993), we were much more operational than strategic. It was about getting the submission out the door as quickly as possible. The Prescription Drug User Fee Act (PDUFA) was brand new and implemented to accelerate the review timeline for new drug applications (at that time, the average was more than 30 months).  Everything was paper-based. Harmonization efforts were new and the patient voice was first being heard. Fast forward 25 years and regulatory professionals are no longer the gatekeepers; we are a key to strategic decision making, including business development.
How did you come to specialize in regulatory intelligence and policy?
I started my regulatory career as a generalist, which is a fancy way of saying that we needed to know and do everything. That morphed into a strategy and liaison role. In both of those roles, I was charged with keeping up with the ever-changing regulatory environment. As access to electronic information grew and health authorities became more transparent, there needed to be a person or group responsible for monitoring, analyzing and interpreting the information being published.

In 2003, I organized monitoring, analysis and communication of recent regulations, and guidance for the regulatory affairs department I was working in. My co-workers appreciated the updates, but it was only a small part of my role. At the 2005 RAPS Annual Conference, I presented on defining and analyzing precedent and after the session, an attendee spoke with me about an open regulatory intelligence position at her company. She sent me the job description, and it was very similar to what I was doing part-time in my strategist role. I applied for that role and got the position. I became the director of US regulatory intelligence at Sanofi, and from there moved on to other roles within the group including head of the US regulatory policy and intelligence. Regulatory policy activities rely heavily on solid regulatory intelligence, so the move to policy seemed to be the next step. I now head up regulatory policy and intelligence at Seattle Genetics.
How has technology changed the practice of gathering regulatory intelligence in recent years?
I can recall my first presentation on this subject at the RAPS Annual Conference in 1997. It was entitled, “Internet Intelligence.” It sounds strange when I think of it now, but back then this was cutting edge. Imagine an engaged audience discussing file transfer protocols. The internet and information available on health authority websites was a new phenomenon. As the amount of information grew, we started to track changes to websites with tracking technology, which at the time was all the rage. Then there were mailing lists, RSS feeds, newsletters, free and fee-based subscriptions, databases, social media…almost too much information. We now have tools available to us that can make monitoring and surveillance much more targeted. And with some health authorities providing open-source data, we have the ability to provide a deep dive on metrics and trends.
What advice would you give to someone who wants to specialize in regulatory intelligence?
Do you like finding a needle in a haystack? Do you have a broad base of regulatory knowledge? At least five years regulatory affairs experience? Regulatory intelligence is not just knowing where to find something, it also takes skills such as being an effective communicator and being able to analyze, interpret and integrate information to all levels of the organization. If you like a job where every day is something new, then RI might be for you.
How do you think the profession will change over the next five years—whether driven by technological changes or other factors?
Although the deliverables in regulatory intelligence won’t change much, how we monitor and conduct surveillance will need to change to adapt to the ever-evolving use of “big data.” We’ve started using Tableau to visualize data and I hope, in the near future, to start using automated extraction and classification of approval-related information using natural language processing.
Do you have a personal philosophy that helps guide you in your career, in life or both?
I’ll start with my career. I felt that it was my obligation to give back to a profession that has provided me tremendous opportunities over the years. I’ve been volunteering in some capacity for the last 25 years at both RAPS and DIA, and will continue to do so. I have served as an author, speaker, chapter chair, board member and this year, program chair for the 2019 Regulatory Convergence. I recently was awarded the DIA Americas Inspire Award for volunteer excellence. I find it strange to be rewarded for doing something you love to do—and very humbling.

As far as life goes, I am doing my best to slow down and to enjoy life more. As an information junkie, this is very hard to do but I can report that I traveled to Austria for 14 days last December without a laptop. I did sneak an old smartphone with me so I could, under cover of night, read my emails.
What is something you are passionate about other than work or family?
I am very passionate about education and mentoring the future generation of regulatory professionals. This includes my time as an assistant professor at Temple University, running RAC study groups for the RAPS New York/New Jersey Chapter, and conducting multiple cohorts of a two-day regulatory affairs basics course for post-doctoral bench researchers to help prepare them for a transition to government or industry employment.


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