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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.

2007 to

(Undisclosed Consulting Company)

President

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.

2003 to 2007

Scios Inc., Division of Johnson & Johnson

Research & Development

Director, Protein Chemistry and Drug Development Team Leader

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.

1994 to 2003

Scios Inc.

Research

Staff Scientist, Protein Expression Group

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.

1989 to 1990

California Biotechnology

Research

Scientist

Founded a lab that was dedicated to the development of protein expression hosts and vectors to support manufacturing of clinical products. Staff included Expert 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.

1987 to 1989

Robert Wood Johnson Medical School, University of Medicine and Dentistry of New Jersey

Department of Biochemistry

Research Assistant Professor

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.

1983 to 1987

State University of New York at Stony Brook

Department of Biochemistry

Postdoctoral Fellow

Studies on bacterial signal peptide structure-function using in vitro mutagenesis.

• Working as a consultant, Expert 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 in Search for an /Organisation in Mammalian Cell Expression of Human Proteins.