Lessons Learned from a Junior-Intermediate Level Investigator’s Adventures with Industry: Successe...
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Lessons Learned from a Junior-Intermediate Level Investigator’s Adventures with Industry: Successes, Failures, and Various Forms. Gregory M Marcus, MD, MAS Associate Professor of Medicine Director of Clinical Research, Division of Cardiology University of California, San Francisco.

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Gregory m marcus md mas associate professor of medicine

Lessons Learned from a Junior-Intermediate Level Investigator’s Adventures with Industry: Successes, Failures, and Various Forms

Gregory M Marcus, MD, MAS

Associate Professor of Medicine

Director of Clinical Research, Division of Cardiology

University of California, San Francisco


What the talk is about

What the Talk is About

  • $

  • NIH, Foundations, Industry

 Meaningful Research


What the talk is about1

What the Talk is About

  • $

  • Does this talk relate to me (you)??

  • Industry

    • Money for your own projects

    • Money for their projects

    • And…

 Meaningful Research


What the talk is about2

What the Talk is About

  • Money for day care


Gregory m marcus md mas associate professor of medicine

  • “Sponsorship of drug and device studies by the manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

    • Useful to know and think about

    • This report does not and cannot explain why


Realities some might say downsides

Realities (some might say “downsides”)

  • The company’s job is to make money

    • And sell their product or device…or create one that will sell

  • How you as an investigator are perceived

  • Preclusion from certain activities (such as some guideline writing groups)


Realities some might say downsides1

Realities (some might say “downsides”)

  • The scary one:

    • There is data that investigators with COI are more likely to report positive results1-4

      • Although more recent data has actually failed to demonstrate an association in both oncology5 and cardiology.6

  • Riechelmann RP et al. J Clin Oncol 2007

  • Lerner TG et al. Contemp Clin Trials 2012

  • Jang S et al. Am J Clin Oncol 2011

  • Valachis A et al. J Clin Oncol 2012

  • Bariani GM et al. J Clin Oncol 2013

  • Aneja A et al. J Am Coll Cardiol 2013


Not all coi is the same

Not all “COI” is the same

  • Research funding

    • By definition you are conflicted

      • Every phase III trial of any FDA-approved pharmaceutical

  • Money for a talk

    • Various forms (they give you their slides versus make your own talk)

  • Consulting

    • Advisory board or steering committee

  • Inventorship and Equity


Imagine the purist view no relationships

Imagine the purist view: no relationships

  • Research funding

    • By definition you are conflicted

      • Every phase III trial of any FDA-approved pharmaceutical

  • Money for a talk

    • Various forms (they give you their slides versus make your own talk)

  • Consulting

    • Advisory board or steering committee

  • Inventorship and Equity


Mood baseline

MOOD: BASELINE


Mood papers

MOOD: PAPERS


Mood grants

MOOD: GRANTS


Lesson one

Lesson One


Gregory m marcus md mas associate professor of medicine

Canine ventricular tachypacing-induced CHF model

PFD = pirfenidone (an anti-fibrotic drug)

Lee K, et al. Circulation 2006


A clinical trial

A Clinical Trial

  • Long discussions regarding potential study designs

  • Power point with 3 potential study designs (higher cost and impact to lower cost and impact)

  • Half of first slide interrupted and discussion began

  • Nada


A clinical trial lessons learned

A Clinical Trial: Lessons Learned

  • A great opportunity:

    • At junior stage, default should be “yes”

  • Learned from the experience

    • Those three study designs apply to a lot of AF therapies

    • The template used for paper proposal can be recycled

      • Bullets

      • Minimal References

      • 2-4 pages

  • Some of these things take a looooooong time


Another clinical trial

Another Clinical Trial


Another clinical trial1

Another Clinical Trial

  • Came down to the budget

  • Didn’t happen


Another clinical trial lessons learned

Another Clinical Trial: Lessons Learned

  • Became familiar with budgeting for a multicenter trial

  • Which meant familiarity with multiple facets of a multicenter trial

  • Learned about meetings with CEO/ other members of other potential collaborating companies

  • Saw my mentor “in action”


Another clinical trial lessons learned1

Another Clinical Trial: Lessons Learned

  • Actually received some $

  • Unrestricted

  • Never received a start-up

    • Professional memberships

    • Travel

    • Investigator-initiated studies


Lesson one1

Lesson One

YEAR 7 Large grant/ PI of Coordinating Center for multicenter trial


Lesson 2

Lesson 2

Creative Inspiration via Multidisciplinary Exposure


Survey studies

Survey Studies

  • More than one treatment strategy commonly used in clinical practice

  • Equivocal data regarding which is superior

  • Test what people do and why

  • Rate control versus rhythm control in AF


Survey studies easy versus good

Survey Studies: Easy (versus good)

  • E-mail using the AMA Masterfile

    • Can not receive e-mail addresses directly

    • Every e-mal blast cost 475$ per thousand

    • Turns out not accurate

    • Could not determine who answered the survey

  • Compensation

    • Could not do electronically

    • Donate to charity

      • Can not do from UCSF


Survey studies easy versus good1

Survey Studies: Easy (versus good)

  • Got residents involved (good)

  • Response rate 19%

  • Found general internests not familiar with guidelines

  • Published in American Journal of Cardiology

  • Learned what NOT to do


Lesson 3

Lesson 3

Learn from Experience


Survey studies easy versus good2

Survey Studies: (easy versus) Good

  • Good data that primary prevention ICDs save lives in a large population

  • The number of ICDs implanted is substantially less than expected

  • Why?

  • Physician knowledge of guidelines

  • A potential mutual interest with device companies


Survey studies success

Survey Studies: Success

  • Most important metric for a survey study

    • Response rate

  • Methods to increase response rate

    • Cash

    • Short survey

    • Mail

    • Hand written addresses

    • Signed invitation letter

    • Actual stamps


Survey studies success1

Survey Studies: Success

  • Was not going to do it unless could do it right

  • Knew this was important and of interest

  • Dinner- personal meeting


Survey studies success2

Survey Studies: Success

  • BUDGET SCENARIO 1:

  • Honoraria are provided directly by St. Jude Medical.

    • No indirects on those payments

    • Only pay what have to

    • Possible participant perception problems

  • Total direct costs for budget scenario 1: $100,000 (with a plan to complete the study over a one year period). Note this does not include the honoraria that would be paid directly by St. Jude Medical.

  • Total including indirects if provided as an unrestricted grant (3%): $103,000

  • Total including indirects if provided as a regular (not unrestricted) grant (54.5%): $154,500


Survey studies success3

Survey Studies: Success

  • BUDGET SCENARIO 2:

  • The honoraria are provided by UCSF.

    • Perception probably better

    • We address, mail, keep track

    • BUT, have to assume a best case scenario response rate of 60% in this case.

  • Total direct costs for budget scenario 2: $200,000

  • Total including indirects if provided as an unrestricted grant (3%): $206,000

  • Total including indirects if provided as a regular (not unrestricted) grant (54.5%): $309,000


Lesson 4

Lesson 4

Grants and Contracts = Your Friend


Contracting

Contracting

  • St Jude

    • No contract because it was a gift

    • Worked in my favor


Contracting1

Contracting

  • Somalogic

    • Able to measure 1,000 biomarkers in blood

    • Eager to move forward

    • Did not review pre-existing contract (“material transfer agreement”/ “MTA”), sometimes “data distribution agreement”/ “DDA”

    • Concern regarding intellectual property

    • Never saw the primary data

    • UC grants and contracts will help with this


Money for their projects

Money for their projects

  • Site PI for an industry sponsored multicenter trial

  • Pros:

    • Some pay well (may turn into discretionary funds)

    • Get to see how they do it

    • Get to be involved in cutting edge drugs/ technology

    • May be opportunity for ancillary studies

    • Potential authorship


Money for their projects1

Money for their projects

  • Site PI for an industry sponsored multicenter trial

  • Cons:

    • Often payed per patient

      • Catch 22 if want to hire an RA

    • IRB/ contracts may take a while

      • Often requires back and forth with sponsor

      • CAN TELL IRB IF COMPETITIVE ENROLLMENT

    • Can miss out if out-competed

    • May not be authorship opportunities

    • May not be intellectually satisfying


Money for their projects2

Money for their projects

  • Site PI for an industry sponsored multicenter trial

  • Practicalities:

    • They often low-ball the budget

    • You can and should negotiate costs

      • Especially start-up costs!


Money for your their projects

Money for your/ their projects


Money for day care

Money for day care

  • Contacted by start-up company

  • Liked the idea

  • No funding

  • Responsive – opportunity through alacrity

  • Now “Consulting CMO”

  • VC meetings

  • Forming connections


Money for day care lessons learned

Money for day care: Lessons Learned

  • Contract is between you and the company

    • UCSF can be of some help

  • May be concern regarding IP when tell them need to pay UC Regents

  • UCSF Office of Technology Management is a good resource

  • Patents and what can be released

    • If not released, company may be concerned


Money for day care lessons learned1

Money for day care: Lessons Learned

  • Money:

    • Retainer

    • Advisory Board

    • Equity

      • IF NOT FUNDED WHEN DISCLOSE, DON’T HAVE TO PAY INTO COMP PLAN WHEN SELL STOCK


Conclusions

Conclusions

  • Industry $

    • Money for your own projects

    • Money for their projects

    • Money for daycare

  • Be careful!

    • Perception

    • Exclusion from other activities

    • Bias

  • Their job is to make money

  • Our job is to advance science and medicine


Gregory m marcus md mas associate professor of medicine

Thank You


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