Erik Foehr, Ph.D.—Dr. Foehr is an expert in the areas of bioanalysis, immunogenicity risk assessment and drug development. He directs assay development, validation and testing in a GXP-compliant environment to support drug product characterization, as well as non-clinical and clinical studies. Dr. Foehrs experience directing labs at Bay Bioanalytical Laboratory and BioMarin Pharmaceuticals has given him a
Erik Foehr, Ph.D.—Dr. Foehr is an expert in the areas of bioanalysis, immunogenicity risk assessment and drug development. He directs assay development, validation and testing in a GXP-compliant environment to support drug product characterization, as well as non-clinical and clinical studies. Dr. Foehrs experience directing labs at Bay Bioanalytical Laboratory and BioMarin Pharmaceuticals has given him a unique perspective on the importance of bioanalysis on the biophamaceutical and medical device industry. Dr. Foehr was a Senior Scientist at the cancer diagnostic start-up, Diamics, and Program Leader/Senior Scientist at AGY Therapeutics, a proteomics company with a neuroscience focus. Erik Foehr received his Doctorate at the University of California, Irvine in the lab of Dr. Ralph Bradshaw. He was a Fellow at the J. David Gladstone Institutes department of Immunology and Virology. He has published in the areas of bioanalysis, immunology, cancer, and neuroscience.
Bioanalytical research and development (GLP, GMP, CLIA)
Analytical Characterization (purity, identity, concentration, stability)
Medical Device chemical characterization (extractables, leachables, heavy metals)
Regulatory filings (IND, NDA)
Pharmacology and Toxicology
Vice President @ Vice President of Analytical Services. Lead expert team of analytical and bioanalytical scientists and oversee research, development and validation of GMP and GLP methods. Responsible for department business development, budget, operations and compliance. Ensure high quality, timely, and compliant deliverables. Identify business growth opportunities in the areas of pharmaceutical, biotechnology, medical device, and nutraceutical company endeavors. Expert in the areas drug development, analytical sciences, and GMP/GLP regulatory compliance. From November 2013 to Present (2 years) Hercules, CaliforniaSenior Partner @ SP deploys teams of top quality, deeply experienced experts to provide
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For over 35 years, we have perfected our ability to initiate and develop creative
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insightful and take pride in every solution we craft. From April 2014 to Present (1 year 7 months) Washington D.C. Metro AreaConsultant @ Biotechnology Consulting with expertise in Bioanalysis, Immunogenicity Assessment, Biomarkers, Diagnostics, Medical Device Characterization, Regulatory Compliance and Scientific Communications.
-GLP bioanalytical and immunogenicity
-CLIA in vitro diagnostics, lab developed tests
-ISO characterization of medical devices From September 2011 to Present (4 years 2 months) San Francisco Bay AreaBiotechnology Expert @ Contribute to the design and implementation of non-clinical and clinical studies
Prepare regulatory filings of IND and CTA modules and directly interact with FDA and other agencies
-Evaluate drug candidates for progression through different phases of development
-Developed diagnostic devices that resulted in 510(k) approvals
-Evaluate diagnostic device technical feasibility, and intellectual property protection From August 2011 to Present (4 years 3 months) Senior Director @ Direct bioanalytical laboratory, including research, development and validation of GMP and GLP methods. Ensure regulatory compliance, and operational efficiency. Identify and develop business opportunities and client relationships. Support pharmaceutical, biotechnology, medical device, and nutraceutical company endeavors. From December 2011 to November 2013 (2 years) Hercules, CaliforniaDirector @ Director of laboratory with oversight of non-clinical and clinical bioanalytical assay development, validation and testing
Establish best practices for implementing PK, immunogenicity, and bioamarker assays
Operate GLP compliant environment for sample testing and reporting
Contribute to bioanalysis sections of multiple IND/CTA filings
Negotiation and implementation of Post marketing commitments relating to bioanalysis of small molecule and biotherapeutic drugs
Identify, evaluate, and implement new technologies
Coordinate contractual and technical aspects of external relations From 2007 to 2011 (4 years) Associate Director @ Associate Director of Bioanalytical Research and Development Group. Established and expanded group of bioanalytical scientists and research associates tasked with development, validation and troubleshooting methods to support non-clinical and clinical studies. Addressed FDA required improvements to immunogenicity, PK and biomarker assays as part of post marketing commitments for Naglazyme. Supervised CLIA scientist and validated clinical biomarker (GAG assay for MPS disorders). Conducted PK assay validation and clinical implementation for tetrahydrobiopterin,supporting Kuvan drug approval. From 2005 to 2007 (2 years) Novato, CASenior Scientist @ Senior scientist and lab manager responsible for identification of cervical cancer diagnostic markers. Provided clinical operations support and facilitated 510(k) application. Coordinated the construction of a custom built laboratory including clean room, cell culture facility, and microscopy suite. From 2004 to 2005 (1 year) Senior Scientist @ Scientific and project lead to discover cancer targets for glioblastoma indication using genomics and proteomics platforms. Validated molecular targets using a variety of techniques, including siRNA, immunohistochemistry, cell based assays and mouse xenograph models. Developed functional monoclonal antibodies to cellular targets. Successfully licensed program to biotechnology company. From 2001 to 2004 (3 years) Scientist @ From 2000 to 2001 (1 year) Post-Doctoral Fellow @ Researched cellular signaling pathways with an emphasis on inflammation, cell proliferation, and neuroscience.
Genomic and proteomic discovery of signal transduction pathways
Developed assays to study cellular mechanisms
Establish and characterize animal disease models and transgenic lines for discovery and development purposes From 1998 to 2000 (2 years)
Doctor of Philosophy (Ph.D.), Immunology @ Post Doctoral Fellow at J. David Gladstone Institute From 1998 to 2000 Ph.D., Biochemistry @ University of California, Irvine From 1994 to 1998 Masters, Molecular Genetics @ Arizona State University From 1992 to 1994 Bachelor of Applied Science (B.A.Sc.), Molecular Biology @ University of California, Davis From 1987 to 1992 Erik Foehr is skilled in: CLIA, NDA, GMP, Program Management, Biotechnology, Validation, IND, Drug Development, Regulatory Submissions, 21 CFR Part 11, Lifesciences, Pharmaceutical Industry, FDA, Immunology, Assay Development, Cell Culture, Pharmacology, Cancer, Biomarkers, Toxicology, Life Sciences, GLP
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