As the head of Innovation and Digital Health, Gaelan Ritter and his team are responsible for creating and developing innovations across BMS. He co-leads the BMS digital innovation pillar for global drug development, which is enabling a spectrum of digital solutions, including several types of digital trial capabilities.

Mr Ritter is an industry leader in the development and infusion of digital innovation solutions to enable optimization of pharma drug development. In past roles Mr Ritter has led and developed strategic partnerships with large academic medical centers and networks. He has also supported trial design and start-up for the BMS oncology and immunology programs. This experience led him to develop industry leading trial design software and processes that create digital protocols and feed downstream systems and processes. He is passionate about not only the ideation and creation, but the development and business change that creates lasting advancement in the industry. Mr Ritter holds an MBA from Temple University along with MS in human physiology and biophysics from Georgetown.

Gayle Wittenberg is VP and Head of Neuroscience Data Science and Digital Health at Janssen R&D, focused on embedding data science and digital health to add value to the pipeline end-to-end across the Neuroscience portfolio. She and her team leverage molecular data, deep phenotyping, digital health and real-world data to enable decision-making and solution development for Neuroscience compounds from target identification to product launch.

Dr Wittenberg has over 15 years of experience across the pharmaceutical and diagnostics industries, driving data science research into products. Dr Wittenberg joined Janssen Neuroscience in 2011 as Director, Integrative Solutions and Informatics. She founded and was Head of Translational Research and Precision Medicine, Research IT in 2016. She created and led the Intelligent Automation team in Pharm IT in 2019, before moving back to the NS TA as Senior Director, Neuroscience Data Science. Prior to Janssen, Dr Wittenberg was Head of Personalized Healthcare, at Siemens. She earned her doctorate linking Computational and Experimental Neuroscience at Princeton University in 2003.

Chloe is a researcher and creative based in Manchester, UK. She specializes in qualitative and collaborative projects dedicated to amplifying the voices of people often underserved by research. With over 5 of years industry experience, Chloe's expertise spans diversity, inclusion, and intersectionality in research across sectors including healthcare, social, and consumer. She is an experienced facilitator in community-based participatory research methods, such as co-creation and co-design, with underserved communities including patients, LGBTQ+ people, and those tackling sensitive health issues like addiction, chronic illness and medical mistrust. Chloe loves speaking with and learning from experts by experience and is passionate about embedding inclusivity in her work to achieve more equitable health outcomes for everybody.

Stacey Bledsoe, RN, MSN joined Gilead Sciences in July 2023 as the new Head of Global Clinical Trial Diversity and Inclusion. Stacey will be responsible for leading the effort to increase the diversity of Gilead’s clinical trials across the portfolio while bolstering Gilead’s stance to understand how treatments affect all the populations. Stacey has over 20 years of experience in the pharmaceutical industry across multiple disciplines including Research & Development, Global Health Outcomes, Medical and Six Sigma.

Prior to joining Gilead Stacey spent over 20 years at Eli Lilly & Co where she had a demonstrated success in Six Sigma methodology, Health Outcomes research, medical information, and the hospital payer environment. She recently led Lilly’s diversity and trials initiatives across the portfolio through partnerships and internal and external collaboration, earning the company a rating of Gold. She has shared her enthusiasm and passion for driving the industry’s path toward more diverse clinical trial access and inclusion by engaging in national boards, speaking at multiple conferences, interviews, and publications. She also created and built the Lilly Global Medical Outreach Program, which used medical professional working at Lilly to provide medical services to underserved communities in countries such as Africa, Greece, and South America.

Stacey’s passion for patients and emphasis on serving the most vulnerable began before she entered the pharmaceutical industry. She held a Registered Nurse role on the Level III Newborn Intensive Care Unit at Riley Hospital for Children. Stacey earned her Bachelor and Master of Science of Science in Nursing from Indiana University. Stacey is driven by a goal to influence and ensure all patients have the same access to clinical research and life changing medications that will ultimately improve their lives. Stacey resides in Indianapolis, Indiana with her husband of 22 years, three daughters with one at her alma mater Indiana University, and Yorkie, Sam.

Mary Brantner is Sr. Director, Head of Clinical Program Optimization and Innovation at Insmed Inc. In her role, she identifies opportunities to leverage technology to streamline and optimize conduct of clinical trials. She has 35 years of experience in the Pharmaceutical and Device Industry, having worked at Daiichi Sankyo, Mallinckrodt, and Becton Dickinson before joining Insmed. Her recent roles have been in the Global Development Operations and Process and Systems area. She has overseen Global Development Operations functions that include Clinical Operations, TMF Operations, Process Excellence and Training, Clinical Trial Disclosure and Transparency, Clinical Systems, and Medical Writing. One of her current responsibilities at Insmed is supporting the Insmed Google Cloud partnership as a business owner representing Development Operations on various workstreams.

Dr Mike Lu is the Head of Clinical Design & Data, Gilead Design & Innovation. Prior to joining Gilead, Dr Lu held multiple oncology product development roles at Genentech: RWD Platform Strategy Leader; Clinical Strategy Leader, and senior clinical scientist where he served as the lead clinical scientist on the Kadcyla global filing team. Additionally, he has held various clinical development roles at Exelixis, BMS, and Novartis in multiple therapeutic areas.

Paul Evans, PhD has worked in the pharmaceutical industry for over 30 years. He is currently President and CEO of Velocity Clinical Research, which owns and operates investigator sites across multiple therapeutic areas in the US and Europe. From a private equity start-up in 2018 Velocity has grown to be the largest SMO (Site Management Organisation) in the world under Dr Evans’s leadership and is focused on solving the delays caused by the inherent inefficiencies of the clinical research process. This was particularly critical during Operation Warp Speed to develop the COVID19 vaccines in which Velocity contributed more patients than any other organization.

He started his career establishing and managing research sites in the UK and was a founder of one of the first European SMOs. Dr Evans joined the CRO sector in 2005 building global site networks that partnered strategically rather than being selected tactically by the CRO and continued to work on innovative patient recruitment campaigns in some of the most challenging environments across all continents. In two of the world’s largest CROs he has led global functions that have included site intelligence, study start-up, feasibility, site contracting, patient recruitment and Investigator payments. Few people have had the opportunity to spend so much of their careers working both on the investigator and sponsor sides of the GCP divide and this breadth of experience gives him a unique insight into the challenges faced by the drug development industry.

Susan Budinger started her research career at Duke in 1991, soon after her graduation as a proud Blue Devil. During the next 2 decades in oncology cooperative group research, she delighted in identifying research design and process pain points and exploring ways to address them, with the goal of improving the lives of researchers and participants. In 2013, she joined the Duke Office of Clinical Research to promote centralized research support, programs and policies designed to assist and guide the Duke research community. As Director of Research Operations, she leads a team of exceptional project managers and collaborates with other administrative offices to create and manage pathways into clinical research careers for students and interns.

Joan Chambers is a senior consultant advising research projects and the Center’s membership programs. She brings more than 30 years of senior management experience — across a variety of strategic and operating roles - in the life sciences industry. Joan serves on a number of boards and committees including US PharmaTimes, Citeline Awards, the Pharmaceutical Business Conference Group, and One Rare. Ms Chambers is an active member of the Drug Information Association (DIA), has published extensively in trade journals, and is a frequent speaker at industry conferences.

TBA

Rachel Sher is a prominent Food and Drug Administration (FDA) regulatory leader with sophisticated experience in policy and legislative strategy who helps support life sciences companies as they navigate the broader FDA regulatory process across all stages of a product’s life cycle.

With nearly 20 years of experience in the health policy space, specifically in the pharmaceutical and medical device arenas, Rachel provides a multifaceted approach to solving issues clients face in the medical products area, advising on compliance with the many complex legal and regulatory requirements governing successful product review, launch and marketing. She also helps clients facing serious challenges in this process consider a subsequent or corresponding legislative strategy to advance any additional needs surrounding their development programs.

Rachel previously served as the Vice President of Policy and Regulatory Affairs for the National Organization for Rare Disorders (NORD), where she led its federal policy and regulatory work with respect to the FDA and other federal agencies, as well as on Capitol Hill and in the states. Sher also served as Deputy General Counsel at the Association for Accessible Medicines (AAM), where she helped oversee the AAM’s legal affairs, including the review of advocacy and policy statements. Prior to her time at AAM, Sher worked in the Commissioner’s Office at the FDA where she led the agency’s engagement on the 21st Century Cures Act legislative process, which involved working directly with FDA leadership and medical product centers to give strategic advice and guidance. Prior to heading to the FDA, Rachel spent ten years on Capitol Hill working as FDA Counsel for the Committee on Energy and Commerce, where she had the rare opportunity to oversee the entire FDA-related portfolio, drafting and negotiating all major FDA legislation enacted during her tenure.

Dennis Salotti is an accomplished executive with two decades of experience in clinical research. Currently serving as the Executive Director & Head of Clinical Outsourcing & Innovation at Jazz Pharmaceuticals, he oversees strategic initiatives within sourcing that foster innovation in clinical trial management. His leadership has been instrumental in driving efficiency and quality in outsourcing practices, ensuring external relationships and solutions drive value for the business.

Prior to his role at Jazz Pharmaceuticals, Mr Salotti held several senior positions at notable organizations including serving as Chief Operating Officer for The Avoca Group, where he spearheaded operational strategies, contributing to the company's growth and success. His tenure saw significant advancements in various areas of quality and compliance, including innovative approaches to vendor qualification processes, and the creation of the Diligent Pharma platform.

Mr Salotti’s commitment to advancing clinical research extends beyond his corporate roles. He serves as Adjunct Faculty at Drexel University College of Medicine, where he shares his expertise with future industry professionals. With a Master of Business Administration from NJIT and a Master of Science in Clinical Research Organization Management from Drexel University, Mr Salotti combines academic rigor with practical experience to drive innovation and excellence in the pharmaceutical industry. Throughout his career, Mr Salotti has demonstrated exceptional leadership and strategic vision, earning him recognition such as Drexel University's 40 under 40 award and the Professor's Excellence Award from New Jersey Institute of Technology