Adopting Virtual R&D in Drug Development

Transcription

1 Adopting Virtual R&D in Drug Development 2016

2 Table of Contents 1. Why virtual R&D? 2. Project management team for drug development 3. Project initiation 4. Clinical study team considerations for virtual R&D company 5. Project execution/monitoring/closing 2/13

3 Why Virtual R&D? ü New drug development involves complex project structure ü Qurient is a virtual R&D biotech company developing new chemical drugs ü Virtual R&D utilizes external resources, common concept in other industry area ü Goal of implementing virtual R&D is to give efficiency by being a small organization 3-5 Years Biology Chemistry Manufacturing Toxicology Clinical Study Regulatory 3/13

4 Project Management Team CEO (1) ü Compact organization structure Efficient communication Minimize unnecessary political issues R&D PM (12) ADMIN (6) BD (1) Sharing common goal ü Function & Project based team structure Generalist, but specialist in some degree Utilize external expertise ü Decision making through team argument Ahn Lee Kim Biology MFG Toxicology Kim Lee Ahn PJT A PJT B PJT C Specialist Generalist 4/13

5 Drug Development Pathway ü Drug development is a continuous rolling-wave plan Building blocks until NDA ü Single project manager managing up to early phase 2 study stage is recommended P3 Nonclinical Study NDA P1 Phase 2 study Phase 1: DDI, formulation change study Early phase 2 study 6Month Tox 2Month Tox P2 Phase 1: SAD & 14Day MAD In vivo gene Tox Safety 14Day General Tox DMPK Pharmacology Secondary Primary pharmacology pharmacology 5/13

6 Project Initiation ü Simple review process focusing science and patients benefit Data package Licensing Committee review GO / NO GO FOR COMPOUND IS THAT WILL (MAY) BECAUSE Cancer patients at stage 3 and 4 who failed standard of care First in class in oncology drug in non small cell lung cancer Cure people who failed standard of care Patients who failed standard of care are having low survival rate. This compound will increase it by 2 fold Cost of treatment will be decreased by 2 fold 6/13

7 Clinical Study Team Considerations Small size CRO Mid size CRO Large size CRO Flexibility Communication speed H M L H M L Process risk (eg. lack of SOP) H L L ü Small size CRO for Pilot studies Plans to minimize process risk are highly required ü Mid size CRO for Studies with straight forward design using small number of sites (eg. Phase 1 study) ü Large size CRO for Global multisite studies May lose significant amount of time just for communication between global teams 7/13

8 Clinical Study Team Considerations CRO/Site Role Sponsor - Project PM Main Main Site/CRO PM - - CRA Main Main PK analysis Main Main Medical monitoring Main Main Clinical Pharmacology Sub Sub Regulatory support Main Main DM, Biostat Main Sub Medical writing Main ü Separate roles that may have conflict of interest (eg. RA support) ü Sponsor should have oversight on necessary roles CRO is CRO ü Prepare plans to externalize necessary roles 8/13

9 Clinical Study Team Management ü F2F meeting is always better ü If needed, consultants are involved in day-to-day communication ü Understanding cultural background is very important in communication 9/13

10 Project Execution Quality Scope ü Project is divided into work items - Work times are managed by Gantt chart - Knowledge on duration, cost, dependency of work item is company s know-how ü Time, Cost, Scope, Quality management ü All project managers have a PMP certification 10/13

11 Project Monitoring ü Project Management System (QPMS) - Action, Decision, Risk management, Issue tracking - Replace unnecessary internal reporting process ü Groupware - Resource monitoring ü Safety database - Clinical safety database 11/13

12 Project Closing ü Deliverables - QC - Data registration (Electronic DB or Document storage room) ü Lessons learned report - Company s know-how - Significantly reduces risk and increases efficiency for future similar projects 12/13

13 THANK YOU! 감사합니다. 김정준 (June Kim) 13/13