An often surprisingly big step: from an academic scientist to a pharmaceutical entrepreneur Dr. Sven GMP Consultant / Qualified Person info@becker-gmp.de 1
Introduction How academia meets GMP - observations and experiences frequent problems of academic institutions by the implementation of GMP standards reasons for time delay in building GMP-facilities and bringing them into service suggestions for solutions Rotterdam, NL 2
Translation: scientific results into pharmaceuticals (1) Reasons for the decision in an academic institute: development of a new therapeutic approach encouraging data in R&D / preclinical studies therapeutic option for diseases with bigger number of cases maintain the promise of economic success Decision-making: administration of institute / head of working group clinical partners but.. Rotterdam, NL 3
Translation: scientific results into pharmaceuticals (2) Academic institutions are often not fully aware about the consequences: free work of a Researching Scientist regulated work of a Pharmaceutical Entrepreneur Three underestimated aspects by changing a research lab into a GMPfacility: it costs money time personnel Rotterdam, NL 4
Costs: premises GMP-laboratories / production Premises: clean room conditions / Annex 1 air ventilation system (filtered air, air circulation, regulation of maintenance of air pressure cascade) GMP conform room accouterments (walls, ceilings, floors, doors, windows ) monitoring system (pressure cascade, air humility, temperature, function of GMP relevant equipment ) water, effluents, heating, electro-techniques, LN2 w/o technical equipment (LAF) / lab furniture costs ca. 4.000 to 6.000 / m 2 GMP-laboratory Rotterdam, NL 5
Costs: premises side laboratories / QC Premises: side laboratories / QC air ventilation system (e.g. fume cupboard) monitoring system (function of GMP relevant equipment, e.g. refrigerators, deep freezers, incubators ) water, effluents, heating, electro-techniques, LN2 w/o technical equipment / lab furniture costs ca. 1.000 to 2.000 / m 2 side laboratories / QC Rotterdam, NL 6
Time consuming steps (1): product development Successful preclinical tested scientific product pharmaceutical product adoption to GMP compliant production (methods, material) testing for stability and function Qualification of equipment Validation of processes Rotterdam, NL 7
Time consuming steps (2): QA - System Establishment of a Quality Assurance System: establishing document system (SOPs, risk analysis, Q&V) VMP, SMF audits (internal & external) system for handling OOS-results organization of training for personnel system to check quality standards at cooperation partners preparation for inspections of authorities (& time for post processing / error handling). Rotterdam, NL 8
Time consuming steps (3): qualification works Qualification of Premises Confirming of room conditions to Annex 1 Hygiene monitoring Qualification of the monitoring system concurrent monitoring of GMP room conditions Time consuming steps (1-3) Experience: duration min. 3 4 years Rotterdam, NL 9
Costs & time (1): personnel Qualified Personnel: QP Head of production. head of quality control head of QA technical stuff (GMP experience) Problems for academic: finding adequate personnel is time & cost consuming personnel has to be educated (self-teaching) vs. high wages for qualified staff wages in industry ca. 30 60 % higher than in academic institutions > problems to find adequate staff Rotterdam, NL 10
Costs & time (2): establishing GMP facility to remember: Costs for establishing a GMP facility Time and costs for product development Establishing QA-system Qualification works Finding & teaching personnel Costs have to be taken for years before 1st preparation is sold! to be considered: Keeping GMP standards (monitoring, re-q, re-v, documentation.) will bind 60-75% of your personnel Rotterdam, NL 11
Costs: manufacturing license After Qualification & Validation: calculated costs for compilation of documents CTD modules Analysis of 1 st clinical data ca. 80.000 120.000 Rotterdam, NL 12
Time: solve judicial questions Realization of project stagnates because academic partners (e.g. scientific institute and medical clinic) haven t solved judicial questions upfront: who is the pharmaceutical entrepreneur? what are the judicial consequences? how responsibilities are shared? questions concerning sharing costs and benefits.. Bringing these questions to the legal department during project realization: costs a lot of time! Rotterdam, NL 13
Suggestions for solutions (1) As soon as it is conceivable that GMP shall be established: Upfront communication between all parties involved in the project (scientists & physicians, administration of academic & medicinal institutes, legal department) get an overview about timelines to expect invite GMP experienced partners or external help for the realization of GMP aspects Rotterdam, NL 14
Suggestions for solutions (2) send personnel to GMP seminars; keep partners informed about GMP requirements account for GMP development in financing grants apply for cost recovery for the implementation of clinical studies Rotterdam, NL 15
Thank you very much for your attention. Rotterdam, NL 16
Rotterdam, NL 17