Articles

Newsletter Spring 2019 - Founder, Dr. Zan Fleming

From Kinexum Founder 

Dear Kinexum friends and family, 

This issue of Kinexions is a special one, and I have a long note for it.  

First, I salute the important article on the landscape of artificial pancreas device systems by Dr. Prasad Palthur, Co-founder and Vice President of Design & Development of Innoneo Health Technologies. I first met Prasad years ago in a collaboration to develop a novel therapy for diabetes, but more recently I have been collaborating with Prasad in developing a potentially game-changing healthcare platform. Prasadbrings years of experience in healthcare, pharmaceutical, and technology sectors and a talent for approaching complexity across multiple disciplines.His article is a major resource for those who want to understand the technology involved in the artificial pancreas.It is a formidable article, which we are honored to publish here. It is also the first of a series of installments on the artificial pancreas, which will appear in future Kinexions newsletters. Future pieceswill include the regulatory landscape, directions for future development, and innovative leaders and product candidates.  

Prasad’s article is a reflection ofKinexum’scommitment to make a difference in advancing products to prevent or better manage diseases of all kinds.As part of Kinexum’s pro bono efforts, westrive to inform, enlighten, and inspire members of the biomedical research, development, and commercialization communities, as well as all healthcarestakeholders. We do that with this newsletter, our cross-cutting publications, our behind-the-scenes advocacy for continuous improvement of development and regulatory practices and policies, and in conferences that we support. Kinexum is heavily involved in the Metabesity movement. “Metabesity” refers to the constellation of chronic, non-communicable diseases of aging, from diabetes and obesity to cardiovascular and neurodegenerative diseases to cancer and the aging process itself, that have common metabolic roots and thus may be susceptible to common solutions. The first Metabesity Congress launched in October 2017 in London, and the next one will take place at the Carnegie Institution for Science in Washington, DC,on October 15-16Metabesity is the most important project of which I have been a part of during my career. You will not want to miss the conference in October. 

Second, I take great pride in the achievements of our Kinexers, and we are especially proud of Dr. Joy Cavagnaro. Joy is a leading expert in preclinical safety and development strategies for biopharmaceuticals and advanced therapies (gene and cell products). During her tenure at CBER at FDA and among many other things, she was a force in the International Conference for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Joy was instrumental in the development of the ICH S6 guidance. This guideline was unique in its emphasis on science as the driver for the appropriate safety assessment. To this day, Joy’s work is foundational to the development of complex molecules and advanced therapies. Joy’s work only picked up speed after her departure from FDA; her career spans academia, CROs, biotech, and government. 

I might not have met Joy at FDA because she was at CBER and I was at CDER, but we were chosen to represent FDA in several different ICH expert working groups, and I have supported Joy’s efforts ever since. We shared numerous adventures in Brussels, Tokyo, London, and other venues. This has been an abiding collaboration and friendship.Joyhas another passion and commitment in her life:she is also alongtime and highly successful coach forSpecial Olympics Virginia and coached Team Virginia’s swimmers at the 2018 USA Games. Joy is not only a preeminent scientist, buta great humanitarian.   

Finally, I want to thank all who have supported me in the months leading up to my father’s death at age 94. Jack Fleming was one of the most brilliant and creative of all physicians and medical scientists whom I have known. He started doing medical research during his early days after medical schoolworking on blood substitutes to save the lives of gravely wounded soldiers and civilians. He wrote his first book a few years after finishing his medical training. Dad was on a course to be one of the most prominent and celebrated physicians of his generation.   

Jack Fleming could have been professor of an endowed chair at a great university, but he chose to come back to his hometown of Pensacola and serve the community. Even so, in his busy practice, he continued to publish medical articles regularly. Just before he retired, he co-authored a major textbook on nuclear cardiology. That book was directly related to another collaboration—one with Dr. Ken Ford who went on to found the world-famous Institute of Human and Machine Cognition in Pensacola. That project, a computed expert diagnostic system,was a very early example of applying artificial intelligence to adiagnostic system. Dad was always either ahead of his time or right on the cutting edge.   

Dad was also beloved by his patients, and, as a cardiologist, saved the lives of many of them. Dad often got up in the middle of the night to attend to a critically ill patient in the ER and then got up early to perform rounds at more than one hospital. Dad somehow found the time to bring medical technologies to each of Pensacola’s three major hospitals long before much larger cities had them. He brought a major hospital to the city alongside one of the country’s largest multi-specialty clinics, which he led.  

On top of all that, Jack was a very accomplished vocal soloist and creative composer. With my Mom, Carolyn, he wrote multiple songs and musicals, one of which is Seaplane! and has been performed over 40 times at Washington’s Kennedy Center and in other cities. The two also published books together; Thinking Placesis one of their best. 

One of Dad’s greatest songs from Seaplane! has the line:We stand on the shoulders of those who have gone before us.Let us not forget that. Let us also offer our shoulders to those who come after us. 

To your health! 

Zan