Advances in Biobanking Practice Through Public and Private Collaborations E-Book
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- Herausgeber: Bentham Science Publishers
- Kategorie: Fachliteratur
- Sprache: Englisch
Advances in Biobanking Practice Through Public and Private Collaborations presents an analysis of methods and current models of partnership between public and private organizations designed to improve biobanking practices in European countries. Chapters describe the state-of-the-art of public-private collaborations in biobanking on a global scale, innovative approaches to public-private partnerships, the role of a quality management system in biobanking collaborations, quality standard criteria specifically shaped for tumor biobanks, theoretical and practical access conditions to biobanks, the general legal framework governing biobanks at national, European and international levels and a concrete public-private partnership model for managing sample requests.
The contributions in this book include examples of established biobanking institutions (such as Spanish National Cancer Research Centre, National Institute of Health, Italy, and 3C-R, France among others) which serve to give readers a concrete perspective on current biobanking practices and relevant legal and ethical issues that shape the field. This book is an ideal handbook for all medical researchers, healthcare professionals and biobanking stakeholders seeking information about international biobanking practices and business models.
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Seitenzahl: 217
Veröffentlichungsjahr: 2017
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Advances in Biobanking Practice Through
Public and Private Collaborations
Edited by
Elena Salvaterra
Founder and Director of Areteva,Sherwood House, 7 Gregory Boulevard,Nottingham, Nottinghamshire, NG7 6LB
&
Julie Corfield
Coordinator Scientific Projects and Regulatory Affairs,Exem Italia s.r.l., Italy;ISBEScience and Policy Committee Advisor (US),ESBB Founder Member (EU), Organ Preservation Alliance Member (US)
BENTHAM SCIENCE PUBLISHERS LTD.
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FOREWORD 1
The present book addresses a significant gap in our collective knowledge on biobanking advancement through public-private partnerships. These partnerships are often alluded to in the peer-reviewed literature however one remains hard pressed to find and review a convincing, consistent body of evidence. The book moves quickly and effectively beyond a descriptive listing of the current landscape and sets as its core quest the aim of improvement. This improvement is multi-faceted: it can involve amongst others individual biobanks, collaborative projects, reference/national centers, qualitative standards, Intellectual Property (IP) issues, rights and obligations of stakeholders; all brought together for the common purpose of public and private benefit.
Over the past two decades the biobanking field has enjoyed a period of sustained investment, growth, wider scientific acceptance and development. Additionally, individual biobanks have benefited by support from very active, scientific community-driven societies, such as ISBER, the International Society for Biological and Environmental Repositories, and others. This has created a strong foundation for the regular exchange of experiences, the development of best practices and creation of educational tools with a global reach, especially as the biobanking field develops in Asia, Africa and south America. However, as the global financial crisis has developed into an enduring pressure for tighter cost control, expense justification and even cost retrieval, new operational models need to be considered for long-term sustainability in biobanking. This book investigates these alternative approaches which can operate in collaboration with the private sector yet without limiting their public benefit.
The editors have selected six distinct perspectives to provide a holistic approach in their subject. These are: Current practices; Quality management systems; Specimens quality; Rights and obligations of stakeholders; Collaboration models and Case studies. Sub-themes include the complementation and conflicts of different sectors and skill sets; the accreditation options and processes; the inherent trust in sample acquisition and processing, including biosafety. At the same time legal frameworks, different collaboration models and case studies are being brought together as a living corpus of evidence. It is indeed a very good collection of workable examples presented by some of the most respected scientific leaders in the field.
This book is an impressive and comprehensive study that moves beyond stereotypes that the biobanking field has often faced. It analyses why partnerships work and the future aspects that still need to be explored. Within the ISBER community there is the acute realization that private partners, commonly from the pharmaceutical industry, are often an essential component in addressing complex, healthcare related questions effectively and efficiently. The public –private partnerships have the potential to form a long-term, reliable infrastructure network enabling the discovery of new pharmaceutical agents, effective re-purposing of existing ones and preparedness in global health emergencies. I sincerely hope that more such examples will develop and strengthen in years to come, allaying public hesitation, and that a similar body of evidence will be developed in the not too distant future from our colleagues in Asia, Africa and south America.
FOREWORD 2
When walking the long way in the development of new products and methods to be used for patient treatment or diagnosis, medical translational research needs to be able to exchange knowledge and biomaterials in the public-private domain. Collaboration in this area is often indispensable for the final innovation of patient care. Funding institutions understand this need and increasingly try to stimulate this important domain where many exciting and interesting opportunities can be found. At the same time, it is also a difficult area to work with biomaterials as it means yet another boundary where you need to learn to deal with new often stricter rules with respect to ethics and regulatory issues. Yet this is certainly not the only aspect important for a smooth cooperation, also the quality of the samples are very crucial. Especially where reproducibility is concerned which can be a show stopper easily and unexpectedly encountered. Certainly the moment after the research process where a developed method or product needs to be validated for its intended use. In this step, one has to rely on the quality of the routine diagnostic samples which might be collected under very different pre-analytical conditions as the samples that were used in the discovery phase. The infrastructure of the biobank becomes very important. It should reflect or better yet make use of the existing routine diagnostic pathways. In addition, the quality of the diagnostic sample is in need for improvement to facilitate new products and methods more efficiently.
Of course there is an array of ways how the public and private partners can collaborate. Therefore, the editors have invited and selected the experts in their fields with much care to write chapters on:
The importance, benefits and unique results that are obtained from the public private partnerships,Theoretical collaboration models and good examples of practical solutions and tips,How quality can contribute to the collaboration,The influence on legislation and ethics,Concrete examples of public-private collaborations based on local infrastructure synergies.This logical line is also chosen to set up the book to become a consistent and structured overview of the complex domain of public private partnership. It consists of six interesting chapters, where each chapter starts with an abstract of the content. The field is an exciting and dynamic one with many opportunities for scientists from the academic setting and companies to find common grounds to synergistically grow in win-win environments.
PREFACE
The reflection on collaboration between public and private institutions in biobanking is crucial for making advances in this field.
Precision Medicine (PM), digitization and virtualization are quickly changing the biobanking landscape by asking for new models and concepts of synergies between public and private (or for profit) organizations.
However, this theme is currently under-analysis both in the literature and in scientific debates. The need for developing or improving collaborations between public and private institutions is recognized by several scholars but it still remains a niche topic in biobanking.
Furthermore, the reasons for developing public-private synergies (also called partnerships) are usually connected to biobank sustainability, on the public side, and to the acquisition of academic know how, on the private side.
This interpretation of the public-private-partnership (PPP) in biobanking seems to simplify the complexity of the issues related to public and private collaborations. It also seems to reduce the huge potentiality of promoting public-private synergies for biobanking advances and the related benefits for both public and private organizations working in this field.
Taking the above discussion into consideration, this ebook analyzes perspectives, methods and concrete ways to change the current models of collaboration between public and private organizations in order to improve biobanking practices.
The first chapter (Morente and colleagues) describes the state-of-the-art of public-private collaborations in biobanking on a global scale and it defines potential ways to improve these synergies. By highlighting that “the promotion of health” unconditionally should be the final goal of any partnership between public and private organization, Morente et al., list several criteria to reconsider the current theories of PPP in biobanking.
Innovative approaches to public-private collaborations in biobanking are suggested by Lawlor and colleagues (chapter two). After an extensive analysis of “old” and current strategies of liaison in this realm, Lawlor et al., recommend concrete models and methods of PPP to improve the biobanking practice.
The quality management system as a key aspect for public-private synergies in biobanking is the subject of chapter three. Bravo and colleagues extensively analyze the work of the technical committee “ISO T C 276 biotechnology” related to biotechnology standardization by focusing on biobanks and bioresources. The authors give a clear explanation of the role of ISO biotechnology standards to improve the quality of services for biobanks and to offer access to new markets for industries.
The description of quality standard criteria specifically tailored for tumor biobanks is provided by Bonizzi et al., (chapter four). The authors report the standard requirements to be followed for processing samples and data in daily practice. These criteria are not different for public or private “partners”. High level of quality is demanded by each organization for using the samples stored in the biobanks, regardless of the public or private nature of the inquiring institutions.
The access conditions to biobanks is the theme analyzed in chapter five by Verlinden and colleagues. After a deep analysis of the general legal framework governing biobanks at national (Belgium), European and international levels, Verlinden et al., consider the access conditions to human biological samples and associated information.
Access conditions to samples and information stored in biobanks within the concrete model of the “HUB-BTB- 3CR” is the subject of chapter six. Di Donato et al., describe the HUB-BTB- 3CR which is a centralized organization for managing sample requests. This model enables public and private researchers to directly access the biobanks which are part of the hub. Although tailored for organizations operating in France, this prototype of public-private collaborations could be used in other countries with modifications as per requirements.
Moving from the theory to the practice, this ebook suggests an accessible analysis of the main issues related to public-private partnerships in biobanking. It considers apparently conflicting concepts, such as academia, industry, profit and solidarity illustrating that they are not necessarily in contrast when trust, transparency and reciprocity are the basis of public-private collaborations in biobanking.
List of Contributors
Public-Private Partnerships in Biobanking: Current Practices
Manuel M. Morente*,Francisco de Luna,Maria C. Marín,Nuria AjenjoAbstract
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.
INTRODUCTION: THE CHALLENGE OF PERSONALISED MEDICINE
Biospecimen science is a young and evolving discipline that arose from the paradigm shift induced by the great biotechnological advances that took place in the last decades of the 20th century and by the accessibility and knowledge of the human genome and its progressive application to healthcare in Personalised Medicine [1, 2]. These changes are triggering, indeed, a revolution in the study and understanding of more complex and multi-factorial diseases such as cancer,
diabetes, and cardiovascular or neurodegenerative processes. This increased knowledge of the pathogenic bases of complex diseases is not merely of academic value, but it also has practical value that enables improvements in their prevention, diagnosis, prognostic evaluation and therapeutic approaches. Developing and evaluating novel therapies and diagnostic products requires access to rigorously designed and well-structured collections of biospecimens, and this places biobanking infrastructures in a critical position for the discovery, development and implementation of new drugs and products [3].
PUBLIC-PRIVATE RELATIONSHIPS: A NON-HOMOGENEOUS MODEL
Not only the academia and health care sectors are involved in this challenge, but also the industry [4], although their objectives do not always coincide. There are many nuances, but it can be said that health promotion and disease control are true goals in both sectors, although they are approached from different angles.
Before continuing this discussion, it is important to note that 'private' and 'public' have different meanings in different cultures and social models. Indeed, both terms have specific and differentiated connotations in, for instance, the United States of America, Europe, East Asia or emerging countries. Not only do these concepts have different meanings, but the private and public domains in the health care systems and biomedical research, including infrastructures such as biobanks, have a different weight. In addition, we can say the same about Europe as a whole, and about specific European countries, especially when an essential component of the discussion refers to health care systems. Domestic differences in public health care systems, in the development of funding of biomedical research by private charities, or in the dependence of research on public agencies are pivotal elements in private-public partnerships in biobanking.
Such differences also apply to biobanks. Thus, it has been said that “Commercial biobanks are attempting to position themselves as a, if not the, solution to problems that include a lack of public trust in researchers and lack of financial resources to support the prospective creation of collections that meet the highest scientific and ethical standards in the non-profit sector” [5]. This loss of trust is partially secondary to some examples of unethical practices that occurred in the past, and it has been suggested discomfort with the idea of gain from the mere transfer or exchange of human genetic material and information. However, this is not the actual situation in most of Europe, where academic research and researchers enjoy a high level of public trust, which is clearly higher than for industry-related research.
