Thomas Hartman Of The International Society for Pharmaceutical Engineering (ISPE) On The Exciting Developments In US High Tech Manufacturing

An Interview With David Leichner

Attitude. Smile, say thank you, and always do the right thing. Often times we are confronted with some significant challenges in the workplace — always doing what is right vs. what may be popular. This has and continues to serve as a north star for my personal behaviors and decision making.

The global shortage of computer chip manufacturing has highlighted the urgency for the US to have a robust High Tech Manufacturing sector. As a result, the Biden administration has signed a bill to boost chip manufacturing in the US. In addition to computer chips, what other exciting advancements and innovations are US companies making in High Tech manufacturing? What is coming out in the near future? What would it take for the US to become a High Tech Manufacturing powerhouse? To address these questions, we are talking to leaders of High Tech Manufacturing industries. As a part of this series, I had the pleasure of interviewing Tom Hartman.

Thomas (Tom) Hartman is President & CEO of the International Society for Pharmaceutical Engineering (ISPE), which includes the ISPE Facility of the Year Awards (FOYA), an honor recognizing the best in pharmaceutical engineering. Prior to his appointment, Hartman was Vice President of GMP Operations, Biopharmaceutical Development & Supply for GSK. With over two decades of experience in critical chemistry, manufacturing and controls functions and a strong regulatory perspective, Hartman has effectively conducted business in multiple regions including the US, UK, Europe, Asia, & South America. In addition, he has extensive experience in negotiating supply contracts with multiple international CMO/CRO’s.

Prior to joining GSK in 2001, he held multiple engineering and operations roles with a major US based chemical manufacturer, including a five-year expatriate role in the Netherlands, culminating with responsibilities as head of engineering for one of the largest chemical facilities in the US. Hartman has been a member of ISPE since 2001 and served nearly 7 years on ISPE’s Board of Directors prior to being appointed to his current role.

Thank you so much for joining us in this interview series! Before we dive in, our readers would love to “get to know you” a bit better. Can you tell us a bit about your ‘backstory’ and how you got started in manufacturing?

I joined GlaxoSmithKline (GSK) in 2001 following a career in the Chemical Industry. My initial role was Engineering Director. My role was expanded several times to include Engineering, IT, and Manufacturing Operations. I was named VP of GMP Operations in the Biotechnology Group in 2012 and held that role until my retirement from GSK in 2020.

Can you share the most interesting story that happened to you since you began your career?

Transitioning from the chemical industry to the biotech industry was quite a change — there were many stark differences, but one stuck out to me the most. In the chemical industry, you wear protective clothing to prevent the product from contaminating your body. But in the biotech industry, you wear protective clothing to protect the molecule from contamination caused by you.

Can you please give us your favorite “Life Lesson Quote”? Can you share how that was relevant to you in your life?

For me, there are three quotes that are equally important:

1. Seek perfection and deliver excellence.
2. Quality trumps speed.
3. Complacency will cause us to fail.

These concepts are all relevant and interdependent. We all strive for perfection in all we do, but it is likely that perfection is not achievable. However, delivering excellence is achievable. To truly achieve excellence, the quality of your work product that cannot and should not be compromised with the desire to move at a pace that compromises quality. And finally, like with any business, taking your customer base for granted or not innovating your processes or services will likely cause your business to fail in the long-term.

Ok wonderful. Let’s now shift to the main focus of our interview about High Tech Manufacturing. Can you tell our readers about the most interesting projects you are working on now? How do you think this will help people?

ISPE seeks to solve the most complex pharmaceutical industry challenges. To accomplish this, we have established a community of practice (CoP) network that consists of subject matter experts supporting multiple technical topics. These networks include Cell & Gene Therapies, Large Molecule Biotechnology, and traditional small molecules to name a few. In these CoP’s, the latest technologies are discussed, and white papers or conference content is progressed. These often form the basis for a solution to complex industry issues.

Some examples of these solutions are flexible facilities capable of manufacturing multiple product modalities, facilities with a strong digital platform to support quality and efficiencies, and opportunities to advance regulatory harmonization. With the right solutions to complex problems, the industry should move closer to making medicines available from a cost perspective to patient populations across the globe.

In addition to what you are working on, what other exciting advancements and innovations are US companies making in High Tech manufacturing?

There is tremendous focus on digitization of manufacturing process and analytical technologies, and for good reason. This is the first step in ensuring all process performance and analytical data can be properly stored in a validated repository. By doing so, this data becomes readily accessible for analysis and, over time, can be utilized to drive innovation or expedite licensure.

As an example, there is a large volume of clinical performance data generated for thousands of potential medicines. The molecular structure of the medicine is known, the quality attributes of the medicines are known, and its performance in humans is known. With time — years not months, and through utilization of AI, companies can drastically reduce the time between molecular discovery and product launch.

From your vantage point as an insider, what exciting developments will be coming out in the near future?

ISPE celebrates and recognizes the best of the best in the industry through the Facility of the Year Awards (FOYA) program. This annual program recognizes state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, to reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery.

What are the three things that most excite you about the state of US High Tech Manufacturing? Why?

1. The deployment of high tech manufacturing is progressing incredibly quickly. Pharmaceutical manufacturers realize they must embrace technology and innovation more than ever, as this will be a significant competitive advantage.
2. Longer term, I anticipate that high tech manufacturing should reduce the cost of goods manufactured, thereby making medicines available to worldwide populations. It is critical for the industry to reduce the cost of goods to make them available to all populations, including that of developing economies.
3. The workforce of the future. Ultimately, the next generation plant operator will be far more skilled in advanced manufacturing and digitization than ever before.

What are the three things that concern you about US High Tech Manufacturing? What would you suggest needs to be done to address those concerns?

1. Artificial intelligence will have great benefits for the pharmaceutical industry and the patents they serve. However, if used maliciously or with mal intent, AI could pose significant issues for the industry, and more importantly, for patients.
2. The lack of Regulatory Harmonization creates obstacles that may slow the pace of innovation.
3. The lack of a diverse and capable workforce will limit the pace of innovation and technological advancements.

To address each of these concerns, ISPE provides education, conference content, and subject matter expertise in each of these areas. Specifically, ISPE is forming an Artificial Intelligence community of practice to engage subject matter experts and regulators on the use of AI in the industry. ISPE’s regulatory steering council (RSC) is currently conducting an industry survey on regulatory barriers to innovation that will feature largely in the ISPE Annual Meeting in Las Vegas Nevada, from October 15–18, 2023. In addition, the ISPE Foundation is working diligently to build the workforce of the future by providing financial assistance to diverse students and emerging leaders, enabling them to attend our Annual Meeting regardless of socioeconomic status.

Based on your opinion or experience, what would it take for the US to become a High Tech Manufacturing powerhouse?

The US is already the world leader when it comes to innovation and advancements in pharmaceutical technology. To ensure this remains the case in the future, government sponsored innovation, regulatory engagement, and reshoring of our small molecule manufacturing base will be critical.

As you know, there are not that many women in High Tech Manufacturing. Can you advise what is needed to engage more women in these industries?

What is needed is a comprehensive effort within the industry to attract, recruit, and retain a diverse and capable workforce. This will take energy and time to address. ISPE and the ISPE Foundation see this as a core responsibility and opportunity to accelerate the industry to this state. By providing financial support for students and emerging leaders to our worldwide conferences and introducing them to the industry and our education sessions, we help provide the first step to addressing the gap. And this doesn’t just apply to women — this is a critical strategy to ensure marginalized groups are properly represented in the industry in general.

Fantastic. Here is the main question of our interview. What are your “5 Things You Need To Create A Highly Successful Career In High Tech Manufacturing?

1. Get out of your comfort zone and have the courage to learn and engage on topics where you are not the subject matter expert. I moved my family to Europe early in my career. Taking the risk, both on a personal and professional level, turned out to be truly transformative. Over the course of those five years, I experienced more growth than ever before.
2. Embrace change. Change is a certainty, particularly in High tech manufacturing. When I started my career we communicated across the globe by phone, or by written and typed memorandums. Now we have virtual meetings and communicate via e-mail. That’s real progress. What’s next?
3. Seek to understand before being understood. Listening is the key to learning. I have learned over the years to listen to unique perspectives and embrace cultural differences. Interpersonal relationships are the key to getting things done.
4. Have a plan. If you fail to plan, you are planning to fail. When you look int the mirror, you are looking at the person primarily responsible for your personal growth and development. Understanding my skills and being realistic about my career growth enabled me to determine and plan my next steps for advancement.
5. Attitude. Smile, say thank you, and always do the right thing. Often times we are confronted with some significant challenges in the workplace — always doing what is right vs. what may be popular. This has and continues to serve as a north star for my personal behaviors and decision making.

You are a person of great influence. If you could inspire a movement that would bring the most amount of good to the most amount of people, what would that be? You never know what your idea can trigger. :-)

Make transformational medicines affordable for patient populations worldwide.

How can our readers further follow your work online?

ISPE.org

Thank you so much for the time you spent doing this interview. This was very inspirational, and we wish you continued success.

About The Interviewer: David Leichner is a veteran of the Israeli high-tech industry with significant experience in the areas of cyber and security, enterprise software and communications. At Cybellum, a leading provider of Product Security Lifecycle Management, David is responsible for creating and executing the marketing strategy and managing the global marketing team that forms the foundation for Cybellum’s product and market penetration. Prior to Cybellum, David was CMO at SQream and VP Sales and Marketing at endpoint protection vendor, Cynet. David is the Chairman of the Friends of Israel and Member of the Board of Trustees of the Jerusalem Technology College. He holds a BA in Information Systems Management and an MBA in International Business from the City University of New York.