Makoto Nagaoka, PhD​

Makoto Nagaoka, PhD is a Senior Director and Head of Regulatory Affairs Japan at Fortrea, leading Regulatory Strategy Consulting and regulatory submissions in Japan.

Soo-Kiang Cheah, MTM, BSc

Soo-Kiang Cheah, MTM (Biotechnology), BSc (Pharmacy) is a Senior Director at Fortrea, leading Consulting regulatory submissions across the Asia Pacific region.

Robin Zhang, PhD​

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.

Marisa Dodulik, MS​

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.

Sanjay Jain, PhD, MBA​

Sanjay Jain is an Executive Director in Global Regulatory Affairs Strategy with nearly 30 years of experience in product development and regulation.

Teresa Oblak, PhD​

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.

Alicia Baker McDowell, DRSc, MS, EMBA

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.

Maximizing data from a limited patient population through an adapted FIH SAD/MAD design

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