Hear from the experts who wrote the book

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| 02 April 2020 | By Randolph Fillmore 

RAPS has introduced a new, comprehensive resource that promises to find a secure place on every regulatory professional’s bookshelf. Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition, spans 18 chapters with updates from more than 30 leading regulatory experts. Topics range from why it is no longer enough for today’s regulatory professional to just focus on regulatory guidance, to a primer on regulatory intelligence, to defining regulatory strategies for chemistry, manufacturing and controls (CMC), to knowing how to interact with regulators. Based on real-world experience, the authors offer new insight and practical guidance to help you and your organization reach your strategic goals in a more effective and cost-efficient manner.
For all the details on what’s in the new edition and what made an updated book necessary, RAPS spoke with editors William K. Sietsema, PhD (WS) and Monica M. Meacham, PhD, (MM) and co-author Eric Brass, MD, PhD, (EB), professor emeritus at the University of California, Los Angeles, industry consultant and former FDA advisory committee chair.
RAPS: Why was a second edition of this book necessary?
WS: Since the first edition, there have been major changes in regulations and standard practices. This new edition reflects those changes and offers regulatory professionals a useful update to valuable information.
EB: Yes. Regulatory affairs is constantly changing and this revision was meant to be relevant to, and reflective of, the newest regulations and practices.
MM: Some of our colleagues are at their early career stages and a book such as this is useful to have handy as it offers the learning experiences of our contributing authors to those who may be new to the regulatory profession.
RAPS: Looking at the message in Chapter 1, “Introduction to Regulatory Strategy,” why is it no longer enough for a regulatory professional to focus on knowing regulatory guidances?
MM: Today’s regulatory professionals need a deep understanding of what it means to move a product forward, which markets might be best for commercialization, how to identify target markets and be able to consider the perspective of the health authority. It’s also necessary to be able to identify product problems in advance, identify risk factors and solutions, and develop good negotiation and communication skills as well as a working knowledge of cutting-edge science.
EB: I agree with Monica, but I want to add that today’s regulatory professional is working on a team and each member of the team has different skill sets. With integration of these skills, the team can optimally – and when appropriate – move beyond guidances. So it’s important to know the limits of guidances, be scientifically and technically savvy and be able to take the lead in innovation.
RAPS: Chapter 3 addresses regulatory intelligence (RI). Can you offer a snapshot of what the chapter says about RI best practices and strategies? What are the key qualities of an RI professional?
WS: It helps to be extremely persistent and always be searching for useful information. Several companies have developed databases for regulatory intelligence. These databases can be a tremendous resource to the regulatory professional as they are a collection of valuable information from diverse sources and are easy to search. However, many require paid subscriptions. Clinical trials databases are useful, such as www.clinicaltrials.gov. In the US, the Freedom of Information Act also provides access to many types of information sources. There are several professional associations for regulatory professionals and these organizations are excellent sources for networking and information.
RAPS: Chapter 4 discusses the elements of a global regulatory plan (GRP). Just what is a GRP?
WS: That chapter was written by Neal Storm, director of global regulatory affairs at Amgen. He compares a global regulatory strategy to a roadmap for obtaining drug product regulatory approvals in desired markets. The GRP is intended to support the product’s clinical development phases but also may support regulatory activities throughout the product’s lifecycle. Later-phase plans may include strategies supporting postmarketing activities or plans for continued expansion into new markets. For example, the GRP lays out steps in postmarketing studies, pharmacovigilance activities and how to generate periodic safety reports. The GRP is a living document and must be versioned to support different product lifecycle stages.
RAPS: Speaking of strategies, Chapter 7 is all about CMC and related regulatory strategy. What educational and experience backgrounds are necessary to be a CMC regulatory professional?
MM: There are many related fields one can be involved in before moving to regulatory. Which field one comes from might depend on the related regulatory job and be job specific. For working in cell therapies, engineering cell biology background might be best. A background in immunology might be better for working on antibodies or drugs developed for immune-related indications. Regardless, people with a science background might transition from manufacturing quality control positions. QC positions often depend on specific technical and scientific knowledge.
EB: As a chemical engineer, I always recommend chemical engineering as a good educational background! But that’s particularly relevant here. Certainly, pharmaceutical chemistry or cell biology and biochemistry are useful. People working in CMC regulatory come from a wide range of sciences and technical backgrounds, as Monica said, whether pharmacy related or another analytical science field. Many regulatory people don’t start out in regulatory but jump into it after having experience in another field, some with science or medical backgrounds. That suggests the value of lifelong learning and the reason this book was published. The book helps in career building and, given the wide range of knowledge and functional areas under regulatory affairs, learning is certainly a lifelong, necessary proposition. Continuous learning also a career-building exercise.
RAPS: Perhaps one of the most important functions for the regulatory professional is interacting with regulators. Our readers will be highly interested in Chapter 13, “Interacting with Regulators” and Chapter 16, “Preparing for an FDA Advisory Committee Meeting.” How can a company decide who is their best-prepared team member to interact with regulators and who should go to “The Big Show,” the FDA advisory committee meeting?
EB: Who should interact with regulators varies enormously across companies based on company size and flexibility. While it might be good practice to send your best and brightest, companies want to make certain to send those who have the best communication skills, who have a certain mindset and the ability to think on their feet, as well as those with the most expertise. In these very short but high stakes meetings, I cannot emphasize enough the importance of knowing the regulator’s culture and being able to figure out what regulators are thinking even when they don’t say what they are thinking.
MM: Many companies are spending a lot of time rehearsing and role playing prior to such a meeting and they start preparing for meetings months in advance. The coachability of a team member, especially inexperienced members, is important.
WS: In Chapter 16, “Preparing for an FDA Advisory Committee,” Michael Vivion, PhD, principal at ECG Healthcare, explains that for the regulatory participant, such a meeting can be career defining, offering the opportunity to demonstrate cross-functional leadership, communication excellence and organizational talent. He goes on to say, “The FDA Advisory Committee Meeting has been called everything from the Super Bowl of FDA meetings to regulatory theater. The meeting is unique—part regulatory, part science, part medical care, part public policy and part performance.” He advocates having advanced mock meetings, a solid preparation strategy, engaging outside expertise and developing logistics, everything from booking transportation and hotels to acquiring audiovisual equipment and security.
EB: FDA calls an advisory committee meeting when they need outside expertise to make a decision on a product approval. Issues to be discussed often are known to the company from earlier communications with FDA, so the company has an opportunity to bring in experts who can address the relevant issues, issues important to the company as well as issues important to FDA. There is value in having expert speak to expert, peer speak to peer. The company has the opportunity to bring in an expert who is known to the panel members. This might be important for both the core presentation as well as the Q&A. This is what preparation is really about. It requires a lot of training to behave effectively in this environment, an environment that is very different from what most academics have experienced. Most companies underestimate the amount of time, money and work necessary to prepare for an advisory committee meeting, especially those involving more controversial products.
RAPS: We are hearing more and more about the importance of communication skills for regulatory professionals. Chapter 17 is about medical writing strategies. Why is medical writing an emerging area of importance?
WS: Good medical writing is important because the regulatory professional is increasingly becoming the company’s communicator-in-chief. This chapter is new in the second edition and emphasizes that every regulatory strategy requires written documents. Written documents are often the only means by which strategic regulatory goals can be achieved. So, regulatory documents are used to seek required answers to questions and to secure or confirm alignment with regulatory agencies.
The chapter’s author, Kathryn Wekselman, PhD, vice president of regulatory MaxCyte, Inc., says that many industry veterans can point to examples of regulatory strategies that have achieved their intended goals despite written documents that were not particularly clear or well presented. She talks about considering the writer’s audience—the regulators—and considering the regulators’ mission and realities. She also says that writing clearly is more difficult than it might appear, and then she leads the reader through ways to make their writing clear and concise.
RAPS: Well, thank you all and congratulations on putting together a fine book that should help those regulatory professionals who are early in their careers and serve as a valuable resource for seasoned veterans.
Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition is now available from RAPS. For more information, take a look inside one of the chapters.                                                                         
Randolph Fillmore is a technical writer for Florida Science Communications Inc. Direct all inquiries to featureseditor@raps.org.


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