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Andreas Fischer, PhD
Managing Director, Germany

Andreas_edited.jpg
  • LinkedIn

  • 25 years consulting industry experience including:

  • 20 years self-employed (IMP management, pharmaceutical and analytical development, GMP quality management, CMC project management and business development)

  • 5 years with PwC in Switzerland (R&D strategy consulting)

  • 3 years Contract Manufacturing Organization (Fisher Clinical) in Switzerland (Project Management & Business Development

  • 2 years academic research in Germany (Technical Biochemistry)

Specialties

  • Business Process Re-engineering

  • Continuous Improvement/operational excellence

  • Process & Project Management

  • IMP Supply Chain Management

  • Outsourcing & Vendor Management

  • IMP Quality Management (SOP Systems, Process flow)

  • GMP Auditing

Experience

Major multi-national pharmaceutical companies (HQ /US & Germany):

  • Global projects to re-engineer and harmonize global pharmaceutical development and IMP supply chain process

  • Introduction of performance measurement by defining and implementing appropriate KPIs according to balance scorecard approach

  • Optimization of IMP process (Quality, Time, Cost), including an integrated QA system to support and improve the clinical supply process

  • Evaluation, selection and pilot facilitation of Manufacturing Execution System (MES) to support global IMP supply chain

Globally active IMP contract packagers (HQ / US):

  • Identification, selection and planning of new EU facility

  • Acquisition Strategies for EU customers

  • Evaluation of business options for a European subsidiary and support in later disposition

  • Market surveys on future outsourcing practices of major pharmaceutical companies

Major multinational pharmaceutical and small biotech companies (HQ / US & Germany):

  • Project Management of Phase I-IV trials (small Ph I to major international Ph III), including IMP vendor selection and outsourcing management

  • Multiple GMP/GDP vendor compliance audits

  • Identification of IRT systems for international trials, compilation of User Requirement Specifications and conduction of User Acceptance Tests

  • Development and implementation of GMP IMP Quality Management System including SOPs for IMP process

  • Development of Pharmaceutical Development Handbook

Training Activities:

  • Specialized in-house trainings on GxP guidelines within the IMP management

  • Training and coaching of new staff in IMP management

  • Specialized in-house training at GMP/ GCP interface, i.e., educate clinical operations staff on details and requirements of IMP supply chain

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