Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries

5 Questions with a Life Sciences Lawyer: Brian Malkin

By on December 28, 2021
Posted In Uncategorized

Brian Malkin
Practice Focus Area: FDA (Health Industry Advisory)
Office: Washington, D.C.
Years at Firm: 1+

What is your favorite part about practicing life sciences law at McDermott?
I joined McDermott because of the depth of expertise in its life science practice, which I had been missing at other specialty or large law firms. The depth of expertise allows us to work collaboratively for clients, each with different disciplines and strengths. My favorite parts of practice at McDermott are the opportunities for us to work in cross-collaborations, because it allows us each to offer input and provide added value to our clients from these different perspectives without the need to form working groups from multiple firms.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today?
My practice in FDA and IP law focuses primarily on pharmaceutical and biological product development and life cycle intellectual property protection. While the COVID pandemic has been detrimental in many aspects, in some sense it has opened an opportunity for increased contact with the agency for new product development, particularly for products to treat COVID, rare or orphan diseases and other unmet needs.

I particularly enjoy helping companies have successful meetings with FDA to obtain valuable product development input, as well as address any challenges that come up during the way. At the same time, I think these opportunities for increased feedback may be a challenge for our clients because they are either hesitant to reach out to FDA as “the regulator,” or they may go about meeting with the agency in a sub-optimal manner. These sub-optimal meetings may occur when our clients choose to go it alone and do not work with subject matter experts to properly prepare for FDA meetings.

What kind of client work gets you most excited when it comes across your desk?
As mentioned above, I get most excited about helping clients with new product development, particularly for products to treat current unmet needs, including for rare or orphan diseases, where product development needs to be very strategic. I also like working with clients to maximize the long-term returns from their new products by combining FDA regulatory and intellectual property considerations. Along the way, I am also there to assist our clients when navigating FDA inspections or addressing challenges that may arise in compliance or other areas, and help them obtain or maintain their product approvals.

What is the proudest moment of your career to date?
Given that a lot of my work may happen behind the scenes, I cannot take full credit for all of the successful product development moments that may occur with my assistance. My proudest moments, however, center on times when I have helped companies prepare for successful FDA meetings for new product development feedback. I am particularly proud when those meetings then lead to strategic and efficient clinical development and product approvals, providing new treatment and diagnostic options for the public. I think this reflects on my history as a former FDA regulator, where the focus is on the public health, and I view these new treatment options as valuable contributions to the public health.

Do you have any volunteer or pro bono work you focus on?
Given my interest in new product development and recognizing that many of these new ideas may come from startup companies, I like to provide pro bono mentoring to biotechnology startup clients. I also teach at a number of law schools (Georgetown University Law Center; American University Washington College of Law) and graduate university programs (Yeshiva University/Katz School of Science and Health; Catholic University) as an adjunct professor or regular guest lecturer for biotechnology entrepreneurs to learn more about FDA regulatory product development and intellectual property development and strategy.

Click here to learn more about Brian’s practice.




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