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“Optimizing Your Involvement In Clinical Trials”

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Investigator Landscape

Pre 1995

focus on science

close and collegial

largely academic based

safety and efficacy

few intermediaries

simple and minimal oversight

Ken Getz

Post 1995-now

focus on markets

distant and contractual

community, for profit based

speed and cost

many diverse intermediaries

complex and strict oversight

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Investigator Landscape (continued)

78% of Americans consider their physician the most trusted source for medical and health-related information but only 17% report that they learned about clinical research from their specialty or primary care physician.

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Challenges Recruitment

Bureaucracy

Protocol Complexity

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Recruitment Challenges

Information provided by sponsor is not comprehensive enough for the investigator to make a good projection on their ability to recruit for the trial.

By the time the protocol is finalized it may be a completely different recruiting picture for the investigator compared to the initial information provided by the sponsor.

Protocol complexity has increased, making it more difficult to find patients that meet inclusion and exclusion criteria or be willing come to all the appointments needed for all the procedures that are required.

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Recruitment Challenges

Budgets are often not presented until late in the process and sometimes are so far off from the investigators perspective there is no reason to even negotiate.

Investigators in large practice groups have difficulty getting referrals from other physicians in the group because the other physicians are so busy and do not think to refer patients even if they are willing to do so.

Protocols are often developed without real world input from experienced clinician investigator and coordinators.

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Bureaucracy Challenges

Investigators, especially at academic institutions, often are caught between the institutions legal department and the sponsor’s legal department.

Repeated disputes over the same language in contracts often occurs and is resolved with virtually the same results and causes delays in study start up.

It was acknowledged that the IRB is outside of the sphere of influence of the sponsor and that investigators need to work with their institutions to streamline IRB processes.

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Protocol Complexity Challenge

Protocol complexity is making doing the trials difficult and time consuming for patients, physicians and their staff.

In addition to increased protocol complexity, numerous amendments required impact getting the trial done.

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CompetitionWhat is it that number one and two Pharma companies do better

than the others?

Enhance opportunity for clinical research

Listen to original research

The Ops people have authority to make decisions and make themselves accessible; e.g.: access to decision makers during study

Clinical team extremely supportive

Better data entry system

Commitment to the clinical trial process

Well organized; emphasis on rigorous science experienced

Science

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How is Novartis an Opportunity?

Field Ops committed to engaging investigators that have patients that could benefit from novel treatments, matching your interest with our needs.

Our portfolio provides research opportunities.

Engaging you when the protocol is well defined.

Novartis partners with you to create recruitment strategies to help you be successful. “A hands on approach.”

The National CRADA simplifies the contract negotiation process with Novartis, as start up efficiency is a key success factor.

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Novartis Clin Ops Mission

“

“To deliver quality data in a timely manner through strong relationships.”

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Matching Interest with Need

The Novartis Portfolio offers opportunities

Development (phases 1-3)

Life cycle management (phase 4)

Therapeutic Areas

Cardiovascular Disease, Diabetes

Respiratory Disease, Dermatology

Infectious Disease (Hepatology), Immunology (i.e. lupus, Arthritis)

Transplant immunosuppressive therapies

Neuroscience (psychiatric illness, MS, seizure disorders, Parkinson's)

Ophthalmology (macular degeneration)

Oncology

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Matching Interest with Need Planned Trials

Cardiovascular Disease

Treatment for Chronic Systolic Heart Failure

Respiratory Disease, Dermatology

LABA and LAMA alone and in Combination in COPD

LABA/Steroid in Asthma

Biologics in Psoriasis

Nicotine Vaccine (2011)

Add-on Treatment in Pulmonary Atrial Hypertension

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Matching Interest with Need Planned Trials

Infectious Disease (Hepatology), Immunology (i.e. Arthritis, Gout)

Transplant immunosuppressive therapies

Pretreatment for Dialysis

(non-interferon) Treatment for Hepatitis B and C

Treatment for acute resistant Gout flares

Biologic in OsteoArthritis and RA

Neuroscience

Novel treatment for Multiple Sclerorsis

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The Way Forward

Field operations colleagues are the first point of contact.

The CRA is responsible for conducting screening

Supported by an in-house clinical team

Once interests are known, local teams nominate potential investigators to match Novartis needs with your interest

Finding solutions to start up trials quickly will add to success