Expert Consulting and Expert Witness Services

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 Expert  728090

Expert in Pharmaceutical Development, strategy planning and execution


Available for your Consulting and Expert Witness Needs

Switzerland
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise:

Listed with other top experts in: 

Expert graduated in Biology at the University of Utrecht, The Netherlands, in 1984. From 1985-89 he was a PhD student at the University of Basel. The research in the field of gene regulation was carried out at the Friedrich Miescher Institute (FMI; Ciba-Geigy) in Basel with an FMI-fellowship. From 1989-91 he worked, with an EMBL-fellowship, as a Postdoctoral fellow at the European Molecular Biology Lab (EMBL) in Heidelberg, Germany in the field of gene expression. From 1991-92 he was Scientific assistant at the University of Munich, Germany in Protein Molecular Biology. In 1992 he started working at Hoffmann-La Roche, Basel, as a Scientist in Biotechnology. In 1994 he became a Global Project Leader in the Drug Development Department and in 1998 Lifecycle Leader in the Primary Care Business Department of Roche Strategic Marketing. In 2004 he moved to Santhera Pharmaceuticals as head of Development and built up a pharmaceutical development group starting from scratch. With this development organisation Santhera achieved its first regulatory license, from project start to approval, in four years. In 2009 Expert became CEO of Eustralis Pharmaceuticals and in parallel founded a consulting agency, Expert's Firm. In his long career in pharmaceutical industry Expert has been involved in all aspects of pharma research, ranging from technical development, preclinical development and clinical development to registration and marketing. During his career he was personally involved in the design of multiple technical, preclinical and clinical development programs. He was in charge of setting up and running multiple clinical trials and and was responsible for various IND and NDA filings in the US, Europe and Japan. Also, as head of a marketing team, he has been involved in launch preparations and drug marketing. Using his background in science, combined with his experience in Development and Marketing Expert has successfully managed multiple Due Diligence procedures for the assessment of potential in-licensing candidates. Expert has experience both in large pharmaceutical as well as in small biotech companies. During his time in large pharma industry, when he additionally gained significant experience in developing drugs for the Japanese market, he was involved in therapeutic areas such as Parkinsons disease, RA, Depression and Anxiety and Congestive Heart Failure. In small biotech he worked in the field of Orphan diseases such as Friedreich's Ataxia, Duchenne Muscular Dystrophy and Leber's Hereditary Optic Neuropathy. He is currently involved in the field of Traumatic Brain Injury (TBI). Overall, most of his pharmaceutical expertise is in the field of Neurology and related areas.
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pharmaceutical product development

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pharmaceutical industry

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pharmaceutical drug

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pharmaceutical research

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pharmaceutical technology

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drug development

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development process

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drug therapy

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new drug

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investigational drug

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investigational drug procedures

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new drug application

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drug labeling requirement

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drug regulation

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drug product approval

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drug validation

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European drug registration

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European standard

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European statute

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drug clinical trial

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clinical trial

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drug monitoring

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adverse drug reaction

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drug-drug interaction

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pharmacodynamics

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drug bioavailability

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drug toxicology

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DNA synthesis


Show Secondary and Basic Areas of Expertise

Education:
Year   Degree   Subject   Institution  
1989   Ph.D.   Molecular Biology / Gene Regulation   University of Basel / Switzerland  
  Masters   Biology   University of Utrecht/ The Netherlands  

Work History:
Years   Employer   Department   Title   Responsibilities

2009 to

 

(Undisclosed Consulting Company)

 


 

President

 

Expert provides consulting services for strategic planning and execution of pharmaceutical drug development.

2004 to 2009

 

Santhera Pharmaceuticals

 

Development

 

Vice President

 

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.

1999 to 2004

 

Hoffmann-La Roche

 

Business

 

Lifecycle Leader

 

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.

1994 to 1999

 

Hoffmann-La Roche

 

Development

 

Project Leader

 

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.

1992 to 1994

 

Hoffmann-La Roche

 

Vitamine Division

 

Scientist

 

Molecular Biology /Genetic modification of micro organisms to develop bacterial strains to be used for vitamine production.

1991 to 1992

 

Ludwig Maximilians University Munich

 

Plant Molecular Biology

 

Assistent Professor

 

Molecular research into the functioning of the Thylacoid membrane (Photosynthesis). Supporting and supervising Ph.D. students

1989 to 1991

 

EMBL (European Molecular Biology Laboratory)

 


 

Post Doctoral Fellow

 

Research into the field of protein expression in eukaryotic models for gene splicing.


Career Accomplishments:
Associations/Societies

Expert is a lecturer at the European Center of Pharmaceutical Medicine


Publications:
Publications and Patents Summary

Expert has 14 publications and 5 patents


Consulting Services:
Selected Consulting Examples:
  • Due Dilligence assessment on a potential In-licensing compound for the biotech company: CardioLynx, based in Basel SwitzerlandIn 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.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Recent Litigation Client Requests:
  • Expert for consulting on breach of contract case
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

International Experience:
Years   Country / Region   Summary
1994 to   USA   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.
1994 to   EU (Europe)   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.
1994 to   Japan   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.
2007 to   Australia   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.

Language Skills:
Foreign Language   Description
English   Expert's mothertongue is Dutch.

He has excellent language skills in English.

German   Expert has excellent language skills in German.

Market Research:
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.

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:
Training/Seminars

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.

Supplier and Vendor Location and Selection

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.

Other Skills and Services

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.


 

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