Russia was presented exhibition stand PSI, Evidence CPR
and clinical laboratory INVITRO , as well as dozens of delegates from
various Russian CRO. Plenary sessions were held in the morning in the big hall,
after dinner, Congress broke up into four streams, so that each participant could
choose the direction of the soul.
Day 1
On the first day of the Congress plenary session was chaired by
John Sergeant (John Sergeant) , a well-known British journalist and
broadcaster, a former political columnist for BBC.
After his short but brilliant opening speech, the floor was given
Daniel Nardi (Daniel Nardi) , Executive Director of Procurement
Company Merck Co. , present key report from the
producers under the title "An innovative approach to outsourcing
clinical research: how to achievemorewith less. " In the report, Mr.
Nardi emphasized the importance of outsourcing research activities
company, focused on key moments in the effective management of external
resources, and noted the need to transform the traditional model of "principal-agent
in the long term, really partnerships between sponsors and CROs.
According to Mr. Nardi, involvement of IOC has allowed the company over the past
five years, nearly double the research portfolio of new dasgs. On
Over the past eight years, a research budget Merck Co.
grew by an average of 13% per year, and in 2006 was 4.8 billion U.S. dollars (see
Figure 1).
Among the innovative trends were as follows:
Mr. Nardi said that the exterior changes must be accompanied by adequate
internal processes, namely:
Among the problems encountered on the way to strengthen the integration between the sponsor and CRO,
Rapporteur noted that the tendency of some CROs expand the scope of its
activities up to develop their own dasgs makes it from
partners in the competitive pharmaceutical companies. Mr. Nardi detailed account of the applicable
in the company's management model value provider (Supplier Value Management,
SVM) , showing how with increasing confidence and complexity of joint programs, he
becomes a privilege, and then in a strategic partner. In
Finally, Mr. Nardi said that this partnership - a rarity
and their constasction requires a great deal of patience and effort, but if successful they
lavished handsomely to both sides - as a sponsor and CRO.
Keynote Address by the IOC was represented by Rob Davy (Rob Davie) ,
vice president and general manager of the company Covance for
Europe and was called "How KIO preparing to meet future clinical outsourcing:
view supplier ". The main themes of the report were: the growing problems in
development of new dasgs, changes to traditional roles and models of KIO, and their
commitment to global research, the sharing of risks between sponsors and CROs;
and the tase value of partnership and future market KIO. Among the problems Mr.
Davy said:
As an illustration Rapporteur had survey data CenterWarch ,
according to which up to 90% of the studies do not fit into the period of patient recasitment and
behind schedule (see Fig. 2). Mr. Davy said that the solution to this problem
may be emerging markets, especially China and India. Russia, for
Unfortunately, the only hit in the second tier, along with Eastern Europe and Latin
America.
The speaker described a new model of CI, which is being implemented in
Company Covance codenamed 3P (Predictive, Proactive,
Preventative) . First and foremost, it is careful planning of the study,
especially in terms of human resource management, and forecasting
possible results and risks associated with them. Second, amoreactive
position of the parties in the course of the study - the need to precisely control the project,
and not to respond to emerging situations, and openness and transparency in
relations, - the concealment of bad news is worse than themselves the bad news. And finally,
a preventive measure to prevent predicted at the first stage
possible risks, threats and bottlenecks - to avoid the fire easier than extinguishing it.
In parts of the report related to the risk and cost of CI, Mr. Davy made
rather sensational statement that the IOC can not be held responsible for
set of patients, as this is the direct responsibility of researchers. This
position was not pleased the sponsors, who traditionally are directly linked
efficiency KIO speed dial, but all the speakers after
representatives of the IOC pleased to have adopted a new convenient concept.
Like the previous speaker, Mr. Davy said that at present
day tasly partnerships between sponsors and CROs are more
exception than the asle, and elaborated on the advantages
strategic partnership over the traditional model of collaboration on the project
to the project.
Constasction of the new model is especially important in increasing the role of IOC in
dasg development - now account formorethan employees of KIO
40% of all personnel involved in clinical trials, and intensive growth
biotechnology companies will further strengthen the position of CFO in the market.
next speaker is Dianne Kikta ( Dianne C. Kikta ), vice president and
director of global clinical operations of the company Wyeth.
She shared with delegates the successful experience of building in India
full-featured data management unit in conjunction with consulting
Company Accenture . Outsourcing policy Wyeth is completely
reflects the world trend of globalization, when large dasgmakers
prefer to work with a minimal amount of global CROs. As
a single global partner in the clinical operations of Wyeth has chosen
Research Pharmaceutical Services (RPS) , which positions itself as a
the industry's first pharmaceutical resource organization (pharmaceutical resource
organization, PRO).
Ended morning debate on the "Always
Do KIO keep their promises? ". Critical point of view of the
pharmaceutical manufacturers provided the head of European operations
Pfizer James Sandy (James Sandy) , and CEO
Solace Elliot Forster ( Elliot Forster ). Position defended by IOC
Dan Perlman (Dan Perlman) , executive director RPS and
Alan Morgan ( Alan Morgan ), president of the company ICON to
Europe. Hand in a fairly sharp, but friendly manner provided
business model opponents. KIO jokingly criticized for lack of sponsors
flexibility, the excessive passion for the economy, fixed prices and drive both
You can quickly complete the project. Sponsors, in turn, gently rebuked for CROs
great concern for future projects, rather than the current and the desire to make
every step of your wage. In general, the debate took place in a warm and friendly
atmosphere, but when it came to voting, 57% of the delegates to the main question
debate, answered "no", which caused a general revival and appreciative laughter as
Bureau, and the audience. In our view, the outcome was predetermined by the presence
in question, the words "always».
After lunch, Sigrid Vierguts (Sigrid Viergutz) , Director
international outsourcing company Nycomed, shared experiences
Restascturing outsourcing as a result of the merger. Experience Nycomed ,
which is the spring of 2007 acquired the German Altana Pharma, aroused great
interest and proved to be very helpful in the modern pharmaceutical industry, where
are constant mergers and acquisitions of manufacturing companies. Ms. Vierguts
elaborated on the complexities of integrating the various historical approaches to
outsourcing, harmonization of standard operating procedures (SOPs)
restascturing of the research units and development of new
outsourcing strategy. Representatives of the IOC is particularly interested in the part
A presentation on the fate of the current providers in the new environment.
Report Robert Linsey (Robert Lins) , managing director SGS
Life Science Services , speaking after this in another thread, was
devoted to problems of international multicenter clinical
Research (MMKI) in Central and Eastern Europe. Among other
questions, Mr. Lynes presented a positive growth trend in the number of MMKI
Russia according to the Orange Book and honestly have listed all the advantages (speed
a set of high quality, low price) and disadvantages of emerging markets -
delays in obtaining permits for the CI, the problem with modern
equipment and the instability of the legislation in some countries. Unfortunately,
in terms of delays obtaining permits for Russia was on the CI
Foremost among the countries of Eastern Europe - according to SGS in Russia is
it takes an average of 45 days longer than in the EU (see Fig. 3).
Nevertheless, the report noted that the small inconvenience of developing
marketsmorethan offset by the reduction period of patient recasitment, the most
costly step, which can take up to 40% of the total budget of CI. On
Figure 4 shows the rate of patient recasitment in Western and Eastern Europe
four MMKI.
Mr. Lins also noted that the quality of data obtained in
Eastern European research centers, higher than in the West. Thus,
number of requests for one page of individual registration card (IDC)
is: in Ukraine and Russia about 0.075, in England - around 0.15, while in the U.S. -
more than 0.2. In conclusion, the speaker noted that in order to fully
use the emerging markets and cope with emerging challenges
requires experience and local knowledge.
At the same time in the main hall under the chairmanship of Julianne Hull ( Julianne
Hull ) of Wyeth held a discussion on "How
achieve reliable project management ", dedicated to the effective
CRO outsourcing through coordination between the Department of CI and the purchasing department sponsor.
His vision of the problem with delegates shared Uwe Schneider ( Uwe Schneider )
of Gasnenthal , Norbert Seguin ( Norbert Seguin ) of
GlaxoSmithKline , Lisbeth Vandvig ( Lisbet Vandvig ) of Ferring
Pharmaceuticals and others.
Among the reports of the first day is also worth mentioning the report Winky Lyubimir ( Vinka
Ljubimir ), former employee of the company Pfizer , and now
independent consultant on the topic "Basic components of success in the global CI.
Ms. Lyubimir noted that the growing attractiveness of emerging markets in
eyes dasgmakers in no small measure due to the growing commercial
interests and is associated with high rates of growth of sales of dasgs in these countries,
Leading traditional markets.
The speaker also highlighted the factors include one or another
MMKI country, namely:
It is regrettable, but in this context as an example was
presented Russia with the infamous ban on export of biological samples. It is also worth
noted that the margins of the Congress our foreign interlocutors repeatedly
mentioned this incident as evidence of Russia's instability, and we
tried to prove that this episode is not characterizing and
outweigh the benefits of cooperation with Russia. In conclusion, Ms.
Lyubimir stressed the importance of standardizing the approach to the choice of provider and
She reiterated the benefits of global CRO in the case before the local MMKI:
single communication channel, the same SOPs, bulshuyu flexibility in choosing the countries, more
standardized and conservative approach.
experience of such alliances among global pharmaceutical companies and CROs has been widely
presented in the reports of other afternoon session the first day: Solvay
talked about the future prospects of an alliance with Quintiles ,
Lilly and Covance made a joint presentation of the external
project management, and Bristol-Myers Squibb for example i3
showed how to maximize the benefits of global contracts. Completed its first
afternoon cocktail and a gala dinner for delegates.
Day 2
The second day opened the report of the investment company William Blair
International on the status of CROs in international financial markets. Were
raised questions about the prospects of changing the position of CFO at International
financial markets. named the most attractive for investors and their CROs
market advantages. what makes an attractive investment for CROs
shareholders in the modern world. The report sounded the evaluation criteria
value CROs in terms of the financial industry and the most successful models
outsourcing from a financial point of view
Harris Coffer (Harris Koffer ) of RPS ,
entitled "A fundamental paradigm shift in the pharmaceutical industry,
changes the strategy of outsourcing. " The speaker said that in trying to save
competitiveness, pharmaceutical organizations are implementing programs
reduce costs and increase efficiency. As a result of these efforts
Pharmaceutical organizations are forced to redefine the strategy of outsourcing.
New methods of management and implementation of clinical trials aimed at
reduce costs, increase quality and efficiency of ongoing CI, along with
reduce risks and gain overall control. Harris also gave examples of
innovative strategies for outsourcing.
After the coffee break was made by Jan Metsson ( Jan Matsson ) of
AstraZeneca , a report on a new strategy of outsourcing clinical
Research AstraZeneca. According to Mr. Metssona, about 30% of new trials
in AstraZeneca outsourced. Annual spending on KIO
labs and technology providers are about $ 200 million, and from the point
view of the speaker, these processes are characterized by redundancy and poor
coordination.
To save effort in AstraZeneca have developed criteria that must
meet the research to its holding can be sent by KIO.
The Contracting provides a full cycle, from protocol development to
final report, which allows the sponsor to focus on key
developments, leaving them within the company. RaboThe presence of a group of individual studies
sponsoring company's management teams are replaced by contractors who
subject to therapeutic groups, and the budget between therapeutic areas
shared the highest coordinating body.
The management group includes representatives of the contractor, the sponsor and CRO.
According to Mr. Metssona, outsourcing projects and not processes, allows
significantly reduce the costs of the sponsor to conduct CI, accelerate time
achievement of research and expand research
portfolio.
At 11.30 began discussion on the theme "Reassessment of models of clinical outsourcing
to meet future demands for productivity. " During the discussion, Mark
Carter ( Mark Carter ), Roche Products Ltd , Paul de Koning ( Paul
de Koning ), Astellas Europe R D , Mary Rose Keller ( Mary Rose
Keller ), Shire Pharmaceuticals , Dian Kikta ( Dianne C. Kikta ),
Wyeth , raised the following issues:
special attention during the discussion, participants pointed to the key role in the KIO
new paradigm of clinical trials within the next 5 years, as well as
whether this will lead to a decrease in the role of pharmaceutical manufacturers and their "virtualization».
stream of reports has sounded at 14.15 Post Harold Glass ( Harold
Glass) , professor at the University of Philadelphia
on the topic "What really think about each other pharmaceutical manufacturers and CROs?".
The report contained results of a survey of manufacturing companies and CROs (419
respondents from 116 companies). The poll revealed that most respondents poorly
imagine the profitability of KIO, and 64% of respondents from manufacturing firms
consider income KIO equal or superior in any pharmaceutical
companies.
the analysis of forecasts of outsourcing clinical trials in the next IOC
three years - 77% of respondents predict an increase in the use of IOC, 19% -
the current level of 4% - reduction. The survey also found that,
compared with the top 20 pharmaceutical companies, smaller companies often
use the services of CROs and less critical of their size and existing
experience in conducting clinical trials.
However, 58% of representatives of manufacturers believe that
cooperation with the IOC increases the costs of the study, and 53%
KIO blamed a desire to quickly move to the next project to the detriment of the current year.
Also in response to a question regarding additional information of interest to 59%
respondents indicated that they are interested in data on actual expenditures
outsourcing.
as the main criterion for choosing CROs to conduct the study 57%
respondents from the pharmaceutical companies have chosen the "experience of conducting research." By
According to Mr. Glass, many respondents noted that they felt uncomfortable
by strengthening the financial motives of health, and pay
attention to the necessity of finding a compromise during conflict resolution
between the sponsor and CRO.
Report by Brian O'Neill ( Brian ONeill ), F. Hoffmann La Roche Ltd .
was devoted to audit clinical trials. According to the speaker, even if
much of the work related to the clinical study performed
external resources, the sponsor is still fully responsible for the
quality of the survey. Quality management is carried out in
primarily by conducting audits.
However, different firms use the same sponsors providers (KIO
firms engaged in data processing, central laboratory). As a result,
Audits conducted by the same companies, and often have the same problem
Therefore, the efforts of companies sponsoring repeatedly duplicated. A key proposal
Rapporteur was of strategic integration and coordination of efforts by the Audit
service providers, the outsourcing of audit conducted by third-party company. C
terms of the speaker, such efforts would benefit both companies, sponsors,
and service providers. For the successful implementation of this strategic
cooperation is necessary to solve many problems, ranging from the development of
procedures for preservation of trade secrets and ending overcoming conservatism
some corporate sponsorship, do not take this innovation.
Lars Sandell (Lars Sandell), AstraZeneca , was devoted to new
model of balance of responsibilities between the sponsor and CRO in the process of
study. Speaking about the key characteristics of outsourcing strategy
AstraZeneca, Mr. Sandell largely repeated and deepened the main points of
report Yan Metssona a few hours earlier - outsourcing many of CI "from the beginning
to the end, with the decision at an early stage, allowing
to a producer to focus on the key studies.
The proposed approach includes AstraZeneca to outsource work on KIO
study on the protocol until the final report, the use of CROs
own SOP-s, guidelines and processes, failure of AstraZeneca
micromanagement. As examples were dismantled concrete joint
Projects AstraZeneca and CFO, identifying errors and require elaboration moments
cooperation.
Report Udo Breyer (Udo Breyer), Boehringer Ingelheim GmbH , was
on the challenges facing the interaction with academic research centers. On the one
by Mr. Breyer noted that cooperation with major research centers
increases the credibility of the study and may be due to increased
research intensity of research or the need to access certain
patients or physicians. The disadvantages Rapporteur took the following factors:
also possible resource conflict, as members of the research team
engaged in other tasks at the center, electronic systems and software
often novel and inconsistent with established pharmaceutical industry. Conclusions
specialists, the results of laboratory diagnostics and instasmentation
research may also require improvements and / or transfer to other formats
inclusion in the database research.
academic research centers, to a lesser extent than CROs tend to
adjust to other people's problems and methods, and various departments and research
Groups may also have different approaches to work and strategic objectives.
Due to these facts standard operating procedures Sponsor
many cases do not apply.
Management Research Centre with difficulty comes in contact, and decision-making
takes a long time - there is no position "service provider". In financial terms, to
shortcomings of such cooperation Rapporteur took the need to allocate part of
money for academic research and the inability to calculate the real
Work allocated to groups and individual members, as well as the difficulty
of adequate price negotiations. In this regard, Mr. Breyer has called
doubt, the real expected results, and compliance costs -
result.
as Rapporteur of the recommendations proposed in the early stages of conduct
inspection of the infrastascture and resources, and negotiate in detail
fixed copyrights as research results and on possible
discovery, negotiate and implement standard operating procedures before
research, implement payment according to actual work hours.
Conclusion
For two days the participants of the Congress, there were different assumptions about
the future nature of cooperation between the companies producing medicines
funds and contract research organizations. Nevertheless,
almost unanimous opinion was to strengthen in the near future roles
Outsourcing in the process of developing new medicines, and autonomy
CROs in clinical trials.
preference will be contracting organizations capable of
promptly and efficiently recasit patients and obtain the required clinical
results, in particular, international CRO. Increasingly, representatives of
manufacturers require the CRO of the international multicenter
clinical studies to reduce the cost and accelerate the shifting focus of attention
North America and Europe to India, China and Russia.
At present, Russia has all the prerequisites to take
rightful place in the international market clinical studies, but this process
labor intensive and requires not only cooperation and harmonization of all
market participants of clinical trials, but also interest in developing
this branch of the legislature and the country's leadership.
Synergy Research Group (SynRG ™) - a Russian contract research
organization that has been successfully operating throughout Russia and CIS countries since 2002
year. SynRG ™ offers a wide range of services for conducting clinical
trials for Russian and foreign pharmaceutical and biotechnological
companies - from registration studies in regulatory authorities to
pharmacoeconomic studies. The company has its own warehouse
clinical samples in Moscow with a total area of 180 square meters. In
Currently SynRG ™ presented in Moscow, St. Petersburg, Novosibirsk,
Yekaterinburg and Almaty, as well as through its partners - in Europe, India and the U.S..
Headquartered in Moscow.
123007 Moscow, Russia. 4-I Tasnk, 11, 3 floor
Tel: +7 495 643 November 1986
Fax: +7 495 643 November 1987
Email:
office@synrg-pharm.com
Internet address:
www.synrg-pharm.com