Dale Baker

As an Associate Director/Senior Principal Research Scientist, Preclinical Safety Assessment (PSA), I serve as a project toxicology representative supporting multiple cross-functional teams in the development of small molecules for multiple therapeutic areas. I also assist in liaising with various contract sites and internal stakeholders including oversight for studies conducted at external CROs and daily activities on non-GLP studies. I work closely with several functional areas including DMPK, medicinal chemistry, biology, pharmacology, bioanalysis, formulations, CMC, project management, and toxicology operations. Additionally, I serve as the in silico genetox subject matter expert sitting on an safety oversight committee and my group runs in silico mutagenicity predictions, as well as sensitivity and irritation predictions, for the company.

• Serve as departmental representative in project teams, conducts all toxicology and safety pharmacology studies required to support drug development, and coordinates with cross-functional departments within the company. o Ensure high quality and integrity of the data as well as proper interpretation and valid conclusions in support of product safety prior to initiating clinical trials in humans and regulatory submissions. o Directs and participates in the review of technical data for adequacy, quality, additional testing requirements, cost and timing for development of potential acquisition drugs and new technologies. o Prepares, reviews toxicology protocols and reports and toxicology portion of INDs, NDAs, CIB, CDS, BLAs, CTDs. Responds to regulatory questions on safety matters and participates in discussions with the FDA or other ministry of health as needed. o Ensure NTS leadership and the R&D management team are fully informed of the progress and scientific endeavors through research memos, special presentations. o Participates in the initiation, preparation and review of SOPs and other departmental work practices/aids and prepares project status updates on a regular basis. o Manage project-related budget. o Evaluate published/unpublished data and provides risk evaluation on new ingredients/impurities/leachable for regulatory submissions, clinical trials in humans and post-marketing support. o Attends scientific meetings and symposia. o Maintains state-of-the-art knowledge of the rapidly developing new in vitro/vivo technologies, global standardization of rapid drug development methodologies, changing regulatory requirements and with literature in the related scientific fields for sound risk management.

As a Senior Research Scientist, Preclinical Safety Assessment (PSA), I served as a project toxicology representative supporting multiple cross-functional teams in the development of small molecules for multiple therapeutic areas. I also assisted in liaising with various contract sites and internal stakeholders including oversight for studies conducted at external CROs and daily activities on non-GLP studies. I worked closely with several functional areas including DMPK, medicinal chemistry, biology, pharmacology, bioanalysis, formulations, CMC, project management, and toxicology operations. Additionally, I served as the hERG screening department liason to discovery research.

BioreclamationIVT is a worldwide provider of biological and in vitro products to pharmaceutical, biotechnology, diagnostic, academic, contract research organizations (CRO) and government institutions. We specialize in control and disease state matrices manufactured from human and animal whole blood, plasma, serum, tissues and other fluids which are used in drug discovery, compound development, clinical and research diagnostics. We can immediately add value to your drug discovery and preclinical development program by providing large lots of hepatocytes, other cell types, and subcellular fractions along with associated media. BioreclamationIVT's products enable scientists and biomedical researchers to better understand the pharmacokinetics and drug metabolism of newly discovered compounds and the effects on disease processes. o Built market position by locating, developing, defining, negotiating, and closing business relationships o Identified trendsetter ideas by researching industry and related events, publications, and announcements; tracking individual contributors and their accomplishments. o Located and proposed potential business deals by contacting potential partners; discovering and exploring opportunities. o Screened potential business deals by analyzing market strategies, deal requirements, potential, and financials; evaluating options; resolving internal priorities; recommending equity investments. o Closed new business deals by coordinating requirements; developing and negotiating contracts; integrating contract requirements with business operations. o Assisted organizational leadership in making decisions that are based on sound science o Prepared procedural recommendation reports o Prepared and presented scientific material regarding BioreclamationIVT products and the science behind the products o Provided scientific expertise to clients

As a Scientist II, Exploratory Toxicology, I was responsible for in vitro toxicology assay development in both immortalized and primary cell types supporting both screening toxicology and investigative toxicology efforts. I also served as a project toxicologist supporting multiple cross-functional teams in the development of small molecules for oncology indications. Additionally, I served in non-science roles as the administrator for the Aperio Scanscope digital pathology system, site safety committee member and IT Advisory Board member.

Associate Scientist - Investigative Toxicology Automation development lead In Vitro Toxicology Assay development Project Management

Pfizer-Legacy Pharmacia (Kalamazoo, MI) • In-vitro toxicity screening support • Automation support • Novel Assay development