Ricarda Cramer (MBA), Managing Director
• Pharmacist, 15+ years experience in pharmaceutical industry, incl. head of business unit
• Strategic marketing & portfolio management, R&D, production, RA
• Launch excellence, Six Sigma, Blitz-Kaizen
• Advisor to the European Bank of Reconstruction and Development
• Industry experience: Schwarz Pharma, UCB, Fresenius Kabi
• Strategic marketing & portfolio management, R&D, production, RA
• Launch excellence, Six Sigma, Blitz-Kaizen
• Advisor to the European Bank of Reconstruction and Development
• Industry experience: Schwarz Pharma, UCB, Fresenius Kabi
Michael Firgens (MBA), Senior Advisor
• Master of Biochemistry and MBA in General Management, 12+ years experience in pharmaceutical and biotech industry in in Europe, USA and Asia
• R&D, program management, regulatory affairs, CMC, clinical development, business development, commercial and business strategy
• Development planning and strategy execution for complex biopharmaceuticals, first-in-class molecules, advanced therapy medicinal products (ATMPs), orphan drugs, biosimilars, medical devices (e.g. antibodies, gene and cell therapies, bacteriophage therapies, small molecules); agency interactions and regulatory submissions in the EU and US (CTA/ IND, MAA/ BLA, ODD); international tech transfer projects; due diligence
• Industry experience: Sanofi, Dr. Kade, Fresenius Kabi, Biopharma Excellence
• R&D, program management, regulatory affairs, CMC, clinical development, business development, commercial and business strategy
• Development planning and strategy execution for complex biopharmaceuticals, first-in-class molecules, advanced therapy medicinal products (ATMPs), orphan drugs, biosimilars, medical devices (e.g. antibodies, gene and cell therapies, bacteriophage therapies, small molecules); agency interactions and regulatory submissions in the EU and US (CTA/ IND, MAA/ BLA, ODD); international tech transfer projects; due diligence
• Industry experience: Sanofi, Dr. Kade, Fresenius Kabi, Biopharma Excellence
Dr. Christoph Küster, Senior Advisor
• Pharmacist, 20+ years in pharmaceutical industry
• Pharmaceutical development, LEAN transformation / LEAN quality, re-structuring, change management, process optimization, Six-Sigma, quality
• Certified pharmacist for drug information, chairman of section industrial pharmacy of German Pharmaceutical Society (DPhG)
• Industry experience: Sanofi, Boehringer-Ingelheim, Sandoz, Novartis
• Pharmaceutical development, LEAN transformation / LEAN quality, re-structuring, change management, process optimization, Six-Sigma, quality
• Certified pharmacist for drug information, chairman of section industrial pharmacy of German Pharmaceutical Society (DPhG)
• Industry experience: Sanofi, Boehringer-Ingelheim, Sandoz, Novartis
Dr. Hermann Osterwald, Senior Advisor
• Pharmacist, 30+ years experience in the pharmaceutical industry
• R&D, production, sales and marketing, business development
• Restructuring, process and plant optimization, lean Six Sigma
• Advisor to BfArM, APV board member and member of several boards in the pharmaceutical industry
• Industry experience: Nextpharma, Celesio, GNR-Pharma, Jenapharm, Smith Kline Dauelsberg, Madaus, Nattermann
• R&D, production, sales and marketing, business development
• Restructuring, process and plant optimization, lean Six Sigma
• Advisor to BfArM, APV board member and member of several boards in the pharmaceutical industry
• Industry experience: Nextpharma, Celesio, GNR-Pharma, Jenapharm, Smith Kline Dauelsberg, Madaus, Nattermann
Monika Osterwald, Senior Advisor
• Pharmacist, 30+ years experience in pharmacy and 25+ years in industry
• Pharmaceutical development, transfer projects, contract manufacturing sales, procurement, reorganization, process optimization & harmonization, supplier qualification, auditing, supply chain management
• Certified auditor for EU GMP Part II since 2014
• Industry experience: Nextpharma, Celesio, Jenapharm, allphamed Pharbil, Smith Kline Dauelsberg
• Pharmaceutical development, transfer projects, contract manufacturing sales, procurement, reorganization, process optimization & harmonization, supplier qualification, auditing, supply chain management
• Certified auditor for EU GMP Part II since 2014
• Industry experience: Nextpharma, Celesio, Jenapharm, allphamed Pharbil, Smith Kline Dauelsberg
Sonja Moritz, Senior Advisor
• Master of Public Health/Epidemiology (Charité Berlin), 10+ years in international medical device industry
• Project management, Internal Audits, Strategic Procurement, R&D, Sales, Commercial Excellence
• Feasibility / acceptability studies, quantitative & qualitative research (Helmholz Institute for Infectiology), policy work / public relations at UN/WHO
• Industry experience: Siemens Healthineers, Johnson & Johnson Ethicon, Abbott Diagnostics
• Project management, Internal Audits, Strategic Procurement, R&D, Sales, Commercial Excellence
• Feasibility / acceptability studies, quantitative & qualitative research (Helmholz Institute for Infectiology), policy work / public relations at UN/WHO
• Industry experience: Siemens Healthineers, Johnson & Johnson Ethicon, Abbott Diagnostics
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