Archives: Speakers

Dr. Harald Enzmann received his MD from the Ruprecht Karl University of Heidelberg, Germany, and went on to hold research positions at the German Cancer Research Center, the University of Erlangen, Bayer AG, and the American Health Foundation (NY, USA). Since 2002, he has held several key roles at BfArM, the German regulatory authority for medicines. Notably, Dr. Enzmann represented Germany as a CHMP member from 2005 to 2018, and chaired the CHMP from 2018 to 2024. He currently serves as the Head of European and International Affairs at BfArM.

Julie Solbjerg Appel is a Scientific Director in Clinical Risk Management & Oversight at Novo Nordisk. With more than 20 years of experience in clinical development, she has been closely involved in the evolution of risk-based approaches from their early implementation through today’s data-driven oversight models. Today, Julie focuses on the intersection of RBQM, data analytics, and digital transformation, helping shape future approaches to quality and risk management through innovative processes, data-driven oversight, and technology-enabled solutions.

Miguel has over 25 years’ experience in our industry in various capacities in Informatics, Clinical Operations, Data Sciences and Quality Assurance. In earlier roles at Bayer and Roche, Miguel led a Quality Risk Management, Risk Based Monitoring, and Business Intelligence and Analytics driven oversight and continuous improvement groups and programs.

Since joining Alnylam in 2019, Miguel has led the development and implementation of the Risk Based Quality Management (RBQM) approach and system in the organization.

Currently Miguel is the Director, Clinical Risk & Analytics at Alnylam.  This RBQM team manages and carries out the risk management and centralized statistical monitoring processes and system across Alnylam trials.

Kevin Bugin is the Head of Regulatory Policy and Intelligence at Amgen, Inc, where he leads a diverse team of professionals engaged in promoting innovative, efficient and effective approaches to developing and providing access to safe and effective new therapies to patients. Prior to his current role, Dr. Bugin was the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER). In addition, he led the establishment of the CDER Center for Clinical Trial Innovation (C3TI) which aimed to promote the implementation of innovative clinical trial approaches in drug development. From May 2020 through May 2021, Dr. Bugin served as the Chief of Staff for the Therapeutics Response Efforts as part of the US Government’s HHS and DOD operation formerly known as Operation Warp Speed.

Michala Worrell is Executive Director, Project Management at ICON and a leader within ICON’s Centre for Obesity. She has more than 20 years of clinical research experience and specialises in obesity trial strategy, patient recruitment and retention, site engagement, and operational delivery of global obesity development programmes.

Simon Bruce, MD is vice president, internal medicine at ICON plc where he leads drug development strategy across metabolic and cardiometabolic programs. Based in San Diego, he has focused much of his recent work on obesity and GLP-1 therapeutics, including trial design challenges in the shift from weight-centric endpoints to comorbidity and functional outcomes

Kevin He is a global commercial leader with nearly two decades of experience spanning across biotech, life sciences, industrial gases, and financial services. He currently serves as Business Development Director at Deep Intelligent Pharma, the #1 AI-powered CRO, where he supports U.S. market expansion efforts. Kevin has driven growth at large global organizations such as Thermo Fisher Scientific, WuXi AppTec, and Air Products, while also guiding startups through international expansion. He holds both his undergraduate degree and MBA from Pennsylvania State University and is based in the Greater Philadelphia area, where he actively serves on the leadership teams of several nonprofit organizations.

Yvonne is a clinical development and strategic partnership leader with more than 25 years of industry experience, including two decades in global clinical operations and more than 10 years dedicated to Biotech partnerships. Her experience spans Phase I–IV development across Neuroscience, General Medicine, Hematology/Oncology, Rare Disease, and other complex therapeutic areas.

At Thermo Fisher Scientific, Yvonne provides executive leadership for Biotech strategic partnerships, bringing together capabilities across the enterprise to advance delivery excellence, innovation, operational scalability, and continuous improvement. Throughout her career, she has built and expanded strategic partnerships, developed high-performing teams, and championed operating models grounded in trust, transparency, and accountability. She is passionate about creating highly integrated partnerships that accelerate R&D and ultimately deliver greater impact for patients.

Bill Cooney founded MedPoint Digital in 1990 and now leads the company’s Innovation Lab, where he develops innovative digital solutions for global biopharma organizations. His current focus includes RASPberry AI™, MedPoint’s AI-powered platform designed to streamline clinical trial operations and accelerate research outcomes. Bill’s career includes positions with Wyeth/Pfizer, AbbVie, Abbott, and Discovery/Publicis Healthcare.