Pharmaceutical/biotechnology industry perspective• why pharmaceutical/biotechnology companies

should collaborate• what the pharmaceutical/biotechnology company

can provideExamples of collaboration

• safety and efficacy studies• cost effectiveness studies• treatment and functional status studies• clinical outcome measurement studies• quality-of-life studies• development of registries• guideline implementation and evaluation studies

Collaboration with risk sharing

Barriers to PartnershipPharmaceuticallbiotechnology companyManaged care organization

Case StudyThe Kaiser approachKaiser Permanente Northern California Region

• size of membership• number of facilities• number of physicians/staff

Creation of the Permanente Medical Group Research In­stitute

• mission

• goals

Long Range Strategic Research Planning Process27 Research areas identifiedFour categories

• evaluate and contribute to community health• attract and retain customers• provide care/care delivery• evaluate care

Gap analysis

• importance• adequacy

Top six research areasExamples: models of care; cost models

2:05 pm

The Role of the Health Care FinancingAdministration in Funding Clinical StudiesSteven Sheingold

2:25 pm

Why is Medical Device Technology MovingAbroad and How Can We Stop It?

James s. Benson

Learning objectives: It is the speaker's intent to:proVide at least five primary reasons for the increas­ing movement of the u.s. medical device industry tooffshore locations; discuss at least four deleteriOUs ef­fects caused by this escalating trend; and discuss waysin which the medical device industry is attemptinghalt this movement, which include: (1) legislative at­tempts to reform the Food and Drug Administration;

(2) legislative attempts to reform u.s. product liabilitylaws; and (3) attempts to effect FDA reform at the agencylevel.

THE medical device industry in the United States isundergoing radical changes. Numerous forces of boththe public and private sectors are dramatically increasingthe cost of product development and commercialization.Forces affecting the industry include a burdensomeregulatory process, increased pressure to contain health­care costs, an increasingly litigious environment, morerestrictive reimbursement policies, and diminishing ven­ture capital funds. These forces alter access to marketsand financing, and forces the industry to adapt, refocus,and reallocate its resources.

In the attempts to remain competitive, U.S. medicaldevice manufactures have made some significantchanges. Increasing numbers of companies are movingclinical trials and manufacturing facilities offshore. Re­search and development dollars, and new product intro­ductions, are following in the wake.

Together, these public and private forces are threat­ening the high quality of health care long enjoyed bypatients in America. Patients in the U.S. often receive thelatest advances in medical technology months or evenyears after than patients in other countries. This reflectslost opportunities to save lives, reduce hospitalizationcosts, and improve patient quality of life.

2:45 pm

Clinical Trials for Medical Devices: Focus onCarotid StentsSusan Alpert, PhD, MD

Learning objectives: It is the speaker's intent to discussthe FDA's role in clnical investigation ofmedical deVicesseeking marketing approval in hte U.S.; to provide wx­amples of significant risk and non-significant risk de­vices and the processes by which approval for studies ofthese devices are obtained; and to describe the role oftheFDA in the regulatino of medical device manufacturersas distinguished from physiians' fleXibility in the prac­tice of medicine.

THE FDA's role in the conducting of trials is first oneof patient protection. The law provides a role both forthe FDA and for institutional review boards (IRB) in as­sessing protocols and consent forms for any investiga­tion of medical devices that involves human subjects, asregulated in the Investigational Device Exemption (IDE).In this regulation, trials of medical devices are catego­rized as significant risk or non-Significant risk. Significantrisk studies require a full IDE with approval by both IREand FDA, whereas non-significant risk studies require anabbreviated IDE, which includes IRE approval but doesnot require review or approval at the FDA level.

Questions are often raised as to the need for an IDEfor a study of a device that is already in the marketplace.Although marketed devices may be used by a practitio­ner as appropriate for a patient according to the prod­uct's labeling or in ways that are considered off label, the

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