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Regulatory Intelligence and Policy

Posted 20 December 2019 | By Gloria Hall 

Regulatory Intelligence and Policy

To support the release of the Q4 Regulatory Focus Article Series, Regulatory Intelligence and Policy: Shaping the Global Landscape, RAPS hosted a lively discussion on Regulatory Exchange with three regulatory intelligence experts, Meredith Brown-Tuttle, Matt Medlin and Kirsten Messmer. The experts , who were all authors in the series, offered their perspectives on the importance of regulatory intelligence and the integral role RI professionals play in defining strategy for companies in regard to development, approval and maintenance of products, as well any changes to regulations impacting the global regulatory landscape. This article presents the questions and answers from the 11 December online discussion.

Q: What records or documents are used to identify potential reviewers? Once found, how do you request those reviewers?

MBT: Once I have the list of attendees for an FDA meeting, I do a search on the FDA website for their names or if I have PharmaPendium, I use that to search for specific reviewer names. Once you find the reviewers names and the drugs associated with it you can go to Drugs@FDA and pull the administrative documents looking for past meeting minutes. This will help you understand the previous questions posed to the agency and the response by the review team. In terms of the authoring phase, I use similar class of approved drugs and pull their summary basis of approval documents at Drugs@FDA and review the meeting minutes to help me address questions the division repeatedly asks about or to assist in regulatory strategy.

MM: A good source for this is the review documents for *recent* relevant drug/biologic reviews on FDA.gov. I tend to identify the critical questions for the package then target the discipline specific reviews. My feeling is that CMC will have tough FDA responses. I will search for related therapeutics, recent quality review summaries and analyze the responses and individual reviewers that provided them. In many instances, FDA will assign the reviewer, often based on prior experience with related programs, but you can request specific disciplines and individuals in the meeting request letter. I would add, given the high rate of turnover at FDA, a review of FDA’s recent reviews is best. You can also confirm that a particular reviewer is still with FDA via the HHS Employee Directory. In my experience, that database stays pretty current.

Q: When you describe RI to someone new to regulatory affairs, how do you differentiate the discipline from everything else that a regulatory professional does?

MBT: Well it all depends, of course, the great regulatory answer. I usually give an overview of the three prongs of regulatory intelligence: policy, strategy and operations to start off with and what each accomplishes. For small companies, I usually say that RI is combined into a person's job and everyday function and not a distinct function, so you will have to do a lot of everything and RI will not be kept current since it is not a priority. So for a small company, its very muddled and not differentiated. As a company gets larger, RI needs to be differentiated as a distinct function to support strategy and policy needs, and it is at that transition time for companies that can be the hardest (from small to medium to larger), trying to set up a company, establish the new functions, establish metrics, budget for tools and manage expectations from the internal stakeholders.

KM: To add to Meredith's response, for me RI works in three steps: we monitor the landscape, analyze the information and then we form a strategy (what actions are needed). In the current fast-moving environment, it is incredibly important to keep up-to-date with new requirements to ensure time- and cost-effective drug development. An RI professional needs to quickly understand the content of the new regulatory requirements/information and determine what kind of action might be needed.

Q: A new guideline impacts your business. What do you do now?

KM: Great question. Once I've identified that the guideline has an impact on business, I look to see if it impacts a specific group within the company or our overall business and also if it impacts clients. A further consideration is if processes have to be changed due to the new guideline.

These questions help to channel whether the publication of this guideline needs to be disseminated to a specific group, e.g., senior leadership of a therapeutic area or across the company to all regulatory affairs colleagues. It will also determine the style of presentation, for example: leadership: short and concise, overall: more detail.
Within PPD, we also have an escalation mechanism that further assesses the impact and escalates as needed. From my perspective that one would be my first call to bring it to their attention for further actioning.

Q: A question for Matt. What training do you attend or provide?

MM: First, I learned quite a lot from Meredith's RI 101 book. I think this was a seminal work in the evolving definition of RI and something that can be absorbed outside of any webinar or conference. After that the workshops offered by RAPS (online or face to face conferences or workshops) were very helpful for me to get foundational knowledge on the discipline.

Q: What is the difference between regulatory intelligence and regulatory policy?

MBT: Intelligence is reactive. It is the synthesis of the information into actionable items to help ensure the success of the company and it can be new regulations, guidelines, etc. Policy is creative and is a predecessor to intelligence (RI) working with legislators to shape future regulations, guideline documents, etc. Without policy, intelligence wouldn't exist.

MM: I agree on this point. One way to discriminate between regulatory policy and intelligence activities is to consider that often policy work is public and focused on influencing or discussion with external stakeholders. RI often is a matter of internal dialog within the company.

KM: Matt and Meredith, I agree with both of you. Perhaps as an example: policy would be if you comment on draft guidances or comment at public meetings to help shape the regulatory environment versus intelligence being developing strategies for drug development in a cost- and time-efficient manner following these regulations, guidelines and policies.

FDA usually announces new draft guidances open for comment or public meetings that can be attended. The Federal Register will provide the information on how to provide the comments and deadline. For meetings that information is provided in the announcement.

Q: What are some of your favorite regulatory intelligence websites?

MBT: Well it all depends on the question and the applicable country. A great place to start is Google since you can conduct refined searches there. For a list of resources please visit the Regulatorium.

KM: STAT
Pink Sheet

MBT: Another new tool I've found is ClinRegs. This site provides a cross comparison of clinical trial requirements around the globe and it's free!

MM: Here are some of my favorites:

Clinical Superiority Findings
Learn About FDA Patient Engagement
Mobile Health News
Postmarket Requirements and Commitments
RAPS Regulatory Recon
Table of Surrogate Endpoints That Were the Basis of Drug Approval or Licensure

Q: My question is regarding managing regulatory updates (in particular for medical devices) when the guidance/regulations are not in English. For example, guidance documents in Chinese, Japanese, etc. How to do an assessment if the guidance documents can impact a future regulatory strategy or a product under development when the guidance documents are in native languages and not in English? Getting these documents translated is normally very expensive. If the manufacturer does not have a local agent who can guide on the new changes in the legislation or on a new guidance, what is the route the RA team can follow to make sure the released guidance does not impact their product? Do most companies get these documents translated or buy the English versions?

KM: Great question and I fully understand where you are coming from. Even for a large company like PPD, these translations are cost-prohibitive unless absolutely necessary. Cortellis does provide translations for many languages, but there is a time-delay. Often we will utilize internal colleagues that do speak that language to provide us the main points for further assessment.

MBT: The cheap answer is Google Translate. I use that as a first pass to see if I want to have the document translated and determine if it is important to know about. Once I make the determination that it is important and that the distributor doesn't have a translation, then I buy it in English (if available) or have it translated. I work with the same translation company consistently so that I always get the best deal in terms of cost.

Q: How do you manage non-regulatory team members that disseminate RI without analysis or a complete understanding?

MM: The answer to this is that you can't. It's impossible to manage the dissemination of RI information from all corners of the company to stakeholders. Often, non-regulatory folks within the company consider this just a helpful heads-up to all involved and that they are assisting as a team player. What you can do is discourage the activity within the organization or signal that you (or whoever is responsible for RI) is happy to be the first gate for this information. What you can control completely is that the RI function within the company provides considered and thoughtful synthesis and impact analysis along with any hard-hitting late-breaking piece of regulatory information when it's disseminated. If you establish yourself or your function as an oasis in the ongoing onslaught of new regulatory developments, key stakeholders will eventually recognize this and learn that your response and analysis of a new piece of RI is worth the wait.

Q: I was wondering if you could provide the single best Google search tip you have?

MBT: I will let Matt answer with some technical tips as he has really taught me a lot of things. I think the best things to remember is to let your curiosity take hold and ask the question—that's really the first step for any search and it's amazing what you will find it you ask the question in a variety of ways using a potpourri of terms—because if you don't get it with searching "IB" then use "investigator's brochure" or investigator brochure." Don't be afraid to ask and don't be afraid to dig deeper and go through more than a page of Google search returns. It sometimes feels like finding a “needle in a haystack,” but the information is out there (isn't that an "X Files" quote?)

MM: First start with Google Advanced Search.

Just seeing the fields is enlightening regarding what is possible in your pursuit to become a master of Google-Fu. One quick trick I love is to search just a specific site, i.e. "site:fda.gov" search term. Also try another search engine with different algorithms like duck.duck.go. Surprising sometimes what that will yield with the same terms.

Conclusion

RAPS Regulatory Exchange online community gives regulatory professionals an opportunity to ask experts in a specific regulatory topic area the questions they’ve always wanted to know or couldn’t figure out or didn’t know where to start searching. Regulatory Exchange is free for all RAPS members and is another way RAPS shows its dedication to the continued education of its members. 

The 11 December Regulatory Exchange showcased RAPS commitment to promoting best practices for regulatory professionals, enabling interaction between participants and experts in order to share important regulatory intelligence insight.

About the Experts

Meredith Brown-Tuttle, RAC, FRAPS, is the principal consultant for Regulatorium a company specializing in regulatory intelligence, writing and strategy. She is the author of IND Submissions: A Primer, published by Barnett, Regulatory Intelligence 101, published by RAPS, numerous articles and currently serves as the chair of RAPS Editorial Advisory Committee. She can be contacted at theregulatorium@gmail.com.

Matt Medlin, PhD, RAC, is manager, US Regulatory Affairs R&D – Pipeline for Chiesi USA, Inc. His professional interests include the application of Regulatory Intelligence, Policy and Strategy toward the development of drugs and biologics for the treatment of rare diseases. He can be contacted at matt.medlin@chiesi.com.

Kirsten Messmer, PhD, RAC, is a principal regulatory affairs specialist in regulatory intelligence solutions at PPD. She is co-chair of the DIA Regulatory Intelligence Working Group. Messmer received a PhD in neuroscience from the University of Sheffield, UK. She can be contacted at Kirsten.Messmer@ppdi.com.

Cite as: Hall G. “Regulatory Intelligence and Policy.” Regulatory Focus. December 2019. Regulatory Affairs Professionals Society.

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