Dr. Martin Stapf - Consultant

Independent Consultant & Interim Manager: Pharma, Biotech, Medical Technology and Diagnostics

VITA

Broad International BioPharmaceutical Professional with more than 20-years experience in Pharma Industry/Biotech, Medical Technology and Diagnostics focused in Oncology and Nephrology. Experience in various roles in Big Pharma/Bio Tech., Med.Tech. as well as Small and Medium Sized Companies.
I have a „Hands-on-Mentality“, being persistent and get things done within tight timelines and within pre-set budgets. In 2013 I’ve initially started as Independent Consultant and Interim Manager.

Focus:

  • General and Country Management, „Gobal“
  • Company Foundation & Growth
  • Post Merger Integration
  • Market Access Management
  • Pre-Marketing and Launch of Drugs and Devices
  • Set-up and Growth of new Business Areas, P&L Responsibility
  • Strategic Business Development
  • HEOR and Reimbursement Strategies
  • Develop and Implement Sales & Marketing Strategies
  • Consulting: Life Science & Drug Development

REFERENCES

  • Pharmaceuticals: Oncology and Nephrology – Originator Aranesp® and Generics.
  • Oncology: Precision Medicine: DACH Country Management Germany, Austria, Switzerland and Nordics.
  • Medical Technology: Nephrology: Renal Replacement Therapies.
  • Consulting/CRO: Life Science & Drug Development Consulting.

Companies & Cultural Sensitivity

  • Big Pharma/Biotech/Medcial Devices: AMGEN, GAMBRO.
  • Small/Medium Size Companies (SMC): PAREXEL, HIKMA, NANOSTRING TECHNOLOGIES Inc.
  • Start-Up: Foundation of EPN GmbH, the first non-US-subsidiary of AMERISOURCEBERGEN CORPORATION.
  • USA (12-years), Sweden (6-years), MENA (5-years, Middle East North Africa).
  • Establish a Business Unit (BU) Structure and found the BU „Nephrology“ at AMGEN. Responsible for creating and setting-up the Marketing Umbrella Concept and for all Pre-Launch-Activitie, e.g. Phase-3-Study including 240 dialysis centers.
  • Successful Launch of the Block-Buster Drug Aranesp® setting-up the Key Account Management (KAM).
  • Foundation of the EPN GmbH as first European entity of AMERISOURCEBERGEN CORP, USA. Setting-up the Business Model „Managed Care“, based on the new Health Care Legislation „Integrated Care Concept“ (§140 ff. SGB V) as General Manager.
  • Post-Merger Integration of the aquired HIKMA Pharma GmbH with the RIBOSEPHARMA GmbH Pharma. Successful General Management of the HKMA Pharma GmbH and the B.V. of Germany, Austria and Netherlands. Successful development of the hospital business and the oncology business.
  • Diagnostics/Pharma: Country Manager responsible for Germany, Austria, Switzerland & Nordics. Development of the business model and successful Launch of the In-Vitro-Diagnostic-Test (IVD) for Breast Cancer (BC) in Germany , Switzerland and Austria (DACH).
  • Diagnostics: Creating the new Business Model to promote the prognostic IVD-Test to realize personalized/individualized medicine for Early Breast Cancer (EBC).
  • Successful Market Access with the IVD-Test in Onkology, Early Breast Cancer („EBC“) starting at University Clinics followed by out-patient facilities.
  • Set-up a Key Opinion Leader (KOL) panel as expert group to promote the IVD-test on relevant congresses within scientific speeches..
  • Successful integration of the IVD-Test in most relevant guidelines („St. Gallen Guidelines“, German „AGO-Guidelines, US „NCCN-Guidelines) as very important mile stone within the Scientific Marketing for Market Access.
  • Establish an „Early Market Access Program“ („EARP“) as intermediate solution before general reimbursement by statutory insurances within the German Health Care System. Overall responsibility, e.g. Aquisition of Key Centers, set-up of logistics, establishing a invoicing system for the members, Pathologists, Gynecologist/Breast Surgeon/Nanostring. Meet all internal and external compliance rules and receiving approval by the relevant stakeholder within Nanostring, e.g. Legal, Finance, Regulatory Affairs and Senior Management.
  • Medical Technology – Nephrology, Hemodialysis: Ramp-up sales starting as Product Manager and being promoted to Group Product Manager of the most important prduct groups (Medical Devices & Drugs). Set-up the new Business Unit „Peritonealdialysis“ to expand revenues: Establishing and Grow this business as responsible Head of Marketing and Sales.
  • Pharma/Biotechnology: AMGEN: Successful Pre-Marketing-Phase and Launch of the Blockbuster Product Aranesp®. Founding and establishing the Key Account Management for the Hospital (In-Patient) and Out-Patient-Sector.
    Drug Development Consulting: B-2-B: European Vice President Account Management: Set-Up the Account Management. Establishing Account Management Groups in : Berlin, Freiburg, Paris and Uxbridge/UK. Clients: Small, Midsize und „Big Pharma“ companies. Responsible including P&L for Europe but also for the multi-national company „LG“ as Vice President Europe Account Management.
  • Diagnostics – Onkology: Launch Prosigna® Genexpression Assay for Early Breast Cancer („EBC“) as personalized Therapy to avoid not necessary Chemotherapy. Market Access including P&L responsibility. Negotiation with and successful cooperation with AMGEN to promote Prosigna® on shared events in Germany.
  • „B-2-B“ Model: Cooperative Sales Model: Establish a cooperative sales model for 13 Eastern European Countries within a „B-2-B“ approach in a cooperation with an established and successful company in these countries.
  • Responsible coordination to establish the mandatory document as basis for the reimbursement decision of the relevant authorities: Federal Joint Committee („G-BA“) as highest decisive body for reimbursement and the independent Institute for Quality and Effectiveness in Health Care („IQWiG-Institute) who evaluates the applications for reimbursement and is the consulting body of „G-BA“.
  • Form and establish an external and independent team of specialists to support the internal departments:
    + Onkology (Gynecology) andPathology + Leading Medicinal Law Firm + Internal US-Stakeholders: Medical Affairs, Legal, Regulatory Affairs & Research.
  • Set-up and implement an „Early Access Reimbursement Programms (EARP)“, to grant access to the prognostic IVD-Test „Prosigna®“ for private but also for statutory patients. Establish all necessary documents within compliance, regualtory and legal regulations.
  • Lobbying to include the new „nCounter-Technology“ &“Prosigna® in the relevant scientific Guidelines (AGO, NCCN, St. Gallen Guidelines).
General Management

Commercial leadership including P&L responsibility & stakeholder management.

Strong Sales & Marketing Focus

Lead Sales & Marketing Department, Pre-Marketing & Launch a Block-Buster-Drug, Business Devlopment, KOL-Management.

CRO Services Business

Consulting perspective „to see it with client´s eyes“.

Hands-on-Mentality

Hands-on-Mentality, strong communicator and negotiator on all levels.

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