Foreword Special Focus Issue: Bioanalytical laboratory management
For reprint orders, please contact [email protected]
Preface to the 2014 special focus issue of Bioanalysis on bioanalytical laboratory structure and management “...we honestly think that each of these models and perspectives, although they may be viewed to be different, really fit their operation and strategy well.” Two years ago, on a sunny afternoon, the editors of this special issue met at the beautiful Plainsboro library (just a short distance from Princeton University) for one of our regular scientific gatherings. We discussed what would be most useful to help the bioanalytical community deal with the rapidly changing landscape of bioanalysis, an important and unique discipline supporting drug discovery and development pipelines. We felt that in the last 10 years or so, the technologies and regulations have been frequently discussed and shared at various symposia and meetings, and have also been extensively published in scientific and professional journals. On the other hand, and having observed many different bioanalytical operations in the last 20 years, the editors, with experience in managing bioanalytical laboratories in both pharmaceutical and contract research organizations (CROs), and with over 40 years bioanalytical experience combined, felt that it would be beneficial to share knowledge and stimulate a discussion on how to effectively provide bioanalytical support to drug development pipelines. With efforts of generations of bioanalytical scientists and the introduction of better and faster analytical instruments, such as LC-MS/MS, as well as advancements such as multiplexing made in ligand-binding assays, bioanalysis is playing an increasing important role for drug development programs. Managing bioanalytical laboratories is an art that requires fine balance of many areas. We hope this special issue will bring more discussion in sharing successful laboratory operation models.
10.4155/BIO.14.107 © 2014 Future Science Ltd
The landscape change of bioanalysis over the past 20 years has been quite significant (mergers, co-development of drugs, in-licensing, out-licensing, global filings, and so on), along with rapid advances in bioanalytical sciences (better understanding of LC-MS/MS, new products and new modalities, among others) and regulations (global regulations, harmonization efforts, enhanced regulation standards post recent inspections, and so on). Pharmaceutical companies are facing increasing challenges for enhancing productivity while reducing costs. With mergers and acquisitions, internal resizing is unavoidable. Pharmaceutical industry and technology are also advancing rapidly. Technologies and infrastructure used in bioanalysis 10 years ago may have become inadequate to address today’s new applications, new challenges and new therapeutic targets. The role of bioanalysis has rapidly evolved. Bioanalytical groups have many tasks and need frequent interactions with groups such as metabolism, pharmacology, toxicology and pharmacokinetics/dynamics, among others. Overall, bioanalytical strategy discussion is becoming a routine topic within each organization and this strategy is often modified along with organizational changes. In this special issue on bioanalytical laboratory structure and management, we are very pleased and honored to have industrial opinion leaders, from both pharmaceutical companies and CROs, candidly present their perspectives on various aspects of real world bioanalytical challenges, ranging from scientific issue resolutions, to laboratory management, global outsourcing strategy, global harmonization, and adding value to project teams.
Bioanalysis (2014) 6(10), 1275–1277
Naidong Weng Author for correspondence: Pharmacokinetic, Dynamic & Metabolism, Janssen Research & Development, Spring House, PA 19477, USA [email protected]
Qin C Ji Author for correspondence: Analytical & Bioanalytical Development, Bristol-Myers Squibb, Princeton, NJ 08543, USA [email protected]
part of
ISSN 1757-6180
1275
Foreword Weng & Ji In the first part of this special issue, authors from several global pharmaceutical R&D companies present aspects of the operation modes at their respective companies. The choice of operation mode depends on the overall strategy, infrastructure, personnel and many other contributing factors. It is fair to say that each model serves well for its specific need. Sydor et al. from AbbVie discussed how to build and sustain a high efficiency, high quality and low cost internal regulated bioanalytical laboratory to support drug development needs [1] . They discussed how they set up the right infrastructure, method establishment strategy, automation optimization and quality systems to ensure cost–effectiveness, efficiency and quality. A good planning and metric measurement system was also important. Summerfield et al. from GlaxoSmithKline elaborated on the integration of internal and external bioanalytical support to deliver a diversified pharmaceutical portfolio [2] . In their view, bioanalytical scientists should have a strong line of sight to the portfolio and hence the business objectives, which is a strong motivator for maintaining employee engagement and high productivity, while containing costs and maximizing data quality and timeliness. Similarly, Verhaeghe also gave an overview of the bioanalytical outsourcing strategy at Janssen Research and Development [3] . He specifically discussed the selection of preferred providers and some of the challenges for conducting outsourced work in Asia-Pacific countries. Wilson et al. from AstraZeneca discussed their practical approach to bioanalysis delivery and the role of the preclinical bioanalysis and toxicokinetics department at AstraZeneca [4] . In comparison, with just a decade ago, with much fewer resources, they were able to successfully support a larger portfolio by strategically outsourcing a large portion of bioanalytical work while maintaining core internal bioanalytical capabilities in key areas. Aubry from Bristol-Myers Squibb emphasized the importance and benefits of having bioanalytical scientists participate in development teams. Bioanalytical scientists not only deliver the data, but also help the team to look at the data with context as their take, what Aubry vividly called “a seat on the table” [5] . This project-based organization benefits the laboratory and project teams by maintaining assay history and project knowledge, minimizing assay redevelopment and transfers, and providing information-rich analytical data. Similar views were also expressed by Dudal et al. in their article on how the bioanalyst plays a key role in interdisciplinary project teams in the development of biotherapeutics – a reflection of the European Bioanalysis Forum [6] . CROs have become a pivotal part of global bioanalytical community. They are gradually transitioning
1276
Bioanalysis (2014) 6(10)
from ‘just’ service providers to key development partners. Our experts from CROs nicely presented their perspectives on how to manage bioanalytical laboratories. Lin and coauthors from Frontage Laboratories, discussed how to maximize the benefits of global resources and practices and how to drive consistency by using laboratory information management system, training and harmonized standard operation procedures [7] . They also highlighted how to overcome the challenges of conducting bioanalytical support globally. In an editorial paper, Dieter Zimmer shares his personal perspective on bioanalytical outsourcing strategies with a focus on differences, benefits and challenges of bioanalytical outsourcing to local (national) versus international CROs [8] . His conclusion is that there are no clear pros and cons either for local or international CROs. The decision depends on multiple factors, as outlined in his article. In particular, the geographical site where most of the preclinical or clinical studies will be performed, as well as previous experience with individual CROs might be key factors influencing the decision. Unger et al. from Worldwide Clinical Trials discussed the science of laboratory and project management in regulated bioanalysis [9] . The paper covers almost every aspect of a bioanalytical CRO – from scientific method development to detailed planning and project management, and from instrument automation to appropriate communication with the sponsors. It is so right that it is everyone’s responsibility to ensure that bioanalysis is performed to the best scientific and regulatory standards of the day.
“
We believe we achieved our goal of compiling and presenting different views and perspectives on bioanalytical laboratory structure and management.
”
In this special issue, we are also very delighted to include the ‘Bioanalysis Zone: Laboratory Management column highlights’ written by Chad Briscoe of PRA [10] . In his on-going online column, laboratory managers are invited to make contribution. The topics range from staff motivation, to laboratory management, regulatory compliance and many other areas. We hope Bioanalysis Zone, along with this special issue, will reveal some of most important yet unpublished bioanalytical business strategies and practices. We believe we achieved our goal of compiling and presenting different views and perspectives on bioanalytical laboratory structure and management. These insights from industry leading experts are invaluable to the bioanalytical community. Based on our personal experiences of being in several very successful
future science group
Preface to the 2014 special focus issue of Bioanalysis
bioanalytical organizations, we honestly think that each of these models and perspectives, although they may be viewed to be different, really fit their operation and strategy well. Of course, model or strategy will evolve to suit future needs.
the Plainsboro library to envision, plan, discuss and deliberate on the topics of this special issue. They also acknowledge the constructive review of this preface by ME Arnold, AF Aubry (Bristol-Myers Squibb Company) and P Timmerman (Janssen Research and Development).
Acknowledgements
Financial & competing interests disclosure
The authors would like to express their deepest gratitude towards Bioanalysis and especially to the editor of this special issue E Koutsouki. Without the support from her and Bioanalysis, this special issue would never have materialized. They would also like to thank all the authors for their dedication and openness in sharing their perspectives and practices. They would also like to thank their families for allowing them to use some of the most beautiful Saturday afternoons to sit at
N Weng is an employee of Janssen Research and Development and QC Ji is an employee of Bristol-Myers Squibb Company. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.
References
6
Dudal S, Staack RF, Stoellner D et al. How the bioanalyst plays a key role in interdisciplinary project teams in the development of biotherapeutics – a reflection of the European Bioanalysis Forum. Bioanalysis 6(10), 1339–1348 (2014).
7
Lin ZJ, Zhang T, Pasas-Farmer S, Brooks SD, Moyer M, Connolly R. Global bioanalytical support. Bioanalysis 6(10), 1349–1356 (2014).
8
Zimmer D. Outsourcing strategy: local versus international contract research organizations. Bioanalysis 6(10), 1279–1281 (2014).
9
Unger S, Lloyd T, Tan M, Hou J, Wells E. The science of laboratory and project management in regulated bioanalysis. Bioanalysis 6(10), 1357–1372 (2014).
10
Briscoe C. Bioanalysis Zone: Laboratory Management column highlights. Bioanalysis 6(10), 1283–1285 (2014).
1
Song Y, Dhodda R, Zhang J, Sydor J. A high efficiency, high quality and low cost internal regulated bioanalytical laboratory to support drug development needs. Bioanalysis 6(10), 1295–1309 (2014).
2
Summerfield S, Evans C, Spooner N, Dunn J, Szapacs M, Yang E. Integrating internal and external bioanalytical support to deliver a diversified pharmaceutical portfolio. Bioanalysis 6(10), 1311–1319 (2014).
3
4
5
Verhaeghe T. Bioanalytical outsourcing strategy at Janssen Research and Development. Bioanalysis 6(10), 1321–1327 (2014). Wilson A, Silvester S, Woods K. A community of practice approach to bioanalysis delivery: the role of the Preclinical Bioanalysis and Toxicokinetics department at AstraZeneca. Bioanalysis 6(10), 1329–1337 (2014).
Foreword
Aubry A-F. A seat at the table: the benefits of integrating bioanalytical sciences into development project teams. Bioanalysis 6(10), 1291–1293 (2014).
future science group
www.future-science.com
1277
For reprint orders, please contact [email protected]
Preface to the 2014 special focus issue of Bioanalysis on bioanalytical laboratory structure and management “...we honestly think that each of these models and perspectives, although they may be viewed to be different, really fit their operation and strategy well.” Two years ago, on a sunny afternoon, the editors of this special issue met at the beautiful Plainsboro library (just a short distance from Princeton University) for one of our regular scientific gatherings. We discussed what would be most useful to help the bioanalytical community deal with the rapidly changing landscape of bioanalysis, an important and unique discipline supporting drug discovery and development pipelines. We felt that in the last 10 years or so, the technologies and regulations have been frequently discussed and shared at various symposia and meetings, and have also been extensively published in scientific and professional journals. On the other hand, and having observed many different bioanalytical operations in the last 20 years, the editors, with experience in managing bioanalytical laboratories in both pharmaceutical and contract research organizations (CROs), and with over 40 years bioanalytical experience combined, felt that it would be beneficial to share knowledge and stimulate a discussion on how to effectively provide bioanalytical support to drug development pipelines. With efforts of generations of bioanalytical scientists and the introduction of better and faster analytical instruments, such as LC-MS/MS, as well as advancements such as multiplexing made in ligand-binding assays, bioanalysis is playing an increasing important role for drug development programs. Managing bioanalytical laboratories is an art that requires fine balance of many areas. We hope this special issue will bring more discussion in sharing successful laboratory operation models.
10.4155/BIO.14.107 © 2014 Future Science Ltd
The landscape change of bioanalysis over the past 20 years has been quite significant (mergers, co-development of drugs, in-licensing, out-licensing, global filings, and so on), along with rapid advances in bioanalytical sciences (better understanding of LC-MS/MS, new products and new modalities, among others) and regulations (global regulations, harmonization efforts, enhanced regulation standards post recent inspections, and so on). Pharmaceutical companies are facing increasing challenges for enhancing productivity while reducing costs. With mergers and acquisitions, internal resizing is unavoidable. Pharmaceutical industry and technology are also advancing rapidly. Technologies and infrastructure used in bioanalysis 10 years ago may have become inadequate to address today’s new applications, new challenges and new therapeutic targets. The role of bioanalysis has rapidly evolved. Bioanalytical groups have many tasks and need frequent interactions with groups such as metabolism, pharmacology, toxicology and pharmacokinetics/dynamics, among others. Overall, bioanalytical strategy discussion is becoming a routine topic within each organization and this strategy is often modified along with organizational changes. In this special issue on bioanalytical laboratory structure and management, we are very pleased and honored to have industrial opinion leaders, from both pharmaceutical companies and CROs, candidly present their perspectives on various aspects of real world bioanalytical challenges, ranging from scientific issue resolutions, to laboratory management, global outsourcing strategy, global harmonization, and adding value to project teams.
Bioanalysis (2014) 6(10), 1275–1277
Naidong Weng Author for correspondence: Pharmacokinetic, Dynamic & Metabolism, Janssen Research & Development, Spring House, PA 19477, USA [email protected]
Qin C Ji Author for correspondence: Analytical & Bioanalytical Development, Bristol-Myers Squibb, Princeton, NJ 08543, USA [email protected]
part of
ISSN 1757-6180
1275
Foreword Weng & Ji In the first part of this special issue, authors from several global pharmaceutical R&D companies present aspects of the operation modes at their respective companies. The choice of operation mode depends on the overall strategy, infrastructure, personnel and many other contributing factors. It is fair to say that each model serves well for its specific need. Sydor et al. from AbbVie discussed how to build and sustain a high efficiency, high quality and low cost internal regulated bioanalytical laboratory to support drug development needs [1] . They discussed how they set up the right infrastructure, method establishment strategy, automation optimization and quality systems to ensure cost–effectiveness, efficiency and quality. A good planning and metric measurement system was also important. Summerfield et al. from GlaxoSmithKline elaborated on the integration of internal and external bioanalytical support to deliver a diversified pharmaceutical portfolio [2] . In their view, bioanalytical scientists should have a strong line of sight to the portfolio and hence the business objectives, which is a strong motivator for maintaining employee engagement and high productivity, while containing costs and maximizing data quality and timeliness. Similarly, Verhaeghe also gave an overview of the bioanalytical outsourcing strategy at Janssen Research and Development [3] . He specifically discussed the selection of preferred providers and some of the challenges for conducting outsourced work in Asia-Pacific countries. Wilson et al. from AstraZeneca discussed their practical approach to bioanalysis delivery and the role of the preclinical bioanalysis and toxicokinetics department at AstraZeneca [4] . In comparison, with just a decade ago, with much fewer resources, they were able to successfully support a larger portfolio by strategically outsourcing a large portion of bioanalytical work while maintaining core internal bioanalytical capabilities in key areas. Aubry from Bristol-Myers Squibb emphasized the importance and benefits of having bioanalytical scientists participate in development teams. Bioanalytical scientists not only deliver the data, but also help the team to look at the data with context as their take, what Aubry vividly called “a seat on the table” [5] . This project-based organization benefits the laboratory and project teams by maintaining assay history and project knowledge, minimizing assay redevelopment and transfers, and providing information-rich analytical data. Similar views were also expressed by Dudal et al. in their article on how the bioanalyst plays a key role in interdisciplinary project teams in the development of biotherapeutics – a reflection of the European Bioanalysis Forum [6] . CROs have become a pivotal part of global bioanalytical community. They are gradually transitioning
1276
Bioanalysis (2014) 6(10)
from ‘just’ service providers to key development partners. Our experts from CROs nicely presented their perspectives on how to manage bioanalytical laboratories. Lin and coauthors from Frontage Laboratories, discussed how to maximize the benefits of global resources and practices and how to drive consistency by using laboratory information management system, training and harmonized standard operation procedures [7] . They also highlighted how to overcome the challenges of conducting bioanalytical support globally. In an editorial paper, Dieter Zimmer shares his personal perspective on bioanalytical outsourcing strategies with a focus on differences, benefits and challenges of bioanalytical outsourcing to local (national) versus international CROs [8] . His conclusion is that there are no clear pros and cons either for local or international CROs. The decision depends on multiple factors, as outlined in his article. In particular, the geographical site where most of the preclinical or clinical studies will be performed, as well as previous experience with individual CROs might be key factors influencing the decision. Unger et al. from Worldwide Clinical Trials discussed the science of laboratory and project management in regulated bioanalysis [9] . The paper covers almost every aspect of a bioanalytical CRO – from scientific method development to detailed planning and project management, and from instrument automation to appropriate communication with the sponsors. It is so right that it is everyone’s responsibility to ensure that bioanalysis is performed to the best scientific and regulatory standards of the day.
“
We believe we achieved our goal of compiling and presenting different views and perspectives on bioanalytical laboratory structure and management.
”
In this special issue, we are also very delighted to include the ‘Bioanalysis Zone: Laboratory Management column highlights’ written by Chad Briscoe of PRA [10] . In his on-going online column, laboratory managers are invited to make contribution. The topics range from staff motivation, to laboratory management, regulatory compliance and many other areas. We hope Bioanalysis Zone, along with this special issue, will reveal some of most important yet unpublished bioanalytical business strategies and practices. We believe we achieved our goal of compiling and presenting different views and perspectives on bioanalytical laboratory structure and management. These insights from industry leading experts are invaluable to the bioanalytical community. Based on our personal experiences of being in several very successful
future science group
Preface to the 2014 special focus issue of Bioanalysis
bioanalytical organizations, we honestly think that each of these models and perspectives, although they may be viewed to be different, really fit their operation and strategy well. Of course, model or strategy will evolve to suit future needs.
the Plainsboro library to envision, plan, discuss and deliberate on the topics of this special issue. They also acknowledge the constructive review of this preface by ME Arnold, AF Aubry (Bristol-Myers Squibb Company) and P Timmerman (Janssen Research and Development).
Acknowledgements
Financial & competing interests disclosure
The authors would like to express their deepest gratitude towards Bioanalysis and especially to the editor of this special issue E Koutsouki. Without the support from her and Bioanalysis, this special issue would never have materialized. They would also like to thank all the authors for their dedication and openness in sharing their perspectives and practices. They would also like to thank their families for allowing them to use some of the most beautiful Saturday afternoons to sit at
N Weng is an employee of Janssen Research and Development and QC Ji is an employee of Bristol-Myers Squibb Company. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.
References
6
Dudal S, Staack RF, Stoellner D et al. How the bioanalyst plays a key role in interdisciplinary project teams in the development of biotherapeutics – a reflection of the European Bioanalysis Forum. Bioanalysis 6(10), 1339–1348 (2014).
7
Lin ZJ, Zhang T, Pasas-Farmer S, Brooks SD, Moyer M, Connolly R. Global bioanalytical support. Bioanalysis 6(10), 1349–1356 (2014).
8
Zimmer D. Outsourcing strategy: local versus international contract research organizations. Bioanalysis 6(10), 1279–1281 (2014).
9
Unger S, Lloyd T, Tan M, Hou J, Wells E. The science of laboratory and project management in regulated bioanalysis. Bioanalysis 6(10), 1357–1372 (2014).
10
Briscoe C. Bioanalysis Zone: Laboratory Management column highlights. Bioanalysis 6(10), 1283–1285 (2014).
1
Song Y, Dhodda R, Zhang J, Sydor J. A high efficiency, high quality and low cost internal regulated bioanalytical laboratory to support drug development needs. Bioanalysis 6(10), 1295–1309 (2014).
2
Summerfield S, Evans C, Spooner N, Dunn J, Szapacs M, Yang E. Integrating internal and external bioanalytical support to deliver a diversified pharmaceutical portfolio. Bioanalysis 6(10), 1311–1319 (2014).
3
4
5
Verhaeghe T. Bioanalytical outsourcing strategy at Janssen Research and Development. Bioanalysis 6(10), 1321–1327 (2014). Wilson A, Silvester S, Woods K. A community of practice approach to bioanalysis delivery: the role of the Preclinical Bioanalysis and Toxicokinetics department at AstraZeneca. Bioanalysis 6(10), 1329–1337 (2014).
Foreword
Aubry A-F. A seat at the table: the benefits of integrating bioanalytical sciences into development project teams. Bioanalysis 6(10), 1291–1293 (2014).
future science group
www.future-science.com
1277
