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RAC EU online Workshop

Register for the self-paced course starting Feb. 7, 2017 

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ECTD Group Meetings

These meetings have resumed as quarterly get togethers for 2017

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North Carolina Regulatory Affairs Forum

NCRAF is an association of regulatory affairs professionals centered in the Raleigh-Durham-Chapel Hill "Triangle" of North Carolina USA. NCRAF is dedicated to providing education and support for the continuing professional development of individuals who have an interest in regulatory affairs activities as they apply to research, development, or manufacture of drugs, biologics, or medical devices.

Upcoming NCRAF Events:


2017 NCRAF Annual Round Table


5:30 - 8:30 pm



As in years past, our Round Table Dinner will feature a networking reception with complimentary bar, followed by buffet dinner with seating at multiple tables, each featuring a speaker who will lead the dinner discussion on a different topic. Each table therefore will be a unique opportunity to learn about and discuss a topic of your choosing with a local expert in the topic, in a small-group setting (5-10 persons/table).  Register early to get the table of your choice - many tables sell out well before the event date!

Speakers and Topics are:


THIS TABLE IS FULL.  Table 1: Global perspective on orphan drug regulations - compare/contrast process in US, EMA, Australia, and Japan

There are approximately 7000 rare diseases affecting less than 10% of the world’s population. It was obvious in the 80s that incentives must be provided to encourage drug manufacturers to invest time and money to develop products that affect a small population in the world. United States was the first country to bring a legislative change, an Orphan Drug Act, following which many countries around the world established regulations for orphan drug products or medicines for rare diseases. In the United states, orphan drug designation can be requested for products for diseases affecting population of less than 200,000. In the EU orphan medicine status can be requested for a life-threatening disease where there is no existing alternative treatment and if the prevalence of the condition is not be more than 5 in 10,000 or it must be unlikely that marketing of the medicine would generate sufficient returns to justify the investment needed for its development.  Japanese regulatory agency considers drugs and devices for orphan designation if they can demonstrate high efficacy and safety for rare and serious diseases affecting 4 in 10,000 people where no alternative treatment exists. In Australia orphan drug status can be requested based on the rarity of disease occurrence (1:10,000). This round table discussion will cover the process for obtaining an ODD status, regulations and incentives to manufacturers of products for rare diseases in the US, EMA and in global markets including tax incentives, protocol assistance and market exclusivity.

Sathya Ganesan, Ph.D., RAC has over 15 years of experience in drug discovery (endocrinology and women’s health, oncology of breast and prostate) and medical device development (implantable device for orthopedics, soft tissue repair and cell therapy) in academic and industry setting. She is currently a Manager in Regulatory Affairs at PPD Development, LP (PPD). At PPD, she provides regulatory strategic advice and global regulatory project management to clients for commercial and government sponsored research. Prior to that, at Grifols, she managed and executed regulatory strategies and tactical decisions from project inception to regulatory approval, serving as a contact for regulatory agencies. Sathya has also worked as a Senior Scientist at Affinergy, LLC where she led preclinical studies for the company’s first product brought forward for regulatory approval. Sathya received her Ph.D. in Biochemistry at the University of Rochester and a postdoctoral fellowship at Duke University


THIS TABLE IS FULL.  Table 2: EU CT Regulations

This group will discuss  the changes and challenges on the new  EU Clinical Trials Regulation

Bhargavi Rao joined PPD in 2013 after having finished her PhD at UNC-CH and postdoctoral work at NIEHS.  She has been working as a regulatory Affairs lead overseeing global regulatory submissions for large multinational Phase II and III studies over a wide range of therapeutic areas.


THIS TABLE IS FULL.  Table 3: Getting Started: Requirements for First time in Human Studies

This group will discuss meeting the regulatory requirements in moving from the laboratory to the clinic. Many clinical holds result from misinterpreted safety margins or poor dose justifications. This discussion will include in vitro and in vivo pharmacology and general toxicology studies, with a focus on selecting a starting dose for an  IND-opening study.

Greg Hileman is a Senior Regulatory Scientist and Strategy Advisor for Cato research. He has over 30 years of industry experience, including more than 20 years in regulatory affairs. He has a rich regulatory experience, formulating strategies for the request and conduct of regulatory agency interactions involving FDA and EMA, for the content and submission of regulatory files including INDs, NDAs, CTAs and MAAs, and for achieving Orphan Drug, Fast Track and Breakthrough designations.  With over 60 unique INDs, he has addressed the First time in Human question across in many therapeutic areas and across multiple FDA divisions.


Table 4: CAR-T Cells – Development and Approval Play-by-Play

More fiercely anticipated than any sport showdown – be it football, a boxing versus Mix Martial Arts bout or any other sports highlight talked about – was the battle for approval of the first CAR-T cell therapy. First, bets were placed on who of the three contenders –  Juno Therapeutics, Kite Pharma or Novartis – would be first to file. After Novartis narrowly beat Kite in the Food and Drug Administration (FDA) filing, the anxiety heightened with respect to what the regulatory approval would bring. On 30 August 2017, Novartis’ KymriahTM was the first CAR-T cell therapy to receive approval globally. We will discuss the play by play development, special considerations, risks and some of the innovative decision making by the sponsor and the FDA.


Kirsten Messmer, PhD, RAC, is a Principal Regulatory Affairs Specialist in the Regulatory Intelligence Solutions team at PPD. Dr. Messmer received her PhD in Neuroscience from University of Sheffield. She has completed a number of post-doctoral research fellowships, and worked to develop stem cell therapies for neurodegenerative diseases. In her current position at PPD, she is part of a specialist team of regulatory affairs personnel that provide regulatory intelligence to clients and various departments within PPD to support efficient, compliant and successful clinical research and drug development. Dr. Messmer also manages the compilation and release of the monthly company regulatory affairs newsletter The GRiD (Global Regulatory intelligence Digest) and is member of PPD’s Advanced Therapy Forum..


Table 5: Regulatory Innovation and the RMAT Designation

The FDA’s focus on innovation is driving modernization of the regulatory framework. The 21st Century Cures Act included several provisions to accelerate and incentivize drug development, including creation of the Regenerative Medicines Advanced Therapy (RMAT) Designation. This designation confers several regulatory benefits to qualifying cell therapies and tissue products intended to treat serious or life-threatening diseases. This roundtable will explore implications of the FDA’s Innovation Initiative, and discuss the process associated with obtaining the regulatory benefits of the RMAT designation.


Kevin Healy has over 10 years of Regulatory experience and has had positions of increasing responsibility within large pharma, biotech, and a contract research organization. At Roivant, he is leading the development and execution of global regulatory strategies for several products across multiple therapeutic areas. He has worked on several large global programs and has expertise in leveraging expedited regulatory pathways for rare diseases and therapies for unmet medical needs. Kevin joined Roivant Sciences from Mallinckrodt Pharmaceuticals, where he was a Senior Director leading the Autoimmune and Rare Disease portfolio. At Mallinckrodt, Kevin also led the development of several products in the pain therapeutic area, including the filing and registration of Xartemis XR®. Kevin began his career at a contract research organization in Research Triangle Park, NC, and spent several years at Gilead Sciences, where he served on global development teams for HBV and HCV treatments. Kevin received his BS in Biological Sciences from Cornell University, completed his PhD in Biochemistry at the University of Wisconsin-Madison, and completed a postdoctoral research fellowship at the University of North Carolina at Chapel Hill. Kevin has completed his Regulatory Affairs Certification and has been an invited speaker at numerous local and national conferences.


Table 6: Communicating Benefit-Risk is Fundamental to Device Approval and Market Adoption

A key question at the end of a company’s pivotal trial is, “Did we make our endpoints?” While demonstrating safety and effectiveness important, sponsors may be missing an even more important question. That is, “Does the benefit outweigh the risk?” The FDA guidance on Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications provides clear direction from FDA on the framework for assessing benefit-risk.

Developing key benefit-risk messages and communicating them effectively are critical in marketing applications, advisory panels and technology assessment committees. A thorough benefit-risk assessment is the foundation for the messages surrounding unmet need, proposed indication, patient population, clinical trial results and broader clinical application. Importantly, these data can provide the cost-benefit evaluation to make reimbursement decisions. The FDA framework considers factors such as the type, magnitude, duration, and probability of benefits; the nature of adverse events and device complications; disease characteristics; patient tolerance for risk; and the availability and benefit-risks of alternative therapies.
Using real-world examples, this presentation provides practice examples for each of the factors that contribute to a positive benefit-risk assessment. It will teach you how to communicate these assessments in marketing applications, and advisory panel presentations.
Learning Objectives:
Upon the presentation’s conclusion, you should be able to:
• Identify the factors that comprise the benefit-risk assessment
• Develop key messages necessary to communicate a positive benefit-risk
• Tailor the benefit-risk messages to each key audience: FDA, advisory panel, payer, patient and health-care-practitioner

Jim DiBiasi is known for his ability to lead diverse teams and help them succeed at decisive communications opportunities. Jim provides strategic and tactical communications counsel and coaching to top executives, scientists, and doctors at pharmaceutical, biotech, and device companies. Jim has guided scientists and executives through numerous regulatory communications, such as pre-NDA and IND meetings and challenging advisory committee meetings. He has been instrumental in developing 3D's proprietary process and communications tools to help clients analyze their audiences and prepare for their communications in more effective ways. A gifted communicator, Jim has practical experience in front of the camera and before live audiences. He has crafted and delivered hundreds of presentations and served as a legislative lobbyist and media spokesperson for Fortune 200 companies, leading them through numerous communications crises.


Table 7: "Seeking Yes” |  Effective communications in job search and beyond.

In this session, we’ll focus on methods, tips and forms of communication including when to use “move to bcc” in email sequences, how to approach people for response, reasons to use email versus LinkedIn inmail and vice versa, proper calendar invitations, and the best “final attempt” message for non-responders..

Don Alexander is a recruiter with over 19 years of professional and executive search industry experience who has spent the last 14 years focusing exclusively on talent acquisition nationwide for mid career to senior level professionals in the Life Sciences sector (Biotechnology, Pharmaceutical, Medical Device, Diagnostics and supporting Services and Tools). He has successfully completed hundreds of recruitment projects that have involved senior level individual contributors through C level executives, with particular emphasis on sales, business development, marketing, product development, project management and pre-clinical R&D. In addition, Don has prior experience recruiting in Technology and Engineering.


Table 8: Privacy Please!  Data privacy rules for medicine and research in the US and the EU

Be honest - as a patient, your doctor and the rest of your medical team need to have access to very personal information about you, in order to provide you with quality care.  Do you know exactly what the law says about what they can and cannot do with your personal information - and how it is different if you are a patient versus if you are a clinical trial subject?   At this table we will obviously discuss HIPAA but also the EU Data Protection Regulation and the EU-US Privacy Shield (as relevant for medical product research, development, and clinical/medical services), and how these various legal frameworks are similar and dissimilar to each other.  Participants will learn which types of entities must have a “privacy officer” under any of these frameworks, and leave with a basic toolkit for that role.  Participants will also learn what *their* data privacy rights are as a patient in the US (and what would be their rights in the EU).


Maria Oyaski is currently the Privacy Officer (and Regulatory Affairs Director) at Metabolon, an analytical testing services company focusing on LC-MS/MS analysis of metabolomics in clinical specimens and other biological samples.  She is a regulatory affairs scientist with over 15 years experience in the industry, and a frequent speaker for NCRAF.


Table 9: What’s in the Mix for PDUFA VI?

The Prescription Drug User Fee Act (PDUFA) was authorized for the sixth time as part of the FDA Revitalization Act (FDARA) on August 18, 2017.  

PDUFA VI, which will be in effect for FY2018 through FY2022, retains the review goals and other essential features of “The Program” initiated under PDUFA V for new molecular entities and original biologics. On the other hand, notable updates to the fee structure and nuances to meeting management have been introduced.
While the application fee for an original application with clinical data has increased by 19%, to about $2.4 million, orphan products remain exempt and there are no application fees for supplements.  Establishment fees have also been eliminated.  Fees on approved products will constitute 80% of user fee payments, and program fees, for up to 5 products per approved application, have more than tripled relative to FY2017 product fees, to $304,062 from $97,750.
End-of-Phase (principally EOP2) meetings have been separately designated within the Type B framework.  EOP meetings will be scheduled later, and will require provision of briefing documents earlier, than other Type B meetings, reinforcing the criticality of these meetings for most development program.
We will review these changes and speak to some of the other PDUFA and FDARA updates at our table.

Drusilla Scott is Vice-President, Regulatory Affairs, at BioDelivery Sciences, where she is working on products for the treatment of pain and addiction.  Prior to joining BDSI, she worked at Cempra Pharmaceuticals, EMD Pharmaceuticals, Isis Pharmaceuticals, Parke-Davis/Warner-Lambert, and Pennwalt Corporation.   She holds a BS in Chemistry from Western Carolina University and a PhD in Pharmacology from the University of North Carolina, and is also a North Carolina Certified Paralegal.


THIS TABLE IS FULL.  Table 10: Leveraging Real World Evidence in Regulatory Approvals

Both the passage of the 21st Century Cures Act and new user fee laws have placed a spotlight on necessary efforts to shift the pharmaceutical industry and the FDA towards utilization of Real World Evidence (RWE) to support approvals for medical products. In an increasingly global and digital age, the value of patient data through such avenues as electronic medical records has great potential for reducing the time and cost of development and promoting better understanding of healthcare opportunities among patients, physicians, and payers. In his September 19th speech to the National Academy of Sciences, the FDA Commissioner, Scott Gottlieb, asserted that adopting RWE in support of drug development programs and issuing FDA guidance on the topic were high priorities of the Agency. These sentiments were echoed by the director of CDER, Janet Woodcock, when she stated that the clinical trial system is broken and we need better ways to collect patient data. This table will discuss the need for and implications of regulations and guidance regarding use of RWE in drug development and regulatory approvals.


Nicole M. Baker recently entered the world of regulatory affairs as an intern at Roivant Sciences, Inc in March of 2017. Subsequently, she obtained a position as a manager in the Global Regulatory Affairs Department at Roivant where she is receiving a fast-paced crash course in global drug development. Nicole obtained her PhD in September 2016 from the University of North Carolina at Chapel Hill Department of Pharmacology. She performed her graduate studies investigating the druggability of oncogenic pathways in pancreatic cancer under the mentorship Dr. Channing J. Der. Nicole was intensely interested in science writing and drug development during graduate school and sought several local opportunities to learn more about regulatory affairs during her graduate career. She founded the UNC Science Writing and Communication Club in 2015, which afforded her the opportunity to interface with many local regulatory professionals and medical writers, further piquing her interest in drug development. The passage of the 21st Century Cures Act and her work on rare diseases at Roivant inspired an intense interest in patient perspectives and leveraging real world evidence to support regulatory approvals.


Table 11: eCTD - What’s the Big Deal

How to Switch Existing Applications from Paper to Electronic

-How are eCTD submissions different from Paper
-Mindset changes.

Margaret Schubert has 18 years’ experience in drug development.  She spent her first 13 years working in the CMC arena.  Ms. Schubert attained Regulatory Affairs Certification for the United States in 2012. Since 2012, her duties have shifted to Regulatory Publishing, with gradually increasing responsibilities and experience in the Regulatory Operations group at Cato Research. Ms. Schubert is well versed in both paper and eCTD formats


Table 12: CANCELED  - eCTD - Regulatory Intelligence

This table has been cancelled. Our apologies.


Table 13: Priority Review Vouchers

Priority review vouchers can reduce the time of marketing application review by FDA from 10 months to 6 months.  Sometimes referred to as the golden ticket, in this discussion we will review the priority review voucher system, the advantages they offer, and pathways to obtain a priority review voucher.


Kelly Roney has extensive experience in research and pharmaceutical development.  She has served as a senior regulatory program leader for multiple development projects, and has experience from the pre IND through NDA stages of pharmaceutical development.  Dr. Roney has experience in CNS, oncology, pediatrics, obstetrics, pelvic floor disorders, immunology, and infectious disease products.  Her primary areas of expertise include regulatory strategy, medical writing, and clinical development.


THIS TABLE IS FULL.  Table 14: IND Submissions: Past, Present, and Future

The discussion will center on topics based on IND submissions from a brief historical perspective into the present and what can be expected in the future. We will touch on the eCTD requirements for IND submissions including details from relevant new FDA guidances. We will also focus on challenges that regulatory professionals might face by transformational changes such as automation technology with respect to IND submissions.

Dr. Rudy Fuentes has 16 years’ experience in biomedical science, with proficiency in drug development, regulatory affairs, quality assurance, International Conference on Harmonization, good clinical practice, good manufacturing practice and federal regulations. He obtained a Ph.D. in pharmacology from the University of Pennsylvania and more recently the Regulatory Affairs Certification (US) from the Regulatory Affairs Professional Society.  Dr. Fuentes is a Regulatory Affairs Manager at QuintilesIMS where he manages regulatory and/or technical project, for both internal and external clients. He provides strategic regulatory and/or technical consultancy on a variety of projects including management of INDs, submissions in eCTD format, development of briefing documents and preparation for FDA meetings.


Table 15: 5 Years after GAIN: QIDP Progress

This roundtable will discuss the QIDP process and the GAO report from 2017.  Understand the differences between qualified ID product and qualified ID pathogen.  Is a Guidance needed? Do not miss an opportunity to fast track development.
Joan L. Drucker, MD is the Vice President and Head of the Infectious Diseases and Vaccines Center of Excellence. The IDV Center of Excellence is a cross-functional team charged with overall strategic guidance for drug development and clinical trials for infectious diseases or vaccines. Dr. Drucker graduated from Harvard University and from University of Virginia School of Medicine. After completing a residency in Internal Medicine at Faulkner Hospital (Tufts), she completed a fellowship in Infectious Diseases at Duke University Medical Center. Dr. Drucker was a consulting faculty member in the Division of Infectious Diseases at Duke for 10 years.
Dr. Drucker began her career in the pharmaceutical industry at Burroughs Wellcome Co and GlaxoWellcome (now GSK), and held senior leadership positions in both US and international clinical research and medical affairs. Subsequently she was Chief Medical Officer at Trimeris Inc., Radiant Development, and Accelovance. Dr. Drucker has broad therapeutic area experience, with a focus on infectious diseases and vaccines. She has directed successful regulatory submissions for INDs and NDAs in multiple indications.





ECTD Group Meetings

The ECTD Group has moved to quarterly meetings using a discussion group format rather than lectures on a specific topic.
The meeting schedule is listed below.  The specific topics announced in an email sent out by the ECTD Group and will be posted prior to each meeting on the NCRAF website.

All meetings are scheduled for 12:00 - 1:30 pm.  Location is variable. Please check the schedule below for location updates.

The current meeting schedule is:

March 23 (Thursday): Opportunity to share take-aways from DIA RSIDM 2017 - Impact Pharma, 79 TW Alexander Drive, Building 4401, Suite 100, RTP, NC

June 27 (Tuesday): Review of new/updated eCTD guidance documents - location to be determined

September 19 (Tuesday): Program and location to be determined

December 5 (Tuesday): Program and location to be determined

Click here to see details