ipharma - contract research organization
TRANSCRIPT
IPHARMA Clinical Services in
Russia and EAEU
IPHARMA LLC
CRO in ChemRar group
IPHARMA is a well-established CRO that manages clinical trials in Russia
and EAEU.
Clinical branch of ChemRar group, and partner of Skolkovo Innovative center.
population over 172 million people
centralized healthcare system
IPHARMA VALUES
Innovation and professionalism in clinical research for healthy generations.
ADVANTAGES OF WORKING WITH IPHARMA
Leading positions on the market of Russian innovative drugs*.
Opportunities for drug localization, investments, and market access.
Full cycle of drug development: formulation, batches, QC, preclinical, clinical.
Medical and PV expertise with access to top scientists and KOLs.
Quality management systems and experienced staff.
* according to ACTO analytical report for 2013 - 2015
ADVANTAGES OF WORKING WITH IPHARMA
Medical expertise and the use of adaptive
design in registration studies.
Scientific research platform available for the conduct
of preclinical, early phase and bioequivalence
studies.
Development of the optimal drug market access strategy in
accordance with the local regulatory requirements.
Full cycle of clinical development from
early phase trials to registration and post-marketing PV.
QUICK FACTS 2013-2017
Innovative products in clinical
pipeline
Protocols written
Regulatory approvals
Clinical sites
Healthy volunteers enrolled
Patients enrolled
Original drugs filed for
registration
50+
60+
40+
190+
380+
4
1600+
CLINICAL DEVELOPMENT
PHASE I
PHASE III
Registration• Dose Finding
• Proof of Concept
• Pilot Studies
DOSSIER
REGISTRATION
PHASE I
• First in man
• DLT/MTD
• PK/PD
PHASE II
• Dose finding
• Proof of concept
• Pilot studies
PHASE III
• Superiority
• Non-inferiority
• Compliance and QoL
Innovative drugs
Next-in-class
Biosimilars
Fixed-dosed combinations
New formulations
Generics
CLINICAL TRIAL APPROVAL IN RUSSIA
Preparation
months1-2
• IB, Protocol, ICF
• Sites & Investigators
• Local insurance
• CMP Quality
CTA
Review
Clinical Trial Application Licenses
IPHARMA MoH Experts MoH IPHARMA MoH
months2.5 month<1
Decision
Scientific
Expertise
Ethical
Expertise
Study Drug Import
Lab Samples Export
THERAPEUTIC AREAS
Registration
No. Studies BE Phase I Phase II Phase III Phase IV
Cardiology 2 2
Dermatology 2 1 1
Endocrinology 4 1 2 1
Gastroenterology 3 1 1 1
Neurology 6 3 2 1
Oncology 12 2 5 2 3
Psychiatry 4 3 1
Pulmonology 3 1 1 1
Rheumatology 2 1 1
Surgery 1 1
Transplantation 1 1
Urology 2 1 1
Virology 19 1 7 9 2
TOTAL 61 4 24 18 13 2
CLIENTS
COMPANIES AND STARTUPS OF CHT "CHEMRAR"
GENERAL MANAGEMENT
Chief Operating Officer
MEDICAL DEPARTMENT
N=9
Medical Director
QPPV
Medical Advisors
Medical Associate
Assistant
CLINICAL DEPARTMENT
N=26
Director of CinOps
Project Managers
Senior Clinical Research Associates
Clinical Research Associates
Project Administrators
QA DEPARTMENT
N=3
QA Director
Training & QA
Managers
ADMINISTRATIVE DEPARTMENT N=4
Administrative Director
Senior Administrator
Office Administrator
Programmer
BD DEPARTMENT
N=4
BD Director
BD Manager
Marketing Manager
Assistant
IPHARMA QUALIFIED STAFF (N=48)
Natalia Vostokova, PharmD
Chief Operating Officer
• Graduated from the Moscow Medical Academy in
2004
• In Clinical Research Since 2004 (CRA Project
Manager Commercial Manager COO)
• Phase 1-3 Clinical Trials in Russia and Ukraine
(Russian, US, and European Pharma and Biotech
Companies)
• 30+ Audits and 4 FDA Inspections
• Leading IPHARMA LLC since 2012
IPHARMA TEAM (N=48)
Julia Trakhtenberg, MD, PhD
Medical Director
• Graduated from the Moscow Medical Academy in
1997
• Residency and Post-Graduate Study in
Endocrinology (1997 to 2006); PhD in 2006
• In Clinical Trials since 2001 (Sub-Investigator
Medical Monitor Medical Director)
• Phase 1-3 Clinical Trials in Endocrinology,
Ophthalmology, Gastroenterology, Pulmonology,
Hematology, Cardiovascular diseases
• Head of the Medical Department of IPHARMA
since 2012
MEDICAL DEPARTMENT (N=9)
Oksana Karavaeva, MD
Director of Clinical Operations
• Graduated from Smolensk Medical Academy in
1998
• Residency in Endocrinology (1998 to 2001)
• In Clinical Trials Since 2001 (Medical Expert
CRA Project Manager Director ClinOps)
• Phase 1-3 Trials in Neurology, Oncology,
Psychiatry, Pediatrics, Endocrinology, CV, GI,
Urology, and Ophthalmology
• Head of the Clinical Department of IPHARMA
since 2012
CLINICAL DEPARTMENT (N=26)
Konstantin Semenov, MD
QA Director
• Graduated from the St. Petersburg Medical
Academy in 1996
• Residency in Psychiatry (1996 to 1999)
• In Clinical Research Since 2000 (CRA Auditor
QA Director)
• More than 15 Years of Clinical Trial Auditing
(Clinical Sites, CRO, Labs, Depots), Reception of
Audits and FDA Inspections
• Trained in Russia and UK
• Head of IPHARMA QA Department since 2012
QUALITY ASSURANCE DEPARTMENT (N=3)
Anna Rashina
BD Director
• Graduated from the Belgorod State University in
2005 and the State University of Management in
2010
• In Clinical Research Since 2004 (Assistant PM
Head of PM group BD Director)
• More than 12 Years as PM at Central Lab
(Phase 1-4, BE, Post-Marketing trials), 50+ Audits
• Head of IPHARMA BD Department since 2016
BUSINESS DEVELOPMENT DEPARTMENT (N=4)
Vyacheslav Rogov
Administrative Director
• Law school of Moscow Economic and Legal
University in 2010
• Over 10 years in clinical research (jurisprudence,
audit, compliance)
• Member of the Ethics Committee
• Head of the Expert Group 2.2-2.4, Laboratory of
program management and projects development in
the field of Living Systems
• Head of IPHARMA Administrative Department
since 2017
ADMINISTRATIVE DEPARTMENT (N=4)
Natalia Vostokova, PharmD
Chief Operating Officer
Mobile: +7 (926) 098-36-33
IPHARMA LLC (ChemRar group)
5, Nobel street, Moscow, 143026, Russia
Tel.: +7 (495) 276-11-43
Fax: +7 (495) 276-11-47
Web: www.ipharma.ru
We will be happy to conduct a complimentary feasibility for your study
and provide you with the best clinical trial solution.
Anna Rashina
Business Development Director
Mobile: +7 (903) 578-33-23