Expert Details

Expert in Recombinant Protein Expression/Production, Molecular Biology

Expert ID: 727040 California, USA

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Through an 18 year career at California Biotechnology, Scios Inc., and Johnson & Johnson, Expert has gained extensive experience in the molecular biology of recombinant protein production especially in microbial systems such as E. coli (inclusion body and soluble), Pichia pastoris, and S. cerevisiae. During his leadership of the protein expression group at Scios (a JNJ Company) he was responsible for IND-enabling development of expression systems for clinical testing of biologics, as well as production of proteins for use as small molecule drug screening targets. In the latter role, Expert pursued many eukaryotic and mammalian expression systems as well including insect cells using the baculovirus expression system and CHO (mammalian) cell systems based on stable expression from CMV or GS promoters, or using Epstein Barr virus vectors for rapid semi-stable transient protein expression. He has also led cross-functional drug development projects from pre-clinical research though IND-filing and has an active consulting practice in this area.

Expert’s broader drug development interests have been in the area of wound healing and angiogenesis through his work on VEGF or vascular endothelial growth factor (1 paper, 2 patents/applications), cardiac peptide hormones such as the natriuretic peptides (1 patent application, 2 papers), and growth factors such as Heparin-binding EGF-like Growth Factor or HB-EGF (1 paper).

Expert holds a Ph.D. in Molecular Biology from Purdue University, West Lafayette, IN and a B.S. in Chemistry with honors from the University of Georgia. He was a postdoctoral fellow at SUNY, Stony Brook (now Stony Brook University) and a Research Assistant Professor at the University of Medicine and Dentistry of New Jersey in Piscataway.

Working as a consultant, ExpertPollitt took an important management position with a promising biotech company, leading its Process Sciences team to develop manufacturing processes for an oral biologic (see http://www.trinitybiosystems.com/about/management.html). A small and growing developer of small molecule anticoagulant drugs turned to Expert to help them take advantage of a discovery that offered an opportunity to develop a biologic. Expert helped the company, which did not have internal molecular biology or protein expression expertise, to explore recombinant protein expression options and develop an E. coli expression system.A start up biotech had in-licensed its first product, a biologic expressed in E. coli, from a well known university. The expression system had several deficiencies and the company lacked the needed molecular biology or protein expression expertise to correct them. Expert designed and had a third-party vendor synthesize an expression system which was better suited to industrial manufacturing than the system obtained from the academic laboratory. In addition, Expert assisted with interpretation of genetic characterization of the host organism required by FDA.A small biotech had just gone public and received an infusion of a large amount of capital. Eager to make rapid progress, the company started numerous drug development projects but couldn’t recruit the needed drug development leadership quickly enough to keep each of its project teams on track. One of the teams in particular, was struggling with a difficult preclinical development path. Expert was brought in to take over the leadership of the preclinical team and coordinate preclinical model development and toxicology studies.A small biotech company developing several antibody therapeutics was challenged with the need to manage numerous early drug development project teams. Expert was brought in to help each of the teams coordinate efforts of various functional groups involved and institute appropriate project management practices.

Expert may consult nationally and internationally, and is also local to the following cities: San Jose, California - San Francisco, California - Sacramento, California - Oakland, California - Stockton, California - Fremont, California - Modesto, California - Salinas, California - Santa Rosa, California - Hayward, California

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Education

Year Degree Subject Institution
Year: 1989 Degree: PhD Subject: Biochemistry & Molecular Biology Institution: Purdue University
Year: 1978 Degree: BS Subject: Chemistry Institution: University of Georgia

Work History

Years Employer Title Department Responsibilities
Years: 2007 to Present Employer: Undisclosed Title: President Department: Responsibilities: Consultant supporting early drug development projects by providing project management, team building and strategic planning. Specialized in projects transitioning into the clinic and early clinical development through Phase 2.
Advisor to CMC teams on development of host-vector systems to support manufacturing of recombinant biologics.
Years: 2003 to 2007 Employer: Scios Inc., Division of Johnson & Johnson Title: Director, Protein Chemistry and Drug Development Team Leader Department: Research & Development Responsibilities: Acted in dual role as Director of Protein Chemistry and Compound Development Team Leader for VEGF121. As VEGF121 Team Leader, had overall responsibility for compound development through IND filing. As Director of Protein Chemistry, extended reach of department to include all biophysical studies of drug-target interaction including traditional enzymological characterization, crystallographic analysis of inhibitor-target co-crystals, isothermal calorimetry, and surface plasmon resonance studies of small molecule binding affinity.
Years: 1994 to 2003 Employer: Scios Inc. Title: Staff Scientist, Protein Expression Group Department: Research Responsibilities: Assisted with CMC section of Natrecor? NDA submission, authoring host cell and vector molecular biology sections. Served as Project Leader for preclinical drug development projects targeting modulation of protein kinases. As part of a team, evaluated new drug targets based on scientific rationale, clinical and regulatory feasibility, market size and portfolio considerations. Assumed responsibility for protein chemistry as well as expression molecular biology within the Cardiorenal program. Staff includes a Ph.D. and two research associates in the expression group and a Ph.D. and three research associates in the protein chemistry group.
Years: 1989 to 1990 Employer: California Biotechnology Title: Scientist Department: Research Responsibilities: Founded a lab that was dedicated to the development of protein expression hosts and vectors to support manufacturing of clinical products. Staff included ExpertPollitt and two research associates. Developed a set of standardized expression vectors for E. coli in which the various functions were contained on modules (ie., promoter, replication origin, antibiotic resistance) so that molecular biology could respond rapidly to events during fermentation testing. Worked closely with fermentation department to ensure host strain would be amenable to high-density fermentation and scale-up.
Years: 1987 to 1989 Employer: Robert Wood Johnson Medical School, University of Medicine and Dentistry of New Jersey Title: Research Assistant Professor Department: Department of Biochemistry Responsibilities: Research involved structure-function of the bacterial signal peptide. Demonstrated specificity between signal peptide structure and associated mature region. Identified and cloned the major cold shock protein in E. coli.
Years: 1983 to 1987 Employer: State University of New York at Stony Brook Title: Postdoctoral Fellow Department: Department of Biochemistry Responsibilities: Studies on bacterial signal peptide structure-function using in vitro mutagenesis.

Career Accomplishments

Awards / Recognition
He received a National Research Service Award as well as a Small Business Innovation Research (SBIR) grant from the NIH.
Publications and Patents Summary
He is named as an inventor on 7 US patents and applications in the area of protein expression, protein modification, and methods for protein production. He is an author of 15 publications in the fields of cardiac hormones, growth factors and protein secretion.

Additional Experience

Vendor Selection
Collaborates with preselected vendors of molecular biology services to supply clients an expression-ready vector or, if needed, an intact host strain for evaluation of protein expression.
Marketing Experience
• Scientific assessment of drug development opportunity, including evaluation of drug target, disease indication, pharmacology and toxicology data
• Scientific due diligence and evaluation of potential in-licensing or investment opportunities
Other Relevant Experience
• Assistance with preparation of host-vector section of IND filing for FDA
• Work with patent counsel to identify and capture valuable intellectual property arising during the development process.
• Project management of early drug development projects

Fields of Expertise

applied molecular biology, biochemistry, biologic (product), biological transcription, DNA manipulation, DNA synthesis, peptide synthesis, protein post-translational modification, protein synthesis, revascularization, translation, molecular biology translation, angiogenesis, recombinant protein expression, skeletal biology, applied biochemistry, biological buffer, DNA fingerprinting, bioanalytical chemistry, lysogeny, transfer ribonucleic acid, biocatalysis, vasodilation, animal research, biological oxidation, active transport, cell death, ribosome, cell transformation, bacterial inhibition, angstrom, Northern blotting, Southern blotting, mitosis, vascular biology, protein biology, antigen synthesis, molecular medicine, molecular oncology, molecular cardiology, molecular biochemistry, biological cell development, eukaryote, eukaryotic molecular biology, developmental biology, biological cell differentiation, biological safety, bioavailability, biological drug level, genetic sequencing, gene expression regulation, cellular regulation, guanosine triphosphate, molecular genetics, cell membrane transport, fermentation, cytokine, DNA structure, cell (biology), protein engineering, nucleotide, biological process, polymerase chain reaction, gene amplification, RNA, amino acid, wound healing, respiration, protein sequencing, plant molecular biology, mutagenesis, animal molecular biology, molecular biology, microbiology, heredity, genetics, genetic manipulation, genetic engineering, gene expression, fungus, cloning technique, blood coagulation, biology, bacillus, antigen-antibody interaction, antigen, antibody production

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