Co-Chair, Decentralized Trials & Research Alliance

Adjunct Assistant Professor, Rutgers University

Vice President, Foundation for Sarcoidosis Research

Craig Lipset is an advisor, educator, advocate, and innovator focused on novel solutions for clinical trials and medicine development. He is the founder of Clinical Innovation Partners, providing advisory and board leadership with pharma, tech, and investors.  Craig is Co-Chair for the Decentralized Trials & Research Alliance and Vice President of the Foundation for Sarcoidosis.  He is Adjunct Assistant Professor in Health Informatics at Rutgers University and serves on the Advisory Council for HL7 Project Vulcan and External Stakeholder Board for IMI Trials at Home.

Craig was previously the Head of Clinical Innovation and Venture Partner at Pfizer, and on the founding management teams for two successful startup ventures.

In her over 25 years of experience, Rosalie “Rosie” Filling has transformed R&D operations in every company she has worked for, developing clear-cut strategies to help advance clinical trials with high-quality operational execution and scientific excellence.

Rosie is the Vice President, Senior Global Head R&D Operations Endo International plc. She is part of the global R&D leadership team and is charged with the coordination and implementation of clinical development strategies for the company’s research and development. She provides strategic direction and oversight of the R&D Operations team, which includes clinical operations, data management, biostatistics, medical writing, clinical supplies, trial master file/inspection readiness and business operations. This integrated team handles the execution of all aspects related to Endo’s clinical trials. Endo has active research and development programs in men’s health, orthopedics, and endocrinology. Beyond these therapeutic areas, the company also has focused development in the areas of sterile injectables and complex generic products.

Rosie’s main focus at all times is on the end users—the patients. Bringing new and, at times, life-saving medications to patients drives Rosie’s sense of purpose.

Rosie joined Endo from Lupin Pharmaceuticals in Blue Bell, PA where she was Senior Director, Head of Clinical Operations, and built the clinical operations organization to support the US and Global R&D Organization. Prior to Lupin, Rosie spent nearly five years at Teva in Frazer, PA where she was the US site head of Clinical Operations and was responsible for the successful delivery of Inhalation, Women’s Health, and Cardiovascular clinical trials. Earlier in her career, Rosie held various roles at Eisai, MGI Pharma and PPD.

Rosie earned her B.S. in Biology with a minor in Chemistry from the University of Pittsburgh.

"Work Hard, Stay Calm, and Cure Cancer! This is Peter O'Neill's motto while conducting oncology clinical trials at Cellectis, where he is Senior Director of Clinical Operations. Peter was named to PharmExec’s list of "2020 Emerging Pharma Leaders” and has been conducting clinical trials for over 24 years, formerly at Incyte, Sanofi, and Beth Israel Deaconess Medical Center. He is passionate about developing new therapies for patients, with a focus on innovative strategies to enhance the clinical trial experience for participants, caregivers, and care teams.

John Gregg, Pharmaceutical industry executive, John Gregg, has extensive experience in worldwide clinical development and commercialization of new anti-infective drugs. He has spent much of his career in senior roles directing the development and commercialization efforts for a large number of antibiotic, anti-protozoal, anti-fungal and anti-viral drugs. He is a veteran of new product development leadership positions at Pfizer, Novartis, J&J, BMS, and more recently his start-ups, Symbiomix Therapeutics, LifeQual Pharmaceuticals, and AkaRx. He is now the CEO of a BalinBac Therapeutics, Inc., a specialty infectious disease and microbiome modulation company. He was trained as a microbiologist and has led multi-disciplinary anti-infective drug development teams at the largest pharmaceutical companies, as well as small, private specialty firms directing the work of colleagues and contract laboratories

Jill has worked in the industry for over 25 years. She is the Chief Growth Officer at the Center for Information and Study on Clinical Research Participation (CISCRP) where she has worked since 2007. I joined CISCRP in 2007 to advance our mission to inform and empower patients and the public as partners in clinical research. Throughout my tenure, I have led a variety of teams and functions in delivering on our mission and advocating for public health literacy, patient education and engagement.

In my new role as Chief Growth Officer, I focus on nurturing our established relationships, building new ones, and on identifying and developing new opportunities. As a non-profit innovator, CISCRP is uniquely positioned to serve patient communities and clinical research stakeholders throughout the world with the highest quality educational and advocacy services. I’m so excited about the trajectory of CISCRP’s growth and welcome the opportunity to nurture current and new relationships and collaborations.

As a non-profit innovator, Jill serves patient communities and clinical research stakeholders throughout the world with the highest quality educational and advocacy services.

Jill received her MBA from the Fox School of Business at Temple University, and she resides in Bucks County, PA with her husband, three children and three dogs.

Narayan has and ten (10)+ years of award-winning and progressive experience delivering the highest standards of clinical data management at Bayer and Bristol Myers Squibb (BMS). Bayer Gold Award 2017, Bronze Award 2016, and Pinnacle Award 2015; BMS Performance Award. In-depth knowledge of all aspects of clinical data management, reporting, reconciliation, study reviews, and standards development that drive pharmaceutical businesses forward. 

Passionate sustainability and procurement leader with the mission to put ESG at the heart of all supplier relationships. 15+ years' senior level experience, driving strategic partnerships and embedding sustainability goals into supply network. Collaboration catalyst, initiative builder, and speaker, I put responsible sourcing front and center in business and procurement strategy.

Dr. Ram Raju has a distinguished career over 40 years as a healthcare provider, teacher, researcher and community organizer. In his role at Northwell Health, Dr. Raju set the strategic vision to improve population health by finding ways to meet the needs of its most vulnerable communities, by examining the existing programs aimed at improving the health system's response to the community's needs and working with local organizations to address them. Northwell Health is the largest healthcare provider in the state of New York, is a system with 23 hospitals and 830 outpatient facilities that sees 2 million people every year in the New York metro area and beyond.

Carrie Lewis has close to 20 years of varied Clinical Research experience.  Carrie is currently an Executive Director, Clinical Program Optimization at Endo Pharmaceuticals where she oversees Clinical Operations (Phase 2-4) as well Business Operations, eTMF/inspectional readiness, and Training/Oversight.  Prior to Endo, Carrie garnered extensive knowledge in many roles while in academia, at large sponsors, generic sponsor, as well as a global CRO.  She has a master’s degree in Clinical Research Administration and has experience in multiple therapeutic

Adam joined Bristol Myers Squibb in 2016 and has held various roles in Oncology Clinical Protocol Operations, Oncology Clinical Development and Global Clinical Trial Strategy & Operations.  Adam is currently the Global Development Operations Therapeutic Area Head for Solid Tumor Oncology leading a team of Operation Portfolio Leads with Full Development.  Before joining BMS, Adam worked for several other sponsors (Wyeth, Merck) and CRO partners across all phases of development and multiple indications including Metabolism, cardiovascular, CNS and Oncology.   Having started his clinical career as a Clinical Nurse Assistant he built upon this experience at the patient bedside and started in industry with a role in data management but has spent the bulk of his time in clinical trial management (project and portfolio management).  Adam holds his Bachelor of Science in Biology and French and a Master of Business Administration.  Adam lives in Pennsylvania, with his wife, Marci, and two children, Vivienne and Oliver.  He is an avid morning runner and usually starts his day with a few miles run and the obligatory few cups of coffee.

Kathleen Frenia Cohen is Vice President and Head of Clinical Development Operations at Marinus Pharmaceuticals.  Prior to joining Marinus, she spent 20+ years at PRA Health Sciences in a variety of project management and operational oversite roles. Kathleen graduated from the University of the Science in Philadelphia with a PharmD and completed a post-doctoral fellowship in Pharmacoeconomics and Outcomes Research from Rutgers College of Pharmacy. Kathleen resides in Media, PA.

Ella Balasa is a patient advocate, consultant, and a person living with cystic fibrosis. She has committed her time to empowering patients and advancing healthcare strategies. She speaks publicly about the value of patient perspective and has a passion for distilling clinical information for patient communities. Through opportunities working with healthcare organizations on content strategy, writing, speaking, clinical trial development, and sharing the patient experience she aims to affect the healthcare landscape by raising awareness of rare diseases, promoting self-advocacy to patients, and valuable insights to organizations. More of her work and experiences can be found at www.ellabalasa.com.

Dr. Ehrhardt is a biophysicist with a Ph.D. in human physiology. Throughout her career, she focused on driving biomedical research through efficient application of innovative technologies and strategies. She built and led successful teams in industry, including at Merck, where she headed a laboratory providing leading technologies for cell-based research from early discovery through manufacturing; and at BMS where Dr. Ehrhardt led and grew an international clinical assay team to robustly cover large scale registrational and translational clinical analysis generating clinical decision-driving data and mechanistic insights for immuno-oncology, cardiovascular, immunology, metabolic and rare disease studies. Before returning to Merck, Dr. Ehrhardt fulfilled one of her scientific aspirations at CHDI Foundation, designing and implementing successful clinical biomarker discovery and development strategies for Huntington’s disease. Currently, at Merck, Dr. Ehrhardt is providing strategic and technical leadership for the development and implementation of industry-leading and QC-friendly cell-based assays and models for potency determination that reflect the unique mechanisms of biologics products in clinical studies and beyond.

Venkat Sethuraman is currently the Global Head of Biometrics and Data Sciences at Bristol Myers Squibb, where he is accountable for the biostatistics/quantitative support to R&D Global Development and Medical organization. In addition, Venkat leads the Innovation Pillar for the Global Drug Development.

Prior to BMS, Venkat was a partner at a management consulting firm, where he led the R&D clinical development and operations. While there, he worked closely with R&D leaders of top 10 pharma companies in driving data-driven clinical decision-making, leveraging advanced analytics and data science. Venkat has held various leadership roles at BMS, Novartis Oncology and GSK leading quantitative and biometrics organization. Venkat has diverse research interests and consulting experience in industry that includes clinical trials design, innovative trial models, data science, and most recently, digital efforts in clinical research.

Venkat received a PhD in statistics from Temple University and an MBA from the Wharton School of the University of Pennsylvania. He currently serves on the Board of Association for Women in Science (AWIS) and has served on the board of the Biopharmaceutical Section of the American Statistical Association.

Adam Kinsey is currently Associate Vice President and Regional Head of North America for Global Clinical Trial Operations (GCTO) at Merck Research Laboratories. He has over 25 years of clinical research experience, with the last 8 at Merck. He has been a key leader within GCTO, most recently serving as Executive Director, GCTO Clinical Sciences & Study Management (CSSM) and Therapeutic Area Section (TAS) Head: Melanoma, Hepatobiliary Cancers, and Innovative Strategies. Previously, Adam was Clinical Research Director (CRD) Oncology where he served as Director of country clinical operations activities in the United States for Merck’s oncology pipeline. Adam started his career as a CRA and has traversed through various roles in clinical operations of increasing responsibility and scope. He also has experience across a wide array of therapeutic areas and with companies of different sizes and operating models. Adam has a bachelor’s degree in biology from Rice University in Houston. He completed post-baccalaureate course work at Houston Baptist University and coursework toward a Master of Public Health (MPH) degree at the University of Texas School of Public Health in Houston.

Linda Goler Blount, MPH, is the President and CEO of the Black Women’s Health Imperative, the only national organization focused on Black women’s emotional, physical and financial health. Since joining the organization in 2014, Ms. Blount has overseen more than $20 million invested in Black women and research to prevent chronic disease and HIV, ensure reproductive justice and healthy maternal outcomes, and advocate for health promoting policies. Ms. Blount, an epidemiologist, edited IndexUS, the first research on Black women’s health based on healthy Black women. Her career includes successful tenures at CDC, the Coca-Cola Company and consulting with health ministries in countries in Europe, Africa and the Caribbean.

Jenifer Ngo Waldrop joined the Black Women’s Health Imperative (BWHI) as Executive Director of the Rare Disease Diversity Coalition (RDDC) in October 2022. Before joining the leadership team of RDDC, she developed models and programs for diversity, equity, and inclusion initiatives to support multiple business units with Fortune 500 companies and organizations in Asia, Canada, and the US.

Jenifer has led initiatives at non-profit organizations where she recruited local community members to participate in numerous health-related fundraising events and developed programs to target disparities and underrepresented groups. In addition to facilitating development and fundraising, Jenifer developed a reputation for successful coalition building.

Jenifer received her undergraduate degree from Colby College and her Master of Human Resources Development from Villanova. As the Professional Development Director of the National Association of Asian-American Professionals (NAAAP) of Colorado, Jenifer continues her outreach in society. Through this organization, she mentors formally and informally.

Dynamic leader in clinical operations with over 25 years of experience across various therapeutics areas.  After obtaining her master's degree in microbiology and immunology from a Canadian university, she joined the pharmaceutical industry where she held positions of increasing responsibility, most recently leading the clinical operations team at a small biotech company.  She has worked on programs in all phases of clinical development, in small and large organizations, and is recognized for building highly successful teams.  Her focus is providing guidance and removing obstacles to enable the team to execute efficiently while maintaining a strong sense of teamwork and enthusiasm.  She is passionate about helping others grow and develop and places a high priority on working with the members of her team to achieve their goals.

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. Jen is passionate about patient co-design as she grew up with juvenile idiopathic arthritis, 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. Jen 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 to ensure the patient voice is included.

Jenny Wakefield is an Adult and Pediatric Oncology and Critical Care Registered Nurse, ACRP-CP and CCRA Certified. Jenny graduated with her BSN from Florida International University in Miami, Florida, and has worked in Clinical Research since 1997 in a variety of roles, at the Site, CRO and Sponsor levels in all Phases of Global Clinical Trials and multiple disease indications. With her diverse experience, Ms. Wakefield brings a unique level of insight to the challenges faced in the management of Clinical Trials. Jenny currently is the Senior Director of Quality and Clinical Operations at Incyte. Ms. Wakefield’s specific focus is delivering Quality Programs with a humanistic approach, blending what’s expected from Clinical Research Professionals with what the real world presents.

Dr. Abdel-Meguid has extensive experience in drug discovery. He built and managed a number of successful departments and drug discovery programs. He founded Shifa Biomedical Corporation (Shifa), a company dedicated to the treatment of cardiovascular diseases. He also founded ProXyChem, a company focused on providing drug discovery solutions to the biotech and pharmaceutical sector. Prior to this, he was Chief Scientific Officer and Co-Founder of Suntory Pharmaceutical Research Laboratories (SPRL), a structure-based drug discovery company dedicated to the treatment of cardiovascular and immune disorders. Before the formation of SPRL, he was Worldwide Director of Structural Biology and Director of Macromolecular Sciences at SmithKline Beecham (SB), now Glaxo SmithKline (GSK). He also served as Director of several therapeutic programs. Prior to SB, he was head of Biophysical Sciences and Protein Engineering at Monsanto. He has a PhD in Physical Chemistry and MS and BS in Biochemistry.

Candice Estes is as a Clinical Trial Manager at Incyte and works extensively in the decentralized trial space. She holds her Masters of Public Health in Epidemiology from the University of Alabama at Birmingham and has worked in Clinical Research since 2013 in a variety of roles including a Data Manager, Biostatistician, Oncology Research Coordinator, Clinical Trials Specialist and multiple levels of Clinical Research Associate. Ms. Estes’ specific focus lies in pushing dermatologic products forward, bridging the gap between clinical operations and global monitoring and operationalizing decentralized trials.

Multilingual professional with 15+ years experience with informatics & digital technology in the pharmaceutical / biotechnology industry. With university degrees in Bioinformatics and in Clinical R&D, Hassan has a great mix of pharmaceutical industry Drug Discovery and Clinical Operations knowledge and Informatics. He has contributed in driving forward the vision of patient centricity and digital health at BI by promoting the Remote Clinical Trial model, and implementing several innovative digital health technologies in Clinical Trials to drive Patient Centricity. A great communicator with superb interpersonal skills, Hassan regularly interacts with key stakeholders to provide innovative solutions to critical problems. He is highly motivated in constantly seeking to improve processes and efficiency while driving innovation, and acts as a key contributor to multiple projects. Over the years, he has developed experience working in a global organization that requires collaboration with multidisciplinary international partners and is an invited guest speaker in several global Pharmaceutical and Clinical R&D conferences. Hassan is an active contributor to Transcelerate and the Clinical Trials Transformation Initiative (CTTI).

Terry Katz is Senior Director of Biostatistics and Data Management Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA International, and a Statistician at Schering-Plough. He holds Accreditation as a Professional Statistician and Certifications as a Quality Engineer and a Six Sigma Green Belt. He is Chair of DIA's GCP-QA Community; formerly he was a Core Committee member for NJ CDISC User Group and Chair of the Statistical Taskforce for the Animal Health Institute. Terry also completed a 3-month Fellowship in Kenya to improve capacity and capability for the local hospitals to run oncology clinical trials.

Keith Kennedy is a subject matter expert in eCOA/ePRO, eConsent, tele visits, wearables and other decentralized clinical trial tools. For over 15 years, Keith has consulted pharmaceutical, medical device and biotech companies on the best strategy to collect patient facing data in clinical trials in order to maximize patient compliance, increase data quality and decrease patient burden. A distinguished career in healthcare sales leadership, talent development and product education.

Ellen Weiss is the Vice President, In-Home Solutions, Decentralized Clinical Trials at PCM Trials. Ellen brings decentralized clinical trial visits to patients with PCM Trials experienced Certified Mobile Research Nurses. She is mastering the logistics of dosing and testing clinical trial participants where they live, work, and study. With nearly a decade of home visits learnings, Ellen has a unique perspective on how decentralized clinical trials have changed over the years and what the future looks like.

In my role, I am responsible for leading ICON’s country and site selection strategy ensuring that every project ICON undertakes benefits from a data-driven approach, optimized to reflect customer priorities, and with a probability of success calibrated to each customer’s risk preferences.

I started my journey working for a local health insurance company supporting actuarial (claims data) analysis, and then joined a local CRO to help them develop a data-driven site identification strategy to support their late phase studies.  Since then I’ve held a number of Feasibility, Site Identification, and Study Start-up focused roles across midsize and large CROs.

I’m an expert in trial modelling and leveraging artificial intelligence to inform country and site selection. I have really enjoyed helping to develop ICON’s OneSearch platform as well as leading initiatives to deliver next-generation scenario planning capabilities.  As we work to bring the best of both organizations together I’m excited about exploring new opportunities to excite and delight our customers through data-driven delivery.

Sverre Bengtsson started in the clinical trials industry over 30 years ago. He started as a statistician/statistical programmer, later into data management and since over 20 years into business development. He has been working in both CRO’s as well as in clinical trials technology companies, including the global first ePRO company. Sverre is very interested in making clinical trials efficient, in both study design but also in the processes and technologies used. Sverre co-founded Viedoc Technologies 19 years ago and is responsible for some of the major accounts but also the vision around the company. He’s on the board of both some industry organisations and in clinical technology companies.

Trained as a neuroscientist, Rohit Nambisan is a product executive with experience leading product development organizations in pharma, medical devices, personalized medicine, health IT, healthcare data and analytics, and AI. Prior to co-founding and leading Lokavant, Rohit was most recently the Head of Digital Product at Roivant and the Head of Product at Prognos Health. Rohit holds an M.S in Management and Engineering from MIT, an M.A. in Neuroscience from Boston University, and a B.A in Cognitive Neuroscience from UC Berkeley.

Kevin is Vice President of Product with global responsibility for product strategy and delivery of
Medidata's RTSM solution. Kevin has spent his entire 30 year career in the Life Sciences arena
working in clinical research, medical devices, systems and software delivery, and project
management. Kevin has a well-rounded background that is technology focused and includes a deep
understanding of the Pharmaceutical industry and clinical trial life-cycle. Kevin first started in
IRT/RTSM at ICON Clinical Research in 2002 where he led the Project Management team responsible
for large clients and was instrumental in unique and innovative design initiatives.

Alison Bedenkop is a Senior Director, Patient Recruitment and Retention at Worldwide Clinical Trials. Alison has been in clinical trial research for over 20 years, with the past 13 years focusing on global patient recruitment and retention.  Alison is passionate about diversity and inclusion and works towards building greater awareness of clinical trial opportunities in the local community.

Ted Kirby is currently the Head of Product and Brand Marketing at Saama. Prior to Saama, Ted served as Senior Director, Product Marketing at Medidata, where he oversaw product marketing for Medidata's platform. He was previously Director of Account Management at Medable, where he oversaw commercial relationships with Medable’s key Pharmaceutical and CRO accounts. His previous experience also includes stints at AiCure, a VC-backed startup using visual artificial intelligence for medication adherence in clinical trials, Deloitte and IQVIA. Ted earned his undergraduate degree in business administration from the University of North Carolina at Chapel Hill and his MBA from Columbia Business School.

As Vice President, FSP Commercial and Operational Strategy, Neil Berger is an operational and commercial strategist for clinical development outsourcing solutions at Parexel. Bringing 20 years of commercial and research operations experience, he is a recognized expert in holistic and cross-functional approaches to talent development – integrating acquisition, development and retention to meet long-term portfolio needs for biopharmaceutical sponsors.

Prior to joining Parexel in 2015 as a commercial account leader, Neil held a range of positions of increasing responsibility in project management and client services for Pharma Medica Research, a contract research organization based in Canada.

Neil earned a Master of Business Administration degree from Schulich School of Business, and holds a master’s and bachelor’s degree in science from McGill University.

Atul is a physician with over 18 years’ experience in Clinical Research, Drug Development, and clinical practice, after getting education from top medical schools of India. Atul joined Navitas in February 2021, and prior to that he has worked with leading organizations like Ranbaxy, Panacea Biotec, Max Neeman International and Apcer Life Sciences. Atul has rich leadership experience in providing end to end scientific guidance in drug development (Phase 1-IV) across multiple therapeutic area portfolios, in diverse regulatory environments including FDA, EMA, MHRA, ANVISA and DCGI. Atul has been extensively involved in defending clinical strategy proposals with respect to scientific rationale, timelines and budget with senior executives. He has worked as Global Medical Lead (USA, Europe and Asia Pacific) in more than 50 studies across the continents for both drugs and devices. Atul has been involved extensively in developing complex innovative trial designs for complex protocols reducing the huge costs and time associated with standard clinical randomized controlled trials.

Apart from being a medical lead, atul has multifaceted experience in diverse clinical research domains including medical writing (Protocol, IB, CSR, eCTD etc), medico-regulatory (IND, NDA, BLA), drug safety and operations. Atul has been actively involved in multiple DSMBs and SRCs. He has been involved in negotiating clinical plans with FDA during pre-IND and type C meetings.  He has been the part of successful marketing authorization approval of breakthrough therapies including PD-1 inhibitors, V2 antagonist, multiple biosimilars, vaccines and several repurposed therapies (for MDD, narcolepsy, psoriasis)

As Clario’s Chief Medical Officer, Dr. Todd Rudo provides medical and scientific leadership across the organization. Passionate about leveraging our scientific expertise to support our customers’ success, Dr. Rudo has focused efforts on optimizing our solutions across the therapeutic areas. His team supports Clario’s clients by providing expert consulting services on scientific and regulatory strategy, and ensures our product portfolio is scientifically robust, generating high quality data to support clinical trial endpoints. Dr. Rudo has a particular interest in applying innovative technologies to improve the scientific rigor of clinical trials, while maintaining focus on the customer experience, including minimizing patient and site burden. With nearly 20 years of clinical cardiology and pharmaceutical research experience, Dr. Rudo has focused his career predominantly on drug safety. He has worked within therapeutic areas including oncology, immuno-inflammatory diseases, urology, and cardiometabolic diseases, and has achieved board certifications in internal medicine, cardiology, cardiac electrophysiology, nuclear cardiology, and adult echocardiography.

Lauren joins us with over 25 years of pharmaceutical development experience in both large and small pharmaceutical company settings.  Her career started as a clinical monitor with Covance which eventually led to oversight of clinical and medical affairs operations teams at Wyeth, Pfizer, Cephalon and Teva across multiple therapeutic areas.  Her biotech experience includes Head of Clinical Operations and Project Management at Recro Pharmaceuticals and, most recently, Head of Clinical Operations at Aceragen Pharmaceuticals (formerly Idera Pharmaceuticals).

Lauren holds a BS in Biology from the University of Scranton and an MBA in Biotechology and Health Industry Management from Pennsylvania State University.

Donna’s diverse career began in healthcare as a registered nurse and evolved to focus on technologies that support patients in clinical research.  Donna has published articles in trade journals and presented at pharmaceutical industry conferences on topics including patient centricity, improving enrollment success, eCOA, BYOD, and more.  With over 18 years in the clinical trials space, Donna currently serves as Senior Vice President, Strategic Solutions at YPrime, where she is responsible for developing and growing strategic partnerships.  Donna earned her Bachelor of Science degree in nursing from Thomas Jefferson University.

Joe Im is currently the head of digital health technology operations at Regeneron.  He has 15 years of experience within the clinical trial space, where he’s been able to exercise his interest in cutting-edge technologies and his passion to improve the lives of patients. He has held positions on the supplier and sponsor sides within the COA project management function, as well as in imaging category management.  In his current role, he leads a team responsible for deploying and operating digital health technologies such as eCOA, sensor devices, digital apps, medical devices, and eClinical solutions in clinical trials. Joe has successfully led initiatives at Regeneron including the COA operations team development, adoption of eCOA BYOD as a standard modality, and development of a decentralized trial operating strategy.

David Cutler is the Director of Project Management at WCG for the EAC service line. David provides leadership to the WCG EAC organization and serves as a subject matter expert for management of endpoint adjudication committees. In his current role, David leads WCG’s EAC Project Management group with a focus on developing and managing expert committees in alignment with industry and regulatory best practices.

David has over 15 years industry experience and prior to joining WCG David worked in a variety of leadership roles in healthcare, academic, and nonprofit organizations building healthcare delivery programs and managing research teams. David spent the early part of his career developing and managing operations for NEURO-NET, a program aimed at improving long term outcomes for patients with catastrophic injuries. Prior to his focus on EACs, David’s work in clinical research was at a large public hospital building clinical research infrastructure enabling underserved patient populations to gain access to industry sponsored clinical trials and public/private grant funded research initiatives.

David holds a Bachelor of Arts in Psychology from the University of California Santa Cruz and a Master of Arts in Counseling, Health Psychology from Santa Clara University.

Alex Ireland is Associate Director Business Development at Novotech, the leading Asia Pacific centered global biotech CRO.  During her tenor, she has worked with 125+ biotech companies on 400+ studies in preparation for their upcoming Ph 1-3 clinical trials. Prior to joining Novotech, she worked for a small biotech company in a variety of business development and operational roles. Alex graduated from Boston University with a Master of Public Health.

Tom Gottschalk has worked in the life sciences industry for over 25 years.  His first 10 years were spent as a Pharmaceutical Representative and Product Manager for Bertek Pharmaceuticals, Merck, and GSK.  He then joined RxSolutions as a commercial services account representative before transitioning into a focused clinical role after creating the RxStudy Card offering.  He joined TrialCard in 2019 via its acquisition of RxSolutions.  For over 12 years, Tom has been committed to changing the paradigm of the traditional clinical trial supply process through the RxStudy Card.