• twitter
  • Facebook
  • LINE


   Teijin Alira Health Webinar Flyer.pdf

COVID-19によるパンデミックは世界中のヘルスケア市場に脅威を与えていますが、米国においても例外ではありません。ヘルスケア世界最大市場である米国において、このパンデミックが米国のヘルスケア市場にどう影響を与えたのか、産業界はどのように対応したのか、そして規制当局となるFDAがEmergency Use Authorization(緊急使用許可)といったプロセスを通じて、COVID-19によって影響を受けた医療者や患者に対して、新しい医療を提供しようとする企業をどうサポートしているのか、を知ることは極めて重要です。

今回、帝人ファーマ㈱は、米国マサチューセッツ州に本拠地を置くヘルスケアコンサルティング企業のAlira Health社をお招きし、昨今のCOVID-19下における米国ヘルスケア市場の概況、及びパンデミックに対応するFDAのガイドラインやポリシーについて紹介頂くウェビナーを開催する運びとなりました。





オンラインミーティングシステム Microsoft Teams





日本時間 内容
8:00-8:10 Welcome & Introduction
- Akihiro Maeda, Home Healthcare New Biz Planning Dpt., Teijin Pharma Ltd.
8:10-8:20 U.S. Healthcare Market in the Time of COVID-19 Summary
- Aude Ouensanga, Partner, Alira Health
8:20-8:35 Discussion of FDA Policies in the Time of COVID-19
- Mary McNamara-Cullinane, Senior VP of Regulatory, Alira Health
8:35-8:50 Emergency Use Authorization (EUA) Program to Accelerate Consideration
and Decisions of COVID-19 Related Medical Devices and Therapeutics

- Mary McNamara-Cullinane, Senior VP of Regulatory, Alira Health
8:50-9:00 Q&A Session


Akihiro Maeda.jpg帝人ファーマ株式会社 在宅医療事業企画部 担当課長 前田 明寛


Aude Ouensanga.jpgAude Ouensanga, Partner, Alira Health

Aude Ouensanga is a Partner at Alira Health. She joined the firm’s Paris office in 2012 and has worked out of the Boston area headquarters since 2015. In that time, Aude has managed dozens of market access, commercial due diligence, corporate strategy, and M&A projects for U.S., EU, and Japan-based clients in MedTech and Pharma. She advises both start-ups and multi-billion dollar global corporations in their business development. Aude is an investment manager for two of Alira Health Ventures’ incubated companies, Computational Life and FireFly Innovations,for which she also serves on the board.Prior to joining Alira Health, Aude worked as an M&A Analyst at BNP Paribas Corporate & Investment Banking for the chemicals sector and as a Strategy Analyst at Novartis Pharma.
Aude graduated from French Grande Ecole EM Lyon Business School where she specialized in Finance and Strategy and is a registered investment banker in the US, holding FINRA Series 79 and 63 certifications.

Mary McNamara-Cullinane.jpgMary McNamara-Cullinane, Senior VP of Regulatory, Alira Health

Mary McNamara-Cullinane is a regulatory expert bringing over 25 years of regulatory experience to Alira Health. Prior to joining Alira Health, Mary has had her own consulting firm since 2011 (MMC Regulatory Consulting).
Mary worked as a Senior Regulatory Consultant to MEDIcept, as Senior Director of Regulatory Affairs for Intrinsic Therapeutics, and held executive positions in Regulatory Affairs for Echo Therapeutics, Z-Medica Corporation, Molecular Biometrics, and Medical Device Consultants. Earlier in her career, she was a scientist at Hygeia Sciences (acquired by Carter-Wallace). Mary McNamara-Cullinane has over 25 years of regulatory experience in the medical device, diagnostics, combination product and biotech industries. She has successfully authored over 175 510(k)s, multiple PMAs, De Novo submissions, requests for classification and designations submissions as well as been responsible for several clinical trials.
Mary has focused on helping emerging companies navigate challenges during development while establishing appropriate clinical, regulatory, and compliance pathways. Mary has a BA in Biology from Mass College of Liberal Arts, with concentrations in Molecular Biology and Medical Technology. She did post graduate studies at Northeastern University in Cardiovascular Health and Exercise Science. She is Regulatory Affairs Certified and has written extensively for various industry journals and newsletters on a broad range of topics related to regulatory affairs.






帝人ファーマ株式会社 在宅医療事業企画部