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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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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 Investigator’s Adventures with Industry: Successes, Failures, and Various Forms

  • $

  • NIH, Foundations, Industry

 Meaningful Research


What the talk is about1
What the Talk is About Investigator’s Adventures with Industry: Successes, Failures, and Various Forms

  • $

  • 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 Investigator’s Adventures with Industry: Successes, Failures, and Various Forms

  • Money for day care



Realities some might say downsides
Realities (some might say “downsides”) manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

  • 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”) manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

  • 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 manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

  • 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 manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

  • 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 manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”


Mood papers
MOOD: PAPERS manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”


Mood grants
MOOD: GRANTS manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”


Lesson one
Lesson One manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”


Canine ventricular tachypacing-induced CHF model manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

PFD = pirfenidone (an anti-fibrotic drug)

Lee K, et al. Circulation 2006


A clinical trial
A Clinical Trial manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

  • 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 manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

  • 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 manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”


Another clinical trial1
Another Clinical Trial manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

  • Came down to the budget

  • Didn’t happen


Another clinical trial lessons learned
Another Clinical Trial: Lessons Learned manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

  • 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 manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

  • Actually received some $

  • Unrestricted

  • Never received a start-up

    • Professional memberships

    • Travel

    • Investigator-initiated studies


Lesson one1
Lesson One manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

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


Lesson 2
Lesson 2 manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

Creative Inspiration via Multidisciplinary Exposure


Survey studies
Survey Studies manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

  • 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: manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”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: manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”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 manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

Learn from Experience


Survey studies easy versus good2
Survey Studies: (easy versus) manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”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 manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

  • 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 manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

  • 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 manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

  • 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 manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

  • 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 manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

Grants and Contracts = Your Friend


Contracting
Contracting manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

  • St Jude

    • No contract because it was a gift

    • Worked in my favor


Contracting1
Contracting manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

  • 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 manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

  • 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 manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

  • 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 manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

  • 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 manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”


Money for day care
Money for day care manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

  • 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 manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

  • 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 manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

  • Money:

    • Retainer

    • Advisory Board

    • Equity

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


Conclusions
Conclusions manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”

  • 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


Thank You manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”


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