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FDA Insight: Advanced Manufacturing

Dr. Jeffrey C. Baker, Deputy Director of the FDA’s Office of Biotechnology Products in the Center for Drug Evaluation and Research, joins Dr. Shah for a discussion on how FDA’s efforts help innovation and implementation of Advanced Manufacturing technologies regarding food and drug safety.

FDA Insight: Episode 22 – Transcript

>> Anand Shah: Welcome back to another episode of FDA INSIGHT.

I’m Dr. Anand Shah, the Deputy Commissioner for Medical and Scientific Affairs here at the FDA. Thank you so much for joining us for another great episode.

This week, we’ll be discussing FDA Advanced Manufacturing efforts which is a topic of great public health concern. The FDA is partnered with other government agencies and industry to help innovation and implementation of Advanced Manufacturing technologies regarding food and drug safety.

My guest today is Dr. Jeffrey Baker, the Deputy Director of the FDA’s Office of Biotechnology Products, Center for Drug Evaluation and Research. Dr. Baker is the FDA liaison to the Advanced Manufacturing National Program Office at NIST where he engages with biopharmaceutical manufacturing stakeholders to advance the National Strategic Plan for Manufacturing in the United States.

Dr. Baker, welcome to FDA Insight.

>> Jeffrey Baker: Thank you for having me.

>> Anand Shah: Well, let's jump right in. What is advanced manufacturing?

>> Jeffrey Baker: Well, that's a great place to start. The President's Council of Advisors on Science and Technology identifies advanced manufacturing as a family of activities that depends on the use of coordinated information and automation, computation, software sensing, and networking and makes use of cutting-edge materials and emerging capabilities enabled by the physical and biological sciences. So, for instance, areas of nanotechnology, chemistry and biology. So, advanced manufacturing is a term to describe capabilities that use new technology to assure highly efficient and reproducible outcomes in manufacturing. It's not a list of equipment or assays, but a way of using 21st century technology to give us the outcomes we all want.

So, key areas of development in advanced manufacturing are process intensification, and examples would be continuous manufacturing or advanced online analytics, and perhaps deployment of artificial intelligence and machine learning, emerging tools and clinical development and assessment and in commercial manufacturing. You know, there's also a robust discussion underway in the community about such topics as advanced manufacturing and distributed manufacturing or adaptive risk management.

>> Anand Shah: Is the FDA using advanced manufacturing or is the agency directly involved with the technology?

>> Jeffrey Baker: Oh, the FDA strongly supports advanced pharmaceutical and biopharmaceutical manufacturing. Twenty years ago, the Strategic Plan for Advancing the Regulatory Sciences identified “Support for New Approaches to Improve Product Manufacturing and Quality” as a priority. And the agency has provided both intramural and extramural research funding to advance the manufacturing sciences in these areas ever since. The FDA laboratories are very active in manufacturing research in order to assure that our reviewers are current and make data driven decisions based upon, again, current science.

The FDA partners with manufacturing innovation institutes such as America Makes, which is focused on additive manufacturing and 3D printing, Bio-FAB, focused on regenerative medicine, and the National Institute for Innovation in the Manufacturing of Biopharmaceuticals, or NIIMBL.

These are public private partnerships. They're all part of the Manufacturing USA network, and they bring together thought leaders from industry, government and academia to encourage and enable domestic manufacturing through the deployment of advanced manufacturing technologies.

Now there's some kind of perception that regulatory hurdles inhibit the deployment of advanced technologies in pharmaceutical and biopharmaceutical manufacturing.

Five years ago, CDER, the Center for Drugs launched the Emerging Technologies program to help facilitate deployment of advanced manufacturing. More recently, CBER lost launched the CAT, or the CBER Advanced Technologies Team, which is charged with assuring risk based, patient centered review of new technologies.

Now FDA can only review what submitted, but we can encourage the industry to submit their ideas to the FDA for review. We really want companies to know that new is not a regulatory hurdle.

>> Anand Shah: Dr. Baker, regarding products that fall under FDA regulation, what is the agency's role in advanced manufacturing?

>> Jeffrey Baker: Well, I think that we're taking many steps to help realize the potential advanced manufacturing. This includes issuing guidance on emerging technologies and working with medical product sponsors to clarify regulatory and data requirements necessary to support product applications which use advanced manufacturing technology. We review and approve medical products that are made with continuous manufacturing. For instance, advanced regulatory science proactively addresses regulatory challenges presented by these manufacturing technologies.

>> Anand Shah: Why is advanced manufacturing important to public health, emergency preparedness and response?

>> Jeffrey Baker: Well, first and foremost, advanced manufacturing is about understanding the science engineering behind manufacturing processes, using all data available to assure the outcomes we want. The greater this understanding, the more informed decisions we can make about what's a big deal and what's a little deal and the more agile we can move.

Process intensification profoundly enables rapid, flexible responses to emerging health care needs. Prospective risk assessments, the supply chain and operations build resilience into the health care system and make room for shifting priorities and a patient centered way.

You know, advanced manufacturing is about using modern data gathering and analysis to map your process. What can happen. What should happen. How you can make it more efficient and robust. And we all know that it's important to make your map before you're on the road. A map doesn't tell you where you will or won't go. That helps you make really good decisions, informed decisions about where you can and can't go quickly and easily.

This is particularly important in manufacturing biologics. The reason we go to living cells at all to make these medicines is because we as chemists don't stand a chance of synthesizing the complex molecules. Our science is good, but nature’s synthetic machinery is another class altogether. Advanced manufacturing technologies let us characterize these engineered biologies at the molecular level and ensure control of both product and processing.

>> Anand Shah: Dr. Baker, let's talk a bit about medical products. Can advance manufacturing technologies be used to produce all drugs, including vaccines? And how about medical devices?

>> Jeffrey Baker: Oh, absolutely. As we said, advanced manufacturing is about taking advantage of an emerging set of tools to synthesize, analyze, assess, distribute, and deliver health care solutions! One of the reasons that FDA is such a supporter of Advanced Manufacturing principles is that they are the most fungible of assets. We want to have the best 21st Century toolbox we can to make the medicines we need but also to be there for the medicines we haven’t even thought of yet.

>> Anand Shah: Let's rewind a bit to public health. Emergency preparedness. How can advance manufacturing, technology support covid-19 and other pandemic preparedness?

>> Jeffrey Baker: Well, a good example is FDA working in partnership with the NIH, the Veterans Administration, and America Makes to support non-traditional manufacturing approaches, such as 3D printing, to address devices shortages including PPE, personal protective equipment. Through this partnership, 3D-printable designs for COVID response are given a clinical assessment by the VA and the NIH posts them on the 3D Print Exchange. FDA has, among other things, provided information on labeling and testing for face shields and face masks.

Another example is the rapid development and assessment of therapies for patients suffering from COVID infections and, of course, vaccines to prevent them.

Another area that does not get much attention sometimes is using advanced manufacturing analytics to maintain the supply of, quite frankly, a vast array of medicines that patients need during the pandemic and protecting the public from counterfeit or misrepresented products.

If we do advanced manufacturing well, it is data driven, risk based, and patient centered, and these capabilities keep us ready for what might come next.

>> Anand Shah: This is such an exciting area of science. Do you have any parting thoughts, Dr. Baker, regarding advanced manufacturing?

>> Jeffrey Baker: Well, you know, the United States remains an innovation engine, but sometimes it seems the clutch coupling that engine to the drives of U.S. manufacturing is a bit broken.

21st Century science seems to be fully deployed and on the march for new apps, new products, new therapies, new devices, but the manufacturing capabilities to make these products uses 10, 20, 30-year-old methodologies and control strategies. If the same innovation and enthusiasm that goes into rapidly finding health care solutions and getting them approved for launch were put into the manufacture of these medicines, I think there would be positive disruptive change in the robustness, cost, and efficiency of these processes.

As long as manufacturing is viewed as a cost center, companies will minimize cost, and minimize risk, and minimize change.

I think our challenge is to present manufacturing as a value center and to not so much minimize cost but optimize that value. I believe in the value of reliable and agile drug supply chains, and I believe fervently that using antiquated manufacturing approaches and control concepts, having a commitment to sort of a “this is how we have always done it” prevents us from realizing the value to society of innovations in these health care solutions.

>> Anand Shah: With that, Dr. Baker, it's time to wrap up this episode, I want to sincerely thank you for taking the time to join us this week on FDA Insight.

>> Jeffrey Baker: Well, thanks for having me.

>> Anand Shah: In the weeks ahead, we'll be covering a variety of topics that are important to public health. As always, we'll be providing you insight in plain language to help you understand the products that we regulate, the issues that we face, and the processes that we follow.

We hope you enjoyed this episode of FDA Insight. Please subscribe on your favorite podcast app, such as Apple Podcasts, Google Podcasts, Spotify and Pandora. Thanks for listening, and I wish everyone a great start to the New Year.

[end of transcript]

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