Meredith Brown-Tuttle, RAC Director APT Pharmaceuticals, Inc. The Tools of Regulatory Intelligence: Where to Start when Developing Regulatory Strategy or Answering a Question Meredith Brown-Tuttle, RAC Director APT Pharmaceuticals, Inc.

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What is Regulatory Intelligence “The act of gathering and analyzing publicly available regulatory information. This includes communicating the implications of that information, and monitoring the current regulatory environment for opportunities to shape future regulations, guidance, policy, and legislation.” DIA Regulatory SIAC, Regulatory Intelligence Working Group Copyright 2009 Meredith Brown-Tuttle

What is Regulatory Information? Can be oral, written, published, unpublished, etc. Basic building blocks of intelligence, the raw information Copyright 2009 Meredith Brown-Tuttle

Information vs. Intelligence Intelligence is active and related to analysis and surveillance Information is the raw data used to create intelligence Copyright 2009 Meredith Brown-Tuttle

Regulatory Intelligence RI allows a regulatory professional to Create a strategy for a product Create a development plan for product Research past precedence and adjust for current regulatory climate Advise personnel Write or construct a marketing application incorporating all Agency requirements and Adjust marketing application to ROW needs Copyright 2009 Meredith Brown-Tuttle

Copyright 2009 Meredith Brown-Tuttle Researching the Topic Define your topic with key words or concepts such as: transdermal patch validation batch 505(b)(2) done to date for analgesics How to file a 505(b)(2) How to file Canadian CTA, INN Name, etc. How many products received fast track, priority review and received orphan designation Don’t be afraid to use Google! Copyright 2009 Meredith Brown-Tuttle

Copyright 2009 Meredith Brown-Tuttle Researching the Topic Use key terms as you would for a Medline search If subject looking for is complex, break it down into a few key words to start with Can do a “search within results” to further refine topic if too many “hits” are returned or if need to add more key words Be willing to put the time in to drill down into documents Do a search for terms on screen (control f) Copyright 2009 Meredith Brown-Tuttle

Copyright 2009 Meredith Brown-Tuttle Researching the Topic Develop checklists for where to start for certain questions Checklists are divided by clinical, nonclinical and CMC Checklists give sources to start with so you make sure you check all available sources Great to have on hand for training Copyright 2009 Meredith Brown-Tuttle

Sources of Regulatory Intelligence Common: Regulations Guidance Documents (preamble and comments) Panel Meetings Previous approvals Less common Interactions with reviewers Warning Letters/Untitled Letters Interactions with other regulatory professionals FDA presentations Competitor information FOI requests Compliance guides MAPPs Copyright 2009 Meredith Brown-Tuttle

More than Regulations and Guidance Documents Regulations and guidance documents tell ½ the story. These sources describe the black and white story … most of regulatory is gray! Guidance may be waived There might be no guidance at all Interpretation of guidance varies with company and their experience Copyright 2009 Meredith Brown-Tuttle

Regulatory Information Finding regulatory information is not usually found in one location. You need to have numerous sleuthing techniques in your armamentarium to be able to address the scope and breadth of questions posed to you For each question put forth, there are numerous sources to begin your search Copyright 2009 Meredith Brown-Tuttle

Sources of Regulatory Information On-line professional and scientific article subscriptions Regulatory agency Web sites Previous regulatory submissions (internal to the company) Competitor’s previous submissions Competitor’s marketing literature Specialized regulatory intelligence software Copyright 2009 Meredith Brown-Tuttle

Sources of Regulatory Information Email alerts Educational conferences Regulatory reference and information sites Local chapter meetings of various organizations. Colleagues Business intelligence websites and databases FDA Advisory Committee meeting minutes Books Consultants Copyright 2009 Meredith Brown-Tuttle

Regulatory Information Databases Provide the ability to conduct focused research and surveillance, some summarizing and integration Provide daily or weekly updates Some provide limited analysis of documents Still need to do analysis of information and impact to current program/product Allow for integration of regulations into SOPs Copyright 2009 Meredith Brown-Tuttle

Regulatory Information Databases 80+ countries available out of 194 in the world Country specific regulations provided in the local language (can translate for a fee) Key word or full text searches by country of choice Information structured logically by subject matter Access to current, revoked and draft documentation/information Expert summaries/Explanatory documents Copyright 2009 Meredith Brown-Tuttle

Regulatory Information Databases Explanatory documents that guide you through a country’s drug/device registration process How to start a clinical trial Maintenance of a clinical trial Adverse Event Reporting Scientific Advice Orphan application How to construct a marketing application How to deal with variations or changes of marketed products Copyright 2009 Meredith Brown-Tuttle

Transforming Information into Intelligence Research topic and cull all pertinent information about your research topic from resources Read pertinent information about the research topic Write a summary of each piece of information once read Pull together all pieces of information and analyze how they fit and impact each other Write up your analysis Copyright 2009 Meredith Brown-Tuttle

Transforming Information into Intelligence Once you have summarized the information, you will need to put it in a standard format to integrate the current position and recent information to deliver information to your target audience Target audience can be: Regulatory department Product team General distribution to company as a whole Management Various departments Copyright 2009 Meredith Brown-Tuttle

Transforming Information into Intelligence Subject: CMC, Clinical, Safety, non-clinical, etc. Regulations, directives, guidance documents… Proposed or recently codified regulation/ directive/guidance document Explanation of how recent information will affect current practice and proposed changes (if any) to current practices to comply or be in-line with new information How will new information affect your target audience/team or strategy Save/file for future use and don’t be afraid to update Copyright 2009 Meredith Brown-Tuttle

Questions Contact Information askmeredith@usa.net 21