Regulatory Intelligence: what is it? & How can it help your company's
Regulatory Intelligence: what is it? & How can it help your company's drug development? 15 April 2010 Sybille L. Sauter, Ph.D., R.A.C. Senior Regulatory Scientist Cato Research, Ltd. ssauter@cato.com Copyright © 2010. Cato Research Agenda • What is regulatory intelligence, and why is it important? • Where can you find information for regulatory intelligence (RI)? • How to use, interpret and present RI information? • Final thoughts • Questions Copyright © 2010. Cato Research What Is Regulatory Intelligence? Copyright © 2010. Cato Research Definition of 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” • Definition as per the DIA’s Regulatory Intelligence Network Group – a special interest area community Copyright © 2010. Cato Research The Regulatory Intelligence Process Research Question Search and collect applicable documentation Surveillance Review new information Summarize information Analyze information Interpret - new information in light of current systems Integrate - modify current practices, regulatory strategy or SOPs based on new information Source: RA Focus, December 2007 Copyright © 2010. Cato Research RI Includes Three Categories of Intelligence • Regulatory landscape – Research agency review recommendations and opinions about previous approval/rejection of products • Existing and/or emerging competitor products – Analyze competitor information to devise development programs and assess the relative position of the product to existing/emerging products • Submission routes – Analyze legislation/guidance documents to identify potential routes of submission, procedural steps of the submission process, and agency requirements needed for approval Copyright © 2010. Cato Research RI Allows a Regulatory Professional to.. • Generate a development plan • Investigate precedence and update for current regulatory landscape • Advise personnel of various disciplines • Generate a marketing application compliant with all Agency requirements • Adjust marketing application to global needs • Create a regulatory strategy for a product Copyright © 2010. Cato Research Regulatory Intelligence Is… • Key duty of the RA department • Vital to maintain compliance • Critical to successful product development • Highly interactive with other disciplines Interpretation of RI information shapes company’s regulatory strategy Copyright © 2010. Cato Research Regulatory Strategy • Regulatory strategy incorporates the drug development plan, an outstanding issue or question, background information, regulations and/or guidance documents, strategic advice and recommendations on implementation • Regulatory strategy could be seen as the adaptations a company makes to move its product from the development state to achieving marketing approval Source: Meredith Brown-Tuttle, Bay Area Clinical Roundtable, 2006 Copyright © 2010. Cato Research Why Is Regulatory Intelligence Important? Copyright © 2010. Cato Research …Because RI Provides the Regulatory Professional with Information to: • Identify opportunities – Broader indications – Roadmap to product approval • Identify possible hurdles – Compliance issues – Change in requirements for specific indication • Predict Agency approval requirements • Predict Agency review times • Answer specific development questions raised by team Copyright © 2010. Cato Research Benefits of Regulatory Intelligence • Increase compliance • Decreased time to approval • Decreased costs of product development • Maximize target market(s) Copyright © 2010. Cato Research Successful RI Is a Powerful Business Driver • RI identifies competitive advantages in a increasingly complex regulatory landscape for global drug development • RI is now recognized as more than just a strategic driver RI is a key business success differentiator! Copyright © 2010. Cato Research Remember… • Working in RI does not mean that you are acquainted with everything • It’s more important to know where to look and how to use the information that has been gathered Copyright © 2010. Cato Research Where to Mine for RI Information? Copyright © 2010. Cato Research RI Information for Drugs, Biologics or Devices • Sources of information differ • Surveillance resources differ • Consultants/CROs used differ • Analysis of information is similar Goal is the same: Approval of marketing applications Copyright © 2010. Cato Research Sources of Regulatory Intelligence • Common – – – – Regulations Guidance documents Panel meetings Previous approvals • Less Common – Warning letters – Interactions with Agency reviewers – Interactions with other regulatory professionals – Agency presentations – Competitor information – FOI requests Copyright © 2010. Cato Research Additional Sources for RI • • • • • • • Discussion groups/blogs/twitter Global regulatory agency websites Harmonization and standardization efforts Professional journals and newsletters* Labels, SPCs (summary of product characteristics) Specialized RI software* Regulatory alerts/updates/newsletters/subscriptions and services* Educational resources RI/Research providers and RI sites* Business intelligence websites* Pharmacopeias Advisory Committee Update Information* Industry and trade associations – Regulatory • • • • • • *may require a fee Copyright © 2010. Cato Research FDA Has a Twitter Site Copyright © 2010. Cato Research Regulatory Affairs Discussion Groups/Blogs www.pharmalot.com www.cafepharma.com www.eyeonfda.com www.biotechblog.com www.organgebookblog.com blogs.wsj.com/health www.patentbaristas.com www.fiercepharma.com www.patentlyo.com/patent www.invivoblogspot.com carl1anderson.wordpress.com www.fdalawblog.net www.fiercebiotech.com www.piperreport.com druganddevicelaw.blogspot.com www.ask-cato.com pharmagossip.blogspot.com Copyright © 2010. Cato Research How to Access FDA Approval Information? • Drugs@FDA includes most of the drug products approved since 1939 • The majority of patient information, labels, approval letters, reviews etc. available for drug products approved since 1998 • Product approved between 1939 and 1998? – Search for publicly available SBA (summary basis of approval) – If SBA not available, go to FOI website (some documents can be purchased for a fee) Copyright © 2010. Cato Research Access to EU Approval Information? • EPAR: European Public Assessment Report – EPAR reflects the scientific conclusion reached by the Committee for Medicinal Products for Human Use (CHMP) at the end of the centralized evaluation process – The summary, list of authorized presentations and the product information (SPC, labelling and package leaflet) are provided in all EU languages – A-Z listing of EPARs http://www.ema.europa.eu/htms/human/epar/a.htm Copyright © 2010. Cato Research Betaferon EPAR Site Copyright © 2010. Cato Research RI Databases for Drugs, Biologics, and Devices • Several database providers • Provide worldwide regulatory information • Explanatory documents guide you through a country’s drug/device registration process • Conduct focused research and surveillance, some summarize and integrate • Can set up for daily or weekly e-mail updates • Key word or full text searches • $1-8+K annually per module or country per user Copyright © 2010. Cato Research RI and Competitive Intelligence Providers (Fee Databases) Companies Websites Tarius www.tarius.com IDRAC www.idrac.com PharmaPendium www.pharmapendium.com Compliance Control www.compliance-control.com Clinivation www.clinivation.com Adis R&D Insight www.wolterskluwerhealth.com BioPharm Insight http://www.biopharminsight.com/biopharm_in sight.html MedTRACK www.medtrack.com/research/default.asp Pharmaprojects www.pharmaprojects.com Copyright © 2010. Cato Research Globalization of RI • More and more companies are conducting trials and filing marketing applications worldwide (Pfizer example) – Norvasc launched in 1990: 9 years to market in 60 countries – Viagra launched in 1998: 2 years to market in 60 countries • Staying abreast of worldwide regulatory information is increasingly important as a change in the global landscape can affect the global regulatory strategy Copyright © 2010. Cato Research Considerations of Global RI • Familiarity with international regulations (RAC) • International agency websites – Language barrier • Paper vs electronic submissions • Consider cultural differences • Country-specific reimbursement systems • Cross-talk between international regulatory agencies (e.g. between the ICH regions US, EU, Japan) Copyright © 2010. Cato Research Information Sharing Agreements Between Regulatory Agencies • • FDA and China: since 2007 FDA and European Medicines Agency: since 2003 – All legislation and guidance documents governing medicinal products – Post-authorization pharmacovigilance data and safety concerns arising from periodic safety update reports and post-authorization obligations and commitments – Information on quality defect or product recalls – Information in applications for scientific advice, orphan medicine designation, marketing authorization or postauthorization activities – GMP Inspection reports and product sample results – GCP Inspection reports Copyright © 2010. Cato Research Consequences of Information Sharing for Regulatory Strategy • Critical issues that surfaced during review of your application with FDA may also be known to the European Medicines Agency • If FDA identified a problem with request for orphan, it’s possible that the reasons for request denied were shared with European Medicines Agency Copyright © 2010. Cato Research Global Regulatory Agency Websites: Language Barrier Country/Region Information in English Comment European Union (28 Member States) Some Member Information on products States approved via the centralized procedure by the European Medicines Agency is in English Switzerland Yes (partial) Some documents available in French and German only Japan Yes - China No - India Yes - South Africa Yes - Brazil No - Israel Yes - Copyright © 2010. Cato Research Global Regulatory Agency Links Global Regulatory Websites www.clinicalresearch.com/Professionals/Pages/GlobalR egulatoryAgencies.aspx www.rainfo.com www.drw-research.com/resources.html www.globepharm.org/links/resource.html www.fda.gov/oia/agencies.htm Copyright © 2010. Cato Research Regulatory Information/Research Providers and RI Sites Provider Contact Information Biologics Consulting Group www.bcg-usa.com/regulatory/reglib.php Clinivation www.clinivation.com/worldview/index.php Datamonitor www.datamonitor.com DRW Research&Info Services www.drw-research.com European Regulatory Intelligence www.eraconsulting.com/eri Global Regulatory Affairs Consultants www.globalregulatory.com Graematter, Inc. www.graematter.com Noblitt & Rueland www.fdaconsulting.com Prous http://integrity.prous.com Reg123 www.reg123.com RegIntel Ltd www.regintel.com RegSource www.regsource.com RAPS www.raps.org RA Info www.rainfo.com Regulatory Intelligence Centre www.ric.d-target.com VerveHealth, LLC www.vervehealth.com/services.html Source: RA Focus, December 2008, December 2009 Copyright © 2010. Cato Research Business Intelligence Websites www.biospace.com www.hoovers.com Social.eyeforpharma.com www.biotech-intelligence.com www.bna.com www.cbinet.com www.centerwatch.com www.datamonitor.com www.datamonitor.com pharmalicensing.com www.espicom.com www.imshealth.com/portal/site/imshealth www.pipelinereview.com www.pharmalive.com Source: RA Focus, December 2009 Copyright © 2010. Cato Research Pharmacopeias and Advisory Committee Update Information Pharmacopeia Website Address US Pharmacopeia www.usp.org European Pharmacopeia www.edqm.eu/site/page_628.php Japanese Pharmacopeia http://jpdb.nihs.go.jp/jp14e Codex Alimentarius www.codexalimentarius.net/web/index_en.jsp Advisory Committee Update Contact Information AdComm Bulletin www.idrac.com Advisory Committee Updates https://secure.iian.ibeam.com/events/fdcr003/ 20100/index.jsp?autoLogin= FDA Advisory Committee Website www.fda.gov/ohrms/dockets/ac/acmenu.htm FDA Live www.fdalive.com Source: RA Focus, December 2009 Copyright © 2010. Cato Research New: Portal for Rare Diseases and Orphan Drugs (www.orpha.net) • Searchable database of >5,600 rare diseases • Lists disease prevalence (# cases/100,000) • Provides descriptions (with literature references) of – Cause of disease – Clinical and biochemical features – Diagnosis – Clinical management – Molecular and population genetics – Animal models – History Excellent resource for the production of orphan designation requests! Copyright © 2010. Cato Research Monitoring RI Information: Surveillance Copyright © 2010. Cato Research Definition of Surveillance • “Worldwide monitoring of regulatory information looking for changes in the regulatory landscape” Source: Meredith Brown-Tuttle, Bay Area Clinical Roundtable, 2006 Copyright © 2010. Cato Research How to Keep Up With the Constantly Changing Regulatory Landscape? • Monitor Agency’s websites • Subscribe to relevant journals, newsletters • Get daily e-mails from regulatory websites, commercial information provider websites • Attend relevant conferences/advisory meetings • Talk to colleagues and consultants • Employ a regulatory information database Copyright © 2010. Cato Research Surveillance Copyright © 2010. Cato Research Copyright © 2010. Cato Research Surveillance: How Often? • Periodic Surveillance – Conduct only when a question comes up – Done when resources are limited – Topics of interest might be missed • On-going surveillance – Allows you to stay abreast of new developments that need attention – Can employ a database for continual surveillance Copyright © 2010. Cato Research How to Use, Collect, Analyze, and Present RI? Copyright © 2010. Cato Research Applied RI - Example 1 • Q: “Is it really necessary to request an EOP2 meeting with FDA?” Copyright © 2010. Cato Research Applied RI – Example 1 • FDA offers an end-of-Phase 2 meeting to discuss final pivotal studies • Positive impact on first-cycle approval rates for companies that held an EOP2 meeting (2006) % Approval 100 Approval Rate in First Review Cycle 80 60 40 52% 20 29% 0 EOP2 mtg No EOP2 mtg Copyright © 2010. Cato Research Independent Evaluation of FDA’s First Cycle Review Performance • • http://www.fda.gov/downloads/ForIndustry/UserFees/Presc riptionDrugUserFee/ucm127982.pdf 2008 final report – Drivers and hypothesis of multi-cycle reviews – First cycle approval rates by year, by application type, by review designation – Overview of FDA sponsor communication – Effect of meetings on approval rates – Filing review issues – Impact of major issues identified on approval rates – Etc. Copyright © 2010. Cato Research Applied RI – Example 2 • Q: “What do we know about the competitor product(s)?” Copyright © 2010. Cato Research Applied RI – Example 2 • Essential info to be gathered on competitor products – Trade and INN name(s) in all countries – Drug class – Submission and approval dates in all countries – Non-approval? – Route of administration; presentations – Pivotal clinical studies – Label/SPC – Submission info: standard/priority review, fast track, accelerated review? EU: centralized, decentralized or mutual recognition procedure? Copyright © 2010. Cato Research Applied RI – Example 2 • Additional RI information that may be useful – Overview of current regulatory landscape for that type of product and in the markets identified for product distribution – Status of competitor products under development • Generate RI report including executive summary reviewing competitor products on the market and under development, the current regulatory landscape and submission routes used by competitor products Copyright © 2010. Cato Research Applied RI – Example 3 • Q: ”Does our product qualify for orphan? How would we get orphan designation and what are the differences between the US and the EU?” Copyright © 2010. Cato Research Applied RI – Example 3 FDA website Copyright © 2010. Cato Research Applied RI – Example 3 European Medicines Agency website Copyright © 2010. Cato Research Applied RI – Example 3 • Research regulations, guidances, Agency websites, previous orphan designations for related products and other relevant websites • Summarize findings for the US and the EU such as – Definition of orphan designation – Regulatory requirements for orphan drug product – Benefits for orphan drugs (tax breaks, grant programs, reduced/waived fees etc.) – Estimated costs/timeframe for orphan designation request Copyright © 2010. Cato Research Applied RI – Example 3 • Highlight differences between the US and the EU • Provide summary conclusions on – Whether or not the product might qualify for orphan designation – Whether to apply in the US, the EU, or both – Implications of orphan designation on overall development plan Copyright © 2010. Cato Research Final Thoughts Copyright © 2010. Cato Research Objective of RI: Identify Competitive Advantage Business Develop. Regulatory Affairs CMC Manufac. Regulatory Intelligence Sales Marketing Toxicology Preclin. Copyright © 2010. Cato Research Establishing a RI Project at Your Company: Key Steps • Identify a need for RI activity • Identify internal resources for RI • Establish list of RI sources appropriate for your needs (e.g., websites, databases, consultants, CRO) • Discuss and clarify the scope, costs, format, and timeframe of the RI Report • Collect and analyze RI information, and generate a RI Report addressing the predefined question(s) • Make presentation to all Departments that may benefit from this information • Update as necessary Copyright © 2010. Cato Research Points to Consider When Outsourcing RI • Consultant or CRO? • Clearly define the scope • Clarify delivery format upfront • Provide timeframe and spending cap • Realize that one question often leads to many more… • Allow for “early kill” Outsource operational aspect of RI and use RA Department’s time to interpret the information and develop a regulatory strategy Copyright © 2010. Cato Research Questions? Sybille Sauter Senior Scientist, Regulatory Affairs Cato Research ssauter@cato.com 858-452-7271 Copyright © 2010. Cato Research Cato Research Links Cato Research Website www.cato.com Cato Research Blog www.ask-cato.com Follow Cato Research on Twitter twitter.com/catoresearch Copyright © 2010. Cato Research
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