Speakers

Mackenzie Abramson, MPH, CPH, CHES, is a rare and chronic disease patient dedicated to advocacy for herself and all patients alike. Diagnosed in her mid 20s, she dove headfirst into higher education so that she could bridge the gap between public health and rare disease. Ms Abramson spent hours learning the art of self-advocacy in environments where it seemed like her diagnosis odyssey would never end. Ms Abramson’s journey led her to spend years advocating for herself and others on an International Scale. She found her community through participating in and speaking publicly about her journey at events with patient advocacy organizations such as Global Genes, NORD, EDS Society, NIH Rare Disease Day and more. Ms Abramson shares her story, offering insights into how she learned to navigate the challenges that came along with a rare diagnosis, hoping it will empower others facing similar situations.

Fueling her passion, Ms Abramson pursued and completed a Masters in Public Health, driven by the desire to convert her personal experience and dedication to rare disease research and advocacy into a career. Today, she is deeply entrenched in the rare disease research space, dedicating my time to supporting patients, caregivers, families, and friends impacted by rare and chronic diseases.

Jillian Agnew, RN, CCRC, is the Senior Clinical Research Nurse at St. Johns Center for Clinical Research in St. Augustine, Florida. She received her Certification in Clinical Research (CCRC) in 2021 and is currently the lead study nurse for all cardiovascular trials at her site.

Prior to research, Ms Agnew worked in multiple areas of nursing including Emergency, Home Health, Public Health and Trauma Critical Care at the University of Maryland R. Adams Cowley Shock Trauma Center in Baltimore, Maryland. Critical care will always be near and dear to her heart, but research has quickly become her favorite kind of nursing. “I really enjoy the relationships I develop with my research patients. I love seeing pictures of their kids, grandchildren, pets, etc. It shows how much they appreciate the amount of time you are investing in them. I also love that I have a career that brings me so much job satisfaction. Every day, I feel like I am making a difference and working towards a larger goal for the greater good.”

Outside of work, Ms Agnew and her family enjoy geocaching, game nights with friends and spending time at the beach.

Adrelia Allen, PharmD, is a 22-year veteran of the pharmaceutical industry working in sales and clinical research at Merck. She has held positions of increasing experience as a Clinical Research Associate, Clinical Trial Project Manager, and Clinical Research Manager (CRM). She is currently the Executive Director of Clinical Trial Patient Diversity, where she is responsible for the strategy and execution of activities for the diverse representation of patients in clinical trials. Dr Allen has a Doctor of Pharmacy degree from Florida A&M University College of Pharmacy.

As Director of Operational Design & Patient Engagement within Global Development Operations at Amgen, Tracy Artim, MSN, CRNP, leads an amazing group who focuses on bringing the patient and caregiver voice into clinical trial design. This allows Amgen study teams across therapeutic areas to develop trials that have reduced burden, and which meet the needs of diverse groups of patients. Ms Artim focuses on building capabilities within the function and demonstrating value of Patient Engagement to Senior Leadership which has led to year-over-year growth.

Prior to entering the pharmaceutical/biotechnology industry, Ms Artim practiced as a Nurse Practitioner. She obtained her Master of Science in Nursing from the University of Pittsburgh and her Bachelor of Science in Nursing from Duquesne University.

Annlouise R. Assaf, PhD, is a pharmaco-epidemiologist who is a Senior Director, Patient Health Activation Expert, Global Medical Patient Impact Assessment (GMPIA) within Worldwide Medical and Safety at Pfizer. In Dr Assaf's role she partners to evolve the science and practice of quality benefit risk communication. This focus allows for the improvement of patient health activation and equity and the optimization of patient-facing health content so that patients can make informed shared decisions about their treatment with their healthcare providers, use their medications safely and appropriately, and improve value outcomes. Prior to joining Pfizer, she spent many years in academic medicine and clinical research. She received her doctorate from Roswell Park Cancer Institute at the State University of New York at Buffalo, and is currently a Professor (Adjunct) at Brown University School of Public Health and the University of Massachusetts School of Medicine.

As Director of Clinical Research at The Michael J. Fox Foundation (MJFF), Eda Baykal-Caglar, PhD, focuses on advancing the Foundation's patient-centric mission through patient engagement in research to accelerate progress toward a cure for Parkinson's Disease. She leads MJFF's patient engagement team that forges partnerships with patients, research volunteers, industry and academic scientists, and the online smart-match tool Fox Trial Finder to increase the flow of participants into Parkinson's disease clinical trials.

Dr Baykal-Caglar started her career as a physicist but driven by her interest in creating an impact through science to advance community health, patient advocacy, and education, she switched careers to work in nonprofits and healthcare. She holds a PhD in Physics and an MS in Biotechnology and Physics Education. In her free time, she enjoys hiking, listening to podcasts, reading, and traveling with her husband and daughter.

Jimmy Bechtel is the Society for Clinical Research Sites’ (SCRS) Vice President, Site Engagement. He brings experience from both the site and sponsor sides of the clinical research industry to his critical role with SCRS. Mr Bechtel provided a variety of support within the site spectrum in previous positions as data specialist, patient recruiter and operations manager. On the pharma side where he worked in innovation project management, Mr Bechtel utilized his previous professional experience to encourage a site-centric environment and create ease for sites working with a major sponsor company. This multifaceted background allows Mr Bechtel to bring a unique perspective to the work he does on behalf of the sites. At SCRS, Mr Bechtel is in charge of developing and executing the company’s site-facing initiatives, and works closely with key industry partners to build out various SCRS partnership programs. He also manages some of SCRS’s large industry initiatives that are based on innovative concepts and helps oversee the organization’s membership.

To be announced

Robyn Bent, RN, is the director of CDER’s Patient-Focused Drug Development (PFDD) Program, an effort to systematically obtain patient input and facilitate the incorporation of meaningful patient input into drug development and regulatory decision making. Prior to joining FDA, Ms Bent was a Chief Scientific Program Specialist at the National Institutes of Health. She has extensive experience in clinical trial design, conduct and oversight. Ms Bent earned a Bachelor of Science in Nursing from The Catholic University of America and a Master of Science degree from George Washington University.

Angela Bilkhu joined Roche Canada in 2018 where she was a Senior Manager with the Federal Government Relations and Policy Team. She focused on delivering innovative strategies and plans that established a favorable policy environment for Roche’s pipeline specialty molecules. In this role, Ms Bilkhu worked to support policy and access priorities in rare diseases, oncology and neurosciences, building meaningful relationships with key stakeholders, including patients, caregivers and patient organizations to embed their voice into Roche Canada’s policy strategies and tools. In 2020, Ms Bilkhu joined the Global Patient Partnership Team to assume a newly created role focussed on patient-centric research and development activities in the solid tumor space. Ms Bilkhu worked closely with Roche-Genentech’s Product Development teams and the patient community to ensure Roche’s research and development activities are patient inclusive. Ms Bilkhu is looking forward to continuing these efforts in the hematology space and as the Global Patient Networks R&D Community of Practice Lead.

Meghan Blair, MS, CIP, is the Associate Director for Regulatory Affairs in the [Medical Oncology/CAR-T] Clinical Research Unit of the Abramson Cancer Center. In her role, Ms Blair is responsible to lead a team of Regulatory Affairs Professionals in providing clinical trial support associated with ensuring compliance with local, state and federal regulations governing review and reporting for human subject research. Her leadership attributes include ensuring clear expectations for professional and service-oriented performance, providing the necessary training and tools to ensure success both individually and as a team, and following performance using quantitative metrics. She values accountability, responsibility and transparent communication as fundamental factors that determine the success of her team. Ms Blair serves as a key opinion leader and subject matter expert as related to interpretation and application of regulation to the day-to-day clinical trial operations. Her passion for streamlining process to reduce regulatory burden and improve efficiency in the maintenance of required essential regulatory documentation is paramount. Ms Blair has defined best practice for the creation and maintenance of electronic regulatory investigator site files for the ACC leveraging the new technology, SiteVault. Outside of work, Ms Blair enjoys gardening, reading and watching the birds from her deck.

Kai Bode is a Principle Scientist at Merck Research Laboratories (MRL). In his role, Mr Bode supports the evaluation and implementation of digital health technologies for clinical research in an effort to mitigate the risk and maximize the potential of innovative solutions.

Eucharia Borden, MSW, LCSW, OSW-C, FAOSWis the Vice President of Programs and Health Equity at Family Reach. In this newly created role, Ms Borden oversees the organization’s program development and delivery. This includes the expansion of Family Reach’s Cancer Equity Initiative, focused on meeting the needs of the most under-resourced and financially vulnerable populations in the cancer community.

Ms Borden has dedicated the last 16 years of her career to the oncology field, working in patient advocacy and direct social work practice within acute inpatient and outpatient hospital settings. She is a past President of the Association of Oncology Social Work and a recognized AOSW Fellow.

In her previous role as Vice President, Health Equity, at Cancer Support Community, Ms Borden was responsible for ensuring that CSC headquarters’ research, program, policy, and operations integrated relevant components of health equity, inclusion, and social determinants of health across all activities. Her steadfast commitment to ensuring all patients — regardless of race or socioeconomic status — have access to life-saving care has positioned her as a sought-after thought leader within the healthcare community. She has earned national media attention for her work and expertise in this space, including a Survivorship Today interview with award-winning actor and advocate Sterling K Brown and a leading spot in the “In Her Shoes” campaign hosted by Bristol Myers Squibb.

As Vice President, Programs and Health Equity, at Family Reach, Ms Borden is responsible for strategic growth, innovation, and program implementation. Working alongside Famly Reach's internal team and external partners, Ms Borden will ensure Family Reach deepens and broadens its impact on families facing cancer nationwide.

Vanessa Boulanger brings over 15 years of experience to her role as Director of Patient Engagement at Boehringer Ingelheim, where she is responsible for advancing patient engagement strategies and expanding cross-functional capabilities to operationalize the science of patient input. Previously, Ms Boulanger served as Executive Director of Strategic Partnerships at the Amyloidosis Research Consortium (ARC) where she worked at the intersection of research, strategy, and community engagement to reimagine how cross-stakeholder collaboration can advance equitable science and targeted impacts on behalf of patients. Prior to ARC, Ms Boulanger was the Director of Research at the National Organization for Rare Disorders (NORD) where her work focused on the needs of the rare disease community and the fit-for-purpose use of data. Ms Boulanger holds an MSc in Global Health and Population from the Harvard T.H. Chan School of Public Health and she currently serves as a member of the AcademyHealth Disparities Interest Group.

Jessica Brescher, MPH, has almost 20 years of clinical trial experience in pharmaceuticals and medical devices. At Bristol Myers Squibb, in addition to being a Sr Clinical Scientist, she co-leads an initiative to allow patients to self-identify their sexual orientation, gender identity and intersex status in their clinical trials. Ms Brescher is also a Doctoral Student at Drexel University, where her research focus is the ethical inclusion of sexual and gender diverse patients in clinical research. Her commitment to diversity and representation as a moral imperative underlies the passion she brings to all her work.

Nicholas Brooke is the Founder and Executive Director of The Synergist, an incubator and managing organization to multi-stakeholder platforms that brings key players together with the express aim of solving significant societal problems through collective actions. The Synergist also helps individual organizations to build the capacity and capability to better engage with key stakeholders in partnerships to solve societal issues.

Under Mr Brooke’s leadership, The Synergist acts as a backbone, providing vision, strategy, stakeholder alignment and execution on multiple international, multi-stakeholder programs. Bringing his Synergist and caregiver hats together, he is the Executive Director of PFMD.org, a pre-competitive multi-stakeholder global collaborative platform dedicated to stimulating innovation in medicine and device lifecycles, digital health and health system through systematic patient engagement, WITH patients.

Mr Brooke is Economist by training and was previously CEO of an award-winning digital agency, providing cutting-edge digital strategy to global corporations across multiple sectors. His deep understanding of how digital strategy can facilitate and accelerate collective action, and generate evidence for informed decisions drove him to see the potential for an independent organization that can enable partnerships and drive them to jointly solve societal challenges.

Working with key players from across the public-private spectrum, The Synergist currently manages shared value programs including From Testing to Targeted Treatment (FT3), Motherhood Collective Impact, and PFMD as well as contributes to European public-private partnerships including IMI-Conception, IMI-Paradigm, and IMI-Gravitate.

Beth Brooks is Head, Patient Insights and Behavioral Sciences (PIBS), within the Patient-Informed Development and Health Value Translation team at Sanofi.

The PIBS team generates insights about patient populations of interest to the R&D organization. Among other things, the team uses this information to establish diversity and inclusion recruitment objectives for studies in the United States. Based on these insights and additional findings, the team uses behavioral science principles to develop tools to address recruitment and retention challenges that some patient populations may present in clinical trials.

Kathryn (Katie) Capanna, MBA, has nearly 20 years of experience in medical device development and regulation. She is dedicated to building productive partnerships and programs to drive more patient-centered medical product innovation, evaluation, access and care, and to advance health equity. She serves as Deputy Division Director within FDA CDRH’s Office of Strategic Partnerships and Technology Innovation (OST), in the Division of All-Hazards Response, Science and Strategic Partnerships (DARSS). In that role, Ms Capanna was part of a management team responsible for FDA’s emergency response to COVID-19, with a focus on helping ensure continued availability of critical medical devices and supplies, by monitoring for shortages and coordinating regulatory and US government mitigations. She also oversees multiple teams with a broad portfolio of strategic partnerships and programs, including the Patient Engagement Advisory Committee (PEAC), the Medical Device Innovation Consortium (MDIC), the Patient Science and Engagement (PSE) Program, the Medical Device Development Tools (MDDT) Program, the CDRH Network of Experts and the Patient and Care-Giver Connection (P&CC). Previous roles at FDA include Senior Advisor in the Office of the Center Director, where she led and supported various strategic initiatives around Clinical Trials Innovation, Real World Evidence, and efforts to improve diversity and inclusion in clinical research and product development for medical devices. She began her FDA career in the Division of Cardiovascular Devices, leading multi-disciplinary teams in evaluating an array of life-saving and sustaining technologies, and conducting research and outreach projects working with industry, academia, professional associations, patient organizations and across government agencies, to advance device innovation and reduce sex and gender disparities in cardiovascular device evaluation and care. Ms Capanna is a biomedical engineer by training and spent some time in the MedTech industry as well as academic research prior to her time at FDA.

Hayley Chapman is a Senior Program Director with Patient Focused Medicines Development (PFMD). She has a Masters in Health Science from the University of Toronto and has worked in the healthcare sector for over 25 years focusing on the development and evaluation of partnerships between life science companies, patients, and patient organizations.

With PFMD, Ms Chapman leads several key strategic initiatives including Patient Engagement Activities in the Post Launch Phase, Monitoring Patient Engagement to Learn Strategies, and Patient Engagement & Patient Experience Data Fusion. These projects include co-creation with global, multi-stakeholder working groups to ensure that what matters most and is important to patients, family members, and caregivers is incorporated into decision-making for product development and within the healthcare system.

Ms Chapman not only has a professional interest in patient engagement but has also contributed to several provincial and national Advisory Boards sharing her caregiver perspective following her son's cancer diagnosis and treatment. She is currently a member of both the Oncology Family Advisory Council and the Patient and Family Advisory Council at Sick Children's Hospital in Toronto.

Zachary Cline, PhD, was born in the suburbs of Philadelphia, and earned his Bachelor's, Master's, and PhD from local universities. After completing his PhD in Mathematics from Temple in 2019, he took a position as a Visiting Assistant Professor at Bucknell University, where he conducted research and taught courses in Calculus, Probability and Statistics for four years. In May 2023, he joined TREND Community as a Data Research Analyst, creating models and conducting data analyses about online rare and chronic disease communities.

Dr Selena Daniels, PharmD, PhD, serves as the Deputy Division Director in the Division of Clinical Outcome Assessment at the FDA. She provides direction, oversight and leadership to a team of expert analysts who provide consultation and advice on clinical outcome assessment (COA) endpoint development and validation, including considerations for clinical trial design, conduct, analysis, interpretation and reporting for regulatory determinations of medical product benefit.

Prior to joining the FDA in 2015, Dr Daniels worked in the Health Economic and Outcomes Research (HEOR) group at Allergan, Inc (now Abbvie) for almost five years, where she developed and executed HEOR strategies, as well as developed and implemented innovative COA strategies and endpoints for clinical trials.

Dr Daniels received her Doctor of Philosophy degree in Education at Nova Southeastern University and Doctor of Pharmacy degree at Loma Linda University.

Ebony Dashiell-Aje, PhD, is a leading expert in clinical outcome assessment (COA) design and implementation, advising on COAs, study endpoint issues and regulatory science. As a health outcomes researcher and methodologist, Dr Dashiell-Aje is driven by her passion for public health and promoting patient-focused medical product development. Dr Dashiell-Aje has notably contributed her research expertise in academic, consulting and regulatory environments to arrive at evidence-based solutions, and to shape health policy.

TBA

Trish Davidson, MPA, has extensive experience -- most recently developing an international Biomarkers and Outcome Measures Consortium for a rare disease patient advocacy group and 13+ years at the Lupus Foundation of America -- developing and directing patient and professional educational programs, research symposia and consortia involving diverse stakeholder communities in clinical care and clinical research. Ms Davidson collaborates with Tufts CSDD Executive Director, Ken Getz on a variety of initiatives involving building and sustaining relationships with professionals in government, advocacy, academia and industry. Ms Davidson received her BA and Masters of Public Administration (MPA) from the University of South Carolina.

Chris DeFelice is a results-driven leader with a successful record of managing teams to create leading-edge technology. He is a self-taught software engineer with more than 17 years of experience building and optimizing web applications, possessing a high level of fluency and experience using various technologies and frameworks. Mr DeFelice founded TREND Community with his wife, Maria, after their daughter was born with PWS. He brings an inspiring technical vision to his team and endeavors to create a culture of innovation and personal growth.

Christopher Dell, MBA, is a member of the Patient Technologies team at Pfizer where he is responsible for the successful implementation of eData clinical technology – mainly focused on eCOA but also supporting connected devices. Mr Dell has been with Pfizer for almost 8 years. Prior to his current engagement at Pfizer, Mr Dell spent over 5 years at 2 different ePRO vendors, managing the successful implementation of various projects in device-based, IVR and IWR modalities. Mr Dell was also with Wyeth for 4 years and Pfizer for 2 years between 2006 – 2012 as part of a team that defined the ePRO standards at the time.

Devra Densmore began her journey in patient advocacy at nine, when she saw a news program highlighting the impact HIV/AIDS had on Ryan White’s life. Her academic work at the University of Wisconsin-Madison (BA) and the Evans School of Public Policy and Government Affairs (MPA) focused on how to better incorporate patient insights into HIV/AIDS policy to better address the needs of vulnerable populations. In the years that followed, she worked in hospitals, both domestic and internationally, incorporating the patient experience into quality improvement measures; accelerated trial recruitment via patient engagement; represented patients in front of the FDA; formed coalitions between advocacy groups to mobilize communities around legislative advocacy; and led the formation of an advocacy function at multiple biotech companies. After 18 years of strategic advocacy leadership, Devra formed Elevate Advocacy, a boutique consulting firm focused on providing differentiated patient engagement and advocacy counsel with a health equity lens. Her impact has been felt in rare and common disorders, including: ALS, Lupus Nephritis, Membranous Nephropathy, Major Depressive Disorder, Postpartum Depression, Prostate Cancer,Reproductive Health, SCN2A-DEE, SCN8A-DEE, and Trigeminal Neuralgia.

Victoria DiBiaso, MPH, BScN, has 20+ years of clinical research experience. She holds a Master of Public Health and is a nurse by training. She has been awarded the distinction as one of the Top 20 Industry Innovators for her efforts to integrate insights from patient communities and clinical trial institutions into R&D decision making. Her work has been highlighted in the Wall Street Journal, various publications and keynote speeches.

More than a decade ago, she was one of the first industry leaders to establish a series of trial site & patient networks to provide advisory expertise to development staged clinical programs. These upfront partnerships have help transform the company’s development model whereby the therapies of tomorrow are not simply developed for patients but rather in partnership WITH patients and their stakeholders. This is reflected in the full end to end integration of patient experience and priorities across 100% of all indications, development programs and clinical trials at Sanofi; including prioritization decisions in the preclinical space.She recently established, and Chairs, the US based PALADIN Consortia bringing together advocacy and industry leaders to optimize collaborations that hold the potential to transform the pace of medicines development.

Ms DiBiaso is also an active research volunteer and advocate for the Parkinson’s Disease community. Aside from supporting clinical research education efforts, she has run 4 marathons and climbed Mount Kilimanjaro on behalf of Parkinson’s research and awareness.

Maha's, MS, MRA, CCRC, educational background is in Clinical Research Regulatory Affairs, Biotechnology and Life Sciences. At Penn Medicine, our goal is to bring new treatments and innovative approaches to improve patients’ lives.

Ms Dutt’s portfolio at the Office of Clinical Research includes navigating clinical research sites through the complex maze of resources we offer at Penn Medicine. This includes patient recruitment, training requirements, research application implementation and maintenance; and, most importantly facilitating patients and caregivers as they try to find the right trial for their needs.

Marie Emms has over 25 years of experience in healthcare communications, spanning public relations, medical education and R&D patient engagement.

Ms Emms joined Johnson & Johnson two years ago as Global Head of Investigator & Patient Engagement, responsible for growing, developing and supporting a team in the creation of engagement programs to strengthen patient recruitment and retention globally.

She specializes in the development and execution of strategic integrated communications programs to support sites and their patients through the clinical trial journey, from initial awareness and consent through to compliance and adherence. Ms Emms has worked on a wide range of therapeutic areas across neonatal, paediatric, adult and geriatric studies.

Cross-functional collaboration is essential for the creation and delivery of effective strategies that drive enrollment and engagement in the clinical trials that enable sponsors to bring drugs to market faster and to the patients that need them.

Ms Emms’s unique Commercial and Clinical insight, as well as her spirit of partnership, encourages and ensures successful collaboration. Ms Emms defines what it means to be a leader in today’s rapidly changing healthcare industry. She has a genuine and singular passion to improve the lives of patients – a passion that motivates and energizes her colleagues and everyone with whom she interacts.

Laura is a leader in ZS’s Clinical Development Excellence team with a central focus on Human-Centric Trials. She has spent the last 15 years helping life sciences companies improve decision-making through deeper understanding and engagement with patients and HCPs. Her deep expertise in developing scalable insights, strategies, and capabilities for driving site and patient participation and engagement in clinical trials has allowed companies to accelerate new therapies to market, while keeping the patient the central focus of their mission.

Emily Epstein, LMSW, is a Clinical Behavioral Health Specialist at the Genetics and Personalized Cancer Prevention Program at Weill Cornell Medicine. There, she provides valuable support to patients and their families as they navigate hereditary cancer syndromes. She has been called an "empathy advisor" due to her commitment to helping healthcare providers and researchers approach their patients with compassion and understanding. Through her experience as a patient with Hereditary Breast and Ovarian Cancer Syndrome due to a BRCA2 mutation, Ms Epstein brings awareness and perspective to panels, advisory boards and support groups. She collaborates and coordinates research to enhance patient-centered testing, coordinated care, support, and research in hereditary cancers. Ms Epstein holds a bachelor’s degree from New York University and a master’s in social work from Fordham University’s Graduate School of Social Services.

Gunnar Esiason is a cystic fibrosis and rare disease patient leader. He is the head of patient engagement at RA Capital's venture group, RA Ventures. Mr Esiason has been the face of fundraising efforts for the Boomer Esiason Foundation, which has yielded close to $200 million raised for the fight against cystic fibrosis since 1993. He was a founding advisor of the non-profit No Patient Left Behind, and previously led patient operations at a leading clinical trial technology startup. Mr Esiason has been a leading voice on rare disease market access issues with health policies opinions featured in The Hill, Wall Street Journal and STAT News. Mr Esiason holds an MBA and MPH from Dartmouth College and a BA from Boston College.

Jeff Evitts is the Senior Vice President of Sales of AutoCruitment. He brings over 20 years of experience and knowledge in the life science industry as a leader of world class sales teams in serving their customers. He will lead our sales team with our focused vision of partnering with clients to provide an accelerated path to new therapies with a customized, results-driven focus on the patient journey, from recruitment and beyond. Previously, Mr Evitts held various sales leadership roles with C3i and Medidata. He received his bachelor’s degree from Shippensburg University.

Ricki Fairley, MBA, is the co-founder and CEO of TOUCH, The Black Breast Cancer Alliance addressing Black Breast Cancer as a unique and special disease state, with the overall goal of reducing the mortality rate for Black women.

Ms Fairley founded and serves as co-host for “The Doctor Is In,” a weekly live breast cancer advocacy web series on the BlackDoctor.org Facebook page that reaches over 3 million viewers. She is a founding member of #BlackDataMatters, in partnership with Citizen, The Center for Health Care Innovation and Morehouse School of Medicine to encourage and elevate the importance of Black Women participating in clinical trial research.

In January 2022, she started the When We Tri(al) Movement to change the game on Black women participating in clinical trials to improve outcomes for Black women with breast cancer with culturally humble and provocative communication that has resulted in thousands of Black women entering clinical trial research. She also actively assists pharmaceutical companies in revamping and designing their clinical trial recruiting materials.

Amy Fesmire-Baus has spent over 15 years in the pharmaceutical industry, most recently working to break down patient barriers to clinical trial participation by incorporating the Patient Voice into clinical research protocols and building clinical trial awareness with Patient Advocacy Groups, all while making sure both efforts were inclusive of diverse populations. In addition, Ms Fesmire-Baus has managed the Engagement and Diversity Strategy across the Multiple Myeloma portfolio. What sets Ms Fesmire-Baus apart is her personal connection to the patient perspective. As a congenital heart disease patient and advocate, she has volunteered with a Patient Advocacy Group for over 10 years. Her contributions include serving as a Peer Mentor, as a contributing team member on several initiatives, and as Chair for fundraising events. Ms Fesmire-Baus’s commitment extends beyond organizational roles, as she has actively participated in Conference Scholarship Committees, leading the way in providing opportunities for others. Ms Fesmire-Baus’s passion for empowering patients is evident in her leadership role in developing an Education Strategy and creating a book specifically tailored to patients undergoing open-heart surgery as adults. Her dedication to sharing knowledge and empowering others is further exemplified by her role as a speaker at national and regional CHD conferences.

Patrick Floody, MBA, is the Head of the Global Clinical Trial Services group at Regeneron where he is responsible for global site management, central monitoring, study feasibility and site selection, study/site start up, eCOA and patient technology initiatives. He has been with Regeneron for just over 3 years.

Mr Floody spent 25 years at Pfizer, with most of his time spent in clinical program operations but also included time in GCP Quality (level 1) and Analytics. He has extensive international experience in drug development and helped establish the Pfizer country office development teams in Latin America, India and other parts of Asia. Subsequently, he spent 10 years in Pfizer’s Development Japan organization as Head of Japan Development Operations and Development Japan Portfolio & Project Management Groups. He was the recipient of Pfizer’s PGRD Achievement Award in 2007.

Mr Floody is a former officer in the U.S. Army and is a veteran of the first Gulf War. He holds a bachelor’s degree in Biology from the University of Rhode Island and a Master of Business Administration from Temple University.

Colton Flowers was born and raised in Phoenix, Arizona. He holds a Master's in Human Language Technology and a Bachelor's in Linguistics from the University of Arizona. He first began his career in NLP and machine learning through internships at the French National Center for Scientific Research and the German Research Center for Artificial Intelligence. Since 2021, Mr Flowers has served as an NLP Engineer at TREND Community, developing systems to understand the language of rare disease.

Max Flurie, PhD, possesses a blend of clinical and research experience dedicated to serving rare and chronic disease communities. Beginning his career as a speech-language pathologist, Dr Flurie shifted his focus to data and analytics. He received his PhD in Communication Sciences and Disorders at Temple University where his research focused on language and cognitive functioning in acquired and neurodegenerative conditions. Dr Flurie joined TREND Community in 2021 and currently serves as a Senior Data Scientist where he oversees various research and analytical initiatives that support insights into rare and chronic disease through social listening.

Christie Fry is Director, Strategic Technology Innovation at AbbVie. Ms Fry has 30 years of experience in clinical research, including patient recruitment, data management and digital health innovation. In her current role, she is responsible for leading strategy, operations and implementation of decentralized clinical trials (DCT). In addition, Ms Fry actively assesses opportunities requiring innovative tactics to improve existing activities and processes within Clinical Development Operations. She is also involved in industry activities, focusing on technology, improving site experience in clinical trials and in the set up of new capabilities to drive patient centricity in drug development.

After nearly 30 years of experience working with non-profits across the country, Susan Gaffney joined the National Health Council in March 2020 and is now its Executive Vice President of Membership, Development, and Events.

Ms Gaffney provides strategic direction for the groups fundamental work of ensuring that its robust membership is engaged and supported while tackling the critical issues related to chronic health conditions, which are at the heart of the NHC’s mission.

Ms Gaffney’s progressive experience in both the health and non-profit sectors allows her to draw on a range of skills and experiences in helping to drive the NHC’s work.

Previously, Ms Gaffney had been the National Director of Membership and Governance at NAMI, the National Alliance on Mental Illness, where she focused on nonprofit governance, compliance, strategy, and member support. She has also worked in a variety of roles in the nonprofit education and health sectors in Washington, DC, New York, and San Francisco including the Department of Child and Adolescent Psychiatry at Columbia University College of Physicians and Surgeons and the Mount Sinai Adolescent Health Center.

Growing up in Long Island, New York, Ms Gaffney is especially proud of her background as a first-generation American who maintains dual citizenship with her family’s ancestral home in Ireland. As a mother of three boys, family is near and dear to Ms Gaffney’s heart and just as part of the NHC’s work includes advocating on behalf of caregivers, Ms Gaffney herself has firsthand experience in that role, having spent over 10 years helping to care for her own parents during their struggles with chronic health issues.

Ms Gaffney earned a master’s in Nonprofit Management and Public Policy from the Milano School of Policy, Management, and Environment at The New School in New York City, and a bachelor’s in history from St. Bonaventure University. She is certified in Group Facilitation by the Institute of Cultural Affairs and as a Change Management Practitioner by Prosci.

Kenneth A. Getz, MBA, is the Executive Director and Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he conducts research focusing on drug development management and operating strategies and tactics; protocol design practices; and global outsourcing, investigative site and patient recruitment practices and policies. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise. A well-known speaker at conferences, symposia, universities, investor meetings and corporations, Mr Getz has published extensively in peer-review journals, books and in the trade press and writes a bi-monthly column nominated for a Neal Award in Applied Clinical Trials. He holds a number of board appointments in the private and public sectors including WCG and ORA and serves on the editorial boards of Pharmaceutical Medicine and Therapeutic Innovation and Regulatory Science.  Mr Getz received an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University. Mr Getz is the founder of CenterWatch, a leading publisher in the clinical trials industry.

Kenneth A. Getz, MBA, is the Executive Director and Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he conducts research focusing on drug development management and operating strategies and tactics; protocol design practices; and global outsourcing, investigative site and patient recruitment practices and policies. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise. A well-known speaker at conferences, symposia, universities, investor meetings and corporations, Mr Getz has published extensively in peer-review journals, books and in the trade press and writes a bi-monthly column nominated for a Neal Award in Applied Clinical Trials. He holds a number of board appointments in the private and public sectors including WCG and ORA and serves on the editorial boards of Pharmaceutical Medicine and Therapeutic Innovation and Regulatory Science. Mr Getz received an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University. Mr Getz is the founder of CenterWatch, a leading publisher in the clinical trials industry.

Annie Gilbert is the Global Patient and Site Engagement Lead at Boehringer Ingelheim responsible for shaping, developing, and implementing patient and site journey strategies during clinical development, to create customer value across all countries and regions. Previously Global Patient Advocacy Relations Manager at Boehringer Ingelheim and Patient Research Manager at Merck, Ms Gilbert is an established and well published patient advocate and researcher with 30+ years’ experience in the pharmaceutical industry including more than 20 years in Patient Engagement. Other roles include Global Market Access Manager with Lundbeck A/S in Copenhagen and Public Affairs Director with Cello Communications, UK. She has managed numerous advocacy and patient access projects on behalf of healthcare organizations including measuring patient experience in Ovarian Cancer and studying access to treatments and services for people with Rheumatoid Arthritis and Ankylosing Spondylitis. Specialties include developing and managing patient access strategies through stakeholder engagement, identifying the barriers and enablers to better service delivery, and providing the evidence needed to advocate effectively for change. 

Susan Gilchrist works on the Lilly CoDesign team gathering feedback from external partners; physicians/investigators, study coordinators, payers, and patients to influence the global development of the clinical portfolio while looking to improve the customer experience and provide meaningful benefit to patients. She is an advocate for innovation in clinical research while ensuring participant preferences and needs are incorporated into trial designs. Susan previously held a concurrent role as the Community Manager for @LillyTrials while also developing the Lilly Trials website with a focus on educating potential participants and helping them match to trials. Susan has had a variety of roles at Lilly across medical, clinical, and marketing. She is an RN and prior to Lilly worked at the bedside and in clinical research.

Angi Gillen, MS, Senior Director, Head of Patient Experience, is leading a new program at Gilead, building a framework for incorporating Human Centered Design and Patient Voice into Clinical Development. She has over 20 years of proven cross-functional collaboration in drug development with demonstrated results in Clinical Operations and has worked across several therapeutic areas throughout her career. She has a Bachelor of Science degree in Molecular Biology from East Carolina University and a Master of Science in Biotechnology and Bioinformatics from Johns Hopkins University.

Tara Gipp leads the patient engagement team within Regeneron’s Global Trial Optimization team. She has a passion for ensuring patient and site burden is reviewed and assessed during clinical study development and is committed to reducing burden and barriers to participation. Patient focus in her career started when developing HIV treatments whilst employed at Pfizer and was further cemented when spending 10 years at Cancer Research UK. At Cancer Research UK, she led initiatives to incorporate patient views into trial design and garner direct on-study feedback to improve patient experience on clinical trials. Her current work includes having a detailed understanding of patient and caregiver needs early in study design, ensuring clinical trial participation is easily accessible to all trial participants, collecting near immediate feedback on-study from sites and participants as well as a priori feedback on study design. Ms Gipp has a Bachelor’s degree in Chemistry from Northwestern University.

Jamie Goldfarb was diagnosed with Stage IV melanoma in January 2011, when her son was just 11 weeks old. Upon diagnosis, her oncologist told her that he would do everything in his power to buy her 6 more months. Ms Goldfarb joined a clinical trial at the National Cancer Institute (NCI) and is now completely disease-free. Having worked in patient recruitment for 8 years and having her own life saved by a clinical trial, Ms Goldfarb's personal mission is to spread information about the importance of medical research as far and wide as possible. To this end, she is involved with the Melanoma Research Alliance, the Melanoma Research Foundation, the Melanoma International Foundation, CISCRP, the Alliance for Regenerative Medicine, the Association of Clinical Research Professionals, and Imerman Angels. She also serves as a research advocate for NCI, and works one-on-one with people with cancer to help them navigate their treatment options, including clinical trials.

Heidi Green, PhD, MSci, has spent her professional career dedicated to practicing creative research methods that identify barriers and enablers to facilitating inclusive clinical research. Dr Green has a PhD in Applied Health Sciences, specializing in patient recruitment to trials, and before joining COUCH spent eight years working within an academic research environment at the University of Aberdeen’s Health Services Research Unit which won the Queen’s Anniversary Prize for Higher and Further Education in 2018. Her work aims to increase the level of high-quality inclusive clinical research, with the goal of one day ensuring that everyone has an equal opportunity to participate in clinical research.

Samantha (Sam) Guild, JD, left a successful career as a litigation attorney in 2008 to become the Director of Education, Public Policy and Advocacy for AIM at Melanoma, the foundation her mother, Valerie, founded after Sam’s sister Charlie died of melanoma in 2003.

As President of AIM at Melanoma, Ms Guild works closely with grantors and the AIM team on future goals for the foundation. A large part of her role at AIM includes the oversight of the creation of resources for patients, caregivers and health care providers—resources such as patient treatment decision-making tools, AIM’s melanoma oncology nursing website, IO Essentials website and the AIM at Skin Cancer website.

In her public policy work, Ms Guild led the effort in California that resulted in the passage of the first bill to ban minors under 18 from using tanning devices. She also oversees AIM’s effort to support oral parity and step therapy legislation on the state and federal levels.

In her advocacy role at AIM, Ms Guild sits on a variety of governmental and non-profit working groups and committees where she advocates for the skin cancer community, including NCCN, SWOG and ECOG, and the ASCO’s systemic therapy melanoma working group. She is frequently asked by researchers and industry to share the patient perspective on topics of importance to their research.

Ms Guild received a bachelor’s degree from Clark University in Worcester, Massachusetts. She earned her law degree from the University of the Pacific, McGeorge School of Law, in Sacramento, California.

Lani Hashimoto is dedicated to connecting trials to patients with 25 years of clinical trial experience, operational expertise, and extensive industry relationships. Joining Novartis in October 2013, she has worked on innovation and operations teams. this year including grassroots efforts to engage with patients. In 2018, she joined the TransCelerate Patient Experience initiative and has been co-leading the team for the last two years. Ms Hashimoto recently transitioned to a patient engagement role in US late phase trials focused in the US.

Gary Ho is a co-founder of the Gout Support Group of America and also holds the position of Senior Community Director at TREND Community. He is committed to advocating for gout patients and the rare disease community. Mr Ho's strong leadership and empathy have played a crucial role in raising awareness and providing support. He brings his professional expertise in healthcare advocacy to empower patients and launch impactful awareness campaigns. Through his efforts, he has significantly contributed to improving healthcare outcomes.

Jen Horonjeff, PhD, is a patient advocate and the Founder & CEO of Savvy Cooperative. She was named one of the 50 Most Daring Entrepreneurs by Entrepreneur Magazine, alongside Elon Musk and Reese Witherspoon, for her work at Savvy, which helps companies equitably gather input and insights from diverse patients. Dr Horonjeff is passionate about patient co-design as she grew up with numerous autoimmune diseases, and survived a brain tumor as an adult. She also holds a PhD in Environmental Medicine, and previously worked as a health outcomes researcher, a human factors engineer and user-centered designer, and an advisor to the FDA. Dr Horonjeff serves on the Board of Directors for The Sequoia Project, a non-profit focused on health data exchange, the Advisory Board of Trialbee, a clinical trial recruitment company, and numerous other committees. Utilizing her unique perspective, Dr Horonjeff strives to give patients a platform to have their experiences be heard, included, and equitably valued– because the future of healthcare is co-designed with patients.

Stacie Hudgens is the CEO and Principal Scientific Advisor of Clinical Outcomes Solutions, a global Outcomes Research strategic consulting group. She has over 27 years of research experience, specializing in research design and statistical and psychometric analysis; and 24 years of direct experience in clinical trials and in health and economic outcomes research ranging from early academic work to industry to consultancy. Ms Hudgens has published extensively (over 160 peer-reviewed articles and conference presentations) on patient outcomes with a passionate and dedicated focus of ensuring the patient's voice is included in all research activities.

Stacy Hurt, MHA, MBA, is an award-winning 25 year pharma executive who bridges the industry/consumer gap as a stage IV cancer survivor and 24/7 caregiver to her son with a rare disease. Her unique professional and personal experience position her as an esteemed patient advocate as well as an influential pioneer in Patient Engagement. In Ms Hurt’s role as Patient Advocacy Ambassador at Parexel, the first of its kind, she commands a seat at the table on behalf of patients and caregivers to examine and reduce patient burden thus increasing participation and retention along the clinical trial patient journey. Ms Hurt was named to the 2022 Medika Life Top 50 Influential Voices in Healthcare. She resides in Pittsburgh, PA with her husband and two sons.

Emily Idoni is a Senior Account Director in Langland’s US office. In her almost six years at Langland, she has gone from successfully delivering master materials and translations, to leading best-in-class creative work, and now, to leading the team to strategically deliver on each project’s specific needs and KPIs. Whether oncology, women’s health, or rare disease, she is inspired by the possibility of touching patients’ and caregivers’ journeys and giving each stakeholder the best possible experience while they engage with clinical research.

Before joining Langland, Emily worked in a small, nimble agency that specialized in brand development and digital ecosystem, which she uses extensively when co-creating clinical studies’ brands.  From working on a variety of brands in a variety of industries, like specialty pharmacy, nonprofits, and manufacturing, she is acutely aware of the importance of a consistent brand and message and looks to provide this consistency to clinical research participants whenever possible.

Throughout her time at Langland, Emily has led a variety of projects ranging from study brand development to full study support including digital recruitment. She has worked on more than 20 therapies and delivered materials in over 35 languages. Because of this breadth of experience, she is able to share insights and recommendations, all while working to be the best possible steward of any budget.  

Karen Jackler, MPH, has oversight of the FDA Center for Biologics Evaluation and Research (CBER) patient engagement activities. Working with scientific and policy staff across the FDA, she identifies patient engagement opportunities and assures CBER’s coordinated participation in them. With a professional background in public health and strategic communications and expertise in project planning and mobilizing diverse teams, she is a leader in promoting the importance of the patient voice in FDA’s decisions about biologic medical products.

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Korinne Jew, PhD, BSN, joined Medtronic in 2011 as a clinical research associate and has taken on a succession of roles with increasing responsibility within the Clinical Research and Medical Science (CRMS) function. In her current role of Sr. Director Enterprise CRMS, Dr Jew serves as sponsor of the Medical Science council to drive the value of the function as a strategic partner to the business. She also leads the enterprise Patient Engagement Strategy to ensure that patient input is incorporated throughout the product life cycle. Dr Jew holds a Doctor of Philosophy in Integrative Physiology from the University of Colorado-Boulder as well as a Bachelor of Science Degree in Nursing from Regis University. After her education and training in the academic research setting, she left to pursue her nursing degree and practiced as a critical care nurse prior to joining Medtronic

Diagnosed in her teens, Sabina Kineen is passionate about educating others how the diagnosis of an inherited, rare disease can impact an entire family and sharing the unique perspective of living as both a patient and a caregiver. Ms Kineen strives to use her own life experiences, including her involvement and participation in clinical trials, to support patients and industry in order to build bridges and encourage health equity and patient engagement.

Catherine Koola Fischer serves as the Director of Patient Engagement for the Institute for Clinical and Economic Review (ICER) and is committed to strengthening the patient voice within ICER value assessments. Her role includes outreach and onboarding for ICER reviews, enhancing ICER’s resources to be more patient-friendly, and nurturing relationships with patient community partners. She serves as the Co-Chair of ICER’s Patient Council which was formally launched in July of 2023. In addition, Ms Koola Fischer is a Steering Committee member of HTAi’s Patient and Citizen Involvement Interest Group (PCIG) as well as the US HTA representative for the Medical Device Innovation Consortium (MDIC)’s Health Economics Patient Value (HEPV)’s working group. Ms Koola Fischer has her MPH in Epidemiology from Emory University and her BS in Psychology from Texas A&M University.

Sarah Krüg is the founder of the Health Collaboratory, a global innovation hub that paves the path for participatory co-design and collaboration in healthcare, with a focus on amplifying the voice of the patient and care/support partner in the design, development and continuous improvement of healthcare innovations. The Health Collaboratory has launched various innovations such as Prescription to Learn®, a Health GPS, and the Patient Shark Tank®, among others. Through the Patient Shark Tank ®, over 19,000 patients and care/support partners across disease states have evaluated innovations across the globe, including technology, education, research, and policy. 

Ms Krüg is the CEO of CANCER101, a patient advocacy organization whose mission is to help patients and care/support partners navigate the cancer journey and partner with their healthcare team to make informed decisions. She is also the Acting Executive Director and Past President of the Society for Participatory Medicine, a patient: clinician member driven organization, whose mission is to enable collaborative partnerships between patients and healthcare professionals. She serves on the board of the National Organization for Rare Disorders.  Ms Krüg is also the author of “A Roadmap to Wellness”.

She previously held the position of Global Education Director as well as Patient Advocacy Lead at Pfizer. She also established the Global Investigator Initiated Research Program at Pfizer.  Prior to joining Pfizer, Ms Krüg spearheaded the development of the Disease Management Clinical Pathways and conducted clinical research at Memorial Sloan- Kettering Cancer Center. 

Lorena Kuri is currently serving as Head of Diversity Strategy for R&D, where she is responsible for driving the Diversity in Clinical Trials enterprise strategy, with the objective of recruiting a Patient population that is more reflective of the real world and aligned with the epidemiology of the disease studied.

She holds a BA in International Business from Tec de Monterrey, a Masters in Strategic Management and Human Capital from Universidad Anahuac and a D&I Certificate from Cornell.

She is a founder and board member of SGM Alliance, a non profit that looks into improving Health Equity for Sexual and Gender Minorities. She is an active Red Shoe Movement Ambassador and member of WOCIP (Women of Color in Pharma) where she previously held a board role.

Stacey Langley is a devoted advocate for patient rights and improved healthcare experiences. With a background as a community health worker and peer recovery specialist, she brings a unique perspective on patient advocacy.

Having personally navigated physical disability, autoimmune disease, behavioral health, and recovery, Ms Langley understands the significance of empowering individuals to become active participants in their healthcare journey. She firmly believes that every patient deserves a voice and that collective advocacy can drive meaningful change.

For over a decade, Ms Langley has been an active participant in various campaigns in the LGBTQ+, progressive, and low-income communities, all aimed to improve patient outcomes, amplify patient voices, and address systemic issues in healthcare.

Beyond her advocacy work, Ms Langley is also a sought-after speaker known for inspiring and educating diverse audiences. Originally from Houston, Texas, and having spent over a decade in the New York City area, she currently resides near Martinsburg, West Virginia. Ms Langley holds an AAS in Information Systems from Pierpont Community and Technical College and a certificate in Community Health from Berkeley City College.

David Leventhal, MBA, is the Senior Director, Data Sharing & Disclosure Lead at Pfizer, Inc. He oversees the expansion and implementation of Pfizer’s Clinical Trial Data Sharing Policy and serves as a single point of leadership for enterprise-wide sharing of sponsored clinical trial data. He is also a representative to stakeholders within and outside of Pfizer as it relates to data sharing. As such, he partners with leaders in the clinical research community. Importantly, Mr Leventhal manages centralized data sharing governance at Pfizer as they continue to demonstrate their commitment to transparency and data sharing. He has been with Pfizer for 27 years, and in that time has served in a variety of R&D and innovation functions.

Barry Liden, JD is the Director of Public Policy. He works with the Schaeffer Center leadership to amplify the Center’s impact on public policy through the development and implementation of high-impact strategies; research translation through the strengthening of existing and new methods for maximizing dissemination and uptake of our initiatives; and liaising with key stakeholders through the creation and cultivation of relationships with internal and external stakeholders.

Mr Liden was with Edwards Lifesciences from 2002-2022, where he served in various roles, including patient engagement, government affairs and communication. Most recently, he served as the Vice President of Patient Engagement, where he pioneered the advancement of the patient engagement function in the medical device industry. Mr Liden was formerly an Associate Professor at Georgetown University’s School of Nursing and Health Studies from 2018-2022 and Adjunct Faculty at USC Annenberg from 2002-2007. He is also the former Chair of MDIC’s Science of Patient Input Working Group.

Mr Liden is a USC Sol Price School of Public Policy alumnus and received his JD from Loyola Law School.

Jarrod Longcor is the Chief Operating Officer at Cellectar Biosciences, Inc. bringing with him more than 25 years of pharmaceutical and biotech experience. Previously, he was the Chief Business Officer for Avillion LLP. In this role, he was responsible for executing the company’s unique co-development partnership strategy. Prior to Avillion, he held a number of key positions in multiple biotech companies, including Vice President of Corporate Development for Rib-X Pharmaceuticals, Inc. (now Melinta Therapeutics) where he was responsible for identifying and concluding several critical collaborations for the company, including a major discovery collaboration with Sanofi Aventis valued over $700M. In these roles, Mr Longcor has been responsible for clinical development, including 2 FDA approved drugs, research and discovery, business and corporate development, alliance management and strategic planning. Based upon his extensive experience with clinical development, he has encouraged Cellectar Biosciences to take a patient-centric approach to execution of clinical trials.

With over a decade of experience working directly with patients and sites, Rachael MacQueen, MBA, is no stranger to understanding patient burden. She has spent the bulk of her career helping to build better, more efficient, patient and site friendly trials through patient centric solutions.

In her current role, as Senior Manager, Patient Centricity with Moderna she ensures that in all the trials Moderna delivers, they are considering novel solutions that meet patient needs and that their trials are designed and executed with those needs in mind.

Before Moderna, she was Director of Delivery for the Patient Experience Unit of CorEvitas, where she played a key leadership role and led the operational delivery of research services for qualitative and quantitative patient insights.

Ms MacQueen received her Master of Business Administration and Bachelor of Arts degrees from Marshall University in Huntington, West Virginia.

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Jean McCoy, EVP, Partnerships for Reverba and accelerates the company’s growth by ensuring they are dependable partners who are consistently bringing value to their clients. Her knowledge of what this requires is based on more than 25 years of leadership in biopharmaceutical marketing and commercialization. She is an outspoken authority on patient engagement who frequently gives keynote addresses about our pioneering work in both the commercial and clinical arenas.

Maggie Kuhl is Vice President of Research Engagement at The Michael J. Fox Foundation, the largest non-profit funder of Parkinson's research. She leads a team engaging community partners and gathering patient experience data toward patient-focused drug development, as well as practicing and piloting recruitment and retention methods to enable faster trials. Ms Kuhl directs recruitment strategy for the Foundation’s Parkinson’s Progression Markers Initiative, a longitudinal observational study with remote screening and enrollment at 50 international sites for thousands of participants. Prior to joining the Foundation in 2013, Ms Kuhl worked in communications at the National Institutes of Health. She studied public health and journalism at the University of Maryland.

Yvonne McLean Florence, MDiv, is a wife, mother and G-mom who was diagnosed with early stage breast cancer and now living with no evidence of disease. She is a breast cancer survivor, the former President/Founder of Sisters R Us Circle of Survivors and an independent patient advocate.

She received a Masters of Divinity from Palmer Theological Seminary formerly Eastern Baptist Seminary in 2010, completed the AACR Scientist and Survivors Program, National Breast Cancer Coalition Project LEAD Program in 2018, the University of Pennsylvania Community Research Scholar Program in 2019; and, in 2023 the MBCRC Advocate Researcher Program and the Alamo Advocate Scholar Program during the San Antonio Breast Cancer Symposium.

Ms McLean Florence has been involved in patient, research and public policy advocacy with an emphasis on clinical trials, community participatory research, diversity, equity and inclusion, quality of care/life for patients and survivorship. As a way to keep the voice of the patient elevated in cancer research, she continues to serve on numerous peer review panels for local and national organizations as a patient advocate, a patient stakeholder, a consumer reviewer and advocate mentor.

She is one ten ambassadors for the National Coalition for Cancer Survivorship (NCCS) 2023-24 Elevate Ambassador Program and a member of their Cancer Policy Advocate Team (CPAT). She is also blessed to represent Delaware County in the Pennsylvania Breast Cancer Coalition’s Traveling Exhibit 67 Counties, 67 Women Affected by Breast Cancer and serve as a County Block Captain for their Driving Out Breast Cancer Campaign.

Christine McLennan joined BioNTech during the global pandemic, as she was impressed with BioNTech’s passion and commitment to improving the health of people worldwide with innovative immunotherapies. In her current role, she partners with patient advocacy groups to create awareness of clinical trials designed for patient populations with unmet medical needs.

Ms McLennan began her career as a clinical nutritionist at McMaster University in Ontario, Canada, where compassionate, patient-centered care and evidenced-based medicine were fundamental to clinical practice. She has been involved with patient support groups for over 30 years. Early on in her career, Ms McLennan helped to establish a local chapter of the Canadian Diabetes Association and also served as the nutrition advisor for local support groups for people with Inflammatory Bowel Disease and Celiac Disease. She then moved to the Department of Preventive Medicine and Epidemiology at Boston University, where she managed NIH-funded research studies in heart disease, arthritis and osteoporosis. Since 2008, she has directed clinical trials for a wide range of therapeutic indications for various CROs and small biotechs in the Boston area. She has great passion for preventive medicine and endorses advocacy work that promotes surveillance and early intervention among high-risk populations. Her goal as a healthcare professional is to engage in efforts that create access to effective and affordable health care for people across the globe.

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A native of Puerto Rico, Irisaida Méndez is a seasoned Multicultural Communications and crisis management executive with over 20 years experience leading National and Global initiatives.

A mother of four, first diagnosed with gynecological cancer in 2017, which remotely metastasized after nearly one year in remission. Following her stage IV diagnosis, Ms Méndez challenged chemo-brain side effects by studying to become a certified end-of-life doula. She then launched IMKahlo, an organization that helps women boost their confidence and courage with tools to help cope with the side effects of chemo, radio and immunotherapy. Through IMKahlo, she also encourages patients to take control of their end-of-life wishes by normalizing death conversations and life planning, such as creating legacy projects to be remembered by.

Ms Méndez has been a guest speaker at many state and national conferences and advocacy events. “Research saved my life,” she says. This is why her IMKahlo team and she participate in the American Lung Association’s Fight for Air Climb stair-hikes. Additionally, she has served as the Mission Chair for this event for the past two years and the current year, inspiring participants to use laughter to expand their lungs, catch a breath of (clean/fresh) air and climb for hope.

Ms Méndez collaborates regularly with non-profits and Latin American Organizations in the U.S. She serves as a member of the Latino Leadership Council at Compassion and Choices. For the past two years, she has taken the role of LUNG FORCE representative for the state of Florida, carrying on advocacy efforts in Capitol Hill, raising awareness about the need for NIH funding to keep performing research and the importance of affordable healthcare for everyone.

Erica Mercado brings more than 15 years of patient recruitment and engagement experience to her role at BBK Worldwide, where she serves as Director of Growth Strategy and oversees the development of strategic programs to support successful study enrollment. Ms Mercado creates and deploys innovative and successful strategies that generate awareness and engagement surrounding clinical research for study sponsors, advocacy organizations and patient thought-leaders. Prior to her current role, Ms Mercado served as Senior Account Supervisor, ensuring patient recruitment and engagement efforts achieved performance goals. She has also served as BBK’s Director of Innovation, playing an integral role in product development – anticipating, developing and delivering innovative patient recruitment and engagement technologies to improve the clinical trial experience. In 2018, Ms Mercado was selected as one of the top 100 most inspiring people in the life sciences industry by PharmaVOICE magazine, in recognition of how she inspires and motivates those around her, her influence as a corporate leader and her positive impact on the industry through her actions.

From Virgin Atlantic’s award winning service to the exemplary front of house service at the London 2012’s Olympic and Paralympic Games, Linda Moir has been responsible for her outstanding operations in HR and customer service management. Ms Moir’s career took off with British Airways, where she worked in HR for air traffic control before rising to HR Director of National Air Traffic Services. In her time spent at the UK’s largest airline, Ms Moir experienced an environment of significant changes as the company transitioned from public to private ownership. In 2003, Sir Richard Branson hired Ms Moir to ‘make flying fun’ as Virgin Atlantic’s Director of In Flight Services, and she certainly did: after completely overhauling the training, recruitment, promotion and performance management of 5,000 Cabin Crew, the highest customer satisfaction scores in the airline’s history were recorded. Throughout the process, she oversaw significant business growth whilst consistently driving the airline’s catchy promise of ‘Brilliant Basics, Magic Touches’. When it was announced that London would host the 2012 Olympic Games, Ms Moir knew this was a once in a lifetime opportunity and that she had to be involved. She developed the powerful ‘blended team’ approach, combining professional stewards with volunteer ‘Games Makers’; consequently, the tarnished reputation of the British service industry was profusely redeemed through a three-year programme of engagement, and the Games Makers became one of the most iconic and memorable symbols of the games. Ms Moir’s unparalleled success in HR and customer service management serves as an inspiring model of performance delivered through people.

Joanne Monaghan, RN, CCRC, is a highly experienced healthcare professional with a passion for patient care and clinical research. With a career spanning over two decades, she has established herself as a dedicated and knowledgeable registered nurse since 1993. Ms Monaghan’s expertise and commitment to delivering exceptional care has made a significant impact on the lives of countless patients.

In 2005, Ms Monaghan transitioned her career into the field of clinical research, assuming the role of a clinical research coordinator. With her strong clinical background and meticulous attention to detail, she quickly excelled in managing complex research studies and ensuring compliance with regulatory requirements. Ms Monaghan’s in-depth understanding of study protocols, data collection, and participant recruitment has contributed to the successful execution of hundreds of clinical trials.

Since 2021, Ms Monaghan has taken on the role of Site Director at Boston Clinical Trials, a prestigious research institution renowned for its groundbreaking contributions to medical advancements. As Site Director, she oversees the coordination and management of multiple research projects, working closely with interdisciplinary teams to ensure the smooth operation of clinical trials. Ms Monaghan’s leadership skills, problem-solving abilities, and effective communication have played a crucial role in fostering a collaborative and efficient research environment.

Beyond her professional accomplishments, Ms Monaghan remains dedicated to ongoing education and professional development. She actively participates in workshops, conferences, and seminars to stay abreast of the latest advancements in clinical research and nursing practices.

In her spare time, Ms Monaghan enjoys giving back to the community through volunteer work, spending time with her family and her 6 year old German shepherd.

Anne Marie Morse, DO, is a board-certified and fellowship-trained pediatric neurologist. Her clinical interests include sleep-wake disorders in neurologic disease, narcolepsy and hypersomnia disorders and neuroimmunology. Her research interests include sleep-wake disorders in neurologic disease, hypersomnia disorders and sleep-wake disorder phenotyping. Dr Morse earned her degree in osteopathy from Rowan University. She completed her residency and her child neurology fellowship at the State University of New York, Downstate Medical Center. She completed another fellowship in sleep medicine at the Albert Einstein College of Medicine of Yeshiva University, Montefiore Medical Center. Dr Morse is certified by the American Board of Psychiatry and Neurology in neurology with special qualification in child neurology.

Barry Nelson has been a resident of Boston for over thirty years and has deep ties to the local community. A retired risk management professional, with credentialing for business continuity and disaster recovery planning, Mr Nelson has a background in technology that extends across multiple industries, including financial services and banking, airlines, and government contracting.

Since 2012, Mr Nelson has served as a patient experience presenter and patient advisor and he regularly participates in patient and family centered conferences, patient experience panels, and other events where he discusses opportunities for improving long-term health care outcomes. Mr Nelson has participated on multiple research initiatives that focus on patient centered outcomes and healthcare improvements at the Brigham and Women’s Center for Patients and Families and the Dana-Farber Cancer Institute. Mr Nelson’s spirit of activism is centered on his Christian faith and he is the co-chair of the “Somebody Prayed For Me, Let Us Pray with You” weekly prayer call.

As a patient volunteer at Brigham and Women’s Hospital Center for Patients and Families, Mr Nelson supports several Patient Family Advisory Councils, Steering Committees, Patient-Centered Outcomes Research Initiatives (PCORI), and other research goals focused on patient care and engagement. Mr Nelson also volunteers at the Dana-Farber Cancer Institute and provides support for marketing, fundraising, and community outreach.

Mr Nelson is a volunteer and board member for common cathedral, a nonprofit faith organization focused on the homeless community, providing weekly worship on the Boston Common, Street Ministry, educational outreach program to youth and their support entities.

Patrick O Gee, Sr, PhD, JLC, is Founder & Chief Executive Hope Dealer, iAdvocate, Inc. Dr Gee graduated from the American University School of Public Affairs in 2012 with a Doctor of Philosophy in Justice, Law & Criminology. Dr Gee is a former Peritoneal/Hemodialysis patient due to suffering from Diabetic Kidney Disease. He has been a Post-Kidney Transplant Recipient since April 2017. Dr Gee is also a retired Major/Chief of Security from the Virginia Department of Corrections; and currently serves as the Founder & CEHD of iAdvocate, Inc., a non-profit Faith-based Health & Wellness organization. He is also an Ordained Minister at Mountain Movers Ministry in Richmond, VA. As a Patient Representative for the Diabetes Kidney Disease-Collaborative Task Force and an advocate for those living with chronic kidney disease and the morbid conditions that contribute to this disease, such as diabetes, cardiovascular disease, hypertension and obesity, Dr Gee uses his personal experiences to teach, coach, mentor and educate others on how best to manage their outcomes. He also ensures that underserved, undervalued and disenfranchised communities of color have a voice in their quality of life and equitable healthcare access. He also serves as Chair of the Kidney Health Initiative's Patient Family Partnership Council and is on ASN's APOL-1 Kidney Disease Steering Committee.

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As CEO, Carlos Orantes provides leadership and strategic direction for site network. With over 30 years of experience within the life sciences industry, his career has included executive leadership, operational management, LEAN Six Sigma process improvement, as well as systems and technology deployment.

Most recently, Mr Orantes served as Executive Director, Site Operations for Accelerated Enrollment Solutions, a business of PPD and ThermoFisher Scientific. There, he led the site operations for the Americas site operations in support of the company’s vast global clinical trial network.

Prior to joining PPD, Mr Orantes served as Chief Executive Officer of Amplify Clinical and Accel Research Sites, where he developed the business strategy to effectively compete in Phase II-III clinical research involving multi-therapeutic trials and specialty vaccines. He also led activities related to both companies’ asset purchase by private equity.

Earlier career positions included 20 years of operational, quality assurance, process improvement and laboratory management roles of increasing responsibility at Covance, now part of LabCorp.

Mr Orantes earned a Master of Business Administration degree from Old Dominion University, and a Bachelor of Science degree in biology from George Washington University. He is a certified Lean Six Sigma Black Belt from Six Sigma Academy.

Michelle Ouellette is dedicated to creating patient partnerships for clinical development. In her current role she leads new initiatives that bring together stakeholders to advance the Syneos Health and Patient-Powered Medicine mission to harness the power of lived experience by researching and applying real world insights to drug development and delivery. Ms Ouellette has 15+ years of experience in health marketing communications including pharmaceuticals, spanning therapeutic areas and in both pre- and post-marketing. Ms Ouellette serves on the board of the White Coats Foundation, a global organization that aims to raise awareness about the role of clinical trials in advancing medical science and healthcare. Ms Ouellette enjoys yoga, travel and volunteer work with Cavalier Rescue USA.

Ylenia Paleari, PhD, is a rare disease expert with almost a decade of experience in the industry. She has worked at Chiesi Farmaceutici SpA for five years, leading the Global Rare Diseases R&D Patient Engagement team. Her team is responsible for incorporating the patient perspective into every aspect of the drug development process. With her deep knowledge of the rare disease space and experience in academia and industry, Dr Paleari is committed to translating basic scientific research into effective therapeutic interventions. She has held various positions in academia and industry and moved from pre-clinical to clinical research. In addition to her work at Chiesi, Dr Paleari serves as a local patient association board member dedicated to raising awareness about rare cancers. Dr Paleari is passionate about making a positive impact in patients' lives, and her work reflects that dedication.

Eugenia Pankow is a crucial member of the Servier Pharmaceuticals Patient Advocacy and Engagement team. As the US Research & Development (R & D) Advocacy Lead, Ms Pankow assures that patient engagement in the research process meets the expectations of regulatory bodies, advocacy organizations and internal and external stakeholders. She works to enhance the clinical development process by engaging patients, caregivers, and advocacy groups. Ms Pankow plays an integral role in developing and maintaining advocacy group relations, and is committed to elevating the insights of patients, caregivers, and advocacy groups throughout the clinical development process. Ms Pankow started her career working for the NJ Child Protective Services agency advocating for abused and neglected children. Her time in child protective services led her to serve as the director of a NJ nonprofit adoption agency. She worked with children, birth parents and adoptive parents in building families and providing resources and services for them. Seeking another avenue to utilize her social work skills and nonprofit experience, Ms Pankow obtained a position with AbbVie as a patient advocate specializing in Crohn’s, Ulcerative Colitis, Psoriasis and Psoriatic Arthritis. She remained with AbbVie for five years before securing a position at Allergan on their newly established patient advocacy team. While at Allergan, she worked with her cross functional teams, patients and advocacy groups specializing in the areas of rare disease and gastroenterology. Being an advocate for those in need has been a common theme in Ms Pankow's career and throughout her life. Ms Pankow has dedicated her life to serving and supporting others throughout her career.

Kristin Parkhurst is an Associate Director, Global Trial Optimization - Diversity, Equity, and Inclusion (DEI) at Regeneron. In her role, Ms Parkhurst leads the DEI in Clinical Trials capability within Global Trial Optimization ensuring DEI considerations are embedded into strategic study planning and execution processes across the portfolio. With more than 12 years of industry experience, she started her career in medical devices before transitioning to the Phase I unit at MD Anderson Cancer Center. It was there that she fell in love with clinical trials and the patient journey, which she has carried with her ever since. At ICON, she was a Global Clinical Trial Manager assigned to Pfizer first supporting cardiovascular and later vaccines. She then moved into Site Identification and Feasibility, supporting a wide variety of sponsors and therapeutic areas before coming to Regeneron.

Emily Parks is a chronically ill young professional based out of the Washington DC area working in behavioral health and patient advocacy. Having been diagnosed with short bowel syndrome in infancy and unable to absorb nutrition orally, she was dependent on Parenteral Nutrition until receiving an isolated small bowel transplant from MedStar Georgetown University Hospital.

Despite these challenges, Ms Parks has both traveled and lived internationally, is a graduate of Boston University and currently works outside of Washington DC as a Supervising Vocational Specialist. In this role, she coordinated a team that aids individuals with mental illness in obtaining and maintaining employment. Combining her expertise in behavioral health with her lived experience of navigating multiple tertiary hospitals firsthand has led her down the path of studying the impact of medical trauma and medical PTSD on patients and their treatment outcomes as well as the power of conscious communication throughout the US healthcare system.

Ms Parks serves as the Massachusetts Pilot Director for Health Advocacy Summit, a member of Young Adult Representatives of RDLA through the EveryLife Foundation for Rare Diseases, the secretary of MedStar Georgetown Hospital’s Patient & Family Advisory Council for Quality and Safety and has been an invited speaker at multiple national forums.

Nisha Patel, MBA has over 20 years of practical experience in the pharmaceutical and healthcare industry. In her current role at GSK, she is looking to make an impact towards inclusivity in clinical trials and overall health equity. Ms Patel started her career working as a clinical pharmacist at different health systems and outpatient clinics in Philadelphia.

She has held a variety of different roles bringing leadership and a deep knowledge of the drug development process from molecule to medicine. She has expertise in multiple disciplines (R&D, Global Medical Affairs, Clinical Operations, Commercial) in the following therapeutic areas: CNS, Oncology, Respiratory and Biologics/Biosimilars.

She attended Drexel University where she received an MBA and a Bachelor of Pharmacy from University of Science in Philadelphia. She has a passion for education and communication with a focus on patients.

Bray Patrick-Lake, MFS, recently joined FDA CDRH’s Digital Health Center of Excellence where she supports partnerships and projects related to patient-generated health data, digital measures, decentralized trials and remote monitoring to promote patient access to digital health technologies to improve their health. She began her career as the founder/executive director of a patient advocacy organization. Most recently she served as Senior Director of Strategic Partnerships at Evidation Health, where she developed field shaping collaborations to support the regulatory and clinical acceptance of digital measures, and design digital health programs that engaged patients in achieving next best health actions. She has served on the Digital Medicine Society’s Scientific Leadership Board and DataCC steering committee, and steering committees for Reagan Udall Foundation IMEDS and Medtech Color. Past service includes the All of Us National Advisory Panel, National Academies of Sciences, Engineering and Medicine Health Science Policy Board, and PCORNet’s Executive Leadership Committee. Additional roles include Director of Stakeholder Engagement for the Clinical Trials Transformation Initiative (CTTI) where her work involved bringing patient advocacy organizations, industry, academia and government stakeholders together in CTTI’s efforts to improve clinical trials. Later as Director of Patient and Stakeholder Engagement at the Duke Clinical Research Institute she led patient engagement efforts for numerous industry sponsored studies and federal research programs. During this time, she co-chaired the Advisory Committee to the NIH Director that authored the vision for Precision Medicine Initiative’s Cohort Program (now All of Us Research Program), which led to her role as Interim Director of Engagement.

Karen Peterson is the Founder and Chief Patient Advocate of Karen’s Club, Ms Peterson was inspired to help other patients of color, understand the complex and sometimes skeptical world of clinical trials.  A Stage IV Triple Negative Breast cancer survivor, Ms Peterson is also a founding member of the Patient Community Council at Foundation Medicine, a consultant for Blue Note Therapeutics and a Cancer Research Institute- Immuno Advocate.  Ms Peterson was the featured patient speaker at the Biden Cancer Initiative’s 2019 presentation at ASCO, and the 2020 Inaugural AACR Cancer Disparities Progress Report presented to Congress.  Her inspiring story has been shared with Cure, Essence, Health and People magazines as well as ABC Radio Networks “Perspective” and The Today Show.  Lastly, Ms Peterson successfully completed the exclusive 2021 Robin Hood/Blue Ridge Labs Fellowship Program, where she co-created (with her partner Nava Friedman) the highly anticipated advocacy platform https://www.karensclub.org/

As a self-taught programmer and serial entrepreneur, Maria Picone brings more than 20 years of experience managing operational and strategic ventures in the biotech and pharmaceutical industries. After their daughter was born with Prader-Willi Syndrome, Ms Picone and her husband committed to creating solutions for rare diseases and founded TREND Community. She uses her platform as Founder and CEO of TREND to advocate for and bring hope to people living with rare, chronic and emerging diseases.

Heather Pin has spent most of her career in project, program and change management for pharma software development and implementation. She joined Sanofi in 2014, and currently works in the global Patient Informed Development & Health Value Translation department. Ms Pin and her team drive reporting and impact measures with a razor-sharp focus on commitment to listening and translating patient concerns and insights. This analytical data provided by Ms Pin and her team delivers new health care solutions so that patients can experience improved quality of life. Ms Pin’s other duties include providing operational, interdepartmental and business management solutions.

Racquel Racadio, MPH, is the Global Director of External Medical Engagement in Amgen’s R&D Organization. She provides strategic leadership in the external healthcare ecosystem via relationships with professional societies, cooperative groups and thought leaders. She also partners with internal and external teams to advance patient engagement, health equity and diversity in clinical research goals. She founded and, until a few months ago, directed Amgen’s RISE (Representation in Clinical Research) Team, which is fully dedicated to improving the diversity and representation of patients and investigators from historically excluded groups across Amgen’s clinical research programs. In that role, Ms Racadio oversaw the embedding of inclusive research principles across the clinical trial lifecycle and drove engagement with the broader stakeholder community to listen, learn and partner on efforts pursuing greater health equity. Ms Racadio has been with Amgen for 5 years and in the life sciences for 15 years, bringing an extensive background in developing and executing clinical trials and public health research studying racial, ethnic and gender-related disparities in health care access and health outcomes.

Swathi Ramesh is the Director of Patient-Centered Developed for the Early and Late Respiratory and Immunology (R&I) Therapeutic Areas at AstraZeneca. In this role, she works closely with the Chief Medical Office’s Patient Sciences team to deliver patient centric services to program and clinical trial teams in R&I. This includes the areas of patient insights, clinical trial diversity and inclusion and collaborating with patient organizations. Prior to this role, she started in MedImmune as a Clinical Project Manager, overseeing early R&I studies. She continued this role within AstraZeneca, where she also managed a COVID-19 clinical trial. She has extensive knowledge about clinical operations, patient centricity within R&D in pharma. Before this, she worked in the hospital setting as a research coordinator, managing clinical trials in numerous therapeutic areas which include: neurology, neurosurgery, cardio-thoracic surgery, interventional cardiology, hepatology and infectious diseases. She is passionate about advocating for the patient and site voices in clinical trial drug development and looks forward to contributing to the fast-growing landscape of patient centricity within drug developing to co-create studies with patients.

Ash Rishi is founder and CEO of COUCH Health, a global creative health engagement agency that serves to make health research inclusive. Its focus covers a range of solutions, including patient insights and engagement through to recruitment and retention within health research. Mr Rishi has over 15 years of experience in the industry, navigating the diverse needs of big pharma through to smaller biotech companies. With experience that covers the full medicine lifecycle, from pre-clinical to lifecycle management, his passions lay in working to make research more inclusive and has founded Demand Diversity a non-profit in 2023.

Donna Sattler is a Diversity and Inclusion advocate, leading internal and external industry initiatives to improve health equity by implementing inclusive standard data collection and analysis strategies to engage marginalized populations. Ms Sattler has supported Data Management and Statistical Programming roles for over 22 years. As a clinical data standards specialist, she has demonstrated an understanding of clinical trial tools and processes, gaps in those processes, and created opportunities to make improvements for better data standards harmonization and compliance across the enterprise.

Core Competencies: CDISC/CDASH & SDTM Standards implementation, data integration, compliance tools, project management, mentor, coach and line management. PROUD LGBTQIA+ ally. Disability Advancement Working Group lead team member, driving patient and communities’ initiatives. Industry partnerships: CDISC, Pharma SUG, PhUSE, DIA: Planning and Academic Committees & working groups. Currently an active member of CDISC: CAC Member, CDASH Co-Lead and SOGI working group member.

Peter Schaeffer, MBA, has worked in the pharmaceutical industry for approximately 20 years in both the Pre-Clinical and Clinical areas. During this time, he worked in roles to improve performance and decision making, led continuous improvement programs and collaborated with teams to drive new ways of working. In his current role of Digital and Process Optimization at GSK, Mr Schaeffer is focused on finding and implementing digital health solutions to improve patient, site and sponsor ability to deliver clinical trials. He also co-leads the Patient Experience workstream for TransCelerate, aiming to improve participant experience on trials.

Roslyn (Roz) Schneider, MD, MSc, FACP, FCCP, is a physician and patient, dedicated to human-centered design in healthcare and research. That is, intentional listening, partnering and co-creating with people living with various conditions to accelerate positive outcomes.

The consistent thread through Dr Schneider’s career is aligning practices with what people articulate they need and want in their lives. She’s practiced Internal Medicine, Pulmonary, and Critical Care Medicine, hospital administration, academia, consulting, and in industry where she's co-created guidance, tools, and calls to action toward making person-inclusiveness standard practice across the industry. Separate from her BioMarin role, in the community, Dr Schneider is Chair of the Board of the American Lung Association’s New Jersey Chapter.

Dr Schneider received her Medical Doctorate from Mount Sinai School of Medicine in the US, and Masters in Pharmaceutical Medicine from Hibernia College in Ireland. She practiced and led postgraduate medical training for 20 years and was a Clinical Professor of Medicine at the Albert Einstein College of Medicine. She was awarded Global Fellowship in Medicines Development by GMDP Academy in 2023, is a fellow of the American College of Physicians, American College of Chest Physicians, recognized in 2021 by CUNY School of Medicine with their Strong Women in Medicine Award, and in 2023 with their Dean’s Distinguished Alumna Service Award.

Rick brings 25 years of pharmaceutical industry experience and leads Jumo Health's Sales, Customer Success, and Marketing teams. Before joining Jumo Health in 2018, Rick led the new business growth efforts for health care agency, Greater Than One.  He has also served in several leadership positions with WebMD/Medscape, and spent nearly a decade in sales leadership at Epocrates contributing to the Company's successful IPO and subsequent acquisition by Athenahealth.

Ebony Scott is currently in the role of Senior Manager, Patient & Community Engagement, Digital Optimization on the RWE Clinical Trials team at Walgreens Boots Alliance. For 15+ years she has led or partnered on initiatives that address health inequities and the underrepresentation of communities of color in clinical research. Prior to her current role, she led the health equity efforts at the Lupus Research Alliance (LRA), and its clinical trials management affiliate Lupus Therapeutics (LT) as the Director of Health Equity. In this role, she developed Project CHANGE by LT: Community-based Health Action Network to Generate Trial Participation and Eliminate Disparities. Project CHANGE is based on the principles of Community-Based Participatory Research in identifying inequities that negatively impact participation in lupus clinical trials among African American/Black lupus patients, and the creation of solutions through partnership with community stakeholders.

Jessica Scott, MD, JD, is a Patient Engagement leader who brings to Legacy Health Strategies a combined acumen of medicine and law, together with innovative thinking allows her to drive culture change in medical product development within organizations which results in mutually beneficial outcomes for patients and industry. She is also an experienced ambassador for medical policy issues and patient engagement to organizations and agencies on a global level.

Dr Scott is known as a credible and trusted thought-leader and collaborator, bringing novel solutions, digital strategies, and patient-centered approaches to biotech, med tech and pharmaceutical industries and across multi-stakeholder groups.

Dr Scott has deep knowledge of the pharmaceutical industry with senior leadership positions at both GlaxoSmithKline and Takeda where her focus has been on building patient perspectives into the process of R&D, enhancing trust and fostering a sense of true partnership with patients. She leads by inspiring others and engendering high levels of engagement with skillful, timely, and consistent delivery of initiatives and solutions that bring more medicines of value to patients, faster.

Dr Scott has received awards for innovative and impactful work in Patient Engagement including the Trail Blazer Award and PharmaVoice100 as one of the top 100 most inspiring leaders in the industry. She is actively involved as a strategic advisor to Bioethics International, Patient Focused Medicines Development, DIA Patient Advisory Council and remains actively licensed to practice law in North Carolina where she also practiced as a Family Physician for over a decade.

Mark Scullion is the CEO of Atlas Clinical Research, a therapeutically driven clinical research site network built on centralized process excellence and integrated technology. Mr Scullion has spent more than 17 years in the clinical research industry. Before Atlas, Mr Scullion was most recently the Global Head of Trial Monitoring for Novartis AG, and also previously held leadership roles at Syneos Health and IQVIA, where he developed novel approaches to clinical trial design and execution. At Novartis Mr Scullion led a group of clinical professionals delivering over 300 clinical studies in partnership with 14,000 investigative sites across the world.

With over 25 years of experience in the biopharmaceutical and contract research organization (CRO) industry, Samir Shah is a pharmaceutical executive with documented expertise in developing new verticals and platforms in the clinical development sector of pharmaceutical services. Mr. Shah’s most notable achievement has been the pioneering, developing and maturing a new outsourcing paradigm (Functional Service Provider Model) for large and midsize bio-pharmaceutical organizations to prosecute their clinical development portfolio. This new paradigm now represents a multi-billion dollars of annual R&D spend. Mr. Shah’s expertise and focus is supporting biopharmaceutical organizations with evaluating core/critical/non-core competencies, workforce optimization models, and unlocking outsourcing optimization value in clinical development. In addition, he is well-versed in complex integrations creating sustainable and nimble organizations, M&A activities for scale and new offerings, and innovative enterprise deal development and maturation. This new paradigm now represents multi-billion dollars of annual R&D spend.

Rucha Shah has been living with a rare disorder. Her commitment lays in advocating for accessible healthcare and improving health outcomes for the broader patient community, especially the next generation of patients. Currently, Ms Shah leads a patient advocacy group for patients and caregivers at the Children’s Hospital of Philadelphia and the Hospital of University of Pennsylvania. She also collaborates with various national organizations and pharmaceutical companies on bringing forth initiatives which make meaningful connections within the disease community, improve the quality of life for patients and to increase awareness within the larger community.

Ms Shah attained her Master of Science degree in Clinical Research Organization and Management from the Drexel University School of Medicine in Philadelphia, PA. She further completed certificate coursework in Advancing Health Equity from ECOG-ACRIN Cancer Research Group and Research Advocacy Network as well as certificate coursework in Artificial Intelligence in Pharma and Biotech from the Massachusetts Institute of Technology. Professionally, Ms Shah works as a clinical research project manager within the oncology space. She strives to apply the "lessons learned" from her patient advocacy experiences to her professional work by building the trials to be more patient centric and accessible.

Recent Works: Woolford T, Andemariam B, Blaylark R, Colasanti R, Shah N, Jonassaint C, Trimnell C, Sheth S, Davis J, Gallagher E, Zaidi AU, John H, Shah R. Setting Industry Standards for Patient Engagement, Partnership and Care: The Patient Vision Project. Poster and Oral presentation at NORD. October 16, 2023. Washington DC, USA.

Lisa Shea, MPH, RD, is the Scientific Patient Engagement Research Lead at Johnson & Johnson. Her team is responsible for connecting Medical and Scientific Affairs colleagues across 5 therapeutic areas with patients and caregivers directly to listen and act on their insights and enable a patient-inclusive approach to research. The team has a strong commitment to amplify the patient voice externally to help shape the healthcare decision-making.

Prior to her current role, Ms Shea led the strategy and operations of a newly-designed evidence generation planning process to align marketing and research functions across the therapeutic areas for optimized research execution and ensure external stakeholder needs are prioritized. Prior to joining Janssen, Ms Shea led the external engagement strategy around the use of comparative effectiveness research (CER) and patient-centered outcomes research as a Health Policy Liaison at GlaxoSmithKline, ensuring policy positions were grounded in scientific evidence.

Prior to her work in industry, Ms Shea worked for a non-profit designing and implementing a school-based training program using community-based participatory research techniques and evidence-based resources. She is a trained Registered Dietitian who continues to instill a passion for health, wellness and patient-centered research and innovation every day.

Ms Shea received a Master of Public Health degree at Drexel University in Philadelphia and completed her dietetic studies at James Madison University in Virginia.

Regan Sherman has a diverse work experience in the field of patient advocacy and communications. Ms Sherman most recently was the Director & Head of Patient Advocacy at Entrada Therapeutics, where they were responsible for establishing and leading patient advocacy engagement. Prior to that, they worked at Orphazyme A/S from 2018 to 2021, serving as the Director & Head of Patient Advocacy Relations. At Sanofi Genzyme, they held the position of Associate Director of Rare Diseases Patient Advocacy from 2015 to 2018, managing relationships with the rare disease patient community and facilitating partnerships with patient organizations. Before that, Ms Sherman worked at JPA Health Communications as an Account Director from 2011 to 2015, specializing in advocacy relations for healthcare clients. From 2008 to 2011, they directed communications activities at the Cancer Support Community, and from 2006 to 2008, they were a Coordinator for Scientific Programs at the American Society of Clinical Oncology.

Ms Sherman attended James Madison University from 2002 to 2006 where they obtained a Bachelor of Arts (BA) degree in Health Communication Studies.

TBA

Wendy Slavit is a Senior Health Scientist in FDA’s Patient Affairs within the Office of the Commissioner. In her role, she collaborates with patient communities and the FDA medical product Centers to incorporate patient and caregiver perspectives into FDA’s work. Ms Slavit leads and manages FDA’s Patient Engagement Collaborative (PEC). She has over 20 years of experience translating science, health research, and policy into easy to comprehend information for patients, caregivers, and the public. Ms Slavit has a Master of Public Health (MPH) from Emory University and a BA from Tufts University. She is also a Certified Health Education Specialist (CHES).

Jaye Bea joined Immunovant, Inc., a clinical stage biotech company, as Head of Patient Advocacy in June 2020. Her twenty-five-year career in health care includes extensive experience in the public and private sector focused on advancing the needs and interests of patients and caregivers. Prior to joining Immunovant, Jaye Bea was Celgene’s Global Director of Patient Advocacy and Life Cycle Management, Inflammation & Immunology. Prior to Celgene, Jaye Bea worked at Boehringer Ingelheim where she helped establish and implement a patient engagement strategy. Prior to Boehringer Ingelheim, she was an Engagement Officer at the Patient-Centered Outcomes Research Institute where she helped establish programs and processes to bolster patient and stakeholder engagement in research and monitor PCORI’s funded portfolio for innovative patient engagement methods and practices.

Su Smith is Head of Patient Strategy at Origins, the patient focused specialist agency. Origins transforms our client’s strategies and results through connecting them with the power of the patient. Our patient focused work delivers significant incremental value across medical, clinical development and regulatory approval and market access around the globe. We enable our clients to truly put the patient at the heart of everything they do and realize greater success as a result. Ms Smith works closely with our clients and patient experts to design programmes that create value and leverage the power of the patient. Ms Smith is known for her passion, strategic counsel and problem-solving prowess.

Erica Smith, PhD, SVP of Business Development at Spencer Health Solutions, is an accomplished business development and scientific executive. Erica has played an integral role in transforming the sales and marketing organizations of several companies throughout her career, including positions at Cognivia, Charles River Laboratories, Pfizer, and others. Erica received her PhD in Biomedical Engineering from The University of Michigan in Ann Arbor.

A proven biopharmaceuticals and healthcare solutions strategist focusing on life science process improvement, Mr Sonbol has nearly 20 years of experience in Phase I-IV, IDE and 510(K) clinical research and healthcare business operations. He’s successfully managed a data management organization and worked with Fortune 500 companies such as Medtronic, Abbott Vascular and Johnson & Johnson. Through breakthrough strategies, Mr Sonbol helps achieve notable results in improving clinical trial outcomes.

Brett R South, MS, PhD, is a Medical Informatics specialist, Global Medical Patient Impact Assessment (GMPIA) within Worldwide Medical and Safety at Pfizer. Dr South received his doctorate in Biomedical Informatics from University of Utah which instilled a strong love and passion for implementation of technology applied to healthcare particularly as it relates to the use of AI and its potential impact on patient outcomes and clinical decision making. In Dr South’s role he partners with other colleagues to apply biomedical informatics, artificial intelligence (AI), natural language processing (NLP), machine learning (ML) approaches to support informed values-based decision making. These activities focus on use of AI-assisted sentiment analysis, use of LLMs to develop patient facing content including infographics and plain language summaries. As well as automation of literature scoping and scanning, and application of technology to support horizon scanning, evidentiary body assessment, identification of KoL (experts and institutions) to support opportunities for collaboration and development of priority assets. Prior to joining Pfizer, he worked as a Biomedical Informatician at IBM Watson health and spent many years working as a researcher and investigator with the Department of Veteran’s Affairs and in academic medicine at University of Maryland, and University of Utah.

Alicia Staley is the VP Patient Engagement at Medidata.  She has over 20 years of experience in software design and information systems management and works to infuse the patient perspective throughout the product development lifecycle and help engage patients in novel ways.

Alicia is also a three-time cancer survivor, first diagnosed with Hodgkin’s disease as a sophomore during college. Over the past 10 years, she has applied her engineering background to improve the patient experience for those dealing with cancer.  With an extensive network of patient advocates and non-profit organizations, she collaborates with a wide range of stakeholders to improve processes and policies that affect patient care and clinical trials.  She has co-led several research studies on how patients share information in online forums and seek out clinical trial opportunities.

An early adopter of social media, she co-founded #BCSM, which attracts over 1,000 global participants each week to its scheduled online discussions. Since its launch, #BCSM has been showcased at SXSW in 2013, 2014, 2015, and 2017 and is recognized as the gold standard for disease-specific social media networks.  She’s co-led numerous research studies on how patients share information in online forums

She is the 2019 eyeforpharma Patient Champion award winner for her extensive patient advocacy and engagement work. She truly understands the critical issues facing patients seeking to engage in clinical research.  With a keen focus on improving access to clinical trials, Alicia is passionate about making a difference for patients seeking clinical trials.

Jean Stimola-Sposaro has over 20 years as a healthcare provider, patient advocate and educator and 17+ years in Pharmaceutical R&D [Pharmacovigilance & Epidemiology, Clinical Quality & Safety, Bioethics, Patient Engagement & Patient Focused Drug Development], focusing on the value of industry collaboration to ensure the accelerated development of the highest quality, safe and effective, innovative, “fit for patient” treatments and healthcare solutions. Ms Stimola-Sposaro has obtained a Masters in Healthcare Pharmaceutical Law & Policy later in her career journey that provided her with the foundational knowledge necessary for an integrated regulatory perspective and meaningful engagement strategies which will matter most to patients and their loved ones. Harnessing the power of all stakeholders to secure an ecosystem where patients, care givers, advocates and health systems ensure global health equity, diversity and patients as well-informed decision makers when it comes to their own healthcare choices and treatment options.

Stephanie Terrey is the senior director of patient experience research at CorEvitas, part of Thermo Fisher Scientific, leading the team in conducting qualitative and quantitative research with patients and caregivers that cultivate accurate and meaningful insights to assist clients in the development of patient-centric programs. Ms Terrey has over 15 years of experience conducting and overseeing research in pharmaceutical and nonprofit settings. Ms Terrey previously worked at IQVIA as the associate director of patient insights and at RTI International as a research scientist. Ms Terrey earned a BA in psychology from Meredith College and a MA in industrial and organizational psychology from East Carolina University.

As the President and Chief Executive Officer, Veronica (Ronnie) Todaro is the leader of the organization and is responsible for all aspects of the overall path and direction of the firm in collaboration with other leaders and the team. She provides strategic counsel to key clients as well as thought leadership in specific areas. Prior to joining VOZ, Ms Todaro has served as the Executive Vice President and Chief Operating Officer for the Parkinson’s Foundation since 2016 where she led the development and execution of strategy and day-to-day operations. Prior to her role as EVP, COO, Ms Todaro held the role of Vice President of National Programs at the Foundation, where she created and drove patient engagement initiatives for more than a decade. Ms Todaro is a pioneer in the field of patient engagement and advocacy within the Parkinson’s and broader disease community and has been an invited speaker at national and international conferences. She is a founding member of Patient Focused Medicines Development (PFMD), serving on the Board and Executive Committee, and has served as Chair of the Patient Leadership Council and on the Executive Committee for the Clinical Trials Transformation Initiative (CTTI); as a member of the Patient Engagement Advisory Panel for the Patient-Centered Outcomes Research Institute (PCORI); and on the Advisory and Program Committees for the Global Annual Meeting of the Drug Information Association. Ms Todaro earned her MA in Public Health in Planning and Administration from the University of Michigan and her BA in Public Policy at Cornell University.

As the Clinical Digital Health and Innovation Lead within Global Clinical Development at Chiesi, Dr Eva Topole spearheads diverse cross-functional collaborations with the aim to integrate digital health solutions into patient-centric clinical trial designs, aiming to alleviate patient and site burden. Her primary focus extends to defining novel endpoints that align with patients' needs, achieved through collaboration with clinical teams across various respiratory therapeutic areas. Leveraging her clinical expertise and profound knowledge of respiratory therapeutic area, coupled with a passion for innovation, Dr Topole collaborates with relevant functions in R&D to build capabilities that enhance clinical trials, ensuring they better cater to patients' needs and provide insightful data across different respiratory therapeutic areas.

Before joining the pharmaceutical industry, Dr Topole served as a Senior Consultant in Respiratory Medicine and led the Functional Respiratory Diagnostic Department at the University Clinic of Respiratory Disease and Allergy in Golnik. Subsequently, she assumed the same role at the University Medical Center Ljubljana.

Shawn Trutna is Senior Patient Engagement Lead at Syneos Health and is responsible for the strategizing, developing, and implementing patient and retention initiatives that pertain to strategic accounts at Syneos Health. Mr. Trutna has held previous positions in the last 17 years that have focused on research site recruitment optimization, digital outreach campaigns, HCP referring platforms, and connecting with patient advocacy organizations. He has a passion for problem solving and optimizing patient awareness initiatives in clinical research studies in multiple indications. Shawn earned a MS degree in Exercise Physiology from East Carolina University and a MS in Clinical Research and Development at Campbell University. In his spare time, Shawn enjoys spending time riding his bike with his MS Bike team members and listening to new music when his 9 year old son allows him to.

Rebecca Vermeulen, RPh, brings a variety of experiences and capabilities to her role as Head of Patient Partnership for Global Medical Affairs at Roche. She has spent over 30 years in the pharmaceutical industry and has served in a variety of functions including Medical Affairs, Clinical Research, Sales, Medical Communications, Medical Science Liaisons, Patient Partnership, Digital Health and Six Sigma. Ms Vermeulen has led teams spanning multiple organizational units and has been responsible for creating global standards for engaging with healthcare professionals and patients. Having served as a senior leader for a number of years, she knows how to demonstrate value in bringing new medicines to patients. Ms Vermeulen is currently a board member for Patient Focused Medicines Development (PFMD), Champion for the Roche International Women’s Network, Past Chair Board of Directors for the Drug Information Association (DIA), Chair Emeritus Corporate Board of Directors for the Healthcare Businesswomen’s Association (HBA). Ms Vermeulen was also recognized as one of the 100 Most Inspiring People in the Life Science Industry by PharmaVOICE 2020.

Desirée A. H. Walker was diagnosed with breast cancer at age 38 with a recurrence at 47. Her diagnoses motivated her to become a patient advocate to share her talents and aid diverse communities. She uses her platform to be a voice for the voiceless and pay it forward by educating and empowering people around the world. She serves as Young Survival Coalition’s Board President and is a member of the National Coalition for Cancer Survivorship’s Cancer Policy Advocacy Training; the Society of Integrative Oncology’s Patient Advocate and the Health Equity, Inclusion and Belonging Committees; and the NCI SWOG Recruitment and Retention and Patient Advocate Committees, among many others. She also facilitates support groups for women of African descent who are dealing with breast and gynecological cancers. Ms Walker has appeared on ABC World News with Dr. Richard Besser, CBS with Dana Tyler, NBC’s TODAY Show, The Good Fight with Pat Battle, Here and Now with Sandra Bookman, The Breakfast Club with DJ Envy, Angela Yee and Charlamagne Tha God and NBC’s Weekend Today in New York. She is a graduate of the National Breast Cancer Coalition’s (NBCC) Project LEAD®. As a patient and research advocate, she brings her experience to a team of cancer researchers at Columbia University’s Mailman School of Public Health, the University of Wisconsin-Madison, Memorial Sloan-Kettering Cancer Center and Weill Cornell Medicine. She feels blessed to enjoy time with family and friends and bakes gourmet bread pudding. She is a foodie, enjoys traveling, the performing arts and sporting events.

Henry Wei, MD, is Executive Director, Development Innovation at Regeneron, aimed at accelerating clinical research. Dr Wei previously worked at Google, the White House, Aetna, and McKinsey. Dr Wei has co-authored several patents on applied artificial intelligence in healthcare and on real-world data, outcomes and drug safety. He earned his MD at Cornell, his graduate and undergraduate degrees at Harvard University, and did additional informatics training at Stanford and Harvard.

Dr Wei is an adjunct faculty member at Weill-Cornell Medicine in Health Policy and Research. He currently leads TransCelerate’s pragmatic trials workstream within the Real-World Data initiative.

Dr Westergaard’s role at Evernorth focuses on designing solutions that use integrated health data to improve clinical trial efficiency, such as real-world data informed study design and site selection for faster patient recruitment. Dr Westergaard’s unique blend of clinical trial and pharmacy experience combines the perspectives of patients, payers and network partners to create innovative solutions that improve patient care.

As President, Angie Wheeler leads the US marketing research business within Lumanity. Her role includes partnering with the Life Sciences Industry to provide deep understanding, leverage insights, and identify opportunities to drive product commercialization and optimization. She is privileged to lead the Patient Center of Excellence at Lumanity, which is committed to improving patients’ health by accelerating and optimizing access to medical advances. Her passion is elevating the voice of patients within Life Sciences and working to implement patient engagement best practice throughout the drug development lifecycle.

At Novartis, Jennifer Yip’s mission is to find novel approaches to leveraging data and technology to design better clinical trials, accelerate patient recruitment, drive patient engagement, and re-imagine clinical trial data collection and management for the US Medical Affairs organization. Before joining Novartis, Ms Yip held global clinical and commercial digital innovation roles at other big pharma and led global product marketing in eClinical, healthcare, and ad tech technology organizations.

Enming Zhang, PhD, is a data scientist at TREND Community, with a multidisciplinary background in Mathematics, Statistics and Health Informatics. Her commitment to advancing patient-centered health care by applying a holistic approach to patient data was developed during her PhD in Health Informatics at Indiana University Indianapolis.

Mike Zincone is the US Senior Director of Patient Advocacy on Pfizer’s Global Patient Advocacy team. He has 25 years of diverse bio-pharma experience (all at Pfizer) with demonstrated success and credibility in working with patient advocacy organizations and leading teams.

During his tenure with Pfizer he has worked across multiple roles in positions of increased accountability. Some highlights worth noting include:

1) A diversity of jobs which allowed him to work across multiple disease areas that include Diabetes, CVD, Neurology, Women’s Health, Pain, Long Term Care, Oncology, Anti-infectives and Rare Disease

2) 10+ years of directly leading teams at Pfizer across both sales and advocacy based positions

3) 15 years of patient advocacy experience in Oncology, Rare Disease and Public Policy

4) Served on multiple leadership and advisory positions in Pfizer and the advocacy community around topics such as long term care, patient navigation, survivorship, biomarker testing, shared decision making, health literacy, developing patient advocacy functions and patient centered clinical development.

Mr Zincone believes that all successful partnerships are built upon maximizing the collective expertise of relevant stakeholders. From this foundation the sky is the limit on what can be accomplished on behalf of patients. He is a graduate of Rutgers Cook College with a degree in Environmental Business & Science.