Tom Stephan Email & Phone Number

Wilmington, Massachusetts, Us

As Study Director, work directly with clients to design and implement DMPK related studies. DMPK subject matter expert responsible for the scientific and logistical matrix management of the technical staff providing formulation and in vivo support.-Principal Investigator and subject matter expert for study conduct, design and interpretation-Primary contact for the planning and execution of Sponsor interactions related to research and method development for the design, scheduling, conduct and reporting of studies-Ensure raw data is accurate, complete and in appropriate order to meet protocols/SOP specifications-Prepare high quality final reports appropriate for the study including method development, qualification, sample analysis and pharmacokinetic reports-Provide oversight of the laboratory and mentor scientific staff in areas such as protocol interpretation, method development and refinement, study related problem resolution and technique validation-Provide scientific expertise in study conduct, design and interpretation.-Direct the development and communication of departmental systems, SOPs, policies and procedures

PHARMACEUTICAL SUPPORTUsing expertise in identifying critical pathways and efficiently focusing limited resources to support reaching key milestones in lead candidate progression our mission is to assist clients in meeting aggressive timelines from lead identification through filing an IND. This is accomplished because we understand that every program is unique and requires thoughtful planning and tailored study design to meet the specific needs within your organization. As part of your team we commit to delivering the best quality DMPK, in vitro ADME and bioanalytical support to your program in the most cost effective way possible. Please contact us for a more detailed scope of service.

Project team leader for small molecule TRPM8 agonist program and Myelovenge protein therapeutic program. Responsible for the Pharmacology and Toxicology Department budget and 1 FTE (chemist). Primary therapeutic area supported was oncology.-Project team leader responsible for development and submission of a TRPM8 small molecule agonist IND (approved in 2012); authored Nonclinical Written and Tabulated Summaries, Pharmacokinetics Written Summary and Toxicology Written Summary-Responsible for pharmacokinetic and selected toxicology studies to support the TRPM8 agonist program-Performed nonclinical and clinical PK analysis using the Phoenix WinNonlin platform-Updated annual reports and investigator brochures as necessary for the TRPM8 clinical program-Supported European regulatory filing for Provenge (MAA and IMPD) -As part of a core business development functional team, provided DMPK and in vitro ADME guidance to evaluate potential licensing, partnering and acquisition opportunities following corporate due diligence procedures-Internal expert providing DMPK support for clinical development-Responsible for building a DMPK/ADME/Tox platform to support the discovery, lead optimization and early clinical development of small molecule therapeutics -Direct CRO activities investigating nonclinical and clinical pharmacokinetic, metabolism and toxicological questions; communicated results to stakeholders-Provide toxicology guidance for clinical development (eg, evaluated and summarized the potential for process contaminants to impact the safety of Provenge in the clinic)

Branford, Ct, Us

Direct DMPK, in vitro ADME, bioanalytical and pre-formulation strategies supporting discovery, lead optimization and preclinical development. Responsible for the Pharmaceutical Development Department budget and 6 FTEs. Primary therapeutic areas supported were oncology and immunology.-Designed, implemented and directed the strategy for PK/ADME discovery and lead optimization support including associated bioanalytical activities, pre-formulation activities, in vitro ADME activities and in vivo PK/TK activities using the Phoenix WinNonlin platform for modeling/simulation-Responsible for all final data analysis, interpretation, report generation and presentation to stakeholders -Provide bioanalytical, pre-formulation, DMPK and in vitro ADME guidance to support licensing efforts and other business development interests. -Champion for and initiator of strategy to optimize Syk inhibitors for therapeutic development targeting cancer and RA-IACUC committee chair with additional responsibilities for protocol generation specific to PK models, selected efficacy models and animal facility SOP’s-Company representative on multiple partnered program project teams; responsible for presenting Pharmaceutical Development Department strategies and relevant study data to those teams-CRO Management of non-GLP and GLP studies associated with toxicology, pharmacokinetics, metabolism, formulation development, bioanalytical and drug like property assessments-Responsible for the pharm/tox package of an out-licensed small molecule that was submitted and IND approved in 2008

Lead the preclinical DMPK/ADME discovery and lead optimization support activities. Manage 8 FTEs. Primary therapeutic areas supported were oncology and immunology.-Implemented strategies to provide quality in vivo pharmacokinetic support with increased throughput-Championed the implementation of the fundamental strategies used for in vitro ADME support within ICOS-Designed, executed and interpreted pharmacokinetic studies and selected in vitro ADME studies-Used in vitro models of metabolism to investigate metabolic liabilities of small molecules to drive medicinal chemistry efforts and compare the metabolic profiles of potential tox species-Managed in vitro studies to assess test article solubility in simulated gastric and intestinal fluid, distribution of test article in whole blood and protein binding-Led the bioanalytical activities (LC.UV and LC.MS) through 2002-Led the pre-formulation activities through 2001-Modeled pharmacokinetic data using the Phoenix WinNonlin platform to predict alternative dosing strategies for preclinical efficacy models-Modeled exposure/response relationships to support in vivo pharmacology studies-Represented the DMPK/ADME interests within the different project teams by educating and assisting the teams in developing specific strategies for meeting project goals-Reviewed PK sections of an IND approved in 2000 for a small molecule targeting LFA-1-Communicated data via written reports and internal presentations-Company representative on multiple partnered program project teams; responsible for presenting DMPK/ADME strategies and relevant study data to those teams

Provided assay development, preclinical and pre-formulation support. Primary therapeutic areas supported were cardiovascular and infectious disease.-Investigated and characterized different liposome drug delivery systems-Pre-formulations (solubility, stability and dissolution testing); ELISA development-Investigated the use of Caco-2 cells as a model system for intestinal transport/metabolism -Provided technical support for pharmacokinetic studies

Doctor Of Philosophy (Ph.D.), Pharmacology

Bachelor'S Of Science, Biochemistry And Molecular Biology (Topical Minor In Human Relations)