Here's what real students had to say:

Real Results, Real Success

★★★★★ As a Medicinal Chemist, I found this course incredibly valuable. It takes you from 'zero to hero' through topics like Study Design, Pharmacokinetics, and the IND Application process. The mix of clear video explanations and practical workbooks makes the step-by-step learning feel very intuitive. It’s a must-have resource for anyone looking to master the fundamentals of nonclinical toxicology.
Farbod Salahi

Medicinal Chemist

★★★★★ I've been in drug development for years and always felt like I was missing the full nonclinical picture. This course finally gave me that foundation. The way it's organized makes even the most complex concepts click. Worth every penny.
Cassandra O'Malley

Technical Director of Nonclinical Programs

★★★★★ I came into drug development from a completely different background — I had no nonclinical knowledge whatsoever. This course changed that. I can now walk into any meeting, follow the nonclinical discussion, and contribute meaningfully. In my role, understanding the science behind what my clients are going through has been a game changer for my career.
Andrew Parry

Director Client Relations

★★★★★ I truly appreciate the effort and expertise that went into creating this course. The content is clear, engaging, and highly relevant, making it much easier to grasp complex topics in nonclinical development. It’s evident that a lot of thought was put into both the structure and delivery. This has been an incredibly helpful learning experience, and I’m grateful for the opportunity to learn from such well-crafted material.
Yvonne Will, PhD

Founder, SCIENTIA

→ Company Reimbursement ←

Did you know your company may cover the cost? Course Justification Letters are available to download for free in the Introduction/Free Preview to submit for approval.

There is no degree for this.

Nonclinical development is one of the most complex parts of drug development — and almost nobody teaches it. You learn it on the job, in meetings where you're already expected to know it, from colleagues who are too busy to explain it. Until now. This course is everything I've learned in 15+ years of guiding drugs from discovery to IND — finally in one place. Whether you're in regulatory, clinical, CMC, project management, or just starting out in pharma, this is the foundation you were never given. 500+ slides. 14 modules. Real cases. No fluff. The pharma industry has been waiting for this course. And now it's here.

Pick the tier for your development:

Every tier gets the full 12-module curriculum + 2 bonus modules. Choose 1-Year Access for focused learning, Lifetime Access for permanent reference, or Lifetime + Coaching for personalized support and monthly Office Hours with Dessi. How fast do you want to level up?

What You'll Learn

16 Chapters · 118 Lessons

  1. 1

    Introduction

    1. Introduction Free preview
    2. Introduction Video Free preview
    3. (Included in full purchase)

      Course Abbreviations

    4. Course Justification Letter - Executive Tier Free preview
  2. 2

    Module 1: Foundations of Nonclinical Development

    1. (Included in full purchase)

      Module 1 Introduction

    2. (Included in full purchase)

      Module 1 Workbook

    3. (Included in full purchase)

      Lesson 1: What Is Toxicology

    4. (Included in full purchase)

      Lesson 2: What Does a Nonclinical Toxicologist Actually Do

    5. (Included in full purchase)

      Lesson 3: The Drug Development Pipeline

    6. (Included in full purchase)

      Module 1: Dessi's Takeaways

    7. (Included in full purchase)

      Module 1 Knowledge Quiz

  3. 3

    Module 2: GLP v. nonGLP — The GxP Universe

    1. (Included in full purchase)

      Module 2 Introduction

    2. (Included in full purchase)

      Module 2 Workbook

    3. (Included in full purchase)

      Lesson 1: The GxP Universe

    4. (Included in full purchase)

      Lesson 2: GLP Deep Dive

    5. (Included in full purchase)

      Lesson 3: nonGLP Strategic Uses

    6. (Included in full purchase)

      Module 2: Dessi's Takeaways

    7. (Included in full purchase)

      Module 2 Knowledge Quiz

  4. 4

    Module 3: Study Design Fundamentals

    1. (Included in full purchase)

      Module 3 Introduction

    2. (Included in full purchase)

      Module 3 Workbook

    3. (Included in full purchase)

      Lesson 1: The Art of Study Design

    4. (Included in full purchase)

      Download: Toxicology Study Design Guide

    5. (Included in full purchase)

      Lesson 2: Dose Selection Strategy

    6. (Included in full purchase)

      Lesson 3: Route and Frequency Considerations

    7. (Included in full purchase)

      Lesson 4: Endpoint Selection

    8. (Included in full purchase)

      Download: Toxicology Study Protocol Checklist

    9. (Included in full purchase)

      Case Study: Jesduvroq

    10. (Included in full purchase)

      Module 3: Dessi's Takeaways

    11. (Included in full purchase)

      Module 3 Knowledge Quiz

  5. 5

    Module 4: Species Selection and Considerations

    1. (Included in full purchase)

      Module 4 Introduction

    2. (Included in full purchase)

      Module 4 Workbook

    3. (Included in full purchase)

      Lesson 1: Meet the Species

    4. (Included in full purchase)

      Lesson 2: How to Select the Right Species

    5. (Included in full purchase)

      Lesson 3: Special Considerations and Edge Cases

    6. (Included in full purchase)

      Module 4: Dessi's Takeaways

    7. (Included in full purchase)

      Module 4 Knowledge Quiz

  6. 6

    Module 5: Toxicology Study Packages

    1. (Included in full purchase)

      Module 5 Introduction

    2. (Included in full purchase)

      Module 5 Workbook

    3. (Included in full purchase)

      Lesson 1: Small Molecule Tox Packages

    4. (Included in full purchase)

      Lesson 2: Large Molecule Tox Packages

    5. (Included in full purchase)

      Lesson 3: Oncology vs. The World

    6. (Included in full purchase)

      Lesson 4: Specialized Packages

    7. (Included in full purchase)

      Case Study: Fruzaqla

    8. (Included in full purchase)

      Module 5: Dessi's Takeaways

    9. (Included in full purchase)

      Module 5 Knowledge Quiz

  7. 7

    Module 6: Safety Pharmacology

    1. (Included in full purchase)

      Module 6 Introduction

    2. (Included in full purchase)

      Module 6 Workbook

    3. (Included in full purchase)

      Lesson 1: What Is Safety Pharmacology

    4. (Included in full purchase)

      Lesson 2: The Core Battery

    5. (Included in full purchase)

      Lesson 3: The Latin Square

    6. (Included in full purchase)

      Lesson 4: Off-Target Pharmacology

    7. (Included in full purchase)

      Module 6: Dessi's Takeaways

    8. (Included in full purchase)

      Module 6 Knowledge Quiz

  8. 8

    Module 7: Pharmacokinetics in Toxicology

    1. (Included in full purchase)

      Module 7 Introduction

    2. (Included in full purchase)

      Module 7 Workbook

    3. (Included in full purchase)

      Lesson 1: PK vs. TK

    4. (Included in full purchase)

      Lesson 2: TK Deep Dive

    5. (Included in full purchase)

      Lesson 3: Exposure Margins vs. Safety Margins

    6. (Included in full purchase)

      Lesson 4: Using PK/TK Data Strategically

    7. (Included in full purchase)

      Module 7: Dessi's Takeaways

    8. (Included in full purchase)

      Module 7 Knowledge Quiz

  9. 9

    Module 8: Interpretating Toxicology Data

    1. (Included in full purchase)

      Module 8 Introduction

    2. (Included in full purchase)

      Module 8 Workbook

    3. (Included in full purchase)

      Lesson 1: Breaking Down a Tox Study

    4. (Included in full purchase)

      Lesson 2: Adverse Effects

    5. (Included in full purchase)

      The Adverse Finding Checklist

    6. (Included in full purchase)

      Lesson 3: NOAEL Determination

    7. (Included in full purchase)

      Lesson 4: Target Organ Toxicity

    8. (Included in full purchase)

      Module 8: Dessi's Takeaways

    9. (Included in full purchase)

      Module 8 Knowledge Quiz

  10. 10

    Module 9: Strategic Planning — DC to IND

    1. (Included in full purchase)

      Module 9 Introduction

    2. (Included in full purchase)

      Module 9 Workbook

    3. (Included in full purchase)

      Lesson 1: DC-enabling Strategy

    4. (Included in full purchase)

      Lesson 2: 0 to IND

    5. (Included in full purchase)

      Download: IND-enabling Program Checklist

    6. (Included in full purchase)

      Lesson 3: Back-Calculating Your IND Timeline

    7. (Included in full purchase)

      Module 9: Dessi's Takeaways

    8. (Included in full purchase)

      Module 9 Knowledge Quiz

  11. 11

    Module 10: The IND Application

    1. (Included in full purchase)

      Module 10 Introduction

    2. (Included in full purchase)

      Module 10 Workbook

    3. (Included in full purchase)

      Lesson 1: Anatomy of an IND

    4. (Included in full purchase)

      Lesson 2: Authoring Nonclinical Summaries

    5. (Included in full purchase)

      Lesson 3: SEND The Dataset Requirement You Can't Ignore

    6. (Included in full purchase)

      Lesson 4: IND Submission and FDA Response

    7. (Included in full purchase)

      Module 10: Dessi's Takeaways

    8. (Included in full purchase)

      Module 10 Knowledge Quiz

  12. 12

    Module 11: CRO Selection and Management

    1. (Included in full purchase)

      Module 11 Introduction

    2. (Included in full purchase)

      Module 11 Workbook

    3. (Included in full purchase)

      Lesson 1: What to Look for When Outsourcing to a CRO

    4. (Included in full purchase)

      Download: CRO Site Visit Checklist

    5. (Included in full purchase)

      Lesson 2: The Sponsor-CRO Partnership

    6. (Included in full purchase)

      Lesson 3: Study Monitoring and Oversight

    7. (Included in full purchase)

      Lesson 4: Managing Problems and Changes

    8. (Included in full purchase)

      Module 11: Dessi's Takeaways

    9. (Included in full purchase)

      Module 11 Knowledge Quiz

  13. 13

    Module 12: Advanced Topics and Emerging Trends

    1. (Included in full purchase)

      Module 12 Introduction

    2. (Included in full purchase)

      Module 12 Workbook

    3. (Included in full purchase)

      Lesson 1: NAMs

    4. (Included in full purchase)

      Lesson 2: Novel Modalities

    5. (Included in full purchase)

      Lesson 3: Data Is Not Strategy

    6. (Included in full purchase)

      Lesson 4: Regulatory Deep Dive

    7. (Included in full purchase)

      Lesson 5: Animal Welfare and the 3Rs

    8. (Included in full purchase)

      Case Study: Skysona

    9. (Included in full purchase)

      Module 12: Dessi's Takeaways

    10. (Included in full purchase)

      Module 12 Knowledge Quiz

  14. 14

    BONUS: Calculating Human Starting Doses

    1. (Included in full purchase)

      Bonus Module A Introduction

    2. (Included in full purchase)

      Bonus: Calculating the Human Starting Dose

  15. 15

    BONUS: All Things DABT

    1. (Included in full purchase)

      Bonus Module B Introduction

    2. (Included in full purchase)

      Bonus: All Things DABT

  16. 16

    Library of Nonclinical Tools

    1. (Included in full purchase)

      Toxicology Study Design Guide

    2. (Included in full purchase)

      Toxicology Study Protocol Checklist

    3. (Included in full purchase)

      IND-enabling Program Checklist

    4. (Included in full purchase)

      CRO Site Visit Checklist

    5. (Included in full purchase)

      The Adverse Finding Checklist

    6. (Included in full purchase)

      Study Status Tracker

    7. (Included in full purchase)

      Study Calendar Template

    8. (Included in full purchase)

      Nonclinical Budget Template

    9. (Included in full purchase)

      API/Test Article Calculator

About Dessi

Dessi McEntee, MS, DABT is a board-certified toxicologist with 15+ years of hands-on experience leading nonclinical development programs across biotech and pharmaceutical companies. As a fractional Head of Toxicology, she's guided dozens of programs from preclinical research through IND submission and beyond—navigating everything from first-in-human studies to FDA meetings. Dessi has seen (and solved) the costly mistakes that derail timelines, waste budgets, and stall careers, and she's spent years translating complex toxicology into actionable strategy for cross-functional teams. Frustrated by the lack of practical, real-world training in nonclinical development, she created this course to give the next generation of drug developers the insider knowledge she wishes she'd had from day one—without the trial-by-fire learning curve. • Board-certified toxicologist  • 15+ years industry experience • Fractional Head of Toxicology • Biotech Board Member • Author, Data Is Not Strategy

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