Table # and Topic

Description

Speaker & Bio

 14 _ "De-Risk Submissions: Increase your IQ for Right 1st Time Submissions"

Khyati Desai and Mayra Marquez

 This session will discuss quality and regulatory challenges during drug development process and continuous improvement to ensure right 1^st time submissions. Depending on a phase of program, manufacturers can take various steps such as the use of sources of regulatory intelligence, risk assessments and implement various process improvements in place to navigate inspections and regulatory submission processes for subsequent submissions.

Khyati Desai PharmD, MS, RPh is an Associate Director with 9 years of regulatory CMC submission experience across small and large molecules. Khyati has started her career in quality control followed by academic research and a fellowship. She has worked across all phases of programs. In her current role, she leads regulatory CMC strategy as well as authoring of Module 2 and 3 documents for global IND/CTA and BLA submissions. Khyati has led various initiatives within CMC to use regulatory intelligence sources to improve quality of regulatory submissions and contributed to cross functional initiatives for process improvement and data integrity.

Mayra Marquez, BSIE, MBA, LSSMBB serves as the Chief Operating Officer for LaSalle Group International. Holds over 25 years of experience leading local, regional, and global roles in continuous improvement, business consulting, business strategy and transformation, project management, Business Process Management (BPM), Supply Chain, Manufacturing, Change Management and Diversity, Equity and Inclusion. She has broad and dynamic Fortune 500 experience in Medical Device, Pharma, Healthcare, Biotech, Gene Cell Therapy, Energy, and Fashion.

As part of continuous improvement, business transformation and BPM, Mayra led process improvements and transformations for most of the phases of drug development, focused on process quality, compliance, agility, and competitiveness.

 13 _ Regulatory Considerations in Development of  Ophthalmic Products (and other localized delivery routes)

Olu Aloba

 This discussion will cover general regulatory considerations for ophthalmics drug development and especially focus on what makes FDA regulatory requirements for ophthalmics different from those for other types of new drugs. This topic will be of interest to those involved in or curious about regulatory and development strategy and preparing or supporting regulatory submissions for ophthalmics.  Applicablity of these considerations to other similarly localized routes of administration (e.g. otic, dermal, vaginal) will also be discussed.

 Olu Aloba, PhD, is Vice President of CMC services at Premier Consulting, a division of Premier Research. He has more than 30 years’ experience in pharmaceutical development and more than 10 years as a consulting regulatory strategist and CMC subject matter expert. He has been the

pharmaceutical development and regulatory strategist for more than 200 development programs and more than 50 NDAs and investigational and abbreviated new drug applications including small molecules, biologics, and combination products. He has published and presented widely on drug development regulatory topics and is a co-author of the 2023 RAPS article of the year.

 12_Cell and Gene Therapy Regulatory Affairs: Applying Recent FDA Guidance

Scott Burger

 This roundtable will discuss content and application of recent CGT-related FDA guidance.  These include CGT-specific guidance on potency assurance strategies, development of CAR-T cell and gene-edited products, safety testing of ex vivo expanded allogeneic cells, and use of human-and animal-derived materials in manufacturing CGTs and tissue-engineered products.  In addition, the session will address common causes of regulatory problems with CGT products and how to avoid them. 

Scott R. Burger, MD, is the founder and principal of Advanced Cell and Gene Therapy, a consulting firm specializing in cell and gene therapy product development, providing expertise on regulatory, GMP manufacturing, and strategic aspects of these products. With over 30 years of experience, Dr. Burger has consulted for over 200 companies across North America, Europe, Australia, and Asia, advising on a wide range of CGT products for immunotherapy and regenerative medicine at all stages of development.  Dr. Burger has consulted on over 100 regulatory submissions for CGT products, has been an invited speaker at internal FDA workshops, and has served on the USP Cell, Gene and Tissue Therapies Expert Committee. 

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.

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.

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

Prem Narang

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 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.

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

Michael Lance

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 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.

4 _ “Tip and tricks for uncomplicated collaborative authoring"

Meagan Eldridge

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 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.

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

Stephanie Byrd

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

Stefan Burde

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1 _ "Transitioning to a Career in Regulatory Affairs"Linda Bowen

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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.