Principal Consultant/Clinical Drug Development Specialist

• Board-certified physician with over 20 years in drug development, specializing in autoimmune, dermatologic, neurologic, and rare diseases, leading clinical programs to global approvals

• Expert in managing clinical submissions and regulatory strategies for EMA, FDA, and PMDA, with a proven track record in securing approvals for biologics and biosimilars

• Skilled in directing Phase I–IV clinical trials, including pediatric studies, and developing impactful strategies for biopharma clients as a global medical lead

• Experienced in cross-functional leadership, scientific communication, and advisory board establishment, enhancing medical affairs and publication planning

Board-certified physician in Internal Medicine and Clinical Pharmacology with over 20 years of experience in drug development and regulatory strategy. Expert in leading clinical programs from early-stage research through to global approvals (EMA, FDA, PMDA), across autoimmune, dermatologic, neurologic, and rare diseases. Proven track record of guiding cross-functional teams, managing clinical submissions, and delivering impactful strategies for biopharma clients as a medical expert and global medical lead.

• Led global clinical programs in inflammatory, autoimmune, neurologic, dermatologic, and rare diseases

• Secured regulatory approvals by managing interactions and submissions to EMA, FDA, and PMDA for biologics and biosimilars in HAE, MS, RA, Febrile Neutropenia, Psoriasis, Atopic Dermatitis, and Hidradenitis suppurativa

• Directed the design and execution of Phase I–IV studies, including pediatric studies and proof-of-concept trials where no regulatory guidance existed

• Authored and reviewed MAA/BLA/NDA dossiers and led scientific advice meetings with regulatory bodies

• Conducted gap analyses for clinical programs and dossiers; redesigned development strategies to align with regulatory and scientific expectations

• Supported due diligence and in-licensing decisions, assessing clinical feasibility of early-stage compounds and later-phase assets

• Developed educational initiatives and publication plans, and established scientific advisory boards and publication steering committees

• Served as medical lead for post-marketing safety studies, patient survey design, and data interpretation for PASS and NIS studies in thrombosis, hemophilia, and lysosomal storage disorders

• Directed pivotal Phase III trials for Icatibant in hereditary angioedema (HAE)

• Led clinical operations, regulatory submission and response management, and medical affairs strategy for global markets

• Guided the regulatory submission process (EMA and FDA), including authoring clinical summaries for Modules 2.5 and 5

• Developed the pediatric investigational plan and efficacy endpoints and evaluation tools

• Built the medical publication and established advisory board to support the product launch