Expert Details
Pharmaceutical Development, strategy planning and execution
ID: 728090
Switzerland
Due Dilligence assessment on a potential In-licensing compound for the biotech company: CardioLynx, based in Basel Switzerland
In the course of this project a set of preclinical and technical study reports were analysed and a assessment report was provided. The report was discussed with the responsible managers of CardioLynx who were able to make a quick decision after a procedure of two weeks.Preparing lectures for the University of Basel in the field of Drug Development. Expert was asked to prepare a set of lectures for the hospital personel involved in clinical studies to create a better understanding for all of the activities required for a new drug approval.Preparing a business plan and an analysis of the development plan for KellSa SA, a company involved in the development of medical devices.
Education
Year | Degree | Subject | Institution |
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Year: 1989 | Degree: Ph.D. | Subject: Molecular Biology / Gene Regulation | Institution: University of Basel / Switzerland |
Year: | Degree: Masters | Subject: Biology | Institution: University of Utrecht/ The Netherlands |
Work History
Years | Employer | Title | Department |
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Years: 2009 to Present | Employer: Undisclosed | Title: President | Department: |
Responsibilities:Expert provides consulting services for strategic planning and execution of pharmaceutical drug development. |
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Years | Employer | Title | Department |
Years: 2004 to 2009 | Employer: Santhera Pharmaceuticals | Title: Vice President | Department: Development |
Responsibilities:At Santhera Expert was responsible for building up a pharmaceutical development organisation in the biotech environment, starting from scratch. He set up technical, preclinical and clinical development group, as well as a QA organisation. With this development organisation he brought the first clinical candidate of the company from early development to approval in a period of 4 years. |
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Years | Employer | Title | Department |
Years: 1999 to 2004 | Employer: Hoffmann-La Roche | Title: Lifecycle Leader | Department: Business |
Responsibilities:Leading a global team of > 50 members from Research, Development and Business, aiming at filing, launching and marketing a compound in the major markets Europe, USA and Japan. Responsibility for designing a Development and Launch plan for one of the major portfolio projects in the field of Depression. Leadership of the team performing the Phase I, II and III studies for this project. IND filing and NDA preparation. Overseeing design of technical, pre-clinical and clinical strategies. Strong additional involvement in both early as well as late stage projects. Line responsibility for the Business Team based both in EU and US. Assessment of project value on an ongoing basis in order to support portfolio decisions. Member of the Disease Area Strategy Team (DAST) advising the company on decisions in planning for future focus areas of research. Development and Business input in licensing-in of products. |
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Years | Employer | Title | Department |
Years: 1994 to 1999 | Employer: Hoffmann-La Roche | Title: Project Leader | Department: Development |
Responsibilities:Global strategic leadership of project teams, overseeing all development activities aiming at NDA filing in the major markets US / EU and Japan. The project teams included representatives of the technical, preclinical, clinical and marketing departments. Filing of New Drug Applications (NDA) in the major markets Europe, USA and Japan. Assess project value on an ongoing basis in order to support portfolio decisions. Overseeing NDA and product launch preparatory work, carried out by the technical, preclinical, clinical, regulatory and business departments. |
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Years | Employer | Title | Department |
Years: 1992 to 1994 | Employer: Hoffmann-La Roche | Title: Scientist | Department: Vitamine Division |
Responsibilities:Molecular Biology /Genetic modification of micro organisms to develop bacterial strains to be used for vitamine production. |
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Years | Employer | Title | Department |
Years: 1991 to 1992 | Employer: Ludwig Maximilians University Munich | Title: Assistent Professor | Department: Plant Molecular Biology |
Responsibilities:Molecular research into the functioning of the Thylacoid membrane (Photosynthesis).Supporting and supervising Ph.D. students |
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Years | Employer | Title | Department |
Years: 1989 to 1991 | Employer: EMBL (European Molecular Biology Laboratory) | Title: Post Doctoral Fellow | Department: |
Responsibilities:Research into the field of protein expression in eukaryotic models for gene splicing. |
International Experience
Years | Country / Region | Summary |
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Years: 1994 to Present | Country / Region: USA | Summary: All activities in the field of drug development in which Expert has been involved over the last 16 years have been aimed at global registration of new drugs. As a rule all plans and activities are discussed with the FDA: All development programs include clinical studies in the US. |
Years: 1994 to Present | Country / Region: EU (Europe) | Summary: All activities in the field of drug development in which Expert has been involved over the last 16 years have been aimed at global registration of new drugs. As a rule all plans and activities are discussed with the EMEA: All development programs include clinical studies in the EU. |
Years: 1994 to Present | Country / Region: Japan | Summary: All activities in the field of drug development in which Expert has been involved over the last 16 years have been aimed at global registration of new drugs. As a rule all plans and activities are discussed with the MHW (japanese Health authority): Most development programs in which he was involved included clinical studies in Japan. |
Years: 2007 to Present | Country / Region: Australia | Summary: Expert is currently involved in the funding activities for Eustralis Pharmaceuticals, An Australian-European collaboration. The set up of Eustralis foresees research in Australia and Development in the EU / US. Expert is in the process of setting up this organisation. |
Career Accomplishments
Associations / Societies |
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Expert is a lecturer at the European Center of Pharmaceutical Medicine |
Publications and Patents Summary |
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Expert has 14 publications and 5 patents |
Additional Experience
Training / Seminars |
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Expert is a lecturer at the ECPM (European Center of Pharmaceutical Medicine) and has prepared lectures and workshops concerning drug development both for professional as well as non-professional audiences. Expert has been reponsible for the preparation of multiple presentations in both public and closed hearings with Health Authorities, in the US, EU and Japan in order to discuss or defend drug development plans. |
Vendor Selection |
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Over the last 5 years Expert has built up a development group from scratch in the biotech environment. And is currently starting up a new company under similar conditions meaning performing frug development using the "virtual company model". Consequently he has extensive experience in sourcing and locating vendor / suppliers for all areas required in drug development. |
Marketing Experience |
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Expert has extensive experience in pharmaceutical industry both from a large pharma perspective and as well as from the small biotech perspective. He has been involved in various corporate deals and has extensive experience in negotiations with venture capital funds. |
Other Relevant Experience |
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Expert has a broad experience in performing due diligence procedures on potential in-licensing candidates. He background in science development and marketing allows him to select a team of professionals and analyse any potential clinical development candidate within a short period of time, providing assessment reports highlighting strong and weak points of the compounds under review. |
Language Skills
Language | Proficiency |
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English | Expert's mothertongue is Dutch.He has excellent language skills in English. |
German | Expert has excellent language skills in German. |
Fields of Expertise
pharmaceutical product development, pharmaceutical industry, pharmaceutical drug, pharmaceutical research, pharmaceutical technology, drug development, development process, drug therapy, new drug, investigational drug, investigational drug procedures, new drug application, drug labeling requirement, drug regulation, drug product approval, drug validation, European drug registration, European standard, European statute, drug clinical trial, clinical trial, drug monitoring, adverse drug reaction, drug-drug interaction, pharmacodynamics, drug bioavailability, drug toxicology, DNA synthesis, antirheumatic agent, central nervous system agent, drug interaction, date rape drug, drug identification, pharmaceutical marketing, protein drug, active pharmaceutical ingredient, drug discovery, pre-approval inspection, antidepressant drug, antiarthritis drug, antisense drug, drug formulation, Current Good Manufacturing Practice, Food and Drug Administration validation, prodrug, drug metabolite, animal drug testing, pharmacoeconomics, drug processing, antitumor drug, controlled-release oral drug delivery, antiviral agent, acne product, drug resistance, drug stability, biological drug level, pharmaceutical analysis, drug analysis, validation, drug delivery, drug blood level determination, color additive, clinical pharmacology, process validation, pharmacology, pharmaceutical color additive, pharmaceutical chemistry, Food and Drug Administration new drug code, drug environmental effect, drug metabolism, biotechnology, anti-inflammatory drug