Award Winner (Frederick Carleton Award) 2023: Michael Blackton

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Michael Blackton

Michael Blackton

Blackfin Biopharm Advisors

One day back in the early 1990s I found a two-line print ad in the San Francisco Chronicle that said simply, “Purification Operators Needed”.  The ad had a company name, IDEC Pharmaceuticals, and a phone number.  I faxed my resume and started my daily boring bookkeeping for the family business. Within an hour I got a call.

I ended up getting the job, and very soon I found myself in a small cleanroom (smaller than my home office!) with a 500mL protein A column and this thing called a batch record. We were purifying the first bioreactor lot for C2B8 – later called Rituxan. That same year, I found myself moving with IDEC from Palo Alto to San Diego where we were building a manufacturing facility – my task was to set up downstream processing. In San Diego, the Validation Manager was a guy named EJ Brandreth, who later became my supervisor, and is a person who to this day is a great colleague, and friend, and the person who showed me how important our work is. EJ had a simple rule: Join the Parenteral Drug Association, and PDA will help you learn what your job is.

So began a long journey of collaboration with the PDA. We were all encouraged to go to conferences, learn, and volunteer. I did just that – at first just rote learning, and then some understanding, and then some ideas and theories spurred on over many a drink with newfound colleagues at PDA. I moved on from IDEC but remained an active member of PDA. After I gained enough experience, I had the great opportunity to work on several Technical Reports, starting with what was later TR-61, Steam In Place. At this time, I moved on to Lilly, and during a phone call with EJ, I learned about the Process Validation TR.  I wanted in so I put EJ on hold, and immediately called Hal Baseman, who was on the Board.  Hal got me on the team, and I was off to the races – funny I remember that call like yesterday! That PV Technical Report became TR-60.  So, a little PDA trivia: TR-61 was started two years earlier than TR-60!

Over the years I was fortunate to speak at a few meetings and was asked to lead the TR60-2 supplement on Oral Solid Dosages. By now, I had transitioned to cell therapy, and thanks to Becky Divine, I became a member of the BioAB, later called the Biopharmaceutical Advisory Board. The reason I was interested in leadership was because I feared that PDA just might be behind the 8 ball on these new therapies. I remembered how back in the early days of monoclonals, it was PDA that helped me navigate the quality, regulatory, and manufacturing issues. Why, I thought, despite a few EU conferences, is PDA not super active in this space and providing those in cell and gene therapy the same training I received at those conferences long ago? How can PDA develop best practices, strategies, and resources for Cell and Gene Therapy? BioAB will help me get the message out.

Then I called Hal again. With the help of people like Josh Eaton at PDA and Vijay Chiruvolu who was a friend from the TR-60 days and at Kite, we were able to take the time spot for an aging facilities conference Hal was chairing. Vijay and I became co-chairs of the first US-based Cell Therapy conference. We had over 100 people at that conference! It was a blast, and we immediately planned the next year, and the year after that – each conference having more attendees, and people like Tom Whitehead from the Emily Whitehead Foundation and Peter Marks from FDA! During this time I was fortunate to work for a great team putting TR-81 together, which continues to be a great resource for control strategy development for cell therapies. Vijay and I also started the ATMP Interest Group, which was announced during one of our conferences.

I remember telling Josh Eaton after the second conference that I would like to be on the PDA Board of Directors, “sometime in the next 5 years”.  I was then as I am now, super passionate about the promise of cell therapy and I wanted the entire organization to be as passionate as me!

That same year, in July 2019, I was fishing in Florida while on vacation.  My phone rang and I answered. It was Richard Johnson, PDA President at the time. Here I am reeling in a snapper when Richard asks me if I would like to be a member of the Board of Directors as a strategic appointment to advance ATMP! I said yes, but after I land this fish!

So began my tenure on the PDA Board of Directors. Despite the COVID-19 pandemic, the 2020 ATMP conference was well attended as a virtual meeting; all while we were managing the impact of COVID on PDA -  it was a very hectic time! Later, Stephan Krause and I justified and started the ATMP Advisory Board, where I am currently the immediate past chair.

My journey with PDA has been incredible! One thing that Martin Van Trieste (Past Board Chair) told me is that PDA will not get you a better job. PDA, he said, will get you the knowledge and resources to earn a better job. Martin was correct that evening at the bar in San Antonio.  Without the PDA, I would not have nearly the knowledge I have today.  This is not important though. What is important to me are all the people I know as a result of my work with PDA and who continue to influence my life for the better. People like Richard Johnson, Josh Eaton, Stephan Krause, Sue Schniepp, Hal Baseman, Tom Whitehead, Becky Divine, Marc Glogovsky, and of course, EJ Brandreth.

About Michael Blackton

Michael is a seasoned professional with over 30 years in the biopharmaceutical industry, joining the Parenteral Drug Association (PDA) in 1996. Currently, as the founder and principal of Blackfin Biopharm Advisors, he leads a consultancy dedicated to advancing therapies to market.

Throughout his career, Michael has worked in Quality, Operations, and Manufacturing, showcasing expertise in monoclonal antibodies, small molecules, medical devices, and advanced therapies. His notable roles include serving as Senior Vice President of Cell Therapy Manufacturing at Nurix and Global Head of Quality at Adaptimmune.

Michael's biotech journey began at IDEC Pharmaceuticals, where he developed downstream processing methodologies for Rituxan. He has contributed significantly to Eli Lilly, Millennium Pharmaceuticals, and Biomarin.

In addition to his corporate achievements, Michael has been actively engaged with the PDA, serving as a past Board Member, where he co-founded and serves as  past chair of the ATMP Advisory Board. He co-founded the ATMP Interest Group and contributed to several PDA Technical Reports, white papers, and regulatory comment requests. Michael's leadership and contributions underscore his commitment to advancing the biopharmaceutical industry.

Michael Blackton