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Quality Research Today for a Better Tomorrow




Corporate Capabilities
1580 McLaughlin Run Road
Pittsburgh, PA 15241
412-257-4461
www.pprresearch.com
Primary Physicians Research is an established clinical research provider
 We offer:
 10 independent, community-based research sites
       2 multi-specialty sites

 Over 25 years of experience
 Over 700 trials.
 Dedicated QA/QC department, assuring quality
 conduct as well as patient safety
 70+ physician network of investigators
 A rapidly growing database of over 300,000
  patients
       Nearly 33,000 study participants (2005-2011)

 A strong history of high-quality performance
       Strong Enrollment
       Reliability
       Clean Data
       Quick Turnaround
History of strong performance




Phase I-IV and OTC clinical trial capabilities
     Ability to accommodate specialist trials

Able to handle large, quick enrollments, due to seasonal issues
Consistent history of achieving and exceeding contracted enrollment
Overenrolled in over 30% of studies from February 2006 – February 2011
Primary Investigators, Sub Investigators, and highly trained staff at each site to
oversee and execute the study protocol
Fully equipped neighborhood offices that offer convenience and familiarity to study
subjects.
A proven track record in pediatric and adult research.
PPR’s Facility
PPR’s dedicated research facility is located within the Jefferson Regional Hospital




  Comfortable waiting room


                                                          On site PI




                  State of the art on-site
                     lab capabilities                            Separate monitor
                                                              room with high -speed
                                                               Internet, Fax, Phone.
97% of patients completed study protocols

Studies conducted between January 2002 - February 2011

Studies Conducted                                                         300
Total Enrollment Since 2002                                          30,800

Total Completed                                                      29,974

                                                  2.5-Year Average Study Yield
                                                    Jan 2008- February 2011




                                             3.3%
                                                                                                      Patient completion %

                                                                                                      Patient drop-out %



                                                                  96.6%

Note: The above is all-inclusive of studies taken on by PPR during the period - without regard to size, type, ease/difficulty or
continuance/discontinuance.
PPR has a strong history with numerous pharmaceutical companies:



                 7 Largest Sponsors – 10 Year Snapshot



                                                    Novartis                 Merck
                                                     13%                     24%
                                  Pfizer/Wyeth
                                      14%
                                                                                                        Abbott
                      Lilly
                                                                                                         4%
                      1%
                                  Sanofi
                                   15%
                                                                              GSK
                                                                              29%




Note: The above represents PPR’s mix of business by number of studies across its 7 largest customers over the last 10 years
Quality Assurance

Our quality assurance goal is to achieve, sustain, and improve quality in all
aspects of research within the clinical site arena.


PPR’s QA Department has been organized to drive a data quality focus
throughout the organization. This is achieved by:

    Training staff on an ongoing basis

    Monthly meetings to identify and correct potential adverse trends in
    data quality

    A Quality Assurance Liaison visits sites monthly to correct identified
    problems and trends and works with PIs to ensure adherence to protocol
    and GCP’s

    In-house audits are performed and quality indicators are reviewed on a
    per trial basis

    Identifying and implementing best practices for delivering quality data
Strong Clinical Trial Management Information System


Clinical Conductor manages the large amounts of data involved with the
operation of a clinical trial.


Some of the benefits of using a CTMS include:

Improves recruitment efficiency

Better management of budgets and financials

Tracks advertising responses

Full oversight of multiple trials at multiple sites
Recruitment and marketing: A top priority




PPR has a marketing and site recruitment team who is solely dedicated to patient
enrollment
Marketing techniques play a pivotal role in how targeted patients become aware of
clinical trials
In-house marketing staff creates advertising and marketing tools that are used by
sub-investigators and site personnel to increase enrollment
Staff adheres to ICH guidelines in obtaining IRB approvals for marketing tools
Online marketing and social media tools

PPR utilizes online marketing resources and social media tools for patient
recruitment

 PPR maintains an active
  online presence through it’s
  website, social media
  networks, and craigslist

Recent Accomplishments:

 Used Craigslist.com to
  recruit nearly 75% of goal
  patients in an osteoarthritis
  study with a contracted goal
  of 20 patients

 Used Craigslist.com to enroll
  over 100% of the set 40
  patient goal in a Women’s
  Health study
Trial Experience
PPR has conducted numerous vaccine trials including:


Diptherial/Pretussis/Tetanus   Haemophilus influenza type B
DTaP                           Hepatitis A
Tetanus/Diphtheria             Hepatitis B
Varicella                      Human Papillomavirus
eIPV                           Plague
Rotavirus                      Respiratory Syncytial Virus (RSV)
Influenza (intranasal          Anthrax
Influenza (injection)          Diphtherial/Pertussis/Polio/Tetanus
Influenza (cellular)           Meningococcal A,C,W,Y
Meningococcal A,C,Y,W-135      MMRV
Meningococcal B                Herpes Simplex Virus
Lyme Disease                   Hepatitis AB
Parainfluenza                  PIV3RSV
Pneumococcal                   Dtap/Hib/IPV (Pentacel)
DTaP/IPV/Hep B (Pediarix)
PPR has conducted numerous therapeutic and nutritional trials:



Asthma                     Topical Otologicals
Osteoporosis               Topical Ophthalmologics
Osteoarthritis             Contraceptives
Obesity                    Arthritis
Herpes simplex             Back pain
Antivirals                 Pharyngitis
Diabetes                   Acute bronchitis
Strep throat               Chronic bronchitis
Antipyretics               Sinusitis
Lipids                     Pneumonia
Influenza                  Otitis media
Pharmacokinetics           Bacterial vaginosis
Migraine                   Infant formula
Atrial Fibrillation        Hypoactive Sexual Desire
                             Disorder
Our Clients
PPR has a strong history with numerous pharmaceutical companies:

Aventis                                Genentech                                      Osiris Therapeutics

Abbott                                 Gilead Sciences                                Pfizer

Advancis                               GlaxoSmithKline                                Pharmacia

Alcon                                  GlaxoWelcome                                   Protein Sciences

Allergan                               Inspire                                        Roche

Almirall                               Iomai                                          RWJ
 Prodesfarma
                                        Johnson & Johnson                              Sanofi
Aviron                                                                                 Sanofi Aventis
                                        KV Pharma
BioCryst                                                                               Sanofi Pasteur
                                        Eli Lilly
Bristol Myers                                                                          Sepracor
                                        Mead Johnson &
 Squibb
                                         Company                                        Schering-Plough
Cephalon
                                        MedImmune                                      Shire
Chiron
                                        Merck                                          Takeda
Dimethaid
                                        NABI Pharmaceutical                            VaxGen
Dynavax
                                        Novartis                                       ViroPharma
Dynport
                                        Ortho-McNeil                                   Wyeth
Note: The above is meant to show PPR’s substantial client base developed over time. It should be noted that some of the above listed clients have
since merged, been acquired or otherwise joined with competitors.
PPR has strong relationships with CROs and others:


 Advanced Biologics           MDS                      PPD
 Covance                      OmnicareCR               Quintiles
 I3 research                  Parexel                  United Biosource Corp
 Icon                         Pharmanet


PPR is proud of its working relationships with government agencies
 The National Institutes of Health
     Working on protocols that have been initiated by the NIH
 The Department of Defense
      Worked on vaccines to protect military men and women over the last 5 years
 The Division of Microbiology and Infectious Diseases (DMID)
     Approved by the DMID to work on vaccine trials in collaboration with NIH and VTEU sites
      Created QA/QC program that has been approved by the DMID
 Subcontractor for the Vaccine and Treatment Evaluation Units (VTEU) program
      Partner with the University of Saint Louis to work with them in numerous vaccine trials
PPR provides:




Experienced leadership oversees the key functions supporting trial success


Clinical staff receives extensive training and is dedicated solely to conducting
research


Consistent and strong enrollment


Quality data


A team dedicated to delighting our clients!
Our clinical research team:
 Primary Physicians Research welcomes the opportunity to speak with you to provide more
 information about our experience conducting clinical trials or for the opportunity to conduct a
 clinical trial for you. Please contact us:

                                          PRESIDENT & CEO
                                             Paul E. Curley
                                      Phone :412-257-4461 ext 212
                                           Cell: 610-745-9155
                                       curleyp@pprresearch.com


                         EXECUTIVE DIRECTOR, COMMERCIAL OPERATIONS
                                    Carol L. Miller, LPN, CCRC
                                   Phone :412-257-4461 ext 127
                                         Cell: 724-518-9531
                                     millerc@pprresearch.com

                                      BUSINESS DEVELOPMENT
                                              Corry Knuth
                                      Phone :412-257-4461 ext 126
                                          Cell: 724-570-4798
                                       knuthc@pprresearch.com

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PPR Capabilities

  • 1. Quality Research Today for a Better Tomorrow Corporate Capabilities 1580 McLaughlin Run Road Pittsburgh, PA 15241 412-257-4461 www.pprresearch.com
  • 2. Primary Physicians Research is an established clinical research provider We offer: 10 independent, community-based research sites 2 multi-specialty sites Over 25 years of experience Over 700 trials. Dedicated QA/QC department, assuring quality conduct as well as patient safety 70+ physician network of investigators A rapidly growing database of over 300,000 patients Nearly 33,000 study participants (2005-2011) A strong history of high-quality performance Strong Enrollment Reliability Clean Data Quick Turnaround
  • 3. History of strong performance Phase I-IV and OTC clinical trial capabilities Ability to accommodate specialist trials Able to handle large, quick enrollments, due to seasonal issues Consistent history of achieving and exceeding contracted enrollment Overenrolled in over 30% of studies from February 2006 – February 2011 Primary Investigators, Sub Investigators, and highly trained staff at each site to oversee and execute the study protocol Fully equipped neighborhood offices that offer convenience and familiarity to study subjects. A proven track record in pediatric and adult research.
  • 4. PPR’s Facility PPR’s dedicated research facility is located within the Jefferson Regional Hospital Comfortable waiting room On site PI State of the art on-site lab capabilities Separate monitor room with high -speed Internet, Fax, Phone.
  • 5. 97% of patients completed study protocols Studies conducted between January 2002 - February 2011 Studies Conducted 300 Total Enrollment Since 2002 30,800 Total Completed 29,974 2.5-Year Average Study Yield Jan 2008- February 2011 3.3% Patient completion % Patient drop-out % 96.6% Note: The above is all-inclusive of studies taken on by PPR during the period - without regard to size, type, ease/difficulty or continuance/discontinuance.
  • 6. PPR has a strong history with numerous pharmaceutical companies: 7 Largest Sponsors – 10 Year Snapshot Novartis Merck 13% 24% Pfizer/Wyeth 14% Abbott Lilly 4% 1% Sanofi 15% GSK 29% Note: The above represents PPR’s mix of business by number of studies across its 7 largest customers over the last 10 years
  • 7. Quality Assurance Our quality assurance goal is to achieve, sustain, and improve quality in all aspects of research within the clinical site arena. PPR’s QA Department has been organized to drive a data quality focus throughout the organization. This is achieved by: Training staff on an ongoing basis Monthly meetings to identify and correct potential adverse trends in data quality A Quality Assurance Liaison visits sites monthly to correct identified problems and trends and works with PIs to ensure adherence to protocol and GCP’s In-house audits are performed and quality indicators are reviewed on a per trial basis Identifying and implementing best practices for delivering quality data
  • 8. Strong Clinical Trial Management Information System Clinical Conductor manages the large amounts of data involved with the operation of a clinical trial. Some of the benefits of using a CTMS include: Improves recruitment efficiency Better management of budgets and financials Tracks advertising responses Full oversight of multiple trials at multiple sites
  • 9. Recruitment and marketing: A top priority PPR has a marketing and site recruitment team who is solely dedicated to patient enrollment Marketing techniques play a pivotal role in how targeted patients become aware of clinical trials In-house marketing staff creates advertising and marketing tools that are used by sub-investigators and site personnel to increase enrollment Staff adheres to ICH guidelines in obtaining IRB approvals for marketing tools
  • 10. Online marketing and social media tools PPR utilizes online marketing resources and social media tools for patient recruitment  PPR maintains an active online presence through it’s website, social media networks, and craigslist Recent Accomplishments:  Used Craigslist.com to recruit nearly 75% of goal patients in an osteoarthritis study with a contracted goal of 20 patients  Used Craigslist.com to enroll over 100% of the set 40 patient goal in a Women’s Health study
  • 12. PPR has conducted numerous vaccine trials including: Diptherial/Pretussis/Tetanus Haemophilus influenza type B DTaP Hepatitis A Tetanus/Diphtheria Hepatitis B Varicella Human Papillomavirus eIPV Plague Rotavirus Respiratory Syncytial Virus (RSV) Influenza (intranasal Anthrax Influenza (injection) Diphtherial/Pertussis/Polio/Tetanus Influenza (cellular) Meningococcal A,C,W,Y Meningococcal A,C,Y,W-135 MMRV Meningococcal B Herpes Simplex Virus Lyme Disease Hepatitis AB Parainfluenza PIV3RSV Pneumococcal Dtap/Hib/IPV (Pentacel) DTaP/IPV/Hep B (Pediarix)
  • 13. PPR has conducted numerous therapeutic and nutritional trials: Asthma Topical Otologicals Osteoporosis Topical Ophthalmologics Osteoarthritis Contraceptives Obesity Arthritis Herpes simplex Back pain Antivirals Pharyngitis Diabetes Acute bronchitis Strep throat Chronic bronchitis Antipyretics Sinusitis Lipids Pneumonia Influenza Otitis media Pharmacokinetics Bacterial vaginosis Migraine Infant formula Atrial Fibrillation Hypoactive Sexual Desire Disorder
  • 15. PPR has a strong history with numerous pharmaceutical companies: Aventis Genentech Osiris Therapeutics Abbott Gilead Sciences Pfizer Advancis GlaxoSmithKline Pharmacia Alcon GlaxoWelcome Protein Sciences Allergan Inspire Roche Almirall Iomai RWJ Prodesfarma Johnson & Johnson Sanofi Aviron Sanofi Aventis KV Pharma BioCryst Sanofi Pasteur Eli Lilly Bristol Myers Sepracor Mead Johnson & Squibb Company Schering-Plough Cephalon MedImmune Shire Chiron Merck Takeda Dimethaid NABI Pharmaceutical VaxGen Dynavax Novartis ViroPharma Dynport Ortho-McNeil Wyeth Note: The above is meant to show PPR’s substantial client base developed over time. It should be noted that some of the above listed clients have since merged, been acquired or otherwise joined with competitors.
  • 16. PPR has strong relationships with CROs and others:  Advanced Biologics  MDS  PPD  Covance  OmnicareCR  Quintiles  I3 research  Parexel  United Biosource Corp  Icon  Pharmanet PPR is proud of its working relationships with government agencies  The National Institutes of Health Working on protocols that have been initiated by the NIH  The Department of Defense Worked on vaccines to protect military men and women over the last 5 years  The Division of Microbiology and Infectious Diseases (DMID) Approved by the DMID to work on vaccine trials in collaboration with NIH and VTEU sites Created QA/QC program that has been approved by the DMID  Subcontractor for the Vaccine and Treatment Evaluation Units (VTEU) program Partner with the University of Saint Louis to work with them in numerous vaccine trials
  • 17. PPR provides: Experienced leadership oversees the key functions supporting trial success Clinical staff receives extensive training and is dedicated solely to conducting research Consistent and strong enrollment Quality data A team dedicated to delighting our clients!
  • 18. Our clinical research team: Primary Physicians Research welcomes the opportunity to speak with you to provide more information about our experience conducting clinical trials or for the opportunity to conduct a clinical trial for you. Please contact us: PRESIDENT & CEO Paul E. Curley Phone :412-257-4461 ext 212 Cell: 610-745-9155 curleyp@pprresearch.com EXECUTIVE DIRECTOR, COMMERCIAL OPERATIONS Carol L. Miller, LPN, CCRC Phone :412-257-4461 ext 127 Cell: 724-518-9531 millerc@pprresearch.com BUSINESS DEVELOPMENT Corry Knuth Phone :412-257-4461 ext 126 Cell: 724-570-4798 knuthc@pprresearch.com