BPL’s Study Planner and Site Selector applicationis used to

Help our clients quickly and efficiently:

• Analyze sponsor, public, and commercial clinical study data

• Match to the patient populations & disease prevalence

• Examine the competitive market

• Run “evidence-based” allocation scenarios

• To generate a high quality, empirical based INVESTIGATOR TARGET LIST

How do we do it?

BPL Utilizes Multiple Data Inputs and Collates Various Data Sources

DiseasePrevalence

Per Subject

Cost

Ethics Approval

Time

Contract Approval

Time

Site Feasibility

Data

Past Enrollment

Performance

Expected Subject

Contribution

Potential # of Sites

Monitoring Resource

Availability

Identify the Mix of Countries & StatesThat Will:• Optimize Enrollment Time• Minimize Costs • Achieve Strategic Business Objectives• Analyze Multiple Data Inputs• Accommodate Resource Constraints

Strategic Marketing

Needs

CompetitiveLandscape

Drug Importation

TimeEnrollmentTime

RegulatoryApproval

Time

First, We Start by:

Performing a protocol feasibility analysis.

• Using Dx (health claims) and Rx (prescriptions) data available in the US, we examine the patient population (anonymously and in aggregate) against the inclusion / exclusion criteria

• Applying a series of “filters” based on the study criteria, a total “available” population is derived

• Comparing that against the total number of unique patients claims from the past year (which represents approximately 70% of the total patient claim population), and applying a straight-line algorithmic analysis, the projected % of the entire disease state population meeting the requirements and available for the study is calculated

• Filters are then turned “on” or “off” to determine if a sufficient number of patients potentially exist to meet the protocol needs

Second, We Run Scenarios:

Using the BPL application,

• The data is collated into a single database

• The study parameters are entered into the system

• Various analyses with multiple scenarios are created Disease prevalence, patient population, subject cost, trial experience,

and competitive studies are included in the analysis

• Based on the Client’s overall plan, the mix of domestic vs international targets is identified Then, the initial analysis focuses on region and country level targets Subsequent analyses detail specific countries to the state or territory

level (i.e. US, Canada, India, China)

• All analyses are based on criteria and input from the client’s therapy team

Example of Scenario Comparisons:

Third, We Generate the Country and State List:

From the various analyses selected.

• The results of the selected analyses is summarized into a table of top countries and states within which to focus the study Site counts and patient counts within those geographies are

summarized and ranked

• Additional information such as # of active studies is provided and factored into the ranking

• Each analysis also generates the named physician list for that geography Specific details such as current and 12-months prior study counts in a

designated disease state are provided Contact information such as all addresses, phone numbers, and email

addresses are provided

Identifying the Top Locations to Focus the Study

State/Country PopulationState/Country Site Counts

Top Investigator

Counts

Total Investigator

Counts (Some Trial Experience)

Total Physician

Counts (Treating

COPD)

Total # of COPD

Patients

Client Sites Identified

# of Active Studies

Rank

AK 3,904,380 41 49 125 2446 51085 4 14 1

HA 8,251,243 34 43 164 3155 98090 4 13 2CO 1,466,917 26 33 78 2863 68054 3 11 3WI 2,432,792 27 36 81 2419 50072   18 4

NE 2,852,548 16 22 42 1145 22102 1 11 5AZ 6,338,755 14 15 24 913 24084 2 11 6

CA 6,553,215 68 91 270 7453 97610 6 18 7NJ 8,685,920 16 24 30 983 23125   6 8NY 9,297,729 32 52 28 1486 28518   14 9

NC 4,061,032 18 22 64 1580 41276 1 9 10ND 3,861,515 14 25 52 1646 29496 1 10 11GA 1,544,750 12 15 78 1946 47195 2 9 12

MA 4,449,755 16 34 14 829 14710   15 13MD 2,618,344 9 16 20 923 20877   9 14IN 3,345,289 12 13 26 938 20933   5 15

LA 1,293,204 11 14 28 673 11532 1 6 16TN 2,156,719 8 8 50 1420 49358   5 17MO 1,878,415 12 20 20 510 9504 2 9 18

AL 3,627,851 16 19 9 321 9684   13 19MI 1,071,822 10 12 52 2088 51023 1 14 20

WA 2,468,424 15 16 31 955 10573 1 5 21SC 1,407,709 19 25 79 1485 38276 4 13 22KY 3,241,474 7 8 28 1447 51310   8 23

VA 1,712,091 8 8 36 1067 28398 1 13 24NE 2,774,571 5 16 10 308 5400   10 25                   

Mexico 3,423,900 88 130 - - - 3 18 26                   

France 1,182,034 26 41 - - - 0 4 27

Thailand 2,404,784 37 43 - - - 0 2 28China 6,735,130 64 135 - - - 0 9 29

Finland 8,911,296 29 37 - - - 0 3 30

Austria 5,356,845 11 14 - - - 0 7 31UK 5,113,439 112 207 - - - 0 13 32

Switzerland 7,275,567 17 38 - - - 0 3 33Netherlands 1,897,641 48 102 - - - 0 10 34

Norway 4,438,557 19 23 - - - 0 2 35

Then, Individual Investigator Details are Provided:

For each of the identified sites.

• The selected site list is graphically mapped against the patient populations by county in the US

• Specific details about each investigator worldwide is available from a direct drill-down link Details about the current study activity, associated sponsors, related

physicians, and study details are provided

Identifying the Top Sites

Last Name

First Name

SpecialtyMatchin

g On-going

Matching

Total On-

goingTotal

Num of Patients

Patients within Zip

3Organizations Address City

Postal Code

State

Smith Stuart Critical Care Medicine, Internal Medicine, Pulmonary Medicine

0 2 0 3 3135 7278 Radiant Research - Atlanta West (Protocare, Inc)

3820 Medical Park Drive, Suite 1100

Austell 30106 GA

Jones Kenneth Internal Medicine, Pulmonary Disease, Sleep Medicine

0 2 0 2 2408 16703 Louisville Pulmonary Care, PLLC

4003 Kresge Way Suite 312 Louisville 40207 KY

Johnson Stephen Allergy and Immunology, Internal Medicine, Pediatrics

0 2 0 13 1053 16703 Family Allergy & Asthma Research Institute - Louisville

9800 Shelbyville Road, Suite 220

Louisville 40223 KY

Robertson Allan Critical Care Medicine, Internal Medicine, Pulmonary Disease

3 5 3 8 1031 2412 Seton Medical Management - Mobile Diagnostic Center PC

6701 Airport Boulevard, Suite A 101

Mobile 36608 AL

Jacobs W. Campbell Pulmonary Disease 0 1 0 1 1013 3424 Carolina Pulmonary & Critical Care PA

1333 Taylor Street Suite 6F Columbia 29201 SC

Fritsch Daniel Critical Care Medicine, Internal Medicine, Pulmonary Disease, Sleep Medicine

1 3 2 11 920 2945 Pulmonary Associates of Brandon

910 Oakfield Drive, Suite 102

Brandon 33511 FL

Colbert Kenneth Critical Care Medicine, Internal Medicine, Pulmonary Disease

2 5 3 6 884 2408 Chest Diseases of Northwestern PA

3580 Peach Street , Suite 103A

Erie 16508 PA

Hiltabrand James Critical Care Medicine, Pulmonary Medicine

0 3 0 3 797 6099 Cleveland Clinic 9500 Euclid Avenue Cleveland 44195 OH

Santangelo Thomas Internal Medicine, Pulmonary Medicine

0 2 0 2 797 6099 Cleveland Clinic 9500 Euclid Avenue Cleveland 44195 OH

Kandula Graham Internal Medicine, Pulmonary Disease

0 2 0 3 761 4107 Charleston Pulmonary Associates

125 Doughty Street Suite 200

Charleston 29403 SC

Cosgrove Marc Pulmonary Disease 0 1 0 1 721 1359 Bend Memorial Clinic, PC

1501 NE Medical Center Drive

Bend 97701 OR

Zalewski Glenn Critical Care Medicine, Internal Medicine, Pulmonary Disease, Sleep Medicine

2 8 3 10 712 3805 Pulmonary Associates of Richmond Inc - Boulders Office Park

1000 Boulders Parkway, Suite 200

Richmond 23225 VA

Murphy Michael Critical Care Medicine, Pulmonary Disease

0 1 0 1 614 3883 Sleep Disorders Center Florida - Vero Beach

1355 37th Street, Suite 302 Vero Beach 32960 FL