Community Based Community Based Clinical Trials Clinical Trials - - PDF document

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Community Based Community Based Clinical Trials Clinical Trials

LaDale K. George Partner, Foley & Lardner LLP

Sponsored by: Sponsored by: Abraxis Abraxis Oncology Oncology

Peter D. Eisenberg, M.D., FACP California Cancer Care, Inc. Brian Cornblatt, Ph.D. Director, Translational Research, St. Joseph Medical Center of Towson, Maryland

Clinical Research: Clinical Research: Making the Right Decision for Making the Right Decision for Your Practice Your Practice

LaDale K. George Partner, Foley & Lardner LLP

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Acknowledgements Acknowledgements

• Michael Blau
• Gregg Britt, CEO of INNOVIS, LLC
• Melissa Roth
• Donna, Avery & Quincy

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Agenda Agenda

• Overview of the research and clinical

innovation industry

• Evaluating clinical research program
• ptions
• Designing and implementing the right

program

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Industry Overview Industry Overview

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Industry Overview Industry Overview (cont

(cont’ ’d) d)

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The Drug Approval Process The Drug Approval Process

Preclinical Preclinical Testing Testing Product Product Creation Creation File File IND IND Phase I Phase I-

• III

III Clinical Clinical Trials Trials File File NDA NDA Phase IV Phase IV Clinical Clinical Trials Trials

Years Years Years Test Population Test Test Population Population Purpose Purpose Purpose Success Rate Success Success Rate Rate

6.5 6.5 6.5 Laboratory and animal studies Laboratory Laboratory and animal and animal studies studies Assess safety and biological activity Assess safety Assess safety and biological and biological activity activity 5,000 compounds evaluated 5,000 5,000 compounds compounds evaluated evaluated 1 1 1 20-80 healthy volunteers 20 20-

• 80

80 healthy healthy volunteers volunteers Determine safety and dosage Determine Determine safety and safety and dosage dosage 5 enter trials 5 5 enter trials enter trials 2 2 2 100-300 patient volunteers 100 100-

• 300

300 patient patient volunteers volunteers Evaluate effectiveness, look for side effects Evaluate Evaluate effectiveness, effectiveness, look for side look for side effects effects 3 3 3 1,000-3,000 patient volunteers 1,000 1,000-

• 3,000 patient

3,000 patient volunteers volunteers Verify effectiveness, monitor adverse reactions from long- term use Verify effectiveness, Verify effectiveness, monitor adverse monitor adverse reactions from long reactions from long-

• term use

term use 1-3 1 1-

• 3

3 Review process/ approval Review Review process/ process/ approval approval 1 approved 1 1 approved approved

File IND at FDA File IND at FDA File NDA at FDA File NDA at FDA

• Safety and

Safety and biological activity biological activity

• Toxicology

Toxicology

• Preclinical results

Preclinical results

• Study/protocol

Study/protocol design design

• Case report form

Case report form development development

• Selects sites from pool

Selects sites from pool

• f thousands where
• f thousands where

enrollment and enrollment and monitoring of 1,000 monitoring of 1,000-

• 10,000 patients takes

10,000 patients takes place place

• Data entry and

Data entry and verification verification

• Regulatory affairs

Regulatory affairs

• Pharmacoeconomics

Pharmacoeconomics

• Must comply with

Must comply with quality assurance quality assurance

• Continue chemical

Continue chemical analytical and analytical and stability studies stability studies Early Research/ Early Research/ Preclinical Testing Preclinical Testing Phase I Phase I Phase III Phase III FDA FDA Phase II Phase II Additional post- marketing testing required by FDA Additional Additional post post-

• marketing

marketing testing testing required required by FDA by FDA Phase IV Phase IV 8

Industry Overview Industry Overview (cont

(cont’ ’d) d)

• 8,386 clinical trial conducted in the U.S. in 2005.

(BCC Research)

• Spending for clinical trials in the U.S. $25.6 billion in

2006, projected to rise to $32.1 billion in 2011, an average annual growth rate (AAGR) of 4.6%. (BCC Research).

• $1.2 billion is the average cost of developing a new

biotechnology product. (Tufts Center for the Study of Drug Development)

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Clinical Research Program Options Clinical Research Program Options

Our Philosophy “Research and clinical innovation should be integrated into the operations and should support the advancement of the

• rganization’s strategic goals”

“The best defense is a good offense”

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Clinical Research Program Options Clinical Research Program Options (cont

(cont’ ’d) d)

• Clinical Research is a strategic decision

– Articulate the “why” – Articulate the “what” – Articulate the “how”

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Clinical Research Program Options Clinical Research Program Options (cont

(cont’ ’d) d)

• Articulate the “why”

– Scientific value – Reputation enhancement – Recruitment and retention of clinical talent – Expanded therapeutic options – Quality enhancement – Revenue diversification and enhancement

• Articulate the “what”

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Discovery Development/ Validation Clinical Innovation Clinical Integration

Translational Spectrum of Health Innovation

• Broad Adoption of

Innovation into Standard Practice

• Bed Side Treatments
• Clinical Protocol

Development

• Quality Care

Initiatives

• Outcomes Improve-

ment initiatives

• Health Services/

Cost Benefit Research

• Ground Breaking Health

Knowledge/Advancements

• Basic Science
• Bench Research
• Animal Studies
• Epidemiological Study

Development

• New Molecules
• New Drug Therapies
• New Devices
• New Diagnostics
• Novel Nursing

Intervention

• Surgical Techniques
• Early Adoption Process
• Validated New

Therapies/Approaches

• In-House Validation/Outcome

Studies

• Phase IV Clinical Trials
• Impact Analysis
• Epidemiological/Community

Health Impact Studies

• Technology Assessment
• Pre-Clinical Therapeutic

Development

• Non-Therapeutic Research
• Phases I, II, and III Clinical Trials
• New Device Trials
• Diagnostic Validation Studies
• Clinical Procedure Refinement/

Validation

• In-House Validation Studies

Clinical Research Program Options Clinical Research Program Options (cont

(cont’ ’d) d)

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Areas of Innovation and Research

Technology Assessment Education / Academic Affiliation B a s i c & A n i m a l R e s e a r c h Clinical Trials Research Subject Protection Program B i

• s

p e c i m e n & D a t a R e p

• s

i t

• r

i e s . Nursing Research Q u a l i t y O u t c

• m

e s Public & Population Health

Key Therapeutic Service Lines

C a r d i

• v

a s c u l a r Oncology O r t h

• p

e d i c s N e u r

• s

c i e n c e s P e d i a t r i c s / W

• m

e n ’ s H e a l t h C r i t i c a l C a r e / P u l m

• n

a r y

Clinical Research Program Options Clinical Research Program Options (cont

(cont’ ’d) d)

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Designing and Implementing the Designing and Implementing the Right Program Right Program

• Articulate the “How”

– Designing and implementing a clinical research program

• Step 1: Obtain meaningful understanding of

research activities

• Step 2: Design and implement effective research

infrastructure

• Step 3: Evaluate and adjust control systems

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New Study Study Feasibility Budget and Contracts Human Subject Regulatory Protections Clinical Operations Subject Recruitment/ Enrollment/Retention Monitoring and QA (Clinical) IRB Reporting Study Closeout

Clinical Research Flow Chart Clinical Research Flow Chart “ “Follow the Trial Follow the Trial” ”

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Designing and Implementing the Designing and Implementing the Right Program Right Program

• Step 2: Design and implement effective

research infrastructure

– Accessibility – Accountability – Reliability

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CRO Hospital

Hospital IRB

Principal Investigators

Commercial IRB

Sponsors Government

Designing and Implementing the Right Designing and Implementing the Right Program Program

(cont (cont’ ’d) d)

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Sponsors Hospital

Centralized Research Program Principal Investigators Hospital IRB Commercial IRB

CRO Government

Designing and Implementing the Right Designing and Implementing the Right Program Program

(cont (cont’ ’d) d)

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Designing and Implementing the Designing and Implementing the Right Program Right Program

(cont (cont’ ’d) d)

• Step 3: Evaluate and adjust control

systems

– Establish compliance baseline – Periodic operation audits

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Randomization Site Patient Health System Physician Clinic Non-Health System Physician Clinic Health System Ancillary Service Health System Emergency Depart. Service Health System Inpatient Service Health System Outpatient Service Non-Health System Service Research and Non- Research Service Sites Non-Health System Inpatient Health System Inpatient

Clinical Research Flow Chart “Follow the Patient”

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Contracted Parties NIH Research Site Investigator Research Clinical Service Research Staff Services Research Site Indirect Costs Recruitment Costs Regulatory Fees Use of Funds Source of Funds Philanthropy Industry Site/Investigat

• r Self Funded

Investigator Compensation Reports Time and Effort Fair Market Value Compensation Tax-Exempt Compliance

Clinical Research Flow Chart “Follow the Money”

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Summary Summary

• Clinical Research is a strategic decision
• Identify the Areas of Research and

therapeutic activity

• Designing and implementing a clinical

research program

• Understanding current research activities
• Establish research infrastructure
• Implement control systems

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Clinical Trials in the Community: Clinical Trials in the Community: Why They are Important and How Why They are Important and How to Succeed to Succeed

Peter D. Eisenberg, M.D. California Cancer Care

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Agenda Agenda

• What is the current situation?
• Who am I?
• Clinical trials in general
• Why participate?
• What are barriers?
• Protocol and other considerations
• Problems
• Possible solutions
• How to get started

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Office Office-

• Based Medical Oncologists

Based Medical Oncologists

• Want to provide state-of-the-art therapy
• Provide 85% of cancer care
• Provide most chemotherapy in the out-

patient setting

• Are experiencing:

– decreasing reimbursement – increasing hassles

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Oncology Clinical Trials Oncology Clinical Trials

• More oncology drugs in development than in any
• ther therapeutic area
• New drug combinations -- new drugs are

typically added to existing regimens

• Supportive medications -- growth factors, anti-

emetics and mucosal protectants

• Many new molecules with different properties

– Immunotherapy, vaccines, angiogenesis inhibitors, small molecule kinase inhibitors

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Pharmaceutical industry Pharmaceutical industry

• Market penetration is more difficult because:

– Proliferation of new drugs and treatment

regimens – FDA restrictions on drug promotion – Increased competition for physician’s time – Less doc access – More competition for study patients

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Agenda Agenda

• What is the current situation?
• Who am I?
• Clinical trials in general
• Why participate?
• What are barriers?
• Protocol and other considerations
• Problems
• Possible solutions
• How to get started

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Who am I? Who am I?

• University-trained
• Active in NSABP and ECOG as trainee
• Active in cooperative group studies as private

practitioner since 1979

• Active in pharmaceutical company trials since 1983
• Founder and past PI, Sutter Health Cancer

Research Group 1989 to 1999

• Past Member Exec Committee, NSABP
• PI, California Cancer Research Network

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Our Studies Our Studies

Abbott 4 Adria 13 Aesgen 1 Akzo/Organon 1 Allos Therapeutics 2 Alpha Therapeutics 5 Alza 4 Amgen 8 Angelini 1 Ascenta 2 Aventis 3 AZ 8 Bayer 4 Berlex 3 BioMedicines 2 Boehringer-Ingleheim 5 Boehringer-Mannheim 4 BristolMyers Squibb 3 British Biotech 2 Centeon 1 Centocor 1 ChugaiUpjohn 3 Ciba-Geigy 7 Corixa 1 CTI 5 Cytogen 2 Daichi 2 Dendreon Corporation 1 Dupont-Merck 1 Enzon 1 Exelixis 3 Faulding/Harris 2 Fujisawa 1 Genentech 12 Genetics Institute 1 Genitope 1 Glaxo 7 GlaxoSmithKline 7 GlycoDesign 1 Helsinn 3 Hoechst 2 Hoffman LaRoche 6 Imclone 3 Inex 2 Isis 3 Jansen 5

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Our Studies Our Studies (cont

(cont’ ’d) d) Knoll 3 Kosan 1 Ligand 6 Lilly 6 Luitpold 2 Marion Merrell Dow 6 Matrix 2 McNeil 1 Merck 10 MGI 7 Nordic Merrill Dow 1 Novartis 12 Nuvelo 1 Oncotech 1 Ortho 5 OrthoBiotech 6 OSI 2 Parke-Davis 2 Pfizer 17 Pharmacia 18 Pharmacyclics 2 PharmaNet 2 Rhone-Poulenc Rorer 12 Sandoz 1 Sanofi & SanofiSynthelabo 8 Schering-Plough 5 Searle 1 Serono 1 SmithKline Beecham 18 Solvay 1 SuperGen 5 Sugen 1 Syntex 1 Taiho 2 The Liposome Company 1 Threshold 2 Upjohn 2 US Surgical 1 Wyeth 1 Xcyte 2

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Agenda Agenda

• What is the current situation?
• Who am I?
• Clinical trials in general
• Why participate?
• What are barriers?
• Protocol and other considerations
• Problems
• Possible solutions
• How to get started

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A Clinical Trial A Clinical Trial

• Is a scientific study of a new therapy in

human beings

• Aims to show the superiority of one

treatment over another

• Provides valid and convincing evidence

about the effects of a medical therapy

Why Perform Clinical Trials? Why Perform Clinical Trials?

• The purpose of a clinical trial is to provide

valid and convincing evidence about the effects of a medical therapy

• A well conducted randomized trial

provides the highest quality information in clinical debates

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Agenda Agenda

• What is the current situation?
• Who am I?
• Clinical trials in general
• Why participate?
• What are barriers?
• Protocol and other considerations
• Problems
• Possible solutions
• How to get started

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Why do we do Clinical Trials? Why do we do Clinical Trials?

• It is our job

– get answers – help patients

• It is fun
• It makes money
• If not us, who?

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I Expect Patients Want to Know That: I Expect Patients Want to Know That:

• The treatment I offer is based on well-

designed clinical studies

• The treatment shows evidence that it is

superior to others

• It is safe, or that the side effects are

manageable

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Benefits of Performing Trials Benefits of Performing Trials

• Patient care is improved (even off-

study)

– Control arm is best therapy – Investigational agent may be better

• Patients stay in our practice and may

even come from the university

• Enhanced professional reputation
• Increased revenues

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Why is Pharma Interested in us? Why is Pharma Interested in us?

• We are where the patients are!
• We use the drug in the real world
• We’ll be enthusiastic if it works and use it

when it is approved

• Potentially faster initiation
• Potentially fewer hassles
• We’ll recommend it to our friends!

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Agenda Agenda

• What is the current situation?
• Who am I?
• Clinical trials in general
• Why participate?
• What are barriers?
• Protocol and other considerations
• Problems
• Possible solutions
• How to get started

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Obstacles to Implementing Cancer Obstacles to Implementing Cancer Clinical Trials Clinical Trials

• Fear of jeopardizing patient relationship
• Difficulty obtaining patient informed

consent

• Discomfort with randomization (or

placebo)

• Time demands
• Protocol demands (inflexibility,

monitoring)

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• Concerns regarding privacy and

confidentiality

• Costs (data monitor, reimbursement)
• Lack of physician leadership
• Lack of practice commitment

Obstacles to Implementing Cancer Obstacles to Implementing Cancer Clinical Trials Clinical Trials (cont

(cont’ ’d) d)

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Not all Docs are Skillful Recruiters Not all Docs are Skillful Recruiters

• Screening-Accrual Ratios for NCI

Cooperative Clinical Group Studies in Selected Disease Areas

Disease site # Contacts# SubjectsRatio Lung 155,000 1,395 111:1 Colon/rectum 151,000 2,687 56:1 Breast 142,900 3,890 37:1 Prostate 103,000 436 236:1

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Adults vs. Kids Adults vs. Kids

• 2 to 4% of adults enroll in clinical trials
• 65 to 70% of children enroll in clinical trials
• 28% of our newly diagnosed stage IV

colon cancer patients participated in clinical trails

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Agenda Agenda

• What is the current situation?
• Who am I?
• Clinical trials in general
• Why participate?
• What are barriers?
• Protocol and other considerations.
• Problems
• Possible solutions
• How to get started

Protocol Considerations Protocol Considerations

• Is the protocol suitable for the office-based

setting?

– Appropriate patient population – Unusual lab tests/timing – Extra patient monitoring visits

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Choose a Trial Choose a Trial

A trial must: – reflect our style of practice – BH & Xeloda – answer a question we want to answer – not be onerous to:

• patients
• staff

– compensate fairly

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Agenda Agenda

• What is the current situation?
• Who am I?
• Clinical trials in general
• Why participate?
• What are barriers?
• Protocol and other considerations
• Problems
• Possible solutions
• How to get started

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Problems Problems

• Lots of drugs in development
• Lots of competition for patients and docs
• Lots of disincentives to enter patients
• Therefore, limited access to patients
• Inability to measure capabilities of

investigators:

– Accrual – Speed – Quality

• Limited Pharma resources

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Problems with Sponsors Problems with Sponsors

• Don’t understand realities in caring for

patients

• CROs
• Move slowly -- “hurry up and stop”

– Contracting, budgeting, consents

• High staff turnover
• Don’t consider docs as partners and

customers

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Problems with Docs Problems with Docs

• Research is not a priority

– Pressures of patient care -- time

– Don’t make the synapse -- time – Don’t understand economics

• Lack efficient systems to identify, enter

and follow patients (EMR)

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Problems with Docs Problems with Docs (cont

(cont’ ’d) d)

• Unwilling to commit staff and time to do it

right

• Lack of responsiveness to sponsor, CRO,
• wn staff
• Don’t always give value for dollars
• May lose interest during trial – poor drug

performance or interaction with sponsor

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Problems Problems

• Cancer is unlike headache or

hypertension—patients have untreated stage IV breast cancer for a minute!

• We’re still doing trials the way we did

years ago—swapping a computer screen for a paper CRF is not progress

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Agenda Agenda

• What is the current situation?
• Who am I?
• Clinical trials in general
• Why participate?
• What are barriers?
• Protocol and other considerations
• Problems
• Possible solutions
• How to get started

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What I Learned What I Learned

• Provide a business to work with--docs tend to

be poor business people with conflicting pressures – Return phone calls – Work for pay – Don’t whine

• Establish policies and procedures
• Hire smart
• Pay well
• Get colleagues’ buy-in
• Be realistic

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We Should We Should

• Identify folks with whom we wish to partner
• Think systems and establish standards
• Be on first name basis
• Collaborate in protocol design, etc.
• Have standard contracts, budgets and

consents

• use standardized orders, forms and
• ther tools
• know the capabilities of doc’s practice—

subject population, methods of identification

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Docs Need Docs Need

• Truly effective drugs
• Studies which simulate our practice
• Ability to estimate accrual & identify subjects
• Ease of entering and following patients
• Simpler systems
• Information systems
• partnerships with sponsors
• standards for protocols, contracting, CRFs

and source documents

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Agenda Agenda

• What is the current situation?
• Who am I?
• Clinical trials in general
• Why participate?
• What are barriers?
• Protocol and other considerations
• Problems
• Possible solutions
• How to get started

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Find a Trial Find a Trial

• What illness & stage you want to study?
• Read—journals and your trash
• Call medical directors
• See reps and medical liaisons
• ASCO Annual Meeting
• Talk to others

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Be a Good Business Person Be a Good Business Person

• Respond to faxes, calls, e-mails immediately
• Do what you say you’ll do
• Be realistic in your predictions and

commitments

• Hire smart folks--pay them well
• Be committed
• Manage the research business
• Be fair
• Be a partner

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Summary Summary

• Participation in clinical trials is:

– the right thing to do – a good business move, done correctly – fun

• Collaboration and being a good business

person is the name of the game!

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Oncology Clinical Trials: Oncology Clinical Trials: The Value of Collaborations The Value of Collaborations

Brian Cornblatt, Ph.D. Manager, Oncology Clinical Trials Office Director, Translational Research The Cancer Institute at St. Joseph Medical Center

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Collaborations & Oncology Collaborations & Oncology

• “Collaborate” – to work together
• At the St. Joseph Medical Center the new

Cancer Institute was built around a MULTIDISCIPLINARY CARE model

– Treatment and supportive care for cancer patients involves a number of different medical and health care professionals – Health care professionals together consider all treatment options and develop an individual plan for each patient – The goal is to reduce mortality and improve a patient’s quality of life

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Lung and Bronchus Cancer Lung and Bronchus Cancer (Making the Diagnosis) (Making the Diagnosis)

• Medical History and

Physical Exam

• Performance Status

Assessment

• Imaging Tests (PET/CT,

MRI, Bone Scan)

• Sputum Cytology
• Fine Needle Biopsy
• Bronchoscopy
• Mediastinoscopy
• Thoracentesis
• Throracoscopy
• Blood Tests

Biopsy & Pathology Review (Surgeons, Pathologists) Internists & Oncologists Radiologists

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Collaborations & Clinical Trials Collaborations & Clinical Trials

• Successful clinical trials require a team effort

– Any potential new trial at SJMC is initially reviewed by the probable PI and the Oncology Clinical Trials Office (CRA, CRN) – Next, the trial is presented at the appropriate Multidisciplinary Conference (Thoracic, Breast, GI) and everyone in the room fills out a survey (for assessing overall interest amongst the team) …includes Medical Oncologists, Surgical Oncologists, Radiation Oncologists, Nurses, Pathology, Supportive Care

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Clinical Trial Survey Clinical Trial Survey

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Collaborations & Clinical Trials Collaborations & Clinical Trials

• Successful clinical trials require a team effort

– Any potential new trial at SJMC is initially reviewed by the potential PI and the Oncology Clinical Trials Office (CRA, CRN) – Next, the trial is presented at the appropriate Multidisciplinary Conference (Thoracic, Breast, GI) and everyone in the room fills out a survey (for assessing overall interest amongst the team) …includes Medical Oncologists, Surgical Oncologists, Radiation Oncologists, Nurses, Pathology, Supportive Care – If interest is high, additional staff (Pharmacy) may be asked to review before Regulatory preparations begin

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Collaborations & Clinical Trials Collaborations & Clinical Trials

(cont (cont’ ’d) d)

• When a trial officially opens a presentation is again

given at the appropriate Multidisciplinary Conference and laminated cards are handed out to all in attendance (trial synopsis, eligibility)

• If necessary, an in-service educational session is

initiated in physician’s offices so the entire staff is aware of the trial

• All Multidisciplinary Conference coordinators (nurse

navigators) now send out the list of patients to be presented at least 3 days prior (gives Oncology Clinical Trials Office time to go over eligibility)

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Catholic Health Oncology Network Catholic Health Oncology Network (CHON) (CHON)

• In 2007, ~ 1.4 million new cancer diagnoses will

be made in the U.S.

• 15% of the patients (210,000) will be treated at

the 61 designated NCI Centers (Hopkins, Lombardi, etc…)

• The remaining 85% (1,190,000) will be treated

across the country at community hospitals

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NCI Centers NCI Centers

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NCI & CHON NCI & CHON

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Catholic Health Oncology Network Catholic Health Oncology Network (CHON) (CHON)

• Goal - “Raise the bar” for cancer care

across the network

– Offer Phase I/II/III Clinical Trials

• Allows for optimum therapies in cancer care
• Unique trial offerings (possibly not available to NCI

centers)

• Complement existing trials network-wide

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Catholic Health Oncology Network Catholic Health Oncology Network (CHON) (CHON) (cont

(cont’ ’d) d)

• Design CHI-wide Video/Teleconference

Network

– Develop Multidisciplinary Care as the Standard of Care in CHI – Simulcast Multidisciplinary Care Conferences CHI-wide – Identify patients for clinical trials

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Catholic Health Oncology Network Catholic Health Oncology Network (CHON) (CHON) (cont

(cont’ ’d) d)

• Create recognized Oncology research

network

– Develop Tissue/Biofluid Repository – Develop CHON cohorts for Epidemiological studies

• Etiology of cancer (risk factors)
• Outcomes studies
• Unique opportunities to study “orphan”

cancers/populations

– Develop Core molecular facilities nationwide

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Catholic Health Oncology Network Catholic Health Oncology Network (CHON) (CHON) (cont

(cont’ ’d) d)

• Collaborate with NCI designated Cancer

Centers

– Breast Cancer Chemoprevention Studies (Johns Hopkins) – At local level, many physicians interested in participating in unique chemoprevention trials

78 Change in the US Death Rates* by Cause, 1950 & 2001

* Age-adjusted to 2000 US standard population. Sources: 1950 Mortality Data - CDC/NCHS, NVSS, Mortality Revised. 2001 Mortality Data–NVSR-Death Final Data 2001–Volume 52, No. 3. http://www.cdc.gov/nchs/data/nvsr/nvsr52/nvsr52_03.pdf 2 1 .8 1 8 0 .7 4 8 .1 5 86 .8 1 93 .9 5 7 .5 1 9 4 .4 2 4 5.8 1 00 2 00 3 00 4 00 5 00 6 00

Heart Diseases Cerebrovascular Diseases Pneum onia/ Influenza Cancer

1950 2001

Rate Per 100,000

Cancer Statistics 2004, American Cancer Society

The Problem Identified ... The Problem Identified ...

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Vegetable Consumption and Breast Vegetable Consumption and Breast Cancer Risk Cancer Risk

• Epidemiological studies (10 case-control and 7

prospective cohort) provide evidence for a modest inverse relationship between quantities

• f fruit and vegetables consumed and the risk of

developing breast cancer

• In the majority of the studies, only limited

information on cruciferous intake was available

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broccoli brussels sprouts cauliflower Chinese cabbage horseradish parsnip radish wasabi watercress white mustard

Cruciferae Cruciferae (aka (aka Brassicaceae Brassicaceae family) family)

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Chemoprevention Chemoprevention

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SULFORAPHANE DOSE (μmole) TUMOR INCIDENCE 20 40 60 80 0 75 150 TUMOR MULTIPLICITY 0.0 0.5 1.0 1.5 2.0 0 75 150 * p < 0.05 ** p < 0.01

* * ** **

• Overall, the incidence, multiplicity, and weight of mammary tumors

were significantly reduced, and their development was delayed

Prevention of DMBA Prevention of DMBA-

• induced

induced Mammary Tumors Mammary Tumors

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Localization of SULT1A1 Induction Localization of SULT1A1 Induction by Sulforaphane by Sulforaphane

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• Trial is designed around already-planned procedures (mammoplasty/mastectomy)

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Summary Summary

• Multidisciplinary Care, Clinical Trials, &

Collaborations

• Catholic Health Oncology Network &

Clinical Trials

• Collaborations with NCI designated

Cancer Centers

– Breast Cancer Chemoprevention Study

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Contact Us Contact Us

LaDale George Partner Foley & Lardner LLP 321 North Clark, Suite 2800 Chicago, IL 60610 Tel: 312.832.4388 lgeorge@foley.com Brian Cornblatt, Ph.D. Director, Translational Research St. Joseph Medical Center of Towson, Maryland 7601 Osler Dr., Bldg A, Suite G15 Towson, MD 21204 Tel: 410.337.4812 briancornblatt@catholichealth.net Peter Eisenberg, M.D., FACP California Cancer Care, Inc. 1350 South Eliseo Dr. Greenbrae, CA 94904 Tel: 415.925.5000 peisenberg@cal-cancer-care.com