May 2019 – Dark Horse Consulting (DHC) is proud to announce the recent addition of three full time consultants to our team. Each of the new hires were carefully selected for their best-in-class capabilities and experience in the Cell and Gene Therapy field. These additions are expected to both strengthen DHC’s existing capabilities and to broaden technical offerings through new expertise in preclinical science and program management.
Rob Allen, Ph.D. (Principal) brings to DHC thirteen years of broad project leadership and program management experience in global biopharmaceutical development. Rob’s experience spans companies ranging in size and development stage from small and early to large global, publicly-listed companies. His experience includes overall development strategy and clinical operations including trial design and execution. Prior to DHC, Rob led teams developing embryonic stem cell-derived therapeutics for spinal injury and cancer. Rob oversaw overall development strategy, cross functional team leadership and first-in-human clinical trial initiation of the company’s allogeneic cancer immunotherapy platform therapy. A large part of his role was to represent the organization to investors and at scientific conferences. Rob has experience of the integration and execution of project management best practices into global programs to ensure project delivery and alignment, applying program management tools including the Target Product Profile (TPP), Quality Target Product Profile (qTPP), the development of integrated development plans and project plans (MS Project, Merlin Project Plan), Gantt chart creation and development timeline planning, to ensure delivery on quality, time and cost and appropriate project resourcing, oversight and enablement of accurate and timely reporting of project progress and challenges to executive management and Board of Directors.
Nate Manley, Ph.D. (Senior Consultant) brings fifteen years of development experience of experimental and clinical-stage therapies to the Practice, with particular focus on preclinical modelling, stem cell biology and neurobiology. Nate’s expertise spans preclinical model development and execution, process optimization, Intellectual Property, product characterization and comparability testing. In his previous role, Nate led the preclinical development of an allogeneic cell therapy for spinal cord injury. His wide range of responsibilities included the development of assays to characterize pluripotent cell banks, process intermediates and final clinical drug product, plus the development of candidate release and potency assays. Nate set up and managed an in-house vivarium, executed animal studies and authored regulatory documents. He was also central to the development and optimization of new methods for the production of clinical drug product, improving reproducibility and manufacturability, and led comparability efforts. Previously, Nate directed the preclinical pharmacological evaluation of neural stem cell transplantation therapies to treat stroke injury, completed in vivo efficacy testing and designed novel viral vector-based tools to profile transplanted cells in vivo.
Uzma Shoukat-Mumtaz (Consultant) brings twelve years of industry experience in process development, technology transfer and GMP manufacturing of cell and gene-modified cell therapy products, including modifications using Sendai and retroviral vectors and transfection by electroporation. Uzma’s previous experience includes the cGMP manufacture of pluripotent cell therapies, the maintenance of strict cGMP manufacturing standards for equipment maintenance, technical writing including SOPs, batch production records and materials specifications. Uzma is a qualified clinical site trainer, with extensive experience of the dose preparation of cell therapy products. Uzma also brings hands-on expertise in cell line development, stem cell differentiation, cell banking and the delivery of gene constructs to primary tissue-derived cell lines and reprogrammed primary cells. Uzma has extensive experience in protocol optimization for the differentiation of iPSCs into a variety of different cell types and subsequent characterization and the preparation of high quality cell banks. Uzma has previously designed and managed core cell culture facilities, designed and executed cell culture and scale-up processes, and has served as a person-in-plan during challenging technology transfers.