How to get started...

One of the things I am asked most frequently is how I handle integrating onto a CMLR or MARC as I take on a new client or engagement. There are certainly company cultural and group dynamic issues to consider (to be covered in a future blog post), but I generally start at the beginning and try to get to know a product as well as possible with the end goal of developing a product risk profile.

This is a methodical start, but it gives me a solid grounding for what lies ahead. I always request from the client and gather from public sources the following documents and assemble them electronically or in an old school binder for ease of use:

• Product regulatory history including advisory comments and other correspondence with OPDP/APLB

• FDA summary basis of approval for the product

• Minutes of key meetings with FDA concerning the product including Pre-NDA and Phase 3 meetings

• Reprints for Phase 3 trials and other key studies

• Relevant FDA guidance (e.g., concerning the therapeutic area, class of product such as controlled substances, study types, endpoints assessed in pivotal trials)

• FDA or other (e.g., DOJ, FTC, DEA) enforcement concerning the product or other products in the therapeutic area

• Description of the key product programs (e.g., sampling or voucher, patient support, copay, and speaker programs)

• Most recent brand plan or strategic plan for the product

• Description of any ongoing or recent litigation or investigations related to the product or its programs

• Key promotional assets including the CVA and patient brochure

• Update on any recent or anticipated labeling changes or FDA submissions

• Timeline of anticipated materials that will need review in the next 6 months and meeting schedule

• List of all approved promotional assets for the product and their respective expiration dates

• List of CMLR/MARC members, coordinators and project owners

It may difficult to secure all these items and it can be a time consuming on the front end, but it will give you a very clear snapshot of the product, its risk profile and your possible workload across the next 6 months.

I hope that this helps you get started on your next CMLR or MARC assignment. More to come on how to think about those group dynamics issues...

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