Conference Report: Impacting Biology Through Analysis

Abstract

The 12th Annual Symposium on Chemical and Pharmaceutical Structure Analysis (CPSA 2009) was held on 26–29 October 2009 in Langhorne, PA, USA. This annual meeting began in 1998 and was the first industry-led event to focus on the specific needs of industry researchers. The goal of CPSA is to provide an indepth review of innovative technology and industry practices through open discussion of industry-related issues and needs. Education and specialized training are the foundation of all CPSA events: ‘Where Technology and Solutions Meet’.

Kevin Bateman of Merck served as the 12th Annual Symposium on Chemical and Pharmaceutical Structure Analysis 2009 Program Chair. The 2009 program focused on ‘Impacting Biology Through Analysis’ and highlighted current industry trends. To open the conference and ensure lively discussions, the Program Chair welcomed the participants and stated that “Biology needs fast, high resolution analysis” and so the meeting began.

Ian Jardine, Vice President of Global R&D at Thermo Fisher Scientific, delivered the Plenary lecture. His talk on ‘The Impact of High-Performance Mass Spectrometry on Biology Research’ provided a unique perspective on the current and future use of MS in the pharmaceutical industry. The research demands in the life sciences were benchmarked, along with recent analytical technologies that feature increased sensitivity and resolution.

If high-performance technology is the future of biology research, then integration is the enabler. Todd Gillespie of Eli Lilly led a discussion on ‘High Performance Workflows: Emerging Applications for Simultaneous Qualitative–Quantitative Analysis.’ Automation, optimization and integration were identified as key areas of focus for industrial endeavors. Furthermore, miniaturization (i.e., microfluidics) was highlighted as a future impact area, particularly for sample-processing routines and chromatographic-based separations.

The ways that analytical technology is transforming the life sciences were evident in the sessions on ‘Why Biomarkers for Toxicology and Clinical Diagnostics Fail,’ ‘small Molecule Biomarker Assay Development and Validation,’ ‘Protein Based Biomarkers,’ and ‘Toxicity Markers.’ Specifically, MS, separation sciences and bioinformatics were identified as powerful tools for future success – in both discovery and the clinic. Rick Morrison, Executive Director and Global Head of Exploratory Drug Metabolism at Schering-Plough Research Institute, stated in his talk, “don’t make assumptions – get the data!” He concluded that “integration of PK/PD into pharmacology studies during lead optimization requires a culture shift and scientific concordance.” These experiences (from data to culture) seemed to be shared throughout many of the sessions at CPSA 2009.

The focus of the conference is not exclusively on what you can do with novel technologies but how you can use these technologies in an industrial setting. Mark Hayward of Lundbeck Research USA and Ragu Ramanathan of Bristol-Myers Squibb co-chaired the popular CPSA Vendor Session, where the ‘latest and greatest’ technologies and solutions are presented in a most unique format – 5-min vendor presentations – dubbed by many as the ‘5 minutes of fame.’ Here, the ‘what’ and the ‘how’ in the world of analytical technologies and related services were presented. So what was new at CPSA 2009? New CRO companies – Agilux Laboratories (Worcester, MA, USA); Alliance Pharma (Malvern, PA, USA); PharmaCadence (Hatfield, PA, USA) and RMI Laboratories (North Wales, PA, USA) – formally announced their newly formed analytical services laboratories. Also, Protein Discovery and New Objective announced a comarketing agreement during the CPSA 2009 Vendor Session. The marketing agreement involves GelFree 8100 Fractionation System (Protein Discovery) and PicoFrit nanobore chromatography columns (New Objective) and Digital PicoView nanospray sources (New Objective). The combined technologies will provide an integrated, standardized workflow – from sample to spray – for top-down protein analysis.

As a testament to the powerful movement and preference toward high-performance (technology and workflows), Walter Korfmacher of Schering-Plough Research Institute was awarded the Distinguished Analytical Scientist Award, an honor bestowed each year to recognize industrial researchers who have had an extraordinary impact in the analytical sciences. In his lecture, Korfmacher provided a ‘highlight reel’ of data that delineated the past, present and future of MS in drug discovery. Previous winners of the award include Mark Cole, Pfizer; Rick King, Merck Research Laboratories; Brad Ackermann, Eli Lilly and Tom Covey, MDS Analytical Technologies.

CPSA 2009 Keynote lecturer, Thomas Baillie, Dean of Pharmacy at the University of Washington, provided more insights into MS performance in the pharmaceutical industry as well as perhaps one of the most memorable quotes of the event. “Of the many technological advances that have been introduced in recent years, accurate mass LC–MS/MS seems destined to revolutionize applications in drug metabolism” he stated.

Perhaps an insider’s look into the future pharmaceutical laboratory setting was gained in the sessions on ‘Tools for Understanding Biology Through Analysis,’ ‘small Interfering RNA and Gene Silencing,’ ‘Peptide and Protein Quantitation’ and ‘High-Throughput Quantitation: Going Faster by Going Slower.’ These sessions were highlighted by outstanding presentations that resulted in some provocative questions. “Is it better to be sensitive and specific or accurate and reproducible?” asked Pat Bennett of Tandem Labs. “How selective is SRM quantitation?” This was the question presented to the attendees by Gérard Hopfgartner of the University of Geneva.

The ongoing transformation of the pharmaceutical industry was also a hot topic at CPSA 2009. Lucinda Cohen of Merck Research Laboratories led a discussion on ‘Maintaining our Innovative Fitness during Times of Transition.’ Collaboration on a global level, as well as distributed strategies for research and development, were highlighted as some of the future realities.

The sponsored workshops provided even more validation on the future needs and uses of high-performance analytical technologies. The session on ‘High-Performance Nanospray’ hosted by New Objective provided future insights into the future use of nanospray-based technologies and formats. Workshop participants Susan Abbatiello of The Broad Institute of MIT and Harvard, Tom Covey of MDS Analytical Technologies, Rick King of PharmaCadence and Gary Valaskovic of New Objective shared their recent data and findings with equimolar response phenomena as well as tips to improve chromatography performance with nanospray. The group also led a discussion on the prospects of high-performance quantitation (enhanced sensitivity and selectivity). Abbatiello’s statement, “nanospray is a harsh mistress” seemed to galvanize the workshop, particularly amongst early practitioners of electrospray LC–MS, as similar sentiments were indeed expressed during the late 1980s and early 1990s.

Vitalea Science hosted a workshop on ‘High- Performance Clinical Studies,’ with presentations on accelerator MS applications and uses. Recent studies that involved the novel uses of microdoses and microtracers were discussed amongst a stellar panel that included Thomas Baillie of the University of Washington, Steve Unger of Wyeth Research and John Vogel of Vitalea Science. Radioanalysis in the context of addressing metabolites in safety training considerations as well as perspectives on future US FDA Guidance and the corresponding ICH guidelines and recent experiences with universal and equal quantification across any matrix were discussed.

‘High-Performance Sample Preparation’ was the focus of the workshop sponsored by Protein Discovery. Recent experiences with the quantitation of proteins and peptides were described in detail. One of the take-home messages focused on the need (or opportunity) for more powerful sample-preparation technologies. Examples of protein isolation and enrichment in a clinical setting were discussed and targeted goals (a sample preparation wish list) were delineated by the panel – Brad Ackermann of Eli Lilly, Russ Grant of LabCorp and Chuck Witkowski of Protein Discovery.

Another highlight of CPSA 2009 was the presentation by Yining Zhao of Pfizer who formally introduced the inaugural CPSA Shanghai event to be held on 7–9 April 2010 in Shanghai, China. Zhao presented detailed information regarding the state of the pharmaceutical industry in China, which has the “fastest and highest growth amongst all the emerging markets.” Zhao stated that “China has a large scientist pool, but these scientists are hungry for innovative thinking and industry training.” Zhao will serve as co-chair for the inaugural event, which will aim to continue the CPSA tradition of an event ‘Where Technology and Solutions Meet’ as well as the premier event ‘Where East Meets West’. For more information, please visit the CPSA Shanghai conference website [1].

Plans are already underway for the 13th Annual Symposium on Chemical and Pharmaceutical Structure Analysis (CPSA 2010). The event will be held at the Sheraton Bucks County Hotel on 18–21 October 2010 in Langhorne, Pennsylvania, located 40 min outside of Philadelphia. Petia Shipkova of Bristol-Myers Squibb will serve as CPSA 2010 Program Chair and the conference will feature stimulating topics and discussions on the theme ‘From Data to Biology: Analytical Measurements to Drive Pharmaceutical R&D.’ Brad Ackermann of Eli Lilly will present the Plenary lecture, while Jonathan Josephs of Bristol-Myers Squibb will deliver the Keynote lecture.

Finally, the CPSA Colloquium Series is a new event to be featured during the CPSA 2010 annual meeting and will be chaired by Roger Hayes of Merck Research Laboratories. The theme of the CPSA 2010 Colloquium will be ‘A Practical Guide to Regulated Bioanalysis.’ The goal of this event will be to provide attendees with an opportunity to further enhance the specialized training from the CPSA short courses and provide focus on industrial activities related to regulatory issues and industrial workflows. The CPSA Colloquium will be held in parallel to the CPSA 2010 Symposia on Tuesday 19 October at the Sheraton Bucks County Hotel, Langhorne, PA, USA.

For more background information and details regarding the CPSA annual meetings, please visit www.milestonedevelopment.com.

Financial & competing interests disclosure

The authors have no 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. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.