Main Interests
- Regulatory Affairs (D, EU): Pharma, MD, IVD, CDx, mainly for Start-Ups and SME
- Clinical Research (sponsor, CRO, site and GCP experienced): Pharma, MD, IVD, CDx
- Strategic preparation of Phase … Clinical Trial Structures
- Phase 0 and I reducing risks of/for newly developed stand-alone compounds
- Phase II and III ensuring harmonization of Market Authorization and Market Access activities as early as possible
- Developing / maintaining cooperation’s, partnerships (corporations, institutions, administrations, public authorities) and top-level networks (KOL)
- Lecturer in Regulatory Affairs, Clinical Research, Health Economics
Keywords
Consultancy, Trouble Shooting, Team Building, Management Experiences, Pharma, Medical Devices, In-Vitro Diagnostics, Companion Diagnostics, CRO, Clinical Research, Clinical Trials, CTR, Clinical Evaluations, Performance Evaluations, CER, PER, Regulatory Affairs EU, Start-Ups, SME, Negotiations, Authorities, Institutions, Horizon Europe, IHI
Qualification Matrix
BIO Juergen Blume
| After having studied German Studies, History and Theology at Heidelberg University, Juergen started his career ‘77 successfully as pharma sales representative becoming regional sales manager in ‘78 already. In the following years he expanded BD’s B2B Business in DACH and established for Mallinckrodt the new department “New Product development & MR” successfully. For DeTrey-Dentsply he run 2 BSUs on European level and developed/led the first Europe-wide dental marketing campaign which had its crowning success at the French Dental Exhibition in Paris. Back in Pharma he ensured Block Drug’s Pharma Business switch to fulfilling the new German Drug Act. His experience and competency helped Medic Alert Foundation to set up a gGmbH in Germany responsible for the first international medical device tracking activity in D, PL, CZ, SK, H. The products in question were erroneous heart valves from Pfizer/Shiley. Juergen headed this activity as General Manager. After that acted as Project Head for the German Medicinal E-Health Card Initiative, followed by translating these experiences as VP for GCG America active mainly in the US (ARC, VA, etc.). From 1995 to 2013 he was Owner/Chief Executive Officer leading CERT Healthcare PRE GmbH as Notified Body in Middle-Europe for the Republic of Uzbekistan until 2005. In parallel CERT started in 2003 to specialize on consultancy for start-ups and SME in pharma, biotech, and medical device. In some cases, successful work resulted in joining the clients e.g., BioPheresis as Director Business Development/COO; CONCERT Medical Optics as CEO; CSD as Director Medical Research setting up a new CRO combining clinical and market research for better results. To intensify his market understanding Juergen acted for a limited time as Head Clinical Studies of a study center. Within the above activities Juergen joined the Steinbeis Research Center MBT (Medical Devices & Biotechnology), a spin-off from Heidelberg University, supporting developments in biotechnology. Since 2006 he is constantly active involved in its business and acting as Head/Vice Head. From 2012 to 2016 Juergen acted as Director Medical Research & RA for start-up, Immungenetics at Rostock. He led the preparations for the repositioning of an existing drug incl. the prep of the Phase IIa and IIb-III. The new target indication was Alzheimer and its therapy and diagnosis in form of a companion IVD. This was accompanied by setting up a consortium to prepare an application for Horizon 2020 funding with the projects DrainAD and CleanCNS. Juergen was heading all required negotiations and activities. After retirement in 2016 Juergen concentrates on his work in the Steinbeis Research Center MBT consulting start-ups and SME, supporting also a major CRO internally and externally. Since 2001 Juergen is continuously active as lecturer for Clinical Research, Regulatory Affairs, Project- and Data Management with main regards on CTR, MDR, and IVDR. Main areas of interest are clinical trials and Companion Diagnostic projects. |
Memberships are an extraordinary information basis and help to make us strong and well informed partners
- DiagnostikNet Berlin-Brandenburg e.V. (DNBB), Berlin
- European Association of Pharma Biotechnology e.V. (EAPB), Berlin
- European Hematology Association (EHA), The Hague, NL
- German Physicians Cancer Society e.V. (DKG), Berlin
- German Society for BioMedical Engineering e.V. (DGBMT/VDI), Frankfurt
- German Society of Regulatory Affairs e.V. (DGRA), Bonn
- Medical Development Group (MDG), Boston, USA
- Middle European Society for Regulatory Affaire (Megra), Munich
- Regulatory Affairs Professionals Society (RAPS), Rockville, MD, USA
- RAPS Deutschland e.V., Hannover