2024 Round Table Details

Table # and Topic Description Speaker & Bio
1 _ "Transitioning to a Career in Regulatory Affairs"Linda Bowen The round table discussion will focus on repurposing skills attained in other roles that could assist in moving into a RA role. Linda Bowen joined the BioPharma industry in 1983 and has spent the last 30+ years in regulatory strategy, policy, and intelligence roles at Seagen, Sanofi, Bayer, and GSK.  She has been an Assistant Adjunct Professor in the Temple University RAQA graduate program since 1998. Linda holds bachelor's degrees in microbiology and English from Rutgers University and an M.S. in Drug Regulatory Affairs from the Arnold and Marie Schwartz College of Pharmacy, where she was inducted into the Rho Chi Society. She attained regulatory affairs certification for the US, Canada, and Europe, and was an inductee to the 2011 Class of RAPS Fellows. Linda was honored with the Drug Information Association's 2012 Excellence in Volunteer Leadership, the 2019 Americas Inspire Awards, and the 2022 Global Inspire Award - Community Engagement as well as the RAPS 2020 Founder's Award. She is a past two-term member of the RAPS Board of Directors, current chair of the RAPS Industry Board, and immediate past chair of the NJ/NY RAPS Chapter. Linda is past Chair of the DIA Regulatory Affairs Community and founder of the DIA Regulatory Intelligence Working Group. She sat on the planning committee for 2013-2017 DIA Annual Conference, the 2011-2017 RAPS Annual Convergence and was Program Chair for the 2018 & 2019 RAPS Annual Convergence. She is co-chair of the RAPS 2024 and 2025 Regulatory Intelligence Conference.

2 _ “Lab Developed Tests - US and EU Perspectives”

Stefan Burde

  The session will discuss the FDA's final rule on laboratory developed tests (LDT) and describe the European Union's approach to regulation of LDT.  The session is of interest to manufacturers and laboratories who develop home-brew diagnostic tests.  Attendees will learn about approaches to bringing LDTs to market in the US and EU.  Stefan Burde, PhD is the Director, Global Growth IVD at TÃœV SÃœD, a leading full-scope Notified Body under the European Medical Device and In Vitro Diagnostic Regulations (EU) 2017/745 and (EU) 2017/746.  Stefan holds a PhD in Pathology from the University of Rochester, and has over 13 years of experience in the in vitro diagnostic industry and over 10 years of Notified Body experience as an auditor, technical documentation reviewer, and strategic director.  He has spoken extensively at international conferences on topics related to IVDR implementation and compliance.

3 _ “Bridging Science and Compliance: The Synergy between Medical Writing and Regulatory Affairs.”

Stephanie Byrd

  Medical Writing (MW) and Regulatory Affairs (RA) are closely related fields but serve distinct roles in the lifecycle of clinical research and drug development. The synergy between medical writing and regulatory affairs is crucial. Medical writers produce the comprehensive documents needed for regulatory submissions, while RA professionals oversee the submission process and ensure compliance with regulatory standards. Effective collaboration ensures that documentation is not only scientifically accurate but also meets regulatory expectations and facilitates the approval process. This Round table is best suited for beginner and intermediate level individuals interested in learning more about the roles that MW and RA play in the landscape of clinical development. The objectives of the Round table include discussing the various document types that MW and RA support and how these two functional groups work together to ensure that clinical research data is communicated effectively and that new therapies can advance through the regulatory process both efficiently and ethically. The topic is timely for several reasons: increased complexity of clinical research; regulatory changes; emphasis on efficiency and speed; ethical considerations; and career development for individuals wanting to enhance their knowledge and skills.  Stephanie Byrd, PhD, RAC is a Principal Clinical Research Scientist at Syner-G Biopharma Group, a leading provider of CMC, Regulatory Affairs, and Medical Writing solutions for biopharma. Her primary responsibilities as a MW include authoring CSRs, study protocols and protocol amendments, IBs/IB updates, Briefing Documents, submission documents, and regulatory responses and PM tasks that accompany these projects. In addition, Steph works closely with RA (client or internal) to ensure clinical documents within a submission meet the regulations and conform to submission standards. Steph received her PhD in Plant Biology with a minor in Biotechnology from North Carolina State University and studied and received her RAC in 2019.

4 _ “Tip and tricks for uncomplicated collaborative authoring"

Meagan Eldridge

  In a lot of ways, collaborative authoring has made teamwork easier. However, it's not without challenges. If you've worked on collaborative authoring teams, you're probably familiar with issues like process ambiguity, inconsistent writing styles, formatting nightmares, contradictory changes, and overall poor document organization. This round table session will focus on tips and tricks to uncomplicate the collaborative authoring process, while maximizing efficiency and quality.  Prior to starting her own medical writing consultancy, Meagan served in medical writing positions of increasing responsibility across both the contract and sponsor sides of the industry. Meagan finds her greatest career joys in partnering with collaborative, cross-functional teams to produce high-quality clinical and regulatory documents. In addition to writing for any phase of drug development, her growing company is focused on agile medical writing leadership to optimize the document development process, help clients reach their submission goals, and ultimately bring life-changing therapies to patients.

5 _ "Mine Your Business (and Others Too) - Searching for Relevant Data to Guide Regulatory Decision-Making"

Michael Lance

  This table will discuss searching for answers to regulatory questions to guide decision-making.  We will focus on how to develop our questions, how to search for answers to our questions, tools to use, how to present our findings, and, if necessary, when to meet with FDA.  Individuals with a basic understanding of Regulatory Affairs will benefit from this session.  The topic is timely, because there is an abundance of data that must be filtered due to irrelevance.  In addition, key regulatory updates might be ignored by management if not presented in an easily readable format.  Regulatory authorities have also shifted to electronic databases, encouraging private companies to develop machine learning-enabled intelligence services.  Sponsors can now quickly retrieve actionable data to guide regulatory decision-making, giving them a competitive edge. Michael Lance is currently a Senior Regulatory Affairs Associate within the Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC) and Labeling group at United Therapeutics Corporation (UTC or the Company).  His primary role at UTC is to assist in navigating the laws, regulations, and guidances of the US Food and Drug Administration, Health Canada, the European Medicines Agency, and other Rest of World national regulatory agencies.  Additional duties include the review of product labeling and the preparation of regulatory CMC submissions to support lifecycle management and expand our portfolio of solutions for patients and providers.  By fulfilling his responsibilities, UTC will continue to deliver healthcare solutions in compliance with regulatory guidelines and expand its footprint to address novel unmet medical needs for new patient populations.

6 _ "The European Pharmaceutical Legislation revision : where are we now?"

Kirsten Messmer

  The European general pharmaceutical legislation, consisting of a Directive and three Regulations governing medicines approval and supervision (including orphan drugs and pediatric medicines), in the EU are currently undergoing a full review for the first time in about 20 years. The revision aims to ensure an efficient regulatory system supporting innovation and competitiveness of the EU globally while ensuring affordable patient access to medicines. The European Commission proposal package sparked a fierce debate on many of the provisions in the European Parliament and the European Council. Among the most contentious topics are regulatory protection periods, the transferable exclusivity voucher for innovative antimicrobials, definitions of high unmet and unmet medical need as well as the cross-EU market launch requirement. A new Parliament has taken office in Brussels continuing negotiations on the proposed files.  We will discuss the history of these legal documents and how the legislative process works in the E.U. Then we'll dive in for a play-by-play of the negotiations as well as discussing the latest updates that have emerged in the last couple of months.  Kirsten Messmer, PhD, RAC is the owner of KM Intel LLC which supports companies with actionable intelligence to inform their policy and regulatory strategy. She was previously a Senior Research Analyst and contributed to the research and development of content for AgencyIQ on regulatory issues affecting pharmaceutical and biopharmaceutical companies in the United States and the European Union.  Prior to joining Agency IQ, Kirsten was a Principal Regulatory Affairs Specialist at PPD providing global regulatory intelligence to support efficient, compliant and successful clinical research and drug development for biopharmaceuticals and advanced therapies. Before starting at PPD, Kirsten worked at Theradigm to develop stem cell therapies for neurodegenerative diseases before joining ERA Consulting. She held post-doctoral fellowships in London and Baltimore.  Kirsten received her PhD in Neuroscience from the University of Sheffield (Sheffield, UK) and a Biology Diploma from the Eberhard-Karls University (Tübingen, Germany). Kirsten also holds a Regulatory Affairs Certification (RAC) in US regulation.

7 _ "Leveraging DHTs For Enhancing Innovations in Regulatory Science"

Prem Narang

  Use of Digital Health Tech (DHTs) seems unstoppable and use of AI is conjunction is driving further innovation in healthcare. Sensors, computing platforms, and ways to remotely collect data are all driving research in the healthcare/clinical trials space.  Rather than gathering data at pre-set Visits - real time data can now be obtained.  This has created several opportunities in many areas relevant to the development of new products (drugs, devices, diagnostics) for the treatment or prevention of disease and/or conditions.  DHTs have the potential to provide meaningful data on how subjects' feel or function (24 hours a day). Since most of these products are regulated, the presentation will broadly focus on the evolving regulatory framework and considerations when integrating DHT for a specific purpose or use.  This table is for anyone interested in Product Development, Regulatory Affairs, or Regulatory Science.  Prem Narang ('P.K.') serves as the President of P.K. Narang Strategic Consulting and engages with pharma/biotech businesses on strategic product development-regulatory issues as an Advisor.  He brings >30 years of broad pharmaceutical industry experience in business, drug development, compliance (regulatory, quality), and global product registration. A pragmatic leader, with an excellent track record of strategic, scientific & operational leadership focused on excellence, risk management and leading teams to deliver on business goals.  He held global leadership roles in Regulatory, Quality and PV functions at several large pharma. businesses. Before Regulatory roles, he led the US Clinical Pharmacology/PK group for Pharmacia.  He has made significant contributions to the development and regulatory approval of ~18 NMEs.  He received a Masters in Pharmaceutics from West Virginia University and a Ph.D. in Pharmacokinetics from University of Maryland.  P.K. started his career at National Institutes of Health where he established a Clinical Pharmacokinetics Research Lab. to drive integration of exposure-response principles in clinical drug development across multiple institutes.  He has edited two books and authored >60 peer reviewed publications.  He serves as an Advisor to couple of start-ups in pharmaceutical/digital health/machine learning technology space.

8 _ "Software as a Medical Device – or Not. General Wellness and Clinical Decision Support Apps"

David Jensen

 

  The FDA has long regulated software that meets the definition of a device, including software that is intended to provide decision support for the diagnosis, treatment, prevention, cure, or mitigation of diseases or other conditions - often referred to as clinical decision support software. Further, FDA has indicated that they will not examine low risk general wellness products to determine whether they are devices within the meaning of the FD&C Act or, if they are devices, whether they comply with the premarket review and post-market regulatory requirements for devices.
So, what is a “low risk general wellness” app or what apps can be excluded from the device definition? This table will discuss these topics and some examples. 		 David Jensen, Ph.D., RAC is a Senior Regulatory Affairs Scientist in the office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. David uses his 15 years of experience in US FDA-regulated medical product development to advise Duke Faculty and project teams, primarily at the Duke Clinical Research Institute (DCRI), on regulatory strategy development, FDA meetings, regulatory submissions, product manufacturing, and preclinical testing. He assists project teams with the development, coordination, and implementation of complex regulatory projects involving drugs, biologics, devices (including Software as a Medical Device), and dietary supplements. David is also a patent-holding cell & molecular biologist with broad experience in drug discovery and development and with significant scientific knowledge in a variety of therapeutic areas.
Prior to Duke, David held regulatory positions at a major CRO and at a biotechnology company (focused on nanotechnology) and he was a project leader for oncology, osteoarthritis, and virology programs at a major pharmaceutical company.

9 _ "Assessment of the Effects of Drugs on Cardiac Repolarization"

Rachel Rozakis

  This discussion will be focused on thorough QT/QTc (TQT) studies: what they are, why it is important to assess the effects of drugs on cardiac repolarization, and the circumstances in which alternative methods of QT assessment may be used.  This session will be suitable for beginner experience levels. This is a timely and evolving topic, with relatively recent regulatory guideline updates and publications. This will be valuable for participants looking to learn more about regulatory recommendations around the assessment of cardiac safety in drug development. The learning objectives are: - Learn why it is important to assess the effects of drugs on QT; - Learn what a TQT study is and common elements of TQT study design;- Learn what alternatives to a TQT study are available, and how they impact other studies in a drug development program; - QT summary reports - what is included and how they may result in the 'waiving' of a TQT study; - Discuss TQT case study  Rachel Rozakis, PharmD has experience in clinical pharmacology and scientific writing across multiple therapeutic areas in different phases of development, primarily Phase 1. Her therapeutic area interests include cardiology, neurology, oncology, and dermatology. Rachel has authored and contributed to many regulatory documents including Investigational New Drug (IND) and New Drug Application (NDA) sections, clinical study reports (CSRs), protocols, and QT summary reports. Her educational background includes biology (undergraduate degree, UNC Chapel Hill), pharmacy (PharmD, UNC Eshelman School of Pharmacy), and completion of a two-year T32 UNC-Duke Collaborative Clinical Pharmacology fellowship.

10 _ "Demystifying Device Usability Risk Management and Usability Studies: URRA, uFMEA, Usability Study Design, HFE/UE Report and Beyond"

JoAnne Bronikowski and Dong Hodgkins

  This discussion will first look at device usability risk management in relation to ISO 14971, IEC 62366-1, and FDA guidance – reviewing the usability risk management process and what would be necessary to meet the related FDA requirements. Next will discuss usability studies, touching on FDA communications, study protocol design, study recruitment, study conduct, and data collection. Thirdly, the discussion will focus in more detail on the URRA, and uFMEA, what they are, how they are related, along with discussion and sharing of tips for documentation and maintenance that table members may have had related to device usability risk management.  Will close with a brief touch on the HFE/UE report.   JoAnne is a Senior Manager Regulatory Affairs within the medical device team at ICON.  She joined ICON in 2014 after consulting with ICON for a few years.  JoAnne has over 30 years of software experience, including over 25 years of medical device experience in software development, product/project management, quality assurance, and regulatory affairs. She has particular expertise with software as a medical device and embedded medical software systems as well as design controls, human factors, risk management, cybersecurity, and quality systems. She also has extensive experience with regulatory requirements and the preparation of dossiers and submissions for medical devices and combination products. Prior to coming to ICON, she served as Director of Regulatory Affairs and Quality at a software medical device start-up company. JoAnne holds a B.S. in computer science, is a certified ISO 13485 lead auditor, and is Regulatory Affairs Certified.   Dong has doctor degree in molecular biology, master degree in Genetics and MBA. Dong has Over 20 years of experiences within the clinical research field starting from a project assistant through to a senior director and has experience with Phases I - IV clinical trials and medical device usability studies. Dong has in depth knowledge about drug development, from drug discovery, preclinical to clinical, and has managed all aspects of clinical research, including regulatory, clinical operation, safety management and data management. Dong has led North Carolina based Wakefield Clinical Research to help small biotech and medical device companies conduct clinical studies and usability studies in US.

11 _ "Unlocking Hope: Regulatory Innovations in the Treatment of Rare Diseases"

Jason Mercer

  The discussion will be suitable for beginner experience level and will be of interest for anyone interested in orphan drug designation, expedited programs, and recent FDA initiatives such as the newly formed Rare Disease Hub.  The FDA has placed a lot of emphasis on advancing rare disease therapies recently and continues to release new guidances and relevant information related to this topic.  The learning objectives are to learn the requirements for obtaining orphan drug designation, learn about expedited programs relevant to orphan drugs (and biologics), and discuss recent developments at the FDA that impact development of treatments for rare diseases.  Jason Mercer, Ph.D., RAC is a Strategic Program Champion with Facet Life Sciences, a consulting group focused on providing scientific and regulatory support for smaller life sciences companies.  Jason has over 15 years of experience as a regulatory professional supporting the development of drug and biologic products in a wide array of therapeutic areas including dermatology, neurology, oncology, psychology, and PET radiopharmaceuticals.  His primary areas of interest are in the development of innovative clinical and regulatory strategies.  Jason has assisted numerous sponsors in obtaining orphan drug designation, rare pediatric disease designation, and breakthrough therapy designation.  Jason received a Ph.D. in Biochemistry, Microbiology, and Molecular Biology from Penn State University and did a postdoctoral fellowship at the National Institute of Environmental Health Sciences prior to entering the pharmaceutical industry.

 12_Cell and Gene Therapy Regulatory Affairs

Scott Burger

  ((more info coming soon!))  Scott Burger, Principal at Advanced Cell & Gene Therapy, LLC