Hsiao-Lo

About Hsiao-Lo

Accomplished Global Regulatory Affairs Leader with over a decade of experience in bringing new classes of oncology products (small molecules, antibodies, and bispecific antibodies) through the entire clinical development cycle, from IND/CTA, BLA/NDA/MAA, to postmarketing activities in multiple regions. Experienced in codevelopment of novel combination therapies as well as codevelopment of companion diagnostics with therapeutic products. Strong leadership track record, managing and mentoring global regulatory teams for lymphoma portfolio to develop and execute strategic plans that align with corporate objectives. Recognized for critical thinking and creative problem-solving skills. Led multi-functional teams through the developmental hurdles and evolving regulatory environment, leading to simultaneous BLA/MAA submissions and EU approval of odronextamab (CD20xCD3 bispecific antibody) for 2 indications. Influence the internal changes in response to new regulatory requirements, such as leading the oncology dose optimization cross-functional working group in response to FDA’s Project Optimus, educating the oncology group on FDORA regarding the confirmatory trial status to support accelerated approval, and serving as regulatory oncology SME on regulatory intelligence committee meeting to shape FDA’s draft guidance. Independently manage product and project assignments within lymphoma portfolio as well as forecast future portfolio needs. Experience in managing and developing direct reports to achieve corporate and career development goals. Manage the department budget for regulatory staff augmentation.

Experience

1. Director, Regulatory Affairs - Oncology

   Regeneron

   Jan 2023 — Present · Tarrytown, NY, US

   Senior global regulatory lead for lymphoma portfolio. Lead and supervise a team of global and regional regulatory leads to develop and execute global regulatory strategy for bispecific antibodies (BsAb) in 5 indications in non-Hodgkin lymphoma and multiple regions (US/EU/China/Japan) throughout the product life cycle. • Led the successful submission and filing of an original BLA with “Priority Review” for odronextamab for follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) simultaneously. Supervised the submission of MAA and responses to queries for FL and DLBCL, leading to approval of the product in the EU. • Led various types of FDA meetings throughout clinical development, including 3 Type A, 6 Type B (including pre-BLA), 3 Type C, BLA milestones (application orientation, Mid-Cycle, Late-Cycle and Ad-Hoc) meetings. Provided strategic input and oversaw the EMA meetings (scientific advice, pre-submission [PIP and orphan drug designations], oral explanation, rapporteur/co-rapporteur), China CDE written-response-only meeting, and PMDA pre-consultation meeting. • Developed regulatory strategies that enabled expedited registration pathways in multiple regions. Collaborated with cross-functional team to navigate through developmental hurdles, such as lifting clinical holds, addressing approvability issues in the complete response letter, addressing queries for serious breach and urgent safety measures. • Represented regulatory in due diligence process for collaboration deal and worked with the collaboration partner to develop regional registration strategy. • Chaired the regulatory subteams for assigned assets to ensure the subteam outputs support the corporate goals. • Represented regulatory oncology in regulatory intelligence committee meeting to influence FDA’s draft guidance documents on oncology drug development. • Line management responsibilities for a team of 3. Managed the budget for regulatory staff augmentation.

Education

• National Taiwan University

  Master's degree, Veterinary Medicine

• Stony Brook University

  Ph.D., Molecular and Cellular Biology

  2005 — 2011

• National Taiwan University

  Bachelor's degree, Veterinary Medicine