From Strategy to Approval: Case Studies in Advancing Clinical Programs for Emerging Biotech

(Moderator) Mark Lovern, PhD, Executive Director of Medical Science Services, Fortrea

Dr. Mark Lovern is the Executive Director of Medical Science Services at Fortrea and has 25+ years of experience applying model-informed drug development (MIDD). Throughout his career, Mark has led and contributed to numerous projects involving quantitative pharmacology. Prior to his current position, Mark spent over 10 years at Certara in various capacities. His work history has been split between biopharmaceutical companies (GSK and UCB) and companies that support the biopharmaceutical industry (Quintiles and Certara). In addition to modeling pharmacokinetic and pharmacodynamic data across a wide variety of compounds and therapeutic areas, Mark has also taught over 50 technical training workshops on modeling tools and methodology. His most recent therapeutic area experience has been with therapies for infectious disease, metabolic disorders and autoimmune disorders.

Mark earned his PhD in Biomathematics from North Carolina State University in 1997.

Alicia Baker McDowell, DRSc, MS, EMBA, Vice President and Head of Global Regulatory Consulting, Fortrea

Alicia Baker McDowell is Vice President and Head of Global Regulatory Consulting at Fortrea, with more than 29 years of experience in drug development, including over 26 years in global regulatory strategy. She has led product registrations across the globe in over 90 countries and is experienced in direct agency interactions with health authorities including US FDA, EMA, Health Canada, MHRA, NMPA, PMDA, KFDA, TGA and others.

Her experience spans small molecules, biologics, advanced therapies and devices across multiple therapeutic areas. She is also well-versed in rare disease development and expedited development pathways and designations. Alicia leads a global regulatory team that supports product development and manages 40-50 agency meetings per year worldwide.

Alicia has a BS in Biology from St. Joseph’s University, an MS in Regulatory Affairs/Quality Assurance from Temple University, an MS in Regulatory Science from the University of Southern California, an Executive MBA from Quantic School of Business and Technology and a Doctorate in Regulatory Science from the University of Southern California.

Todd Lehman, Head of the Oncology Therapeutic Area, Global Project Management, Fortrea

Todd Lehman is the Head of the Oncology Therapeutic Area, Global Project Management at Fortrea. He brings more than 22 years of leadership experience across clinical operations, project delivery and commercial strategy, with deep expertise in oncology and biotech-focused development. Todd has held senior leadership roles at CROs and biopharma organizations, including leading oncology-focused organizations and overseeing complex global portfolios. Todd holds a Master’s Degree in Biomedical Engineering and a Bachelor’s Degree in Chemical Engineering from the University of South Florida.

Catherine Laing, Senior Scientific Director, Fortrea

Catherine Laing is a Senior Scientific Director at Fortrea with over 20 years of experience in Clinical Pharmacology. She brings extensive experience in First-in-Human, AME and Drug–Drug Interaction studies, supported by a strong background in pharmacokinetics and project management. Catherine provides strategic scientific leadership across study design, including starting-dose justification, maximum-exposure and dose-escalation criteria. She has led numerous dose escalation programs and conducts scientific review across all phases of study delivery, from protocol development to final clinical study reports.