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Ongoing Competitive Clinical Trials Information…
“Mining for Gold”
Zorba B. Lieberman
June 6, 2005
What is TrialTrove?
Competitive Clinical Trials Surveillance Service
 Global coverage of ongoing trials
 Customized Web-enabled database shared
across the enterprise
 Continuously up to date
 Mechanism to include internal intelligence
 Built-in alerting system
 Unlimited research support
Themes for Today
Getting the information
 Where ongoing trials information can be
found and how much is out there
Using the information
 Understand where your competitor is with
executing on their strategy
 Making adjustments to your own drug
development and commercialization strategy
Trials Information Sources
 Web sources including:
• Government (clinicaltrials.gov, cancer.gov)
• Other trials listings sources (controlled trials UK,
Centerwatch)
• Research centers & community hospitals
• Company Web sites
 News feeds
 SEC filings and analyst conference calls
 Medical meetings
Example: Breast Cancer Trials
clinicaltrials.gov
TrialTrove
Diff.
181*
337
1.9x
473*
1,092
2.3x
Actively
Recruiting
Total Trials
* diagnostic, genetic marker, non-Rx treatment trials excluded.
Source: Citeline, clinicaltrials.gov
Example: Breast Cancer Trials
1,092 Trials (2.3x)
Ex-US
431 (5.1x)
US
661 (1.7x)
473 Trials
85
Ex-US
388
US
clinicaltrials.gov
Source: Citeline, clinicaltrials.gov
TrialTrove
How Clients Use Trials Information…
…to understand their competitive
environment
5
4
3
2
1
Number of Trials
Targeted Indications: Bay 43-9006
7
6
0
Head/Neck
Brain, Other
Brain, Glioblastoma
Gastric
Leukemia, Chronic Myelogenous (CML)
Myelodysplastic Syndrome
Skin, Basal Cell Carcinoma
Prostate
Pancreas
Breast
Liver
Ovarian
Melanoma
Lung, Non-Small Cell
Renal
Colorectal
Targeted Cancer Type
Bay 43-9006 trials in 23 countries
1
10
3
22
23
1
2
1
1
3
2
1
Bay-43-9006 Clinical Development Program
2001
2002
2003
2004
2005
2006
Q1/Q2
Q3/Q4
Q1/Q2
Q3/Q4
Q1/Q2
Q3/Q4
Q1/Q2
Q3/Q4
Q1/Q2
Q3/Q4
Q1/Q2
Solid tumors, safety, 46 pts
Solid tumors, safety, 25 pts
AML/MDS, safety, 36 pts
Skin and renal, Bay 43-9006 + CAR and PAC
Solid tumors, safety Bay 43-9006 + OXAL, 24 pts
Phase I
Solid tumors, safety Bay 43-9006 + DOX, 34 pts
Healthy, cardio effects, 20 pts
Glioma, safety, 6-36 pts.
Solid tumors, safety, Bay + BEV, 38 pts
Phase I/II
Solid tumors, safety Bay 43-9006 + GEM, 42 pts
Melanoma, efficacy, 35 pts
Solid tumors, safety/efficacy, 502 pts
Liver, efficacy, 232 pts
Liver, efficacy, 137 pts
Melanoma, safety/efficacy, 20 pts
Melanoma, dose finding, 80 pts
Breast cancer, safety/efficacy, 20-42 pts
Phase II
Breast cancer, safety/efficacy
Notes: OXAL = Oxaliplatin
CML (imatinib resistant), safety/efficacy, 21-50 pts
DOX = Doxorubicin
Ovarian, safety/efficacy, 22-60 pts
GEM = Gemcitabine
Ovarian, safety/efficacy, Bay+GEM, 19-33 pts
CAR = Carboplatin
Ovarian, safety/efficacy, Bay +/- PAX and CAR, 21-52 pts
PAC = Paclitaxel
Pancreas, safety/efficacy/biomarkers, Bay + GEM, 12-35 pts
IFNa = Interferon alfa
NSCLC, efficacy/biomarkers, 227 pts
BEV = Bevacizumab
NSCLC, efficacy/ biomarkers, 12-40 pts
Head/neck, safety/efficacy, 20-40 pts
Key: Completed trials
Prostate (androgen ind.), efficacy/biomarkers, 22-46 pts
Closed trials
Prostate (androgen ind), efficacy/biomarkers
Open trials
Prostate (hormone-refractory), efficacy/biomarkers, 25 pts
Renal, safety/efficacy, Bay-43-9006 + IFNa, 55 pts
Renal, safety/efficacy, Bay-43-9006 + IFNa, 40 pts
NSCLC, efficacy/biomarkers, 20-46 pts
Phase III
Renal, safety/efficacy, 800 pts
The Value of Trials Information for CI
Discovery
 “I didn’t know that [Company X] had initiated a Phase
II trial in Glioblastoma..!”
Get depth of detail
 Details of trial design offer leading edge insights into
competitor plans
Identify patterns
 Asses a competitor’s commercialization strategy
How Clients Use Trials Information…
…to adjust their own development
programs as the competitive
environment changes
0
Targeted Cancer Type
CML
Brain, Medulloblastoma
Soft Tissue Sarcoma
Multiple Myeloma
Small Cell Lung
Head/Neck
Prostate
Myelodysplastic Syndrome
Liver
Brain, Glioblastoma
Melanoma
AML
Ovarian
Gastric
Pancreas
NHL
Renal
Breast
Non-Small Cell Lung
Colorectal
Number of Trials
Phase II and III Anti-VEGF Trials
20
18
16
14
12
10
8
6
4
2
Historical Enrollment Rates
# Patients
# Sites
Enrollment
Period (mos.)
Trial #1
521
51
4
2.6
Trial #2
769
73
12
0.9
Trial #3
536
39
11
1.2
Trial #4
182
18
9
1.1
Source: Citeline
(sample of Alzheimer’s trials data)
Weighted
Average:
Enrollment Rate
(pts./site/mo.)
1.4
Using Trials Information to Make
Internal Business Decisions
 Decide which indications to target
 Predict trial duration
 Assess protocol design
 Optimize geography to find patients
 Identify investigators/KOLs
Summary
 There is a lot of ongoing trials information out
there, but it is very fragmented and diffuse
 Effectively assimilating the fragments can
offer a tremendous competitive advantage
 Besides understanding competitors’ actions
and intent, companies can use this
information to optimize their own drug
development