Our First Newsletter 3-2016

Our First Newsletter 3-2016

Our newsletter is here!

 

 

Don't miss our very first newsletter! Some updates, some reminders and five very exciting additions to our team!

 

Kinexum Services LLC

 

 

Your Kinexum News & Updates

 

 

Our newest members on the team

 

Kinexum is pleased to announce that we continue to expand our expertise across our organization from clinical to medical writing. Not only have we bolstered our regulatory and clinical aptness and skill  in endocrinology, but we are also developing our gastrointestinal and biologic practice with new additions. Our new experts come from a diverse set of backgrounds all with over 25 years of industry and/or FDA experience. Below is a small sampling of the newest members of the team. Click on their name to read a short bio on each new consultant.

 

Brian E. Harvey MD, Ph.D

 

 

Doug Muchmore, MD

Russel Neubauer, Ph.D

Charles Alexander, MD

Michael Schroeder, MS

 

 

 

Client Spotlight

 

Kinexum congratulates one of its oldest clients on being awarded an FDA Breakthrough Therapy Designation.

 

Dr.Zan Fleming, who was previously the senior endocrinologist at FDA, commented:  "This is a landmark FDA decision, not just for the patients with this rare disorder, but for all patients with mechanism-defined, very high risk obesity.  Developing drugs for obesity has been dauntingly difficult, but until now FDA has not reviewed data that fulfilled the criteria for awarding breakthrough or fast track designations to an anti-obesity therapy."  


More about the news

 

 

 

Widely acclaimed  Kinexum presentation

 

Dr. Gordon Cutler shared selected "lessons learned" 

during a career of clinical investigation and drug

discovery.  Topics included the science of selecting targets for drug discovery, useful skills and values for all scientists and the experience of presenting at controversial FDA Advisory Committee meetings.

 

To the full audio presentation 

 

Upcoming Friday Kinexum Call 

 

Dr. Brian Harvey brings a unique set of experience from academia, industry, and FDA where he served in CDRH, CBER, and CDER.  A gastroenterologist, he served as Director of the Divison of GI Products and Inborn Errors.  He will speak on the Kinexum Call this  Friday, March 18. Dr. Harvey gave this talk at the Biosimilars and Follow-On Biologics conference in Philadelphia earlier this month.

 

More about the conference

 

 

Upcoming Events - Domestic


Meet Dr. Zan Fleming in Boston as he gives a progress report:

 

Islet regeneration: Highest unmet clinical need among all metabolic diseases

More information

 

Upcoming Events - International


Meet Dr. Zan Fleming in Berlin as he gives the FDA Perspective. 


More information

 

 

Reflection - What is my profession ?

 

"The curricula of life have made each of us more than just a scientist, physician, communicator, or business leader.  We could answer that question differently on any given day.  The intent of the question is to remind us of the seriousness of the word.  The word profess is rooted in a context in which professing was regarded as a sacred act.  No matter what a person's profession may be, fulfillment and satisfaction soars when we sense that we are living up to this elevated form of professing."

                                                                                                                   Dr. Zan Fleming

 

 

 

 

 

Kinexum Services LLC, PO Box 1260, Harpers Ferry, WV 25425