Tom Stephan

Tom Stephan Email and Phone Number

Ph.D. Pharmacologist (Discovery ADME-PK/Early Clinical Development DMPK) @
Tom Stephan's Location
Durham, Connecticut, United States, United States
Tom Stephan's Contact Details

Tom Stephan personal email

n/a
About Tom Stephan

PROFILE SUMMARY AND CORE COMPETENCIESDrug metabolism and pharmacokinetic leader with over 20 years of experience supporting programs in discovery through early clinical pharmacology development. Working with cross-functional team members to contribute to the progression of clinical candidates in the therapeutic areas of oncology, immunology, infectious, cardiovascular, and genetic disease. Dedicated to formulating data driven decisions and ensuring project advancement by providing DMPK strategies that limit potential liabilities and enhance efficiency through productive use of resources that lead to effective timeline management and movement of optimized clinical candidates more rapidly toward approval. Integrated Communication Strategy – simplify questions for practical discussion within multidisciplinary project teams to allow for focused resourcing and timeline management that facilitates the alignment of program strategies with corporate goals Operational Efficiency and Effectiveness – assessment and management of risk(s) to provide go, no go, and cautionary statements to communicate potential success Team Leadership – management of internal and external resources; including direct reports, project teams, CROs, budgets, and information Intelligence gathering – consolidating information from multiple sources to provide guidance for program progression that is competitive, strategic, and instructional Strategic Vision – champion paradigms to support program specific optimization of potential therapeutics Entrepreneurship – apply novel strategies to the existing DMPK screening and sample analysis process to increase understanding and efficiencies

Tom Stephan's Current Company Details
Biohaven Pharma

Biohaven Pharma

Ph.D. Pharmacologist (Discovery ADME-PK/Early Clinical Development DMPK)
Tom Stephan Work Experience Details
  • Biohaven Pharma
    Director, Dmpk Scientist
    Biohaven Pharma Oct 2023 - Present
  • Te Stephan Jr., Llc
    Consultant
    Te Stephan Jr., Llc Sep 2022 - Present
  • Qed Therapeutics
    Director Dmpk
    Qed Therapeutics Dec 2021 - Sep 2022
  • Charles River Laboratories
    Principal Scientist Iii, In Vivo
    Charles River Laboratories Nov 2017 - Nov 2021
    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
    View
  • Te Stephan Jr, Llc
    Owner, Consultant
    Te Stephan Jr, Llc Jan 2012 - Nov 2017
    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.
  • Dendreon Corporation
    Associate Director Of Pharmacology And Toxicology
    Dendreon Corporation Sep 2008 - Jan 2012
    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)
  • Cgi Pharmaceuticals, Inc.
    Director, Pharmaceutical Development
    Cgi Pharmaceuticals, Inc. Feb 2004 - Sep 2008
    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
    View
  • Icos Corporation
    Principal Scientist, Pre-Clinical
    Icos Corporation Feb 1998 - Feb 2004
    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
    View
  • Procoter And Gamble Pharmaceuticals
    Research Associate, Pharmaceutics
    Procoter And Gamble Pharmaceuticals Feb 1992 - Aug 1993
    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

Tom Stephan Skills

Craft Art Engraving Handmade Jewelry Laser Engraving Small Business Customer Service Management Marketing Public Speaking Research Sales Social Networking Strategic Planning Team Building Social Media Leadership

Tom Stephan Education Details

  • University Of Mn-Minneapolis
    University Of Mn-Minneapolis
    Pharmacology
  • University Of Wisconsin-Eau Claire
    University Of Wisconsin-Eau Claire
    Biochemistry And Molecular Biology (Topical Minor In Human Relations)

Frequently Asked Questions about Tom Stephan

What company does Tom Stephan work for?

Tom Stephan works for Biohaven Pharma

What is Tom Stephan's role at the current company?

Tom Stephan's current role is Ph.D. Pharmacologist (Discovery ADME-PK/Early Clinical Development DMPK).

What is Tom Stephan's email address?

Tom Stephan's email address is ts****@****ver.com

What schools did Tom Stephan attend?

Tom Stephan attended University Of Mn-Minneapolis, University Of Wisconsin-Eau Claire.

What skills is Tom Stephan known for?

Tom Stephan has skills like Craft, Art, Engraving, Handmade Jewelry, Laser Engraving, Small Business, Customer Service, Management, Marketing, Public Speaking, Research, Sales.

Free Chrome Extension

Find emails, phones & company data instantly

Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Get Chrome Extension - Free

Aero Online

Your AI prospecting assistant

Download 750 million emails and 100 million phone numbers

Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.