medical affairs
DESCRIPTION
TRANSCRIPT
Copyright © 2007. All Rights Reserved.
THE UNDERSTANDING PHARMA SERIES
MEDICAL AFFAIRS
Copyright © 2007. All Rights Reserved.
Pre-Launch Launch and Growth Maturity
Note: This is a “directional” illustration of activity fluctuation within the medical information function.
Re
pre
se
nta
tiv
e
Ca
ll V
olu
me
The central—and in some companies, the only—responsibility of Medical Affairs is operating a medical information function to field product queries.
-Page 2-
Primary Medical Affairs Capability
Medical Information
Copyright © 2007. All Rights Reserved.
-Page 3-
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!
Copyright © 2007. All Rights Reserved.
Range of Other Medical Affairs Capabilities
-Page 4-
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
Copyright © 2007. All Rights Reserved.
-Page 5-
Range of Other Medical Affairs Capabilities
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.
De
vo
ted
R
es
ou
rce
s
Low
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
as
e I
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
Copyright © 2007. All Rights Reserved.
-Page 6-
Synthesizing all available research and health economics data, Medical Affairs provides Brand teams with insights about their products.
Range of Other Medical Affairs Capabilities
Contribution of Insights
Brand Team
Clinical Trial Findings
Health Economic ResearchFindings
Message 1Message 2
Living WellMagazine
Copyright © 2007. All Rights Reserved.
-Page 7-
Range of Other Medical Affairs Capabilities
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
Copyright © 2007. All Rights Reserved.
-Page 8-
Range of Other Medical Affairs Capabilities
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
Copyright © 2007. All Rights Reserved.
Disseminating Information
-Page 9-
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?
Copyright © 2007. All Rights Reserved.
Disseminating Information
-Page 10-
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
242322
171615
1098
321
242322
171615
1098
321
27
28
2625
20
21
1918
13
14
1211
6
7
54
27
28
2625
20
21
1918
13
14
1211
6
7
54
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
242322
171615
1098
321
242322
171615
1098
321
27
28
2625
20
21
1918
13
14
1211
6
7
54
27
28
2625
20
21
1918
13
14
1211
6
7
54
Schedule
Press Release
Select
Publications
Meet with
Authors
Copyright © 2007. All Rights Reserved.
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
Copyright © 2007. All Rights Reserved.
-Page 12-
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
0
10
20
30
40
50
60
70
80
90
1st Qtr 2nd Qtr 3rd Qtr 4th Qtr
Non-Registrational Trials
Continuing Medical Education
Copyright © 2007. All Rights Reserved.
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.
Copyright © 2007. All Rights Reserved.
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
Copyright © 2007. All Rights Reserved.
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