Nonclinical Strategy

Learn how to plan and manage nonclinical development programs effectively from start to finish.

Toxicology Study Designs

Understand how to design scientifically sound and regulatory-compliant toxicology studies for successful drug development.

Regulatory Submissions

Master the art of preparing IND submissions, interpreting toxicology data, and making strategic go/no-go decisions with confidence.

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.

Company Reimbursement

Did you know your company may cover the cost? Many pharmaceutical and biotech companies offer professional development budgets that cover courses like this. Before you pay out of pocket check with your manager or HR department — this course may be fully reimbursable. ​A receipt will be provided at checkout for reimbursement purposes.

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?

The syllabus

15 Chapters · 89 Lessons

  1. 1

    Introduction

    1. Introduction 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 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 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)

      Lesson 2: Dose Selection Strategy

    5. (Included in full purchase)

      Lesson 3: Route and Frequency Considerations

    6. (Included in full purchase)

      Lesson 4: Endpoint Selection

    7. (Included in full purchase)

      Case Study: Jesduvroq

    8. (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 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 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 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 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)

      Lesson 3: NOAEL Determination

    6. (Included in full purchase)

      Lesson 4: Target Organ Toxicity

    7. (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)

      Lesson 3: Back-Calculating Your IND Timeline

    6. (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 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)

      Lesson 2: The Sponsor-CRO Partnership

    5. (Included in full purchase)

      Lesson 3: Study Monitoring and Oversight

    6. (Included in full purchase)

      Lesson 4: Managing Problems and Changes

    7. (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 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

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

Invest in the Knowledge That Lasts Your Entire Career

Enroll now and gain the practical skills to excel in drug development. 

$399.00

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