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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.
NCRAF Annual Roundtable Dinner
Thursday, November 12, 2015, 5:30 - 8:30 pm
Location: The Friday Center 100 Friday Center Dr. Chapel Hill, NC 27517
Networking Reception 5:30-6:30
Buffet Dinner and Roundtable Discussions 6:30-8:00 pm
EVENT REGISTRATION HERE - REGISTER TODAY!!!
Registration is $30 for Members, $45 for Non-Members
Attention Students, Post-Docs, and unemployed jobseekers! At checkout, apply the discount code "NCRAF2015" to receive $20 off the registration fee! (yes, we're all on the honor system).
01- Career Development (SORRY, THIS TABLE IS FULL)
Speaker: Brian McMerty (President, Carlyle Conlan)
Description: Carlyle Conlan is a local employment search firm with specialties placing regulatory professionals. Their table is a perennial favorite at this event for anyone in a career transition, or thinking about one!
Speaker Biography: Brian McMerty, MBA
Brian is the Managing Partner of Carlyle Conlan. A graduate of the University of Notre Dame, with an MBA from the Duke University Fuqua School of Business, Brian has held high level executive officer positions in finance and accounting over the years, including Chief Financial Officer of a large, international public real estate development and management company. While employed as a CPA by a Big 8 accounting firm, Brian helped lead the audits of several public and private companies, including one of the largest corporations in the world.
Before joining Carlyle Conlan, Brian led another search firm and several successful high-tech companies. His dynamic style and ability to form solid business alliances has uniquely qualified him to lead Carlyle Conlan. Brian specializes in placing top-tier senior-level and mid-level professionals in world-class companies.
Brian is very active in serving both the communities of Wilmington, NC and Southern Pines, NC where he lives, and the Raleigh-Durham area of North Carolina, where Carlyle Conlan is headquartered. Brian is the Founder of the Cape Fear 50 Club, a club consisting of CEOs of significant organizations, and he serves on the Boards of Advisors for the University of North Carolina – Chapel Hill and Band Together, as well as the boards of many charitable organizations.
02- cGMPs and Inspections: Overview from FDA’s Recent SBIA Meeting
Speaker: Poonam Pande, PhD, RPh, RAC (President, Integrated CMC Solutions)
Description: Summary of learnings from the SBIA event in July 2015 – Focus on cGMPs and FDA Inspections. This round table will provide a summary of the learnings from FDA’s Small Business Industry Assistance (SBIA) event in July 2015 and provide an overview of cGMPs. The six critical systems that FDA inspects for cGMPs will be discussed with reference to the relevant CFR sections and case studies. These six critical systems are Quality, Production, Laboratory, Materials, Facilities and Equipment, and Packaging and Labeling. Different types of FDA inspections and FDA’s approach during inspections will be shared. This discussion will follow an open ended format. Feel free to share your experiences and ask any specific questions related to cGMPs and inspections.
Speaker Biography: Dr. Pande is the Owner and President of Integrated CMC Solutions, LLC. She is a consultant and Subject matter expert to pharmaceutical and non-for-profit organizations on topics of pharmaceutical drug development, regulatory documentation, compliance, training, vendor selection and auditing. Prior to founding Integrated CMC Solutions in 2014, Dr. Pande served at RTI International as a Senior Manager in Analytical Chemistry and Pharmaceutics, Operations Manager, and Controlled Substance Coordinator for the organization. She was overseeing the administrative and technical aspects (formulation, manufacturing, analytical, inventory, shipping) of multiple projects and led a team of 11 staff with emphasis on quality and compliance. She established and initiated several programs including a preformulation laboratory. Dr. Pande’s previous experience has been in manufacturing and technology, regulatory affairs, formulation development, and preformulation at several organizations such as Synthon Pharmaceuticals, Cardinal Health (now Catalent), Banner Pharmacaps, and DuPont Merck. Dr. Pande graduated from University of Maryland, Baltimore with a Ph.D. in Pharmaceutical Sciences in 1995, is a registered pharmacist in NC since 1996, and has a regulatory affairs certification since 2005.
03- Bio Like Me: Recent Events & Current Hot Topics with Biosimilars
Speaker: Kevin Healy
The 2010 passage of the Biologics Price and Competition Act as part of the Affordable Care Act established an abbreviated licensure pathway and encouraged additional development of biosimilars. This March, exactly 5 years later, the approval of Zarxio (filgrastim-sndz) was a landmark in biological and biosimilar drug development history. This table will discuss the regulatory progression of biosimilars, with a focus on current hot topics including interchangeability, nomenclature, exclusivity, and pricing.
Speaker Biography: Kevin Healy is a Senior Director of Regulatory Affairs for Mallinckrodt Pharmaceuticals, a specialty biopharmaceutical company with expertise in developing and commercializing complex pharmaceutical products. Dr. Healy completed his undergraduate research at Cornell University, obtained his Ph.D. in Biochemistry from the University of Wisconsin-Madison, and completed a Post-Doctoral Fellowship at the University of North Carolina-Chapel Hill Lineberger Comprehensive Cancer Center. Dr. Healy has worked in clinical research and Regulatory Affairs throughout his industry career, including experiences with a CRO and Gilead Sciences. For the past five years Dr. Healy has been leading Regulatory activities associated with the development of branded pain therapeutics for Mallinckrodt Pharmaceuticals, and currently is the Regulatory lead for Mallinckrodt’s Autoimmune and Rare Disease platform.
04- The End of Alphabet Soup – The Pregnancy and Lactation Labeling Rule
Speaker: Drusilla L. Scott, PhD, RAC
Description: The decades-in-the-making Pregnancy and Lactation Labeling Rule (PLLR) went into effect on June 30, 2015. The PLLR markedly changes the labeling requirements for information on the use of drugs in pregnancy and lactation. A, B, C, D and X are no more! These over-simplistic and habitually misinterpreted single-letter categories have been replaced by a requirement to include risk summaries, considerations for clinical use and a summary of the supporting data. A new labeling subsection for males and females of reproductive potential has also been added. The result is lengthier and more intricate labeling, but better benefit/risk information. We will discuss the history of the PLLR, the components of the regulation, and labeling examples for products that already include the new content. Early implementation shows that the devil is indeed in the details, with differences in the location of similar information across labeling and compulsory breastfeeding text for non-pregnancy-contraindicated drugs that cannot be universally applied. However, even with the growing pains and regulation’s complexity, the PLLR advances the labeling content for practitioners and patients as they consider the appropriateness of a medication during pregnancy or lactation.
Speaker Biography: Drusilla Scott has worked in regulatory affairs in the pharmaceutical industry for more than 25 years. She is currently Senior Vice-President, Regulatory Affairs, at Cempra Pharmaceuticals, where she is working on the development of two new antibiotics. Prior to joining Cempra, she worked at EMD Pharmaceuticals, Isis Pharmaceuticals, Parke-Davis/Warner-Lambert (later Pfizer), and Pennwalt Corporation (later Fisons Pharmaceuticals).
Dr. Scott holds a BS in Chemistry from Western Carolina University and a PhD in Pharmacology from the University of North Carolina at Chapel Hill. She is also a North Carolina Certified Paralegal.
05- Making a List and Checking It Twice: Using Checklists to Ensure High Quality Regulatory Submissions
(SORRY, THIS TABLE IS FULL)
Speaker: Evan Richardson (Director, Regulatory Submissions, GlobalSubmit, Inc.)
Description: Over time, the volume of documentation FDA expects to support medical products has exploded – so regulatory submissions are far more complex than before. This talk will be about how to get a handle on all that data, make it a coherent whole, and ensure that no puzzle pieces are left out of the box!
Speaker Biography: Evan Richardson has 10 years of experience in regulatory affairs and operations. His experience includes stints with pharmaceutical, biotechnology, and medical device companies, where he's specialized in project management, system implementation, eCTD submissions, and organizational training. Prior to joining GlobalSubmit, Mr. Richardson fulfilled a number of responsibilities within the regulatory departments of Bioventus and Cato Research, both located in North Carolina's Research Triangle Park area. His career achievements include a major role in the approval of 3 distinct marketing applications, hundreds of regulatory submissions (IND, NDA, BLA, and DMF) and a company-wide launch and implementation of a new document management system.
06- Who's on First? The new Module 1
Speaker: BJ Witkin (Impact Pharma)
Description: FDA released a new module 1 specification on June 15th of this year. Come to this informative and fun session to learn about what's included (finally, a place to put the 3674!), what isn't (no, this isn't RPS) and whether it makes sense for your organization to upgrade to it.
Speaker Biography: B J. Witkin has been working as an electronic publisher for nearly 20 years in Nonclinical, Clinical, CMC and Regulatory. He has published and submitted over a dozen paper and electronic initial INDs and managed the lifecycles for a dozen more. In 2013 he published and filed an electronic NDA. He has worked in a variety of positions at GSK and BioCryst and is currently the Regulatory Publishing Manager for Impact Pharmaceutical Services.
07- Name That Drug! How Pharma Companies Name Their Assets
Speaker: Elvis Osei-Tutu (Post-doctoral Fellow, GlaxoSmithKline)
Description: Have you ever wondered how names such as acetaminophen, loratidine, omeprazole, adalimumab, atorvastatin, etc. were derived? Do some of these names seem difficult to pronounce or memorize? Pharma companies name their assets as part of the drug development process. These companies are tasked with giving their compounds both nonproprietary (generic) names and proprietary (brand) names. This discussion will focus on some of the scientific and regulatory considerations during the generic naming process. Participants will get a good overview of the identification, guiding principles and obtaining approval for generic names.
Speaker Biography: Dr. Osei- Tutu is currently completing a post-doctoral Regulatory Affairs fellowship at GlaxoSmithKline. He has a bachelor’s degree in Biochemistry and received his Pharm.D from the Massachusetts College of Pharmacy. Prior to obtaining his Pharm.D, Dr. Osei- Tutu worked at Abbott Bioresearch Centre in Worcester, MA, where he worked in CMC in the area of small scale biologics manufacturing. During his time at GSK Global Regulatory Affairs, Dr. Osei- Tutu has gained experiences in supporting the development of the regulatory strategies for programs involving multiple therapeutic areas, including cardiovascular, metabolic pathways, ophthalmology, infectious diseases, and rare diseases. His regulatory experience includes pre-approval CMC, IND meeting preparation and file, generic naming, and End of Phase 2 meeting preparation.
08- Regulatory Intelligence - Building Strategies for Drug Development
(SORRY, THIS TABLE IS FULL)
Speakers: Kirsten Messmer and Charity Schuller (PPD)
Description: The definition of what exactly is Regulatory Intelligence depends on the need at a particular stage of a specific drug development program. However, in general regulatory intelligence is the monitoring, gathering and analyzing of publically available and experience based regulatory information to develop a strategy for time- and cost-efficient drug development. Some companies may have staff who incorporate this into their “day” jobs or a dedicated team , while others outsource these tasks due to lack of appropriate resources. Regulatory intelligence professionals form a subgroup within regulatory affairs dedicated to developing sound strategies, avoiding roadblocks and finding solutions to various situations when operating in the highly controlled world of regulatory affairs. The talk will cover the questions asked by regulatory intelligence personnel, the tools available to draw information from, the skills set needed and the importance of being ‘in the know’. Case studies will exemplify the processes used to generate an applicable, sound and specific regulatory strategy. Regulatory intelligence is a bit like being regulatory affairs professional, a detective, an analyst/advisor and journalist all at the same time.
Kirsten Messmer, Ph. D., is a Senior Regulatory Affairs Specialist in the Regulatory Intelligence Solutions team at PPD. Dr. Messmer received her PhD in Neuroscience from University of Sheffield and a Biology Diplom from the Eberhardt-Karls University, Tübingen. She completed post-doctoral research fellowships at the Royal Free Hospital and University College London and the University of Maryland, Baltimore before joining Theradigm to develop stem cell therapies for neurodegenerative diseases. She also obtained a Graduate Certificate in Biotechnology Management from the University of Maryland, Baltimore County, which introduced her to regulatory affairs and ethical implications in drug development. In her position at ERA Consulting, Dr. Messmer was responsible for authoring the European Regulatory Intelligence newsletters and bulletins, consulted on biopharmaceutical product development and regulatory affairs as well as being responsible for US FDA interactions and submissions. 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).
Charity M. Schuller, PharmD, RPh, MS, RAC, Director, Regulatory Affairs, has over 17 years of experience in pharmaceutical regulatory affairs. Her current role at PPD includes regulatory project management, regulatory consultation, preparation and review of regulatory agency documents, development plans, support of REMS products and risk management programs, pediatric product development, assistance with FDA meeting preparation and attendance, late stage research and postapproval maintenance across a range of therapeutic areas. Dr. Schuller also provides global oversight of the Regulatory Informatics team covering intelligence, RIM and electronic publishing and submissions. She has previously managed the Global Regulatory Compliance and North America Regulatory Development teams.
Prior to her employment at PPD, Dr. Schuller was employed as a Regulatory Affairs Project Manager at Trimeris Inc. Preceding her position at Trimeris Inc., she was employed by Bertek Pharmaceuticals Inc. (formerly a subsidiary of Mylan) as a Senior Associate in Regulatory Affairs. Dr. Schuller transferred to Bertek from Mylan Pharmaceuticals Inc. where she began her career in Regulatory Affairs.
Dr. Schuller earned her PharmD from West Virginia University, a Masters of Clinical Research from Campbell University and a BA in Chemistry from West Virginia Wesleyan College. In addition, Dr. Schuller received her US Regulatory Affairs Certification (RAC) in 2002.
09- Pre-IND 12-step: Recipe for IND Filing Success
Speaker: Larry Hofmann, PhD (Managing Director, LMH Associates)
Description: Pre-IND drug development program overview of required R & D programs to be completed and documented
leading to the FDA, Type B meeting with agreements obtained and the original IND submission.
Program can be summarized in 12 distinct stages or activities: Regulatory, Chemistry, Pre-Clinical,
Phase 1 Clinical Protocol(s) and Supporting Literature.
The 12 stages begin with senior management approving the staffing for the pre-IND team and later its timeline and budget.
Combined staff input into preparing the extensive FDA pre-IND, Type B meeting’s Information Package.
Lastly, after FDA input and tentative approval at the pre-IND meeting, complete the documents,
with any FDA required changes, and submit the original IND.
Speaker Biography: Larry Hofmann, PhD, is the managing director for LMH Associates. Following his PhD in cardiovascular-renal pharmacology, he has accrued over 25 years experience in clinical research, including medical monitor for 18 IND and several IDE clinical programs, writing over 3-0 study protocols and co-writing over 20 clinical study reports and 5 ISS/ISE’s. He has led production of 6 NDA’s and managed multi-disciplinary IND teams for submission of numerous successful IND filings.
10- Growing Pains - Making Pediatric Clinical Trials Better!
Speaker: Valerie Amspacher, PharmD (ORISE Fellow, FDA)
Description: Discussion will center around the answers to these questions: Why are failed trials important for pediatric patients? Are there specific therapeutic areas that are more difficult to study in pediatric patients? What are the reasons for study failure in pediatric patients? What can we learn from failed pediatric studies?
Speaker Biography: Valerie Amspacher is a pharmaceutical professional with 12 years of experience in Inhaled Product Development at GlaxoSmithKline. She is currently an ORISE (Oak Ridge Institute for Science and Education) Fellow with the Pediatric group in the Office of Clinical Pharmacology at the FDA working on creation of a database of pediatric clinical trial characteristics for studies reviewed by the FDA. She received her Doctor of Pharmacy degree in May of this year from the UNC Eshelman School of Pharmacy in Chapel Hill.
11- Integration of human factors engineering into medical device development
Speaker: Cynthia Nolte (Director, Regulatory Affairs, ICON PLC)
Description: To develop a successful medical device, it’s critical to consider not only what the engineers determine as functioning to specification, but to consider the device users, and think about how to best make it easy for them to use the device correctly.
Speaker Biography: Cindy Nolte, PhD, RAC, has over fifteen years of experience in medical device regulatory affairs, with a focus on drug delivery systems - large volume infusion pumps for intravenous and parenteral routes of administration, diabetes management technologies including insulin delivery devices, glucose monitoring technologies, and stand-alone software products for blood glucose control. She supports manufacturers of these systems in assurance case preparation, non-clinical test design and the development of usability assessment programs that meet current FDA expectations. She has authored 510(k) premarket notifications for a range of complex medical device products and systems including drug delivery systems, stand-alone software products, software-controlled instrumentation, implantable devices, infection control products and tissue engineered products. Prior to joining the company in 1995, she was a staff scientist at Organogenesis, Inc., where she was involved in the design and development of cellular tissue substitutes. Cindy is a member of the Regulatory Affairs Professionals Society, the Association for the Advancement of Medical Instrumentation, and the North Carolina Regulatory Affairs Forum. She holds a B.A. in biology from Wheaton College and a Ph.D. in biochemistry from Boston University.
12- Creating to Spec: the Design Control Process
(SORRY, THIS TABLE IS CANCELLED)
Speaker: Jim Clinton
Description: Design control means changing a medical device to invent a “new and improved” one – but making the changes in a precisely defined and documented way. While the design control process is well-established in the medical device world, the principles are relevant to drugs and biologics also.
Speaker Biography: Jim Clinton is the principal consultant for Quality&Regulatory Consulting, LLC, bringing his 20+ years of industry experience to Pharma and Medical Device quality systems assessments and remediation; design controls; risk management; process validation; expertise in developing and implementing validation protocols; Medical Device 510(k) and PMA development; successful premarket and postmarket compliance negotiations with FDA; project management; and managing cross-functional project teams.
His specialties include Compliance auditing; design control and risk management; supplier qualification; sterilization assessment; quality engineering; process validation; medical device regulatory affairs.
13- Split Personalities: Combination Products
Speaker: Sandra Boyd (Biogen)
Description: Some medical products defy definition – they are a drug and a device, or a biologic and a device, or are a group of products intended for use together. The combinations make for a number of interesting challenges for every entity (sponsor and regulator) involved with bringing such products to market.
Speaker Biography: Sandra Boyd is a Quality accredited (CQA and RAC) and business professional with diverse experience in pharmaceutical, biotechnology, medical device, Contract Research Organization (CRO), and clinical environments. Expertise and accomplishments include:
- Project Management
- Documentation & Records Generation
- Root Cause Analysis & Investigations
- Staff Training & Development
- Laboratory Compliance & Management
- Document Control Management
- Implementation & Auditing of cGMP Systems
- Quality Review of Data & Documentation
- Knowledgeable in cGMP, QSR, GLP, ICH, EU, and ISO 13485 implementation
14- Diagnostics Across Borders: Key Differences of IVD Regulations in the EU vs US
Speaker: Eiichi Sengoku (Manager, Diagnostics and Devices in Global Regulatory Affairs; GlaxoSmithKline)
Description: This talk will focus on the challenges of navigating IVD regulatory oversight in Europe and the US. Furthermore, we will discuss diagnostic tests used in clinical trials and the pathways exploratory diagnostic tests may take. Should the test be a laboratory developed test or a Companion Diagnostic? How will the future EU Regulations affect IVDs? We will examine these questions in further detail.
Speaker Biography: H.E. Sengoku is the Manager of Diagnostics and Devices in Global Regulatory Affairs at GlaxoSmithKline. In this global role, H.E. works in Mobile Health (mHealth) as well as Companion Diagnostics for all divisions of the company. H.E. received his MS in Genetics at Clemson University and his MBA from the University of Wuerzburg in Germany. Previously, he has worked for QIAGEN supporting HLA diagnostics as well as for Sonic Healthcare USA as a Product Marketing Manager for Anatomic Pathology before his current role.
15- FDA’s Golden Tickets: Priority Review Vouchers for Rare Pediatric and Tropical Disease Drugs
Speaker: Matt D. Medlin Ph.D., RAC (Manager, US Regulatory Affairs R&D Pipeline; CHIESI USA, INC.)
Description: Discussion topics at the FDA Golden Ticket – Priority Review Voucher (PRV) table will include:
- Overview and definition of the PRV
- Humble beginnings and the history of the PRV
- Similarities and differences in the pediatric vs tropical disease PRV
- The Creating Hope Act and how Nancy Goodman’s legislation generated inertia for the PRV
- A historical look at the buyers and sellers of PRVs including sales trends
- Functional aspects of the PRV. The who, what, when, where, how, and why of Rare Pediatric Disease Designations and PRVs
- From the Creating Hope Act to the Advancing Hope Act – The uncertain future of the PRV
- PRV References and Resources
Speaker Biography: Dr. Matt D. Medlin earned his Ph.D. in Cellular and Molecular Pathology at the University of North Carolina Chapel Hill. Following graduate school, Matt worked as a Senior Scientist for Vascular Pharmaceuticals Inc., a UNC based startup focused on the development of a monoclonal therapeutic for diabetic indications. His specific area of interest was proof of concept preclinical investigation on the inhibition and regression of diabetic nephropathy.
In 2011, he joined CATO Research Ltd. as a Fellow and trained as both a Regulatory Scientist and Venture Analyst. As a Regulatory Scientist, Matt specialized in the formulation and execution of regulatory strategy, with a focus on the development of drugs and biologics for Orphan indications and/or serious condition.. As a Venture Analyst, he conducted due diligence over a wide range of technologies in seed to late-stage, private and public companies.
In 2015, Dr. Medlin moved into his current position with Chiesi Farmaceutici S.p.A. as Manager of Regulatory Affairs for the U.S. R&D Pipeline. At Chiesi Dr. Medlin manages regulatory workflow, timelines, procedures, and activities in the U.S. He conducts regulatory due diligence evaluations ahead of acquisitions and partnerships and conducts competitive intelligence analysis with ongoing surveillance in specific therapeutic areas. On a functional level Dr. Medlin is tasked with FDA meeting management, planning, and execution for global project teams. He also leads the preparation and review of US regulatory submissions and applications. Dr. Medlin’s projects span several technologies and indications, his area of focus is the development of drugs and biologics for rare diseases in neonatal populations.
16- Medical Writing for Regulatory Professionals
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Speaker: Jennifer Moen, PhD, RAC (Principal Clinical Research Scientist and Associate Director of Corporate Communications, Impact Pharmaceutical Services, Inc.)
Description: Thinking about transitioning into regulatory medical writing? This table will discuss what regulatory medical writing is, what makes a good medical writer, and what medical writers do all day (it’s more than just typing on a computer!). Whether you are in the drug development industry already or are just starting out, this informal discussion will provide insight into the world of regulatory medical writing. Bring any questions you may have!
Speaker Biography: Jennifer Moen, PhD, RAC has over 10 years of regulatory medical writing experience. She is currently a Principal Clinical Research Scientist and the Associate Director of Corporate Communications at IMPACT. Jennifer’s primary responsibilities include managing and authoring regulatory medical writing projects as well as overseeing internal and external communications for the company. Prior to joining IMPACT, she was an Associate Director of Clinical Submissions Writing at UCB Biosciences, Inc. and a Senior Clinical Research Scientist at SRA International and its legacy companies (Constella Group and Lineberry Research Associates).