2023 Round Table Details

Table # and Topic Description Speaker & Bio
1 _ "eSTAR and PreSTAR – Experiences with CDRH’s Electronic Submission Template" The use of the eSTAR template represents a significant change in the way 510(k)s and Pre-Subs are prepared, leading to the need to change templates and work instructions that we worked so hard to prepare.  Let's embrace change!  We will review the eSTAR and PreSTAR process, share ICON’s (and hopefully others) experience with this program, and discuss how the use of these processes helps organize and streamline your submissions to make them easier to prepare and easier for the FDA to review. Cynthia Nolte, PhD, RAC has over 25 years of experience in medical device regulatory affairs and has spent her career embedded in a CRO (Contract Research Organization) environment.  She leads the strategic regulatory affairs team within the medical device consulting services group at ICON, engaging with companies to define and implement regulatory and clinical strategies for medical devices and combination products. Cindy has supported projects across a broad range of therapeutic areas. Cindy also leads teams in MDR and IVDR assessment projects, working with customers to develop and execute compliance plans for their medical devices and in vitro diagnostic 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 and the Association for the Advancement of Medical Instrumentation. She holds a B.A. in biology from Wheaton College and a Ph.D. in biochemistry from Boston University. She is Regulatory Affairs Certified.
2 _ “Regulatory Considerations for Digital Health Technologies (DHTs) used with Combination Products” Currently, interest in connected drug delivery products and other digital health technologies (DHTs) continues to grow rapidly, not only in industry but also at the FDA who just announced the establishment of a DHT Advisory Committee this month. We will explore important business and regulatory factors to consider before starting development of such products, discuss a DHT premarket policy framework to apply cross-departmentally to facilitate software and other DHTs to market and review a few case studies.   Rita Lee has 15+ years of regulatory affairs strategy experience in regulated medical products (combination products, medical devices, and drugs) in startups and larger companies, including over 5 years as global regulatory device lead for combination products and devices.  Rita is currently a Principal Consultant at Suttons Creek, Inc., the device team for pharma for combination products.
3 _ “Is your product a cyber device?  Avoiding an RTA hold for missing cybersecurity information.” This discussion will first look at what product characteristics would make a product a cyber device that would require it to meet the FDA requirements related to cybersecurity.  Secondly, the discussion will cover FDA’s refuse to accept policy related to cybersecurity.  As of Oct 1, 2023, FDA will refuse to accept medical device submissions that do not include certain cybersecurity information.  The discussion will involve a review of what the refuse to accept policy means, a review of the FDA requirements for cybersecurity information in medical device submissions which have been rapidly evolving over the last few years, and sharing experiences that table members may have had related to cybersecurity. JoAnne Bronikowski, RAC 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.
4 _ “Exploring FDA Guidelines: Empowering Innovation in Generative AI and Digital Health" During our session, "Exploring FDA Guidelines: Empowering Innovation in Generative AI and Digital Health," we will delve into several important topics. Firstly, we will explore the common types of artificial intelligence and examine how AI is being integrated into medical devices. We'll then delve into the FDA's current stance on AI technologies and discuss how the regulatory landscape is evolving to accommodate this emerging field. Moreover, we will analyze recently cleared AI medical devices and shed light on the burden of proof required for their approval. By the end of our discussion, attendees will gain a deeper understanding of the FDA's guidelines, the complexities of regulatory compliance in the context of generative AI and digital health, and the opportunities for innovation in this rapidly evolving space.  Shilpa Gampa is a dynamic and accomplished regulatory affairs strategist with expertise in FDA submissions and C-level executive consultation for developing go-to-market strategies. She is currently acting as the regional delivery head for America's clients at Freyr, in her primary role for global market submissions. In addition to her primary role, Shilpa leads the "Central Consulting Services" at Freyr, where she is involved in supporting and establishing service offerings to meet evolving regulatory demands. Her diverse roles bring a holistic perspective to her work, fostering a diverse skill set and a deep understanding of the ever-demanding regulatory needs of various aspects of medical devices.  She has extensive experience in regulatory strategies for various regulated medical products, including combination products, medical devices, IVDs, and digital health devices. Throughout her career, Shilpa has led cross-functional teams, including regulatory, medical writing, and consulting, in developing regulatory strategies and delivering high-quality submissions, resulting in positive regulatory outcomes. Her thought leadership in regulatory affairs and comprehensive understanding of the challenges and opportunities in the digital health device industry make her highly sought after.
5 _ "Regulatory approaches to Cell, Gene, and Tissue Therapies" Regenerative medicines, specifically Cell, Gene, and Tissue (CG&T) Therapies, have been transforming the treatment landscape in a variety of therapeutic areas. Many therapies have been approved in recent years, and there are far more products in development. We will discuss hot topics in the development and regulation of cell, gene, and tissue therapies. We will discuss developmental and regulatory strategies, expedited pathways and designations, the latest CG&T Guidances, and global development / harmonization considerations. Kevin Healy, PhD has extensive leadership experience in developing and commercializing advanced therapies, biologics, and small molecules in diverse therapeutic areas within small- to mid-size biotechs. Most recently, Kevin worked at Enzyvant Therapeutics Inc., where he led the Regulatory and Quality departments and obtained FDA approval for the regenerative medicine, RETHYMIC.   Kevin holds a PhD in Biochemistry from the University of Wisconsin-Madison in Madison, WI, and a BS in Biological Sciences from Cornell University in Ithaca, NY. He was a Postdoctoral Fellow at the Lineberger Comprehensive Cancer Center, at UNC-Chapel Hill. 
6 _ "Exploring FDA’s Focus Areas of Regulatory Science" Learning objectives for this table discussion are:  Recognize where the Office of Regulatory Science (ORSI) sits in FDA’s organizational structure. __ Differentiate between regulatory affairs and regulatory science. __ Describe ORSI’s current focus areas of regulatory science and how they conduct research in these areas.  __  Identify examples of regulatory science. Patricia Termini, M.S., RAC, is the Director of UNC’s Master of Professional Science (M.P.S.) in Regulatory Science program. She has more than 25 years of experience in the pharmaceutical, biotechnology, and consulting industries focused on regulatory affairs strategy, execution, and project management. Ms. Termini has experience working cross-functionally on pre-approval and post-approval regulatory activities and has worked in multiple therapeutic areas including dermatology, infectious disease, oncology, and rare diseases. She has a M.S. degree in Regulatory Affairs and Quality Assurance from Temple University, is RAC certified, and has certificates in drug development and project management.
7 _ "Decentralized Clinical Trials: Things to Consider" The COVID-19 pandemic catalyzed the adoption of decentralized clinical trials (DCTs) and highlighted the critical benefits of virtual elements for patient and physician experience. Clinical-trial sponsors continually seek to make trials faster, and decentralization has emerged as a critical tool in this pursuit. It involves bringing an increasing proportion of a trial’s activities to patients rather than patients to sites.    Typically, 70% of potential participants live >2 hours from a trial site, so decentralization has the potential to broaden access and diversity. Decentralization may reduce investigator workload, since traditional site activities may be performed remotely by others or by trial participants themselves. Trial Spectrum:  1. Fully Decentralized; 2. Hybrid; 3. Fully Centralized.   Recognizing the potential benefits, the FDA has issued a guidance for sponsors     https://www.fda.gov/media/167696/download           We will further discuss trial planning/conduct aspects and regulatory considerations for pragmatic, risk-based, feasibility assessments. Prem Narang ('P.K.') serves as the President of P.K. Narang Strategic Consulting, which provides advisory services to businesses on development-regulatory matters.  He brings >35 years of experience and a track record of strategic, scientific and operational successes leading to multiple new drug approvals. He has held Global leadership roles in Regulatory & Quality domains. Prior to those, he was the US Head for Clinical Pharmacology/PK at a large pharma. He received his Ph.D. in Pharmacokinetics from University of Maryland. He currently serves as an Advisor to start-ups and to the MPS Program in Regulatory Science at UNC-ESOP.
8 _ "When a single pivotal trial might be sufficient - FDA's thoughts" At this table we will be discussing what constitutes substantial evidence of effectiveness. In its most recent draft guidance of September 2023, FDA has provided examples of what can be considered confirmatory evidence to substantiate efficacy demonstrated by a single adequately controlled clinical trial. The new guidance complements the two earlier guidance documents released in 1998 and 2019 and provides details on the types of data – clinical, mechanistic and animal data that can be used as confirmatory evidence. Sathya Ganesan is a Regulatory Science Lead at UCB, Inc. where she provides regulatory strategic leadership for products in oncology and neurology indications. Prior to UCB, as Director of Regulatory Affairs, she provided regulatory strategic leadership support for the development and filing of G1 Therapeutics’ first NDA for Cosela™ (Trilaciclib). After a certification in US-RAC, Sathya started her regulatory career at Grifols followed by a position as Global Regulatory Affairs Lead at PPD. With a PhD in Biochemistry, she pursued a bench career as a scientist for a decade before moving into regulatory. 
9 _ "How to - IND gap analysis and requirements/filing an IND application" Investigational New Drug (IND) application is a request for authorization from the FDA to administer an investigational drug or biological product to humans. It is required for conducting clinical studies to collect safety and effectiveness information for new drugs or biologics that are not approved for marketing. This session discusses Non-clinical, CMC and Regulatory requirements for IND and how to identify any gaps and how to take help of FDA prior to submitting an IND. Prabodh Kandala has a PhD in Biomedical sciences and an executive MBA. He worked as a pre-clinical scientist in Academia focusing on oncology and then as a CMC product development scientist in Pharmaceutical Industry for over 7 years before becoming a regulatory strategist for past 4 years. Prabodh is currently Associate Director, Global Regulatory Affairs Solutions at Syneos Health.
10 _ "Mind the Gap - Early Identification of Issues for a Successful NDA or BLA" Completion of pivotal clinical trials is often viewed as the critical path item to submitting a marketing application to the FDA. Experience has shown that planning your marketing application should come long before completion of the pivotal clinical trials; in fact, investors will demand it.  A serious, methodical re-evaluation of the regulatory, clinical, nonclinical, and chemistry, manufacturing, and controls (CMC) development programs to assess NDA/BLA-readiness long before completion of the pivotal clinical studies is recommended. This re-evaluation will allow for early identification of issues and allow for more focused interactions with the FDA.  This table will discuss the benefits of a gap analysis as part of the planning process for a marketing application. While every marketing application is unique, specific advice pulled from regulatory experience with marketing applications will be discussed. Dr. Sheila Plant earned her Ph.D. in neurobiology from the University of North Carolina Chapel Hill and her master’s in health services from the Duke University Medical Center’s Clinical Research Training Program.  She was RAC (US) certified in 2011.    Dr. Plant has 20 years’ experience in biomedical sciences, including more than 12 years in clinical research. Her therapeutic areas of experience include oncology, dermatology (topical anti-infectives, antivirals, and analgesics), hematology (thrombocytopenia, transfusional iron overload), neurology (Alzheimer disease, multiple sclerosis, Down syndrome, ALS), endocrinology (diabetes, calcium deficiency, pancreatic enzyme replacement therapy), cerebrovascular (stroke), and cardiovascular research. Since joining Allucent, Dr. Plant has authored Food and Drug Administration (FDA) meeting packages, developed regulatory strategies, prepared for and attended multiple face-to-face meetings (including an oncology advisory committee meeting) with the FDA, and managed both Investigational New Drug application (IND) and New Drug Application (NDA) submissions to FDA, as well as Clinical Trial Application (CTA) submissions to Health Canada.   As Senior Director, Regulatory Affairs for the United States, she provides strategic leadership for the Regulatory Strategy department at Allucent. In addition, Dr. Plant has many project-level responsibilities, including writing and reviewing regulatory, clinical, and scientific documents; clinical trial management, pharmaceutical development, and regulatory project management; providing scientific consulting; and assisting with the preparation of business development proposals.  
11 _ "Regulatory Medical Writing: Who, What, and Why" What is regulatory medical writing? This table will discuss what regulatory medical writing is, who makes a good medical writer, and why we do it. 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! Nancy Gasper Smith, PhD, RAC, is the SVP of Medical Writing Services at Syner-G BioPharma Group, LLC.  Nancy has 15 years of regulatory medical writing experience, specializing in guiding small- to mid-size biotech/pharma companies to the finish line with their NDAs/MAAs. Syner-G’s medical writers author a variety of clinical documents across various therapeutic areas including, but not limited to, CSRs and protocols, integrated summaries, and Module 2 components (clinical overviews and clinical summaries).
12 _ "Briefing Document Development from a Medical Writer’s Perspective" Briefing documents are cross-functional strategic documents that support regulatory interactions with health authorities. This session will briefly cover the types of FDA meetings, the interconnectedness of the meeting request and briefing document, timeline considerations, important information to be gathered at the kickoff meeting, and development of the key content from a medical writing perspective.   Meagan is a clinical regulatory writer with nearly a decade of experience working in contract research organization and sponsor settings. In 2023, she launched into full-time medical writing consulting. As a consultant, she is leading clinical writing programs for sponsors and supporting authoring/development of key regulatory deliverables. Meagan works from home in rural NC (Wilson county) and is a mom of 3 kids (ages 7 years, 4 years, and 8 months).  
13 _ “Everything everywhere all at once - The European Commission's thicket of issues” There are several big legal texts going through the E.U. legislative process including the general pharmaceutical legislation which includes the proposed directive and regulation, the Substances of Human Origin (SoHO) regulation and the EMA fees regulation. We will talk about what types of legislative texts exist in the E.U., what changes these various proposed texts bring about in how biopharmaceuticals are regulated and discuss additional steps in the legislative process as well as the potential impact on the industry and our work. Kirsten Messmer, PhD, RAC is a Senior Research Analyst and contributes to the research and development of content for Agency IQ on regulatory issues for the United States and the European Union.  Prior to joining Agency IQ, she 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 Diplom from the Eberhard-Karls University (Tübingen, Germany). She also holds a Regulatory Affairs Certification (RAC) in US regulation.
14 _ “IVDR Transition – Marketing IVDs in the EU" The timelines for full IVDR compliance have been extended, so we can relax, right?  Wrong!   We will review the requirements of the IVDR including specifically:  -- Which requirements already apply for devices currently on the market.  -- Which devices must already be fully IVDR compliant. -- The timelines for full compliance of different device classes and recommended timelines for Notified Body application.      There will be an opportunity to “ask me anything” about IVDR implementation and Notified Body processes, so bring your questions. Stefan Burde, PhD is the Director, Global Focus Team IVD at TÜV SÜD, 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 9 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.
15 _ "Obtaining mentorship in clinical research" Join us for an engaging presentation on the invaluable role of mentorship in the field of clinical research. This session aims to shed light on the significance of mentorship, especially for aspiring researchers and professionals keen on excelling in the realm of clinical research. In this session, we will delve into the benefits of mentorship, share practical strategies for finding the right mentor, and emphasize why mentorship matters within the clinical research community. Alkka Johnson, Projects Manager, is a life science professional with both a PharmD and MBA degrees from Campbell University. With a diverse educational background in pharmacy and strong business acumen, Alkka brings a unique skill set to the role of Project Manager at Polaris.  Alkka  collaborates with the talented team at Polaris Compliance Consultants to exceed client expectations and deliver exceptional results. With a passion for excellence and a dedication to ensuring compliance, Alkka is enthusiastic to make a significant impact in the success of Polaris clients.