Archives: Speakers

Dr Bea Mann, PhD, is vice president and oncology therapeutic expert at ICON. As the head of the Oncology Drug Development Services group, Dr Mann is responsible for overseeing the scientific and medical oncology clinical development strategies globally. She brings to ICON more than 16 years of pharmaceutical industry experience (Medical Affairs) having worked as a medical & scientific advisor in the field of oncology and haematology at Roche and GSK. She has extensive experience across all phases of development from pre-clinical to commercialisation. Dr Mann joined ICON in 2016 and in her current role has an expert understanding of the oncology research environment and a thorough understanding of the rapidly changing guidelines for the development of anticancer drugs from study design to protocol development. She has a PhD in Medicinal Chemistry & Drug Development from Nottingham University, UK and was a major contributor to the identification, development, and commercialisation of two linker molecules as part of her oncology research.

Olivia Waterer is a Senior Risk-Based Quality Management (RBQM) Operations Consultant at TRI, where Olivia helps sponsors and CROs implement practical, effective RBQM strategies that strengthen oversight and improve study quality. With more than four years’ experience in RBQM operations, Olivia works closely with clinical teams to optimise risk management processes, centralised monitoring, and quality oversight approaches that support more informed decision-making throughout the clinical trial lifecycle.

Peter Ronco is President of IQVIA Biotech, where he leads the strategic direction, operational excellence and delivery of high-quality clinical development solutions for biotech and emerging biopharma companies. With more than 30 years of experience across the pharmaceutical and biotech sectors, he brings deep expertise in designing efficient development programs and advancing innovative approaches to trial design and execution. Prior to joining IQVIA Biotech, Peter held senior leadership roles in global clinical operations, regulatory operations and medical affairs at Johnson & Johnson and Bristol Myers Squibb.

Tina Karunaratne is a global clinical operations and program management executive with over two decades of leadership experience across the healthcare, biotechnology, and pharmaceutical industries. She is recognized for her expertise in strategic clinical operations, program leadership, vendor governance, patient advocacy, and operational excellence.

Tina is the Founder and President of Bridge to Compassionate Care (BCC), a 501(c)(3) non-profit organization dedicated to improving access to healthcare, clinical trials, education, and support for underserved patient populations, caregivers, and rare disease communities. Through BCC, Tina works to bridge gaps between patients, advocacy groups, healthcare providers, and the clinical research ecosystem to advance equitable participation and compassionate care.

She is also the Founder and CEO of Karuna Integrated Clinical Services (KICS), a wholly biopharma consulting company that supports small and emerging biopharmaceutical companies through high-touch, strategic clinical operations and consulting services.

In addition to her entrepreneurial leadership, Tina serves in advisory and board roles across multiple biopharma organizations and is actively involved in initiatives focused on clinical trial innovation, patient engagement, diversity in clinical research, and operational strategy.

Tina holds a Doctorate in Law and Policy from Northeastern University and a Master’s degree in Regulatory Affairs from Regis College.

Alex is a podcast host, consultant, and coach helping companies explore and implement more effective ways of getting their drugs and devices out of the lab, and into patients’ lives. As a co-host of the Lab to Lives podcast he uses his 18 years in healthcare innovation to explore the topics at the forefront of advancing how drugs and devices are developed and successfully commercialised. Outside of this he can regularly be found working with companies on their product strategy and implementation, helping companies put these ideas into practice to improve the health of patients worldwide.

Ben Roccanova serves as the client-facing representative of PSI’s executive management team, providing strategic leadership and acting as an escalation point for both internal and external dispute resolution. With 14 years at PSI, Ben brings a wealth of experience in balancing operational, commercial, financial, relational, and reputational objectives. His role is key in ensuring successful and transparent collaborations across various client projects.

Based in PSI’s Philadelphia-area office, Ben’s expertise spans a broad range of operational and managerial functions, allowing him to navigate complex challenges and drive high-quality outcomes for both PSI and its clients. His ability to foster strong relationships and align team goals with client expectations is central to the continued success and growth of PSI’s partnerships.

Erik Scalfaro, is the Co-Founder and CEO of Rivia, a data engine powering clinical trials by unifying all study data into a single intelligence layer.

He brings over 10 years of experience across pharma, clinical analytics, and applied data science. Prior to founding Rivia, Erik held roles at Novartis, IQVIA, and the Swiss Armed Forces, where he worked directly on post-marketing safety surveillance, pivotal registration trials, and exploratory analyses supporting global development programmes.

Erik holds a Master of Medical Science in Health Informatics from Karolinska Institutet, a Master of Science in Data Science from Stockholm University, and a BSc in Neuroscience and Organic Chemistry from University College London.

Dr Sally Dowen is Vice President, Clinical Operations UK at Nucleus Network and a recognised leader in early phase clinical development with more than 20 years of experience spanning regulatory agencies, CRO leadership, and clinical trial delivery.

Prior to joining Nucleus Network, Sally served as Head of Clinical Trials at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and as Director of Clinical Science and Regulatory Affairs at a leading UK early phase CRO, where she held overall responsibility for Clinical Project Management, Regulatory Affairs, and Medical Writing.

A specialist in early phase development, Sally has overseen more than 200 Phase I and II clinical trials across a broad range of therapeutic areas, including oncology, immunology, infectious diseases, CNS disorders, respiratory disease, diabetes, dermatology, and gastrointestinal conditions. Her expertise includes first-in-human studies, adaptive and multipart trial designs, SAD and MAD studies, food effect and drug-drug interaction studies, bioavailability and bioequivalence trials, ADME investigations, thorough QT studies, imaging trials, and studies involving special patient populations.

Known for combining deep scientific and regulatory expertise with practical operational leadership, Sally works closely with sponsors to navigate complexity, solve challenges, and optimise trial outcomes.

In addition to her industry leadership roles, Sally serves as Alternate Vice Chair of the London-Brent Research Ethics Committee, is a member of the UK Health Research Authority’s Phase 1 Expert Advisory Group and the MHRA Phase 1 Stakeholder Group, and is a guest lecturer at King’s College London. She holds a BA in Natural Sciences and a PhD in Molecular Oncology from the University of Cambridge, as well as a Certificate in Human Pharmacology from the Royal College of Physicians.

Alexa Lyons is a Clinical Operations leader with more than 16 years of global CRO experience delivering Phase I–III clinical trials across oncology, hematology, cell and gene therapy, rare disease, and other complex therapeutic areas. She has a proven track record of leading global cross-functional teams, managing multimillion-dollar clinical programs, and successfully delivering high-quality studies in fast-paced, global environments.

In her current role as Senior Project Manager at Premier Research, Alexa leads end-to-end clinical trial execution from study startup through closeout, partnering closely with sponsors and executive stakeholders to drive operational strategy, governance, risk management, and delivery excellence. She also serves as a Project Launch Subject Matter Expert, supporting accelerated startup strategies and execution for high-priority programs across the organization.

Prior to joining Premier Research, Alexa held leadership roles of increasing responsibility at Parexel, where she led global clinical trials and consistently delivered against timelines, financial objectives, and quality expectations while fostering strong sponsor partnerships.

Alexa brings a strong combination of operational leadership, execution excellence, strategic thinking, and process improvement expertise to complex global clinical development programs.