Nohla’s Management Team collectively has decades of experience in corporate development and financing, clinically relevant stem/progenitor cell expansion, hematology/oncology, cGMP manufacturing, process development and scale-up.
Kathleen Fanning President and Chief Executive Officer
Kathleen Fanning is the President and Chief Executive Officer of Nohla Therapeutics. Ms. Fanning has over 30 years of industry experience holding previous leadership roles in both public and private biopharmaceutical companies, most recently serving as Chief Operating Officer at VentiRx Pharmaceuticals. During her tenure at VentiRx, she led strategic planning activities and corporate and business development. She played an instrumental role in the strategic collaboration between VentiRx and Celgene Corporation. Prior to joining VentiRx, Ms. Fanning held senior leadership roles at Cell Therapeutics Inc., as Vice President of Acquisitions and Vice President of Sales and Marketing, with responsibilities that included building and managing the company’s first global sales and marketing organization. She also served as Senior Director of Sales and Marketing at CellPro, Inc. and spent 13 years at Zeneca Pharmaceuticals (now AstraZeneca), with increasing roles of responsibility including Director of Marketing for Oncology Products, where she led the successful U.S. launch of Arimidex®. Ms. Fanning received her B.A. in Zoology from Miami University in Oxford, Ohio.
Colleen Delaney, MD Chief Medical Officer
Colleen Delaney is the Chief Medical Officer at Nohla Therapeutics. She is also an Associate Member and recipient of the Madeline Dabney Adams Endowed Chair of the Fred Hutch Clinical Research Division and an Associate Professor at the UW Department of Pediatrics, Division of Pediatric Hematology/Oncology. Colleen is a member on the Advisory Council on Blood Stem Cell Transplantation of the Health Resources and Services Administration. She also serves on the Boards of Directors of the American Society of Bone Marrow Transplant and the Cord Blood Association.
In 2006, she established and became the Director of the Cord Blood Transplant Program at the Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, which has grown to be one of the busiest such programs in the country and the coordinating center of several multicenter clinical trials. She is the sponsor-investigator of three Investigational New Drug FDA files and has been the Principal Investigator of nine ongoing and completed clinical trials and several ancillary studies.
Colleen is also the Principal Investigator of a research laboratory focused on the role of the Notch signaling pathway in hematopoietic stem cell regulation and ex-vivo expansion of umbilical cord blood stem and progenitor cells for clinical applications. Her group at Fred Hutchinson Cancer Research Center developed novel and clinically feasible methods for the ex vivo expansion of cord blood derived hematopoietic stem and progenitor cells in the presence of Notch ligands. This work was translated into a pilot study investigating the use of ex vivo expanded cord blood progenitors to augment conventional cord blood transplantation. She has since extended this work to investigate the potential of cryopreserved, non-HLA matched “off the shelf” ex vivo expanded cord blood progenitor cells to provide rapid but transient myeloid reconstitution in the setting of cord blood transplant and following dose-intensive chemotherapy.
Colleen received her MD from Harvard Medical School in 1996, and went on to complete a residency in Pediatrics at the University of California, San Francisco followed by a Fellowship in Pediatric Hematology/Oncology at Fred Hutchinson Cancer Research Center/University of Washington.
Shelly Heimfeld, PhD Advisory Board Chair and Executive Vice President, Manufacturing and Research
Shelly Heimfeld is a Full Faculty Member at Fred Hutchinson Cancer Research Center and serves as Scientific Laboratory Director for the cGTP Cellular Therapy Laboratory and cGMP Therapeutic Manufacturing Facilities. These facilities are responsible for all minimally and more extensively manipulated cell components used for treatment of patients at the Center. His primary responsibilities are to ensure the safety, quality, and effectiveness of each product, but also include implementation of new technologies, translation of basic science procedures into appropriate clinical protocols, product development, process improvement, and regulatory compliance.
Shelly is internationally recognized for his research in hematopoietic-derived stem cells and the development of cell processing technologies for improved cancer therapy. His long-term goals have a direct therapeutic focus, many involving the “engineering” of transplant products to improve clinical outcomes. Pre-clinical translation activities include identification of better markers for characterization of hematopoietic stem and progenitor cells, improvements in isolation/purification technologies, and development of ex vivo manipulation strategies that can enhance the therapeutic potential of cells such as T-cell-based immunotherapy for treatment of various diseases.
Shelly is a Past-President for International Society of Cellular Therapy (ISCT), and is a leading authority in the FDA regulations and lab practices needed for clinical cell therapies, including Good Laboratory Practice (GLP), Good Tissue Practice (GTP), and Good Manufacturing Practice (GMP). Shelly continues to work with the FDA and other organizations to facilitate the exchange of ideas and best practices in the rapidly evolving area of Cell Therapy.
Shelly received his PhD in Cell Differentiation from the University of California, Irvine and completed postdoctoral studies with Dr. Irving Weissman at Stanford before going into industry to work as a founding scientist at SyStemix and later at CellPro, Inc., the first company to develop an FDA-approved device for CD34+ cell enrichment.
Tom Swallow Vice President, Finance & Administration
Tom Swallow is the Vice President of Finance and Administration at Nohla. Mr. Swallow has over 30 years of finance and accounting experience at both public and private companies. In his previous role, Mr. Swallow served as Vice President, Finance at VentiRx since 2011. Before joining VentiRx, Mr. Swallow served as Senior Director, Finance for Calistoga Pharmaceuticals, a privately held biotechnology company developing innovative therapeutics for patients with cancer or inflammatory diseases (Calistoga was acquired by Gilead in April 2011). At Calistoga, Mr. Swallow was responsible for managing finance and accounting operations and financial system implementation. Prior to Calistoga, Mr. Swallow worked at ICOS, a public biotechnology company engaged in the discovery and development of product candidates for the treatment of serious medical diseases, where he held the position of Controller and then Director of Finance. Mr. Swallow worked at ICOS from its inception through its acquisition by Eli Lily in January 2007. During his tenure at ICOS, Mr. Swallow was responsible for SEC reporting, investment management, and financial planning and analysis. Mr. Swallow also worked as Senior Director, Finance for Targeted Genetics and as an Accounting Manager for Maryatt Industries. Mr. Swallow holds a B.S. in Accounting from Central Washington University.
Mark Gauthier Vice President, Regulatory Affairs & Quality
Mark Gauthier, Vice President of Regulatory Affairs & Quality, has over 40 years of experience in drug development. He began his career in pre-clinical research, ultimately found his niche in regulatory affairs and has served in increasingly responsible roles in that capacity at The Upjohn Company, Immunex, ZymoGenetics, Acucela and CTI BioPharma, prior to joining Nohla Therapeutics. His extensive history of FDA and EMA interaction combined with a scientific background culminates in an experience base that includes working with recombinant proteins, small molecules, and regenerative medicine products. Mr. Gauthier has shepherded a supplemental NDA for hormone refractory prostate cancer, 2 new NDAs for multiple sclerosis and myelofibrosis products, and a BLA for hemostasis through the FDA review and approval process. In addition, he has been the regulatory manager for numerous active INDs for products being developed for AIDS, cancer, and hemostasis, among others.
Jim DeNike Senior Director, Corporate Development & Investor Relations
Jim DeNike is the Senior Director of Corporate Development & Investor Relations at Nohla. In this role, Mr. DeNike oversees corporate-wide internal and external communications and is the primary contact for the investment community. Throughout his 25-year career in communications and investor relations working for both public and private companies, Mr. DeNike has provided strategic oversight on matters affecting corporate visibility and reputation. Prior to Nohla, he served since 2013 as the Senior Director, Corporate Communications and Investor Relations at OncoGenex Pharmaceuticals, Inc., a public company developing therapeutics addressing treatment resistance in cancer. Before joining OncoGenex, Mr. DeNike served as the Senior Director, Corporate Communications & Investor Relations for Trubion since 2006, and continued to serve as the Senior Director of Corporate Affairs following Trubion’s acquisition by Emergent BioSolutions. Prior to Trubion, Mr. DeNike created and led the role of corporate communications and investor relations for Corixa, a Seattle-based immunotherapy company. In addition to his extensive experience in life sciences, Mr. DeNike began his career working for leading technology PR agencies supporting clients such as Microsoft, HP, 3com and Polycom. Mr. DeNike holds a B.S. in Public Relations from San Jose State University.
Esther Cuno Director, Human Resources
Esther Cuno has over ten years of experience in global human resources in non-profit and for-profit sectors spanning life science, healthcare, and retail industries. Having most recently served as Director of Recruiting for Fred Hutchinson Cancer Research Center, Ms. Cuno also previously held positions at Safeway, Inc. and Starbucks Corporation. Prior to Human Resources, she worked in the legal industry for eight years. Ms. Cuno has a Bachelor of Science in Sociology from Oregon State University; she also earned her Senior and Global Professional in Human Resources certifications with the Human Resources Certification Institute and is a Senior Certified Professional with the Society for Human Resource Management.