Pennington, New Jersey, United States
I am a highly experienced researcher with over 25 years in the biotechnology and pharmaceutical industries in both Discovery and Pre Clinical Development. I have led teams of scientists in identification and optimization of lead compounds/biologics entering Development and resolving issues related to toxicity and teratogenicity. A continual research theme throughout my career has been the intersection of cancer and developmental biology, where I have integrated my training in embryology, cellular and molecular biology and toxicology in identifying novel drug targets and optimization/development of potential cancer drugs. I have also worked in various other disease areas in roles as a biologist, toxicologist and DART toxicologist and find it exciting to be able to contribute to a diversity of research areas. I have established investigative toxicology/DART laboratories multiple times including cell and whole embryo culture facilities, molecular and flow cytometry laboratories as well as zebrafish facilities. I have been active in external stewardship in the toxicology field and have routinely published with over 40 publications and book chapters and a pending patent. Select publications are included in the Accomplishments section.
In addition to responsibilities described below, manage expanded group of Ph.D. and MS. scientists responsible for engaging in investigative in vivo and in vitro studies that characterize biology and toxicity and associated mechanisms of novel biologics, small molecules and other modalities. Lead expanded collaborations across sites supporting assets in the Discovery pipeline.
Oversee DART assessment of the Discovery portfolio including development and roll out of a multiple assay platform for teratogenic liability assessment and gain/loss of function models/approaches to evaluate teratogenic mechanism. Manage scientists engaged in vitro and in vivo investigative toxicology and development toxicology activities occurring within Discovery. Apply in vitro and in vivo approaches to assess adult toxicities to foster optimization of pipeline candidates and/or evaluate mechanism of toxicity. Co-chair discovery teams integrating pharmacokinetic, biotransformation, pharmaceutics and toxicology activities associated with optimization and candidate lead selection. Interpret PD-PK-toxicology relationship for safety assessment of small molecules/biologics. Engage on pharmacodynamic and toxicology biomarker efforts applying novel technologies for biomarker identification and efforts to assess utility. Engage in generation and assessment of microphysiology systems and their application to safety assessment. Engage in licensing/due diligence efforts applying biology and toxicology expertise in review of potential assets. Lead scientific and business activities associated with internal and external technology transfers. Manage budgets and recruitment of staff and represent department on strategic initiatives related to recruitment, retention of talent and career ladder strategies. Represent company on various functions associated with internal/external collaborations and symposiums, and external consortium activities and scientific advisory committees and working groups.
Responsible for strategic planning and oversight of in vitro and in vivo investigative developmental and reproductive toxicology (DART) directives, design and execution of in vivo investigative and GLP studies in support of reproductive toxicology safety packages including monitoring of studies performed in CROs. Provide expert DART consultation to working groups supporting Discovery programs and Pre Clinical Development projects. Managed a team of PhD and MS level scientists in investigative and regulatory directives ensuring timely and quality execution and reporting of investigative and regulatory studies conducted in the reproductive toxicology group. Served as Drug Safety Evaluation representative for cross-organizational steering teams in strategies for optimizing employee retention, external reputation and scientific career development.
Responsible for recruiting and managing staff, establishing laboratories and directing all activities associated with investigative developmental toxicology initiatives, provided expert reproductive toxicology assessments throughout organization, manage toxicology packages and act as toxicology representative on Discovery teams responsible for pipeline transition into Pre Clinical Development and execution of Pre Clinical studies supporting IND packages.
Responsible for discovery of novel, potentially drugable targets (receptor tyrosine phosphatases) and characterization of tissue expression and function using in vitro approaches and in vivo transgenic model systems. Additionally evaluated mechanisms of Gas 6-Axl tyrosine kinase pathway in diseases (leukemia and diabetes) involving generation of multiple transgenic mouse lines and subsequent phenotyping using various approaches integrating molecular biology, histopathology, cell biology and physiology.