Med Affairs Webinar Series

Tuesday, November 28
11:00 AM CST

GLOBAL MEDICAL AFFAIRS ALIGNMENT & LOCALIZATION ACROSS COUNTRIES

• Efficiencies in localizing global medical affairs plans across countries
• Facilitating timely communication between global and in-country teams
• Establishing accountability and governance of deliverables
Presenters:
Deb Braccia, Head of Global Medical Affairs Excellence
KYOWA KIRIN
Casilda Barnes, VP, Head of RA NA & Global Head, Reg. Compliance & Planning
KYOWA KIRIN
Yoshi Kojo, Associate Director, Global Medical Affairs Operations
KYOWA KIRIN

Distinguished Presenters:

Yoshi Kojo, Associate Director, Global Medical Affairs Operations
KYOWA KIRIN

Dr. Yoshiki Kojo is currently Associate Director of Global Medical Affairs Excellence. He has extensive leadership experience in CMC research, medical, digital transformation. Recently, he has been working for management and planning of Global Medical Affairs and implementation of global system in the organization. He holds a Ph.D. degree from the University of Shizuoka.

Casilda Barnes, VP, Head of RA NA & Global Head, Reg. Compliance & Planning
KYOWA KIRIN

Dr. Barnes is a seasoned pharmaceutical executive with more than 25 years of global experience in Regulatory Affairs including regulatory strategy, lifecycle management and regulatory compliance obtained at leading pharmaceutical companies. She has led biologic and small-molecule NDA/BLA filings in oncology, neurology, Immunology and Inflammatory as well as all product lifecycle phases through commercialization. She is currently VP of Regulatory Affairs North America at Kyowa Kirin and Global Head of Regulatory Affairs Compliance & Planning. She is responsible for oversight of the NA operations. As Global Head of Regulatory Affairs Compliance and Planning she provides leadership to a global team by overseeing the execution of regulatory compliance and planning initiatives with Global Regulatory Affairs. In her career she has worked extensively with internal business stakeholders to implement global initiatives, foster solid launch readiness and product lifecycle management across the portfolio that maximizes patient access to innovative medicines. Dr. Barnes holds a Bachelor of Science degree in Pharmacy from Howard University and a Doctor of Pharmacy degree from the Albany College of Pharmacy. She recently received her Regulatory Affairs Certification (RAC) through the Drug Information Association. Dr. Barnes is currently a member of the Healthcare Businesswomen’s Association, Regulatory Affairs Professional Society and Women in Bio.

Deb Braccia, Head of Global Medical Affairs Excellence
KYOWA KIRIN

Deborah Braccia, PhD is a results-driven senior healthcare and biopharmaceutical leader with over 20 years of progressive experience and successes in pharmaceutical, biotech, clinical and academic settings. She is currently SVP, Head of Global Medical Affairs Excellence at Kyowa Kirin. In this role she is responsible for strategically leading Medical Affairs globalization including: technology transformation; process and operations standardization; infrastructure and capability build out; medical information; medical governance and, scientific communications. Extensive medical strategy, product launch and life cycle management experience in the areas of oncology, hematology, and rare disease. Expert in establishing new functions and capabilities within growing and evolving corporations. Nationally recognized as a subject matter expert in various areas of healthcare, particularly in medical affairs, oncology and rare diseases, with over 100 publications, numerous presentations made at scientific congresses, industry meetings and through academic appointments. Extensively published in peer-reviewed journals, book chapters, abstracts, industry-specific publications and educational materials.