About me

Industrial Career

More than 25 years in Big-Pharma and Biotech Industry at

Schaeffler Pharma Consulting (2011 – today) 

Owner

Horizon Pharma INC, Deerfield, IL, USA; Mannheim, D  (2010 –2011)

Executive Vice President Technical Development & Manufacturing, Managing Director Horizon Pharma GmbH

Main activities/ responsibilities at Horizon

• Member of the Executive Management of Horizon Pharma Inc
• Key role in the integration process of Nitec Pharma and Horizon Therapeutics to Horizon Pharma
• Responsible for CMC activities /technical development of all Horizon projects and manufacture of all Horizon products
• Supply Chain Management through reliable external partners
• Actively involved in Duexis and Lodotra/Rayos NDA filings. US approvals received in 03/2011 and 07/2012
• Develop and execute together with License partner filing strategy for regulatory approvals in Asia Pacific and Latin America
• Support Horizon Pharma INC during the IPO in July 2011(NASADQ HZNP)
• Fulfill obligations as Managing Director of German GmbH

Nitec Pharma, Reinach CH, Mannheim D (2004-2010)

Co-founder, Executive Vice President R&D/ Manufacturing / Intellectual Properties
Member of the Board of Directors of Nitec Pharma AG; General Manager

Main activities/ responsibilities at Nitec

• Foundation of Nitec Pharma / Merck KGaA Spin-off in 07/2004
• Rounds of financing in 2004, 2007 and 2008 with a total raise of about m70 US$
• Building up infrastructure of the newly founded company Nitec Pharma
• Clinical Research and Development: Expertise in Rheumatoid Arthritis, Severe Asthma, Osteoarthritis, Neuropathic Pain
• Several publications in clinical journals (2008: The Lancet) and poster presentation at EULAR and ACR congresses
• Technical Development/ Production of modified release and standard tablets
• Supply Chain Management through reliable external partners
• Development and implementation of a Quality System for Pharmacovigilance and Final Product/ EU Market Release
• Successfully passed several inspections by authorities and partners
• In-licensing activities
• Regulatory approvals: Lodotra®: EU Approval 12/2008
• EU Regulatory Scientific Advises (D, SE, UK)
• US FDA activities: pre IND meeting, EOP2 meetings, pre NDA meeting
• Management of IP portfolio worldwide through EU and US patent law firms
• Support to merge Nitec Pharma with Horizon Therapeutics (03/2010)

Merck KGaA (1991-2004)

Several positions: from Pharmaceutical/ formulation Scientist up to Head of Global Pharmaceutical Development

Main activities/ responsibilities at Merck KGaA

• Global development activities managed through centers in UK, France, Germany
• Development of dosage forms with focus on solid orals, novel Drug Delivery Systems, injectables
• Development /validation of analytical methods, stability testing according to ICH
• Manufacturing, packaging, labeling, distribution of clinical trial material for worldwide clinical trials
• Scale up activities / transfer of projects to several manufacturing sites
• Dossier preparation (Quality part): IND, IMPD,  eCTD, NDA
• FDA Pre-Approval Inspections
• Deputy head of commercial manufacturing
• Qualified Person according German Drug Law (AMG §15)
• Member of US based strategic Therapeutic Area Team „Oncology“ responsible for quality including commercial manufacture
• Project Champion of priority projects (EGFR – MAB)
• Due diligence of external projects to be in-licensed

Schwarz Pharma (1991) – Now UCB Group  – Formulation Research Fellow

Boehringer Ingelheim (1988-1990) – PhD in Pharmaceutical Technology/ Drug Delivery

Education

Pharmacist with PhD in Pharmaceutical Development / Drug Delivery Systems