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 jbuse@med.unc.edu

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):

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

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

Clinical trials More difficult than you would think Regulatory burden (contracting, IRB, training, record keeping, audits, meetings, emails, 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

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

Speaking Start locally – MUSC conferences, student teaching CME Promotional

Full-time work

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