KCR: Russia - an accesible market for international R&D in clinical research

Russia –is it an accessible marketfor international research and development?

Nadezhda Ivaneeva, ma, mbaGeneral manager Russia & Kazakhstan

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PAGE / 2 Kcr seminar / stockholm, 18Jun / nadezhda ivaneeva

AGENDA

PAGE / 3

History, geography and few more interesting facts

Why conducting clinical trials in Russia

ACTO and its role

Regulatory timelines: law vs. reality

Regulatory approach and timelines by KCR

Few tips for successful study planning and conduction

Getting marketing authorization

Conclusions

Kcr seminar / stockholm, 18Jun / nadezhda ivaneeva

History, geography and few more interesting facts

Page / 4

International clinical trials started in Russia in early

1990-s


Why conducting clinical trials in russia (1)

Page / 5

Centralized healthcare system, allowing to easier involve

patients in participation in clinical trials

Huge population (more than 140 millions, 73% live in

cities*)

Still lack of governmental programs and standards of

care for some diseases, especially in regions

Clinical sites are accredited by MoH for clinical trials

conduction (1030 accredited governmental and private

medical institutions on 11Jun2014**)

Principal Investigators are GCP trained and to have no less

than 5 years of experience in clinical trials


* Source: Wikipedia

** Source: http://www.grls.rosminzdrav.ru


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Market potential (Source: www.clinicaltrials.gov on 16 Jun 2014)


http://www.clinicaltrials.gov/


Page / 7

KCR exposure to Request for Proposals (RFPs), which

included Russia

RFPs 2012

Other Russia

18%

RFPs 2013

Other Russia

15%

RFPs 2014 (on 09Jun)

Other Russia

23%

Source: KCR’s CRM database (Salesforce.com)


Association of clinical trials organizations (ACTO) and its role

Page / 8

ACTO’s primary objectives are:

Maintaining constructive dialogue with regulatory authorities and

general public aimed at the development of stable local legislative

basis for the clinical trials conduct harmonized with the respective

worldwide standards;

Promoting an ethical business model;

Ensuring a proper and effective balance between the interests of

parties involved in clinical trials including the patients, the medical

community, and the general public and governmental agencies.

Association of Clinical Trials Organizations (ACTO) –

non-commercial organization of the companies/ legal

entities and clinical research community engaged in

clinical trials in Russia (http://acto-russia.org).


http://acto-russia.org/

Regulatory timelines: law vs reality

Page / 9

Timeframes For Issuing Approvals, year 2013

Timeframes

According

Legislation

(Business /

Calendar

Days)

Average

Timeframe

s

(Calendar

Days)

Minimum

Timeframe

s

(Calendar

Days)

Maximum

Timeframe

s

(Calendar

Days)

Sampling

To Conduct Clinical Trials 41/57 87 32 223 177

Timeframes For Issuing Approvals, year 2012

Timeframes

According

Legislation

(Business /

Calendar

Days)

Average

Timeframe

s

(Calendar

Days)

Minimum

Timeframe

s

(Calendar

Days)

Maximum

Timeframe

s

(Calendar

Days)

Sampling

To Conduct Clinical Trials 41/57 116 22 410 199

Source: http://acto-russia.org


Regulatory approach and timelines by kcr

Page / 10 Kcr seminar / stockholm, 18Jun / nadezhda ivaneeva

14 calendar days 75-90 calendar days 21 calendar days

IN

TOTAL

110-125

calendar

days

MoH Approval

CEC Expertise

Pharm Expertise

LEC approvals

IMP import approval

& importation

Export approvals

Importation of

materials

Docs

preparation

E-submission

Paper

submission

Few Tips for successfulstudy planning and conduction

Page / 11

Primary Submission package – what is different?

Local Compulsory Insurance of the life and health of a

patient involved in clinical trials

Contracts with the study sites

External Logistics – advance shipment of IMP and study

materials to Russia (drug labels, CoAs, Proforma invoices,

import approval)

Internal Logistics of IMP and biosamples – distances and

temperatures

* Source: Russian Federal Law № 61-FZ “On Circulation of Medicines” (with amendments)


Getting marketing authorization (1)

Page / 12

According to current legislation* the process of drug

registration should not take more than 210 business days

from the moment of submission of MA Application

This term includes the time necessary for repeated expertise (if needed),but does not include the time, necessary for the clinical trial conduction

In practice the process of marketing authorization takes

around 1 year

* Source: Russian Federal Law № 61-FZ “On Circulation of Medicines” (with amendments)


Getting marketing authorization (2)

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Clinical trial + registration dossier submission

“administrative” expertise of dossier, its division and sending

for expertise

Clinical trial dossier

(expertise)

Registration dossier

(expertise)

Clinical trial approval

Clinical trial conduction

Clinical trial results

Registration certificate

“Stop-time”


conclusions

Russia is especially a good place for clinical trials when a big

number of patients is to be recruited in short timelines,

disease is rare, and the drug is planned for marketing in

Russia. Areas to be carefully addressed: regulatory timelines

& logistics of IMP and biosamples, Contracts with sites.

Russia is becoming more popular (based on KCR internal

data, ACTO and clinicaltrials.gov data).

Clinical trial approval and marketing authorization are not

difficult to get in case one accurately follows local

requirements and practices.

Page / 12 Kcr seminar / stockholm, 18Jun / nadezhda ivaneeva

QUESTIONS& ANSWERSRussia –Is it an accessible market forinternational research and development?

Contact:

Nadezhda Ivaneeva, MA, MBA

General Manager Russia & Kazakhstan, KCR S.A.

Email: [email protected]

mailto:[email protected]

About KCR

KCR is a European Contract Research Organization (CRO) with a dynamic team of nearly

300 professionals operating across 18 countries in Europe as well as the U.S.

With 17 years of experience, more than 350 trials executed, over 30,000 patients recruited

and almost 3,000 sites contracted, KCR is a strategic solutions provider and a reliable

alternative to global CROs, delivering the all-important flexibility.

We provide services on long standing global or local contracts to 12 out of the Top 20

Global Pharma companies, and have been granted by 3 of them with the Preferred

Provider certification.

KCR offers clinical development support via 3 types of professional services:

- Full Service Model for Clinical Development Services (Phase I-IV)

- Functional Service Provider (FSP)

- Post-Marketing Clinical Services

For more information about the KCR offer, please visit www.kcrcro.com or contact us at

[email protected].

KCR S.A

CORPORATE HEADQUARTERS.

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Phone: +48 22 313 13 13

Fax: +48 22 313 13 14

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KCR: Russia - an accesible market for international R&D in clinical research