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50 0 0
20
40
60
80
100
Number of Indications
N umbe r of
Indica tions
1
2-5 6-12 13-29 31-81 Most firms work on
Supporte d
N umbe r of
F irms
433
703
244
50
20
multiple indications.
Indication
E ($ m)
Infectious
AIDS
NSAID
Arthritis
Depression
Neuropharmacolo gical Class
Migraine
Alzheimer’s Disease
Arrhythmia
Cardiovascular Class
High Cholesterol
Optimizing New Байду номын сангаасrug Pipeline – one business opportunity
Ding and Eliashberg, 2002, Management Science
From Pipelines to Portfolios – many business opportunities
June 4-8, 2004
10
From Pipelines to Portfolios
Research Objectives
Understand how risk and expected reward change as the nature of a pipeline changes.
Today: How Phase III variance and expected reward change as the degree of correlation changes
From Pipelines To Portfolios
Min Ding Jehoshua Eliashberg
Pennsylvania State University University of Pennsylvania
Choice Symposium June 4-8, 2004
Outline
June 4-8, 2004
5
Optimizing New Drug Pipeline
One Key Insight - A Pattern of Underspending? (Ding and Eliashberg, Management Science, 2002)
Therapeutical Class
June 4-8, 2004
11
From Pipelines to Portfolios
Indication Level -- Scenario
2. Rank order each business opportunity 3. Build a portfolio by supporting those business
opportunities whose expected values are above a threshold (e.g., marginal return, IRR)
Question: How many alternative approaches should the firm pursue at each NPD stage?
June 4-8, 2004
4
Optimizing New Drug Pipeline
Model Output For each phase in development, we derived the expected reward, variance, and likelihood of having a successful drug candidate. For example, for Phase III, they are, respectively,
– Indication level – Area level
Develop optimal portfolio, given a certain managerial objective
Today: An application for Glaxo-Smith-Kline (GKS)’s Phase III subportfolio
Succeeded:
Correctly recognized the importance of crossproject effects in structuring portfolio Developed the necessary organizational structure (e.g., 3 tier structure at GSK)
Example: SmithKline in mid-1990s (HBR, 1998)
June 4-8, 2004
8
From Pipelines to Portfolios
State of Art Practice – GlaxoSmithKline, 2003
Six Centers of Excellence (Therapeutic Class) for
Psychiatry
Respirator y and
Inflammati on
Indications Supported
In Each CEDD
9 (Stroke) and 3 (ED)
5 (Obesity) and 7 (HIV)
7 (Sepsis), 2 (osteoporosis) and 9 (cancers)
June 4-8, 2004
7
From Pipelines to Portfolios
A conventional approach to portfolio construction
Portfolio construction is the sum of pipelines.
Process:
1. Develop a (not necessarily optimal) pipeline for each business opportunity independently and calculate the expected value
Some theoretical insights An empirical demonstration -- GlaxoSmithKline
June 4-8, 2004
2
Terms Used in Presentation
Indications
Also known as disease Each indication is considered as one business opportunity
Therapeutical Classes
Also known as therapeutical areas, groups, or categories
• e.g., Anti-infective products
Each class has many different indications We use the term “portfolio” to represent the NPD structure for many different indications, within or across different therapeutical classes. A portfolio has many different pipelines (or projects).
E[1(n1)] [1 (1 p1)n1 ]E[0 (s1 0)] n1c1
V[1 (n1 )] (1 p1 ) n1 [1 (1 p1 ) n1 ]E[0 (s1 0)]2
L1 (n1 ) 1 (1 p1 ) n1
We solve for the optimal number of approaches to be supported at each phase in development
552
12 10 3
18 17 7
11 11 4
Novartis 1 1 ?
20 19 7
Pfizer
WarnerLambert
BMS
111 11? 111
2 22 16 10 4 17 11 5
June 4-8, 2004
6
Firms Target Multiple Business Opportunities
Failed:
Risk has not received sufficient attention, ENPV is the most commonly used metric. No rigorous portfolio evaluation process and optimization model exist.
– a survey of new drug portfolios in 1450 firms on 12/31/2002
Number of Indications Targeted by a Firm December 31, 2002
Number of Firms
500 450 400 350 300 250 200 150 100
Drug Discovery (CEDDs)
Cardiovascul ar and
Urogenital
Metabolic and Viral Diseases
Microbial, Musculoskelet
al and Proliferative
Diseases
Neurology and
Gastrointesti nal
Hypertension
130 3078 2036 655 6773
94 1484 5174
Lead firm
BMS Monsanto
Merck Eli Lilly
actual pipeline
21? 222 2 2 1 111
pipeline structure recommended by
our model
• e.g., AIDS
We use the terms “pipeline or project” to represent the NPD structure for a given indication We use “approach” to represent a specific way (e.g., a compound, a biological molecule) of drug development tailored for a given indication.
Clinical Phase I
Clinical Phase II
Clinical
1
launch
Phase III
Alternative approaches: subunit vaccine, recombinant vector vaccine,
peptide vaccine, virus-like particle vaccine, plasmid DNA vaccine, “naked DNA”vaccine, wholeinactivated virus vaccine, live-attenuated virus, etc.
11 (Alzheimer's) and 5 (Irritable bowel synd.)
9 (Depression)
4 (Asthma) and 3
(Rheumatoid arthritis)
June 4-8, 2004
9
From Pipelines to Portfolios
Where does the state of the art practice succeed and fail?
June 4-8, 2004
3
Optimizing New Drug Pipeline
An Example
Bristol-Myers Squibb wants to develop a preventive HIV vaccine ...
Pre-clinical trial
NPD in Pharmaceutical Industry
20
40
60
80
100
Number of Indications
N umbe r of
Indica tions
1
2-5 6-12 13-29 31-81 Most firms work on
Supporte d
N umbe r of
F irms
433
703
244
50
20
multiple indications.
Indication
E ($ m)
Infectious
AIDS
NSAID
Arthritis
Depression
Neuropharmacolo gical Class
Migraine
Alzheimer’s Disease
Arrhythmia
Cardiovascular Class
High Cholesterol
Optimizing New Байду номын сангаасrug Pipeline – one business opportunity
Ding and Eliashberg, 2002, Management Science
From Pipelines to Portfolios – many business opportunities
June 4-8, 2004
10
From Pipelines to Portfolios
Research Objectives
Understand how risk and expected reward change as the nature of a pipeline changes.
Today: How Phase III variance and expected reward change as the degree of correlation changes
From Pipelines To Portfolios
Min Ding Jehoshua Eliashberg
Pennsylvania State University University of Pennsylvania
Choice Symposium June 4-8, 2004
Outline
June 4-8, 2004
5
Optimizing New Drug Pipeline
One Key Insight - A Pattern of Underspending? (Ding and Eliashberg, Management Science, 2002)
Therapeutical Class
June 4-8, 2004
11
From Pipelines to Portfolios
Indication Level -- Scenario
2. Rank order each business opportunity 3. Build a portfolio by supporting those business
opportunities whose expected values are above a threshold (e.g., marginal return, IRR)
Question: How many alternative approaches should the firm pursue at each NPD stage?
June 4-8, 2004
4
Optimizing New Drug Pipeline
Model Output For each phase in development, we derived the expected reward, variance, and likelihood of having a successful drug candidate. For example, for Phase III, they are, respectively,
– Indication level – Area level
Develop optimal portfolio, given a certain managerial objective
Today: An application for Glaxo-Smith-Kline (GKS)’s Phase III subportfolio
Succeeded:
Correctly recognized the importance of crossproject effects in structuring portfolio Developed the necessary organizational structure (e.g., 3 tier structure at GSK)
Example: SmithKline in mid-1990s (HBR, 1998)
June 4-8, 2004
8
From Pipelines to Portfolios
State of Art Practice – GlaxoSmithKline, 2003
Six Centers of Excellence (Therapeutic Class) for
Psychiatry
Respirator y and
Inflammati on
Indications Supported
In Each CEDD
9 (Stroke) and 3 (ED)
5 (Obesity) and 7 (HIV)
7 (Sepsis), 2 (osteoporosis) and 9 (cancers)
June 4-8, 2004
7
From Pipelines to Portfolios
A conventional approach to portfolio construction
Portfolio construction is the sum of pipelines.
Process:
1. Develop a (not necessarily optimal) pipeline for each business opportunity independently and calculate the expected value
Some theoretical insights An empirical demonstration -- GlaxoSmithKline
June 4-8, 2004
2
Terms Used in Presentation
Indications
Also known as disease Each indication is considered as one business opportunity
Therapeutical Classes
Also known as therapeutical areas, groups, or categories
• e.g., Anti-infective products
Each class has many different indications We use the term “portfolio” to represent the NPD structure for many different indications, within or across different therapeutical classes. A portfolio has many different pipelines (or projects).
E[1(n1)] [1 (1 p1)n1 ]E[0 (s1 0)] n1c1
V[1 (n1 )] (1 p1 ) n1 [1 (1 p1 ) n1 ]E[0 (s1 0)]2
L1 (n1 ) 1 (1 p1 ) n1
We solve for the optimal number of approaches to be supported at each phase in development
552
12 10 3
18 17 7
11 11 4
Novartis 1 1 ?
20 19 7
Pfizer
WarnerLambert
BMS
111 11? 111
2 22 16 10 4 17 11 5
June 4-8, 2004
6
Firms Target Multiple Business Opportunities
Failed:
Risk has not received sufficient attention, ENPV is the most commonly used metric. No rigorous portfolio evaluation process and optimization model exist.
– a survey of new drug portfolios in 1450 firms on 12/31/2002
Number of Indications Targeted by a Firm December 31, 2002
Number of Firms
500 450 400 350 300 250 200 150 100
Drug Discovery (CEDDs)
Cardiovascul ar and
Urogenital
Metabolic and Viral Diseases
Microbial, Musculoskelet
al and Proliferative
Diseases
Neurology and
Gastrointesti nal
Hypertension
130 3078 2036 655 6773
94 1484 5174
Lead firm
BMS Monsanto
Merck Eli Lilly
actual pipeline
21? 222 2 2 1 111
pipeline structure recommended by
our model
• e.g., AIDS
We use the terms “pipeline or project” to represent the NPD structure for a given indication We use “approach” to represent a specific way (e.g., a compound, a biological molecule) of drug development tailored for a given indication.
Clinical Phase I
Clinical Phase II
Clinical
1
launch
Phase III
Alternative approaches: subunit vaccine, recombinant vector vaccine,
peptide vaccine, virus-like particle vaccine, plasmid DNA vaccine, “naked DNA”vaccine, wholeinactivated virus vaccine, live-attenuated virus, etc.
11 (Alzheimer's) and 5 (Irritable bowel synd.)
9 (Depression)
4 (Asthma) and 3
(Rheumatoid arthritis)
June 4-8, 2004
9
From Pipelines to Portfolios
Where does the state of the art practice succeed and fail?
June 4-8, 2004
3
Optimizing New Drug Pipeline
An Example
Bristol-Myers Squibb wants to develop a preventive HIV vaccine ...
Pre-clinical trial
NPD in Pharmaceutical Industry