| Table |
Description |
Biosketch |
| 1_Sean Schofield, Thermo Fisher Scientific_ Competitive Landscapes in Regulatory Affairs |
Competitive landscapes in regulatory affairs are constantly evolving, driven by advancements in technology, changes in regulatory policies, and the dynamic nature of the pharmaceutical industry. Competitive landscapes include a diverse group of topics such as regulations and guidances, clinical trial development, and market share. This roundtable discussion will delve into strategies and best practices for navigating competitive landscapes. We will explore how companies can effectively manage regulatory challenges, leverage competitive intelligence, and stay ahead in a highly regulated environment. 1.Understand the Current Competitive Landscape by gaining insights into trends and developments in and identifying key factors influencing the competitive environment. 2.Navigate Regulatory Challenges by learning strategies for managing regulatory hurdles and exploring best practices for staying updated with changing regulations and policies. 3.Leverage Competitive Intelligence by evaluating the importance of competitive intelligence, learning methods for gathering and analyzing competitive data to inform strategic decisions, and discovering how innovation drives competitive advantage |
Sean Schofield is a seasoned regulatory affairs professional with over 12 years of experience in research, regulatory surveillance, and regulatory strategy for the development of medical products. With a deep understanding of the regulatory landscape and a proven track record in successfully navigating complex regulatory challenges, Sean has been instrumental in guiding companies through the intricacies of compliance and competitive strategy. Sean holds a Doctorate in Pharmacy and Master's in Clinical Research from Campbell University in Buies Creek, NC. He is a recognized expert in regulatory affairs, having contributed to numerous projects evaluating competitive landscapes of approved and investigational products. |
| 2_Rachel Rozakis, Allucent_Marketing Applications: Components of a Successful Submission |
This discussion will include an overview of marketing applications (NDAs and BLAs); what is included, why they are important, and the associated regulatory guidances. This talk will highlight Module 2.7.1 (Summary of Biopharmaceutic Studies and Associated Analytical Methods) and Module 2.7.2 (Summary of Clinical Pharmacology Studies), which are key sections that inform a large portion of approved drug labeling in a marketing application. This session will be suitable for beginner experience levels and will be valuable for participants looking to learn more about regulatory requirements of marketing applications. Marketing applications are a key component of the drug development process and are required for drug approval across the world. The learning objectives are: 1) Learn about what is included in marketing applications for drugs in development as well as various regulatory guidances that inform these applications 2) Learn the difference between 505(b)(1) and 505(b)(2) marketing applications and strategies for labeling and 3) Learn what is required to be included in Module 2.7.1 and Module 2.7.2 and how this information translates to drug labeling |
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. |
| 3_Edit Muhari-Stark, PedMed Consulting LLC_Regulatory challenges in global pediatric drug development |
would like to talk about the recent changes and future directions in pediatric drug development strategies at a global level (depth depending on participants' experience). Following this update, I would like to describe 1-2 case scenarios of challenging pediatric regulatory situations and their solutions (interactive, learning point regarding pediatric extrapolation). In the remaining time I would ask if participants have any challenging scenarios or questions to ask. |
Edit Muhari-Stark, MD, MS is an independent pediatric drug development consultant (PedMed Consulting) based in Chapel Hill, NC. Edit is a pediatrician by training with clinical experience in the UK (2005-2009). Subsequently she joined the MHRA Paediatric Unit in London and became an MHRA accredited medical assessor in 2013. In 2016, she received her ‘MSc in Paediatric Medicines Development and Evaluation' at the University of Rome Tor Vergata in Italy. The MSc program included a 4-month long research fellowship at the FDA Office of Clinical Pharmacology. Edit relocated to the Triangle area in 2016 and started working at the industry side of pediatric drug development initially as a consultant, then as director of pediatric regulatory strategy at BioCryst Pharmaceuticals (2019-2023). She also highly values the importance of pediatric research networks and serves as a board member of MCRN Hungary. Outside of work Edit loves to travel and to spend time with her family. |
| 4_Scott Kelly_Scott Kelly Consulting, Inc._Certain uncertainty in early development: How to Sherpa well in an ill-defined environment |
Early clinical development offers ambiguity, excitement and angst. How can you use your skill set to help your team major on the majors and minor on the minors as you take those first steps? Takeaways: -Soft skills can I contribute ALONG with my professional skill set -Translating and connecting concepts and people -Creating cohesion & continuity on the project -Developing targets: Asset and aspirations |
Transitioned from private practice as a Clinical Psychologist in 2002 to Clinical Research. Established SKC in 2012 to become a Consultant. Has been on Sponsor teams that have received 4 Health Authority approvals (2 whilst consulting). Enjoys the freedom of choosing projects and providing non-technical insights in a technical development industry. Sherpa to wife who completed Kona Ironman in 2023 and will compete in the half-IronMan in Nice, France in Sept 2026! |
| 5_Sherry James, PMP_Phoenix Speaks, Inc._#IAmAI: Augmented Innovation Isn't Always Ethical |
This roundtable discussion will delve into the the ethical implications of using technology platforms to train the next generation of leaders in bio tech, medicine, and other human-centered professions. We will discuss Carl Jung's "The Red Book" to re-evaluate how we develop AI training models and platforms. |
Sherry James, PMP: Creating The Next Generation of Leaders via CBT, ML and AI Since 1999 |
| 6_Meredith Earl_CSL Sequirus_Navigating Updated EMA framework for CMC Variations |
What will be discussed - updates to EMA framework regarding CMC variations: Type IA Annual Reporting, EMA guidance for worksharing of CMC variations (Type IB and Type II), and Key aspects of the revised Variation Regulation. This discussion will be valuable for anyone involved with submitting CMC variations to EMA. This topic is timely as the Type IA annual report and worksharing guidances have been recently introduced and the revised variation regulation goes into effect 15Jan2026. |
Meredith holds both a Bachelor of Science and a Ph.D. in Chemistry. She spent ten years as a formulation scientist at Liquidia Technologies, where she gained extensive experience in drug development and delivery systems. Currently serving as a Senior Manager in Regulatory Affairs CMC at CSL Seqirus, Meredith began her tenure with the company as a Regulatory Affairs CMC Project Manager. Her work primarily focuses on the preparation and submission of post-approval CMC packages for influenza vaccines. She has successfully led submissions to multiple global health authorities, including the FDA, EMA, Health Canada, and the TGA. |
| 7_Anil Kumar Dudam_WuXi Apptec_Authoring CMC Modules 2 and 3 for IND Submissions: Regulatory Expectations and Best Practices |
are critical to demonstrating product quality, safety, and consistency. This round table will focus on practical strategies for authoring clear, compliant, and reviewer-friendly Module 2 (Quality Overall Summary) and Module 3 (Quality) content. We will discuss how to: Translate complex technical data into concise summaries for Module 2. Structure Module 3 to meet FDA and ICH requirements while ensuring data traceability. Anticipate regulatory questions through strategic content organization. Address common pitfalls and reviewer feedback from early-phase submissions. Participants will share experiences, challenges, and tips for aligning scientific detail with regulatory expectations, ensuring a smooth IND review process. |
Anil Dudam is a CMC Regulatory Affairs professional with over 12 years of experience across small molecules, peptides, oligonucleotides, ADCs, and biologics. He specializes in authoring and reviewing CMC sections for INDs, NDAs, BLAs, and global post-approval submissions, with deep expertise in Modules 2 and 3. His background includes developing global regulatory strategies, ensuring compliance with FDA, EMA, and other health authority guidelines, and leading in-house regulatory operations for publishing and submissions. He is known for translating complex scientific data into clear, compliant regulatory content that facilitates efficient health authority review. |
| 8_Kirsten Messmer_KM Intel LLC_Trend spotting - Using regulatory intelligence to identify impactful events and updates |
The regulatory landscape is constantly changing - new regulations, new guidelines, updates to laws all can implement new requirements. However, sometimes “some events†can initiate the need for swift adaptation and implementation of changes to product development. Thinking back a few years, a new virus brought international healthcare systems to a breaking point and significantly impacted clinical trials limiting patient access to trial sites and closing of international borders (particularly in the EU). This led to an increasing focus and acceptance of decentralized trials. But furthermore, there are many “rumblings†in regulatory intelligence updates for which the impact is not yet apparent - think of changes to animal research requirements, EU legislation, artificial intelligence use etc. just to name a few. During the dinner we'll discuss how to screen regulatory updates and identify any key changes that could result in a major impact on regulatory activities. These are the trends to watch. We'll discuss what you've noticed and how it might impact the regulatory landscape, potential timing and how to communicate these observations throughout the applicable teams. |
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 for AgencyIQ on regulatory issues affecting the bio-/pharmaceutical industry in the US and Europe. Before that, 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. Kirsten has held additional positions in university and biotechnology research and has 14+ years' experience in regulatory affairs with a particular focus on regulatory intelligence. Kirsten received her PhD in Neuroscience from the University of Sheffield (Sheffield, UK), a Biology Diploma from the Eberhard-Karls University (Tübingen, Germany) and holds a Regulatory Affairs Certification (RAC) in US regulation. |
| 9_Matthew Barnes_Praecur Consulting Services_Regulatory Perspectives on Quality by Design: What Regulators Really Expect |
Quality by Design as a concept has been part of ICH guidelines for several years but companies can still struggle to successfully implement QbD into their clinical programs. This Round table will look at the history of QbD, why it was introduced, and some common misconceptions teams may have about it. |
Matthew Barnes is a clinical researcher and drug development professional with three decades of experience providing operational oversight and support for drug development programs. He has extensive experience managing large multi-functional teams and providing end-to-end program management for all phases of clinical trials. Throughout his career in the biotech industry, he has provided delivery of proactive program management strategies in collaboration with senior leaders and global business partners to enable successful product launches and optimization of product-life cycles. He has held senior roles in pharmaceutical and biotechnology companies as well as in Clinical Research Organizations. He most recently held a senior position at Virpax Pharmaceuticals leading all of the operational activities for the company's pre-clinical programs. He holds a Bachelor of Science in Biology from Virginia Polytechnic Institute and State University. |
| 10_Kelly Hibbard_ pharma&_The Remote Regulatory Assessment |
After submitting an sNDA, we found ourselves with an invitation to participate in a Remote Regulatory Assessment instead of a BIMO inspection. We had a June 2025 RRA Guidance and nothing else to prepare. If it's of interest, I can give an overview of how it works, how to organize thousands of documents for upload, and other tips. I would definitely include printouts. |
15 years between Reg Affairs and Reg Ops for a sponsor, an NIH CRO, and currently a small Austrian company. |
| 11_Preeta Chugha_Johnson & Johnson_Leadership Skills for Regulatory Medical Writers |
The discussion will focus on behaviors that enhance your ability to influence your teams. We will discuss how medical writers bring value to regulatory documents and which skills you can develeop to demonstrate your value to your teams. |
Preeti Chugha, PhD has 11 years of experience in Regulatory Medical Writing and is currently a manager at Johnson & Johnson. She has experience working in academic research centers, CROs and pharmaceutical companies. She also has a certificate in project management. |
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| 13_Brant Hamel_Sanofi_Get with "the Program" - the review process for NME NDAs and Original BLAs |
Your drug has undergone years of scientific research, preclinical studies, and Phase 1 through Phase 3 trials to reach the final hurdle before approval - FDA review of your NDA or BLA. We will explore what FDA's review of new molecular entity NDAs and Original BLAs (i.e. "the Program") looks like in terms of timelines, interactions, and Sponsor strategies to successfully complete the review process. What unexpected twists and turns may await you as you navigate "the Program"? |
Brant Hamel received his PhD from the Department of Biochemistry and Biophysics at UNC Chapel Hill and completed postdoctoral research at the National Institute of Environmental Health Sciences. He has held regulatory positions at Duke Cancer Institute, Cato Research, Humacyte, Chiesi, and Sanofi where he is currently a Director of Regulatory Affairs. He has worked with both small molecules and biologics across diverse therapeutic areas and at all stages of development including the submission and review process for BLA and NDAs. |
| 14_Stefan Burde_IVDR Solutions_ISO 13485 - Your Gateway to US and EU Markets |
ISO 13485 is the international quality management systems standard for medical devices. With FDA's inclusion of the standard by reference into the Quality Management System Regulation, it becomes the de facto roadmap for medical device quality management systems on both sides of the Atlantic. In this session, we will review the key provisions of the standard, discuss differences of application among different jurisdictions, and provide some practical tips for implementation. |
Stefan Burde, PhD is the founder and principal consultant of IVDR Solutions, a regulatory consultancy focused exclusively on helping IVD manufacturers master the CE-marking process. 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. |
| 15_Cari Kessing_GSK_Analytical Strategy for Regulatory filing in Vaccine and Pharmaceutical Manufacturing |
The discussion will center on global regulatory strategies for analytical and quality control (QC) testing, as well as batch release processes. Key topics include best practices and effective strategies for developing analytical approaches, determining optimal timing for filing backup sites, and exploring the commonality of utilizing both internal and external testing facilities. Additionally, the conversation will address how regulatory authorities handle Mutual Recognition Agreements (MRAs) between countries to streamline data release and avoid redundant testing. The dialogue will also explore innovative approaches to QC testing while navigating regulatory challenges, such as implementing real-time release testing, recombinant Factor C (rFC) testing, and incorporating sustainability measures. The overarching goal of the discussion is to identify and highlight best practices for regulatory submissions related to analytical testing in the manufacturing of vaccines and pharmaceuticals. |
With 18 years of experience in immunology, vaccine, and infectious disease research. I currently serve as Senior Director of Global Supply Chain Analytical Strategy at GlaxoSmithKline (GSK). My career spans vaccine clinical trial testing, technical R&D, and lab operations management, overseeing teams of 150+ scientists and supporting 20+ clinical trials. I specialize in project management, lab operations, troubleshooting, communication, and networking, with a focus on optimizing vaccine supply chains. My long-term goal is to advance into business and liaison roles that drive innovation in vaccine research and production. |
| 16_Sathya Ganesan_UCB_Regulatory Acceleration in Neurodegeneration: New Standards, New Signals |
This roundtable will explore the evolving regulatory landscape of accelerated approvals in neurodegenerative diseases, with a focus on Alzheimer's Disease (AD) and Amyotrophic Lateral Sclerosis (ALS). The session will begin with a brief overview of key changes introduced by the Food and Drug Omnibus Reform Act (FDORA), including FDA's new authority to require confirmatory trials be underway at the time of approval and its expedited withdrawal procedures. We will highlight recent case studies from AD and ALS that illustrate how sponsors and regulators are navigating these reforms- lessons learned, regulatory flexibility, and implications for future applications for registrations. The discussion will be framed to support regulatory science leaders in interpreting FDA's evolving expectations and shaping strategic development plans. |
Sathya Ganesan, PhD, RAC (US) is a Regulatory Science Lead at UCB with over 15 years of industry experience, including a decade in regulatory strategy across oncology, neurology, and rare diseases. She has led multiple IND and CTA filings, FDA interactions, and expedited development programs, including recent work in Alzheimer's and Parkinson's disease. A committed mentor and educator, Sathya served on the executive board of the North Carolina Regulatory Affairs Forum and is actively involved in professional development initiatives through Women-in-Leadership and Healthcare Businesswomen's Association. |
