Mindmapping is a powerful method to capture knowledge and make it accessible. If you landed a jungle, the best you could hope for is a good map. Mindmaps cover intellectual landscapes, and can can smooth out knowledge management challenges. You feel Good (or bad) Knowledge Management Practices when you onboard new team members, go through a gap assessments or due-dilligence, write regulatory submissions and more. The most important aspect of mindmaps is that they preserve context- and context, as we all know, is a crucial ingredient in knowledge and know-how. A fully functional Mindmap can serve as the single point repository for the project, linking together the most basic elements of the raw data and well into the intangible scientific knowledge, industry practice and regulatory framework. Power uses even leverage mindmaps to do project and budget management.

A Mindmap is layered, like an onion- it could describe just the “big picture” of a project, or go all the way through to the finest nuance and details It depends on the authors and time-invested - the more time spent mind-mapping, the more elaborate and valuable it becomes. For the CMC Development of a Pharmaceutical Product, we will work through the initial framework presented below, which is inspired by the CTD structure, introduced in ICH M4Q , Depending on your project, this can be very different at the end, and will continue to evolve:

An mindmap will help you with: Onboarding new team members and consultants Perform gap-assessments Support due-diligence processes Plan and execute Technology transfers Guide your through regulatory submissions and more! You can choose how deep you want to go in creating your map and in presenting your map- depends on the situation and needs.

In a focused mind-mapping session we will build an all-encompassing Mindmap of your project/situation. Hopefully, this will be enough to kick-start your own Mindmapping habit, but I am always here to help. The longer you invest Mindmapping, the more useful it becomes- see available options below. We will touch upon all the moving pieces of your CMC development status including: What is known about the API – Science, Technology and underlying engineering impact Manufacturing aspects Analytical and Quality aspects Regulatory landscape, status and open commmitments Business considerations (CMC oriented) Project specific nuances

Tier-0 Mindmap- Initial project overview and mapping Kickstart your mind-mapping habit! Scope: A 30-minutes hands-on Mind-mapping session with all relevant stakeholders Deliverables: A one-dimensional map telling your entire CMC story, in very high level Confidentiality agreement: Optional Cost: Free - during the pilot phase (ending soon!) --------------------------------------------------------------------------------------------------------------- Tier 1 Mind-map- a detailed CMC overview and roadmap Scope: Session 1: Hands-on mind-mapping workshop with all relevant stakeholders (~3-4 hours) Session 2: Presentation and discussion of CMC Overview and roadmap (~1-2 hrs) Deliverables: A fully functional Mindmap (includes links to source documents, literature and any other information repositories) Deliverable formats: MMAP (Mind Manager)* HTML (Fully functional in any web browser) Picture (as presented in the page above, external links excluded) Hierarchical master document (can serve as a template for Module 3 and other submissions) (optional): online page with functional Mindmap for guest access (helpful in due-diligence and onboarding consultants) Recommended documents to provide (if available): Module 3 Development reports, Regulatory interactions, Company presentations, Service proposals from CMOs and Contract labs, etc. * The technique can be internalized and used independently by using Mindmanager or any other mind mapping software of preference Cost: 3000 USD --------------------------------------------------------------------------------------------------------------- TIer-2 Mind-map(ping) - Ongoing maintenance of project Mindmap Scope and deliverables: A weekly hands-on mind-mapping session with all relevant stakeholders (~1.5- 2 hours) "The knowledge inbox": Open channle for ongoing monitoring of new company knowledge and implementation into the live mindmap Once a quarter: Project-wide training workshop for new employees, consultants, investors, etc. Cost: 3,000 USD/month