Master the Fundamentals of CMC Development

Working in Pharma and Drug Development is not for the faint-hearted.

We are a knowledge-intensive industry, doing high-risk development, and we rely on dozens of domain experts in every step of the way.

Everyone around us speak jargon and "not knowing" is not an option.

But some startups just have to wing it.

They hire consultants and CDMOs, and outsource all the expertise they don't have....

Are you working in such startup?

Or maybe its your team that must know what's going on, and they need someone to train them to deal with all this?

Let me help you speak the language of Drug Development and CMC:

With your teams, consultants and experts

With your service providers and CDMOs

With the Regulatory authorities

What you will learn:

Understand the Regulatory framework of CMC and how it evolves over the lifetime of the project (Phase-appropriate GxP)

Understand the real-life aspects of CMC development- from the nuances of specific products, to the general principles of GMP and Quality Risk Management

Understand Module 3 of the CTD and draft its sections for your project

Know how to select a CMO and kick start an outsourced manufacturing project

Understand key terms in Manufacturing Science and Technolgy

Identify potential CMC gaps and pitfalls in your current project

Better engage with Subject matter experts in Manufacturing Ops and MSAT, Quality Control (QC) and other technical experts

Understand Manufacturing Development and Operations, and how to apply the principles of QBD in the daily work of CMC

Understand the potential impact of Pharma 4.0, Machine learning, AI, blockchain on the very near future

CMC Essential concepts - from start to end, no prior specific knowledge is assumed- See full curriculum below.

Enroll now

Meet the instructor

Hi there! I am Raz Eliav, CMC Development and Regulatory Affairs consultant. I have worked with startups at all phases of development, and of diverse product modalities- mostly biologicals and advanced therapies.

Here is a quick word of introduction to the course content:

Frequently Asked Questions

Frequently asked questions

CETC

CMC Mindmapping

Dedicated training

CMC, Chemistry, Manufacturing and Controls is the umbrella term we use in the industry to describe all the aspects of making pharmaceutical products, in pharmaceutical grade and in compliance with Good Manufacturing Practices (GMP) and other regulations.

CMC Development is one of the main pillars of Drug Development, and it goes hand-in-hand with clinical development.

If you wish to know a little more about the field before jumping both feet it, please check our free crash course:

crashcourse.beyondcmc.com

Introduction to Drug Development and CMC

Introduction to Drug Development and CMC is a free online course on demand on-demand that introduces the field of Drug Development and Chemistry Manufacturing and controls. Developing new drugs is a notoriously risky business... So risky, that all of us in the industry are used to the daily walk through what is known as “the Funnel of Death”, which is the dramatic way of saying, that most pharmaceutical products don’t make it through to the market and this happens for a variety of reasons. First and foremost- some drugs are not safe enough. If we identify signals that the drug is unsafe, we would usually stop the project. This depends on the disease at hand of course, as high-risk disease can accept a high-risk therapy, because sometimes there is no other choice. Now, Safe drugs can make it through up to Phase 3 without fully knowing if they work or not. It’s very challenging sometimes to prove that a drug is effective, in a statistically significant manner. That why we need larger groups of people, and that’s why we reach that point only after years of development. All throughout the Clinical trials, the new drug needs to be manufactured at a very high quality, under many regulations, including the Good Manufacturing Practice. This aspect is referred to as CMC- Chemistry Manufacturing and Controls and it’s a challenge by itself. Drugs are not very simple to make, especially when we expect a very precise and consistent outcome. As we climb up the complexity level of the product, their manufacturing processes is equially complex and hard to scale-up. In some programs, the manufacturing aspect is oftentimes the highest risk element in the project, such as Cell and Gene therapies. and today our understanding of CMC today is very deep, and we are able to deliver more and more advanced products to the market So all this translates, as I said, to a notoriously risky business… The combination of very high development costs, ranging in the “hundreds of millions of dollars” and the many years it takes for development, on top of the very tight regulatory oversight, knowledge-intensive endevors and most importantly- with patient’s lives and health at stake- This is why we call it the “Funnel of death”- because most start ups will not make it through. So what keeps us moving in Drug Development? First and foremost, there is a real human suffering at the end of the road, which can be ameliorated. We will do anything we can for our loved ones when encountering hardships, and are all thankful to modern medicine that saves us from more and more disease and suffering. Wherever there is high-value, there is also a good business case. So in spite Drug Development being a very high-risk investment, the return on that investment is very high when one drug does succeed to make it through.

The course curriculum (subject to adjustments):

Pharmaceutical Development - Overview and context

(**Also available as a standalone, free crash course- check it out here)

The journey of drug development: - from bench to bedside
Introduction to CMC and the CMC Triangle
The Regulatory framework of drug development
Overview of career paths in the pharmaceutical industry

The full story of CMC (a.k.a Module 3 of the CTD)text

(**Also available as a standalone, mini course- check it out here)

The Regulatory Framework of CMC
- The Product- Chemistry, Biology and QTPP
- Manufacturing Ops, Development and GMP
- Quality: Controls, Assurance and Design

The Science and Technology of CMC

Types of pharmaceutical products and their nuances- from Small Molecules to Cell Therapies
Key Manufacturing Technologies- Principles of organic chemistry, Molecular Biology, and common Upstream and Downstream technologies

Manufacturing sites and GMP

Manufacturing sites (In-house/CDMOs) and CMO Selection
Good Manufacturing Practice 101
From Lab to GMP- a typical development workflow

Manufacturing Process Development (Drug Substance)

Upstream Process Development, Starting Materials and Cell Banks
Downstream Process Development
Process "lock" and Comparability (intro)

Pharmaceutical Development and Product Lifecycle

Pharmaceutical and Formulation Development
Drug Product Process development
Containers and Labelling
Case studies of specific product types
Comparability
Technology Transfers

Know thy product- Characterization and Impurities

Characterization principles and techniques
Types of impurities and their significance in product safety/efficacy

Quality Controls (QC)

Analytical methods overview
Quality Controls (QC) and Specifications
·Analytical methods lifecycle and validation

When the product meets the world

Stability and shelf life
CMC operations and product logistics

Quality and Design

Quality Assurance (QA)
Pharmaceutical Quality Systems
Quality Risk Management
Introduction to QBD

The view from the top of the development mountain

Quick recap of all course topics
Pharma 4.0, PAT, IoT, Big Data and current tech stack
Predictive modelling and AI

Final quiz and course certificate

Professionals in CMC-related departments such as:

CMC Project managers in startups and service providers
Quality Assurance (QA)
Quality Controls (QC)
Regulatory Affairs (RA-CMC)
Manufacturing operations and development

Professionals within Drug Developing companies that have daily interactions with CMC Service providers such as CDMOs and service labs

Students in Science and Engineering fields, approaching the end of their studies and considering a career in Pharma (scholarships are available, see below)

Professionals from other disciplines that need a quick orientation to Drug Development and CMC,

You may prefer this shorter overview, available here

Ideal for:

Management and Business Development
Non-CMC R&D
Medical experts
Upper management
Computer and data scientists, joining the Pharmaceutical Development world as part of the industry transition towards Pharma 4.0

Not at all! CMC is highly multidisciplinary and attracts people from diverse backgrounds.

The majority are indeed, with educational and professional background in Scientific and engineering backgrounds, mainly in the life-sciences and chemistry.

Nevertheless, the industry requires experts in higher levels of involvement, such as Project managers, System engineers, Quality Assurance and Regulatory professionals.

The course assumes no prior knowledge and each lecture starts with a quick background and additional resources,

The Pharma field is stepping quickly into the world of Pharma 4.0 which will harness the power of Machine learning, AI, blockchain, and more. So as it evolves there is a huge demand for Computer and Data scientists and Engineers of diverse backgrounds as well

Course details

The course is available to watch on-demand OR Live

For the on-demand version, register below
The Live course runs a few times a year, under the roof of Educo Life Science- use coupon code BEYONDCMC for extra discounts: See details here.

All Beyond CMC students meet once a week at The Tree club: a live Q&A and discussion Zoom call (Usually takes place on Thursdays @ 15:00 CET / 09:00 AM ET)

On-demand version students get 1-year access to:
- Course portal and extra materials
- The Tree Club weekly meetings+ session recordings
- A personal CMC Mind-mapping session (can be under confidentiality agreement)

Cost

1499 $ USD

If you need a brochure for your employer- contact us

Students, people between jobs, and emerging markets: please contact for scholarship. Please include a link to your Linkedin profile (if available) and mention your country of residence and Academic/Employment status

What you get

12-months access to Course portal which includes:
- Training portal and Tree of Knoweldge
- Student's Q&A forum and access to weekly meetings
- All Treeclub session recordings
- Additional resources
Course completion certificate

How to register?

Register in the link below for Credit Card / Paypal payment
For companies:
- Group pricing available
- Payment by wire possible
Please contact for details

enroll now

1,499

Crash-course: The Journey of Drug Development + Certificate

Mini-course: The Full Story of CMC + Certificate

The full CMC Essentials Training Course

Participate in live Tree club meetings

Beyond CMC Training platform and mobile app

1-Year access to Tree club recordings and student forum

Tree of Knowledge (Beta)

Master the Fundamentals of CMC Development

Working in Pharma and Drug Development is not for the faint-hearted.

Let me help you speak the language of Drug Development and CMC:

With your teams, consultants and experts

With your service providers and CDMOs

With the Regulatory authorities

What you will learn:

CMC Essential concepts - from start to end, no prior specific knowledge is assumed- See full curriculum below.

Enroll now

Here is a quick word of introduction to the course content:

Frequently Asked Questions

Frequently asked questions

What is CMC?

Course curriculum

Who is this course for?

Is this only for people with life-science / chemistry background?

Course details

Cost

What you get

How to register?

Master the Fundamentals of CMC Development

Working in Pharma and Drug Development is not for the faint-hearted.

Let me help you speak the language of Drug Development and CMC:

With your teams, consultants and experts

With your service providers and CDMOs

With the Regulatory authorities

What you will learn:

CMC Essential concepts - from start to end, no prior specific knowledge is assumed- See full curriculum below.

Enroll now

Here is a quick word of introduction to the course content:

Frequently Asked Questions

Frequently asked questions

What is CMC?

Course curriculum

Who is this course for?

Is this only for people with life-science / chemistry background?​

Course details

Cost

What you get

How to register?

Is this only for people with life-science / chemistry background?