1. PARALAX Life Sciences
Investment and Executive Consulting Group of Companies for Innovative Implementation of Medical and Life Science Products and Services in Bulgaria

2. What is PLS? A private equity company;
Dedicated to Life Sciences and development of new healthcare strategies;
Investments from private funds in Bulgaria, Germany, Austria;
€ invested since 2008;
23 successful companies;
200 jobs created.

3. Selected Portfolio of Companies
Other related
Life Sciences
Ascendent Medical Center
ProDuCt/ Milray/ CCDRD/ Milray Moldova – clinical trials and personalized medicine projects
SGP Biodynamics – wholesaler of medical devices
NM Genomix– transplantation of cells, B2C genetic diagnosis
Pharmalex Bulgaria – vigilance of drugs, medical devices and cosmetics
Institute for Medical Research – clinical and scientific services
NM Consult
Simbula – consulting company
MilREIT – real estate holding and management company
Several start-ups
3 NGO’s in public interest

4. Why Partners Choose Paralax LS?
Existing infrastructure, including a wholesaler of medical devices and 4 companies for clinical trials in its portfolio;
Excellent contacts with KOLs and stakeholders in all fields of Life Science in Bulgaria;
Employees with relevant expertise in co-operation with competent authorities;
A good network and extensive capacity to expand.

5. Main Credentials Comprehensive regulatory services;
Non-disclosure & confidentiality;
Long term commitment;
Expertise in management of “difficult” and complex medical projects in tough environment;
Excellent contacts in key EU countries.

6. Retail Human Genetics
Offering non-invasive prenatal testing – Prenatest®, Cystic fibrosis screening test, FraX, Factor V Leiden, etc.;
Oncology – Maintrac®, Treatment Map®, BRCA;
Ambry Genetics;
Personalization of therapy – EGFR, RAS, BRAF testing;
Validation tests for Trovagene and The Genomic Institute of Singapore / non-disclosable due to NDA;
Partnering with MammaPrint.
*All this activities without an own genetic lab

7. Wholesale of Diagnostic and Life Science Solutions
In Vitro Diagnostics – infectious diseases, oncology, and human genetics;
Applied Testing – forensics, food safety, and veterinary medicine;
Life Science Solutions – DNA and RNA extraction, PCR kits and reagents, oligonucleotides and genomic services; expression studies
Lab Automation – sample disruption, nucleic acid extraction, detection (analysis), quality assessment, liquid handling, and general equipment.

8. Clinical Trials in Germany, Bulgaria and Moldova
Existing since 1994;
10 + inspections from competent authorities – France, Spain, South Africa, Bulgaria;
150+ audits during different trials;
Huge expertise in BE trials / 20+ annually/ and phase III trials;
Fast and reliable process for permission of clinical trials;
CRA rental might be discussed;
Fast recruitment of patients in specific areas.

9. Outpatient Medical Center
Profile in endocrinology and female health;
Local independent ethics committee, inspected and audited from the Bulgarian Drug Agency;
5-7 Phase III trials p.a.;
10 BE trials p.a. in the dedicated department with 13 beds;
Long history of clinical trials;
Existing reliable database of patients and healthy volunteers;
Doctors with several GCP trainings and record of clinical trials;
English speaking coordinator of CT with GCP trainings.

10. Personalized Medical Solutions
Offering complete workflow for personalized therapy in cancer and hepatitis patients to big pharma;
Genetic testing is not covered by the National health Insurance Fund;
RAS, EGFR, BRAF, PDL1 testing;
Patients centricity of the workflow;
TAT for the entire testing up to 1 week.

11. Clinical and Scientific Services
Scientific projects - exploratory data analysis, abstract writing, literature search services, statistical and epidemiological reports, research proposals, Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS), etc.;
Validation studies – know-how in oncology and infectious diseases;
IMR, along with Joint Genomic Center (JGC), Department of Medicine of the University of Padua (Italy), Hospital for Women‘s Health – “Nadezhda”, and Conofrance/CTI Biotech (France), is a founding partner of Innovation Cluster for Modern Personalization of the Transplantation of Organs, Tissues and Cells.

12. Additional Information

13. THANK YOU! JIVKO IVANOV Managing Director, PARALAX Life Sciences JSC
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address 45 Bacho Kiro Str., Sofia, Bulgaria
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