Advances in Biobanking Practice Through Public and Private Collaborations

Public-private partnerships (PPPs) and relationships are essential to expedite the resolution of the challenges currently facing Medicine. Biobanking is not an island within biomedical research as a whole, and public–private partnerships in biobanking must therefore be considered in the global context of biomedical research. PPPs are certainly desirable, since they offer benefits to both sides, create win-win situations and are extremely advantageous for the whole society, but they have their own limitations and frontiers. The current chapter tries to introduce the general aspects of current PPP practices in biobanking, keeping in mind that the main objective should be the promotion of health rather than the sustainability of biobanks or benefits for industry. Compliance with applicable legislation, mutual trust, transparency and open dialogue are the key components of such partnerships.

Access to high quality human biological samples and associated medical information is an essential prerequisite to biomedical research and innovation for both academia and industry. In particular, the private industry sector needs access to biospecimens and data to develop innovative products to keep or gain market leadership. Interaction between industry and academia is important from a social and economic stand point. One provides sustainable global economy while the other contributes to the scientific knowledge base. The main challenge in such collaborations is reconciling perceived altruism and open collaboration with intellectual property and profit. In order to establish a fruitful collaboration, the partners need to recognize their differences to produce positive outcomes for both and avoid the potential drawbacks that different cultures can encur when attempting to join forces. As seen in previous chapter, biobanking is indeed a liaison between the public and private realms. Models for partnerships must be characterized by a common vision, shared mutually agreed goals, clear commitment and investment from all partners through formalized collaboration and shared decision-making.This chapter focuses on the elements necessary for successful collaboration between public and private realms and looks at various models of collaborations, from traditional models,that existed before biobanking was recognized as a discipline, to recent models of public-private partnership. These include models directly created for private collaborations with biobanks as well as models of collaboration where biobanks play an integral part. The chapter concludes with suggestions for innovative models of public-private synergy in biobanking for the future.

Biospecimens are essential raw materials for the advancement of applied biotechnology. Awareness of the importance of sharing biospecimens has increased in recent years and biobanking activities have facilitated access to them. However, the sharing of such samples for Research & Development could be considerably improved if there were a recognised global agreement about the standard by which to compare their quality. The Organization for Standardization (ISO) is the internationally recognised body that provides guidelines and defines specifications to ensure standardisation of materials, processes and products.The working group two (WG2) of the ISO Technical Committee (TC) 276 established by the ISO on Biotechnology is dedicated to Biobanking. The aim of this working group is to establish sets of standards that apply to the biobanking field, to include human, animal, plant and microorganism samples, thus ensuring that they are of appropriate quality. The availability of worldwide recognized policies and procedures will support access and exchange of samples and related data, giving a major impetus to global use of bioresources for market application. The standard set, which will be based on existing documents and guidelines, will be the foundation of a quality management system (QMS) specifically for biobanking. ISO QMS would enable the establishment of ad hoc global certification that products, processes and/or services conform to relevant standards, technical specifications and guidelines.

Since the beginning, the scientific research was an integral part of the mission of the European Oncology Institute (IEO). Its position is at the intersection between Surgical Units, the Department of Pathology and Research Units. This organization makes the IEO Biobank for Translational Medicine (B4MED) a critical resource that reflects the mission of IEO to perform “Research for Care”. The B4MED collects, catalogues and stores biological samples that are non-essential for diagnostic purposes from patients who provide informed consent for the use of their tissues for research purposes. A direct pipeline with the operating theatres for the collection of tissue samples ensures negligible sample degradation. Surgically-excised pathological and non-pathological tissue samples, plasma/serum, total blood, DNA and RNA are collected and stored according to specific protocols and standard operating procedures. All biobanked samples are managed and tracked through a software package that is fully integrated with the hospital medical records database, pathology database and central registry of patient demographic information. This ensures that each sample is linked to a full complement of anonymous or anonymized (according to patient choice) patient information that is accessible solely by authorized Biobank personnel. The high quality biospecimens collected by the B4MED are used for biomarker and drug discovery experiments, both for basic research and for clinical research, with the ultimate aim of providing excellence in patient care through excellence in research.

Millions of human biological samples and associated data are collected each year for a variety of purposes. These purposes may include basic research, clinical trials and epidemiological studies. The legal framework that determines access to biobanks remains presently unclear. The absence of a defined set of applicable rules on international, European and national level creates legal uncertainty for biobanks and applicants. This chapter reports on four studies concerning the legal structure applicable to “Access to Biobanks”. The first study consisted of a comparative analysis of access arrangements of organizations, biobank networks and biorepositories. The second study included interviews to gather qualitative data on the different perspectives held by stakeholders and experts in relation to the rights and obligations of custodians and applicants with respect to access to HBM and data stored in biobanks. The third study focused on the analysis of the legal framework applicable to access to biobanks. The final study (four) analysed the intellectual property rights (IPRs) in biobanking and the return and sharing of research results. These studies allowed us to formulate recommendations on the improvement of the legal framework applicable to public and private biobanks.

The main purpose of biobanks is to provide private and public organisations with biological resources to be used for research projects but unfortunately this process is often not straightforward. Most biobanks supply biological resources to research teams within their own organizations and have difficulty in supplying samples to external teams. The most difficult step is to obtain a specific collaboration agreement between the two parties. This step takes a long time and often interferes with research planning. Moreover, most of French biobanks are administered and financed by hospitals or public research institutes, which established the biobanks for the purpose of supporting their own researchers. The supply of biological resources in the absence of scientific collaboration was not a part of the original plan. Yet today these biobanks need to supply research teams in private/commercial organisations, to promote the use of their samples, to develop translational research and to obtain a return on investment. The rights and needs of researchers must be take into account but priority must be given to the valorization of the biobank. To encourage optimal use of samples and avoid the costly conservation of unused collections, we propose a “HUB” organization to enhance access to biological resources in France. The development of this organization and drafting of legal agreements must take into account the following considerations: a) the researchers’ current needs must be fully understood: this depends on excellent communications between the HUB and legal representatives of the research teams, and b) the availability of collections through a biobank network must be fully understood: this depends on excellent communications between the HUB and legal representatives of the biobanks.