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.

Foluso Agboola, MBBS, MPH is the VP of Research at ICER. She is responsible for conducting rigorous analyses and critical appraisals of published medical evidence, managing the broader HTA process on reviews, as well as managing the work of members of the evidence synthesis team at ICER. Ms Agboola’s expertise is in the application of principles of evidence synthesis in healthcare and public health decision-making. Prior to joining ICER in 2016, Ms Agboola worked at Mass General Brigham Center for Drug Policy, where she developed economic evaluations to accompany rigorous reviews of clinical evidence, assessed the potential cost and budgetary impact of a wide range of clinical interventions, performed clinical forecasting, and developed pharmacoeconomic models. Prior to that, she worked at the Harvard T.H. Chan School of Public Health on designing evaluation research and the application of measurement methods to assess public health and healthcare system preparedness. Dr Agboola has authored several peer-reviewed publications, conference presentations, and educational materials.

Dr Agboola earned her medical degree from the University of Ilorin, Nigeria, and her Master of Public Health degree in Quantitative Methods from Harvard University. In her spare time, Dr Agboola enjoys going on a bike ride or hiking with her family.

Amanda Beasley is a Director in the Representation in Clinical Research (RISE) team at Amgen. She has been working in preclinical and clinical research for 18 years. She holds a Master's degree in Clinical Research Administration and a Doctorate in Human Services. Dr Beasley's passion to support marginalized and underrepresented individuals paired with her many years of study management experience help to move the RISE vision and mission forward. She specializes in collaborating cross- functionally to build internal infrastructure to make representative studies a part of Amgen’s everyday work. She also works outside of Amgen’s walls partnering with organizations that work directly in the communities where these people live, work, play, and pray to build sustainable presence and trust.

Dr Beasley joined Amgen in 2018 and has held positions of increasing responsibility. She has also been instrumental in improving Amgen’s informed consent template and process to be more patient-centric and efficient. She actively participates in multiple Employee Resource Groups as well and has held past leadership roles within.

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.

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.

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Stephanie Christopher is a Patient Engagement Lead at Pfizer, where she supports clinical research teams to bring patient perspectives into the design and implementation of clinical trials and recruitment strategies.

Prior to Pfizer, Stephanie was the Associate Director of Research Programs at the National Organization for Rare Disorders (NORD), where she directed the IAMRARE™ patient-powered registry program, which allows patients and organizations to inform and shape medical research for rare diseases by launching high-quality, customized registries to collect the data needed to define the natural progression of their disease. In previous roles, Stephanie helped advance real- world evidence research at one of the largest healthcare systems in the western US, helped develop tools to advance patient input in the regulatory review of new medical technologies and was part of a research team seeking to improve the quality of communication between physicians and patients.

Stephanie received her Bachelor of Arts in Communication from Pacific Lutheran University (Tacoma, WA) and Master of Arts in Science, Health, and Environmental Communication from Marquette University (Milwaukee, WI). Stephanie is a Certified Clinical Research Coordinator (CCRC) and a Fellow of the Association of Clinical Research Professionals (FACRP).

Catherine Coulouvrat, MD, is leading a Health Value Translation Unit, within Patient Informed Development and Health Value Translation at Sanofi, R&D. Dr Coulouvrat is physician, specialized in psychiatry and sleep medicine, with 20 years of extensive experience in clinical development, clinical operations, medical affairs, market access and translational research. Dr Coulouvrat has a successful track record in patient relevant outcomes, clinical development strategy for product launch. Passionate about patients' empowerment, education, understanding unmet needs and disease burden for better integration into the clinical development strategies, she thrives to build health outcomes and innovative care models aiming at improved patient quality of life and access to care.

Savine DaCosta is the Clinical Trial Diversity Site Lead at Biogen. In this role she is accountable for driving the strategies and capabilities to ensure diverse representation within clinical research that reflect the epidemiology of our diseases. She is also committed to building trust in underrepresented and underserved communities by identifying, creating, implementing, and measuring community engagements that educate patients on disease and clinical trials. In addition, She is charged with developing and implementing clinical trial site related diversity initiatives to build sustained engagement and trust with communities, patients, and surrounding sites.

DaCosta's career spans more than 25 years in the Pharma/Biotech industry with highlighted areas in sales, marketing, patient engagement and currently DE&I. She is a natural convener, communicator, and solutions provider. She graduated from Boston University with a Bachelor of Science degree in Business Administration. In addition, she obtained a master’s in business administration from Eastern University in St. David’s, Pennsylvania.

She now resides in Pennsylvania with her husband, Tony and one son, and enjoys photography, basketball, and an enjoyable book. As a forever caregiver to a son who has Cerebral Palsy, DaCosta understands first-hand the various challenges that patients with chronic conditions experience and the emotional, social, and physical isolation and frustrations of caregivers. She is driven to educate and empower patients and caregivers to advocate for better health and consider clinical research as a part of their treatment options.

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Michael is a seasoned non-profit professional with years of experience managing health equity-related initiatives. With a passion for public health and community engagement, Michael has worked on strategies and projects that engage stakeholders across industry, government, and advocacy.

Previously, Michael served as a Budget Analyst for the New York City Mayor’s Office of Management, where he analyzed and administered capital and expense budgets for City-supported infrastructure projects and collaborated with City agencies to address challenges in project implementation. In addition to his experience in government, Michael also has experience in private philanthropy, where he supported the implementation of intersectional strategies to advance equity.

Michael joined the National Minority Quality Forum (NMQF) in October 2021 as the organization’s Collaboration Coordinator, where he managed multi-stakeholder interactions, created data use cases to advance health equity, and co-lead advisory boards to inform operational activities in healthcare.

Since 2022, Michael has served as the organization’s Program Manager, where he oversees data partnerships, strategy development and industry-sponsored initiatives for NMQF's Center for Professional & Strategic Alliances, with a special focus on projects related to clinical trial diversity, nephrology and equitable cancer care.

Michael has a Bachelor of Arts in Public Relations from Harding University and a Master of Social Work from Columbia University in the City of New York. He resides in Queens, NY with his husband.

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.

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Lee A Fleisher, MD, ML (Masters in Law) is the Founding Principal and CEO at Rubrum Advising, LLC, a consulting firm dedicated to identifying strategic pathways, including regulatory counsel, to ensure the highest quality care is adopted and diffused across the healthcare sector. From July 2020-July 2023, he was the Chief Medical Officer and Director of the Center for Clinical Standards and Quality for the Centers for Medicare and Medicaid Services. In this capacity, he was responsible for executing all national clinical, quality, and safety standards for healthcare facilities and providers, as well as establishing coverage determinations for items and services that improve health outcomes for Medicare beneficiaries. He serves as a Senior Advisor of the Bipartisan Policy Center and FasterCures of the Milken Institute, Senior Fellow of the Leonard Davis Institute of Health Economics and Visiting Fellow of the Duke-Margolis Center. He is a member of the Steering Committee of CHAI (Coalition of Health AI), consultant to the FDA Digital Health Advisory Committee and a member of the HITAC of the ONC. From 2004 through July 2020, he was the Robert D. Dripps Professor and Chair of Anesthesiology and Critical Care and Professor of Medicine at the University of Pennsylvania and is currently Emeritus Professor and continues to practice clinically. In 2007, he was elected to membership of the National Academy of Medicine.

As the Corporate Global Head of Accessibility at Merck & Co., Inc., Stephen Framil, DMA has been an ardent advocate and practitioner of equitable access across the range of human experience: including the built environment, food sustainability, education, performing arts, and the digital landscape. With over 30 years of executive leadership in business strategy and innovation, policy and governance, procedure and operations, and portfolio management expertise, Dr Framil continues to lead and champion accessibility in multinational corporations, non-profit education, and the performing arts.

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.

Patrick 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.

Jayne Gershkowitz is one of the founding leaders of rare disease company Amicus Therapeutics and has served as Chief Patient Advocate since 2016. She’s responsible for developing and executing global strategies that ensure that the needs of people living with rare diseases and their families are integrated to all company operations and for keeping extraordinary patient dedication as the bedrock of Amicus. Gershkowitz founded the company’s Patient Advisory Boards program, through which patients, families and caregivers openly share their input and concerns with Amicus; leads Amicus’ Public Policy work to advocate for policies that advance innovation and expand access to satisfy unmet needs of those living with rare diseases; and guides advocacy-based evidence generation resulting in multiple publications co-authored with patient community thought leaders and medical key opinion leaders. She established Healing Beyond Disease™, an Amicus philanthropic and volunteer initiative to further serve the rare disease community in meaningful ways. She is a member of the company’s Executive Committee, reporting directly to the CEO, and sits on the board of directors.

Gershkowitz is widely recognized as a trailblazer in Patient Advocacy. In 2023, she was the Imagine & Believe honoree of National Tay-Sachs & Allied Diseases Association. In 2019, she received the second annual “Heart of BioNJ” Award in honor of her selflessness and dedication to patients in the rare disease community. She is a 2018 PharmaVOICE 100 honoree, recognized for providing inspiration and innovation in the life sciences industry. She often speaks about the strategic function of Patient Advocacy at industry conferences and how it is the essence of patient- focused drug development. She is the treasurer of the Board of Trustees of BioNJ and a member of the Board of Trustees of the Healthcare Institute of New Jersey. Gershkowitz is the co- founder and vice chair of the board of Professional Patient Advocates in Life Sciences (PPALS), a non-profit educational organization committed to supporting the function of Patient Advocacy within the biotech and pharmaceutical industries. Additionally, she was the executive director of National Tay-Sachs & Allied Diseases Association from 1998 – 2006.

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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.

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

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Maimah Karmo is the Founder/CEO of the Tigerlily Foundation (Tigerlily)and a twelve-year survivor of breast cancer. On February 28, 2006, at 4:45 p.m., Maimah was diagnosed with Stage 2 breast cancer. She had no family history and was32-years old. While undergoing her second round of chemotherapy, she launched an organization to educate, empower, advocate for and support young women affected by breast cancer. Tigerlily provides breast health, educational, empowerment wellness and transformational programs to young women. After working with Congresswoman Debbie Wasserman Schultz to develop the Breast Cancer Education and Awareness RequiresLearning Young (EARLY) Act, in October 2011, Maimah was appointed to theFederal Advisory Committee on Breast Cancer in Young Women, a committee established by the Affordable Care Act, on which she works to develop initiatives to increase knowledge of breast health and breast cancer, for women under the age of 45 and those at heightened risk for developing the disease. She is a speaker and media personality, regularly called upon to speak on Capitol Hill and other venues,as a health, advocacy and empowerment expert. In 2015, Maimah advocated withMembers of Congress to ensure that young women had access to breast screening. Tigerlily Foundation flew young women to Washington, D.C. to meet with 74 members of Congress. The visit resulted in doubling theHouse and Senate support for the Protecting Access to Lifesaving Screening(PALS) legislation. The bill was signed into law within a month, protecting the lives and rights of millions of women. Maimah has worked with the Centers for Disease Control (CDC) to launch national campaigns and has served as an Ambassador for National Women’s HealthWeek, an initiative of the Office of Women’s Health. Tigerlily Foundation has launched national and global health initiatives focused on ending disparities, through the #InclusionPledge, partnering with global stakeholders, with a call to action to recognize health disparities as a social justice issue; and working to end disparities for black women in our lifetime.

Maimah has appeared in several nations publications. She has also been featured on Fox 5, ABC 7, CBS, the Oprah Winfrey Show, OWN, Good Morning America, theToday Show. Most dear to Maimah’s heart is her 17-year old daughter,Noelle. Maimah earned her BA in Communications from George Mason University and an MBA from the University of Maryland UniversityCollege. In 2010, Maimah published Fearless:Awakening to my Life’s Purpose Through Breast Cancer. Visit www.tigerlilyfoundation to learn more.

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.

Katie King is the Associate Director and DU Lead of Patient Centricity & Engagement for Biogen’s Alzheimer’s Disease pipeline. She brings a wide range of experience in neurodegenerative and neuropsychiatric diseases from not only the CRO, vendor, and sponsor perspective, but also from her firsthand knowledge as both a patient and caregiver. Katie advocates for authentic empowerment of patients and firmly believes that the patient voice should be woven throughout every facet of the clinical research tapestry. In addition to her work in patient engagement strategy development, Katie has dedicated a significant portion of her personal and professional time to the creation of disruptive digital innovations and is known for challenging the “mental red tape” often encountered within the industry.

April Lewis is a 25-year veteran of clinical R&D, with proven success leading global teams focused on innovating and disrupting clinical trial operations. Ms Lewis has served as a key leader on large transformational initiatives including the Quintiles/IMS merger, and GSK’s “Future Ready” Vx/Rx integration strategy. Currently, Ms Lewis leads Innovative Health at Johnson and Johnson, responsible for the development and scaling of novel and innovative solutions for use across Global Development. Ms Lewis holds an MS in Organizational Psychology. Ms Lewis is a proud girl mom, with 3 college-aged daughters.

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.

Gonzalo Linares is the Global Head of Patient Advocacy in R&D at Johnson & Johnson, bringing over 20 years of experience in patient advocacy and corporate affairs. Based in Basel, Switzerland, he is responsible for bringing a systematic and strategic approach to the way J&J partners with advocacy organizations throughout the R&D process. Mr Linares began his career leading advocacy programs with oncology patient organizations in his native Spain in 2004, and has since held increasingly senior global roles in the UK and Switzerland. Most recently, he served as the Global Head of Patient Advocacy in R&D at Novartis, as well as the Global Executive Director of Patient Engagement Neuroscience at the same company, where he worked across Research, Development, and Commercial organizations to integrate the patient community’s perspective.

When he is not behind his desk, Mr Linares is passionate about nature in Switzerland while maintaining strong ties with his family and friends in Spain. Outside of work, he enjoys mountain biking, meditation, and CrossFit.

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.

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.

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.

Beth Moody has over 17 years of clinical research experience with expertise in immunology, pediatrics, and oncology. In her current role as Senior Manager within the Patient Recruitment & Retention team at AbbVie, she supports the development and oversees execution of programmatic patient recruitment strategies within Immunology (dermatology and rheumatology). She leverages cutting-edge recruitment resources and results in successful acceleration of clinical trial recruitment.

Before AbbVie, she was Senior Strategy Lead, Patient Recruitment at IQVIA. She supported key stakeholders, including Business Development, Therapeutic & Medical Strategy team and Functional Team Members, bringing the patient voice to the solution story through insights and specific Patient Centric Solutions’ products and service recommendations to create a seamless patient journey.

Moody earned her Bachelor of Science in Business Management, Marketing from North Carolina State University in Raleigh, North Carolina.

Jon Nelson is a lived-experience expert in mental health. A healthcare communications executive in the biopharmaceutical space for 20+ years, Jon is a tireless advocate and voice for those who, like him, suffer from mental illness. Jon’s mission is to pulverize the stigma associated with mental illness to help the millions who needlessly suffer in silence.

Jon was first diagnosed with mental illness in 2010 and has participated in numerous treatments since then intended to mitigate against its harmful effects.

Having not shown improvement after exhausting all treatment options, in 2022 Jon became one of only a small handful of people in the US to participate in clinical trials aimed at healing mental disorders and related depression.

Known as deep brain stimulation, the procedure was built on the scientific premise that electrical stimulation could reset brains that are in the grip of powerful and devastating psychiatric disorders such as depression, obsessive-compulsive disorder and post-traumatic stress disorder. The procedure was a resounding success. He has been in remission from depression since the day the device was turned on in August 2022.

Of the many physiological and psychological challenges that Jon has endured over the years, perhaps the biggest one he’s yet to overcome is the stigma that’s often associated with mental illness. In today’s world, the resilience of those who have diseases like cancer is often celebrated while those grappling with mental illness are heavily stigmatized.

Rather than succumbing to the challenges of suffering with mental illness and its stigma, Jon instead chose to channel his experiences into a lifelong mission of advocacy and support. Jon currently serves as a strategic advisor for several not for profits including One Mind and Mental Health Collaborative and as an advisor to Motif Neurotech, which develops minimally invasive bioelectronics to treat and monitor severe mental illness.

Most recently, Jon was invited by the NIH to speak at a congressional briefing to discuss progress from the BRAIN Initiative, which fosters better understanding of the human brain and its potential for revolutionizing treatments for neurological and neuropsychiatric disorders.

Jon previously held executive leadership roles across several companies including Omnicom and Syneos Health.

Jon resides in Newtown, PA along with his wife Barbara and their three children, and when he’s not tirelessly serving as a lived-experience mental illness expert, he can be found on the ice coaching youth hockey.

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.

Ifeyinwa (Ify) Osunkwo, MD, MPH, is the chief patient officer of Novo Nordisk Rare disease. Prior to this she served as the inaugural chief patient officer and senior vice president at Forma Therapeutics. In her role, Dr Osunkwo is responsible for realizing Novo’s vision to transform the lives of patients by improving access and care through partnerships with global patient and community stakeholders while driving an internal culture of patient focused medicine development. Dr Osunkwo is an internationally acclaimed expert in the research, treatment and care delivery of sickle cell disease (SCD), pediatric to adult care transition, and the management of chronic pain. She has a passion for health equity and has focused her research on identifying the comparative effectiveness of interventions in eliminating health disparities in Black and brown populations. She has more than 25 years of experience in clinical management, population health using the chronic disease management model and health literacy. She is an accomplished clinician educator adept at training clinical and non-clinical audiences and is also a visionary leader in pragmatic program development and implementation using quality improvement.

Dr Osunkwo is the Founder & Director of the Sickle Cell Disease Enterprise at Levine Cancer Institute and a Professor of Medicine and Pediatrics at Atrium Health - a vertically integrated healthcare system serving 1400+ adults and 400+ children with sickle cell disease in NC/SC/GA. Previously, she was the medical director of the Comprehensive Sickle Cell Disease Program at Children’s Healthcare of Atlanta @ Egleston and Assistant Professor of Pediatrics at Emory University. She directed the Teen Scene Transition Program that provided care coordination and education to facilitate the smooth transition of young adults from pediatrics to adult care. Dr Osunkwo earned a medical degree from the University of Nigeria College of Medical Sciences and Dentistry and an MPH from Johns Hopkins University School of Hygiene and Public Health. She received her pediatric residency training at the University of Medicine and Dentistry of New Jersey and completed her fellowship in pediatric hematology, oncology and bone marrow transplantation at Columbia University College of Physicians and Surgeons. Dr Osunkwo is board certified in pediatric hematology oncology and has led a robust research enterprise garnering over $15 million in research funding and has served as principal investigator on numerous clinical trials over the course of her career.

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.

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.

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.

Maria Restrepo is the Diversity in Clinical Trials Program Director at Medtronic, a global leader in medical technology, where she leads the company’s efforts to ensure diverse patient representation in clinical trials. Dr Restrepo has over 10 years of experience in the MedTech industry, and she joined Medtronic in 2016 as a leader in the Corporate Clinical Operations team, where she oversaw the strategy and governance of the global organization. Dr Restrepo has a BS in Biomedical Engineering from Universidad EIA in Colombia, and a Ph.D. in Bioengineering from the Georgia Institute of Technology in Atlanta, Georgia. Dr Restrepo has a strong passion for health equity and is committed to removing barriers to achieve this.

Sharon Rivera-Sanchez is the Founder and Chief Executive Director of Trials of Color & Saving Pennies 4 A Cure, both are non-profits 501-C3 organizations founded in 2018, and Trials of Color in 2022. The mission is to educate, advocate, and empower cancer patients with a primary focus on Diversity in Clinical trials, awareness, and prevention.

Born and raised in Augusta, Georgia, in 2015, Rivera-Sanchez was diagnosed with Triple Negative Breast Cancer. She has participated in five medical clinical trials. She successfully completed two, withdrew from two, and she is currently involved in one.

Unfortunately, in 2021 Sharon became a caregiver for her brother who passed away from colon cancer. She is currently a voice for the voiceless, she speaks about colon cancer awareness and screening in the black community. She is also a 2022 Project Lead graduate. Rivera-Sanchez has lobbied US Congressmen and collaborated with local advocates in order to achieve health equity for the African American community.

She also serves on many Boards, just to name a few: National Cancer Institute (NCI) Massey Cancer Center (NCORP) Massey Cancer Center -DEI Advisory Committee University of Pennsylvania- The Radcomp Study University of Pennsylvania -Clinical trial Ambassador) GRASP- Member American Association for Cancer Research (AACR) -Member CPAT - Member

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.

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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.

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Anthony K. Taylor, DHSc, MSPharm, is an experienced leader, executive, former clinical research scientist and U.S. Army medic with comprehensive industry knowledge and a proven record for delivering results within large, mid-size, and small pharmaceutical organizations. Dr Taylor is Project Management Professional (PMP®) Certified and has a solid background in leading global clinical programs and teams. He has been in the pharma industry for almost 20 years and has held positions of increasing responsibility. When he is not leading large cross-functional initiatives, Dr Taylor enjoys spending time with his family and playing tennis in the U.S. Tennis Association (USTA). He is recently married, has two children, and lives in the Chicago-area with his family.

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.

As Business Lead for DEI and Patient Experience in Clinical Trials, AnneMarie Winkler has a commitment for Patient Focused Drug Development and integration of the Patient Voice across R&D. Prior to joining Genmab she was Development Unit Lead for Patient Engagement, Equity & Transparency at Biogen, after leading a team as Manager Clinical Operations at Syneos Health, in Merck Research Labs. As Indication Lead for Global Trial Optimization at Syneos Health, Merck; she led End-to-End Feasibility and Recruitment in Tumor Agnostic Basket studies, Novel Biomarkers and Rare Diseases.

During time as Clinical Research Manager and IRB Administrator at Portsmouth Regional Hospital she served on New Hampshire’s Comprehensive Cancer Collaboration: Emerging Issues Work Group, Public Policy Education Committee. It was as Head of Human Rights Protections, and as a Patient Advocate at North Suffolk Mental Health, that she found her true passion is championing the Patient Voice.

Anthony Yanni, MD, is responsible for leading the development and execution of the company’s global patient centricity strategy across all functions of the organization. With a vision to better and more genuinely understand the patient journey in the real-world setting, along with the continued development of a patient-centered corporate culture worldwide, one area in which he is focused is on creating sustainable processes to address key areas that matter to patients and applying their unique insights to the entire product lifecycle – from early research to development and, ultimately, to utilization.

Previously, Dr Yanni held multiple roles at Sanofi most recently serving as Head of Patient Insights, Solutions and Outcomes where he led a global team to create a first-in-industry process to integrate the patient and clinician perspective into research portfolio decision-making.

Earlier in his career, Dr Yanni spent nearly 15 years in clinical practice serving as a primary care physician, Chief of Internal Medicine and Chief Medical Officer for a health system in the Northeastern United States.

Dr Yanni was selected as one of 2021’s 100 Most Inspiring People in the life-sciences industry by PharmaVoice Magazine and most recently was recognized with the Reuters Pharma Europe Patient Champion Award for having “real impact on patients, carers and international health systems”.