Research and development

Research and developmentD. V. Devine, H. W. Reesink, S. Panzer, D. O. Irving, G. F. Körmöczi, W. R. Mayr, Y. Blais, Y. Zhu, K. Qian, Z. Zhu, A. Greinacher,G. Grazzini, S. Pupella, L. Catalano, S. Vaglio, G. M. Liumbruno, J. W. Smeenk, E. A. J. Josemans, E. Briët, M. Letowska,E. Lachert, J. Antoniewicz-Papis, E. Brojer, H. Gulliksson, M. Scott, L. Williamson, C. Prowse, J. P. AuBuchon, J. A. López,P. Hoffman, M. P. Busch, P. J. Norris, P. Tomasulo & R. Y. Dodd

Research is a critical element for progress in blood trans-

fusion. Most countries represented in this survey actively

support or promote transfusion science with organized

research and development programmes. This may occur

through government research funding programmes or

through the operating budgets of blood centres. The pur-

pose of this International Forum is to understand the

kinds of research activities that are undertaken by the

respondents, not on a project by project basis, but to get

a sense of the structures and goals of individual research

programmes or the approaches that different countries

take to ensuring future innovation and discovery for

transfusion medicine.

The questions asked of the respondents were as follows:

1. Please describe the transfusion research programme

operated by your institution. How is it funded? How many

full-time and part-time researchers take part? Graduate

students? Postdoctoral fellows (post-PhD and physician

research trainees)? What is the management structure?

2. Do you have formal linkages to academic, degree grant-

ing institutions (university, technical school)?

If so, do your researchers have faculty appointments in

these institutions?

3. What is the relative proportion of basic investigator-

driven discovery research to development?

4. Does your organization seek to commercialize the

discoveries and inventions from its research effort?

5. Does your research programme engage in formal pro-

gramme reviews?

If so, with what frequency?

6. Is your research subjected to some form of peer-review

prior to the initiation of projects? Is access to funding

competitive?

7. How are specific research areas decided upon?

8. What do you feel are your areas of research strength?

Do you have gaps in specific research areas that you

wish to fill?

9. Does your organization actively pursue international

research collaboration? Many countries have research

funding programmes in place specific to support inter-

national research initiatives. Does your country have

such programmes?

If so, is transfusion research an area that garners

support from the funding programme?

Several recurring elements emerged from the answers to

this forum. The first is a strong emphasis on research and

development that was targeted to the mission of the

responding organization. While some blood suppliers take

a fairly broad view of what constitutes transfusion research,

even they conduct a significant amount of research that is

directly applicable to the problems facing the blood systems

on an ongoing basis. Respondents recognize that there must

be an identifiable return on the investment made in

research. Many transfusion organizations support relatively

little if any pure discovery research, instead leaving that

work to the academic centres. This is likely a reflection of

the challenges in obtaining and maintaining adequate

funding for transfusion research, especially if funding is

directly linked to the operating budget of the blood centre.

The role of the academic medical centres in facilitating

research is very clear in this survey. Blood centres or insti-

tutes with research programmes are linked either formally

or informally with their local medical centres. These orga-

nizations provide familiar research structures that are

attractive to professional scientists, colleagues for collabo-

ration, patient populations for clinical research and access

to researchers in training.

In addition to strong linkages with academic institutions,

most respondents indicated that they are engaged in collab-

orative research and development with the industry rang-

ing from transfer of intellectual property developed by the

blood centre for commercial development to providing

independent assessments of new technologies. The synergy

between industry and independent blood operators for fac-

ile movement of new products to the marketplace is seen as

an important outcome of our collective research effort.

Most research appears to focus on traditional biomedical

research areas of clinical transfusion and blood product–

related research although some respondents have clearly

made research investments that recognize the importance

of research to facilitate the development of policy, funding

models, and the broader strategies required to maintain safe

blood systems. For the most part, research areas of empha-

sis are determined by recognized need within the institution

and some balance among the various areas is stuck through

advisory processes. Of note, once targeted research areas

are set, most respondents report that a system of competi-

tion for funds and peer-review is used to establish exactly

Vox Sanguinis (2010) 99, 382–401

INTERNATIONAL FORUM ª 2010 The Author(s)Vox Sanguinis ª 2010 International Society of Blood Transfusion

DOI: 10.1111/j.1423-0410.2010.01379.x

382

where resources will be invested. This use of external vet-

ting is seen as one method to ensure that we strive for

research excellence. Similarly, organizations with formal

research programmes undergo periodic review of their pro-

grammes most often using arms length external expert

reviewers to provide advice as to the performance and

direction of the programme.

Virtually all respondents indicate some level of interest

in international collaboration and most have ongoing col-

laborations in place or are open to forming them. Many

countries represented in this survey appear to have funds

available that could potentially be accessed for interna-

tional collaboration, but there seems to be some unidenti-

fied barriers to successfully obtaining such funding for

most researchers.

And perhaps of greatest importance for transfusion med-

icine is the focus of all respondents on training the next

generations of researchers either as professional scientists,

technical support staff or research-focused physicians. Even

if not all of these trainees finish up with a significant com-

mitment to research in transfusion, they will all know the

important role that it plays in the future of our profession.

Guest Editor

D. V. Devine

Canadian Blood Services

UBC Centre for Blood Research

2350 Health Sciences Mall

Vancouver, BC, Canada V6T 1Z3

E-mail: [email protected]

International Forum Editors

H. W. Reesink

Department of Gastroenterology and Hepatology

Academic Medical Center

Amsterdam, The Netherlands

E-mails: [email protected];

[email protected]

S. Panzer

University of Vienna

Waehringer Guertel 18-20

A-1090 Vienna, Austria


[email protected]

D. O. Irving

Question 1Over the past 2–3 years, the focus of R&D at the Australian

Red Cross Blood Service (the Blood Service) has moved

from one that was primarily investigator driven to a more

applied approach, specifically aimed at aligning research

priorities with the strategic requirements of the Blood Ser-

vice – conducting ‘leading edge research to meet the needs

of patients’.

Broadly, research projects are conducted within four

strategic areas:

Donor and Community research – in which projects

are designed to provide outcomes that will assist in

understanding the motivators for current and potential

future donors. For example, we are researching what

motivates groups such as generation Y and people with

varying ethnic backgrounds. In addition, we are con-

ducting research into the effectiveness of different types

of marketing communications, non-financial incentives

and appointment scheduling on behaviour outcomes,

such that these findings can then be taken into account

when designing donor recruitment (and retention) pro-

grammes.

Applied and developmental research – in which exper-

imental programmes are designed to provide outcomes

that will improve operational efficiencies and the safety

of our blood products. Projects include studies on alter-

natives to plasma for the storage of platelets; develop-

ment of robust protocols for the cryopreservation and

thawing of platelets and the evaluation of technologies

that can be used for broad spectrum inactivation of

pathogens in blood components (platelets in the first

instance). Research into the development of diagnostic

tests to detect infectious agents such as those that cause

dengue fever is also underway.

Transfusion science research – in which longer-term

research programmes are undertaken in the areas of red

blood cell science, transfusion immunobiology and molec-

ular diagnostics. Such research is aimed at generating

knowledge that has the potential to be translated into more

applied research at a later date. Of particular significance in

this area is research aimed at investigating the changes that

occur to red blood cells during storage and the develop-

ment of experimental models to study transfusion-related

acute lung injury (TRALI), a significant, potentially life-

threatening adverse event associated with transfusion.

Clinical research – the Blood Service is increasing its

activities in clinical research whereby evidence is gathered

from the clinical setting in order to identify potential

improvements in clinical practice. Included in this area are

projects aimed at developing a better understanding of pat-

terns of transfusion practice by linking data from a number

of existing or newly developed data registries and the

conduct of clinical trials of novel procedures that also could

lead to improvements in practice.

The R&D budget at the Blood Service is a component of

the overall operating budget of the organization (which is

funded by Australian federal, state and territory

International Forum 383

� 2010 The Author(s)Vox Sanguinis � 2010 International Society of Blood Transfusion, Vox Sanguinis (2010) 99, 382–401

governments by way of an agreement between the Austra-

lian Red Cross Society and the National Blood Authority).

From 1 July 2010, it is proposed that R&D within the Blood

Service will be block funded.

Full-time researchers: approximately 30

Part-time researchers: approximately 5

Postdoctoral fellows: approximately 20

Graduate students: two currently with this area growing.

Management Structure: Executive Director (reporting to

the CEO) with Senior Research Managers (reporting to

the Executive Director) responsible for each research

strategic area. Together this forms the R&D Leadership

Team.

Question 2The Blood Service has a formal alliance with the University

of Sydney through its Faculty of Medicine, where Blood

Service staff have adjunct appointments. There are also

alliances with other universities in Australia where staff

have adjunct appointments. Such alliances are being devel-

oped on a broader basis to develop co-appointments at both

the Blood Service and Universities, including developing

reciprocal Blood Service appointments for appropriate uni-

versity staff.

Question 3As described earlier, the Blood Service historically has built

its research around investigator-driven projects. This is cur-

rently being refocused to be more strategically aligned to

address gaps in knowledge identified throughout the Blood

Service and the broader transfusion science area. The pro-

portion of investigator-driven research conducted through

the most recent reporting period was approximately 50%. It

is aimed to reduce this proportion although a target has not

been set.

Question 4The Blood Service does not currently actively seek to com-

mercialize any intellectual property generated from its

research projects. However, as part of its new research strat-

egy, this is also an area where significant attention will be

focused such that any new discoveries that are deemed to

be of commercial significance will be actively developed.

Question 5The Blood Service has an external Research Advisory Com-

mittee comprised of both internal and external, indepen-

dent blood transfusion research and clinical research

experts. The Research Advisory Committee is actively

involved in the ongoing review of the entire research pro-

gramme at the Blood Service. At a higher level, the Blood

Service commissioned both internal and external indepen-

dent reviews of its research activities (completed

approximately 2 years ago), which resulted in the imple-

mentation of the new strategy referred to above.

Question 6All research projects initiated within the Blood Service are

subject to [external] peer-review prior to initiation. This is

facilitated through the auspices of the Research Advisory

Committee referred to in point 5 above. Access to funding

is competitive.

Question 7Specific areas of research are decided upon by a combina-

tion of investigator initiation (where research areas are

based on the investigators’ areas of expertise) and actively

searching throughout the Blood Service for areas deemed

to be in need of research. In both instances, however, a crit-

ical question asked when reviewing new research projects

is whether the project proposed is of relevance to the Blood

Service, i.e., purely academic research is no longer carried

out within the Blood Service.

Question 8The Blood Service has research strengths in the areas sum-

marized in point 1 as mentioned earlier. More specifically,

it has strengths in red cell storage lesion, molecular geno-

typing, TRALI, pathogen reduction technologies and, more

broadly, the conduct of clinical trials. At present, the Blood

Service is consolidating its research efforts and will be

reviewing its capabilities within the next 12 months to

identify any areas that may be deemed to be ‘gaps’ in its

repertoire of expertise.

Question 9The Blood Service does not currently ‘actively’ pursue

international research collaborations, since the organiza-

tion is in the process of embedding its revised research

strategy. However, with that strategy now essentially in

place, we are very keen to develop strategic alliances,

research collaborations and, indeed, staff exchange pro-

grammes with other organizations. While Australia has a

number of research funding programmes in place to sup-

port international research initiatives, transfusion research

is not, currently, an area that attracts any support from

such initiatives.

R&D at the Australian Red Cross Blood Service

David O. Irving

Research and Business Development

Australian Red Cross Blood Service

Level 4, 76–80 Clarence Street

Sydney NSW 2000, Australia


384 International Forum


G. F. Körmöczi & W. R. Mayr

Question 1Research at our institution is funded in part by public bud-

get. The amount of this funding allocation is set annually

and depending on recent research and publication activity.

Moreover, each researcher needs to contribute to funding

by means of project-specific third-party grant applications.

Fourteen full-time and two part-time researchers take part.

In addition, a variable number of graduate students (at

present, five) and postdocs (two) are employed. Several

independent work groups are established that are special-

ized in different scientific areas.

Question 2Our institution is the Department of Blood Group Serology

and Transfusion Medicine of the Medical University of

Vienna. The vast majority of the researchers have a faculty

appointment.

Question 3The proportion is about one to one.

Question 4Some developments were commercialized; this, however,

is not the main goal of our research work.

Question 5Yes, there is an annual review by the head of the department.

Question 6Aside from the institutional ethics committee, there is

no formal peer-review of planned projects. Access to fund-

ing is competitive.

Question 7Specific research areas are identified in work group

discussions. Usually, a successful grant application is the

prerequisite for initiation of a research project.

Question 8Areas of research strength include immunohaematology,

immunogenetics, platelet immunology, stem cell biology

and transplantation, and therapeutic and preparative

apheresis. Our institution is part of the biggest hospital in

Central Europe; the considerable patient and blood donor

numbers are advantageous for performing clinical and

applied research; in due future, we plan to expand our work

to cell-based reparative medicine.

Question 9Current international research collaborations include the

frame of the Word Marrow Donor Association (WMDA),

EU COST Action BM803: HLA-Net (European network

of the HLA diversity for histocompatibility, clinical

transplantation, epidemiology and population genetics)

and two further EU projects. Less formal co-operations

encompass many university institutes all over the

world.

Gunther F. Kormoczi

Department of Blood Group Serology and

Transfusion Medicine Medical


Wahringer Gurtel 18-20

1090 Vienna, Austria


Wolfgang R. Mayr

Department of Blood Group Serology and

Transfusion Medicine Medical


Wahringer Gurtel 18-20

1090 Vienna, Austria


Y. Blais

Question 1The Hema-Quebec research division consists of two main

programmes: cell engineering and operational research.

The cell engineering programme is aiming at the compre-

hension of intravenous immunoglobulin (IVIG) mecha-

nisms of action, discovery of blood-product substitutes,

and research on expansion and differentiation of haemato-

poietic stem cells. The operational research programme is

devoted to the improvement of blood transformation pro-

cesses and development of innovative genotyping method-

ologies for identification of blood groups. This group also

provides internal reagents to the reference laboratory. Our

research programmes are funded by internal funds pro-

vided by a fraction of revenues from the operations. The

group is composed of seven full-time scientists that are

associated with Laval University. At present time, we have

three postdoctoral trainees and eight graduate students. The

management structure is as follows: the research in the two

programmes is being conducted by scientists who are

reporting to the cell engineering and operational research

directors. These directors report to the vice-president of

R&D.

Question 2Scientists from our research team are adjunct professors at

Laval University. The University confers adjunct professor

level to our researchers allowing training master, doctorate

students and postdoctorate fellows.



Question 3The proportion of basic research versus development is

about 50:50.

Question 4We are intended to commercialize our discoveries and are

actively seeking for licensing opportunities of our patents,

technologies and products such as monoclonal antibodies.

Question 5The research activities are being reviewed by-annually by a

scientific and medical advisory committee. In addition,

every 3 years, an external panel of experts are invited to

audit our research activities and give recommendations.

Question 6The cell engineering research projects require approval by

the scientific and medical advisory committee prior to be

initiated. The operational research projects are being

approved by steering committee. Internal funding is not

allocated on a competitive basis but is aligned on strategic

orientations.

Question 7The research areas are decided upon strategic orientations.

Question 8Our major basic research strengths are knowledge of IVIg

mechanisms of action, expansion and differentiation of B

cells into plasmocytes, expansion and maturation of hae-

matopoietic stem cells into platelet-producing cells, inno-

vative applications of flow cytometry. Our operational

research group is a major asset for improving blood trans-

formation processes and providing operation with

reagents not commercially available. We are actively purs-

ing collaborations with external researchers and institu-

tions to complete our expertise. Areas of external

expertise that we are interested in are proteomic profiling

of immunoglobulins repertoire, cell culture media devel-

opment, mechanisms of action of IVIG in disease models

other than ITP and lupus.

Question 9We are actively pursing collaborations on international

level. As an example, we are members of the BEST organi-

zation, which is dedicated to improve safety in transfusion.

Canada has several programmes that aim to support inter-

national initiatives: the Canadian Institute of Health

Research (CIHR) supports international research projects

and international collaborations to address a range of

research areas. Similarly, Genome Canada can provide

funds through its International Consortium Initiative.

Quebec provincial organism such as the Fonds pour la

Recherche Scientifique du Quebec (FRSQ) has established

with its French counterpart The FRSQ ⁄ Inserm Program for

Short-term Exchanges, which is designed to help develop-

ing collaboration between Quebec and French researchers.

Grants are competitive and are allocated on merits. If a

transfusion research project meets the expectation of

reviewers, it can be funded.

Yves Blais PhD, MBA

Vice-president Research and development

Hema-Quebec

1070 avenue des Sciences-de-la-Vie

QC, Canada G1V 5C3


D. V. Devine

Question 1Canadian Blood Services maintains a research and devel-

opment programme as an integral part of its operations.

This programme conducts R&D both for internal use and

for external knowledge development and knowledge

translation. The research may be conducted by CBS staff

or may be performed on a contract basis by university-

based researchers. For the CBS-based component of this

research, the research is conducted in five physical hub

locations with two additional staff scientists based off site

in other cities. This distributed model is located either in

CBS facilities or in nearby university laboratory space.

Funding for this programme comes from three main

sources: direct funding from the federal government in

the form of a grant, ongoing support from the main oper-

ating budget of CBS, which is in turn provided by the

provincial governments whose blood system CBS oper-

ates, and research project grants obtained from other

sources by individual investigators or groups of investi-

gators. The latter may come from federal research grant-

ing councils, disease-specific charitable foundations or

industry. The CBS R&D programme has 15 full-time staff

scientists who are working as principal investigators

along with 22 research support staff, an affiliated epide-

miology and surveillance group of four staff, and several

physicians who contribute to the research effort on a

part-time basis. Although the numbers of graduate stu-

dents and postdoctoral fellows fluctuate, there are gener-

ally about 25 graduate students (PhD and MSc) working

in CBS laboratories and another 10 postdoctoral fellows.

Physician research trainees are uncommon, but transfu-

sion medicine residents often conduct small research pro-

jects with CBS staff.



The management structure is such that there is a Vice-

President, Medical, Scientific & Research Affairs who has

overall responsibility for the R&D activity at CBS. The

detailed programme management is undertaken by three

Associate Directors for Research, Development, and Intel-

lectual Property and Business Development, respectively.

There is a R&D business manager and office support staff

based at the CBS head office.

Question 2CBS does not have broad formal affiliation agreements

with other institutions with respect to research and

development, although we are actively seeking to for-

malize our existing arrangements. As a part of the for-

mal job description, all CBS staff scientists must hold a

faculty appointment at the university in their region. At

this writing, all scientists have faculty appointments at

one of Canada’s research-intensive universities. These

appointments are required in Canada to train graduate

students.

Question 3The relative distribution of effort by CBS staff scientists is

approximately 60% towards development work and 40%

towards basic research. Research conducted by others at

CBS is principally applied in nature. For the overall pro-

gramme, there is additional investment in basic investiga-

tor-driven research through partnership with the federal

granting agency. Thus, the overall proportion of funding

allocated to basic investigator-driven discovery research is

closer to 50%.

Question 4Canadian Blood Services has an active intellectual property

protection programme. All research work produced by CBS

scientists must be submitted for internal review and

approval prior to any public disclosure. New inventions are

patented wherever possible and the patent portfolio is used

for further business development. In addition, CBS has

incubated its first start-up company based on technology

invented by a CBS scientist.

Question 5CBS programme reviews are mandated by CBS Board policy

and are an important element of the ongoing programme

funding justification. Reviews have been conducted every

5 years on average.

Question 6Investigator-initiated research is subjected to peer review

prior to funding. Peer review consists of two levels of eval-

uation of full-grant proposals. Prior to the initiation of

peer review, all proposals are reviewed internally at CBS

for relevance to the organization’s mandate; proposals that

are not deemed to be within the mandate are rejected at

that point. Those deemed relevant go on for full peer

review. Initially, the project grant application is reviewed

by 2–3 subject matter experts who provide a formal writ-

ten report. The next level of review is conducted by a

grants panel that is at arms’ length from CBS and that has

the mandate to review proposals for scientific merit. This

panel performs its own reviews of each proposal and takes

the subject matter expert reviews into account. All this

information is used at a face-to-face meeting to decide on

the relative ranking of the grants in the competition.

Development work that is conducted for the purpose of

internal use is not usually reviewed outside of CBS prior to

initiation. Funding for peer-reviewed investigator-initiated

research is awarded on a competitive basis through both

the intramural grant programme to which only CBS

staff members have access and the external funding

opportunities made available in collaboration with our

federal granting agencies.

Question 7Research and development areas are determined initially by

demonstrated gaps in knowledge or operational need.

Research gaps requiring investment in basic research are

initially drafted by CBS management, and then reviewed by

an external scientific advisory committee. Once external

input to the research priorities list has been obtained and

any revisions made, the list is communicated to potential

funding applicants. Specific development projects are

planned in collaboration between development scientists

and managers of the various CBS business lines (transfus-

able products, plasma protein products, stem cells, diagnos-

tic services).

Question 8Our areas of strength in basic research include platelet dis-

orders, intravenous immunoglobulin and immune modula-

tion, cryobiology and coagulation proteins. We also have

expertise in more applied development as it relates to the

assessment of blood product quality, the development of

new quality standards, and the development of new tech-

nologies for product storage, testing or modification. At the

present time, we have significant gaps in engineering

sciences and blood-borne parasitology that we are seeking

to fill.

Question 9Canadian Blood Services actively pursues international

research collaborations in areas that we have identified as

priority research topics. We believe that strong interna-

tional research collaboration is of benefit to all blood

systems. Generally, we fund our own portion of such



collaborative projects. Canada does offer research funding

to international collaborations through programmes that

are either specific to an individual country or geographi-

cal region, or may be targeted to a specific research field.

These programmes may involve the direct support to pro-

ject costs or may support scientist exchange or trainee

personnel support awards. To date, there has been no

concerted effort to seek funding from these programmes

for collaborative international research in transfusion

science.

Dana V. Devine PhD

Vice President,

Medical, Scientific & Research Affairs

Canadian Blood Services

1800 Alta Vista Drive

Ottawa, ON, Canada K1G 4J5


Y. Zhu, K. Qian & Z. Zhu

Question 1Shanghai Institute of Blood Transfusion (SIBT) is a

research institute of Shanghai Blood Center. It has

three research teams working on various subjects,

namely Immunohaematology (Red Cell and Platelet),

Transfusion-Transmitted Disease Prevention and Cell

Therapy.

The immunohaematology team focuses on the

polymorphisms and the functions of glycophorins on

erythrocyte membranes and the mechanisms of oposon-

ized and non-oposonized phagocytosis of erythrocytes.

It also screens and identifies rare blood types in the

Chinese population and is constructing the National

Rare Blood Bank. In the platelet alloimmunity area,

the team conducts studies on HPA polymorphisms

at both the protein level and gene level, and diagno-

ses clinical HPA diseases associated with blood

transfusion.

Transfusion-transmitted disease prevention team stud-

ies the diagnosis, prevention and control of transfusion-

transmitted diseases. Their research field covers

the residual risk assessment of HBV, HCV and

HIV, the development and feasibility assessment of

new techniques for blood screening and pathogen

reduction.

Cell therapy team studies the immunocytes of various

diseases, such as graft-versus-host disease (GvHD) and

autoimmune disease. Now the team has established meth-

ods to prepare human ⁄ mouse NKT cells, human ⁄ mouse

Treg cells, and several human ⁄ mouse DCs, human macro-

phage, human MSCs, mouse Th17 cells and so forth. The

team also establishes an acute GvHD model and a

GvHD ⁄ GVL model induced by allogeneic haematopoietic

stem-cell transplantation.

The research funding of SIBT is granted by institu-

tions of the central government and the Shanghai

Municipal Government. In addition, SBC allocates no

< 1 million RMB (about $142 857 USD) per year as its

own research fund. This fund grants exclusively for the

bid invitation and graduate education at SIBT. The bid

invitation is to support the scientists in blood transfu-

sion area in the whole city. Additionally, SBC pays the

salaries of all scientists as well as the expenses of

research instruments and infrastructure.

We have 25 full-time researchers in all the three

research teams, including eight masters and three doc-

tors. Twenty-one graduate students work in these three

teams.

The Management structure is as follows:

Shanghai Blood Center

Shanghai Institute of Blood Transfusion

Transfusion Transmitted Disease

PreventionCell Therapy

Immunohaematology (Red Cell and Platelet)

Question 2We are the education base of East China Normal University

and Fudan University. One of our faculty members is a

doctoral supervisor and five are masters’ supervisors.

Each year, 6–7 graduate students are enrolled in SBC.

In the recent 4 years, 18 masters and one doctor have

graduated.

Question 3The proportion is 6:4.

Question 4We always try to transfer our research inventions to com-

mercial entities. Patents on blood transfusion areas have

been licensed to several biological companies since the

year 2007, including pathogen inactivation in blood and



blood components, preparing pyridoxal phosphate inter-

cross-linked haemoglobin nanocapsules, preparing the

panels for ALT, and antigen and antibody testing for infec-

tious diseases.

Question 5The research programme is reviewed by the Scientific

Committee and the Ethics Committee of SBC, and by the

granting institutions of all-level at the end of every year.

Question 6The access to funding is very competitive, and there are

both peer-review and reviewing by granting institutions.

Question 7We decided specific research areas by three ways, namely,

our needs of blood collection and supply; the interests

of all-level grants; and our research interests and

capabilities.

Question 8We have two research advantages:

One of our advantages is immunohaematology research;

the China National Blood Group Reference Laboratory

(CNBGRL) is in SBC. A large-scale rare blood group

screening programme was begun at the end of the year

2008 in China. So far a professional rare blood group

website http://114.80.96.204:7010/ has been created by

the China rare blood bank workshop led by Shanghai

Blood Center.

The other advantage is the development of new tech-

niques to improve blood safety. Laboratory research on

LAMP HBV and HCV ⁄ HIV multiple NAT technique has

been finished. The research on solid methylene blue is

nearly completed. The product is already used or will be put

into use by the clinic.

International Cooperation is a difficult problem for us.

We regard it difficult to gather all the research resources

from home and abroad together, such as personnel, instru-

ments and funds.

Question 9We have always tried to cooperate with foreign research

institutions. We have participated in various ISBT and

WHO research workshops, such as the International Stan-

dards of Blood Typing Reagents and International Research

on Blood Type Genetic Diagnosis.

China has many international cooperation programmes.

However, in the medical field, such programmes are

concentrated in areas of Cardiovascular Diseases,

Diabetes, Communicable Diseases, and Tobacco Control.

No programme directly related to blood transfusion is

involved.

Zhu Yongming

President of SBC, No. 1191

Hongqiao Rd., Changning District

200051 Shanghai, China


Qian Kaicheng

Vice President of SBC, No. 1191

Hongqiao Rd., Changning District



Zhu Ziyan

Deputy director of Shanghai Institute of Blood Transfusion, SBC

No. 1191, Hongqiao Rd., Changning District



A. Greinacher

Questions 1 ⁄ 2The Department of Transfusion Medicine is part of the med-

ical school of the University of Greifswald and part of the

University Hospital Greifswald. The department combines

several aspects of transfusion medicine: (i) it is a blood

donation service with an integrated blood donor pro-

gramme, (ii) a laboratory that covers immunohaematology

including red blood cell serology, HLA-laboratory, and a

platelet laboratory including platelet serology and platelet

function analysis, (iii) the department has a strong clinical

link providing the consultant services for transfusion medi-

cine as well as the thrombosis and hemostasis service for

the regional hospitals, including an outpatient clinic for

thrombosis patients and a haemophilia centre, (iv) as part

of the medical school, the department has a lecturing and

training programme for medical students and residents,

and (v) as part of the university the department has a

research programme.

Basic teaching and research resources are funded by the

university with permanent funding of the positions of the

department head, one postdoc, and one technologist and an

annual budget for laboratory reagents of about 80 000 € to

cover all expenses related to student courses and lab-site

practice courses as well as reagents required for research.

However, this funding is insufficient to finance the research

programme and most projects require additional funding

by research organizations or by co-operation with indus-

trial partners. The department usually finances with grant

money obtained from competitive programmes in peer-

review processes two technologists, 5–8 graduate students

and 1–2 postdocs.

The complex and ‘multi-tasking’ structure of the depart-

ment is organized by a hierarchical management structure



with the department head being responsible for all activities

in research and training, patient care, consultant service or

blood bank activities. Within this structure, research projects

are chaired by project by a designated project leader.

The project leader has usually 1–2 graduate students

assigned, while the technologists are helping as a type of

core unit the different project groups. Project groups will

only have a full-time technologist, if they have appropriate

funding.

In addition to the human resources described earlier, the

department has six physicians [one specialized in transfu-

sion medicine (TM), five in training for TM specialization]

and two biologists who are funded by the hospital and who

are primarily responsible for patient care, the clinical labo-

ratories and the blood donation ⁄ blood banking service.

They are, however, also involved in certain research activi-

ties and usually also act as project leaders for the research

projects, as described above.

Question 3The Greifswald transfusion medicine department aims to

focus on basic, investigator-driven discovery, which

accounts for about 70% of the research projects, while 30%

of the resources are used for developmental research. There

is a certain grey-zone for those projects which are based on

quality control data and projects addressing blood donor

research, as part of the data obtained for or in these projects

are obtained using non-research resources.

Question 4Being fully integrated into the academic structures of the

Greifswald University, the department and its scientists

have full access to all resources of the university, including

intramural funding programmes. On the other hand, the

university aims to refinance at least some of these invest-

ments. Scientists are encouraged ⁄ obliged to report new

and potentially important findings to an intellectual prop-

erty agency within the university which then assesses

whether these findings can be patented or otherwise

commercialized.

Question 5As part of the university, the research programme is also

annually reviewed by the faculty review programme and

compared with the other research departments of the medi-

cal faculty.

Question 6See question 1.

Question 7The decisions about which research areas the department

will focus on are made within the group of senior

physicians and scientists of the department. The final

programme is then largely determined by funding avail-

ability.

Question 8A major strength of the Greifswald transfusion medicine

department is its coverage of many aspects of transfusion

medicine allowing a vein-to-vein research approach in

which clinical aspects of patient care and basic research

technologies and approaches are strongly integrated. This

structure results in a strong translational research

approach, which is based on the access to a special infra-

structure for immunohaematology studies and platelet

studies. The strong core group of functional genomics and

proteomics as well as the infrastructure of epidemiologic

research groups and clinical study groups within the

Greifswald University further strengthen this approach.

This interdisciplinary research approach together with

scientists from other departments within the medical

faculty and especially together with scientists of the

faculty of basic sciences had been the basis for most of

the more important publications of the department during

the last 5 years.

Question 9The Greifswald University strongly encourages interna-

tional research collaborations and the Department of

Transfusion Medicine has several active and ongoing

international research projects. There is funding for

international research projects in Germany, but transfu-

sion medicine projects have often only a low success

rate in getting funded. There is no special funding pro-

gramme for transfusion medicine by the general funding

agencies.

A. Greinacher

Greifswald, Germany


G. Grazzini, S. Pupella, L. Catalano, S. Vaglio & G. M. Liumbruno

Question 1The 2005 Italian law n. 219 concerning the ‘New discipline

for blood transfusion activities and national production of

blood derivatives’ updated all regulatory aspects related to

transfusion medicine (TM) activities and focused on the

need for a nationally coordinated blood system [1]. This led

to the institution of the National Blood Centre (NBC) by the

Decree of the Ministry of Health of April 26th, 2006. The

NBC began to operate at the Italian National Institute of



Health on 1st August 2007. The NBC represents the ‘hub’ of

the national blood network and is responsible for both co-

ordination and technical-scientific control and support on

all TM issues regulated by national laws and European

directives. It also represents the institutional body aimed

at reaching and maintaining blood-component and blood-

derivative national self-sufficiency.

In compliance with the above-mentioned law, the

NBC promotes TM scientific research in the specific

areas of quality and safety of blood therapeutics, tech-

nology assessment and development, and blood-inven-

tory self-sufficiency. In addition, it represents the

institutional body aimed at carrying out research studies

on quality and the appropriateness of blood transfusion

practices to pursue homogeneous levels of quality and

safety in TM.

At present, the NBC focuses on the following research

areas:

(1) Blood therapeutics quality and safety:

(a) Nucleic acid amplification technology (NAT):

development and standardization of a panel for HBV-

DNA and of reference standard samples for HCV-RNA,

HBV-DNA, HIV-RNA and West Nile virus-RNA.

(b) Application of proteomics to the study of storage

lesions of red blood cells and to quality control of

plasma-derived and recombinant coagulation factors

VIII and IX [2].

(c) Screening of blood donors for glucose-6-phos-

phate-dehydrogenase deficit and for hereditary sphero-

cytosis and comparative assessment of the storage

lesion of normal and diseased red blood cells for

transfusion.

(d) Collection and analysis of data on cord-blood unit

banking for allogeneic transplantation in the Italian

Cord Blood Network [3].

(2) Technology assessment and development:

(a) Italian platelet technology assessment study (IP-

TAS) [4]: safety, efficacy, anti-HLA alloimmunization

and acute transfusion reactions in onco-haematology

recipients of platelets treated with two photochemical

pathogen inactivation procedures and tested for quality

by proteome analysis.

(b) Feasibility study project for the industrial produc-

tion of in vitro-generated human erythroblasts for

transfusion [5].

(3) Self-sufficiency:

(a) The perception of blood donation–associated

risk [6].

The aforementioned research projects are funded or co-

funded by the NBC, with the exception of the IPTAS project,

which is sustained by the Ministry of Health with funds

dedicated to translational research and cofunded by

Companies operating in the specific sector.

A dedicated staff of the NBC (two full-time and three

part-time physicians) co-ordinate and supervise the above-

mentioned research projects.

Question 2The NBC has no formal links to any academic institutions

since in Italy a specialization in TM has not been so far.

The NBC sponsors a post-degree training in TM held at

the University of Florence as a post-doctoral master.

Question 3About 80% of the research promoted by the NBC is transla-

tional.

Question 4The priority of the NBC is to promote and carry out research

studies, rather than marketing possible discoveries and

inventions.

Question 5Research projects underway are subject to formal reviews

1–3 times a year both for periodical scientific check and to

assess the appropriateness of fund utilization.

Question 6Each single research project is subject to an initial peer-

review and access to funding is a competitive process.

Question 7The institutional mandate of the NBC directs all research

projects towards the above-mentioned research areas.

Question 8The strong point of the research areas is the translational

objective of ensuring homogeneous levels of quality and

safety of blood and blood products and in transfusion prac-

tices.

Other potential research areas are reparative ⁄ regenera-

tive medicine and the study of the impact of emerging

pathogens on transfusion safety and self-sufficiency.

Question 9The NBC is interested in collaborating at international level

with the aim of developing research projects, although cur-

rently in Italy no funds have been earmarked by the Minis-

try of Health for international research projects in TM.

References1 Italian Republic. Law n. 219 of October 21st, 2005. New disci-

pline of transfusion medicine activities and national production

of blood derivatives. Gazzetta Ufficiale della Repubblica Italiana

n. 251, October 27th, 2005



2 Liumbruno GM, Timperio AM, D’Amici GM, et al.: Recombinant

factor VIII concentrates: a comparative proteomic analysis

[abstract]. Vox Sang 2009; 97(Suppl. 1):56

3 Italian Ministry of Health. Decree of November 18th, 2009. Estab-

lishment of the national network of cord blood banks. Gazzetta

Ufficiale della Repubblica Italiana n. 303, December 31th, 2009

4 Rebulla P, Grazzini G, Liumbruno GM, et al.: Pathogen inacti-

vated platelets and prevention of immunological adverse reac-

tions: the Italian Platelet Technology Assessment Study (IPTAS).

Blood Transfus 2009; 7(Suppl. 1):s19–s21

5 Migliaccio G, Sanchez M, Leblanc A, et al.: Long-term storage

does not alter functionality of in vitro generated human erythro-

blasts: implications for ex vivo generated erythroid transfusion

products. Transfusion 2009; 49:2668–2679

6 Liumbruno GM, Pavata G, Bucchi M, et al.: Why people don’t

give blood? A typology of obstacles to blood donation. Vox Sang

2009; 97(Suppl. 1):78

G. Grazzini, S. Pupella, L. Catalano, S. Vaglio & G. M. Liumbruno

Italian National Blood Centre

Via Giano della Bella n.27

00162 Roma, Italy


[email protected];

[email protected];

[email protected];

[email protected].

J. W. Smeenk, E. A. J. Josemans & E. Briët

Question 1Sanquin Blood Supply Foundation has a research pro-

gramme encompassing the whole width of transfusion

medicine as well as immunology. Research ranges from

basic research to applied studies, clinical trials, and donor

studies, as well as product and process development.

Research groups include the following:

(1) clinical transfusion medicine

(2) donor studies

(3) blood-borne infections

(4) immunohaematology

(5) transfusion technology assessment

(6) blood transfusion technology

(7) transfusion monitoring (post marketing surveillance)

(8) immune regulation

(9) autoimmune diseases

(10) blood cell research

(11) phagocyte research

(12) cellular hemostasis

(13) plasma proteins

(14) immunochemistry

(15) molecular cell biology

Sanquin does not receive any direct government

funding. The research programme is funded from sales of

blood and plasma products, research councils (including

European Framework Programs) and charities. Additional

funding is acquired from contract research. Total expendi-

ture for Research and Development amounts to about

22 million euro annually. Funding sources and an overview

of personnel are provided in Tables 1 and 2.

Most researchers have a full-time appointment. However,

a number of staff members from other departments are also

involved in research projects, this holds especially for the

clinical consulting departments.

Annually, over 50 students from universities or poly-

technics perform part of their practical training within our

research departments.

Principal investigators report to the director of research,

who is also member of the executive board of Sanquin.

Question 2A number of Sanquin staff have a part-time appointment at

university hospitals or university faculties, including nine

professorships. Formal collaborations exist with the Aca-

demic Medical Centre, University of Amsterdam (Joint

AMC-Sanquin Landsteiner Laboratory), Leiden University

Medical Centre, and Utrecht University.

Question 3Table 3 lists the composition of our research portfolio.

Question 4Sanquin has an active approach towards valorization of

research. We maintain a patent portfolio for protection of

Table 1 Sources of funding (2008)

Sources of funding %%

Sanquin 65

Dutch Research councils, European Commission 5

Charities, foundations 14

Contract research & Codevelopment 5

Other 11

Total 100

Table 2 Research personnel (2009), (full-time equivalents)

Temporary Tenure Total

Principal investigators 14 14

Senior researchers 34 34

Postdocs 22 22

PhD students 62 62

Blood transfusion

specialist ⁄ PhD fellows

3 3

Subtotal scientific 84 51 135

Technicians 10 83 93

Total 94 134 228



Intellectual Property associated with our own products and

devices as well as for licensing opportunities to third par-

ties. We also have possibilities for licensing out hybrido-

mas. We often engage in codevelopment with and

consultancies for pharma, medical devices industry and

biotech. Our manager business development is also active

in the Life Science Center Amsterdam (LSCA), where exper-

tise on intellectual property and technology transfer is

shared between the partners.

Question 5The research groups of our principal investigators are

reviewed once in every 5 years by an international peer

review committee.

Question 6Externally funded projects (cf question 1) are granted in

competition. For internally funded projects, there is also

competition in place. Projects are reviewed by external

peers before being prioritized by the Research Program-

ming Committee. For the internal projects, funding is avail-

able for 30% of the proposals.

Question 7The decision to endeavour in new research areas is made by

the Executive Board. It will seek advice from the Sanquin

Research Management Team, the Research Programming

Committee and the external Scientific Advisory Board.

Question 8Overall, our research programme fits the needs of transfu-

sion medicine and blood banking in its broadest sense. We

feel that the most successful programmes are immunohae-

matology, immunology, endothelial cell signalling, clinical

transfusion medicine and hemostasis.

Recently a programme was started on cellular therapies,

which we now consider to be an essential area for a modern

blood supply organization.

Question 9All our research groups are actively collaborating interna-

tionally. The Framework Programs of the European

Commission (EC) offer opportunities for larger consortia, and

we are actively involved in a number of FP6 and 7 projects.

Still, many of these EC programmes are focused on specific

research areas, where transfusion research is not at the top of

the list. Dutch programmes for international collaboration

often are linked to European Commission initiatives or based

on regional collaboration with neighbouring countries The

Royal Netherlands Academy of Arts and Sciences has a

number of – often bilateral – schemes for scientific collabo-

ration. Dutch Research Councils and various charities offer

international fellowships for individual researchers.

J. W. Smeenk, E. A. J. Josemans & E. Briet

Sanquin Research

Plesmanlaan 125

1066 CX Amsterdam

The Netherlands


[email protected];

[email protected]

M. Letowska, E. Lachert, J. Antoniewicz-Papis & E. Brojer

The Institute of Haematology and Transfusion Medicine is a

scientific institution focused on haematology and transfu-

sion medicine. It is certified by the International Certifica-

tion Network IQNet and PCBC for the following fields of

activities: expertise healthcare services ⁄ research and devel-

opment studies for advancement in haematology, transfu-

sion medicine and other related disciplines. With an over

50-year experience, a well-equipped laboratory base and a

powerful professional group of specialists and experts, it is

adequately equipped for performing numerous research

and development activities as well as hospital care of

patients. As reflected by the name itself, the research activ-

ity of the institute is focused on haematology on the one

hand and transfusion medicine on the other.

The structure of the Institute is based on mutually sup-

portive six Clinical Wards and four ‘theoretical’ depart-

ments: (i) The Department of Immunohematology and

Immunology of Transfusion Medicine, (ii) The Department

of Quality Assurance and Organization of Blood Trans-

fusion Service, (iii) The Department of Diagnostics for

Hematology and Transfusion Medicine, (iv) The Department

of Immunogenetics.

Question 1The transfusion research programme operated by the Insti-

tute is part of the overall research programme that comprises

several general subject areas. In the last decade, the overall

Institute research activity resulted in approximately 400

publications, 200 of which were related directly to transfu-

sion medicine.

Table 3 Composition of research portfolio (2008)

Type of project %%

Basic research 13

Translational research 34

Clinical transfusion medicine 30

Transfusion technology and product

and process development

23

Total 100



There are three main funding sources for research pro-

jects

• the Institute own funds (low financing)

• application for grants to the Ministry of Science and

Higher Education

• applications for European grants

The Institute employs nine professors, four associate pro-

fessors, 15 PhDs and 19 MD PhDs all of whom are full-time

researchers involved not only in research studies but also in

routine diagnostics (reference laboratories) and in patients’

care.

The Institute is headed by a specialist in haematology

with five deputy directors one of whom is a specialist

in transfusion medicine responsible among others for

the research programme in the field of transfusion

medicine.

Question 2The Institute of Haematology and Transfusion Medicine is

the main research and development centre for transfusion

medicine. The Scientific Board of the Institute has the

power of granting PhD for MDs and habilitation degrees to

PhD doctors (in Poland habilitation follows PhD). MSc and

PhDs for other specialists are granted by Medical Universi-

ties, Universities and other degree granting institutions.

The research workers of the Institute co-operate with var-

ious scientific institutes and clinics throughout the country

as well as with The Medical Centre of Postgraduate Educa-

tion for which it prepares and conducts training courses.

Question 3In transfusion medicine, the Institute is focused on research

and development rather than on basic investigator-driven

discovery research.

Question 4The Institute of Haematology and Transfusion Medicine

does not seek to commercialize the discoveries and inven-

tions from its research effort.

Question 5The general research programme is a 5-year programme,

while the detailed programme is subjected to annual

reviews by the Scientific Board of the Institute of Haema-

tology and Transfusion Medicine.

Question 6The programmes are subjected to peer-review and evalua-

tion depending on the funding source; programmes sup-

ported from Institute funds are presented to the Head of

Department for discussion, then to the Deputy Director for

Science, who presents it to be finally accepted or rejected

by the Scientific Board of the Institute prior to project

initiation. All grants are subjected to reviews. The access to

project funding is competitive.

Question 7Specific research areas are suggested by individual or team

researchers to the Head of the Department, then to the Dep-

uty Director for Science and are ultimately evaluated by the

Scientific Board of the Institute.

Question 8The areas of research strength of the Institute of Hematol-

ogy and Transfusion Medicine in the field of transfusion

medicine are as follows:

• Transfusion Transmitted Infections (analysis of serologi-

cal and molecular markers, epidemiology, polymorphism

of viruses).

• Immunohaematology and Immunology of Transfusion

Medicine (alloimmunization by red blood cells, platelets

and granulocytes: neonatal alloimmune thrombocytope-

nia, neonatal alloimmune granulocytopenia, haemolytic

disease of the foetus ⁄ newborn, haemolytic and non-

haemolytic complications after blood transfusion,

non-invasive prenatal diagnostics in feto-maternal

incompatibility, feto-maternal haemorrhage, molecular

analysis of red blood cell, platelet and granulocyte

antigens, microparticles and lipids in blood components)

• Haemostasis (including molecular biology).

• Techniques in diagnosis of haemophilia and other bleed-

ing disorders.

• Evaluation of the efficacy of pathogen inactivation

methods based on quality assessment of component

parameters following inactivation.

• Evaluation of metabolic and functional studies of RBCs,

platelet concentrates and plasma using modern methods

of flow cytometry, spectrophotometry, aggregometry

(platelets) or methods which determine concentration or

activity of plasma coagulation factors.

• Development of preparation methods for e.g. autologous

fibrin glues and platelet gels.

• Determination of HLA frequency in the Polish popula-

tion.

• Stem cells, cord blood.

With constant progress of medicine there are, as shall

always be, specific research areas that require development

or up grading. For our Institute, such areas are information

technology, cost ⁄ effectiveness, practical stem cell expan-

sion including cord blood stem cells, non-invasive diagnos-

tics, optimal use of blood and blood components in

hospitals, pathogen inactivation technology.

Question 9The Institute of Hematology and Transfusion Medicine is

active in pursuing international research collaboration and



is currently engaged in numerous national and interna-

tional grants with general focus on:

• Validation of methods for collection, testing, prepara-

tion, storage and release of blood and blood components.

• Training for BTS personnel and users of blood and blood

components.

• Haemovigilance for further improvement of the safety

of blood and blood components for clinical use.

• Strengthening of the Quality Assurance system.

• Optimal Blood Use.

The results of expertise activity of the Institute are for-

warded as lectures, abstracts, posters, oral presentations at

international conventions (ISBT, AABB, ISTH, WFH, EHA,

ASH) and national congresses (Polish Society of Haematol-

ogy and Transfusion Medicine, Polish Society for Diagnos-

tic Medicine, Polish Society of Gynecology, Polish Society

of Perinatal Medicine) as well as published in national and

international Journals such as: Vox Sanguinis, Transfusion,

Journal of Transfusion Medicine, Acta Haematologica

Polonica.

The Institute participates in several programmes to

support international research initiatives:

• BOTIA – EC FP6 Specific Targeted Project Improving the

safety of blood and organ supply by creating the

research infrastructure to monitor emerging pathogens

and develop new screening tests.

• EU–Q- Blood-SOP Project cofunded by the European

Commission, Directorate C-Public Health and Risk

Assessment - Grant No. 2004217 (terminated in 2006).

• EUBIS European Blood Inspection System – Project co-

funded by the European Commission – GA No. 2006202

• EU Optimal Blood Use Project (EU OBUP).

• Transition Facility Project PL ⁄ 06 ⁄ IB ⁄ SO ⁄ 03 ‘Develop-

ment of Institutional Control over the safety and quality

of human blood and blood components’.

• European Porphyria Network; providing better health-

care for patients and their families (EPNET).

Furthermore, individual research workers actively partic-

ipate in numerous international societies and working

parties such as International Society of Thrombosis and

Haemostasis, World Federation of Haemophilia, Interna-

tional Society of Blood Transfusion, International Society

of Haematology, The European Haemophilia Therapy Stan-

dardization Board.

M. Letowska, E. Lachert, J. Antoniewicz-Papis & E. Brojer

Institute of Hematology and Transfusion Medicine

Indiry Gandhi 14

02-776 Warsaw, Poland


[email protected];

[email protected];

[email protected]

H. Gulliksson

Question 1The blood banks of the university hospitals in Sweden are

generally organized within departments of clinical immu-

nology and transfusion medicine. In Stockholm, research

and development to a great extent has focused on blood

components and transfusion of blood components, primar-

ily platelets. There is a specific laboratory dedicated for

in vitro studies on preparation and storage of red cells and

platelets [1,2]. In vivo studies of platelets are performed as

well, both in terms of patient transfusion studies primarily

in co-operation with the Center for allogeneic stem cell

transplantation and to some extent recovery and survival

radiolabelling studies [3,4]. The researchers are all part

time. The staff includes one associate professor of the Karo-

linska Institute (head), one postdoctoral fellow, one gradu-

ate student and two research technologists. The funding

varies a lot. However, a major part derives from R&D short-

term contracts.

We are also involved in research projects within the

area of foetal-maternal immunohaematology, e.g. clinical

studies on foetal RHD DNA detection in maternal plasma

and studies on maternal platelet immunisation. Those

projects are funded by the Karolinska Institute and

County Council of Stockholm and involve one postdoc-

toral fellow, one graduate student and two research

technologists.

Question 2All academic degrees are linked to the Karolinska Institute,

the Medical University of Stockholm. There are generally

no faculty appointments in the institutions of the

university.

Question 3Development to improve healthcare and associated meth-

ods is one of the primary objectives of the Karolinska Uni-

versity Hospital. For this reason, development represents

80–90% of our efforts.

Question 4There is no deliberate intention of commercializing our dis-

coveries and inventions. On the other hand, evaluation of

new products for commercial companies for natural rea-

sons has a commercial implication.

Question 5Our research programmes as described in question 4 are

associated with formal reviews with varying frequency

depending on the circumstances.



Question 6There is generally no peer review. We are often asked to

perform certain studies by commercial companies or other

organizations or propose such studies ourselves. For this

reason, we may not always be aware of competitive situa-

tions, although they may exist.

Question 7Existing specific research areas have often existed for

one or several decades. New research areas are

discussed in our executive group and decided upon by

the director.

Question 8Our primary research area of good repute is probably

in vitro evaluations of platelets and red cells. To some

extent, we also perform in vivo studies on platelets. We

wish to elaborate the in vivo area further to have a more

robust organization for patient platelet transfusion and

recovery ⁄ survival studies as well as red-cell-recovery

studies and studies on clinical outcome of massive blood

therapy. In addition, we try to expand our research within

the area of immunohaematology.

Question 9We pursue international research collaboration within

the BEST collaborative and other research teams and

also in cooperation with different manufacturers within

the blood component field. There may be funding

available for research on a European Community

level, provided that institutions from several countries

will be engaged. It may demand a great deal work to

apply for such funding. We have no experience in this

respect.

References1 Gulliksson H, Vesterinen M, Payrat JM, et al.: Extended storage

of whole blood before the preparation of blood components: in

vitro effects on red blood cells in Erythro-Sol environment. Vox

Sang 2009; 96:199–205

2 Gulliksson H, AuBuchon JP, Cardigan R, et al.: Storage of plate-

lets in additive solutions: a multicentre study of the in vitro

effects of potassium and magnesium. Vox Sang 2003; 85:199–

205

3 Diedrich B, Ringden O, Watz E, et al.: A randomized study of

buffy coat platelets in platelet additive solution stored 1–5 versus

6–7 days prior to prophylactic transfusion of allogeneic haemat-

opoietic progenitor cell transplant recipients. Vox Sang 2009;

97:254–259

4 Shanwell A, Diedrich B, Falker C, et al.: Paired in vitro and in

vivo comparison of apheresis platelet concentrates stored in

platelet additive solution for 1 versus 7 days. Transfusion 2006;

46:973–979

Hans Gulliksson

Clinical Immunology ⁄ Transfusion Medicine

C2 66 Karolinska University Hospital

SE-141 86 Stockholm, Sweden


M. Scott & L. Williamson

Question 1The research programme is funded by a combination of (i) a

levy on the blood price to cover microbiology research, sys-

tematic reviews and clinical studies ⁄ trials, (ii) funding from

the Department of Health (National Institute for Health

Research and Grant-in-Aid), (iii) external funding won by

researchers from research councils, European Union, chari-

ties and industry. There are approximately 150 researchers,

under 13 principal investigators (PIs), with a mixture of

PhD students, postdoctoral fellows, career-track 5-year

posts, clinical fellows and research nurses. A research man-

ager and research co-ordinator report to the Medical and

Research Director. During 2010, we will develop the

concept of programme co-ordinators.

Question 2All research is carried out in close collaboration with our

University partners, with which we have research agree-

ments. PIs have either substantive or honorary positions

within the University, and many of our junior research staff

are employed by the University.

Question 3For blood, stem cells, organs and tissues, the ratio of research

to development is about 3:1. However, there is also extensive

product development in the plasma fractionation section.

Question 4We have chosen to exploit our IP through our partner uni-

versities, with support from a consultancy company who

provide advice to investigators.

Question 5Every research project is reviewed annually by the R&D

committee, which includes three international members. In

addition, there are 5-yearly site visits by the international

reviewers, and this time we will include additional experts

to cover specific research areas.

Question 6PIs receive core monies against plans which are reviewed

by the R&D committee. We also run a project grant system

in which projects are sent for external peer review, usually

internationally. These are open to our own staff, and for

clinical studies also to external collaborators.



Question 7/8The programme, developed after an audit of activities, aims

to provide a balanced range of activities that map to our

unique strengths: transfusion microbiology; systematic

reviews and clinical studies to provide an evidence base for

the appropriate use of blood; translational research on cellu-

lar therapies, gene transfer and therapeutic proteins manu-

factured to GMP grade; blood cell genomics; research to

improve thenumberandquality oforgans for transplantation.

Question 9There are strong international links forged by specific

investigators. We do not receive any specific funding allo-

cated for international trials.

Marion Scott & Lorna Williamson

NHS Blood and Transplant, UK


[email protected]

C. Prowse

Question 1The Scottish National Blood Transfusion Service (SNBTS)

includes a specific directorate that undertakes research and

development for the organization. It is funded by the

service, but researchers are also expected to seek external

(grant and commercial) funding to support developments.

Currently, we have about 40 full-time researchers who are

organized in four themes: cell therapies, immunohaematol-

ogy, transfusion-transmitted infection & blood compo-

nents and vCJD. There is an R&D director for the whole

organization and a leader for each of the themes. The R&D

Directorate is also responsible for our library, organizing an

MSc course (in Transfusion, Transplantation and Tissue

Banking) and national support for clinical trials.

Question 2We have formal links (and some joint appointments) with

the Universities in Aberdeen, Glasgow and Edinburgh.

Question 3While it varies from year to year approximately half the

core funding assigned to R&D is for basic research. How-

ever, additional external funds (which vary between 50%

and 100% of core funding) tend to be either for basic

research or for clinical trials.

Question 4The SNBTS actively manages its intellectual property and

seeks to obtain patents and pursue commercialization when

this is appropriate.

Question 5The research programme is reviewed by our Research Advi-

sory Group (RAG) once a year in terms of progress over the

last year and plans for the coming year. The RAG includes

external scientific experts as well as lay representatives and

government observers. Every 4 years, a more strategic

4-year plan is produced and reviewed by RAG; the current

plan runs from 2008 to 2012.

Question 6Research projects are subject to peer review as part of the

RAG process described earlier. Applications for external

funding are competitive; allocation of core internal funding

is on partially competitive as we need to provide continuity

for tenured staff at some level, although there is some flexi-

bility in resource allocation.

Question 7Introduction of new, and curtailment of other, research

areas at a high level should be addressed via the 4- year

planning centre. Our system allows flexibility for

changes of direction within the agreed themes on an

annual or even shorter basis, or if there is urgent need,

particularly if external funds can be sourced to support

novel areas.

Question 8At present, SNBTS is particularly strong in the fields of

regenerative medicine, vCJD, microarray, blood group

genotyping and use of peptides as modulators and reagents

in immunohaematology. Owing to recent retirements and a

lack of suitable applicants, we are weaker in the compo-

nents field than in the past.

Question 9SNBTS has successfully sought international collaboration

in research projects through groups such as ISBT and BEST,

and also through applications for European grant funding.

Work with developing countries has received less emphasis,

although support to WHO and World Bank projects has

been undertaken. We are not aware of funding from pro-

grammes in the United Kingdom specifically aimed at

transfusion other than funding for visiting researchers for

short periods from groups such as the British Blood Trans-

fusion Society

Chris Prowse

Research Director

Scottish National Blood Transfusion Service




J. P. AuBuchon, J. A. López & P. Hoffman

Question 1Puget Sound Blood Center has had an active research pro-

gramme in both basic and applied fields related to transfu-

sion medicine – and haematology, in general – since it

began in 1944. Its founding director, Dr. Richard Czajkow-

ski, was quoted in the newspaper article noting the pro-

gramme’s first blood drive as saying, ‘We do research

because we still don’t know all the uses of blood.’ In the 65-

year interim, the centre’s physicians and scientists have

published more than 800 scientific articles (Fig. 1), and we

are still seeking to learn more about blood.

The research institute is a full and integral part of

the blood centre. It is managed directly by one of the

Executive Vice-Presidents, a member of the blood cen-

tre’s executive team. Its budget is developed annually

based on expected and projected revenues from grants

and contracts and support from blood centre operating

revenues. There are several major sources of funding of

the $7.4 million annual operating budget. (Fig. 2) The

blood centre’s Development Department targets its fund-

raising activities primary towards research, and this sup-

port reduces the funding necessary from operational

sources.

This budget supports the work of 54 full-time staff.

(Table 1). In addition, there are multiple additional staff

involved in research or development activities on a part-

time basis, including, for example, three physicians, two

scientists, and at least four medical laboratory scientists

engaged in or periodically leading clinical or translational

scientific studies. The research institute is currently

engaged in a 10-year programme to double the number of

its principal investigators with a focus on thrombosis

research.

Question 2Puget Sound Blood Center has a formal agreement with the

University of Washington outlining our relationship. All of

our principal investigators and all physicians have faculty

appointments, almost all in the School of Medicine.

Question 3The research and development efforts of Puget Sound

Blood Center have traditionally encompassed the gamut

from basic science to clinical trials to educational endeav-

ours. The blood centre’s researchers helped to explain the

modulation of oxygen transport by haemoglobin and

define the abnormalities in the factor VIII gene leading to

haemophilia in our patients. Among transfusion medicine

specialists, the blood centre is today best known for its

work in practical clinical trials, developing better ways to

produce cryoprecipitate and preserve platelets as well as

clinical trials focused on the practice of transfusion medi-

cine and its advancement and improvement (e.g. TRAP,

VATS, SPRINT, PLADO). However, our basic science inves-

tigations are expanding. Basic investigations include efforts

to define the immunogenic portions of factor VIII and to

develop alternative less immunogenic recombinant pro-

teins for the treatment of haemophilia A, studies aimed at

inducing tolerance to factor VIII in patients with inhibitors,

studies to identify all of the enzymes involved in gamma

carboxylation of proteins so as to develop new anticoagu-

lants, studies of platelet activation mechanisms and inhibi-

tory pathways, studies of the structure and functions of von

Willebrand factor and its role in disease, endothelial cell

biology, studies of genes involved in the generation of

platelets from megakaryocytes, and studies in red-cell

metabolism (related both to inherited disorders and the red-

cell storage lesion) are expanding. Genomic red-cell studies

1950 1960 1970 1980 1990 2000 2010

100

200

300

400

500

600

700

Basic research

Applied research

Total publications

Tissue-related

800

Cum

ulat

ive

publ

icat

ions

Fig. 1 Scientific publications from Puget Sound Blood Center.

Federal funding (57%)

Foundation funding (13%)

Philanthropy (14%)

Blood center operations (15%)

Fig. 2 Support of Research at Puget Sound Blood Center.

Table 1 Full-time staff of Puget Sound Research Institute

Principal investigators 12

Research scientists ⁄ technicians 24

Post-doctoral fellows 8

Graduate students 1

Administrative staff 9



have improved our ability to associate genotype with phe-

notype and expand the availability of ‘rare blood’ for allo-

immunized patients. Other translational work relates to our

operation of a public cord-blood bank in order to improve

the enumeration and preservation of haematopoietic stem

cells. In the very practical realm, our donor testing labora-

tory is also involved in clinical trials of improved or

extended infectious disease assays. Overall, over 90% of the

studies performed by Puget Sound Blood Center staff are

‘investigator initiated’.

Question 4We certainly look for opportunities for commercialization

of our work, and we strive to protect our inventions

through patent filings and Material Transfer Agreements.

However, given the nature of most of our research (either

basic science or clinical application), this is not a major

focus or source of support for our research efforts. Of

potential, commercial benefit is our effort to develop diag-

nostic tests of hemostasis and thrombosis, which will be

offered by the hemostasis laboratory.

Question 5We have instituted a Scientific Advisory Council composed

of internationally recognized experts with expertise across

our focus areas of research. They will meet annually to

review our programme’s success and direction. Thus, they

will be able to provide our Board of Trustees (the blood cen-

tre’s governing body) and the community at large with

assurance that the research of the blood centre represents

appropriate and worthwhile endeavours. In addition, since

our physicians and scientists are faculty members of the

University of Washington, their scholarly contributions

and academic engagements are routinely assessed to ensure

that they are on track for academic promotion according to

the University’s rigorous criteria.

Question 6All research involving human subjects must be approved

by an ‘institutional review board’ (ethics committee) meet-

ing the specifications of NIH regulations. Animal research

similarly passes through an animal research review com-

mittee. Nascent clinical studies involving patients com-

monly are reviewed by the medical staff through their

weekly meetings inasmuch as they all will be handling the

clinical cases and unusual situations during the study as

they arise; useful feedback on practical issues pertaining to

the study often are identified during such discussions. The

projects of each researcher are, of course, reviewed exter-

nally by funding sources and guided, in early years, by a

junior investigator’s mentor. However, there is no formal

internal review committee.

Question 7The direction of the research of the blood centre has

evolved over time more through the interests of the physi-

cian ⁄ scientists recruited to open positions than by design.

However, in the last few years, a concerted commitment

has been made to identify and actively recruit researchers

who will complement existing programmes and create, in

each, a ‘critical mass’. Furthermore, the blood centre is

actively seeking to expand its thrombosis research team’s

breadth and depth by recruitments across a broad scope of

interests and capabilities. These include, for example, phy-

sician scientists interested in the clinical complications of

transfusion in trauma and critical care as they relate to

untoward reactions and thrombosis as well as basic scien-

tists seeking to gain understanding of molecular mecha-

nisms of the coagulation system.

Question 8Our areas of expansion focus are noted above.

Question 9Effective research projects rarely involve a single labora-

tory’s expertise, and collaborations are essential to success.

We have numerous collaborations within the University of

Washington as well as many of the other independent

research institutes in the Seattle area. Several of our inves-

tigators have international collaborators, in countries

including Japan, England, Ireland, the Netherlands, and

other European countries. We are also pleased to be an

active part of the Biomedical Excellence for Safer Transfu-

sion (BEST) Collaborative, with three scientific members of

that group who have engaged in projects across all of the

four teams of BEST (Clinical Studies, Cellular Therapies,

Conventional Components, Transfusion Safety) in their

international studies. We have also been pleased to be able

to offer educational opportunities for blood bankers from

around the world and have also participated in joint

research projects with them (such as defining the effect of a

malarial eradication project on the utilization of blood in

sub-Saharan Africa). We continue to seek other interna-

tional collaborative efforts, particularly in hemosta-

sis ⁄ thrombosis.

James P. AuBuchon MD, FCAP, FRCP (Edin)

President & CEO

Puget Sound Blood Center, USA


Jose A. Lopez MD, PhD

Executive Vice President, Research





Patricia Hoffman, MS

Administrative Director, Research



M. P. Busch, P. J. Norris & P. Tomasulo

Question 1Blood Systems Research Institute (BSRI), located in San

Francisco, California is a division of Blood Systems, Inc

(BSI), the second largest non-profit blood collection and

testing organization in United States. The institute is cur-

rently comprised of 10 investigators (including principal

and clinical investigators), seven Staff Scientists, five post-

doctoral fellows, and approximately 30 technical and

administrative staff. The Director of BSRI also serves as

Vice-President of Research at BSI and is assisted in direct-

ing the institute by an Associate Director and Director of

Administration at BSRI, as well as by the Executive Vice-

President for Medical and Research at BSI. The manage-

ment structure is typical for an academic research institute

with principal investigators responsible for their own

research programmes and extramural funding. The investi-

gators are supported in their research by a strong group of

core laboratories headed by Staff Scientists. BSRI has an

active training programme for postdoctoral fellows and

university-level summer interns: it does not currently

have a graduate student programme or routine access to

University graduate students.

Question 2BSRI has a formal affiliation agreement with the University

of California, San Francisco (UCSF). The investigators at

BSRI all have faculty appointments at UCSF. There is a

career path for investigators at BSRI that corresponds to the

academic paths at UCSF.

Question 3BSRI is focused on investigator-driven basic and transla-

tional research primarily related to infectious diseases,

cell therapy and immunology. The institute also

includes an active group of epidemiology and health-

outcomes investigators engaged in blood-bank safety and

policy research. BSRI investigators publish approximately

50 articles in peer-reviewed journals each year.

Question 4BSRI seeks to provide an avenue for commercialization of

inventions arising from research efforts at the institute,

although the BSRI mission does not include commercializa-

tion. BSRI has an intellectual property policy and a patent

committee to facilitate the filing of patents and

identification of intellectual property with commercial

potential. BSI policy fosters the sharing of commercial

value between the inventors and the corporation.

Question 5BSRI is overseen by the Medical and Scientific Advisory

Committee of the BSI Board of Trustees. An external Scien-

tific Advisory Committee, comprised of six members with

relevant expertise, meets every other year to review the

individual investigators and overall programme. Addition-

ally, investigators are reviewed in depth by a panel of

experts in their respective field every 3 years (program-

matic site-visits).

Question 6The majority of projects at BSRI are funded through extra-

mural sources, including the US National Institutes of

Health, the Centers for Disease Control and Prevention, the

Department of Defense, and industry collaborators. Indus-

try funding is generally unrestricted. Industry funded

research may be focused on areas of mutual interest, but

BSRI always maintains publication rights. Extramural grant

and contract revenue in 2009 totaled over $8 million,

including approximately $5 million in direct funding and

approximately $3 million in indirect funding to cover insti-

tutional overhead costs. To the degree possible investiga-

tors are expected to fund their research with extramural

funds.

Extramural funding in the United States is extremely

competitive and at BSRI is supplemented by intramural

funding. This intramural funding, which currently totals

approximately $4 million ⁄ year, is derived from a combina-

tion of a research endowment fund and Blood Systems

operations revenue. Each year 0.75% of gross revenue from

blood centre and testing is allocated to support research at

BSRI. The application of intramural support is designed to

recruit the best investigators, the establishment of core lab-

oratories needed to support high-quality grant applications

and research and to support investigators between grants

when necessary.

Question 7Investigators are recruited by the Institute director based on

a long-term strategy for the Institute and the investigators’

research interests. Specific research areas ⁄ projects are cho-

sen by the investigators based on their scientific expertise

and interest, the availability of or potential for extramural

funding, and the guidance of BSRI’s Director and the SAC.

Investigators are hired based on scientific excellence in

their demonstrated areas of interest and the relevance of

these areas to furthering the field of transfusion medicine

and cellular therapy.



Question 8Strengths of the research institute include transfusion out-

comes and policy research and virology and immunology

programmes, including virus discovery, detection and char-

acterization of transfusion-transmitted pathogens, viral

entry mechanisms and pathogenesis of viral infections.

Growing areas of research at the institute include cellular

therapy, with an emphasis on preparation of GMP cell ther-

apy products, and genetic epidemiology.

Question 9BSRI participates in a number of international research ini-

tiatives. Major research initiatives in Brazil and South

Africa have been funded through the National Institutes of

Health and International Society of Blood Transfusions,

and training programmes have been funded to teach clini-

cal transfusion medicine research in Asia, Africa and South

America.

Michael P. Busch, Philip J. Norris & Peter Tomasulo

Blood Systems Research Institute

and Blood Systems San Francisco

CA 94118, USA


[email protected];

[email protected]

R. Y. Dodd

Question 1The American Red Cross Biomedical Services supports a

centralized research and development programme located

in the Washington DC metropolitan area at a custom-built

laboratory facility. There are nine doctoral level staff, 26

technical level staff and 16 staff involved in various aspects

of research support, two of whom are part time. The pro-

gramme is managed by the Vice-President, Research and

Development and the two discipline-oriented departments

(Transmissible Diseases and Blood Components) are headed

by doctoral level scientists reporting to the Vice-President,

who reports to the Chief Medical Officer. Currently, there

are no academic trainees. Additional research in the Blood

Services Regions is encouraged. The major portion of the

funding for the central programme (approximately 85%) is

provided by the Red Cross. The remainder is a mix of fed-

eral grants and contracts and income from industry-spon-

sored research.

Question 2There are currently no formal institutional linkages to

degree-granting institutions. One staff member holds a

professorial appointment at one of the area’s research

universities.

Question 3As a result of a relatively recent strategic realignment, dis-

covery research was eliminated and essentially all of the

remaining research work is mission-oriented and develop-

mental in character.

Question 4There is a strong intellectual property policy and it is

expected that key discoveries will be patented or otherwise

protected. Efforts are made to license intellectual property

where possible.

Question 5Individual projects are reviewed internally, but there is no

organized programme review system in place.

Question 6Major projects are subject to management review before

initiation. Project funding is not inherently competitive,

but must conform to available resources.

Question 7Project areas are based upon organizational business needs

and directions.

Question 8Areas of strength include transmissible diseases and epide-

miology, component quality and storage lesions, and

equipment evaluation. A blue ribbon panel report calls for

substantial reinvestment in R & D for the American Red

Cross. It will be important to promote and strengthen the

regrowth of discovery research. Particular operational areas

of for future development are cellular therapies and molec-

ular aspects of immunohematology.

Question 9There is a high level of international networking and a

number of ongoing international collaborations. Senior

staff are involved with international organizations, includ-

ing WHO, ISBT, etc. There is some support for the AABB

PEPFAR initiatives. Government funding programmes exist

that explicitly and implicitly support international research

initiatives: specific support of transfusion medicine

research exists but is not extensive.

Roger Y. Dodd

Vice President, Research and Development

American Red Cross, Jerome H. Holland

Laboratory for the Biomedical Sciences

15601, Crabbs Branch Way

Rockville, MD 20855, USA




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