YOUR PAREXEL CARDIOVASCULAR TEAM

Medical Imaging – Cardiovascular Expertise 1

Peter Gardiner, M.B., Ch.B., M.R.C.P., F.F.P.M., Scientific Advisor 2

Henri Francois Cuénoud, M.D., Scientific Advisor 4

Richard Jacobs, M.D., M.H.A., Senior Vice President, Medical Affairs 5

Edwin Palmer, M.D., Scientific Advisor 6

Peggy Harrigan, Medical Research Scientist 8

MEET YOUR TEAM OF CARDIOVASCULAR EXPERTS

MEET YOUR TEAM OF CARDIOVASCULAR EXPERTS

Idiopathic Pulmonary Fibrosis 2%

Multiple Sclerosis 4%Ischemia 4%

Hypereosinophilia Syndrome 1%

Hypertension 1%

Heart Failure 2%

Erectile Dysfunction 1%Fabry Disease 1%

DVT (Deep Vein Thrombosis) 9%

Allergy/Immunology 1%ACS 1%

Arterial Disease 3%Artherosclerosis 3%

Cancer 30%

Cardiac Safety 3%Carotid Stent 2%

Transfusional Hemosiderosis 1%

Periperhal Arterial Occlusion 1%Periperhal Vascular Disease 1%

Other 1%

Myocardial Perfusion Abnormali-ties (Contrast Agent) 1%Myocardial Infarction 2%Myelodysplastic Syndrome (Transfusional Iron Overload) 1%

Contrast Agent 9%Coronary Lesions 1%Diabetes 1%

Thrombosis (Non-DVT) 4%

Stroke 1%Tachycardia (Paroxysmal Atrioventricular) 1%

Obesity (body composition) 7%

MEDICAL IMAGING:

CARDIOVASCULAR EXPERTISE

PAREXEL Informatics Worldwide Clinical Trial Experience in Cardiovascular Imaging studies (past 5 years)

The specific strengths of our cardiovascular experts include:

As a leading imaging provider for clinical trials, PAREXEL Informatics has a dedicated cardiovas-cular leadership team with more than 35 years of relevant industry experience. These experts offer multiple solutions to standardize cardiovas-cular safety and imaging endpoint assessments. With extensive experience accumulated from sup-porting over 127 cardiovascular imaging studies and more than 164,045 timepoints in echo, multi gated acquisition scan (MUGA), computerized tomography (CT), and magnetic resonance imag-ing (MRI). Our global organization is able to adjust and scale imaging services to meet your needs.

PAREXEL Informatics has best-in-class cardiac imaging analysis and reporting software; DigiView,™ Invia Corridor 4DM, and others as need-ed, coupled and integrated with core PAREXEL technologies. We offer the flexibility you should expect from your imaging partner for early phase, adaptive, and exploratory imaging studies. We have the know-how to implement large, late-phase submission trials effectively and efficiently with rigor, have completed FDA inspections without any findings, and successfully run multiple cardiovas cular studies that have led to regulatory approvals.

• Full trial support from consulting through project execution and regulatory submission

• Intelligent analysis form design to increase data quality

• Application of best practices spread across all cardiac studies

• Single-vendor solution for all cardiovascular imaging modalities, including oncology trials with cardiovas cular safety components

• Cost savings by reducing re-reads and increasing data integrity through independent reviewer accuracy and reproducibility

• Scalability to tailor cardiovas cular imaging solutions to meet individual study requirements

• Program approach to decrease startup time and costs while increasing team efficiency

Peter is a valued part of the PAREXEL Informatics cardiovascular group. He has served as PAREXEL medical owner on over 30 studies, ranging from cardiac safety assessment in breast cancer trials to the evaluation of therapies for peripheral vascular stenosis, including 4 which have led to successful FDA submissions and approvals.

Peter is the former vice president, medical affairs and senior medical officer for BG Medicine, a life sciences company focused on the discovery, development, and commercial-ization of novel, molecular diagnostics based on biomarkers in cardiovascular medicine. He is also president of Gardiner Consulting, LLC, an independent consultancy providing medical, scientific, and regulatory services to the pharmaceutical, biotechnology, and medical device industries and the former vice president, medical sciences for Bristol-Myers Squibb Medical Imaging.

Peter has been a Scientific Advisor to PAREXEL’s cardiovascular imaging team for 6 years and continues to provide sponsor consultation for protocol development and study design, novel imaging modalities, and internal consultation on software acquisitions.

Work Experience

As a seasoned pharmaceutical physician with 25 years of global industry experience, Peter has a proven track record of success in clinical research, medical affairs, and regulatory affairs. His diverse experience ranges from large pharmaceutical companies to small biotechnology organizations and encompasses drug and device development and support, predominantly in the cardiovascular therapeutic, diagnostic, and imaging areas.

Peter’s achievements include U.S. and European approval and launch of a unique drug/device combination pharmacological stress product; clinical, medical, and regulatory support to the market-leading cardiac radio-pharmaceutical and echocardiographic contrast agents; and five investigational new drug (IND) filings and first-in-man evaluations. His experience also includes extensive interactions with regulatory authorities in the U.S., Europe, and Canada regarding product development and labeling issues. Peter was responsible for obtaining the first Written Request for pediatric studies from the FDA’s Medical Imaging Division.

Peter Gardiner, M.B., Ch.B., M.R.C.P., F.F.P.M.Scientific Advisor

Development Area:

MEDICAL IMAGING

Lead Therapeutic Area(s):

CARDIOVASCULAR

Geographic Responsibility:

GLOBAL

Education

Peter received his medical degree from Leeds University and trained in internal medicine and cardiology prior to joining the pharma- ceutical industry. Peter is a member of the Royal College of Physicians and a Fellow of the Faculty of Pharmaceutical Medicine. He has also served as a board member of the Medical Imaging Contrast Agent Association (MICAA), a nonprofit association composed of manufacturers and developers of contrast agents used in the fields of medicine and life sciences. He has acted in various capacities for MICAA, including two terms as board chairman.

For over ten years, Henri Francois has independently reviewed imaging data on 14 studies with PAREXEL. Additionally, he has served as medical owner with PAREXEL, advised on the development of data validation specifications of cardiology specific medical outlier reports, provides protocol and submission consultation to sponsors, and advises on software developments and innovations to better support cardiology trials.

Henri Francois is an associate professor of medicine in the areas of cardiovascular medicine and non-invasive cardiology at the University of Massachusetts Medical School (UMMS) and the UMass Memorial Medical Center, in Worcester, Massachusetts, where he also holds the position of non-invasive cardiologist with specialty in echocardiography. In addition, Henri Francois is an associate professor of pathology and director of the Cardiovascular Pathology Laboratory. Henri Francois has an important teaching position at the University of Massachusetts Medical School where he is director of the Cardiovascular Pathology Course, co-director of the Cardiovascular Pathophysiol-ogy Course, co-director of the Biology of Disease Course (second-year medical school), director of

Cardiovascular System Course (first-year medical school), and co-director of the Organ System Diseases Course (first and second-year medical school).

Work Experience

Under a five-year Clinician-Scientist Award from the American Heart Association, Henri Francois concentrated his research interests in the areas of: the pathogenesis of atherosclerosis; atherosclerosis inhibition; myocardial pathology; and the pathophysiology of arterial spasm, coronary thrombosis, and atherosclerotic plaque rupture. He is the author of several published articles and has received numerous professional awards for his efforts in both research and teaching, including basic science and clinical “Outstanding Teacher Awards” every year since 2001 from medical studentsat UMMS.

Education

A native of Switzerland, Henri Francois received his medical degree from the University of Geneva Medical School, and completed his residency at the Geneva University Hospital. From there, he moved to the United States to complete a fellowship in Cardiovascular Medicine UMMS.

Development Area:

MEDICAL IMAGING

Lead Therapeutic Area(s):

CARDIOVASCULAR

Geographic Responsibility:

GLOBAL

Henri Francois Cuénoud, M.D.Scientific Advisor

Development Area:

MEDICAL IMAGING

Lead Therapeutic Area(s):

CARDIOVASCULAR (SAFETY & EFFICACY) ONCOLOGY MUSCULOSKELETAL

Geographic Responsibility:

NORTH AMERICA

Richard Jacobs, M.D., M.H.A.Senior Vice President, Medical Affairs

An esteemed radiologist, Richard is PAREXEL’s Senior Vice President of Medical Affairs where he has been a leader of PAREXEL Informatics’ medical imaging management team for more than 16 years. He is PAREXEL Informatics’ most experienced medical leader for worldwide clinical trials. He has advised many of the world’s largest pharmaceutical, biotechnology and medical device companies on the use of imaging to determine the effectiveness and safety of their products. He established the PAREXEL Medical Group; now more than 30 full-time med-ical experts including specialists in radiology, neuroradiology, nuclear medicine, oncology, and cardiology, bone metabolism, magnetic resonance (MR) physics and arthritis located in Boston, Berlin and Hyderabad. He also established the company’s panel of more than 30 Scientific Advisors, many of who are world renowned, and 330 active physician consultants in radiology, oncology and cardiology. Richard has established multiple dedicated PAREXEL-imaging reading sites in the US, the EU and in India. He has chaired or lectured throughout the United States, Europe and Asia at conferences on the impact of medical imaging in clinical trials.

Work Experience

Prior to joining PAREXEL, Richard served as chairman of the Department of Radiology and Diagnostic Imaging at Memorial Health Care for six years. Following the merger with UMass, Richard was vice-chair of the Department of Radiology at UMass Memorial Health Care.

Education

Richard received his medical degree from the University of Massachusetts Medical School. He completed his radiology residency at the Mt. Auburn Hospital in Cambridge and a fellowship at the Deaconess Medical Center.

Edwin has been a scientific advisor for PAREXEL Informatics since 2009. He supports PAREXEL in the software development area for nuclear medicine. He is a key PAREXEL reviewer and adjudicator in many prostate cancer trials. He is also experienced in single-photon emission computed tomography (SPECT) imaging on novel imaging tracers in the greater oncology space. He frequently advises sponsors on review flow and patient status determina-tions for prostate cancer trials.

Work Experience

Edwin has over 30 years of extensive radiology experience with a strong emphasis on nuclear medicine and cardiovascular imaging. Currently Edwin serves as an Associate Radiologist and Director of Clinical Nuclear Medicine/PET (positron emission tomography) at Massachusetts General Hospital in Boston. Previously, Edwin served as an Assistant Radiologist and an Assistant in Radiology at Massachusetts General Hospital.

After his residency, Edwin channeled his passion for radiology, nuclear medicine and education into teaching. He has instructed

numerous radiology courses at Harvard Medical School and has been instrumental in both developing and teaching radiological courses at Massachusetts General Hospital. Courses that Edwin has instructed cover a range of topics such as basic nuclear medi-cine, cardiovascular nuclear medicine and the science of radiological imaging, among others. Today Edwin continues to serve as an Instructor in Radiology at Harvard Medical School.

Edwin is licensed with the Massachusetts Board of Registration in Medicine. He is also certified with the American Board of Radiology and American Board of Nuclear Medicine. Edwin maintains memberships with the American College of Radiology, Massachusetts Radiological Society, Radiological Society of North America and the Society of Nuclear Medicine.

As an avid supporter of education and advancing the field of radiology, Edwin has authored numerous reports across a range of topics including, radionuclide imaging, ventilation perfusion scans and PET imaging. Conditions covered in these reports include lymphoma, pulmonary embolus,

Development Area:

MEDICAL IMAGING

Lead Therapeutic Area(s):

CARDIOVASCULAR ONCOLOGY

Geographic Responsibility:

GLOBAL

Edwin Palmer, M.D.Scientific Advisor

glioma,osteomyelitis and septic arthritis. Edwin also authored the book, Practical Nuclear Medicine, which was published by W.B. Saunders in 1992. At Massachusetts General Hospital he serves in a number of leadership roles such as the Nuclear Radiology Fellowship Director and Director Education within the Nuclear Medicine and Molecular Imaging Division. Edwin also sits on the Radiology Resident Selection and Education Committees.

Education

Edwin earned his M.D. from Tufts University School of Medicine in 1978 and immediately after, served as an intern at Boston City Hospital. Subsequently, he completed his postdoctoral training in the Department of Radiology at Massachusetts General Hospital—first performing his residency and then a Clinical Fellowship in Nuclear Medicine.

Peggy joined PAREXEL in 2012 and in her role as a Medical Research Scientist, she sup ports cardiovascular and oncology trials with cardiac safety components, leveraging her 21 years spent as a cardiac sonographer. She is highly proficient in cardiac and vascular examinations (carotid, arterial and venous lower extremity, and aortic ultrasounds). Additionally she provides compliance training to the imaging study team on FDA and Good Clinical Practice regulations. Peggy supports cardiac sonogra-phers at investigator sites by providing detailed seminars on imaging guidelines and required imaging parameters that ensure consistent, accurate, and high quality study data. She has provided reviewer trainings and support for many cardiac safety and efficacy trials and in doing so has established a close relationship with cardiovascular reviewers. When necessary, her cardiovascular background branches into trials with more expanded modality needs, such as coronary angiography, cardiac MR and other vascular ap plications.

Work Experience

Peggy has experience working with patients, physicians, and experienced sonographers across a range of cardiac imaging including situations such as scans immediately after major cardiac surgery, trauma, life support, CODE, and stroke. This included following patients with a wide range of cardiac pathology, as well as surgical patients with coronary bypass, stent, varied medical devices, including left ventricular assist device (LVAD) , and shunt closure devices, and transplants.

Additionally, she has supported academic research publications by culling cardiology images and has trained students at various labs to introduce lab-specific cardiac ultrasound protocols.

Education

In 1998, Peggy received a Certificate in Cardiovascular Ultrasound from the Ultrasound Diagnostic School in New York. She continued her ultrasound training in 2000 at the Thomas Jefferson Medical School, Philadelphia, Pennsylvania. She has been listed on the Cardiovascular Ultrasound Registry since 2009.

Development Area:

MEDICAL IMAGING

Lead Therapeutic Area(s):

CARDIOVASCULAR ONCOLOGY

Geographic Responsibility:

NORTH AMERICA

Peggy HarriganMedical Research Scientist

WHEREVER YOUR JOURNEY TAKES YOU, WE’RE CLOSE BY.

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