Speaker Biographies

Lale Akca, MBA, CCRA, graduated from Marmara University in Turkey with a bachelor’s in English and certification to teach. She began her research career in Vienna performing data support and programming functions for a research organization. She relocated to University of Louisville to begin management of a clinical site that was part of a world-wide research group in 2000. She obtained her MBA from UofL. Lale is a certified clinical research monitor (CCRA) and has 20 years of experience in clinical research management. She currently serves as the Executive Director at the University of Louisville Clinical Trials Unit.

Dr. Nadir Ammour began his career as an oral surgeon in public healthcare moving into clinical development. He is working to bring eHealth/Digital innovation in clinical development to deliver new medicines to patients faster. He led several projects in that space such as the Verkko remote trial, Connected Hospitals Network (EHRs); wearables trials, and on-line patient recruitment. Nadir is a member of the Institute of Innovation Through Health Data, and various cross pharma leadership boards. He led an EIT Health consortium project, EHR2EDC aiming at connecting healthcare and research and involved in several European IHI/IMI Consortia. Dr. Ammour held various global positions previously at Wyeth, now at Sanofi. He is graduated in medical informatics, health economics and an MBA from Reims Management School, besides his Doctorate in Medical Dentistry

As Chief Business Officer, Jonathan Andrus leads Clinical Ink’s solution management and compliance teams to help sponsors and CROs better leverage eSource, eCOA and ePRO data. With more than twenty years of experience, Mr. Andrus brings extensive expertise developing eClinical services that integrate data and technology to help life science companies optimize study execution. At Clinical Ink, Mr. Andrus is responsible for P&L across Clinical Ink’s products and services, and he is also focused on building relationships and forging strategic partnerships with sponsors, CROs, regulatory bodies and clinical research professionals. Mr. Andrus joined Clinical Ink from BioClinica where he led the eClinical Solutions Group to develop their current service offerings, including data management, quality management, implementation services and IWRS. Prior to BioClinica, Mr. Andrus worked in pharmaceutical consulting and with CROs focused on quality, data management and validation. An active thought leader, blogger and presenter, Jonathan served as chair of the Society for Clinical Data Management (SCDM) in 2008 and 2013 and currently serves as the society’s Treasurer. He is also an active member of DIA (North American Advisory Council and Annual Conference Data/Data Standards Track Chair) and ASQ. He earned his bachelor’s and master’s degrees from Temple University’s College of Liberal Arts and Graduate School of Pharmacy and is a Certified Quality Auditor (CQA) and Certified Clinical Data Manager (CCDM®).

Drawing on his engineering background and inspired by his work in clinical medical research as an MD/Ph.D. candidate, Rick Arlow built the first version of the Complion software platform. In close collaboration with leading medical centers, Complion’s industry-leading workflow and eRegulatory document management software was born. Since then, Rick has built a world-class team experienced in clinical research. He is a frequent lecturer for several professional research organizations including ACRP, MAGI and SCRS.

Munther Baara is the product strategy and innovation lead as well as EDETEK’s major industry partnerships. Munther has 25 years of experience in leading the development of numerous clinical systems and business solutions. He has held roles of increased seniority in biotechnology and in the world’s largest pharmaceutical companies, leading global teams and technology implementations. Munther’s experience has been focusing on innovation, trends and emerging technologies in support of the paradigm shift in the execution of clinical trials. Munther was most recently the head of New Clinical Paradigm at Pfizer where he led and/or contributed to transformative technological breakthroughs. Munther also worked on mClinical patient journey (mobile and sensor), blockchain, returning data to patients, Shared Investigator Platform (SIP), clinical aggregation layers, eSource (Industry-Pioneering EHR Data Transfer) and TransCelerate BioPharma Projects. Also, he was awarded the 2018’s Top 20 Innovators in clinical trial advancements by CenterWatch.

Justin Bandura is a Clinical Trial Contract Manager at Boehringer Ingelheim and an attorney admitted in Connecticut. Prior to his career in pharma, he was in sales for over a decade in the areas of medical device and industrial outsourcing. Heavily influenced by his time in medical device sales, Justin brings a collaborative approach to clinical contract negotiations focused on long-term sponsor-site relationships.

Tricia Barrett is the Managing Director at Praxis, leading the day-to-day management of the business. A member of the Praxis team since 2003, Tricia oversees all Praxis operations from proposal generation through completed, enrolled studies. Her experience encompasses a wide range of therapeutic areas and tactical strategies, which brings a unique approach to patient recruitment that focuses on both sound science and innovative execution.

 

Liz Beatty is the Chief Strategy Officer at Inato, a clinical trials marketplace which flips the traditional model and allows sites to participate in the trials that are best aligned with their interests and that of their patients. She is focused on advancing Inato’s corporate strategy, developing partnerships and driving growth in North America. Previously, Liz was the Head of Digital Clinical Trials at Bristol-Myers Squibb where she led digital innovation efforts across Global Clinical Operations. Her team leveraged innovative approaches to increase clinical trial participation and enhance the clinical trial experience for sites, patients, and their care team. Liz previously held positions in clinical operations including managing a global patient recruitment team, and various positions in protocol management and site management.

Jay Bergeron is Director, Digital Client Partner for Early Clinic Development and Integrative Biology at Pfizer. He served as the Scientific Coordinator of IMI-eTRIKS, a $30M Public Private Partnership for building open source translation research information management systems.

Peter R. Bergethon, MD is Vice President and Head of Quantitative Medicine and Clinical Technologies (QMCT) at Biogen. He leads the identification of technologies and methodologies that transform drug development. QMCT creates value by leading the transition of clinical practice in Biogen’s core and emerging growth areas from a qualitative to a quantitative discipline, and connecting the Clinical with the Research enterprise, to advance therapeutics and personalized medicine. Peter came to Biogen in 2017 from Pfizer Worldwide Research and Development where he was Vice President and Head of the Pfizer Innovation Research Lab within the Early Clinical Development group. At Pfizer, Peter led both the Quantitative Medicine group and the Innovation Research Labs where he pioneered mobile and digital clinical assessment technology, human neurophenotyping, and multi-modal data analytics to accelerate clinical development in neuroscience, immunology, rare diseases, and cardiometabolic disease. He is an accomplished clinical neurologist and neuroscientist who, prior to joining Pfizer, was a Professor at Boston University and Tufts University in the Departments of Biochemistry, Neurology, Neurobiology & Anatomy, and Biomedical Engineering.

Joanna has 20 years of clinical trial management experience, spanning from clinical research associate through project director. She is responsible for the implementation, business process adoption and support of various Xcellerate® products including the Xcellerate Portal, Study Dashboard, CRA Dashboard and Portfolio Dashboard. Joanna holds an MS and BS in biology with a concentration in biotechnology from Fairleigh Dickinson University.

Donald Berry is Founder of Berry Consultants, LLC, and a professor in the Department of Biostatistics of the University of Texas M.D. Anderson Cancer Center. He was founding Chair of this department in 1999. Dr. Berry received his PhD in statistics from Yale University, and previously served on the faculty at the University of Minnesota and at Duke University. He has held endowed faculty positions at Duke University and M.D. Anderson. Dr. Berry is a well-known developer of statistical theory and methodology. He has designed and supervised the conduct of hundreds of innovative clinical trials, including Bayesian adaptive trials in cancer and other diseases. He is a Fellow of the American Statistical Association, the Institute of Mathematical Statistics, and the International Society of Bayesian Analysis.

Łukasz received his PhD in biochemistry from Nencki Institute of Polish Academy of Sciences and after enjoying a career in academia he joined pharma industry in 2009. Initially, he was involved in preclinical development programs at Celon Pharma SA, where he led several drug discovery projects in psychiatric and metabolic diseases. Some of these projects are now continued in clinical development phase. Later on, Lukasz transitioned to clinical monitoring roles at Quintiles Inc. (now IQVIA) and then at Covance to eventually join Centralized Monitoring Team at AstraZeneca in 2016. Now Lukasz is leading the Centralized Monitoring group, which guides study teams through study de-risking exercise and identification of areas that are critical to study quality. In the study execution phase the team led by Lukasz performs continuous central monitoring of study data in search of risk signals at study, country, and site levels.

Billy Boyle, an engineering graduate from Cambridge University, is one of the original co-founders of Owlstone Inc. He initially worked on design of the core FAIMS technology before assuming a commercial role, and later focused on medical applications, leading the creation of Owlstone Medical, the global leader in breath diagnostics.

Charles Bradley was SVP Global Development Operations at Annexon Bioscienes located in South San Francisco, CA. Dr. Bradley is an experienced clinical research professional with an in-depth background in all phases of drug development. He is a seasoned senior manager with knowledge of resource allocation, portfolio management, budgetary processes, outsourcing strategies, and regulatory requirements associated with drug development. He has expertise in driving clinical programs forward in entrepreneurial environments, smaller biotech companies, and large traditional pharmaceutical companies. Chuck received his Ph.D. in bioanalytical chemistry from the University of Delaware, received post-doctoral training in Clinical Pharmacology at Uniformed Services University, and is Board Certified in Applied Pharmacology.

Christina Brennan, MD, has devoted her career to clinical research and currently serves as Northwell Health’s senior vice president of clinical research. Committed to the advancement of science and medicine, Christina has more than 25 years of extensive clinical research experience, including over 21 years in clinical research management roles. Throughout her career she has served many roles on clinical trials from PI to sub-investigator to operational oversight. During the pandemic alone she ran all the COVID-19 trials, where in a few short weeks, 1,200 patients were enrolled in trials at Northwell Health. She also performed Northwell's first fully remote (DCT) trial, in which they held their own IND. During that period, she was interviewed by Scott Pelley on 60 minutes prime time which captured more than 8 million viewers. Christina always keeps the patient as a focus point, currently she has partnered with Press Ganey (leading global company for over 30 years for patient surveys) for a pilot as the first site to focus on patient satisfaction surveys for clinical trial participants. She is on the board of trustees for the Association of Clinical Research Professionals as the immediate past Chair. She is on the steering committee and the liaison to the executive committee of the Clinical Trial Transformation Initiative (CCTI), with Duke University and the FDA. She is on the advisory board for Florence Healthcare. She also sits on the oncology advisory board and technology site advocacy group with the Society for Clinical Research Sites (SCRS). She is also an active member of the Women in Bio and the American College of Healthcare Executives. Christina also has authored chapters in textbooks, coauthored many manuscripts and abstracts, and has presented at numerous scientific and research meetings. She developed a clinical trial budget course for CITI. She is an adjunct professor at Yeshiva University and CUNY York College, teaching graduate students on clinical trials.

Pascale Cavillon, PharmD, BCMAS, serves as Global Patient Centricity Director at Ipsen since Nov 2017. Within the Global Medical Affairs Department, she supports the transformation of the company to work with patients, for patients throughout the product life cycle from R&D to commercialization. Over the past 2 years, she has built the first structure to allow collaborative work with patients by working directly with patient organization and supporting the Ipsen team. Before this position, Pascale was Programs Director within global clinical development where she initiated the first patient advisory board. During the past 16 years, she has worked as a coordinator for regulatory submission and has managed programs and studies from Phase I up to Phase IV in the areas of neurology, endocrinology, oncology, women's health, and cardiovascular.

Joan Chambers is a senior consultant advising research projects, the Center’s membership programs, and the PACT Consortium. She brings more than 30 years of senior management experience — across a variety of strategic and operating roles - in the life sciences industry. Joan serves on several boards and committees including US PharmaTimes, Citeline Awards, DIA’s Global Annual Meeting Program Committee (AMPC), DIA’s Student Case Competition, CTTI Project Watchtower Initiative, the Pharmaceutical Business Conference Group, and One Rare. Joan is an active member of the Drug Information Association (DIA), has published extensively in trade journals, and is a frequent speaker at industry conferences.

Amanda is a consultant, subject matter expert, & project manager to pharma, medical device, & CRO customers supporting the implementation of RBQM and working with them to optimize their use of technology within their RBQM strategy.  She also provides risk-based clinical trial operation expertise to support software product development.

Jessica Cordes studied Molecular Life Science in Luebeck, Germany and started her business career for 2 years at the Central Lab MDS Pharma Services as project manager. She moved then to GlaxoSmithKline, where she worked as country project leader for 4 years. In 2013, she moved to MorphoSys, working for four years in an international role as a clinical trial leader. In 2017, she moved to Medigene headquarters as a clinical trial manager and is now leading the Clinical Operations group since 2018.

Over her 14-year nurse practitioner career, MarieElena Cordisco, MA, APRN, NP-C, CCRC has been active in both clinical care and research. She is an experienced family nurse practitioner with specialty in endocrinology. Her current role is AVP of Clinical Trials at Nuvance Health. This health system is located in NY and CT, and has over 80 active clinical trials across all therapeutic areas. MarieElena is a strong advocate for increasing the role of nurse practitioners in clinical trial research. She is actively engaged on the leadership council for the Society of Clinical Research Sites, is the site liaison for her hospital network for the Clinical Trials Transformation Initiative, and sits on the nurse advisory council for Parexel. She holds a Masters of Arts in Professorial Nursing, Post Graduate Certificate Nurse Practitioner, and Certificate of Graduate Study Public Health.

Strategic Visionary in Digital Transformation & Analytics Leadership with Proven Analytics Portfolio Management Expertise With a keen eye for Strategic Vision, I've been at the forefront of advancing analytical capabilities, particularly in site intelligence, operational metrics, and quality indicators. My prowess in Digital Transformation has been instrumental in the on-time delivery and precision of a diverse suite of predictive models, leveraging ML/AI and Generative AI technologies. My role extends beyond mere strategy. I've championed an analytical development portfolio including in-house data & analytics transaction platform serving >1400 users, generative AI, and advanced modeling for business intel, ensuring robust analytical methodologies are in place, which has been pivotal for leadership and governance decisions. My expertise in Business Analytics and Product Analytics has been the backbone of this success, coupled with a budget management responsibility of >$5M. Building and nurturing relationships is at the core of my approach. I've continuously influenced key organizational stakeholders, ensuring the seamless adaptation and implementation of analytics and intelligence strategies. My proficiency in Engagement Management and Data Governance has been crucial in maintaining positive vendor partnerships, emphasizing quality delivery and continuous improvement. As a people leader, I've instilled a performance-centric culture, emphasizing Business Planning and actionable metrics. My commitment to Data Strategies and analytical thinking has ensured project and portfolio deliveries are not just timely but also rooted in process improvement. I've coordinated work with an agile mindset, ensuring products are delivered with consistency and precision. My technical acumen extends to Natural Language Processing (NLP), Business Intelligence (BI), data visualization, and cloud platforms including AWS, positioning me at the intersection of strategy and technology.

Ms. D'Agostino was diagnosed with cystic fibrosis at birth. She graduated from the University of North Carolina at Chapel Hill with degrees in biology and chemistry (Go Heels!) and is pursuing her doctorate in biochemistry at Emory University in her hometown of Atlanta. Ms. D'Agostino is a member of the Data Safety Monitoring Board and co-chair of the Research Summary Review Committee at the Cystic Fibrosis Foundation, as well as the consumer representative for the Pulmonary-Allergy Drugs Advisory Committee at the FDA.

Annick de Bruin is the Director of Research Services at CISCRP. She is responsible for the design, implementation, analysis and reporting of a variety of CISCRP research studies including the Perceptions & Insights studies and numerous Patient Advisory Boards. She has more than 20 years of experience conducting primary and secondary research studies in the healthcare, life sciences and consumer goods industries. She holds an MBA from the Graduate School of Management at Boston University and a Bachelor of Science degree from Bryant University.

Daniel is the Patient Engagement & Advocacy Lead for Europe, Middle-East and Africa at Janssen. In this function, Daniel is part of a global multi-functional leadership team that helps the company to engage with patients in a systematic way, and helps to build partnerships in developing solutions that better meet the existing needs. He also leads a group of colleagues in the region who play a crucial role in working towards a more collaborative approach in innovation. Daniel De Schryver joined Johnson & Johnson in 2001 as Director Corporate Communications. In that function, he initially worked in the field of oncology. In 2006 he joined the Janssen teams working in Infectious Diseases where he helped to maintain and enhance the company’s relationships with the HIV Patient Community. Later, he built the external relationships in the field of Hepatitis C, before becoming the Global Therapeutic Area Communications Leader Infectious Diseases and Vaccines. In this function he developed world wide strategic communications and public affairs programs about infectious diseases and global public health. Daniel has a Master in Romance Philology (Literature) and he started his career as a teacher. After having worked in communications roles in the car industry for several years, he joined the non-profit sector and became country manager for Médecins Sans Frontières in Bosnia, Croatia and Angola. Back in Europe, he headed the Communications department for the organization. Before joining Johnson & Johnson, he worked at Burson-Marsteller as a consultant on corporate communications.

Mieke is a Bachelor of Science in Clinical Chemistry, a pharmaceutical industry professional since 1984 and joined J&J in 2010. As a J&J certified Lean Green Belt she is passionate about driving quality-improvement initiatives using metrics and analytics. In her current role, Mieke develops and manages risk strategies for Pharmacovigilance suppliers, in collaboration with global stakeholders across multiple organizations. Mieke strives to gain additional insights and knowledge by expanding her network and embracing new opportunities.

As former Head of Innovation Management and Scouting at Takeda and as a member of their Digital Strategy team, Ronald helped Takeda with its technology and innovation strategy. Earlier, at the Life Science division of PA Consulting, Ronald led projects for some of the world’s top 10 pharmaceutical companies around strategy, commercialization and digital health. As founder of BioFrontline (first in London and then in Boston), he drives innovation in the pharma industry and helps innovative life science companies with strategy, commercialization and business development. After obtaining MAs in Biotechnology and Molecular Biology and a PhD in Pharmaceutical Biology, Ronald continued with a Postdoc at the neuroscience department of Harvard, before making the transition to industry. As a consultant he got involved in projects related to artificial intelligence and he has been following that field for over 10 years. He is frequently invited to deliver presentations and keynotes related to AI in Pharma and Healthcare and has presented at numerous national and international events. Ronald founded the LinkedIn groups ‘AI – Artificial Intelligence’, ‘Small Molecules’, ‘Boston Biotech’ and ‘Golden Triangle Biotech’ that serve over 10,000 members.

Keith Dorricott is an independent consultant and Director of DMPI Ltd since 2016. He developed his process thinking whilst at Kodak Ltd and is a Lean Sigma Master Black Belt. He has worked in two large CROs leading corporate process improvement for 10 years. He provides expert training and consulting services in metrics (KPIs, KRIs, QTLs), process improvement, and root cause analysis in clinical trials. He provides leadership to the Avoca Quality Consortium on metrics across the clinical trial spectrum including RBQM, QbD, and DCT. He is a member of the Scientific Advisory Board at the Centre for Pharmaceutical Medicine Research at King's College London. Keith's passion is improving the effectiveness and efficiency of processes by working with those on the ground who are running those processes.

Kevin is an Associate Director in Process Excellence & Risk Management at Daiichi-Sankyo. The Process Excellence & Risk Management (PERM) Team partners within Clinical Operations and with other functional areas to optimize clinical trial processes and tools, with a specific focus on risk-based quality management (including risk assessment, risk-based/centralized monitoring, and metrics oversight). PERM members are assigned to study teams and lead process improvement projects, usually in collaboration with CRO partners. Kevin has more than 30 years industry experience working for numerous companies (Wyeth, Rhone-Poulenc Rorer, Pfizer, and Shire) in various positions (Data Management, Database Programming, Quality & Compliance, and Operational Excellence). During that time, he was certified in Lean Six Sigma/Change Management and led multiple cross-functional continuous improvement projects. He received his BS in Biology from Ursinus College and MS in Biology from Villanova University. Kevin currently resides in New Jersey with his wife and spends most of his free time with their three daughters and 2 grandchildren.

Maria Dutarte is the Executive Director of the European Patients’ Academy (EUPATI) since 2020. Maria has previously worked for the European AIDS Treatment Group (EATG) coordinating patient involvement in a number of training initiatives and scientific projects. She has also worked for different scientific and international organisations, e.g. French National Research Center for Scientific Research (CNRS), International AIDS Society (IAS), The Global Fund to Fight AIDS, Tuberculosis and Malaria and The International Foundation for Science (IFS). Her educational background is in International Education and Communications.

Chibby Ebhogiaye is a Product Leader owning the technology strategy across Clinical Planning for GSK with a focus on protocol optimisation, and study visualisation and intelligence across trial operations and site engagement. As a clinical technology innovation leader, Chibby has experience in developing and delivering effective solutions to optimise site feasibility and selection, contract management and budget negotiation, as well as support teams to develop a positive culture around data and technology in industry. Chibby is passionate about driving innovation through the delivery of effective and efficient solutions to make a difference in the conduct of clinical trials.

Liam has spent the last 15 years and managed all key functions of the trial process, but specialises in the intersection of patient recruitment and site management. By focusing in this niche space, he maintained a 97% enrolment rate (in time and on budget) for over 7 years.

Sophie is Director, Feasibility Lead within the Pfizer Study Optimisation group. She holds a Bachelor degree in Biological Sciences and a PhD in Molecular Biochemistry from the University of Reading, UK. Having worked for CROs since graduating, Sophie joined Pfizer in 2011 and has had various roles within the UK and now global groups.

Mohanad Fors is the Head of commercial digital innovation and the Digital Garden, Almirall's new startup accelerator. He led externally focused digital innovation hubs in different locations in the world, including Silicon Valley. He has more than twelve years of experience in sales, marketing and digital marketing with global, emerging markets, Europe, and the Middle East. Mohanad is the founder of successfully exited start-ups with strong knowledge in the start-up community. He won different global awards, including the European Excellence, Clio, and Cannes Lions awards for different innovative projects like the first navigation application for visually impaired patients available on smart watches.

Laura has a unique role which blends internal and external components. Laura is Merck’s assigned leadership to the Oversight Committee of TransCelerate BioPharma, Inc. The Oversight Committee is the primary governing body for decisions related to the operational direction of TransCelerate, including project direction and expected outcomes. Laura draws on her experience as Director of Clinical Operations for a busy therapeutic area and Head of Clinical Performance, Analytics, and Innovation to provide this perspective. Within Merck, she has responsibility for driving internal engagement with key stakeholders. She facilitates adoption and internalization of TransCelerate solutions in alignment with Merck's objectives. Finally, she watches for opportunities to match innovative approaches to potential process improvement initiatives or other areas of focus.

Originally graduated as a Pharmacist in Madrid, and later completed my academic education with an MBA and a Master's in Public Health from Liverpool University. Over 25 years of international experience within the pharmaceutical industry in Regulatory Affairs, Medical Affairs, Marketing, Scientific Communications, and Clinical Operations in global and local positions in areas from cardiovascular to oncological diseases. In the last 2 years, my main professional interest has shifted toward patient-centricity within clinical development, recently taking on new responsibilities as an R&D Patient Officer. The development and coordination of patient-centric activities within Clinical Development programs, support of global and local teams, identification of best practices, and development of KPIs are the main priorities of my new activity.

Rose Gerber is a nationally recognized cancer advocate and cancer survivor. Her experience includes appearing on national television (MSNBC) to speak about cancer care, meeting with legislators in Washington, DC on cancer policy issues, and developing cancer programs. Rose was brought to the COA team to develop its patient advocacy program. One of her first accomplishments was to add an advocacy track to the annual conference, making the meeting one of the few that brings together physicians, administrators, and advocates. She serves as an invited member on national patient advocate panels, steering committees, and cancer coalitions. Rose has also served as a consumer reviewer on the Congressionally Directed Medical Research Programs – Department of Defense Breast Cancer research panels.

Debra has over 16 years of clinical research experience.  Her career began on site as a study coordinator for 5 years, followed by 12 years dedicated specifically to global patient recruitment and retention in the CRO and pharmaceutical spaces.  She has strategic patient recruitment expertise across all clinical trial phases and multiple indications with a special emphasis in rare disease, pediatrics and oncology. Debra currently works as an Associate Director in Patient Recruitment and Engagement at Covance.

Dagmar holds the role of Director, External Engagement & Business Insights in BioResearch Quality & Compliance Organization at Janssen, Pharmaceutical Companies of Johnson & Johnson. She joined the healthcare industry in 1988. She gained several years of experience in preclinical/clinical research at Gruenenthal and continued her career in clinical research at Boehringer Ingelheim in Ireland. In 1998, she joined Pfizer where she held positions in Clinical Monitoring and Project Management, Quality Management, Inspection Management for GCP/ PV Inspections, and as Regulatory Intelligence Lead. She was responsible for Medical Quality Oversight for Pfizer Consumer Healthcare before she introduced the role of Director of Research Management for Pfizer Oncology. In September 2018, Dagmar joined Janssen in her current role.

Laurie Halloran founded Halloran Consulting Group in 1998. Her time as a pediatric ICU nurse had inspired her to start a company that helps move new therapies through FDA processes to get them into the hands of patients desperately in need. By providing a strategic development team, innovative start-up companies could have access to world-class expertise at a fraction of the cost. Since its humble beginnings, Halloran has grown into a successful consultancy of like-minded experts who are dedicated to improving human health by making life science companies better at what they do. Laurie has been named 2018 Women’s Business Enterprise Star by the Women's Business Enterprise National Council (WBENC) and has won a 2017 Enterprising Women of the Year Award from Enterprising Women Magazine. Halloran Consulting Group was also named an Inc. 5000 Fastest Growing Company for the past three years in a row. In 2015, Laurie was honored by the Boston Business Journal as a Woman of Influence, in 2010 was selected as one of the 100 Most Inspiring People in Life Science by PharmaVoice, and in 2009, she was awarded Clinical Researcher of the Year by the New England Chapter of the Associate of Clinical Research Professionals. Laurie earned a Bachelor of Science in nursing from Russell Sage College and a Master of Science in management from Lesley University. She is also a Prosci Certified Change Practitioner.

Jane Hart has worked in the Clinical Research Industry for over 24 years. In her current position with Exact Sciences she leads the Global Clinical Affairs organization. Her team is focused on generating evidence to support the safe and effective use of Exact Sciences products primarily through company sponsored research. Jane started her career in Australia working in breast cancer research and relocated to the US 18 years ago. She is experienced in executing pre and post market studies globally for both drug and devices. Highlights of studies she has managed include FDA approval of a nanocoated cardiac stent, hormonal therapy for breast cancer and chemotherapy for hematological malignancies.

Ana Herradón is the Associate Director, Clinical Trial Manager for Spain and Portugal for Bristol-Myers Squibb, where she is responsible for BMS’ monitoring groups in Spain and Portugal. She leads Site Monitors, part of the Iberia Clinical Operations Organization, to ensure the execution of the Iberian work in terms of recruitment, monitoring and data quality. Ana has 25 years of industry experience pharmaceuticals and has been the TransCelerate Country Lead for Spain and the TransCelerate Program Lead for Bristol-Myers Squibb since 2016. She works to bring knowledge of TransCelerate’s portfolio of solutions within Spain while enhancing voluntary global adoption and raising awareness of TransCelerate’s efforts. Ana holds a Masters in Biotechnology from the Universidad Autónoma de Madrid and a Masters in Environmental Management from the Universidad Politécnica de Madrid.

An experienced clinical trial professional, Keir has been working for Hoffman La Roche for the last 15 years with expertise in clinical trial databases and for the last 7 years as a leader of late stage global clinical trials in clinical operations. Keir joined the Transcelerate initiative ‘’Clinical Research Access’’ three years ago to support in closing the gap between the willingness of the public to participate in clinical research and the limited clinical trial information available to the public on platforms such as clinical trial registries.

I help organizations develop policy and strategy and implement them through the designs of services. They hire me to work on pesky problems, or those of unusual size and shape. They do so aware of safer options because I bring a new way of thinking, that is sophisticated in solving problems without creating new ones elsewhere, including in the future. That’s why I am a special advisor at the Netherlands Ministry of Defense. My job there is to establish an in-house capability in strategic design of services. I am part of a team called xD/Saga that develops new thinking and generates options, for policymakers confronted with difficult problems and sensitive matters. I helped create and establish a similar unit at RVO.NL, an agency of the Ministry of Economic Affairs & Climate. My goal is to equip brilliant minds with thinking and tooling so they can pursue bigger and bolder ideas in the form of systems and services. In 2018, I wrote Thinking in Services, a book that exposes the hidden structures and dynamics that help understand some services fail while others succeed. The book introduces a framework called 16x, for developing strategic narratives and strategic plans.

Todd Johnson joined Halloran Consulting Group in 2017. He has more than 25 years of experience in pharmaceutical development and clinical systems – from beginning his career as a clinical site monitor to developing operational performance dashboards and KPI/data reporting strategies. Having successfully managed clinical programs and assets, Todd is knowledgeable in ICH/GCP, has clinical operations experience across multiple therapeutic areas, and has assisted in several successful IND and NDA submissions. Prior to joining Halloran, Todd led Clinical Information and Informatics groups at Astellas and PPD, with an emphasis on operational performance metric/KPI assessment, data quality, benchmarking, dashboard development and reporting. He worked closely with cross-functional teams in study start-up, clinical operations, data management, clinical programming, biostatistics, medical writing and pharmacovigilance in order to help them identify KPIs (and data sources) that drive their business decisions. He is passionate about data quality and ensuring the right data is used to make better decisions. Todd earned his Bachelor of Science in Biology from the University of Michigan and a Master of Public Health in Epidemiology and Biostatistics from the University of Illinois at Chicago School of Public Health. He also earned a Master of Business Administration in Entrepreneurship and Econometrics and Statistics from University of Chicago Booth School of Business and is currently enrolled in Northwestern University’s Master of Science program in Predictive Analytics.

Phyllis Kaplan is a Senior Project Manager on the Health Communication Services team at CISCRP, focusing on plain language summaries of clinical trial results. When not in the office, she volunteers most of her time as an advocate in the diabetes community and running educational programs for adults with type 1 diabetes. She holds a Master’s degree from Teachers College, Columbia University, and a Bachelor of Science degree from Long Island University.

Marcy Kravet is a seasoned executive with a proven track record in leading global teams and innovating for impact. With over 25 years of experience in the pharmaceutical industry, Marcy has held Clinical Operations leadership roles at Bristol Myers Squibb and EMD Serono. She previously was elected by her peers to serve as the co-chair of the Feasibility Consortium, a think tank dedicated to improving data driven approaches to protocol and site feasibility. As Vice President of Strategic Operations at Inato, Marcy works closely with Client stakeholders and Inato’s Customer Success team to integrate strategic objectives with day-to-day operations ensuring site selection and engagement through the Inato marketplace create substantial value for customers.

Dan has a degree in Business Management Studies and worked for an accountancy firm prior to moving into the NHS in 1996. Currently with over 20 years NHS experience, as a nurse across Malignant Haematology, High Dependency and Coronary Care and then as a Research Nurse, Manager of a Cancer Research Team and then Senior Manager within Research Governance. Dan led on Industry for Trent CLRN since 2011 prior to this post. This current role focuses on the leadership of the NIHR CRNEM Study Support Service for both commercial and non-commercial research across all stages of the study lifecycle. From a commercial perspective this involves a particular focus on recruitment of trials to targets and growth of the sector. Dan also oversees the Workforce Development work stream including the Research Support Team as part of the CRNEM Leadership team.

Alicia Kundtz works directly with Complion’s clients and partners to reframe entrenched models of eRegulatory Management. Alicia believes in facing the challenges of digitization and change management head-on, leveraging over ten years of operations and software implementation experience in heavily regulated industries.

Dr. Mary Jo Lamberti manages multi-sponsored and grant-funded research projects at Tufts CSDD. She has extensive experience conducting market research on pharmaceutical industry practices and trends affecting contract research organizations and investigative sites. She has been a speaker at conferences and has published articles in trade and peer-reviewed journals. Prior to joining Tufts CSDD, Dr. Lamberti was Director of Market Research at CenterWatch. She has also worked on federally funded research studies in science education reform. Dr. Lamberti holds a B.A. from Wellesley College and a Ph.D. in Psychology from Boston University.

Steven brings 14 years of experience in various project management and trial management capacities to his role of Director for the implementation and adoption of the Xcellerate® technology suite.  Steven leads the development and advancement of the Xcellerate Risk & Issue Management system as well as other Xcellerate technologies.  Steven holds a BBA in Management Information Systems from the University of Georgia, a MBA from Kennesaw State University, and holds several project management credentials including the (PMP).

Since 2000, Kai has been a pioneer in patient-facing solutions for clinical trials working with young innovative technology companies. In 2012, Kai co-founded eClinicalHealth, the developers of the Clinpal decentralized clinical trial platform. In 2019 Kai co-founded the DEEP initiative to co-create a novel integrated ecosystem for the development, validation and acceptance of digital measures. Kai continues to contribute in an advisory role with DEEP, which is now an independent company. Through his involvement in technical, operational and scientific roles, he has gained deep and holistic understanding of the clinical trial process and the key mechanisms of our ecosystem. Kai brings his entrepreneurial spirit and creative mindset to support Janssen’s global regulatory policy work across a range of topics. Kai has a passion for broad pre-competitive collaboration and is motivated to modernize the ways our broader ecosystem works together to advance the adoption of novel tools and methods to support efficient and patient-centric pharmaceutical R&D.

Jake LaPorte has many roles and is currently the co-founder of Prisma Therapeutics. He also founded and was the Global Head of The Biome—the digital innovation lab of Novartis. Prior to that, he was Global Head of Digital Development at Novartis and responsible for leading the company’s digital efforts to advance future, patient-centric paradigms of clinical trials. Jake began his career at McKinsey & Company, where he was a leader in their Pharmaceutical R&D practice, during his six-year tenure, developing an expertise in large, complex transformations and innovation. It was on a fateful, extended journey, however, where Jake read Ray Kurzweil’s The Singularity is Near and became captivated by the possibility of digitalizing the Pharmaceutical R&D engine; he has focused his career to the realization of this concept ever since. He co-founded Snapdragon Chemistry with the Head of the Chemistry Department at MIT, which seeks to enable companies to implement continuous flow chemistry in discovery, development, and manufacturing, with the ultimate goal of fully digitizing chemical synthesis. Jake has also held various leadership positions at PPD, Inc., where he collaborated with executives to develop and implement C-level, strategic initiatives, including a long-term transformation to create industry-leading approaches to clinical development in key therapeutic areas. Jake completed his PhD in Organic Chemistry from Harvard University, where he was an HHMI doctoral fellow, and received his BSc in Biochemistry and Mathematics, summa cum laude, from the University of Delaware.

Eric Lawrence is the Alliance Lead for Specialty Lab testing in support of Bristol-Myers Squibb’s Global Clinical Operations. Eric is responsible for enabling successful external partnership strategies thru governance implementation, vendor oversight and strategic risk management across a technologically diverse portfolio of service providers. In his 12 years of service at BMS, he has spanned roles supporting early discovery thru development providing a breadth of experience supporting portfolio management, budgeting, capacity planning and outsourcing management strategies. Eric is passionate to build strategic partnerships with external partners to harness additional value thru continuous improvement initiatives that leads to improved quality in support of clinical trials. He holds a BS in Biology from Rutgers University, a MS in Biotechnology from the University of Pennsylvania and a MBA from Rutgers University.

Andy Lawton has extensive experience in computing, statistics, data management, system design, Quality Management and Risk Based Approach in both Computer System Validation and clinical trials. He is currently consultant and director of Risk Based Approach Ltd. Previously, Andy held a variety of position at Boehringer Ingelheim. Andy was a Founding Committee Member of ACDM, Member of TransCelerate RBM work stream and a Member of EFPIA WG on Data Transparency. His publications include the TransCelerate papers on SDV and Central Monitoring in the TIRS Journal, for which he won “best author of the year 2015 and 2016” from the DIA.

Donna’s career spans across the pharmaceutical industry, professional conference development and legal field as a former practicing attorney. These combined experiences pivoted Donna into her most experienced role in Clinical Operations, with a focus on clinical site contracting, budgeting and payments. Donna leads a global Contracting and Budgeting team for Bayer, building Fair Market Value site budgets and providing training to the country organizations around the world. She also provides guidance and support on contracting and budgeting best practices for the local country organizations. Additionally, Donna is project lead and/or provides support and consultation for several major initiatives at Bayer, including implementation of automated payments and decentralized clinical trials. Donna is also on the Advisory Council on behalf of Bayer for Kits4Life, a non-profit platform to repurpose lab kits and bulk medical supplies from clinical trials for humanitarian aid and research in developing countries. Donna is the Chair of the Site/Pharma on-boarding workstream for Kits4Life. Prior to converting to Bayer, Donna was an Associate Director for PRA Health Sciences and embedded at Bayer as the U.S. Contracts Manager. Donna grew and managed a U.S. team of over 20 clinical contract specialists and associates. She managed the contracts team and operational aspects of clinical contracts, budget negotiations, to those thorny site payment issues. Donna is also a Patient Educator with Pathways Women’s Cancer Teaching Project and a member of their Advisory Council. Her Patient Educator role entails speaking on panels or 1:1 interviews with medical students and residents about her experience as a triple-negative breast cancer survivor. They are unique opportunities for healthcare professionals to learn about patients’ personal experiences through educational dialogue in a less formal setting. Donna earned her JD degree at The Washington College of Law, The American University, and BS in Political Science at Douglass College, Rutgers University. Donna’s five-year residency in Rome, Italy spurred her love for travel and historical adventures. She is married with two daughters, residing in New Jersey. But her heart remains in bella Roma!

Craig Lipset is a recognized leader at the forefront of innovation in clinical research and medicine development. He is the founder of Clinical Innovation Partners, working as an advisor and board member with pharma, tech and venture capital to bring vision and driving action at the intersection of research, digital solutions, and patient engagement. Craig is also the Co-Chair for the Decentralized Trials & Research Alliance, the leading non-profit collaboration focused exclusively on improving access for research participation. Craig is Adjunct Assistant Professor in Health Informatics at Rutgers University, and Adjunct Instructor in the Center for Health + Technology at University of Rochester. He serves on the Board of Directors for the Foundation for Sarcoidosis Research and the MedStar Health Research Institute, as well as on the Editorial Board for Therapeutic Innovation & Regulatory Science. Previously Craig was the Head of Clinical Innovation and Venture Partner at Pfizer, on the founding Operations Committee for TransCelerate Biopharma, and on the founding management teams for two successful startup ventures. He has been listed among the PharmaVOICE most inspiring people in the life sciences (Red Jacket hall-of-fame), Pharmaceutical Executive’s Emerging Leaders, CenterWatch Top 20 Innovators in Clinical Trials, and the AlleyWatch Who's Who in eHealth.

As Vice President of Informatics, Victor Lobanov, Ph.D. is responsible for the conception, development and delivery of Xcellerate^® technology solutions. He received his Ph.D. in computational chemistry from the University of Tartu and his undergraduate degree in chemistry from Lomonosov Moscow State University. Dr. Lobanov has authored more than 40 peer-reviewed publications.

A suburban Philadelphia native, Rob is a former All-American punter at Syracuse and has lived the rare disease journey. In December of 2010, late in his senior season, Rob was diagnosed with anaplastic astrocytoma, a rare and aggressive form of brain cancer. His prognosis at the time was less than encouraging, and his surgery, recovery and treatment took 16 months. Prior to his diagnosis, Rob was on a path to the NFL as a punter, but that opportunity was lost by the time he was healthy enough to train again. A graduate of Syracuse University, Rob pursued a Masters in New Media Management from the S.I. Newhouse School of Public Communications. He also received a B.S. from the Martin J. Whitman School of Management. Rob played football all four years for the Orange and was voted by his teammates as a team captain his final two seasons. He became the second Executive Director of Uplifting Athletes at the end of 2018. Prior to taking over as the Executive Director, Rob served as Uplifting Athletes' Director of Rare Disease Engagement for nearly two years. Rob has a steadfast commitment and connection to the Rare Disease Community as a rare brain cancer patient. As a former star college football student-athlete, his passion and drive to advance the mission of Uplifting Athletes is inspirational. Rob and his wife, Irie, reside in South Philadelphia.

Kelly Loughner is a Senior Associate Director in Clinical Operations at Boehringer Ingelheim and is US Head of the Clinical Contracting Team and Site Budget and Investigator Payments Team. With over 15 years of clinical contracting expertise across all therapeutic areas, Kelly leverages both her in-house and clinical outsourcing experience to construct both internal and external customer focused solutions in streamlining start-up and reducing contractual/budgetary negotiation cycle times. Kelly is active in process improvement/program management and the development of clinical business intelligence databases.

Joachim Lövin has worked in the pharmaceutical industry for over 20 years across various therapeutic areas and organizations. During this time, Joachim has worked in different roles spanning over Data Management, Project Management, Process Development, Senior Business Analyst and Clinical Operations. In his current role as DCT Specialist, Joachim focuses on supporting trials including competence development of Clinical Operations, identifying opportunities, and operationalising Decentralised Clinical Trial Elements across Novo Nordisk. Joachim is the Workstream Lead for the Modernizing Clinical Trial Conduct workstream for TransCelerate Biopharma, and a member of the eClinical Forums Trial of the Future. All of Joachim’s work is aligned with his passion to improve patient experience and accelerating clinical trials. Outside of work, Joachim is an avid hiker and leads a youth squad in the Swedish Outdoor Association.

Beth Mahon is the Global Feasibility Therapeutic Area Head for Oncology within the Feasibility and Advanced Analytics team at Janssen Research & Development, LLC. In this role, she works to enhance program and protocol strategies for better and more cost effective scientific and regulatory outcomes while balancing customer-focused insights and data analytics in early planning and execution of clinical trials. Beth joined Janssen in 2007 and has over 20 years of clinical operations experience.

Dr. Malikova is an Assistant Professor of Surgery at Boston University, School of Medicine, and an Executive Director of Research at the Department of Surgery at Boston Medical Center. Dr. Malikova has PhD in Biochemistry with strong background in biomedical sciences. She also holds a Master’s Degree in Clinical Investigation and Master’s of Business Administration in Health Sector Management from Boston University. She has over 18 years of experience in the biomedical product R&D, clinical development, operations and regulatory compliance fields; with the past 11 years on executive level. In her current role as Executive Director, Dr. Malikova macro-manages research programs in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations and compliance, strategic planning and execution oversight of clinical trials; safety and risk management. She is a member of International Society of Pharmacovigilance (ISoP), and currently serves as the Vice-President of NASoP.

Sylvia Marecki is Senior Director and Head of Portfolio Reporting & Analytics at Moderna. Her team delivers trusted reporting, analytics, and insights to the organization, driving efficiency and innovation, and empowering confident data-driven decision making. Prior to joining Moderna, Sylvia led the Operational Design Center at EMD Serono, establishing advanced and predictive analytics to inform clinical study operational design and delivery. Earlier in her career, Sylvia led development and commercialization of data-driven analytic products and services at Citeline, DRG (Clarivate), and TriNetX, empowering informed decision-making across clinical and commercial functions at all stages of the product life cycle. She received her Doctorate in Pathology and Immunology from Boston University School of Medicine.

Kristin brings more than 25 years of clinical research experience and eClinical technology implementation for pharma, biotech, and CRO's. Previously, she was responsible for overseeing the RBM technology and services practice. A recognized thought leader on clinical operations topics in the areas of RBM, Quality Management, & Clinical Trial Forecasting. 

As the head of Europe for Science 37, Bryan brings strategic oversight to Science 37’s ongoing growth—strengthening its leadership presence and capability to bring clinical research to patients where they are, anywhere in the world.

Bryan brings more than 25 years of pharmaceutical experience. Most notably, he led efforts to innovate and improve clinical trials with data and digital technology in a variety of roles during his nearly 20 years at Novartis. As head of Europe, Bryan leverages an established network of sponsors and service providers developed during his role as co-founder and CEO of DataFusion GmbH—delivering an ecosystem of collaborative networks dedicated to developing innovative solutions to meet the ever-evolving needs of the pharmaceutical, healthcare, and medical device markets.

Bryan is a recognized strategist who continues to drive the pharma industry toward smarter drug development and lifecycle management. He holds a Bachelor of Science in biotechnology from Dublin City University and an MBA from the University of Wales.

 

Carrie is currently the Senior Vice President of Development Operations at X4. She has more than 20 years of experience and has led Global Clinical Operations for top pharmaceutical and biotechnology companies, with extensive experience in oncology global drug development, including clinical trial conduct, close-out, submissions, inspections and approvals. Prior to joining X4, Ms. Melvin was the Vice President of Global Clinical Sciences and Delivery for Oncology at GSK and Vice President of Global Clinical Operations at TESARO (acquired by GSK). Prior to that, she was Vice President of Global Clinical Operations at Kura Oncology. Ms. Melvin has also held positions of Director of Global Development Project Management at EMD Serono and Director of Clinical Operations at Millennium: The Takeda Oncology Company. Ms. Melvin began her pharmaceutical career at Pfizer, Inc. Prior to joining the pharmaceutical industry, Ms. Melvin spent 3 years as a Registered Nurse at a community hospital in Connecticut. Ms. Melvin received her BSN with highest distinction from University of Rhode Island and her MBA from Boston University, School of Management.

Pierre Meulien is Executive Director of the Innovative Medicines Initiative (IMI), a €5 billion public-private partnership between the European Union and the European pharmaceutical industry. He is responsible for the overall management of our programme, which is working to improve and accelerate the entire medicines development process by facilitating collaboration between the key players involved in health research, including universities, pharmaceutical and other companies, patient organisations, and medicines regulators. Dr Meulien joined IMI in September 2015. From 2010 to 2015, Dr Meulien was President and CEO of Genome Canada, where he raised significant funds for the organisation and oversaw the launch of novel projects and networks in the field of genomics-based technologies. Prior to that from 2007 to 2010, he was Chief Scientific Officer for Genome British Columbia. From 2002 to 2007, Dr Meulien served as founding CEO of the Dublin Molecular Medicine Centre (now Molecular Medicine Ireland), which linked medical schools and teaching hospitals in Dublin to build a critical mass in molecular medicine and translational research. Dr Meulien also worked in the private sector with the French biotechnology company Transgene, and with Aventis Pasteur (now Sanofi Pasteur). He has a PhD in molecular biology from the University of Edinburgh and carried out a post-doctoral fellowship at the Institut Pasteur in Paris.

Physician scientist conducting and supporting cutting-edge research in digital medicine. Established record of exceeding performance benchmarks. Passionate and knowledgeable about health policy, precision medicine, novel technologies, and driving more effective, system-wide healthcare management strategies through strategic innovation.

Matt works as a Director of Clinical Supply Technology at Merck. In the current role, he leads the incorporation of innovative clinical supply and clinical trial technologies to improve supply production, trial execution, patient engagement, and decision making in Merck clinical trials. Matt is responsible for enabling global readiness of new CSO facilities, equipment, technologies, & processes, ensuring Merck meets evolving business dynamics for quality and safety, and improving supply production and distribution.

Asmaa Mrabti is a study risk and risk-based monitoring expert at Sanofi. Her role is to ensure a correct implementation and continuous improvement of centralized review and risk methodologies on clinical trials. Asmaa has been working for Sanofi for over 8 years; her previous position held was as clinical trial manager across multiple therapeutic areas and development lifecycle (Phase I, II, III) with a focus on outcome trials.

Mick Mullane, Innovation Lead, NIHR CRN Michael, often called Mick, has worked in digital for over 25 years. Mick has a track record in delivering innovative solutions built on technology, from working with some of the first educational broadband and networks in the 1990’s, to early online and social learning systems in the 2000’s. pioneering the use of SMS text, podcast solutions 10 years ago to a more recently leading the shift of the NIHR onto a collaborative cloud based computing platform, and designing the first NIHR research ‘app’ involving a complete consent process. Mick is a firm believer in the ability of technology to provide an individual with more choice, facilities and importantly more control over their own lives, personal networks and data. Mick is currently working to bring ‘apps’ into mainstream research, to give the patient and participant a greater voice in research, and to connect researchers and patients to the right research. With a strong belief in putting the patient at the very centre of the experience.

Amy Neubauer serves as Director, Data Quality Oversight at Alkermes, a company developing innovative medicines that address the unmet needs and challenges of people living with debilitating diseases, such as schizophrenia, depression, addiction, multiple sclerosis, and cancer. She has 15 years of experience in clinical research with expertise in data management, project management, and vendor management, and is an experienced auditor of clinical trial systems, technologies, services and software. In her current role, Amy is responsible for the development of a clinical data sciences team to lead risk-based approaches and strategic data quality efforts for the organization through development and interpretation of algorithms, code, reports, and visualizations in support of clinical trial operations activities with a focus on impactful data insights and clinical data review.

Mark is Vice President for Healthcare, Life Sciences & Government for IBM, Watson Health & Watson Health Consulting. He has over 25 years experience, clinically and commercially and has worked in the NHS as well as many senior leadership positions in global, European and start up healthcare companies throughout his career.

Mark is responsible for the strategy & team, for Watson health software products and Watson Health consultancy services to their customers. This includes the full software portfolio of Life Sciences, Oncology, Genomics, Imaging, Government, Value Based Care & Population Health Management solutions. As well as leading the team to provide deep industry consultancy services to clients, focussed on digital, clinical and operational transformation.

Gareth Powell is a Business Development Officer for the NIHR Clinical Research Network (CRN). Gareth facilitates key discussions between industry and the Clinical Research Network and is a point of contact for life science companies engaging with the Clinical Research Network. Gareth is able to provide advice to companies on how they are able to tap into the Clinical Research Network study support services to ensure clinical studies are set up efficiently and recruit to time and target. Gareth has been with the Clinical Research Network since 2009. Before joining the Business Development and Marketing team, Gareth previously worked within the Research Delivery Directorate of the Clinical Research Network. He was responsible for supporting interactions between the life sciences industry and NIHR National Specialty Groups across 7 therapeutic areas, providing operational support through feasibility, set-up, and patient recruitment.

Narayanan R (Naru) acts as a Chief Architect and Head of Clinical and Safety solutions for TCS ADD life sciences platform. He also heads the TCS Connected Clinical Trials platform. Naru works closely with multiple pharma companies to develop and implement the strategy for patient engagement and digital technology adoption in clinical development.

Kelly brings 20 years of industry experience to lead the ArcheMedX clinical research business.  She has previously provided strategic leadership and operational oversight to Sponsors and CROs as Vice President at MEDnet Solutions, IND 2 Results, and Rho.

 

Samantha Rogers is a Patient Recruitment & Retention Lead at Takeda, where she develops and executes recruitment and retention campaigns for clinical studies, and is a member of Takeda’s cross-functional Patient Centricity team. Prior to joining Shire in 2016, Sam worked at a patient recruitment agency and has a background in health promotions and public health. Sam enjoys spending time with family and friends, playing tennis, and traveling.

Christina Román is the Sr. Manager of Community Engagement at the Cystic Fibrosis Foundation in Bethesda, MD. In this role, she works on a range of projects at CFF which include managing patient engagement activities across the Foundation. Her work includes overseeing the community groups who contribute to CF research and care initiatives, insights research in the CF Community and overseeing the development of tools to help improve patient engagement. Christina earned her Masters in Public Health in 2013 from the University of Colorado, Denver.

Dr. Rosenberg is a 35-plus-year executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, eclinical, and contract research organization sectors. With his diverse background which includes executive management, clinical and regulatory operations, business development, eclinical technology solutions, and new product/licensing evaluations, he brings tremendous hands-on insights to optimizing the drug development cycle, from the early start-up stage to global product registration. Dr. Rosenberg is Head, Clinical Operations at Beat AML, LLC, a division of Blood Cancer United, and also Managing Partner of eP2Consulting, Inc. since 2001.

Roz leads Parexel’s Patient Innovation Center, dedicated to improving access to clinical research and patient experiences of participants. She is focused on reducing financial, geographical and practical barriers to study participation and is excited by the shift towards greater patient engagement across the drug development lifecycle. Roz also has held roles in patient recruitment and innovation. Her first job in an oncology clinic at Massachusetts General Hospital (USA) sparked her passion for putting patients first.

Jonathan Rowe has 25 years of experience supporting pharmaceutical companies in the development of medical therapies from the clinical, operational and business perspectives. Currently, Jonathan holds the position of Head of R&D Quality and Operations Risk Management at ZS. In this role he partners across the industry to design and implement advanced approaches to identifying and mitigating clinical development risk, and improving end-to-end process, study, site and vendor quality. From 2014-2019 Jonathan was the Head of Clinical Development Quality Performance and Risk Management at Pfizer, where his responsibilities included monitoring, modeling and predicting the Pfizer GCP Quality Management System, leading the analysis of Pfizer’s Clinical Trial Quality Performance and ensuring clinical trial quality risk management is built into all trials. At Pfizer he has held a number of roles including Clinical Director, with responsibility for the Phase IIIb and IV Lipitor program; Director, Intellectual Property Strategy Management; and Senior Director of Process and Performance. Jonathan spent a number of years in “small pharma” as the Head of Intellectual Property and Portfolio Strategy for both Amarin and Dignity Sciences. Jonathan earned his Ph.D. and M.S. at the Albert Einstein College of Medicine and his M.A. from Binghamton University.

Dr. Thorsten Ruppert is senior manager for research, development, and innovation in the Association of Research-Based Pharmaceutical Companies – VFA. In 1999 he received a doctorate in biochemistry at the Free University in Berlin. Also in 1999, he joined NOXXON Pharma AG as a scientist in the Department of Research & Development. From there he moved internally in the clinical research department and in 2002 he became Director of Scientific Marketing, Division of Business Development. In 2005 he joined the VFA, where in his role as Senior Manager Research, Development & Innovation he is responsible for clinical trials, personalized medicine, and biobanking.

Rangaprasad (Ranga) Sarangarajan, Ph.D., is the Senior Vice President and Chief Scientific Officer at BERG who oversees all Research and Development activities including pharmaceutical development & translational sciences strategy development and planning. Dr. Sarangarajan is the co-inventor and co-architect of the BERG Interrogative Biology® technology. This ground-breaking technology is currently focused on next generation R&D innovation in the integration of artificial intelligence-based analytics, bioinformatics and Real-World Data (RWD), and Real-World Evidence (RWE) for speeding up identification/validation of targets, tractability, drug discovery and pharmaceutical development. He is also actively involved in the development of clinical programs in the late stage progress towards registration. Dr. Sarangarajan has numerous U.S. and international patents (granted and pending), covering areas of the discovery platform, cancer, neurology, metabolic diseases, diabetes, obesity and diagnostics. He has published extensively and has presented his research at national and international medical and scientific meetings. He co-authored and co-edited Cellular Respiration and Carcinogenesis, a first of its kind treatise on the role of mitochondrial function and metabolic network regulation in the etiology of cancer as it pertains to the seminal observations made by Otto Warburg.

Scott has extensive experience having predominantly worked in senior positions for large multi-national corporations, mostly as an R&D Sourcing professional. His varied industry experience with both sponsors and CROs includes R&D Sourcing & Procurement, Supplier Relationship Management, and Business Development, with sponsor companies Centessa Pharmaceuticals, ADC Therapeutics, Adare Pharmaceuticals, Novartis Pharmaceuticals, Aventis, and CROs Crovelis, Syneos Health, and Covance.

Hollie Schmidt is the Vice President of Scientific Operations at Accelerated Cure Project for Multiple Sclerosis. She co-chairs the Research Committee of iConquerMS, a participatory research network for MS established to perform and support patient-centered research in MS. In this role she works to promote patient engagement throughout the research process and to develop research collaborations on topics of interest to people with MS. She founded and leads the MS Minority Research Engagement Partnership Network, a multi-stakeholder initiative aimed at promoting racial and ethnic diversity in MS research studies. Before joining Accelerated Cure Project, Ms. Schmidt's endeavors included co-founding a management consulting firm and two software companies. Ms. Schmidt has an MS in Management, as well as a BS and MS in Materials Science and Engineering, all from the Massachusetts Institute of Technology. She also serves on the Institutional Review Board of Beth Israel Deaconess Medical Center and is Secretary for the Multiple Sclerosis Coalition.

Duane Schulthess is the Managing Director of Vital Transformation, a consultancy focused on quantifying and defining innovation and change in the health-care sector. He regularly works with regulators, multi-national corporations, governments, and stakeholder groups, clarifying the impact of health policy changes and technological innovations. He has been a speaker at many leading international conferences including BIO, the European Health Forum Gastein, DIA, and The Basel Biozentrum. Mr. Schulthess’ 2019 BMJ publication titled “Are CAR-T therapies living up to their hype?” is considered a ground-breaking analysis in the field of real-world evidence, and has been cited in presentations by the European Medicines Agency and EUnetHTA. Previously, Duane was the EMEA Head of Corporate Development of The Wall Street Journal, and was the Commercial Director of Science|Business. He has a BA Magna Cum Laude from the University of the Pacific where he was also nominated to the Phi Kappa Phi honour society, and an MBA with Distinction from KU Leuven’s Vlerick Management School. From 1988-91, he was a recipient of a Leverhulme Trust Fellowship at the Royal Academy of Music in London where he won several music performance prizes and competitions while also studying economics on an international exchange programme at Regent’s College. He was recently appointed as a senior associate of the UK’s Royal Society of Medicine.

As a cross-functional leader in development operations and business intelligence, my 16+ years of experience is punctuated by creating top-performing teams, ideating, developing, and integrating leading-edge solutions aimed to optimize clinical programs and accelerate the development of innovative drugs for patients in need...In Life Sciences Time is Life. Oriol holds a Bachelor in Biological Sciences from the Fairleigh Dickinson University, MS Clinical Trials Management from the International University Barcelona, and an Executive MBA from University of California San Diego-Rady School of Management.

Patrick is CEO of Sano Genetics. Sano helps patients with rare and chronic diseases match with research, advance science, and learn more about their condition. The platform is patient-centric and private-by design. Sano enables precision medicine research that was previously expensive and time-consuming, through data-driven matchmaking and home genomic testing.

Dr. Siracuse is an Associate Professor of Surgery at Boston University and an attending vascular surgeon. He has been the principal investigator and co-investigator on multiple global clinical trials, including peripheral arterial disease, surgical nutrition, surgical wound, and venous disease. He has published over 140 papers focusing on comparative effectiveness of surgical interventions, preoperative optimization, and appropriateness of care.

Débora S. Araujo has over a decade of experience in the pharmaceutical industry working and consulting for Fortune 500 companies. During her time in this industry her special focus has been on the business aspects of clinical trials including: clinical contracting and financial management, clinical outsourcing and CRO/vendor management, global clinical trial budgeting and forecasting, clinical financial analytics and metrics/KPIs, site budget development and negotiations, Fair Market Value (FMV) and global investigator site payments. She has also utilized her expertise and knowledge to drive practical change in this industry via thought leadership material, conference presentations, and consulting engagements. Débora’s passion for driving practical change in the industry led her to launch ClinBiz (www.clinbiz.com), an online platform with a dedicated YouTube channel, podcast, blog, and much more where clinical research professionals can stay connected and updated on the latest topics, trends, and technologies related to the business aspects of clinical trials. Débora has also recently published a book on clinical trial agreement negotiations named ‘The Four Villains of Clinical Trial Agreement Delays and How To Defeat Them’ which quickly became Amazon’s #1 New Release in the pharmaceutical and biotechnology category.

Sebastian is a Berlin-based serial entrepreneur and CEO of xbird, a medical AI company detecting health complications for patients. His first venture, Whitewall Healthfoods, was acquired by Schober Ventures, and his second venture, Datamonk, was acquired by Hitfox Group. Before finishing a Finance Degree at Maastricht University, Sebastian worked in Security and Intelligence at NATO.

Ms Sullivan is a Senior Fellow at the Tufts Center for the Study of Drug Development. She has more than 30 years of experience working in the Healthcare and Clinical Research industries helping organizations optimize processes to improve financial and quality outcomes. She is the founder and served as Executive Director of the Metrics Champion Consortium, an industry consortium created to bring clinical research stakeholders together to collaboratively develop standardized performance metrics thathelp organizations oversee and manage studies, identify areas in need of improvement and assess process improvement activities. She has been a featured speaker at industry meetings, published articles in leading journals, hosted the Clinical Trial Optimization Podcast Show, and served on industry advisory boards such as the NIH-NCATS Methods and Process Domain Task Force. Ms Sullivan received her BS in Biology from Trinity College and her MBA from the Amos Tuck School of Business at Dartmouth where she was named a Tuck Scholar.

Mats Sundgren, PhD, MSc, is a distinguished authority in Health Data Strategy, serving both industry and academia. With an impressive career spanning over 37 years in the pharmaceutical industry, Mats has made significant contributions across various domains, including Discovery, Development, Manufacturing, IT R&D, Patents, Clinical Science, and Data Science & AI. His work places him at the forefront of technological innovation in the field. In 2022, following an illustrious 12-year tenure as the global integration lead for Electronic Health Records (EHR) services at AstraZeneca, Mats expanded his professional endeavors. He now holds several key roles: Senior Industry Scientific Director and co-founder of the i~HD (European Institute for Innovation through Health Data), Executive Strategic Advisor for IgniteData, which develops a system-agnostic EHR-to-EDC solution for clinical trials, and Chairman of the Board of the Research Foundation IMIT (Institute of Managing Innovation and Technology). IMIT includes prominent institutions such as Chalmers University of Technology, Royal Institute of Technology, Lund University of Technology, and Stockholm School of Business. Additionally, he serves as a Board Member of the Center for Health Governance at Gothenburg University. In July 2024, Mats assumed the role of Scientific Adviser for IOMED, a company specializing in AI-powered technology for healthcare data activation. In March 2025, assumed the role of R&D Strategy Advisor for ZS Associates. Mats has an extensive portfolio of work, including over 80 publications, books, and patents in Life Science, Economics, and Social Science. His areas of expertise encompass Health Data Science & AI, Clinical Science, Clinical Trials Management, Business Modelling, Innovation & Creativity Management, and Device Development.

In her role as Associate Director of Nursing in the Clinical Trial Support Center, Leah Szumita supports The Leukemia & Lymphoma Society’s (LLS) efforts to educate and support patients and caregivers affected by blood cancers. Through education, advocacy, coaching and decision-support services, Szumita and the team of nurses help patients and their caregivers navigate the process of identifying and participating in clinical trials, and provide support through the continuum of their treatment and care. Prior to joining LLS, Szumita was staff nurse in the Medical Intensive Care Unit at Brigham and Women’s Hospital in Boston, MA where she later became a Clinical Nurse Specialist and Clinical Nurse Educator. Szumita is certified as an Adult Health Critical Care Clinical Nurse Specialist, Critical Care RN and gerontology RN. She graduated from Saint Anselm College with a Bachelor of Science in Nursing and obtained her Master of Science in Nursing at the University of Massachusetts Boston.

Pamela Tenaerts is Chief Scientific Officer at Medable, Inc. Dr. Tenaerts leads efforts to drive responsible adoption of decentralized research methodologies with evidence-based metrics and best practices. Dr. Tenaerts joined Medable from Duke University, where she led the Clinical Trials Transformation Initiative’s (Public Private Partnership co-founded by Duke University and the Food and Drug Administration) efforts to develop and drive adoption of practices that increase the quality and efficiency of clinical trials. She is a member of the Drug Forum at the National Academies of Science, a Dime Founding Members Council member and a Board Member of the MedStar Research Institute. Tenaerts is one of the leading advocates for innovation in clinical trials, with an emphasis on protocol design and QbD, patient engagement, responsible evidence generation and clinical trial methodology improvements. With more than 30 years’ experience in the conduct of clinical trials across a number of stakeholders, she practiced medicine in both the emergency department and as a family practitioner in the private practice setting before embarking on a career in research. She received her MD from Catholic University of Leuven, Belgium, and a MBA from the University of South Florida. She speaks multiple languages.

Marija Todorovic, MSc Pharm, is Associate Director, Global Trial Leader, Portfolio Delivery Operations, Janssen R&D, LLC. Marija holds a MSc Pharm degree from Pharmacy Faculty in Belgrade, Serbia and she has also specialized in Pharmacoeconomics and Pharmaceutical Legislation. She is currently finishing her PhD in Pharmacology. Marija brings along over 14,5 years of experience in clinical research operations, and for the last 10 years she was responsible for the global coordination of clinical trial management activities within Janssen. She was involved in several strategic enterprise-wide initiatives and served as subject matter expert evaluating novel technology solutions to support site selection and site activation. Over the past 2 years, Marija was leading the work package on hospital engagement within the eIT funded EHR2EDC project and supported several other hospital network initiatives within the Janssen R&D Clinical Innovation department, during her recent talent development assignment. She is also actively involved in IMI EU PEARL project, where she supports the activities within several work packages.

Dr Hilde is a passionate generalist with a track record of turning large & complex concepts into realization through collaboration. She joined TCS in 2019 as a Senior Industry Advisor for TCS Life Sciences & Healthcare having spent the previous +25 years at the pharma side where she shaped & led multiple cross-departmental & cross-pharma preclinical & clinical programs to success stories, e.g. Janssen’s Integrated Smart Trial & Engagement program, Transcelerate eConsent program. 

Master's in Applied Statistics, Master's in Experimental Psychology with a concentration in Behavioral Neuroscience, Ph.D. candidate in Systems Engineering

Marissa Volpe is a graduate of Framingham State University where she received her BS in Biology. Marissa started her career working as a Clinical Lab Technologist in an HLA lab in Boston (Center for Blood Research) where she was responsible for performing typing for HLA Class I and Class II antigens and alleles by using molecular DNA typing methods. In 1997, Marissa made the transition to drug development where she gained extensive experience working at a CRO (Contract Research Organization) and small/large biopharmaceutical companies across Boston and in London. Marissa’s first role in the industry was as a Clinical Data Manager where she was responsible for overseeing the collection of clinical trial data from multiple sources. During her time as a Clinical Data Manager, she had the opportunity to work in the London Office for Biogen, where she built a small data management group who had responsibility for several projects. After working in Data Management for 9 years, Marissa decided it was time for a change. In 2006, she moved from the data side of drug development to clinical operations where she started as a Clinical Trial Manager (CTM) responsible for running her own study. Once Marissa got into the Clinical Operations group, she continued to develop and hold positions of increasing responsibility. Currently, Marissa is working at Sarepta Therapeutics as the Vice President, Global Clinical Development Operations. With support from her colleagues, peers, and manager, she has built a high-performing multi-function operations team focused on delivering high-quality studies to advance medicine, particularly in the Rare Disease space. She also recently completed teaching her first master’s course at Boston University focusing on clinical trials as part of the clinical research program. Marissa learned early on that the patient is the number one priority and continues to work daily to ensure we design and implement more patient-centric clinical trials.

Mike Wenger is a software developer and entrepreneur with over 8 years developing solutions for patients.  Mike founded Clinical Trial Connect in 2015 to bring clinical trial matching capabilities to more patient advocacy groups and scaled the platform to support over 20 national patient advocacy groups. Clinical Trial Connect was acquired by TrialScope in October 2019 and Wenger looks forward to continuing to promote clinical trial awareness and helping patients in their journey.

Yan is a consultant gastroenterologist at County Durham and Darlington NHS Trust and an Honorary Consultant at Newcastle Hospitals NHS Trust. He is the Clinical Director of the NIHR National Patient Recruitment Centre (Newcastle) which specialises in rapid recruitment to commercial clinical trials. The Centre utilises a multi-modality 'recruitment engine' which includes intelligent search engines, effective partnerships with primary care, a digital media platform, registries, and traditional advertising. Recent projects include plans to deliver the UK's first fully virtual commercial interventional trial.

Susan Zakarian has over 20 years' experience in clinical trials. As Sr. Manager of Clinical Operations, Susan manages a team of Clinical Team Managers and CRAs. Prior roles have included Clinical Team Manager, Clinical Research Associate, and Study Coordinator. Susan’s interests include training staff and process development.

Mira Zuidgeest works as Associate Professor at the University Medical Center Utrecht. Trained both as pharmacist and epidemiologist and with a PhD in pharmacoepidemiology in the field of paediatric asthma, her current work focuses on clinical trial innovation, both methodological and operational. She is board member of the GetReal Institute (www.getreal-institute.org) and led the development of a decision-support tool for randomised clinical trials integrated into routine clinical practice (www.getrealtrialtool.eu). As academic lead for the IMI Trials@Home project (www.trialsathome.com), she researches possibilities of centring trials around patients rather than clinical sites by use of innovative technologies (Decentralised Clinical Trials).