2019 Americas Sample Management Symposium

The SLAS 2019 Americas Sample Management Symposium course package contains 13 presentations on: 

-Enabling Drug Discovery: Target Validation to PreClinical

-Enabling New Medicines

-Innovative Technology and Process Optimization

-The Common Threads Across All Sample Types. Challenges of  Sample Management Quality and Compliance

Based on presenter permission, 14 of the 19 total SLAS 2019 Americas Sample Management Symposium presentations are available on-demand. The SLAS Americas Sample Management Program Committee selects conference speakers based on the innovation, relevance and applicability of research as well as those that best address the interests and priorities of today’s life sciences discovery and technology community. All presentations are published with the permission of the presenters.

Jeff Gross

Director of Screening, Profiling and Mechanistic Biology

GSK

Jeffrey Gross is a senior director with GlaxoSmithKline, and heads the Screening, Profiling, and Mechanistic Biology group in Upper Providence, PA. He joined GSK in 2001 after a postdoctoral at the University of Wisconsin. During his 18 years with GSK, he has worked in early discovery and developed expertise in many of the core discovery platforms, including high throughput screening, encoded library technology, and fragment-based drug discovery. Throughout his career at GSK, he has maintained a role in assay development, biophysics, and in the weekly in vitro profiling assay work for lead optimization campaigns. A recent focus has been developing scientific approaches in hit qualification, as a strategy to improve the quality and success of discovery efforts. Jeff received a PhD from Temple University, where he studied enzymology, elucidating the mechanism of enzymes in the NAD biosynthesis pathway. His post-doctoral studies were done at the University of Wisconsin-Madison, where he used pre-steady state kinetics, kinetic isotope effects, and mass spectrometry to evaluate reaction mechanisms and intermediates.

Shaun Stauffer, Ph.D.

Director

Cleveland Clinic Center for Therapeutics Discovery, Cleveland Clinic

Dr. Stauffer directs the newly formed Cleveland Clinic Center for Therapeutics Discovery initiated in 2018. He obtained his Ph.D. in organic chemistry 1999 from the University of Illinois Urbana-Champaign under John Katzenellenbogen and did post-doctoral studies with John Hartwig at Yale University before joining Merck & Co. in 2001. While at Merck he worked on drug discovery teams in several therapeutic areas, including Alzheimer’s disease, pain, and cardiovascular disease. In 2008 Dr. Stauffer moved to Vanderbilt University where he built and led several discovery teams, including industry and NIH sponsored neuroscience and cancer drug discovery projects. He is a co-author on over 80 peer reviewed publications and has 28 issued US patents. His interests lie in allosteric modulation, structure-based design, catalysis, and reaction discovery as tools towards enabling problem solving in medicinal chemistry. His therapeutic and target interests include cancer drug discovery, neurodegenerative disease, epigenetics, and metabolomics.

Nicolas Zorn, Ph.D.

Head Compound Library Enhancement and Logistics

Hoffmann La Roche

Nicolas Zorn is currently the head of the Compound Library Enhancement and Logistics team at Roche pRED in Basel within The Small Molecule Research, Lead Discovery organization. Nicolas is an Organic Chemist by training (Ph.D. at the University of Paris 6, PostDoc at Indiana University, US) and has worked for 10 years supporting and driving projects in several disease areas as medicinal chemist and computational chemist at Merck MDS in the USA, then Roche in Switzerland. In the last four years, he has led the Compound Library Enhancement and Logistics team in Basel where all samples are processed and distributed for Small Molecule Research in pRED.

Jean-Claude Marshall

Head of Clinical Biomarker Technologies in Early Clinical Development

Pfizer

Dr. Marshall is the head of Clinical Biomarker Technologies in Early Clinical Development, Pfizer. His group is responsible for the development and validation of novel biomarkers in early clinical trials, spanning mass spec, flow cytometry, ligand binding and genetic biomarkers.

Viral Vyas, MSIS

Lead IT Business Partner Translational Medicine

Bristol Myers Squibb

Viral Vyas is a Lead IT Business Partner at Bristol Myers Squibb responsible for leading teams that deliver informatics capabilities to broad range of scientific stakeholders in the Translational Medicine organization. He received his undergraduate education in Microbiology and Masters in Information Management. Viral Joined Bristol Myers Squibb in 2000 as an Associate Research Scientist in DMPK group and transitioned into R&D IT in 2004. Viral has worked on numerous informatics initiatives that streamlined laboratory workflows. He is passionate about creating informatics strategies that allow scientists to focus on creating scientific knowledge rather than manually assembling and reporting data.

Pierre Baillargeon

The Scripps Research Institute

Senior Robotics Engineer

Pierre is currently the Senior Robotics Engineer within the Lead Identification lab at Scripps Research where he supports Compound Management, High Throughput Screening, Assay Development and Informatics efforts by developing, assembling and integrating novel automated hardware and software. Pierre has worked at Scripps Research since the establishment of the lab in 2005. The Lead Identification lab at Scripps is responsible for supporting both industrial and academic drug discovery efforts with a proprietary >600,000 sample library and the NIH's >300,000 sample MLPCN collection.

Over the past decade at Scripps, Pierre has lead engineering efforts on several novel laboratory instruments including the Plate Auditor microplate inspection platform and most recently the Microplate Assistive Pipetting Light Emitter.

David Calle

AstraZeneca

Monica Betancur

Senior Scientist

Merck

Carla Alpert

Senior Scientist

Merck

Carla R. Alpert is a cell biologist with 25+ years in the cell culture suite. She still remembers the first cell line she handled, the enigmatic and adorable mouse line Neuro-2a. Since those days, Carla's grown hundreds of human and mammalian cell lines and within her department is sometimes called the cell "guru" -- a term she finds very amusing. Carla's applied her cell skills toward cell based assay development, live cell imagine (loves the IncuCyte platform), and managing cell repositories. When not in the cell suite, she enjoys horseback riding, amateur photography and a good book.

Michelle Galante

Group Leader, Operations

Evotec

Sue Crimmin

Vice President Sample Management Technology

GlaxoSmithKline

Nadia Tournier

Biological Licensing Coord

GSK

Nadia completed her Master in Biotechnology at the Ecole National Superieure de Technologie des Biomolecules de Bordeaux (ENSTBB, France). She joined GSK (Stevenage, UK) in 2006 and focussed her career in Biopharmaceutical discovery with an emphasis on characterization of Antibodies and Antibody-like molecules.
More recently, Nadia joined a newly formed Biological licensing centre of excellence in GSK Pharma R&D which remit is to oversee compliance to license restrictions associated with Biological materials and technologies.

Jessie Bin Song, B.S.

Director of Controlled Substance Compliance

Merck & Co., Inc.

Ms. Song currently holds the position of Director of Controlled Substance Compliance at Merck Co. Inc. With over 20 years’ experience in pharmaceutical industry, she has broad experience in manufacturing, packaging, Quality Assurance, technology transfer, business compliance and controlled substance compliance, both domestically and internationally. Ms. Song currently oversees Merck’s controlled substance compliance programs globally, including research, clinical and commercial manufacturing, packaging, and distribution, ensuring compliance with federal, state and international regulations. Ms. Song received her Bachelor of Science degree in Chemical Engineering from Eastern China University of Science and Technology.

Zofia Jordon

Chair of the Controlled Substance Expert Group

Pistoia Alliance

Chair, Controlled Substance Expert Group (Pistoia Alliance) The group shares best practice, learns from external experts and collaborates to improve understanding of current issues in controlled substance legislation and is part of the Pistoia Alliance, a global, not-for-profit members’ organization working to lower barriers to innovation in life science and healthcare R&D through pre-competitive collaboration.

Jefferson Chin, B.Sc.

Senior Scientist

Pfizer

Jefferson Chin is a Senior Scientist in the Compound Management & Distribution at Pfizer located in Groton, Ct. Jeff has a bachelor’s degree in Chemistry from Carnegie Mellon University and an MBA from the University of New Haven.  Jeff has over 30 years of experience in analytical chemistry, organic synthesis and finally compound management. He uses his experience to be the “voice of reason” while interacting with the chemists or biologist and developing new analytical workflows to extend CMD’s capabilities.

Key:

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Enabling Drug Discovery: Target Validation to PreClinical
Trends in Screening and Compound Profiling
Open to view video.
Open to view video. Improving clinical success rates is a key objective in the pharmaceutical industry, and discovery science platforms continue to deploy new strategies aimed at improving success and translation to the clinic. As with others, we recognized that applying the more relevant cellular translational assays at the earliest points in discovery could allow better decisions earlier in the discovery process, and enable the identification of molecules with improved clinical translation In practice, this opportunity would not only be limited to primary cell or mixed cell culture based translational assays, but could also include broader use of organoids, spheroids, iPSC’s and edited cell lines. However, the costs, the complexity of biology, and especially the limited scalability of cells, limit how these can be used at a scale compatible with high-throughput plate-based HTS formats. We embarked on an ambitious campaign to evaluate ultra low volume platforms that would enable broader use of quantity-limited cell. These technologies have been a focus in the screening field for the past decade, so our work was aligned to evaluate these platforms for use in discovery. A key finding of our evaluation was that the biology is remarkably robust, and the fidelity of the biology was retained in most of the ultraminiaturized experiments. However, while many of the technologies show promise, these are not yet robust production platforms, and technologies for delivering compounds still needs to be addressed.
Establishing Small Molecule Discovery at the Cleveland Clinic Lerner Research Institute
Open to view video.
Open to view video. This presentation will discuss the newly formed Cleveland Clinic Center for Therapeutics Discovery (C3TD), its mission, model, and current status towards building a modern compound management and screening facility for investigators at the Lerner Research Institute. At C3TD we embrace the strategic plan supporting our founder’s unifying three pillar mission: care for the sick, investigate their problems, and educate our community. To be successful in contributing to our shared mission, assembled project teams leverage the most innovative approaches currently being explored for the treatment of human diseases and disorders and ‘de-risk’ to a point where these treatment strategies can directly impact patient care. By integrating high performance drug discovery resources and teams in the Lerner Research Institute, medicinal chemistry, molecular pharmacology, biochemistry, structural sciences, and drug metabolism and pharmacokinetics (DMPK) disciplines work together to illuminate and advance scientific breakthroughs beyond the traditional academic lab towards useful chemical probes and IND-ready assets. Robust proven technologies in conjunction with best practices and protocols will be discussed in context of successes and lessons learned in prior academic drug discovery endeavors in neuroscience and oncology.
Building on the Past and Preparing the Future of Lead Discovery through Screening and Compound Logistics at Roche pRED
Open to view video.
Open to view video. This presentation will cover the latest technological developments as well as plans for screening and compound logistics processes at Hoffmann-La Roche Pharma Research and Early Development (pRED) and how this opens new avenues for finding new hits and leads.
Clinical trial biospecimen management: A clinical lab perspective
Open to view video.
Open to view video. Multiple pre-analytical issues are routinely encountered within clinical trials. Bioanalytical laboratories attempt to control for these variables during assay validation, but are often challenged by real world conditions and logistical constraints. In this talk we’ll go through relevant guidance documents and case studies from Pfizer clinical trials.
Innovative Technology and Process Optimization
Digital Innovation in Discovery Labs
Open to view video.
Open to view video. BMS R&D IT has developed a ground-breaking solution using BonitaSoft BPM to provide agility, flexibility, and visibility across discovery organization like never before. BMS’s transformation into a BioPharma required an innovative approach to manage lab workflow across discovery organization. Traditional methods of managing lab workflows were rooted in LIMS that required significant and repeated customization to meet the needs of a continuously evolving R&D environment. Implementations of R&D BPM Framework based on BonitaSoft facilitated the digital transformation of analytical chemistry, vet sciences, histology, biologics, lead optimization, biomarkers, and lab equipment management across R&D. Multiple benefits were realized including: Time savings of 11,000 hours per year realized by discovery scientists. 50% reduction in application delivery time. The need for multiple custom solutions were eliminated resulting in cost savings estimated at $2MM. Increased transparency into lab processes. Access to on-demand live metrics. Simplified and consistent application support. Co-Authors:: Viral, Vyas, MSIS, BMS Yu-Sun Wang, , BMS
Optimizing Processes Using In-House Engineering to Innovate Automation and Sample Management
Open to view video.
Open to view video. Sophisticated and often expensive automated solutions exist for a wide variety of laboratory processes in the sample management environment, however there remain many processes for which commercially available products do not exist or do not fully meet the needs of the end user. Fortunately, the rapid evolution of hardware and software tools over the past decade has made development of custom automation much more accessible for laboratory staff. The result of this evolution can be seen in many labs where technologies such as 3D printers and open source electronics platforms have become commonly utilized tools in the day-to-day operations of the lab. The Lead Identification team at Scripps Florida is one such lab where these tools have been leveraged to address a wide variety of challenges in the Sample Management workspace. Use of these tools has resulted in the development of a number of unique devices including a custom microplate imaging platform, an open-source microplate illuminator and many other things. These have been integrated within our informatics infrastructure in a fashion which has quantitively impacted the efficiency of many processes in the lab by reducing staff workload and improving quality assurance. The advantages of developing in-house automation and lessons learned over a decade of doing so are presented.
Lightning Poster Session
Volumetric Quality Control for Sample Management Automated Applications Using Low Coherence Interferometry
Open to view video.
Open to view video. AstraZeneca and Meniscense showcase a technology collaboration to develop a novel interferometric technology for volume quantification, the technology promises the speed and accuracy needed to support high throughput production of nanoliter dispensed outputs. We share our results demonstrating the successful measurement of nanoliter droplets dispensed into dry wells and the volume change resulting from dispensed nanoliter droplets into a filled well. We discuss how this methodology will enhance the quality control process of a sample management or screening operation.
Management of Non Traditional Samples and or Workflows
Open to view video.
Open to view video. New modality types, such as peptides, oligonucleotides, and compound mixtures present new challenges for sample management groups. At Merck site-based Compound Submission Labs (CSLs) are the primary conduit between medicinal chemists and biologists; therefore, it is important for the CSLs to be equipped with appropriate tools and workflows for handling these new modalities. This poster will illustrate new workflows, liquid handling capabilities, and software recently implemented within the CSLs and will highlight the resulting improvement in both project workflows and cycle times.
Optimizing Off-site Cell Line Repository Curation: Building a Partnership With Sample Storage Experts to Store, Curate and Maintain an Entire Research Site’s Cell Bank
Open to view video.
Open to view video. World-wide, individual cell lines are estimated in the thousands with over 3,400 continuous cell lines available from one repository alone (American Type Culture Collection, ATCC). Large research organizations purchase and accumulate cell lines from ATCC and other world-wide repositories, collaborations, in-house engineering efforts and commercial vendors. As an organization’s cell line inventory grows, so do the challenges of maintaining a quality on-site repository for cell-based scientific research. Primary issues include registration database tools, growing and preparing vials, sample sterility, cell line integrity, ability to find a cell line and easy retrieval. However as modern research companies leverage their best cell culture expertise into basic research and pipeline advancement, few company culturists are available to perform the duties necessary to maintain on-site cell bank repositories. The Research Laboratories of Merck & Co., Inc., Kenilworth, NJ, USA (MRL) Boston site was no exception and by 2016 faced multiple on-site repository challenges including an ageing database, cell line search errors, vial distribution, registration and cell line data, low stock identification, stock replenishment, disaster protection, and cell stock quality. To support the MRL Boston Scientists, an entirely new model was set in place. The new model was built on two pillars: IT support to a new cell line registration database and a qualified, GxP level storage partner with cell banking capabilities. The first step was migration of the old database to a newer database that could engage with the database of Merck’s preferred long-term sample storage partner, Brooks Life Science’s. The newer Merck database, AcBioREG, supported unique sample IDs, thus allowing a “pushable and searchable” identifier between systems, linking the MRL’s AcBioREG cell line registration to physical vials at Brooks Life Sciences. Concurrently, MRL Boston piloted the possibility of using Brook’s BioProcessing Solutions group at RUCDR in NJ to replenish the Boston cell line stocks. Once the pilot cell line replenishment proved successful and database migrations finalized, MRL Boston shipped its on-site 19,000+ vial inventory to Brooks Life Sciences. Additional IT infrastructure and standardized workflows were defined, permitting MRL Boston scientists cell line search, ordering, and receipt of a cell line vial in 1-2 business days. Brooks Life Sciences coordinates with one half time MRL Boston point of contact, creating a combined repository curation effort complete with low vial notifications, cell banking queue requests, active cell banking, quality testing, and stock redundancy in both Brooks facilities. Presented here, this new model illustrates how research sites or organizations can successfully shift the bulk of repository maintenance from internal scientific staff to an external partner all while ensuring cell line access, sustained inventory, bank quality, and cycle-time expectations.
Panel Session: Sample Management as a Career, Not Job
Sample Management as a Career, Not a Job
Open to view video.
Open to view video.
The Common Threads Across All Sample Types. Challenges of Sample Management Quality and Compliance
A Perspective on Biological Licensing Compliance Activities in GSK Pharma R&D
Open to view video.
Open to view video. Innovation and performance in the pharmaceutical industry is increasingly dependent on collaborations, partnerships and access to state of art technologies and materials. At GSK, biological materials and technologies are acquired from commercial vendors, collaborators, academic and governmental institutions. These materials and technologies are always accompanied by contracts, that set the limits of the receiving and providing party rights, in a variety of forms such as general terms and conditions (T&Cs), Materials Transfer Agreements (MTAs), Limited Use Label Licenses (LULLs), Patent or know-how licenses and many more. The cost of non-compliance with terms set in these agreements could be legal, financial and reputational. Therefore, it is of paramount importance that externally-facing companies have the right processes in place to monitor which materials enter into their organization, under which terms and to ensure compliance with the contractual restrictions set by the providing third party. Compliance to biological licenses is an emerging topic and is gaining more visibility since the entry into force in October 2014 of the Nagoya protocol. The aim of this talk will be to share some of the best practices implemented in GSK pharma R&D in order to mitigate the risk associated with Biological licenses including Access and Benefit Sharing (ABS) under the Nagoya Protocol.
Controlled Substance Compliance in Drug Discovery and Clinical Supply
Open to view video.
Open to view video. Controlled substances are highly regulated around the world and the regulations are becoming increasingly complex as legislators try to combat threats posed to communities by illicit drugs and protect the public health. Pharmaceutical and Life Science companies, in our endeavor to find cures for unmet medical needs, manage an even more complex supply chain from compound acquisition and discovery to clinical supply, encompassing storing and transporting chemical inventories, compound libraries and clinical materials internally and externally across a multiplicity of geographies. Adhering to the controlled substance regulations of each country or jurisdiction, both at the federal and state levels, is becoming more challenging. It might often be overlooked or an afterthought. This presentation describes fundamental elements to consider in establishing an adequate system, control, and structure to meet the rapidly changing environment. The presentation also provides practical checklist a scientist or management can consult when handling controlled substances in the context of drug discovery and clinical supply.
Advocating Change: One Synthetic Cannabinoid at a Time
Open to view video.
Open to view video. Pharmaceutical companies routinely work with controlled substances, narcotics and psychotropic drugs, and must have controls in place to meet the legislative requirements. Today these organisations hold and dispense tens of millions of samples in highly automated processes making manual compliance activities impractical. In 2016 the UK government amended the 1971 Misuse of Drugs Act and added a section designed to control the newer synthetic cannabinoids in increasing supply on the black market. Unfortunately, the definition was drawn extremely broadly. The impact of this amendment is that typical Pharmaceutical libraries have seen their controlled compounds rise into the tens of thousands, with the clear majority having no indication of CB1 activity. This has prevented early discovery activities and limited collaborative research due to the inability to ship these compounds outside the UK. Many existing products like Atorvastatin (Lipitor – Pfizer, statin) and Lostartan (Cozaar – Merck & Co, Angiotensin) are also affected. Not only are these proven medicines, and so do not fall into Schedule 1, which is specifically for substances considered by the government to have no medicinal value, but they also do not exhibit any cannabinoid-like activity This talk covers the needs for software packages to identify controlled substances and how the Controlled Substance Compliance Expert Community (Pistoia Alliance) is working with the UK’s Advisory Council for the Misuse of Drugs by providing expertise to narrow the scope of the definition and suggest other measures such as de-minimis limits and research exemptions which should lead to an amendment of the law
Total Quality Management within a Sample Logistics Lab
Open to view video.
Open to view video. Compound Management labs for small molecule applications are well-defined operations particularly within large pharma. Through years of iterations and technology advancements, the CM toolbox has been become filled with technologies that range from inventory storage to nano-liter pipettors for the creation of assay ready plates. Incorporating automation with these technologies has truly aided the CM lab by decreasing the need for manual manipulation throughout the workflow while increasing the quality and throughput of creating the assay ready plate. A secondary effect through all of the continuous improvements efforts, is improved customer satisfaction especially as the delivery of the plates have become more routine and mis-dispenses are minimized. Unfortunately, laboratory errors do occur, and customers demand answers. The CM toolbox needs to include a workflow to critically evaluate each plating “inquiry” and formulate a conclusion that satisfies the key stakeholders.