Gratitude

1. Gratitude.

I wanted to express my gratitude for our interactions we had over the last 18 months.  Together we faced regulatory challenges in a rapidly changing and unstable Regulatory environment.  Repurposing older products or bringing new products to market with a label that accurately reflects the benefits and potential risks of a product benefits the patient and their provider, reinforcing a culture of “getting it right the first time”.   I hope that you feel that I’ve been helpful to you. 

2. A(i)?

2025 was the year of rolling out AI far before it or anyone was ready.  Most of my (and possibly your) apps were “upgraded” with AI.  You will never receive any work from me that relied upon AI for its production.  This year, I saw an associate attempt to generate an approval pathway for a novel therapeutic with it and another AI-generated RO1 Grant application.  Both were utter nonsense.  Regardless of how information is gathered, it must be curated by experienced humans.  Period.

Competition among AI platforms can (and did) wreak havoc on a small business like mine.  In 2026, I will have added administrative support to assist me in ensuring strict compliance with Statements of Work and timely, well-aligned invoicing.   

3.  Communication

Open communication is key to success in both of our businesses.  For me, this will be greatly enhanced by ensuring that work, scientific and personal spaces are ringfenced from each other.  I ask that we all please use the business email, tom@alabiopharma.com and phone number 908.970.8250.   It will help me to help you better. 

4. Focus in the SCIENCE. 

Clearly separating speculation from replicable science-based attributes of new therapeutics remains a priority.  I will continue to call out CROs who try to up-sell you on something that will truly not add value and may add risk for Regulatory filing.  And will encourage you to PUBLISH your work when possible.  Science progresses via cooperation much more quickly than it does by competition.

5.  Partnership.

Wouldn’t any of us want to see our world a better place for our children and grandchildren?  You may know that I’ve been developing a global concept for the local manufacture, compounding and distribution of the World Health Organization’s list of critically needed medications.  This will not require investment in infrastructure, but rather by leveraging the extant generics and compounding pharmacy infrastructure, this can be achieved expeditiously and inexpensively.  We are currently focusing on identifying appropriate tax incentives and grants in order to get this underway, leveraging a developing partnership with MSF.