Kirk Trisler Email & Phone Number

Oakland, CA, US

San Mateo, California, US

Bespoke Biotherapeutics was created to overcome obstacles to the effective natural immune response and limitations of currently approved immunotherapies against cancer by inventing novel, customized (i.e., bespoke) "living drugs" called engineered B-cell therapeutics.Bespoke is reprogramming human, peripheral blood-derived B-cells into intuitive "living.

Boston, MA, US

• CMC Consultant for human tissue derived and differentiated cone cells for cell implantation into eyes to treat cone cell dystrophy. Therapeutic approach should enable expansion into AMD treatment. Technology and IP are.
• Direct process and analytical development and device engineering to enable cGMP production of cells
• Manage technology transfer and manufacturing operations of CDMOs for cell line development, banking and cGMP production
• Integrate analytical development and quality control assays to support critical process parameters as well as GMP critical quality attributes to support clinical drug product manufacturing and pre-clinical.
• Assist with cryopreservation and formulation development of resultant cGMP cellular drug product

Palo Alto, CA, US

• CMC Consultant CIRM Disease Team and CLIN1 Grants, Neurosurgery – Stanford University, Oversee CMC strategy and operations for CIRM Disease Team and follow-on CLIN1 Grant awarded to Dr. Gary Steinberg, Chairman.
• Granted FDA IND clearance in July 2020 with 9 team members
• Manage manufacturing operations of CMO and Stanford pilot production resulting in IND enabling GLP Tox and cGMP material generation
• Assist in analytical development and quality control assays to allow release of cGMP drug product
• Collaborate / coordinate with other consultants: Analytical, Regulatory, Toxicology to facilitate successful GLP toxicology studies and IND submission
• Author documents and CMC SME for FDA Type A&B meeting packages, IND submission, CIRM CDAP annual meetings to support regulatory and funding efforts

• Radimmune Therapeutics is a private, Albert Einstein College of Medicine spin-out that fuses advanced technologies from nuclear physics and antibody conjugation chemistry to discover, develop, and manufacture.
• Manage manufacturing operations of CDMOs for cell line development, process development and cGMP production
• Integrate analytical development and quality control assays to support critical process parameters as well as GMP critical quality attributes
• Manage international radioisotope supply chain to support process development and robust clinical site availability
• Provide technical expertise on pipeline and portfolio expansion candidates

• Gritstone Oncology is a cancer immunotherapy company developing next-generation personalized cancer therapeutics. Responsible for design, construction, budget ($25M/yr), staffing and operations of new 43,000 sq ft.
• Obtained BOD approval to build out in-house bio-manufacturing facility from cost modeled CMO versus in-house cGMP manufacturing scenarios
• Assembled teams to support analytical development, process development & engineering, cGMP manufacturing and facilities engineering (26 FTE hires in 2017)
• Managed CMOs for plasmid, RNA and lipid nanoparticle production
• Represented CMC at FDA Type C and Pre-IND meetings
• Inception to IND clearance in 28 months

Walnut Creek, California, US

• Dark Horse Consulting, Inc. is consulting firm focused on the therapeutic field of cell and gene therapy. DHC specializes in process and analytical development, cGMP manufacturing from IND through approval and.
• EGFR Vaccine for GBM
• Allogeneic CAR-T for NHL
• ESC-based Retinal Progenitor Cells for RP
• MSC-based Neuronal Cells for Stroke
• Leukapheresis facility cGMP design

• Asterias is the newly funded re-initiation of Geron’s regenerative medicine program that re-submitted and re-cleared the Geron human Embryonic Stem Cell derived spinal cord injury IND. As a senior management member I.
• Selected external vendors and CMOs and negotiated and secured effective agreements
• Lead development and technology transfer of vaccine candidate to international cancer charity organization for Phase I study
• CMC representative for new 4500 sq ft GMP clean room facility build out
• Development lead on scale-up/out, formulation development, container closure, site dose preparation, comparability
• Lead successful cGMP relocation of $12M of Drug Product and biologics supporting asset transfer deal closure

South San Francisco, California, US

CMO site manager for novel diffusion micro-device for AMD. Responsible for device production design verification, validation and production of implantable ocular micro-device.

• Geron was the world's first company to gain clearance of IND using human embryonic stem cell derived cell therapy. Directed and managed five separate functional groups (pilot plant, core facility, device engineering.
• Managed Pilot Plant production to generate hESC derived DP for in vivo evaluation and analytical development
• Managed Core facility to standardize cells and raw materials for research and development programs
• Led successful technology transfer programs of cell therapy and vaccine candidates to CMOs (Lonza, GE Healthcare)
• Directed process engineering group including (on-site) clinical dose preparation, formulation, process optimization and formal tracking and trending efforts
• Directed device engineering group that developed devices for clinical cell therapy administrations (510(k) compliant), custom manufacturing, cryopreservation and fill and finish

• Genitope’s lead candidate was a personalized anti-Idiotype based NHL vaccine that advanced into pivotal phase III trial. Lead all contract manufacturing and antibody business development efforts of Genitope..
• Contracted and managed Wuxi/Apptec CMO program for pipeline antibody manufacturing for toxicological and clinical materials (targeting 20 different compounds total)
• Contracted and managed CMO for GMP fill and finish of candidate drug product as well as the critical intermediate APIs
• Identified, evaluated and licensed cell line expression technology for use in pipeline antibody manufacturing, increasing candidate lines product expression ten-fold
• Contracted and managed major chemical firm to develop and manufacture hemocyanin under cGMP, a key intermediate API in Genitope’s phase III personalized cancer vaccine candidate

Post-Doc, Radiation Oncology And Nuclear Medicine

Ph D, Immunology