Peak Spirit/Research & Development

Research & Development

  • Closed

Essential Concepts for BioTech R&D

Deep-dive into the core principles


This course entails:

  • Crucial Concepts & Practices in R&D

  • Supply Chain Differentiations

  • Concepts of Medicinal Chemistry, TPP, and Non-Clinical Safety

Included in This Course

Module 1: The Target Product Profile (TPP)

1.1 Introduction
Preview
⭐ 1.2 Sections of a TPP
⭐ 1.3 How to draft a TPP?
1.4 Benefits of a TPP
πŸ”— Additional Links & Resources

Module 2: CMC-Technical R&D

2.1 What is CMC or Technical R&D?
Preview
⭐ 2.2 Five Steps during the Product Development
⭐ 2.3 What are key elements of CMC?
πŸ”— Additional Links & Resources

Module 3: Good Manufacturing Practice

3.1 What is GxP?
Preview
⭐ 3.2 GMP vs. GDP
Preview
3.3 Main Areas of GMP Regulations
⭐ 3.4 Most Relevant GMP Principles
πŸ”— Additional Links & Resources

Module 4: Non-Clinical & Clinical Supply Chain

4.1 Supply Chain in the Biotech/Pharma Industry
Preview
⭐ 4.2 Drug supply for non-clinical studies
⭐ 4.3 Clinical Supply
4.4 Commercial Supply
πŸ”— Additional Links & Resources

Module 5: Medicinal Chemistry

5.1 What is Medicinal Chemistry?
Preview
5.2 Four Key Components in Medicinal Chemistry?
Preview
5.3 Challenges during Drug Discovery
⭐ 5.4 Main Properties to Optimize Starting from a Lead
5.5 What is β€œDruggability”?
5.6 Can Poor Absorption of a Compound be Predicted?
5.7 What is a Prodrug?
⭐ 5.8 List of Important Techniques Used in Drug Development & Medicinal Chemistry
5.9 Future Directions & Innovations in Medicinal Chemistry
πŸ”— Additional Links & Resources

Module 6: Scientific Advisory Boards for Biotech Companies

6.1 General
Preview
6.2 Pros & Cons for having a SAB
⭐ 6.3 Best Practice Principles for a Productive SAB
πŸ”— Additional Links & Resources

Module 7: Non-Clinical Safety

7.1 Introduction
Preview
⭐ 7.2 What is Non-Clinical Safety?
Preview
7.3 Toxicological Methodologies
7.4 Definitions & Standards of Non-Clinical Safety Studies
⭐ 7.5 Required Studies
⭐ 7.6 Specific Rules for Biologics
πŸ”— Links to Relevant ICH Guidelines:

How to get access

We are excited to hear that you are interested in accessing our content. You can follow the link provided and fill out the form by selecting the courses that interest you. We will then create an offer that suits your preferences and desired access duration.

Frequently asked questions

How long do I have access?

Your access can be determined individually. Usually, we gain access between 3 and 6 months.

Is 1:1 coaching included?

Yes, depending on the package you choose. You can choose whether you want 1:1 Coaching in the Access Request. We will then come back to you for an initial session.

Alternatively, reach out to Siro directly for an initial session, and let's find out how we can help you grow your idea!