University at Buffalo

University of Rochester

Executive Medical Director, ImmunoOncology & Cell Therapies Research & Development at Takeda Pharmaceuticals International Co.

Provide vision, leadership, strategic direction and alignment for high performance cross-functional teams in late-stage development.  Link clinical programs with internal management, investigators, health authorities, and thought leaders.  Provide oversight and execution in close collaboration with research, medical safety, regulatory, clinical operations, biometrics, and medical affairs teams, placing patients and quality first and fostering high performance teams in a matrix environment.

ADC Therapeutics

Vice President, Head of Global Late Stage Clinical Development

Founder of non-profit, providing the vision and leadership to launch a volunteer unrelated umbilical cord blood collection and processing facility in Northeast Ohio.  Assembled and worked closely with cross-functional team to establish the non-profit organization. Activities included meetings with Obstetrics & Gynecology medical and nursing leadership, hospital administrators and IRB officials at Cleveland Clinic, Emory (Atlanta), Piedmont (Atlanta), and Kaiser Permanente (San Francisco) birthing centers, the leadership of established blood banks and cord blood centers, HRSA officials and decision makers at philanthropic foundations.  As Medical Director provide support to assist with the review and development of standards of procedure for collection and processing of umbilical cord blood as the basis for FACT/AABB accreditation and FDA BLA.

Cleveland Cord Blood Center

Medical Director, Founder

Drive integrated program strategy including risks and mitigation for first in class immuno-oncology biologics therapeutics & cell therapies, from lead selection through BLA.  Responsible for asset program oversight and execution in close collaboration with research, non-clinical, clinical, medical safety, development, program management, regulatory, commercial, and manufacturing operations teams.  Translate IND development program strategies and life cycle management between cross-functional teams and senior management.

Regeneron

Vice President, Global Program Head, Oncology

Disease area expert in hematology cell therapy - ensured strategic information flows between the Cell Therapy Franchise and early/late clinical development, commercial, regulatory, and country medical teams.  Established ongoing collaborations with key thought leaders globally.  Developed & supported Cell Therapy communication strategy, training, medical launch plans, & advisory board planning.  Developed & executed cross asset Cell Therapy study protocols.  Authored and assisted with relevant scientific publications.  Planned, developed, & generated scientific & educational programs.  Major focus during 2020-22 on world wide commercial launches of Breyanzi (liso-cel) in relapsed refractory large B-cell Lymphoma setting and Abecma (id-cel) in relapsed refractory multiple myeloma patients.

Bristol Myers Squibb

Vice President, World-Wide Hematology, Cell Therapy Head

Responsible for Immuno Oncology & Cell Therapies clinical science leadership and oversight.  Set the clinical portfolio strategy for internal and external Immuno Oncology & cell therapies assets: built networks, access opportunity, and capability to complement and enable global program teams.  Led professional development, providing feedback and coaching for global clinical leads and associated line function global program team members.  Developed & drove Immuno Oncology & Cell Therapies clinical pipeline and portfolio strategy from proof of concept through submission and launch.  Led clinical cancer Immuno-therapy & Cell Therapies development for the Discovery Search & Evaluation Team in business development & licensure. Ensured scientific & technical excellence of Immuno Oncology & Cell Therapies clinical development programs and deliverables. Represented Immuno Oncology & Cell Therapies externally to the medical community, health authorities, and scientific societies.

Takeda Pharmaceuticals International Co.

Executive Medical Director, ImmunoOncology & Cell Therapies Research & Development

Clinical Lead for 2 cross functional teams, overseeing activities related to clinical development including new label indication for Ruxolitinib (JAK inhibitor; Jakavi) in GVHD in collaboration with Incyte Corp, and label indication for Afuresertib (Akt inhibitor) in relapsed multiple myeloma.  Worked cross-functionally with pre-clinical, manufacturing, quality assurance, regulatory, medical affairs, marketing, legal, biostatistics, data management, pharmacovigilance, and clinical operations.  Responsible for investigator brochure, target product profile, clinical development plan, global clinical protocols, and data safety monitoring.

Novartis

Senior Global Clinical Leader Oncology

Provided medical and scientific knowledge for Novartis Pharmaceuticals Global Development of groundbreaking Cell & Gene Therapies across several therapeutic areas in hematology, oncology, regenerative and solid organ transplant medicine.  Provided Cell & Gene Therapy leadership & staff continuous medical and scientific input in the areas of clinical development, manufacturing, and regulatory matters, thereby further enhancing business development in this fast moving field.  Coordinated with & supported Cell & Gene Therapy Business Development and Licensure in all due diligence activities to examine external technologies in the field, determining evidence of the validity & utility of outside technologies under consideration.  Represented Novartis Cell & Gene Therapy Unit as a senior medical spokesperson at external meetings concerning capabilities & cell product offerings.  Advised the Cell & Gene Therapy Strategy & Stewardship Board in clinical & scientific matters, technology advances, academic & industry trends.  Coached & mentored physicians & staff comprising the Cell & Gene Therapy Unit.

Scientific Officer, Clinical R&D

Responsibilities included developing with team members internationally novel stem cell and T-cell therapy products in hematology and renal transplantation.  Investigated innovative technologies in stem cell and immunology as to proof of concept and logistics.  Provided knowledge in clinical and cell processing to facilitate protocol development and execution globally.  Developed with team members internationally clinical and cell manufacturing data for health authorities review.  Examined cost drivers in health care with cross-functional team members to ensure cost efficient improved stem cell therapies to the benefit of patients internationally.

Global Program Medical Director

Served as Director, Stem Cell Transplant Program at University of Virginia Medical Center with responsibilities to assemble & manage faculty & staff for inpatient service, cellular processing, pheresis, & outpatient clinic processes per FACT guidelines.  Conducted NIH supported laboratory studies focused on transcription factor regulation of hematopoietic stem cells and T lymphocytes of relevance to allogeneic transplantation, and stem cell vasculogenesis in response to ischemia.  Clinical practice focused on malignant/non-malignant hematologic disorders & autologous/allogeneic hematopoietic stem cell transplantation including unrelated HLA-mismatched umbilical cord blood allogeneic transplantation in adult hematology patients.

University of Virginia Health System

Professor of Medicine & Director, Stem Cell Transplantation

Director, Allogeneic Transplant Program at University Hospitals of Cleveland.  Attending physician for 30 bed inpatient service and outpatient clinic.  Conducted NIH supported laboratory studies focused on cell signaling regulation of hematopoietic stem cells and T lymphocytes of relevance to allogeneic transplantation, and stem cell vasculogenesis in response to ischemia.  Clinical practice focused on autologous & allogeneic transplantation in adult hematology patients with specialization in umbilical cord blood as a graft source.

Case Western Reserve University

Associate Professor of Medicine

Attending physician for 15 bed inpatient service and outpatient clinic. Clinical practice focused on autologous and allogeneic stem cell transplantation with specialization in unrelated umbilical cord blood allogeneic transplantation.  Laboratory investigation focused on dendritic cell based immunotherapy for patients with hematologic malignancies, and immune studies in unrelated umbilical cord blood transplantation

Mary Laughlin