Medical Affairs

Copyright © 2007. All Rights Reserved.

THE UNDERSTANDING PHARMA SERIES

MEDICAL AFFAIRS


Pre-Launch Launch and Growth Maturity

Note: This is a “directional” illustration of activity fluctuation within the medical information function.

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The central—and in some companies, the only—responsibility of Medical Affairs is operating a medical information function to field product queries.

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Primary Medical Affairs Capability

Medical Information


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Primary Medical Affairs Capability

Medical Information

Medical Affairs

Healthcare professionals contact the Medical Information group to report problems they have experienced and to ask questions about product use.

Adverse Events

ProductNews!


Range of Other Medical Affairs Capabilities

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In some organizations, operating the Medical Information group is the Medical Affairs group’s sole responsibility.

Complex Disease States

Previously Unaddressed

Need

Unique Scientific Aspects

requiring explanation

Complex or Expensive Treatment Regimens

Medical Information


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Clinical Trials

Favorable findings from non-registrational trials may, however, convince a pharmaceutical company to conduct additional registrational trials, seeking FDA approval of changes to the product label.

Note: This is a “directional” illustration of the roles of the difference in roles for Medical Affairs and Clinical Development.

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Moderate

High

Medical Affairs

Clinical Development

FDA Approval

Pre-Clinical Ph I Ph II Ph III Launch/Growth

Maturity

Stage in Product Lifecycle

Registrational Trials Non-Registrational Trials

Ph

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IIB

This product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen.

AdverseReactions

The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea and vomiting. These effects seem to be more prominent

Precautions

General: Acetaminophen and codeine phosphate tablets should be prescribed with caution in certain special- risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, head

Indicationsand Usage

Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain.

Each tablet contains:

300 mg/30 mg *

ClinicalPharmacology

Codeine phosphate, 7,8-didehydro-4, 5-epoxy-3-methoxy-17-methylmorphinan-6-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula:

Phase IIIB

Warnings

In the presence of head injury or other intracranial lesions, the respiratory depressant effects of codeine and other narcotics may be markedly enhanced, as well as their capacity for elevating effects, such

Contraindications

Update Product Label?

No Changes

New Findings


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Synthesizing all available research and health economics data, Medical Affairs provides Brand teams with insights about their products.


Contribution of Insights

Brand Team

Clinical Trial Findings

Health Economic ResearchFindings

Message 1Message 2

Living WellMagazine


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Medical Affairs cultivates relationships with key opinion leaders in a number of ways.

Study Sponsorship

STUDY GRANT

Preliminary Findings

Request for Participation in Clinical Trials and Speakers Programs

Medical Affairs

Information Sharing

Key Opinion Leader Relationships


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Educational Programs

Arthritis HIV / AIDS Cardiovascular Diseases

These programs are typically in therapeutic areas and disease states relevant to the company’s product portfolio.

Oncology


Disseminating Information

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The Medical Communications group within Medical Affairs designs and executes the publication plan for a product.

Publication Plan

When will the relevant data be available?

When should publications and press releases be scheduled?

What publications are ideal?

What assistance can we provide to the paper’s authors?


Disseminating Information

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In some companies, publication planning is a more strategic undertaking, with greater emphasis on defining the data needed to make the publications effort effective.

What are the key clinical messages?

What data are required to support them?

What gaps are there in available data?

How can those gaps be filled?

When will data be available? When should publications and press

releases be scheduled? What publications are ideal? What assistance can we provide to

the paper’s authors?

Health EconomicsAnd Outcomes Studies

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Schedule

Press Release

Select

Publications

Meet with

Authors

Obtain

AdditionalInformatio

n

Determine Key

Messages

Fill DataGaps

ObtainAdditional

Information

Refine Key

Messages

Make

Data

Decisions

Determine Availability

of Data

Determine Press

Release Schedule

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Schedule

Press Release

Select

Publications

Meet with

Authors


Medical Writing

The Medical Communications group also plays a role in medical writing for products in Phase IIIB and Phase IV trials.

“Dear Dr.” Letters

Presentation Slides

Posters

Abstracts

NEJM

Presentation Slides

Posters

Disease State / Drug

Introduction

Hypothesis

Results

Conclusion


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Medical Affairs may also be part of a promotional review committee, helping the Legal, Regulatory, and Compliance teams verify the accuracy of the clinical messages developed by the Brand team.

=Contraindications

This product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen.

AdverseReactions

The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down. Other adverse

PrecautionsGeneral: Acetaminophen and codeine phosphate tablets should be prescribed with caution in certain special- risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, head injuries, elevated intracranial pressure,

Indicationsand Usage

Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain.

Each tablet contains:

300 mg/30 mg Acetaminophen.......300 mg

Codeine Phosphate*……......30 mg

*WARNING: May be habit forming.

ClinicalPharmacology

Codeine phosphate, 7,8-didehydro-4, hemihydrate, a white

Warnings

In the presence of head injury or other intracranial lesions, the respiratory depressant effects of codeine and other narcotics may be markedly enhanced, as well as their capacity for elevating cerebrospinal fluid

FDA-Approved Package Insert

Legal

Regulatory

Compliance

PromotionalReview

Committee

Brand Team

Verified, Clinically-Accurate Commercial Messages

Copyright © 2007. All Rights Reserved.-Page 13-

Finally, Medical Affairs contributes valuable market intelligence.

Fielding of Medical Queries Ongoing Safety Monitoring

Non-Promotional Studies

Market IntelligenceField Operations

Support for Value Proposition

Health Economics and Outcomes Studies

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1st Qtr 2nd Qtr 3rd Qtr 4th Qtr

Non-Registrational Trials

Continuing Medical Education


Medical Affairs is a global function.

Global Development

Global Medical Affairs

Europe Medical Affairs

Global Commercial

US Medical Affairs

Example of Organizational Structure

Global Development CEO

Asia Medical Affairs

VP Sales and Marketing

Funding

Set Broad Strategy Ensure alignment across markets / avoid redundancy Define criteria for funding studies As appropriate, define global publication plan and pursue global KOL development.


Within individual markets, such as the US, Medical Affairs is sometimes organized by business unit, brand, or therapeutic area, so that the range of Medical Affairs services can be tailored to the complexity of the product and disease state.

Global Medical Affairs

Europe Medical AffairsUS Medical Affairs

Global Development CEO

Asia Medical Affairs

VP Sales and Marketing

Medical Director, Business Unit

Medical Director, Therapeutic Area

Option A

Medical Director, Brand

Option COption B

US Medical Affairs

Medical Director, Brand

Medical Director, Brand C

US Sales and Marketing

Brand ADirector

Brand B Director

Medical DirectorBrand B Funding


Although the precise way in which Medical Affairs defines its areas of specialization varies, for our purposes it is useful to arrange them in three broad groupings: Medical Research, Medical Services, and Medical Liaisons.

Medical Information Center Medical Communications Education and Training

Non-Registrational Clinical Trials

Health Economics and Outcomes

Corporate Accounts Therapeutic Area

VP US Medical Affairs

Medical LiaisonsMedical ResearchMedical Services

Medical Director

Documents

Medical Affairs