DZIF-Product Development Unit (PDU)

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1 November 29, th International VPM Days DZIF-Product Development Unit (PDU) - DZIF-TPMO at HZI - DZIF-OSRA at PEI Thomas Hesterkamp, Helmholtz Zentrum für Infektionsforschung

2 Support from TPMO & OSRA: Bridging the Translational Gap for DZIF Research Groups Research Candidate Preclinical Dev. Clinical Development Registration Drug Research Centers PDU support Vaccine and Pharma Industry Translational Project Management (TPMO) Regulatory Support (OSRA) Sponsor Designation ( 4 (24) AMG) Consulting 2

3 DZIF-PDU Organizational structure Academic Discoverer - drug discovery - basic research Drug developer - development towards first-in-man clinical trial - development towards marketing authorisation November 29,

4 PDU (TPMO and OSRA) builds an inventory database of projects (drug discoveries and stage of on-going product developments) Identifies drug candidates that meet unmet medical need and have market potential Selects the most promising DZIF translational products that may be chosen by the DZIF Board for further development under DZIF rules and DZIF financial support OSRA examines regulatory status and provides support on regulatory and scientific requirements TPMO checks the suitability of IP (in cooperation with TT-offices), designs a translational development plan, incorporates regulatory requirements into the plan, identifies a suitable manufacturer and contract research organisations November 29,

5 Governance of DZIF-PDU 5

6 TPMO: key elements to support product development I.P. check in collaboration with TT-offices Definition of target product profile Search and link to potential CMOs and CROs GMP suitability Fill & finish capacities Production and release plans with Qualified Person (QP) GLP Tox & Safety Pharmacology Development of a scalable, industry-suitable production process by researcher, TPMO, CMO and CRO Definition of product specifications and release criteria by researcher, TPMO, CMO and CRO Clinical trial application November 29,

7 Target Product Profiles Home grown Product Target indication and patient segment Target population Key geographical markets Key efficacy claim Safety Dosage / volume / route Onset and duration of effect Stability, shelf life Presentation, formulation Price US / EU / ROW Gold standard for targeted disease Launch date FDA draft guidance (2007) Indication and usage Dosage and administration Dosage forms and strength Contraindications Warnings and precautions Adverse reactions Drug interactions Use in specific populations Drug abuse and dependence Overdosage Description Clinical pharmacology Nonclinical toxicology Clinical studies References How supplied / storage and handling Patient counseling information Target Market Profile & Strategic Target Profile Therapeutic area and/or disease Unmet medical need Patient population Key drivers for use Competitive assessment versus standard-of-care and contemporary competing products; product differentiation Economic cost of disease Product value drivers Pricing Patient share, revenue projections Investment (R&D, COGS, SGA) Cost of goods Licenses and Royalties November 29,

8 Governance of DZIF-PDU 8

9 Scientific and regulatory support 1. Kick-off meeting at PEI/OSRA with researcher, TPMO, OSRA Discussion of next steps, milestones, Target Product Profile 2. Scientific and regulatory chaperonage provided by OSRA Informal advice on scientific and regulatory issues via TPMO e.g. teleconferences and/or via s 3. Support by TPMO in preparing the Scientific and Regulatory Advice 4. Scientific and Regulatory Advice procedure PEI acts as regulatory authority! BfArM to join process for NCE November 29,

10 Active consultancy Screening for regulatory gaps and needs at the different DZIF partner sites/ttus November 29,

11 National, European and International network Link to BfArM, EMA and EDQM (Pharmacopoia) WHO Collaborating Center for Standardization and Evaluation of Vaccines Member of the WHO Collaborating Center Network for Standardization and Regulatory Evaluation of Vaccines November 29,

12 DZIF setup and project portfolio Neuauftretende Infektionen Tuberkulose Thematische Translationseinheiten (TTU) Malaria HIV Hepatitis GI Infektionen Immun compromised host Neue Antiinfektiva Krankenhauskeime und Resistenzen Produkte Naturstoffe Translationale Infrastrukturen Klinische Studien Afrika Biobanken Bioinformatik Akademie TTU Infrastrukturen November 29,

13 Besondere Infrastrukturen im DZIF Drug discovery technologies Vaccine development Chemical libraries and HTS Natural product collection, fermentation and downstream processing Biophysics and structure based drug design Medicinal chemistry Drug delivery Animal models BSL-3/-4 rodent and NHP BSL-3 imaging in vivo / in vitro BSL-3 GxP environment BSL-3 cell sorting / flow cytometry Expert infrastructures Clinical trial infrastructure Various patient cohorts Primary human hepatocytes GMP cell therapy unit Centre for immune competence monitoring Oligonucleotide and RNA-based therapeutics

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