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2017년 실무교육

 

강연자 소개

John Geigert

Ph.D., RAC, President of
BioPharmaceutical Quality Solutions

John Geigert is President of BioPharmaceutical Quality Solutions, which for the last 15 years has specialized in providing CMC regulatory strategy consulting for the biopharmaceutical industry. He has over 40 years of CMC industrial experience and leadership in the biopharmaceutical industry.

He has held senior management positions as Vice President of Quality at both IDEC Pharmaceuticals Corporation in San Diego and Immunex Corporation in Seattle, and he was Director of Product Development at Cetus Corporation in Berkeley. At these companies, he helped lead the CMC efforts to obtain regulatory approvals for 6 biopharmaceutical products now commercially available in the U.S. and in Europe.

John Geigert has served on the PDA Board of Directors, currently chairs the PDA Biopharmaceutical Advisory Board, and has served as an expert member of the USP Biotechnology Committee. He is the author of the book The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics 2nd Edition, and has written extensively for RAPS Focus (What Senior Management Needs to Know About CMC Regulatory Compliance for Biotech Products (Aug-Nov 2009, 4-part series)), Demystifying CMC Regulatory Strategy (Sept 2011-Mar 2012, 4-part series).

John Geigert obtained his B.S. in Chemistry from Washington State University and his Ph.D. degree in Organic/Analytical Chemistry from Colorado State University.



John Geigert BioPharmaceutical Quality Solutions 대표는 바이오의약품 산업의 CMC 분야에서 40년 이상의 경력을 가지고 있다. BioPharmaceutical Quality Solutions는 지난 15년 동안 바이오의약품 CMC 인허가 전략에 대한 컨설팅을 진행했다.

그는 미국 제약회사인 IDEC와 Immunex의 품질담당 부사장 및 Cetus사의 제품 개발 책임자를 역임했다. 이들 회사에서 그는 현재 미국과 유럽에서 판매되는 6개의 바이오의약품의 인허가 승인을 얻기 위한 CMC 기반을 구축하는데 일조했다.

John Geigert 대표는 최근 PDA(제약기술과 GMP를 다루는 국제 학술단체)의 바이오의약품 자문위원회 위원장과 USP (미국 약전) 바이오기술 위원회의 전문위원으로 활동하고 있다. 그는 ‘The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics 2nd Edition’의 저자이며, RAPS Focus (What Senior Management Needs to Know About CMC Regulatory Compliance for Biotech Products (Aug-Nov 2009, 4-part series)), Demystifying CMC Regulatory Strategy(Sept 2011-Mar 2012, 4-part series)를 집필했다.

John Geigert 대표는 Washington State Universit에서 화학 학사학위를, Colorado State University에서 유기/분석화학 박사학위를 취득했다.

 

 

프로그램 일정

일자 시간 강의주제
10/11(수) 09:00-09:05 Welcome Address
09:05-12:30 CMC Regulatory Challenges For Biologics Are Different
생물학적 제제 CMC 인허가의 특별한 문제들

  • Understanding the terminology landscape used in our industry: biopharmaceutical, biosimilar, CGTP/ATMP
  • Biopharmaceuticals are not chemical drugs – regulatory compliance consequences of the CMC differences
12:00-13:00 Lunch
13:30-17:00 How to Develop an Effective Corporate Risk-Managed CMC Regulatory Compliance Strategy For Biopharmaceuticals
바이오의약품을 위한 효과적인 위해성 기반 CMC 인허가 전략 개발 방안
  • 2 major forces that shape the corporate CMC strategy
  • 5 essential elements of an effective CMC strategy

Critical Importance of Biological Functional Activity Measurement (Potency)
생물학적 기능 활성 측정의 중요성
  • Functional assay landscape: bioassay, surrogate assay, assay matrix
  • Phase appropriate application
10/12(목) 09:00-12:30 Applying a CMC Risk-Managed Control Strategy Throughout the Entire Biopharmaceutical Manufacturing Process
바이오 의약품 제조 공정 전반에 걸쳐 CMC 위해성 기반 관리 전략 적용하기

  • A walk through the entire biopharmaceutical manufacturing process – from clonality of the master cell bank through production
12:30-13:30 Lunch
13:30-17:00 Applying a CMC Risk-Managed Control Strategy Throughout the Entire Biopharmaceutical Manufacturing Process (continued)
바이오 의약품 제조 공정 전반에 걸쳐 CMC 위해성 기반 관리 전략 적용하기 (계속)
  • A walk through the entire biopharmaceutical manufacturing process – from production through purification of the API, on to the manufacture of the drug product

Major Challenge of Demonstrating Biologic Product Comparability After Manufacturing Process Changes
제조 공정 변경 후 생물학적 제제의 동등성 입증시 주요 과제
  • Change is inevitable – the 3 components of comparability demonstration
  • ‘Future’ comparability (comparability protocols) – ‘Extreme’ comparability (biosimilars)
(15 minute breaks around 10:30 am and 3 pm each day)
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