Tim Mitchell Email & Phone Number

Aktis Oncology is working at the forefront of a transformation in radiopharmaceutical therapies, developing first-in-class alpha-emitting agents that safely and efficiently target and destroy cancer cells while minimizing harm to healthy cells.In advanced stage solid tumor cancers with distant metastases, Aktis radiopharmaceutical technology will be used to destroy cancerous cells wherever they reside in the body. In cancers where disease is detected early, Aktis aims to eradicate any cancer cells remaining after surgery to improve cancer cures.With superior cancer-killing potency, Aktis Oncology’s radiopharmaceuticals offer a new precision approach with the ability to overcome the challenges of conventional cancer treatments including chemotherapy and new generations of antibody drug conjugates. Our therapies are engineered with specific properties to not only confer breakthrough efficacy, but also to enhance safety. We believe our approach can provide a powerful new treatment option for all stages of solid cancers.

Winston-Salem, North Carolina, Us

ProKidney, LLC is a late stage clinical cellular therapy company. Our technology has demonstrated effective restoration of kidney function by using the patient’s own (autologous) kidney cells. By contrast, organ transplantation from other donors (allogenic transplants) can be associated with organ rejection and failure. Further, the patient lives with the adverse effects of immunosuppression.ProKidney’s patented technology uses multiple breakthroughs in the manufacturing automation, supply chain and medical delivery of cellular therapy products. While it has long been held that the body contains cells with regenerative power, ProKidney’s technology is able to identify these cells and harness them to restore function lost from chronic diseases.ProKidney’s kidney restoration process begins when a small biopsy of the disease kidney is sent to ProKidney. ProKidney is able to identify the patient’s own healthy progenitor cells, and formulate them into a personalized product that can be re-injected into the damaged kidney for repair and restoration of function. When the manufactured Renal Autologous Cell Therapy (REACT) is injected into the diseased kidney, it integrates into the damaged tissues and restores function by controlling inflammation, fibrosis and angiogenesis to form new functioning tissues and ultimately, a more healthy kidney.

Exton, Pennsylvania, Us

Castle Creek Biosciences, Inc., a privately-held, clinical-stage cell and gene therapy company, is focused on developing and commercializing innovative personalized therapies for patients living with underserved disorders with high unmet medical needs. Our approach to personalized biologics is distinctive based on our proprietary, autologous fibroblast technology platform. By extracting fibroblast cells from a patient’s own skin, we create localized treatments that are compatible with the unique biology of each patient and have the potential to address the underlying cause of disease.

Rockville, Maryland, Us

ICT is building a comprehensive platform of CAR-T products for blood cancers and solid tumors, including an allogeneic CAR-T development program. CAR-T therapies of the future will combine stem cells, gene editing and gene therapy, and ICT is making breakthroughs to combine these technologies, including advances in leveraging hematopoietic stem cells. Chimeric Antigen Receptor T-cells (CAR-T) are created by coupling the antigen-binding site of a tumor-recognizing antibody and the intracellular signaling domain of a T-cell of a patient through gene transduction, so that the cell expresses CAR. After being recoded, the T-cells of the patient are able to generate a large quantity of tumor-specific CAR-T cells targeted to defined cancer cells.I serve as ICT's Global Head of Quality, Compliance & Manufacturing Technology Transfer. I am responsible for the strategic development of ICT’s various quality systems supporting Good Manufacturing Practice – Clinical Development (GMP), Good Clinical Practice (GCP), Good Manufacturing Practice – Commercial Production (GMP), Process Development and Transfer, and Risk Management. I also oversee the transfer and refinement of technology from our Shanghai, China site to North America manufacturing facilities. My scope of responsibility includes: Quality Assurance, Quality Control, Quality Systems, Document Control, Process Development and Establishment, Validation, and Computerized Systems IT. As a member of ICT's executive management team, I oversee all internal and external global third-party CMO quality, manufacturing and development, CRO quality, the development and establishment of ICT's computerized document management systems. In addition, my mission is to hire and develop the company's internal quality and manufacturing organizations to support current clinical trials, and future commercial manufacturing.

At Endocyte, I worked in support of the company's objective to deliver potent therapy to diseased cells, while minimizing the impact on healthy cells. Their proprietary approach is the first to combine small molecule drug conjugate (SMDC) technology with companion imaging agents to assist in therapy selection. More recently, Endocyte has expanded its targeting technology to include advancements in both radio-ligand therapies (RLT) as well as chimeric antigen T-cell therapies (CAR-T). Several of the company's targeted therapeutic and imaging agents are already in the late phase clinical development pipeline as well as in clinical trials for a wide range of cancers and other serious diseases.I served as Endocyte's Head of Corporate Quality responsible for Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) system creation and compliance in support of the company's on-going drug development and advanced clinical research programs.

Memphis, Tn, Us

I served as Cognate's Vice President of Quality and Regulatory in support of the company's new commercial scale cGMP development and manufacturing of genetically altered Cytotoxic T Lymphocytes (CTL's) for cellular therapeutic treatment of various forms of human cancer. Included within my functional areas of responsibility were Quality Assurance, Quality Control, Quality Systems, Validation, and Regulatory Affairs. I also served as a member of Cognate’s Executive Leadership Team reporting directly to the CEO of Cognate.

From the time I joined Celgene, my priorities were to work with the Phoenix site to lead the preparation for multiple major site pre-approval inspections for 2015 and 2016, and oversee operational commercial start-up of regular manufacturing at full site capacity. The first for 2015 being the European EMEA/MHRA, then the US FDA, finally the Japanese PMDA and other global regional regulatory agencies throughout 2016. The pre-approval inspections were in support of the site's commercial launch of Celgene's sterile oncology drug product (Abraxane®). During late 2016, I oversaw quality operations for the sterile commercial production operations of the site, and continued to support further global licensing of Abraxane® in ROW.

Lexington, Ky, Us

I worked in support of strategically transitioning the organization away from the University of Kentucky’s operational control into an independently run company. As a member of the Executive Management Team, a good portion of my time and efforts was involved with marketing and financial structuring and monitoring of the company. In order to fully capture accurate development and manufacturing costs, various accounting systems were necessary to put in place which I helped to establish. I was responsible for the management of several functional groups of the Coldstream Laboratories. Those departments were: Regulatory Affairs, Quality Assurance, Document Control, Quality Control (Analytical Chemistry and Microbiology), and Validation.

Us

Responsible for final facility design, validation, and operational start-up aspects of the overall new commercial Alpha1 Protease Inhibitor (API) product launch, as well as being responsible for the regulatory compliance posture associated with the new $85 million API manufacturing facility (112,000 sq. ft.). This included the development and maintenance of the various technical, operational, and quality systems necessary to provide the facility with full range of support (process design, validation, change control, investigations, exceptions/deviations, master document development, master document review/approval, etc.). Primary focus was to work closely with Manufacturing, Engineering, and R&D to assure project timelines and timely resolution of issues while maintaining a high degree of regulatory compliance and direct interface with FDA regarding the new product.

I managed the quality, validation, regulatory, and technical departments responsible for supporting licensed human antibody manufacturing operations for NABI at both the new Boca Raton manufacturing complex and various contract manufacturing organizations utilized by NABI. Included within these departments of responsibility were the following functions: Quality Assurance, Quality Control (Chemistry and Microbiology), Regulatory Licensing Development, Environmental Monitoring, Analytical Development, Process Development, Validation, and Document Control.

SyStemix, Inc. was engaged in the development of cellular and cell-based gene therapies for cancer, AIDS, and genetic diseases based on the use of isolated, expanded, and gene-modified hematopoietic stem cells.I managed all areas of domestic and European quality assurance and validation for the three SyStemix biological aseptic manufacturing facilities designated for the company’s Hematopoietic Stem Cell isolation and purification manufacturing operations, in support of their clinical development/supply programs. I was responsible for managing and coordinating the development of quality systems for the three sites, plus all validation activities in-house and with outside contractor and consulting firms. I also worked closely with engineering and architectural companies working to support the two new clinical manufacturing facilities that were constructed in Palo Alto, California and Lyon, France, as well as the existing early phase pilot plant facility in Palo Alto. I reported to the VP of Regulatory Affairs.

Indianapolis, Indiana, Us

Responsible for representing Biosynthetic Technical Services and Quality Assurance on the corporate steering committee associated with the validation planning and design of the new Research and Development Manufacturing Facility being constructed in Indianapolis, intended for the manufacture of recombinant derived protein pharmaceutical late-phase clinical trial material.

Indianapolis, Indiana, Us

Provided validation and process technical support to the Biosynthetic Manufacturing Division’s commercial manufacture of biosynthetic human insulin (Humulin). I oversaw and responded to the daily technical and quality issues associated with various operational steps of the Humulin process.

Indianapolis, Indiana, Us

Supported process development and scale-up of clinical manufacturing for the three (3) Biochemical Purification pilot plants within the Research and Development Division of Lilly Research Laboratories in Indianapolis.

Indianapolis, Indiana, Us

Carried out manufacturing activities associated with the commercial fermentation and purification production of Cephalosporins, Tylosin, and Penicillin. Prepared and screened inoculation cultures and performed in-process testing between operational steps of the manufacturing processes.

Master Of Science - (M.S.), Genetic Biology

Bachelor Of Science (B.S.), Biochemistry

Education record