미국FDA승인 세미나/컨설팅 일정
11월 30일 FDA 승인 및 비즈니스 전략 세미나
12월 1일 ~ 2일 FDA 승인 절차 및 비즈니스 전략 컨설팅

행사 개요

행사명 미국시장 진출을 위한 FDA 승인절차 및
비즈니스 전략 세미나·컨설팅
일 시 2022. 11. 30.(수) ~ 12. 2.(금)
장 소 회의실 204호 주 관 인천테크노파크 바이오산업센터
신청방법 (세미나) 사전등록, (컨설팅) 컨설팅 신청 페이지
선착순 사전등록
*영어-한국어 동시통역 제공

미국시장 진출을 위한 FDA 승인 절차 및 비즈니스 전략

1st 11.30. PM 14:00,

Jim Sergi(CSSi Life Sciences)

의료기기에 대한
미국 FDA 승인절차

2nd 11.30. PM 15:00,

Ernesto Chanona (CSSi Life Sciences)

치료제에 대한
미국 FDA 승인절차

3rd 11.30. PM 16:00,

Ernesto Chanona (CSSi Life Sciences)

투자유치 준비, 연방 보조금 및
미국 파트너와 기술 라이선스계약방법

Jim Sergi
Ernesto Chanona

본 웨비나는 (재)인천테크노파크와 Fairfax County 경제개발국의 지원으로 진행됩니다.


의료기기 미국 FDA 승인 절차 및 비즈니스 전략

Jim Sergi (President, CSSi LifeSciences)
  • - CSSI LifeSciences Founder and President
  • - Bay Tower Capital Founder
  • - ProED Communications CEO
Jim Sergi is the Founder and the President of CSSi LifeSciences, a global drug discovery and technology development company providing fully integrated, specialized regulatory and clinical services for pharmaceutical and medical device companies. Prior to this role, Jim was the founder and managing partner of Bay Tower Capital, a life sciences merchant bank and the co-founder and CEO of ProED Communications, a healthcare services and drug development company. Jim has been responsible for over 85 successful NDA/BLA approvals and over 250 medical device approvals.

His academic and medical experience includes Director of Experimental Therapeutics at the Cleveland Clinic Cancer Center, Associate Professor of Medical-Surgical Nursing at the Case Western Reserve University. Lecturer for Oncology at Cleveland State University and Adjunct Faculty and Lecturer for biotechnology at Georgetown University and John Hopkins University Graduate Schools. He has authored over 50 peer reviewed publications and has numerous issued patents.

Jim serves a scientific reviewer for the NIH SBIR/STTR Commercial Readiness Program, as well as a mentor to the NIH/NHLBI and the NIH Larta FeedForward programs. He also serves as a scientific advisor and board member to numerous nonprofits, corporations, private equity and venture backed investment firms, including Defta Partners.

Jim has an undergraduate degree in nursing from Edinboro University of Pennsylvania and a graduate degree from the University of Akron. Jim also serves as the GP of Tonic Bioventures, a venture formation life sciences fund to accelerate and de-risk breakthrough drugs and medical devices to transform patient lives. Jim enjoys open water swimming, fly fishing and cooking in his spare time.

제약 미국 FDA 승인 절차 및 비즈니스 전략

Ernesto P. Chanona (Director of Business Development)
  • - Director of Business Development at CSSI LifeSciences
  • - Adjunct Professor, Johns Hopkins Univ
  • - Board Member, American Red Cross
Ernesto Chanona serves as the Director of Business Development at CSSi LifeSciences. His role focuses on finding new opportunities through strategic partnerships with innovation hubs, international government agencies, academic researchers, and entrepreneurs.

He also teaches at the Center for Biotechnology Education at the Johns Hopkins University. Ernesto trained as a cancer immunologist and developed immunotherapies against colorectal cancer and melanoma at the National Cancer Institute. Prior to joining CSSi LifeSciences, he led the business development efforts, at the Maryland Department of Commerce, that catered to the recruitment, expansion, and export activities of biotechnology companies.

He holds an undergraduate degree in Biology from the Johns Hopkins University and a Ph.D. in pharmacology from the University of North Carolina at Chapel Hill.


  • 성공적인 미국시장 진출을 위한 컨설팅
  • - 컨설턴트 : 세미나 연사 (의료기기 전문, 제약 전문 각 1명)
  • - 내용 : 비즈니스 전략 및 FDA 승인전략
  • - 대상 : 사전신청 및 현장신청 기업
  • * 동시통역 지원