I am responsible for the pathology portions of Blueprint Medicines portfolio in nonclinical development for novel therapies to treat life-threatening diseases with kinase inhibitors in genetically defined cancers. This includes extensive interactions with our CRO partners and internal projects for safety and efficacy testing.

Toxicologic Pathology, published by Sage Publishing, is the official journal of the STP, ESTP, and BSTP. I have overall responsibility for both the daily operations, scholarly quality, and publishing integrity of the primary scholarly journal in the scientific discipline of toxicologic pathology. My responsibilities include management of a paid staff of two (managing editor and imaging editor), a volunteer staff of approximately 10 associate & senior editors, and selection of an editorial board. My daily duties include routine communications on both daily operations and strategic vision with the publisher, editorial team, executive committee of the societies, authors, and professional colleagues throughout the world.

The associate editors are responsible for the day-to-day operations of the peer review process of scholarly, investigative and review manuscripts submitted to the journal. This includes communications with submitting authors, identification of expert peer reviewers, and management of the revision process and ultimately recommending to the Editor-in-Chief the acceptance or rejection decision.

I was elected by other Fellows to serve as President of the International Academy of Toxicologic Pathology from 2021 to 2023. As the immediate past president, I continue to serve as voting member of the board of directors who serves to support the current president and promote the mission of the Academy.

The International Academy of Toxicologic Pathology (IATP) is a global professional scientific organization that establishes the criteria of excellence and accomplishments in toxicologic pathology for accreditation of members (fellows), serves as a worldwide source of experts in toxicologic pathology and organizes unique educational opportunities for toxicologic pathologists, related scientists, and trainees.

During my last 3 years of living in Denmark, I was the toxicologic pathologist for the Novo Nordisk Stem Cell Transformational Research Unit. This was a biotech-like group of cell biologist, medical device engineers, molecular biologist, physicians, pharmacologists, CMC and nonclinical development experts who are using Novo Nordisk's decades of cell culture experience to turn human embryonic stem cells into replacement tissue for diseases such as diabetes, Parkinsons, retinal disease, heart disease, and more. Our goal was simple, we aimed to cure these conditions, permanently. Period. We were very proud on role in developing replacement neurons to treat Parkinson disease which is now undergoing clinical evaluation.

My initial role in Denmark at NN's R&D headquarters was as a principal scientist in pathology with a primary duty as a toxicologic pathology expert in the design, execution, interpretation, and reporting of toxicology studies. This position required extensive interactions with contract research organizations (CROs) which conduct the GLP-compliant toxicology studies required for regulatory submissions in drug applications to regulatory agencies. I was also responsible for developing in house investigative toxicology programs and for pharmacovigilance in discovery studies.

The Novo Nordisk Beijing R&D centre is dedicated to using our expertise in protein technology, pharmacology, and disease models to advance our company's pipeline in diabetes, obesity, hemophilia, growth disorders, and diabetic complications. I am a principal scientist who is responsible for the preliminary safety assessment of novel drug target candidates, I serve as the site veterinarian responsible for the health and welfare of our rodent and dog pharmacology department laboratory animals, I am a team member of the innovation sourcing group who identifies/evaluates collaborations in China, and I intermittently work in Måløv, Denmark in our non-clinical development department as a toxicologic pathologist.

Dr. Keane is a toxicologic pathologist with broad experiences conducting safety studies in nonclinical drug development, environmental chemicals, and medical devices. He has worked throughout North America, China, and Europe and uses his own expertise in collaboration with a network of safety assessment colleagues to facilitate GLP-compliant studies for product registration. Dr. Keane is particularly interested in helping clients bridge opportunities between China and the US and has worked extensively with JOINN Laboratories (http://www.joinnlaboratories.com) in this capacity. Dr. Keane also coordinates and lectures at educational venues throughout the world in support of the Society of Toxicologic Pathology mission (http://www.toxpath.org/).

Responsible for the overall management of the pathology department in its mission to produce timely, high-quality, compliant toxicologic and cost-effective pathology reports. Supervise six anatomical pathologists and one administrative scheduler. Foster an environment of scientific excellence in a GLP-compliant facility. Train staff members in the gross and microscopic evaluation and interpretation of tissue sections from animals exposed to test materials and correlating these findings with necropsy, organ weight and clinical pathology findings. Review and provide editorial input into pathology narrative reports of microscopic, gross, and clinical pathology findings for IND purposes. Assist peer review pathologists with their review of pathology reports and develop positive professional relationships. Develop immunohistochemistry and image analysis techniques for toxicologic pathology. Attend and/or schedule pathologist to attend necropsies as required and provide scientific guidance to necropsy technicians to ensure accuracy and compliance with protocols and SOPs. Interact with sponsors, pathologists, necropsy technicians, histotechnologists, study directors, study coordinators, toxicologists and report coordination personnel. Provide scientific advice in evaluating current technical procedures and in the development of new procedures/techniques. Continuously develop scientific knowledge base and awareness of regulatory updates through participation, presentations, and publications in affiliated scientific organizations.

My term as overall chairperson of the STP Education Committee was completed in 2012. I have currently shifted my focus to the subcommittee responsible for organizing modular education for new pathologists. This program will be a rotating series of courses that will train entry level pathologist in the art & science of toxicologic pathology. The program is currently focused on North America and expects to expand world-wide in the future.I have been a member of the STP Education Committee since 2007 and Chaiperson since 2010. The mission of this committee is to provide overall management to the STP's objective of being a global leader in providing educational and career development resources in toxicologic pathology. This committee is specifically charged with four operational areas:1. Provide quality education in toxicologic pathology focusing on members and on offerings outside the annual meeting.2. Provide career development resources and programs in toxicologic pathology.3. Develop a web-based platform for educational activities and resources.4. Disseminate relevant scientific expertise and information through presentations, publications, scientific symposia and website.

Assumed additional responsibilities beyond those previously described. Current responsibilities are as the Facility Laboratory Animal Veterinarian responsible for welfare of animals and regulatory compliance in a 40000 square foot vivarium housing mice, rats, rabbits, dogs, and cynomolgus macaques.Additional duties are those of Drug Safety Compound Leader for two programs with responsibility for the design, execution, and reporting of IND and NDA enabling drug safety programs for novel compounds indicated for oncology. Other additional duties include the establishment and maintenance of recruiting contacts for departmental staffing needs; collaborative efforts with in-house discovery staff analyzing animal models of human diseases; standing member of investigational (molecular) toxicology council, chairperson of departmental computing upgrade committee on database, telepathology, image analysis, and data management, and back-up facility laboratory animal veterinarian.

Veterinary pathologist in the Division of Drug Safety working on the development of novel therapeutics in GLP environment. Responsibilities include the assessment of tissues in acute and chronic toxicity studies, including 2-year carcinogenicity assays, peer-review of CRO studies, and collaboration on drug discovery projects.

Veterinary pathologist at the 500 person biotech company which developed Cialis®. Responsibilities include direct supervision of the histology and image analysis laboratory and three individuals, which service a variety of research and development projects and include necropsy, histopathology, immunohistochemistry, in situ hybridization, and computer assisted image analysis services. Additionally, involved in the development of animal models for investigation of human diseases and efficacy screening of novel pharmaceutical compounds.