An exceptional collaboration with a team of professionals

Alicia Baker is Vice President and Head of Regulatory Consulting at Fortrea, based in southern New Jersey, with over 30 years of drug development experience, including more than 27 years in global regulatory strategy. She leads a team of experienced product development directors, regulatory strategists, regulatory writers, and patient-centered endpoints experts, supporting nonclinical, clinical, and CMC development, submissions, and global agency interactions, including managing 40–50 agency meetings annually worldwide.

Alicia has registered products in more than 90 countries and has extensive experience engaging directly with global health authorities, including FDA, EMA, MHRA, PMDA, and others. Her experience spans small molecules, biologics, advanced therapies, devices, rare diseases, and expedited development pathways. She holds a BS in biology, two MS degrees in regulatory disciplines, an Executive MBA, and a Doctorate in Regulatory Science

Teresa Oblak, PhD is an Executive Director in Regulatory Strategy Consulting at Fortrea, based in Michigan, where she focuses on clinical regulatory strategy to support global development programs and key regulatory milestones. She has nearly 20 years of drug development experience across regulatory affairs, medical writing, publication planning, and value demonstration.

Teresa regularly supports U.S. IND development, responses to clinical and non-hold issues, expedited program applications, special protocol assessments, pediatric plans, and diversity action plans. She has led FDA and EMA interactions across multiple therapeutic areas, including rare and orphan diseases, spanning small molecules, biologics, biosimilars, and combination products. She also serves as Head of Nonclinical Regulatory Writing.

Before Fortrea, Teresa was a scientific director and lead writer at a medical communications agency. She holds a PhD in Chemistry from Michigan State University and a BS in Chemistry from the University of Michigan–Dearborn.

Dong Yang is Head of Regulatory Affairs at Fortrea China with more than 20 years of experience in drug development and regulatory affairs, supporting IND-, NDA-, and BLA-enabling programs. A board-certified Regulatory Affairs Professional (RAC Global), he leads regulatory strategy and execution, providing scientific review, gap analysis of submission dossiers, and guidance on clinical development planning in collaboration with clients and regulatory agencies.

Dong has led more than 50 regulatory agency interactions, consultation meetings, and key opinion leader engagements across multiple therapeutic areas. His experience includes IND and NDA/BLA submissions, HGRAC filings, and CIQ applications. In addition, he leads Fortrea’s regulatory contributions to the NMPA 14th Five-Year Regulation and Guideline Update and Maintenance Program, supporting evolving regulatory frameworks in China.

Sanjay Jain is an Executive Director in Global Regulatory Affairs Strategy with nearly 30 years of experience in product development and regulation. He has deep experience in CMC and leads CMC writing teams, working across small and large molecules, including advanced therapies, biosimilars and combination products. Sanjay advises on global development and regulatory strategies, regulatory pathways, agency interactions and lifecycle management, covering development from preclinical stages through clinical authorization, expedited programs and due diligence.

Before joining Fortrea (formerly Labcorp, Covance, and Envigo), he held senior roles in biotechnology and pharmaceutical companies and previously served as a university lecturer in pharmaceutical sciences. He completed postdoctoral training in Drug Delivery at UCL and holds a PhD in Pharmaceutical Sciences, an MPharm (Gold Medalist) and an MBA in Pharmaceutical Management.

Marisa Dodulik, MS is an Associate Director of Regulatory Submissions at Fortrea with more than 20 years of pharmaceutical industry experience supporting global clinical development programs across all phases of drug development. She specializes in U.S. regulatory submissions, overseeing the planning, preparation and execution of high-quality IND applications and amendments to the FDA.

Marisa leads complex submission projects, provides regulatory guidance to cross-functional teams and clients, oversees eCTD publishing through DXC Technology, and serves as U.S. IND agent and primary FDA liaison for sponsors. Prior to joining Fortrea, where she has spent 19 years, she held roles in quality assurance and regulatory submissions at other CROs.

She holds a bachelor’s degree in sociology from The College of New Jersey and has completed a Drug Development Certificate from Temple University and a Women’s Leadership Certificate from Rutgers University.

Robin Zhang, PhD is an Associate Director of China Regulatory Submissions at Fortrea with 20 years of experience in regulatory affairs and project management within the pharmaceutical industry. He oversees a broad range of China regulatory submissions, including IND submissions and maintenance, HGRAC filings, CDE clinical trial registrations and import/export permit applications.

Robin also serves as a member of the China Regulatory Intelligence Committee, supporting regulatory monitoring and stakeholder engagements.

He has played a key role in implementing eCTD publishing in China at Fortrea, supporting tool deployment, system maintenance, and team training to strengthen in-house eCTD capabilities.

Prior to joining Fortrea in 2020, Robin was Director of a global research and development center at a major Chinese pharmaceutical company, leading regulatory affairs and global development programs. He holds both a BS and a PhD in Chemistry and Chemical Biology from Nankai University.

Soo-Kiang Cheah, MTM (Biotechnology), BSc (Pharmacy) is a Senior Director at Fortrea, leading Consulting regulatory submissions across the Asia Pacific region. She specializes in regulatory strategy and execution and brings more than 28 years of experience in regulatory affairs, with deep experience in managing regulatory registration activities across Asia Pacific countries.

Prior to joining Fortrea (formerly Labcorp and Covance), Soo-Kiang held senior regulatory roles in the biopharmaceutical and clinical research industries, leading clinical trial and drug registration activities as well as regulatory consulting efforts across the region. She has successfully managed numerous new drug applications across multiple therapeutic areas throughout her career.

Soo-Kiang holds a Bachelor of Science in Pharmacy and is a licensed pharmacist in Singapore. She also earned a master’s in technology (Biotechnology) Management and a Graduate Certificate in medical device regulatory affairs.

Makoto Nagaoka, PhD is a Senior Director and Head of Regulatory Affairs Japan at Fortrea, leading Regulatory Strategy Consulting and regulatory submissions in Japan. He oversees regulatory agency interactions, global RA/IRB/EC submissions and serves as a strategic regulatory advisor to support client‑focused development and execution in Japan.​

Makoto brings more than 20 years of experience across nonclinical regulatory science, clinical science, regulatory strategy and regulatory intelligence, covering therapeutic areas including oncology, neurology, ophthalmology, dermatology and inflammation. Prior to joining Fortrea, he held senior leadership roles in global and Japan regulatory affairs across major pharmaceutical and biotech organizations, leading PMDA and MHLW interactions through approval and shaping regional regulatory policy and development strategies in APAC and globally.​

He holds a BS, MSc and PhD in Pharmaceutical Sciences from Kyoto University and is a licensed pharmacist in Japan.​

Michelle Dawson is a Senior Director in the Product Development Consulting team at Fortrea, based in the UK, with nearly 30 years of experience in pharmaceutical research and development. She has a strong track record in leading drug product development from early clinical phases through launch and post-approval lifecycle management.

Michelle began her career at Novartis Horsham Research Centre, working on dry powder inhaler development, and later spent over 20 years at GlaxoSmithKline research and development as a matrix leader in formulation development, primarily in respiratory medicine. She played a key role in the regulatory approval of multiple Ellipta® dry powder inhalers and later supported post-approval and lifecycle activities in Global Regulatory Affairs. Prior to joining Fortrea in 2022, she served as Director of Formulation Development at Pharmaron UK.

Michelle is a qualified pharmacist, holding a degree from the University of Manchester and a PhD in Pharmaceutics from Cardiff University.

Dr. Audrey Finesso is a Global Senior Director and Clinical Regulatory Strategist at Fortrea with more than 25 years of experience in regulatory affairs and drug development. Based remotely in France near Switzerland, she provides clinical and regulatory strategy to support global development programs, with deep experience in oncology and rare and orphan diseases.

Prior to joining Fortrea, Audrey was Head of the Drug Development Unit at PharmaLex in France for five years, where she led clinical and regulatory strategy and coordinated interactions with major EU and U.S. health authorities, including the FDA, EMA, ANSM, and BfArM. Earlier in her career, she held regulatory affairs roles for more than 17 years at leading biotechnology and pharmaceutical companies, including Amgen, Biogen, Merck Serono, Gedeon Richter, MSD, and Janssen Cilag.

Audrey holds a PharmD from Claude Bernard University in Lyon and an MSc in International Drug Registration and Development from Paris-Saclay University.

Lesley is a Senior Director of Nonclinical Regulatory Strategy within Fortrea’s Product Development and Market Access Consulting team. She brings nearly 30 years of experience providing scientific and regulatory guidance on the nonclinical development of drugs and medical devices, including small and large molecules, ATMPs, impurities and excipients. Her experience includes nonclinical data review, study package design, due diligence and in-licensing support, authorship of expert nonclinical documents, and regulatory agency interactions.

Lesley is a highly regarded regulatory professional and a Fellow of TOPRA and the British Toxicology Society (BTS), as well as an Industrial Fellow of the University of Hertfordshire. She is actively involved in scientific committees and regulatory education, serving since 2010 as Module Leader for the Nonclinical Module of the TOPRA MSc in Regulatory Affairs.

She holds a PhD in Genetics from the University of Leeds and an MSc (with Distinction) in Regulatory Affairs from Cardiff University and TOPRA.

Kristina Davis is a Director in Fortrea’s PaCE Team, which assists client companies with gathering patient-focused validity evidence and measurement regulatory strategy within the context of clinical development in the US and Europe. She has more than 15 years’ experience in the clinical sciences for regulated products including endpoint measure selection and adaptation, study design, statistical methods, regulatory strategy and communication, and development of novel outcome measures (PRO, ClinRO, PerfRO). Dr. Davis has experience in both medical devices (Class II and III) and pharma/biotech (Phases 1 – 4) and working in a variety of therapeutic areas, including rare neurodevelopmental disorders, muscular dystrophies, chronic pain, postpartum depression, urogynecology, sleep, dementia, among others. ​

Dr. Davis earned an MS and PhD in Experimental Psychology from Texas A&M University studying in their Behavioral and Cellular Neurosciences program.​

Carla Sterk is a pharmacist by training and a registered Qualified Person (QP) with more than 30 years of experience in global regulatory affairs, including the last 11 years at Fortrea and its legacy organizations, Labcorp Drug Development and Covance. She previously held regulatory roles at large and mid-sized CROs and consultancy firms.

As an Executive Regulatory Strategist, Carla has extensive experience in global regulatory strategy for oncology products, supporting multiple development programs and regulatory agency interactions with the FDA, EMA and national competent authorities. Her experience includes resolving clinical holds, developing comprehensive development plans and target product profiles, securing orphan drug and expedited program designations and designing regulatory strategies for early access programs.

She has worked across a broad range of investigational products, including small molecules, biologics, biotech products and advanced therapies in oncology and other therapeutic areas such as immunology and dermatology, with experience in abbreviated and repurposed drug pathways.