Colleen Schmitt, MD, MHSMedical Director, Southeastern Clinical Research

Galen Medical Group

Chattanooga, Tennessee

Tracking Budgets & Trolling for Grants

Why Add Research to a Busy Practice?

Increase knowledge about diseases and therapies

Enhance image Participate in scientific

process Access to new therapies Alternative revenue stream

Hjorth et al. Control Clin Trials 1996;17:372Schmitt CM. J Clin Gastroenterol 2000;31:205

Potential Revenue…How?

Understand costs

Understand payment structures

Meet or exceed quota

Hoping for a Pieceof the Pie

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Foreign

PhRMA. Pharmaceutical Industry Profile 2007.

Growth in R&D (Billions)

Drug Development Process

www.phrma.org

PhaseII

PhaseIII

PhaseIV

Impact on Research Practice

PhRMA Annual Report, 2001

Site Selection

40% sites are new for any given trial

How to tap into the pipeline?

91% top 25 Big Pharma useword-of-mouth and networking

56% use external directories64% use internal database

CenterWatch 2001;8:1

Site Selection

Good Clinical Practice (GCP) www.barnettinternational.com www.socra.org SCR GCP update @ utcomchatt.org

Ability to deliver Therapeutic area expertise Strong reputation

Starting from Scratch

Track leads and sources• Feasibility questionnaires

Site CV’s and profile• Target: therapeutic area, sponsor, CRO• Metrics: enrollment, time to quota

Estimate site costs for activities• Fee-for-service basis• Hourly basis

List Site or Profile

www.centerwatch.com Study Brokers

www.invlocate.com www.researchsite.net www.clinicalinvestigators.com

Site Management Organizations (SMO) www.americasdoctor.com stark-smo.com smo-usa.com

Sites last accessed 05.July.2007

Sample Lead Sources

VendorVendor R & D Directions CenterWatch PhRMA NDA Pipeline Clinical Investigator

News Drug Development

Pipeline

WebsiteWebsite www.biz-lib.com www.centerwatch.com www.phrma.org www.fdcreports.com www.ctbintl.com www.biopharminsight.com

Protocol Considerations

Science Safety Feasibility Interest Financial

Sponsor Opportunity for

future work Idea for compound Therapeutic area Monitoring group

Schmitt CM. Gastrointest Endosc Clin N Am 2006;16:751

Meeting quota:Good Clinical Practice

ECOG study62% investigators did not enroll any

study subjects over the 1st year of study80% study subjects enrolled by 10%

investigatorsFewer subjects=more errors

Taylor KM, et al. J Clin Oncol 1994;12:1796

Rules of Thumb for Budget

Everything is negotiable Start with the protocol

Use the visit spreadsheet as rough draft

Scrutinize for undescribed work

Meeting Quota:Good Business Simple GERD trial Budget = $1200 per subject, quota = 10 Costs = $800 per subject + $1350 start-up

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GrossNet

Fee for Service

Full physical examination @ $200 Brief physical examination @ $100 Endoscopic procedures @ $1200 Pelvic examinations @ $200 DEXA scans, CXR, EKG @ $$ Coordinator visit @ $100

Budget Template

Procedure # $ per $ Total

Full PE 2 200 400

Brief PE 4 100 400

EKG 2 25 50

Lab draw 6 25 150

Other visits 4 100 400

DEXA 2 200 400

Total Per Patient $1800

Coordinator Costs

Base salary varies by

education, experience,

geography Benefits 25% base salary Time: long term studies (> 6 mos.),

electronic CRF, adverse events, protocol amendments

ACRP (www.acrpnet.org)DIA (www.diahome.org)

Where the Money Goes

Indirect Costs Lease, telephone, FAX,

computers, postage, banking

Pre-study Costs Travel, protocol review, contract and budget negotiation, regulatory, advertising

During Study Costs

Study visits, procedures, monitor visits, CRF completion, medications

Post-study Costs Query resolution, study close-out

Advertising$2000-3000 (ph. III, chronic disease)

Beware central advertising

Protocol

AmendmentsRegulatory resubmission, extra visits, adverse events

Up-front payments

1-2 patients or 20%

Final payment

1 patient or 15%

Overhead 20-25%

What’s Negotiable?

Anything Else?

Ancillary personnel Adverse events Specimen retrieval for central review Revisions to Case Report Forms (CRF) Follow-up laboratory evaluation

Money Pits

Overnight mail On-site labs (pregnancy test, U/A) Long term document storage Attendance at investigator’s meeting Telephone follow-ups and reminders Electronic data collection

50% > than paper CRF Query resolution Specimen retrieval

Negotiate for Success

Communicate effectively Base budget on protocol Know your costs Know your community and patient

population Understand your prior experience Know when to say “no, thanks”

Accounts Receivable

Beware scam payment systems based on Blocks of patients Query resolution at other sites Database closure

Invoice frequently Document all communication

Who, what, when, how

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Drugs

Biologics

Is the Future Rosy?

PhRMA. New Drug Approvals in 2006http://www.fda.gov/cder accessed 05.July.2007

New Drug Approvals, 2004

Of 29 Approvals in 2006, GI included:Amitiza® (lubiprostone)Pylera™ (biskalcitrate, TCN,

metronidazole)Sutent® (sunitinib)Tyzeka® (telbivudine)Veregen™ (kunecatechins)

PhRMA. Pharmaceutical Industry Profile 2006.

More About the Future Medicare Prescription Drug,

Improvement, and Modernization Act of 2003

Increased exportation of drug development in all clinical phases

Increased generic share in the marketplace

Importation of drugs via borders and internet

Learning curve in litigation

Summary

Lead by example Learn and live by

Good Clinical Practices Be responsible Get involved Require excellence

“There are some things you learnabout swinging a cat by the tailonly by swinging a cat by the tail.”

Mark Twain (paraphr.)Tom Sawyer, Abroad