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Directory of Consultants
Bay Area Biomedical Consultants Network (BABCN)
Name and Educational Degree(s) Karlin, David, MD
Business Name BioPharmDoc Consulting
Certifications ABIM
Education

Please see my Linkedin profile: http://www.linkedin.com/in/biopharmdoc

Business Address 100 Yerba Santa Ave.
Los Altos, CA 94022
Contact information
Telephone:
Email address:
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Specialties

Professional Experience in Biopharmaceutical Clinical Development and Regulatory Affairs Strategic Planning

* European, Asian (including Japanese) and North American drug development strategic planning from Phase I to NDA (or CTD).
* IND preparation.
* Phase I-IV clinical trial design, implementation, analysis, interpretation, and preparation of reports for regulatory authorities.
* NDA preparation.
* Negotiating with the FDA.
* European Community, Japanese, and American Good Clinical Research Practices.
* Diverse therapeutic areas: oncology, hematology, oral mucositis, gastroenterology, hepatology (hepatitis B and C), analgesic, anti-emetic, cystic fibrosis, male and female sexual health, gene therapy, DNA vaccine.
* Evaluation of compounds for licensing and the technology of candidate companies for merger or acquisition.
* Project team management.
* Management of virtual teams using outsourcing with contractors and contract research organizations.
* Preparation of drug development program budgets.
* Writing manuscripts on clinical and laboratory research; medical literature reviews and analysis; publication in peer-reviewed journals.
* Scientific presentation to the investment community.
* Evaluation of biopharmaceutical companies for venture capital firms.
* Intellectual property consulting for law firms.
* Product liability consulting for law firms.
* Medical expert testimony

Experience

Please see my Linkedin profile: http://www.linkedin.com/in/biopharmdoc

Consulting 2013:

* Anemia in patients with chronic renal failure on hemodialysis, myelodysplastic syndromes, brain cancer, cervical cancer; Phase 1, 2, and 3 studies; monoclonal antibodies and tyrosine kinase inhibitors.

Consulting 2012:

* Oral mucositis, brain cancer, prostate cancer, and anemia in patients with chronic renal failure on hemodialysis. 

Consulting 2011:

* Oral mucositis, prostate cancer, colon cancer, lung cancer, brain cancer, and IND and Orphan Drug annual reports. 

Consulting 2010:

* Ovarian cancer, breast cancer, colorectal cancer, lung cancer, and cystic fibrosis.

Consulting 2009:

* Glioblastoma multiforme, non-small cell lung cancer, small cell lung cancer, colorectal cancer study, and cystic fibrosis.

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