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성공하는 Global신약개발의 CMC 전략Cortellis CMC intelligence
클래리베이트애널리틱스제약바이오팀
Julie Kim 과장
1Confidential: Internal Use Only
Agenda • CMC Challenge_New Drug Application
• What is Cortellis CMC Intelligence?
• Live Demo
• Q&A
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성공적인 Global 신약개발의최종관문New Drug Application과 CMC
3© 2020 Clarivate Analytics
Confidential: Internal Use Only
Confidential: Internal Use Only
$2.8BHow much it costs to develop a drug and launch it1
12-18Number of months it takes to complete CMC activities3
50%Number of New Drug Applications that were rejected between 2000 and 20122
Challenges in the CMC space
25%Number of CRLs issued January 2017 to May 2018 due to CMC issues4
Sources:1.Science Direct 2. JAMA Network 3.IMPACT 4.PharmaTech
What are you doing to stay compliant with CMC requirements?
© 2019 Clarivate Analytics 6
Confidential: Internal Use Only
References: 1. 2018 CMR Factbook from Clarivate Analytics: Drawn from the 2018 R&D Investment Metrics Programme2. https://jamanetwork.com/journals/jama/fullarticle/181779 *Based on a survey consisting of 17 different contributing companies (11 Major, 6 Mid and Other). **$2.9B was the average R&D budget for the 17 large and mid-sized companies in CMR
Confidential: Internal Use Only
CMR International
2019 Pharmaceutical R&D Factbook
Confidential: Internal Use Only
CMR International
2019 Pharmaceutical R&D Factbook
• R&D Resources• R&D Pipeline Volume• Regional Comparisons• Therapeutic Area Focus• Success Rates/Cycle Times(Milestone)• Biopharmaceutical Focus• Clinical Functions/Patent• Global Generics Market
Confidential: Internal Use Only
11Confidential: Internal Use Only
CMC Workflow
Review data
& CMC requirements
서류취합Packing
Generation
Packing Submission
Market Launching
Approval
Reject
Confidential: Internal Use Only
Discovery DevelopmentMarketing approval
Chemistry, Manufacturing & Controls (CMC)
Confidential: Internal Use Only
•What is Cortellis CMC Intelligence?
14© 2020 Clarivate Analytics
15© 2019 Clarivate Analytics
Make data-driven decisions with speed and certainty
Unlock hidden insights and bring life to science
Discovery & Preclinical Dev.
Portfolio Strategy & Business Development
Clinical Development & Regulatory
Generics Strategy & Development
Supporting your needs across the drug/device development lifecycle
<<<<< Data | Insights | Consulting | Services >>>>>
Cortellis CMC Intelligence
Developing a drug is difficult. Going to market shouldn’t be.
Supporting your needs across an array of offerings
CMC solutions
Consulting services
CortellisRegulatory Intelligence
The Centre for Innovation in Regulatory Science
© 2019 Clarivate Analytics 16
Cortellis CMC Intelligence가정보기반 CMC 의사결정을도와드리겠습니다.
쉽고빠르게정확한국가별인허가규제정보를확인할수있습니다.
효율적으로국가별인허가규정을비교하여
수출전략수립에도움을드립니다.
시시각각변하는국가별인허가규제대응을위한자원으로중요정보누락을방지합니다.
단일화된플랫폼활용으로시간과노력을최소화할수있습니다.
Save time using
© 2019 Clarivate Analytics 17
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Cortellis Regulatory Intelligence
Country and regional coverage
130+countries & regions for drugs & biologics
© 2019 Clarivate Analytics
*Note: Indicates coverage to be complete in 2020
Located all over the globe to constantly monitor updates
Editorial team 과지역전문컨설턴트
CMC professionals with over 10 years of industry experience
Supplemented by international network of local consultants
Specialized in Product Lifecycle Management
Contribute to Journal of Clinical Studies and DIA Global Forum
Regularly present at industry conferences like DIA and RAPS
© 2019 Clarivate Analytics 19
• 관심국가의 CMC 요구사항을효율적으로추적하여변화하는인허가규정준수를보장
• 비용, 시간및품질등의시장위협요소로부터균형잡힌 CMC 전략수립을도와드립니다.
• 국가별상세인허가규정을이해하여, 특별히지역화된규정이어떻게적용되고차별화되는지보여줍니다.
• Understand detailed official
CMC professional
© 2019 Clarivate Analytics 20
• 관심국가의 CMC 요구사항을효율적으로추적하여진화하는규정준수보장
• 제조, 시험또는유통에대한특정지역요구사항을이해하여귀사의제품역량에가장적합한국가선택
• 잠재적인승인경로를파악하여최적의시장진출경로선택
Regulatory affairs
© 2019 Clarivate Analytics 21
개별규정을확인하기전에국가및조직간인허가제도를시각적으로비교합니다. (FDA vs ICH)
• 관심국가간공통및다양한요구사항식별및이해여러국가에서요구사항을비교하는시간을절약하고중요한차이점을놓치지마십시오.
Use case_최신의전문적인 CMC 인허가규정에대한깊은이해를쉽고빠르게얻을수있습니다.
© 2019 Clarivate Analytics 22
• 국가및조직전반에걸친상세한국가규정,파생공식규정및현지전문지식기반현지인허가관행을시각적으로비교했습니다.
• 제품유형, 제약양식등에따라약물과관련된목표요구사항,ICH의 eCTD 구조별관련정보를쉽게찾을수있습니다.
국가별의약품인허가규정및현지관행의유사점과차이점이해
Use case
© 2019 Clarivate Analytics 23
• 국가및조직전반에걸친상세한국가규제당국파생공식규정및현지전문지식기반현지관행을시각적으로비교
• 제품유형, 제약양식등에따라약물과관련된목표요구사항ICH의 eCTD 구조별관련정보를쉽게찾을수있습니다.
국가별의약품인허가과정을도식화하여쉽고빠르게이해
Use case
© 2019 Clarivate Analytics 24
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