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SWOT ANALYSIS OF CLINICAL TRIALS IN POST-SOVIET COUNTRIES

where the patients are

31 July 2014

4-5 PM (UK time)


WEBINAR RULES

Webinar will be divided into 5 presentations (each ~ 10 min)

All attendees will be asked to mute their microphones

You will be able to ask your questions in the instant message field

during the presentation

QA time after each presentation

Questions can be sent to

[email protected]


PLAN OF WEBINAR Introduction

Vladimir Bogin

(CEO)

SWOT analysis: Georgia

Tsira Jibladze

(Country Head, Georgia)

SWOT analysis: Belarus

Irina Murashko

(Country Specialist, Belarus)

SWOT analysis: The Baltic states

Vladimir Bogin

(CEO)

SWOT analysis: Ukraine

Andrii Paliichuk

(Country Head, Ukraine)

SWOT analysis: Russia

Vladimir Krechikov

(Director of Business Development)


SWOT ANALYSIS OF CLINICAL TRIALS GEORGIA


Tsira Jibladze

Country Manager, Georgia


GEORGIA Population of 4.5 million

• 1,175,000 in the capital Tbilisi

• 200,000 in Kutaisi

• 125,000 in Batumi

Distribution of population by living in

urban and rural area (percentage),

Georgia

53,8 %

46,2 % Urban

Rural


CLINICAL TRIALS IN GEORGIA by therapeutic areas

Source: Ministry of Labour, Health and Social Affairs of Georgia.

49 29

27

21

20

13 12

11

11

9

9 8

5

5

3

1 1

23

OncologyCardiovascularNeurologyEndocrinologyDermatologyPulmonary diseasesRheumatologyUrology(Onco)hematologyInfectious diseasesGynecologyGastroenterologyAllergologySurgeryOtorhinolaringologyNarcologyAngiology


POTENTIAL SITES by therapeutic areas

15

8 7

5 5 4 4

3 3 3 3 3 3 3 2

20

10 9

7 7 5 5 5

4 5

4 4 4 5

3


Data accepted by FDA

FDA INSPECTION RESULTS (2008-2014)

Country # of inspections NAI VAI OAI

USA 1 965 (100.0%) 1 011 (51.5%) 853 (43,4%) 101 (5.1%)

Germany 52 (100.0%) 28 (53.9%) 24 (46.1%) 0 (0.0%)

Russia 51 (100.0%) 37 (72.6%) 14 (27.4%) 0 (0.0%)

UK 27 (100.0%) 10 (37.0%) 16 (59.3%) 1 (3.7%)

Ukraine 17 (100.0%) 10 (58.8%) 7 (41.2%) 0 (0.0%)

Georgia 7 (100.0%) 7 (100.0%) 0 (0.0%) 0 (0.0%)

Israel 4 (100.0%) 4 (100.0%) 0 (0.0%) 0 (0.0%)

Belarus 0 (100.0%) - - -

Search performed on 01 Jul 14, Project 48 - Bioresearch Monitoring Source: http://www.accessdata.fda.gov/scripts/inspsearch/


Short start-up timelines (2 weeks for EC review and 1 month for CA review).

Fast and smooth importation / exportation of IMP and study materials. No Import

License needed for any IMP or CTM.

ICH-GCP compliance

Ease Logistics. All main sites are located just in the 3 cities - Tbilisi, Kutaisi,

Batumi, which allows optimizing logistics.

The process of customs clearance is very transparent and takes 1-2 days. It

allows using “just-in-time” delivery directly to the sites.

Availability of local depots complaint with GSP and GMP

STRENGTHS (1)


Study agreement’s Negotiation and signature process takes about 2-3 weeks.

The majority of clinics in Georgia are private.

Due to the limited number of government medical programs the patients seek

the opportunity to participate in clinical trials in order to receive the advanced

treatment.

High, fast and qualitative recruitment

Low percentage of withdrawn consents.

STRENGTHS (2)


The fact that the most sites are located in 3 big cities decreases the chance for

the patients from rural areas to participate in the clinical trials (due to long

travel time).

The MOH implemented GCP into the local legislation. However, there are no

additional country specific guidelines on clinical trials.

The local legislation requires translations in Georgian and notarizing of all

documents submitted to CA.

WEAKNESSES


The friendly legislation and quick review process by the CA and local ECs.

Constantly growing market – the number of the new clinical trials increases

each year.

A big population of treatment naïve patients.

The number of highly qualified and experienced sites is increasing.

International medical standards (ICD 10)

Low investigators’ fees

Motivated patients and sites

Political and social climate positive towards clinical trials

OPPORTUNITIES


The EU Association Agreement implementation into the local legislation may

cause the increasing the CA/EC review timelines (synchronize with EU

timelines).

THREATS


Georgia is one of the countries with considerable untapped

potential.

Due to a very efficient regulatory review process, Georgia is ideal

for conducting the clinical studies especially for the rescue studies.

The existing legislative framework and organization makes the

development of clinical trials in this country very promising.

High and fast recruitment and high quality of conducting the trials.

GEORGIA: SUMMARY


SWOT ANALYSIS OF CLINICAL TRIALS BELARUS


Irina Murashko

Country Specialist, Belarus


BELARUS

Population of 10 million,

2 million in the capital Minsk

• More than 60 accredited

medical institutions

• 9 of them have accreditation

for oncology trials


STRENGTHS Single contract with institution (+/-)

• Simpler contracting process

Rigid political system (+/-)

• (short-term) stability

Clinical trials legislation compliant with

ICH GCP

Reasonable costs of monitoring

Very short start-up timelines

(2-3 months)

Healthcare system similar to that of

Russia

• Up-to-date equipment and facilities

• Specialized hospitals with access to

targeted patient populations

Positive attitude of Ministry of

Healthcare towards clinical trials


Relatively small population

Single contract with institution

• Insufficient motivation for PIs

Necessity to get all the contracts

approved by the MoH

Necessity of MoH approval for every

drug importation

Limited number of trained CRAs

WEAKNESSES Study materials should be cleared at

customs even if imported from Russia

Limited number of sites in some

therapeutic areas


Clinical trials market far from being

saturated

Treatment-naïve patients

High incidence of rare oncological

diseases as large number of citizens

were affected by Chernobyl disaster

OPPORTUNITIES

Russian is an official language

• no added translations costs

• monitoring from Russia/Ukraine

Low standard of living

• motivation for PIs / low grants

• enthusiastic patients – for many of

them participation in clinical trials

gives opportunity to get the most

modern treatment


OPPORTUNITIES Oncology


Common database of oncology cases

(known as cancer-register):

• About 260,000 oncological patients

registered

• About 40,000 new cases registered

annually

9 large accredited oncological hospitals

with clinical trial experience

About 90,000 patients are treated

annually

Modern equipment - computer

tomography and/or MRI, X-ray digital

systems, mammography, etc.

The main oncological medical

institution - the Republican Center of

Oncology and Radiology

• 18,000 oncological patients per year

examined and treated


THREATS Rigid political system

• Voluntarism of political leadership

• Potential instability (long-term)

Possibility of unexpected changes in

legislation (however very low)


BELARUS: SUMMARY Necessity to get all the contracts

approved by the MoH

Necessity of MoH approval for every

drug importation

Very short start-up timelines

(2-3 months)

Positive attitude of Ministry of

Healthcare towards clinical trials


ICH GCP

Treatment-naïve population in many

therapeutic indications


SWOT ANALYSIS OF CLINICAL TRIALS THE BALTIC STATES


Vladimir Bogin

CEO


ESTONIA, LATVIA, LITHUANIA

Estonia

• Population 1.3 mln

• 107 ongoing studies*

Latvia



* Based on clinicaltrials.gov

Lithuania




STRENGTHS EU/GCP compliant legislation

Short timelines for regulatory activities

– 3-4 months

Favorable legal environment for

medical device studies

No importation license required

(if the drug is imported from EU)

Direct shipments to sites (without local

depot)

High quality of data

Well-equipped sites

Motivated PIs

Political stability

No requirement of local EC approval

(central EC approval is enough)


Limited pool of patients due to small

population (comparing to countries

with large population)

Limited number of sites in some

indications

Private sites have small number of

patients

For Lithuania: additional approval from

“Personal data protection

inspectorate” is required

WEAKNESSES



saturated

Some diseases have higher

prevalence (e.g. community-acquired

pneumonia due to humid climate)

Direct payments to medical institutions

from abroad are possible

OPPORTUNITIES

Less amount of translated

documents (e.g. only translation of

protocol summary is required)

• no added translations costs

• fast preparation of the documents


THREATS Global shift of clinical trials to

countries with large population


THE BALTIC STATES: SUMMARY Limited pool of patients

Short start-up timelines

(3-4 months)

EU compliant legislation

Favorable legal environment for

medical device studies



SWOT ANALYSIS OF CLINICAL TRIALS UKRAINE


Andrii Paliichuk

Country Manager, Ukraine


UKRAINE

Population: approximately

45 millions

Capital: Kyiv (2.8 mln)


The first clinical trials started in 90’s

1,154 international clinical trials have been conducted

since that time

More than 1,500 trial sites with experience in CT

All top 20 CROs have offices in Ukraine

GENERAL INFORMATION


Large patient pool - the second largest patient population

(after Russia) in Eastern Europe.

Strong healthcare system with a centralized structure and vertical

referral system. In 2013, there were 9.8 doctors and 4.8 hospital

beds for every thousand people.

Low number of competitive clinical trials.

Very robust enrollment.

STRENGTHS (1)


Drug-naive patients in many therapeutic areas.

ICH-GCP compliance principles incorporated into legislation.

High level of qualification of investigators for conducting clinical

trials. As a result – high quality clinical trial data.

Savings in costs - average cost per patient in Eastern Europe is

significantly lower than in Western Europe.

STRENGTHS (2)


The new innovative methodologies and techniques are

implemented after it has been done in the USA and EU.

High-tech medical equipment is not available for most of clinics.

Additional expenses for concomitant medications for study

subjects.

VAT tax for the study drug (if not registered in Ukraine).

Requirement of IMPD submission for study approval.

WEAKNESSES


The Association Agreement with the European Union signed by

the Ukrainian government.

IT approach is being widely implemented into the routine practice

of the Competent Authorities.

OPPORTUNITIES


Political instability in the Eastern regions and the accession of

Crimea to Russia.

The risk response strategy is to enroll sites in the western and

central regions of Ukraine.

THREATS


UKRAINE: SUMMARY

Instability in Eastern regions and

the accession of Crimea to Russia

Large population of potential

subjects

Robust enrollment

Clinical trials legislation compliant

with ICH GCP

Treatment-naïve population in

many therapeutic indications


SWOT ANALYSIS OF CLINICAL TRIALS RUSSIA


Vladimir Krechikov

Director of Business Development


RUSSIA

Population of 143,5 million,

12 million in the capital,

Moscow

• More than 1100 accredited

medical institutions all over

the country

• More than 2700 studies

since 2000


STRENGTHS Clinical trials legislation compliant with

ICH GCP

Experienced clinical research staff –

most of CRAs and PMs are MDs and

have PhD

High quality of data proven by more

than 50 FDA inspections for the last 5

years

One of the largest pools of potential

subjects

Robust enrollment

Centralized healthcare system

• Up-to-date equipment and facilities

• Specialized hospitals with access to

targeted patient populations

Plenty of experienced investigators


Additional requirements from Russian

RA on nonclinical studies

Necessity of import/export licenses

Customs clearance of all

inbound/outbound shipments required

Impossibility of direct shipments to

sites – local depot required

Most medical institutions do not

accept payments from abroad

WEAKNESSES 3-4 months for regulatory approval

All documents must be translated into

Russian prior to submission

Wide geographical distribution of sites

– not an easy logistics



saturated

Treatment-naïve patients in many

nosologies

Inclusion of Russian sites in Phase

II/III programs will facilitate drug

registration in Russia afterwards

OPPORTUNITIES


THREATS Current political situation and

sanctions from the US and EU


RUSSIA: SUMMARY Political risks

One of the largest pools of potential

subjects

Robust enrollment


ICH GCP



THANK YOU

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