University of California, Berkeley

Penn State University

R&D Professional and Innovator

Independent Consultant

Consultant

Nanomechanical Gene Delivery

https://basilardbiotech.com/

Basilard BioTech, Inc.

Chief Scientific Officer

Rapid, Personalized T cell Therapies for Cancer

BlueSphere Bio

Vice President - Product Development

Established and directed F1 Oncology R&D operations in San Diego and Shanghai PRC.

Responsible for strategy and overall management of domestic and international R&D pipelines (discovery, preclinical, translational, clinical candidate development, etc.). 

Lead the development of systems and expertise in cellular engineering, modular genetic library design and HT screening, NGS analysis, bioinformatics analysis, high content screening, preclinical research and SOP development, hit to lead activities, clinical candidate nomination and development, and IRB / IND package development.

Worked closely with BD and executive team in developing business direction and evaluating clinical targets and indications, technologies, potential partnerships and collaborations.

Worked closely with legal team in developing and filing IP and determining FTO.

Represented company in presentations to domestic and international audiences.


Developed a novel closed system for cell product manufacturing with tech transfer to clinical GMP manufacturing facility.

Delivered two clinical CAR-T candidates currently in clinical trial for Stage IV metastatic renal cancer (NCT03393936). 

Developed components and systems for a novel autologous point of care CAR-T therapy with demonstration of initial proof of concept.

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Methods and compositions for transducing lymphocytes and regulated expansion thereof
WO2017165245, International Application # PCT/US2017/023112
Frost, Gregory I; Onuffer, James J; Guibinga, Ghiabe H; Kundu, Anirban

Chimeric antigen receptors against axl or ror2 and methods of use thereof
WO2018136570, International Application # PCT/US2018/014122
Frost, Gregory I; Onuffer, James J

Methods of transducing and expanding immune cells and uses thereof
WO2018136566, International Application # PCT/US2018/ 014116
Frost, Gregory I; Onuffer, James J

F1 Oncology

Vice President - Research and Development

Skills: Drug Development · Research and Development (R&D)

Organized and supervised operations of The Cell Propulsion Laboratory (CPL) which was an NIH funded  Nanomedicine Development Center at UCSF/UCB. This encompassed center planning and strategy, organizing center meetings and presentations, budget planning and administration, progress report and grant renewal preparation and submission, public relations (press releases, outreach).

Spearheaded the incorporation, development, and application of basic research findings into translational systems, provided educational and experimental support and instrumentation for trainees in the various CPL associated laboratories, and established and supported preclinical/clinical collaborations

Supervised and mentored graduate students, post-doctoral students, interns, and support staff.

University of California, San Francisco

Associate Director - Center for Synthetic Signaling and Motility Systems Engineering; CPL

Established and supervised a translational medicine lab applying synthetic biology to mammalian cell engineering and adoptive immunotherapy of cancer. 

Built systems and provided expertise in engineering pharmacologically controlled chimeric antigen receptors (CARs) for adoptive immunotherapy of cancer, multiple antigen input receptor systems, and receptor systems that can sense and shape local tissue environments.

Applied background and expertise to establish a discovery / translational platform for the engineering of synthetic cell signaling components and therapeutic responses in engineered cells. The cell types of interest included immune cells, but also stem/progenitor cells with potential applications in adoptive immunotherapy (cancer, autoimmunity, GVHD, chronic infections) and regenerative medicine. Synthetic biology techniques were used to engineer cell biological systems for therapeutic purposes with regard to novel directed responses and safety control systems.

IP developed by group licensed to Cell Design Labs > Kite > Gilead.

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Chimeric Antigen Receptor and Methods of Use Thereof
WO2014127261, International Application # PCT/US2014/016527
Wu, Chia-Yung; Onuffer, James; Lim, Wendell A


http://www.sciencemag.org/content/early/2015/09/23/science.aab4077

Laboratory Head - Pathway to Medicine Translational Laboratory; CPL

Upon returning to academia and the academic research setting, I saw an opportunity to apply some facets of the management style and leadership training that I had developed in the corporate world to the academic setting, and to mentor students to develop a balanced combination of innovation, focus, leadership, and responsibility. I participated as an educator, advisor, and mentor in the UCSF iGEM program and also for graduate student and postdocs that worked in my lab and in collaborating laboratories. I also worked with the City College of San Francisco’s Bridge to Biotech certificate program. I am very appreciative of the UCSF 2012 Great People Award that acknowledged my efforts in contributing to the development of tomorrow's scientists.

Academic Administrator VII - Dept. of Cellular and Molecular Pharmacology, School of Medicine, UCSF

PRINCIPAL INVESTIGATOR, IN VITRO ORGANOTYPIC MODELS OF CNS REGENERATION 

	Awarded  2-year competitive global research grant (Schering AG funded).


GLOBAL RESEARCH COMMITTEE SPEAKER, SCIENTIFIC ADVISORY COMMITTEE MEMBER

	Assembled and supervised committees to review internal drug discovery/development programs in preparation for corporate milestone decisions.


RESEARCH REPRESENTATIVE, GLOBAL DEVELOPMENT TEAM, CATHEPSIN S INHIBITOR. 

	Performed research evaluation for Corporate Business Development and served as member of due diligence team during in-licensing.

  	Developed and established internal research program and development strategy within the international project team.


PROJECT LEADER, CCR5 ANTAGONIST 


CORE PROJECT TEAM MEMBER, CCR1 ANTAGONIST LEAD AND BACK-UP PROGRAM


CORE PROJECT TEAM MEMBER, PDE4 INHIBITOR


PRECONCEPT RESEARCH AND NEW TARGET EVALUATION

	Evaluated / nominated potential targets for immunology, neurology, cardiovascular.




Patents Issued or Pending:

WO2002046424 Bringmann, Peter W; Faulds, Daryl; Mitrovic, Branislava; Onuffer, James; Srinivasan,
Subha. 
Fibroblast Growth Factors.

WO2004002960 Dunning, Laura; Jaroch, Stefan; Kochanny, Monica J; Lee, Wheeseong; Lian,
Xiongdong; Liang, Meina; Lu, Shou-Fu; Onuffer, James; Phillips, Gary; Wei, Guo-Ping; Ye, Bin.
Substituted Quinoline CCR5 Receptor Antagonists.

Berlex Biosciences

Senior Scientist - Immunology

Project leader for tachykinin receptor antagonist program.

    Developed systems and screening assays to identify novel drug leads for G-protein coupled receptors (GPCR's).

Parnassus Pharmaceuticals

Scientist - Molecular Biology

DNA SYNTHESIS FACILITY MANAGER, Dept. of Molecular and Cell Biology, U.C. Berkeley 

	 Managed DNA and RNA oligomer synthesis facility for campus researchers 

	Developed methods to incorporate custom synthetic nucleotide bases into oligonucleotides 

	Advised campus researchers in the design and use of oligonucleotides

Manager - MCB DNA Synthesis Facility

GRADUATE RESEARCH ASSISTANT for Professor Jack F. Kirsch, Dept. of Molecular and Cell Biology, U.C. Berkeley 

Performed structural/functional studies of active site mutants of aminotransferase enzymes

Established structure activity relationships (SAR) for Escherichia coli aspartate amino-transferase (eAAT) and tyrosine aminotransferase (eTAT) enzymes using natural and chemically synthesized unnatural aminoacid substrates

Used a combination of molecular modeling and site-directed mutagenesis to rationally redesign the substrate specificity of eAAT to that of eTAT with subsequent tertiary structure determination by X-ray crystallography

Graduate Research Assistant

LABORATORY MANAGER / RESEARCH ASSISTANT  for Professor C. Robert  Matthews, Dept. of Chemistry, Pennsylvania State University

	Performed independent research using site-directed mutagenesis to probe the folding mechanisms of dihydrofolate reductase and the a-subunit of tryptophan synthase

	Managed day to day laboratory operations

FERMENTATION FACILITY MANAGER, Dept. of Chemistry, Pennsylvania State University
	
    Assisted in the design and establishment of a microbial fermentation facility for department researchers

James Onuffer