Veselin Dekov Stefanov, MBA Business Development Manager

Email: [email protected] Phone: +359 2 448 5785 Fax: +359 2 491 2534 TELL US MORE ABOUT YOUR NEEDS… CUSTOMIZED TISSUE SERVICES FOR YOUR MEDICAL RESEARCH MISSION

The mission of FIDELIS RESEARCH is to deliver “Semper constans et fidelis”* services to the pharmaceutical and biotechnology business by:

Understanding client needs Communicating with all stakeholders openly and in a timely manner Maintaining contemporary knowledge about human tissue regulations Flexible and oriented to client goals Improving the outcome for patients

* Always constant and reliable

ABOUT US VISION

FIDELIS RESEARCH was founded by professionals with extensive experi- FIDELIS RESEARCH is collaborating with key opinion leaders in clinical pathology in FIDELIS RESEARCH’s vision is to provide ence in the medical research field internationally and in Eastern Europe. The the country. procurement services, in compliance with all company is privately owned Bulgarian-American joint venture, with a well- FIDELIS RESEARCH has built a reputation as a trustworthy and professional legislative and legal requirements relevant to the developed network of human tissue collection sites. partner providing flexible, high standard and client focused human tissue pro- business, which will be beneficial for our client’s curement services. We offer a wide range of high quality tissues to biomedi- product development, satisfy all procurement FIDELIS RESEARCH has a broad network of collection sites and supply cal researchers internationally. needs, speed up R&D timelines, and bring the agreements allowing us to provide our customers with both commonly used product faster to the clinical stage of research. and difficult to find specimens. Our goal is to become your single point of access for your human biological materials, research and development needs. SERVICES/ PREPARATION/ DELIVERY 1st MHAT Sofia MHAT “AVIS Medica” MHAT* “Tokuda Hospital Sofia” MHAT “St. Pantaleimon” TYPES SAMPLE DELIVERY MHAT “Vita” US delivery (~ 30-36 hrs) Solid tumors PREPARATION Vita Clinic European delivery (~20 hrs) MHAT “St.Sofia” Hematological malignancies Fresh samples Medical center “Lulin - MED” Lom Biological fluids Frozen samples REGULATORY SHAT “John Paul” MHAT “Lom” Inflammatory diseases FFPE blocks COMPLIANCE MHAT “St. Pantaleimon” Metabolic disorders PBMC European compliance Military Medical Academy Normal tissues Others FDA compliance MHAT “St.Ivan Rilski” MHAT “Asenovgrad”

Pirdop STANDARD OPERATING PROCEDURES *MHAT - Multiprofile Hospital for Active Treatment MHAT “Pirdop” *SHAT - Specialized Hospital for Active Treatment ADMINISTRATION FR.S002 Collection Site Records Retention FR.A001 Standard Operating Procedure ­ FR.S003 Transportation of Infectious and Preparation and Management Diagnostic Substances FR.A002 Documentation Translation FR.S004 Protocol Preparation FR.A004 Sponsor Material Transfer Agreement FR.S005 Master Project Files COLLECTION SITES FR.S006 Subject History Review and Processing MONITORING FR.S007 Project Site Recruitment is characterized with its centralized health system, which means This size of hospitals allows for easy access to concentrated patient FR.M001 Monitor Training FR.S008 Site Staff Training that the majority of hospitals are University and Multiprofile Hospitals for population, fast identification of subject and reduction in time for collec- FR.M002 Site Approval Visit FR.S009 Distribution of Materials, Consumables and Equipment to Collection Site Active Treatment with many clinical departments under same manage- tion of the necessary number of specimens. Such hospitals are located FR.M003 Site Monitoring ment. FIDELIS RESEARCH has access to specialised hospitals. (Hema- in the major cities (Sofia, , Varna, Ruse, Stara Zagora, ) FR.M004 CRF Review and Monitoring REGULATORY tology, Oncology, Cardiology, Endocrinology, Infectious disease etc.) FR.R001 Quality Assurance and Auditing Each hospital has its own dedicated Independent Ethics Committee COLLECTION SITE FR.R002 Informed Consent Documentation Normally such hospitals have from 25 to 50 departments (Dermatology, which is in compliance with ICH/GCP and gives favourable opinion for Oncology, Pulmonology, Endocrinology, Gastroenterology etc.) protocols, ICFs etc. FR.S001 Site Material Transfer Agreement FR.R003 Regulatory Documents Management

PERCENTAGE DISTRIBUTION OF THE MOST PERCENTAGE DISTRIBUTION OF THE MOST COMMON NEW CANCER CASES* IN MALES, COMMON NEW CANCER CASES* IN BULGARIA 2010 FEMALES, BULGARIA 2010

TRACHEA LUNG 20.4 % BREAST 25.8 %

PROSTATE 11.2 % CORPUS UTERI 8.6 %

COLON 9 % COLON 8.6%

BL ADDER 7.7 % CERVIX 7.8 % UTERI RECTUM 7.5 % OVARY 5.5 % AND ANUS

STOMACH 6 % RECTUM 5 % AND ANUS

PANCREAS 3.9 % STOMACH 4.5%

LARYNX 3.6 % LUNG, 4.4 % TRACHEA

KIDNEY 2.9 % PANCREAS 3.3 % BRAIN, NERVOUS 2.2 % BLADDER 2.3 % SYSTEM COLLECTION SITES OTHER 25.7 % OTHER 24.1 %

Easy Access to patients Easy shipment and grouping (DHL ships after 6pm, which allows collection Average time for delivery 2hrs till 2pm at some of the sites and shipping at the same day) * But non-melanoma skin Total population – 7.5 million people FIDELIS RESEARCH works with different hospitals on a project by Experienced and qualified Investigators (Clinical trial experience which ­project basis includes shipment of Bio Fluids, and Specimen to central Labs in Recent change in our approach is that we put a Master Service NEWLY DIAGNOSED PATIENTS (BY INDICATION) ­Europe) ­Agreement in place, thus we reduce time for agreements and Independent Experience working with Dry Ice Ethics Committee approval