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. Author manuscript; available in PMC: 2018 Jan 2.
Published in final edited form as: Biochem Mol Biol Educ. 2016 May 26;45(1):13–24. doi: 10.1002/bmb.20978

Table II.

TSTP Bootcamp modules, key terms and key concepts.

Module Key Terms Key Concepts
Bench-to-Bedside Overview
  • -

    Drug

  • -

    Drug Discovery

  • -

    Drug Design

  • -

    Pharmacodynamics

  • -

    Pharmacokinetics

  • -

    Toxicity

  • -

    Therapeutic window
  • -

    Different factors involved in disease causation

  • -

    How pharmaceuticals work

  • -

    Perceptions versus realities of pharmaceutical companies’ profits and motives

  • -

    Drug development pipeline, timeline and costs

  • -

    “Eroom’s law”

  • -

    In vitro Diagnostics’ (IVD) role in the patient treatment scheme

  • -

    Challenges facing the IVD market
Target
Validation
  • -

    Target

  • -

    Node

  • -

    Serendipity and folk medicine

  • -

    Human genetics

  • -

    Fast followers

  • -

    Pathway genetics
  • -

    Different ways to choose a target

  • -

    Contrast the organization of basic research (disease specific) versus industry research (common targets for multiple indications)

  • -

    How common target approach can help eliminate lost revenue in clinical trials development
Intellectual
Property and
Patenting
  • -

    Non-Disclosure Agreement

  • -

    Material Transfer Agreements

  • -

    Cooperative Research and Development Agreements

  • -

    Patents
  • -

    Purpose of the patent is to encourage the sharing of ideas

  • -

    Rights a patent grants

  • -

    Different types of patents

  • -

    The requirements, cost and timeline for filing a patent

  • -

    Sections of a patent and key points to each, especially the “Claims” section
Pre-clinical
Development
and IND-
Enabling Studies
  • -

    Efficacy

  • -

    Safety

  • -

    ADME

  • -

    Bioavailability

  • -

    Toxicity

  • -

    Animal Modeling

  • -

    New Molecular Entity (NME)

  • -

    NME properties

  • -

    cLogP

  • -

    Solubility

  • -

    Permeability

  • -

    In vivo clearance

  • -

    Investigative New Drug (IND)
  • -

    The cost of development increases exponentially as it moves through the development process

  • -

    Pre-clinical development that is predictive of failure or success in clinical trials can lower the overall cost of drug development

  • -

    Efficacy and safety responsible for 80% of failures for drug candidates in clinical trials

  • -

    Where in the drug development pipeline diagram ADME, PK, bioavailability, toxicity and animal modeling determined

  • -

    Highlight the team science dynamic of drug development

  • -

    The PD properties of the drug, formulation and dosing

  • -

    The IND filing process: timing and cost of moving through the submission process

  • -

    Good Laboratory Practices: why there were started and the purpose they serve
NCATS Clinical
and
Translational
Science Award
(CTSA) Program
  • -

    CTSA

  • -

    Translational science workforce

  • -

    TL1 research training grant

  • -

    KL2 mentored career development grant
  • -

    CTSA program is an innovative national network of medical research institutions working together to improve the translational process

  • -

    CTSA hubs train and cultivate the translational science workforce and provide opportunities for pre- and post-doctoral training in clinical translational science

  • -

    The CTSA program offers grant support for research training, mentored career development, and workforce development

  • -

    Training is provided in non-traditional skills such as regulatory science, entrepreneurship and team science

  • -

    Degrees (MS and PhD) are offered in clinical and translational science
Clinical Trial and
Drug
Development
Planning
  • -

    Drug Development Plan

  • -

    Phase I, II, III and IV

  • -

    Dose Tolerance

  • -

    Dose Escalation

  • -

    Dose range

  • -

    Dose limiting Toxicity

  • -

    Placebo

  • -

    Efficacy

  • -

    Standard of Care

  • -

    Surrogate endpoint

  • -

    Draft package insert

  • -

    cGMP
  • -

    Successfully taking a product through clinical trials requires preparation

  • -

    Requirements and determinations for each Phase (I–IV)

  • -

    Reasons to stop a trial in each phase and ramifications of such decisions

  • -

    Review the actual data from the clinical trial of Imatinib, emphasizing how unusual it is

  • -

    Consider how a drug development plan differs for a large pharmaceutical compared to a small company

  • -

    Emphasize the overall goal of the drug development plan is to submit a New Drug Approval to the FDA and receive approval
FDA – New Drug
Evaluation and
Review
  • -

    NDA

  • -

    Fast Track

  • -

    Breakthrough Therapy

  • -

    Priority Review

  • -

    Accelerated approval
  • -

    Introduce the seven person review team assigned to each application

  • -

    Place the timing of submitting an NDA in the context of the entire drug development pipeline

  • -

    Lay out six step process of review: Pre-submission activities, Process the submission, Create a review plan, conduct the review, take official action and handle post action feedback

  • -

    Walk through a case study submission that raised concerns and how the concerns were addressed

  • -

    Different expedited programs and the consideration for each
Marketing and
Product Launch
  • -

    Marketing

  • -

    Sales

  • -

    Features

  • -

    Advantages

  • -

    Benefits

  • -

    Market Dynamics

  • -

    Product levers

  • -

    SWOT
  • -

    The critical elements of marketing

  • -

    Why marketing is important

  • -

    Differentiate between marketing and sales

  • -

    How market dynamics affect the product development

  • -

    How marketing levers drive a product’s market value

  • -

    Introduce marketing messages and the SWOT analysis.