1. Interacting with Industry
John B. Buse, MD, PhD
Verne S. Caviness Distinguished Professor
Chief, Division of Endocrinology
Director, NC Translational and Clinical Sciences Institute
Executive Associate Dean, Clinical Research
University of North Carolina School of Medicine
Chapel Hill, NC

2. Presenter Disclosure – John Buse
Consultant: None
Employee: None
Research Support: AstraZeneca, Boehringer Ingelheim, Johnson & Johnson, Lexicon, Novo Nordisk, Sanofi, Theracos and vTv Therapeutics
Speaker’s Bureau: None
Stock options: Mellitus Health, PhaseBio Pharmceuticals
Adocia, AstraZeneca, Dexcom, Elcelyx Therapeutics, Eli Lilly, Intarcia Therapeutics, Lexicon, Metavention, NovaTarg, Novo Nordisk, Sanofi, Senseonics, and vTv Therapeutics
Other (advisor under contract with employer):

3. Timeline Lab jobs in high school and college
MD, PhD – immunology of type 1 diabetes
Fellowship – molecular biology of type 2 diabetes
After chief residency, decided that clinical investigation could provide an easier path for someone that was not going to give up clinical work and teaching
DRTC Education Core
GCRC Lab Core
DPP application
Parke-Davis clinical trial
Move to UNC

4. Critical decisions What would you want to do with industry?
Get their money to do your own research
Clinical trials
Consulting
Speaking
Full time work
How do you want to engage with industry?
Personally
Contracted through your employer
What is the gateway?
MSL

5. Clinical trials More difficult than you would think
Regulatory burden (contracting, IRB, training, record keeping, audits, meetings, s, queries )
Business burden (budgeting, invoicing, collecting)
There is more to do that can ever be imagined
You do not get paid until the work is done
Recruiting (EMR, registries, collaborations)
Personnel (coordinator )
Study selection
Be scrupulous with the details
AE assessments
Remember it is investigational

6. Consulting Easier than you would think To be viewed as an expert:
Publish
Stay up on the literature (DC, JCEM, Lancet D&E JAMA, NEJM, Lancet, AIM major preclinical journals at least second hand)
Volunteer with professional organizations (ADA, AACE, FDA, local hospital/healthcare system [P&T, IRB])
When you do have the opportunity to consult
Do your homework
Be honest and true to yourself - do not get sucked into trying to please your host
Participate. Say your piece clearly and try not harp on an issue
Be creative
Be responsive

7. Speaking Start locally – MUSC conferences, student teaching CME
Promotional

8. Full-time work

9. Important take home messages
Partnership with private sector creates a win-win situation
Industry provides resources, scale, need for speed, focus
Academia provides ideas, clinical experience, creativity, clarity
Great opportunity to diversify funding in a challenging time
You probably will have to push to be able to engage industry in a substantial and ongoing way. Lots of concerns about conflict of interest, independence in publishing, intellectual property.
Critical cultural requirements: transparency, communication, flexibility