Sergio Santillana is a medical oncologist with more than 25 years of oncology drug development and clinical practice experience. Prior to providing strategic consultancy services to a variety of life science companies, including Ikena Oncology, he was Chief Medical Officer for Merrimack Pharmaceuticals, focused on developing biologics and nanotherapeutics for solid tumors. Before joining Merrimack, he was Chief Medical Officer for ARIAD Pharmaceuticals, a commercial-stage biotechnology company that was acquired by Takeda. Under Sergio’s leadership, ARIAD obtained US regulatory approval of Brigatinib for the treatment of ALK+ NSCLC, and had continued growth of its portfolio of targeted agents in solid tumors. Preceding his executive role at ARIAD, he served in various oncology clinical development leadership roles at Takeda, GlaxoSmithKline and Eli Lilly. Before entering the biopharma industry, he was a practicing board-certified medical oncologist for 15 years, including tenure at the National Cancer Institute of Peru (INEN) where his research focus was in clinical studies of novel agents. He holds an M.D. and B.S. from the Universidad Nacional Federico Villarreal School of Medicine in Lima, Peru and a M.Sc. in Experimental Therapeutics from Kellogg College at the University of Oxford. He also holds an MBA from the MIT Sloan School of Management.

Steve has 20 years of clinical research experience and has spent the majority of that time working within oncology.  He is driven to help patients by developing new therapies that improve outcomes.  He started his career as a Study Coordinator in the Neuroimaging Center at a McLean Hospital before moving to his first industry position at Genzyme where he worked in various roles within clinical operations and has worked in small biotechs, as well as big pharma.  Steve has spent the last 7 years at GSK working as a Clinical Operations Program lead, and helped the team move an asset from a first-in-human trial through numerous phase II and III trials which have resulted in multiple marketing authorizations around the globe within endometrial cancer and dMMR solid tumors.  He takes a pragmatic approach while focusing on quality, timely delivery, and efficiency.

Fatima is passionate about elevating the patient voice on a global scale.

She believes that understanding patient experiences and challenges is essential to speeding up the development of life-changing medicines. Further, she advocates in support of patients gaining the skills, courage, and knowledge to navigate through a cancer diagnosis, to make informed decisions, and to ensure they can advocate for and achieve the best care possible.

This fierce passion and commitment to putting the needs of patients first is evident in her decades-long career where she is recognized as an influential global advocate thought leader focused on patient centered research, policy, access, and regulatory impact.

She has held multiple senior management positions in healthcare and is a respected member of the biopharma and cancer communities. Fatima has contributed to numerous publications in partnership with the advocacy community and key academic researchers to advance patient-centered care, as well as being included in the PharmaVOICE 100 in 2014 and receiving the Trailblazer Brand Champion Award from PM3670 in 2015

Experienced Data Manager having worked in the following therapeutic areas:
* Oncology
* CNS
* Diabetes
* Infectious Diseases
* Respiratory

Also, experience in Phase I, II, III and IIIb studies in both the EDC environment (primarily in OC RDC and Medidata) and the paper CRF environment.

Provides process development and evaluation.
Develops training for data manager in areas from GCP and the CDM role to query writing and CRF development.
Provides mentoring and general consulting to the DM group.

Specialties: Vendor Management
Risk Analysis & Management
Problem Solving
Team Building and Communication
Training
Mentoring
GCDMP
SQL and SAS Programming
Tableau

Irisaida is a seasoned Multicultural Communications and Development consultant and has worked with renowned corporations looking to penetrate the LATAM and US Hispanic markets.

During her 20 years’ experience, Irisaida has led crisis communications and public relations efforts for disaster relief initiatives with the American Red Cross, FEMA, and United Way. These include first response, deployment, and media messaging of very sensitive issues under high pressure environments for hurricanes Georges, Charles, Jean, Katrina, Irma and Maria. She also developed Spirit Airlines’ Communications Emergency Response Plan and its Emergency Action Team Protocol. She has acted as liaison between FEMA, city mayors, and other government officials during the implementation of FEMA’s intergovernmental communications efforts in South Florida.

She holds a BA in Communications from Seton Hill University and an MA in Employee Relations from the Interamerican University of Puerto Rico. Her additional training includes Managing Communications During a Major Crisis (by the NTSB), Spokesperson training for Crisis Communications, and First Responder’s Emergency Management Certification (by FEMA’s National Training and Education Division).

Colleen has worked in Clinical Data Management since 1989 working at biotech, pharma and CROs.  She has held roles ranging from data processing to data programming to data management.  She has been responsible for the implementation and maintenance of global Data Management strategy for both clinical trials and programs. Provided day to day leadership support for Data project management, medical coding, data systems and quality, and is accountable for overall project delivery.  Participated in clinical and corporate project team interactions on the development of internal data management processes, cross-departmental procedures. Defined, maintained, and updated metrics and other performance measurements, as well as review of external vendor procedures to ensure compliance with corporate expectations.

A Global, Award-Winning Entrepreneur and CEO with more than two decades of experience in the medical cannabis, biotechnology, pharmaceutical, nutraceutical, and medical device industries, Christina’s dedication to revolutionizing patient care is unprecedented. Through her roles as CEO, Spectral Analytics Precision Tele-Monitoring, Founder and CEO of Affinity Bio Partners, Board President and CEO of Affinity Patient Advocacy, Christina has been involved with revolutionary projects and global clinical studies that positively impact patients including formulating new products. Christina has spoken at many events including delivering Keynote addresses as well as organizing her own education events for her multiple companies.

Christina has a personal brand, I am Christina DiArcangelo with a podcast channel (I am Christina DiArcangelo) where she speaks to many exciting, thought-provoking guests. Christina has also developed merchandise under Affinity Patient Advocacy and Christina DiArcangelo and launched a merchandise company called Sparkle Sisters.

Christina has launched an e-magazine called The DiArc. The DiArc is a lifestyle magazine that shines a spotlight on all topics that apply to Christina DiArcangelo.

As an award winning global clinical research pioneer, and Christina is also an Opinion Columnist for CEO WorldBiz, she has utilized the tools at her disposal to champion patient care and provide best-in-class patient advocacy services. For Christina, patient care and safety come first.

As an active Bahai’ and mother to her one son, Christian, she believes that listening, learning, and growing are everyday values that can change the world by impacting our own hearts, homes, and communities.

Experienced biotech leader in contract operations and contract life cycle management with a demonstrated history of working in both CROs and pharma. Skilled in RFP design, proposal process and management, business development and revenue operations.

Experienced Clinical Quality Assurance with a demonstrated history of working in the pharmaceuticals industry. Skilled in Oncology trials, Endocrinology, U.S. Food and Drug Administration (FDA), Quality Assurance, Audits, CAPA & GCP compliance. Strong quality assurance professional with a Master of Business Administration (M.B.A.) focused in Health/Health Care Administration/Management from Ashford University.

Elsa LaVita has grown her patient advocacy career rooted in rare disease and oncology.  Elsa is the Director of Patient Advocacy at MorphoSys where she is responsible for ensuring the patient perspective is integrated into the development and commercialization of the company’s cancer medicines. She acts as the bridge between the company and patient communities.  Elsa holds an MBA from Boston University and a BS from Cornell University.

Maria Florez is involved in research looking at the impact of digital transformation in clinical research and organizational strategies and practices driving improvement in development operations and economics. Maria has been a researcher and strategist in the healthcare sector for 15 years. She has held positions at Cleveland Clinic and at New York-Presbyterian Hospital of Columbia and Cornell Universities and has published articles in trade and peer-reviewed journals. She holds a B.S. in economics and an M.A. in international economics from The Fletcher School of Law and Diplomacy at Tufts University.

Abigail Dirks is a Data Scientist at the Tufts Center for the Study of Drug Development (Tufts CSDD) where she specializes in analyzing large datasets pertaining to industry drug development performance, including clinical research associate (CRA) performance, impact of decentralized clinical trials (DCT), and investigative site burden. She recently received her Master’s in Health Informatics and Analytics from Tufts University and has a BS in Data Science and Mathematics from St. Michael’s College. She also has experience in web development for North Shore Nurse Practitioner Associates, a psychopharmacology practice.

Keya brings 25 years of experience in building and leading high-functioning teams in drug development inclusive of clinical operations, data sciences and trial support services. An executive in operational and commercial roles, she has extensive experience in implementing strategies and delivering excellence for complex, global Oncology trials.

Brian McMahon is the founder of SparkCures and a four-time cancer caregiver. The search for clinical trials is personal for him, because his mother was diagnosed with multiple myeloma. She received a poor prognosis due to genetic factors and a late diagnosis. Within three weeks, she was enrolled in a clinical trial. Participating in the trial gave his family two additional years with his mother that his doctors never thought would be possible. Since then, he’s cared for family members and friends who were diagnosed with cancer. As a caregiver, he’s had clinical trial conversations with doctors for the University of Arkansas to Dana-Farber and a half-dozen hospitals in between. He’s used dozens of advocacy groups and websites to search for clinical trials—and he knows how difficult it is to find them, to understand them and to have the conversations. He also knows there is a better way to help patients and caregiver understand and discover eligible clinical trials.

Elizabeth (Libby) Barksdale, PhD, is the Senior Director of Regulatory Affairs and Scientific Policy for LUNGevity Foundation. In her role she guides the development and execution of LUNGevity’s regulatory strategy as well as the organization’s Transforming Clinical Trials Initiative, a multi-stakeholder effort to streamline clinical trials and make them more patient-centric.

Previously, Libby served as the Assistant Director for Regulatory Science and Policy at the American Association for Cancer Research (AACR), where she led efforts aimed at increasing understanding of the regulatory ecosystem and enhancing the development of oncology products. Before joining the AACR, she was with the Federation of American Societies for Experimental Biology, where she focused on policies related to clinical research and biomedical research training.

Libby received her BS in Biology from Hope College and PhD in Molecular Medicine from The George Washington University. She sought out experiences in science policy while conducting postdoctoral research at the National Institute of Child Health and Human Development.

Dr. Patt is co-founder and principal of RadMD, and is an acknowledged expert in the field of applying medical imaging to new drug development.

He has numerous publications, has served on an NCI Advisory Panel, is a reviewer for major radiology journals, and has been an invited lecturer across the US and Europe on the use of medical imaging in clinical trials.

Dr Patt’s experience includes design and management of site and central reviews for over 500 oncology trials with a focus on early-phase efficiency for better decision-making.

Dr. Claudia Hesselmann, a chemist by training, with a PhD in molecular biology. Claudia has twenty years of expertise in the early phases of drug development. Her experience includes co-founding and holding management positions in various CROs. Her extensive background and social acumen, along with her first-hand knowledge of the industry, led Claudia to co-found ARENSIA Exploratory Medicine in Düsseldorf, Germany. Her primary aim is the contribution of innovative approaches to bring about substantial acceleration to the drug development process and enable more agile patient access to novel therapeutics.

As Director, Services Solutions at Suvoda, Amanda brings more than 10 years of experience working in client services.  Prior to joining Suvoda,  she held positions in science and consulting, operations, product development, and technical implementation with various technology vendors and CROs. With her extensive experience in decentralized trials, Amanda also serves as an eConsent expert at Suvoda. Amanda holds a master’s in Organizational Learning and Development from Suffolk University and a master’s in Health Sciences: Clinical Research Administration from George Washington University.

Julie Martin, MSc, Lean Certified - CEO & co-Owner is a 17-year industry veteran who has led Scimega as CEO for 5 years. Her passion for Scimega’s business and team stems from knowing its expert oncology clinical development services add distinct value to industry stakeholders at a time when it’s needed most. As CEO, Julie’s vision is to secure the company’s long-term success by leveraging her in-depth industry expertise and business acumen. She equates that success with setting a clear vision for the organization’s continued sense of purpose. Her leadership, and collaboration with the managing Board of Directors, combined ensure the business excellence upon which Scimega has built its reputation. Julie plays a vital role in promoting Scimega’s expertise and showcasing Canada’s attributes as a formidable partner in global oncology drug development with an evolving Lean methodology.

Dylan Stoy, PSI’s Therapeutic Strategy Director, is dedicated to conducting and executing better clinical studies in PSI’s core therapeutic areas. Dylan has a wealth of experience in the oncology indication, with research interests in targeted drug delivery systems and optimizing the design and conduct of studies. Dylan has overseen clinical research from various roles including onsite research, design and trial conduct, clinical operations oversight, project management, and therapeutic strategy.

Dylan and his team are devoted to making participation for sites and patients in complex oncology studies more attainable and ensuring that both PSI’s teams and your study sites are highly trained and properly supported to handle any challenges your program might encounter. Dylan works closely with the core business units within PSI, overseeing research throughout the study lifecycle, providing strategic leadership to our teams and collaborators (both internally and externally), and delivering corporate-wide trainings to make PSI your full-service CRO for all things oncology.

Bob Bauer is Executive Director of Operational Strategy at Precision for Medicine.   He is a 23-year clinical operations professional with extensive tenures in both the pharmaceutical sponsor and contract research organization (CRO) sectors. His diverse experience spans across all phases of clinical research, encompassing a wide range of study designs and therapeutic indications. Bob has played key roles in several programs involving rare and challenging to recruit populations and has implemented creative and cost-effective approaches to ensure successful patient engagement and recruitment.

As a Solution Consultant, Jason works with Sponsor organizations to understand their challenges and come up with creative solutions leveraging the elluminate platform. Jason has lead design & development for several products ranging from a Data Management Workbench, Data Integrations, Clinical Operations Platform, Clinical Analytics, and Risk Based Quality Management.  Jason has been in the clinical trials industry for over 15 years and his prior experience includes, global central laboratory, eCOA design, process improvement, and building an automated workforce.

Troy brings a combination of financial expertise, risk assessment/mitigation, clinical research knowledge, leadership skillset, and excellent project management skills to ensure the financial success of clinical research projects.  He truly is honored to work for a company that delivers industry-leading specialized clinical development solutions while still ensuring a culture that coupled with our expertise and technology brings out the best in our team members, our clients, and our partners.

Kate brings 20 years of experience in the research and development of Antibody-Drug Conjugates (ADCs) to her role as Director, Program Management at Mythic Therapeutics.  As a cross-functional matrix team leader, she has remarkable experience in not only communication, risk management, and problem-solving skills but also aligning to corporate goals.

Dr. Filip Janku is the Chief Medical Officer of Monte Rosa Therapeutics. Previously, he served as an Associate Professor of Investigational Cancer Therapeutics and Medical Director of the Clinical and Translational Research Center at MD Anderson Cancer Center. His experience includes many years in early-stage development of new cancer treatments with a focus on proof-of-concept studies of personalized cancer therapies. He has received multiple awards for his research efforts, including the Sabin Family Fellow Award, the Sidney Kimmel Scholar award, Khalifa Scholar Award, several ASCO Merit Awards and an American Association for Cancer Research Scholar-in-Training Award. He is the coauthor of more than 250 scientific articles that have appeared in peer-reviewed journals.

Dr. Janku earned his Ph.D. in Pathobiochemistry and his M.D. from Charles University in Prague. He completed his medical training at Charles University and The University of Texas MD Anderson Cancer Center.

Rashmi Chandra, Project Director, Immuno-Oncology and Cell and Gene Therapy, holds a doctorate in Biochemistry and a PMP certification from Project Management Institute. Dr. Chandra worked as a biomedical researcher for many years prior to transitioning to clinical research. As a result, she has a broad and fundamental understanding of cellular and molecular pathways interrogated during drug development. Dr. Chandra's clinical research experience includes serving as a Research Coordinator, remote Site Monitor and Project Manager for domestic and global studies. Dr. Chandra has start-to-finish project management experience in early phase trials. She has demonstrated strong team leadership and consistently managed high quality clinical trials. Dr. Chandra has cardiac device and stem cell trial experience, along with significant oncology, immuno-oncology and CAR-T cell experience in both solid and liquid tumors across several indications.

Brian joined, the then WestRock, in 2018 as Vice President Global Adherence & Clinicals - the business unit focused on providing Adherence focused, patient centric and Child Resistant Senior Friendly (CR-SF) packaging & service solutions to the Pharmaceutical, Biotech & Clinical Trial industries.

Having majored in marketing, business studies and finance Brians key expertise has been developing packaging solutions supplied to these key markets. Holding a wide range of increasingly elevated positions within companies such as Cardinal Health, Catalent and across several other packaging entities, Brian has gained invaluable insights and a thorough understanding of the demanding requirements, operating systems and ethos of the various market sectors that Smurfit Westrock support today.

Within the last number of years Brian's focus, together with his globally based team, has been to strategically develop a bespoke, best in class global supply infrastructure within the Smurfit Westrock specialized field of Adherence, Clinical Trial and SMART digital & electronic platforms. These cutting-edge solutions encompass electronically enhanced SMART measure and monitor packaging solutions, such as Cere®Pak, together with developing the vision and capabilities of Cere®Screen Digital Display Labels within the Clinical Trial Supplies arena..

Bernard Vrijens is Chief Executive Officer at Advanced Analytical Research on Drug Exposure (AARDEX Group). He is also Invited Professor of Biostatistics at Liège University, Belgium.

Dr. Vrijens holds a PhD from the Department of Applied Mathematics and Informatics from Ghent University, Belgium.

Dr Vrijen’s currently leads a research programme investigating (a) the most common errors in dosing using a simple but robust taxonomy, (b) particular dosing errors that can jeopardise the efficacy of a drug, and (c) the optimal measurement-guided medication management programme that can enhance adherence to medications and maintain long-term persistence.

Dr. Vrijens is a co-author of seven book chapters, over 100 peer-reviewed scientific papers, and named as inventor on 6 patents. He is a founding member of the International Society for Patient Adherence (ESPACOMP), and an active member of several EU- and US-funded collaborative projects around the theme of adherence to medications.

Dr. Vrijens is a highly-accomplished public speaker, having presented lectures at over 200 industry events and scientific conferences around the world over the past 20 years. Public speaking experience includes the NIH Adherence Network Distinguished Speaker Webinar Series, CDER Drug Packaging Summit at FDA, European Society of Cardiology Congress, American Society on Pharmacometrics, WHO Global Forum on Innovation for Aging Populations, among many others.

• BSc in biology from Saint Andrew’s Presbyterian College, US. MSc in Biology from Texas Christian University
• Oncology project-management specialist with almost 25 years of experience in academic, clinical site, and contract research organization (CRO) settings.
• Experience in all phases of reseach (Phase I-III) including Phase IV across multiple study designs such as basket and umbrella studies, 3+3 dose escalation, expansion, accelerated titration, modified toxicity-probability interval, and Bayesian logistic-regression model

Bin Pan has 23 years of experience in clinical research with a strong focus on early-phase oncology trial strategy and execution. She has a scientific background in biochemistry and molecular biology with postdoctoral research in cellular signaling pathways.

Throughout her career, Bin has supported numerous oncology studies through an evolving therapeutic landscape from the early days of mAb drugs such as trastuzumab and cetuximab to the current immuno-oncology revolution with checkpoint inhibitors such as CAR-T and TCR-T.

She maintains a broad knowledge of current oncology therapeutics and the competitive clinical landscape. She provides strategic guidance and operational leadership to internal cross-functional teams as well as a consultative approach to developing novel solutions.

Andrés Escallón, the Vice President of eCOA Solutions Strategy at Suvoda, boasts over 18 years of expertise in the eCOA industry. With roots at PHT Corporation and subsequent leadership roles at ERT, Andrés has been a driving force in eCOA project and program management. Recognized as an eCOA Subject Matter Expert, he joined Suvoda in 2021 as the Vice President of eCOA Practice, building a team and seamlessly integrating eCOA functions into Suvoda’s successful IRT delivery framework. In his current role, Andrés guides Suvoda’s eCOA product and commercial strategy, provides consultative support to industry stakeholders, and serves as the face of the eCOA product, showcasing his strategic leadership in the dynamic eCOA landscape.

A highly experienced and passionate Clinical Supplies Project Manager, Francesco has dedicated the past 17 years to ensuring the seamless execution of clinical trials by optimizing supply chain operations. His deep commitment to this field is driven by a relentless pursuit of excellence in delivering life-saving treatments to patients worldwide.  Throughout his career, he has honed a diverse skill set, encompassing:

• Strategic Supply Chain Management
• Regulatory Compliance
• Cross-Functional Collaboration
• Risk Management
• Innovative Problem-Solving

Francesco’s dedication to the clinical supplies industry is rooted in a profound understanding of the critical role it plays in advancing medical research and improving patient outcomes. He is committed to continuing his journey in this field, always striving to contribute to the betterment of global health.

Dr. Sherris has over 30 years’ experience in translational medicine involving basic research, pharmaceutics and diagnostics. Dr. Sherris has been a successful serial entrepreneur developing biotechnology companies from the ground up, devising corporate strategy, enacting programs and carrying companies through funding and acquisition. Dr. Sherris prides himself as a “roll up your sleeves” CEO, entrepreneur, business development officer, drug developer and scientist, not simply a delegator. Dr. Sherris has worked with venture capital companies, investment banks and angel investors where he has advised and raised well over $100 million for biotech companies. Dr. Sherris has been employed by pharmaceutical and biotechnology companies to manage external (academic groups and contract research organizations) and internal (directly manage, augment and expand internal scientific programs) research and development. Dr. Sherris has been a frequently invited guest speaker at biopharmaceutical business and scientific conferences, a published author and holder of patents in a wide range of therapeutic areas including oncology, ophthalmology, dermatology, neurology, gene therapy and infectious disease. Dr. Sherris has held positions of increasing responsibility in public and private companies. Dr. Sherris has developed drugs from the bench to the clinic, partnered technologies to pharmaceutical companies and raised capital for companies at the triple digit million dollar levels.

Amanda Murphy is the Director of Product Management at GlobalData, a company that focuses on research, data analytics and consulting that provide actionable insight into the pharmaceutical and medical device sectors.  She has 10+ years of experience working in pharmaceutical data science and web platform development (including BioPharm Insight, Lead Sheet, and the Pharma Intelligence Center).  She has developed models and solutions to support Clinical Operations & Feasibility teams plan and optimize trials, including an e-feasibility questionnaire tool resulting in 4x faster response rates from sites.  Amanda also has many years of experience supporting business development at CROs through data-driven lead delivery and CRM integration solutions.

Tom has worked in the life sciences industry for over 26 years, with the first 10 as a pharmaceutical representative and marketing product manager for Bertek, Merck and GSK.

Tom joined Mercalis 16 years ago, created the RxStudy Card offering in 2009 and for the past 14 years has been focused on changing the paradigm of the traditional clinical trial supply process to one of greater efficiency through the RxStudy Card.

Caroline Potts, MSc Health Sciences, MSc Healthcare and Design

General Manager – MRN Site and Patient Services, Medical Research Network

Before joining MRN, Caroline worked in the public sector for 15 years supporting research in hospitals and the primary care setting as well as providing support to research academics by writing funding applications, making submissions to regulatory authorities and running a large portfolio of studies to ICH-GCP requirements in clinical specialties such as stroke medicine, Parkinson’s disease, orthopaedics, gastrointestinal medicine and respiratory medicine. During this time, Caroline was one of the founding members of the UKRD group as well as an Executive member of the RD Forum providing R&D Directors and research staff working in the public sector with strategic guidance in supporting high quality research in the NHS. In her current role, Caroline leads the development and expansion of MRN's global site network, site training programs, and on-site support services.

Harvard educated (BA Biology, JD, MPH), exceptionally well-rounded, and award winning life sciences venture capitalist with operating, entrepreneurial, legal (IP & FDA) and pharmaceutical management consulting experience and a science background. An entrepreneurial journey as a female founder and CEO “growing up” on the tech side (digital health) makes me a unique biotech investor with a founder friendly bent and a lean startup mindset.

20 years of biopharma and healthcare industry experience. Board Director or Observer of 8 biotechs with 3 exits in 2 years. Led/Shepard 3 large pharma deals (AZ, Pfizer, Takeda).

Skilled in life sciences and healthcare venture investing, board governance, BD, strategy, management, fundraising/startup operations, IP law, Food & Drug regulation, tech transfer, and cross-border international business with Asia.