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Wednesday, November 20
 

8:00am

Registration Open
Wednesday November 20, 2019 8:00am - 5:00pm
Essex Ballroom Foyer (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

8:30am

Welcome Breakfast
Enjoy breakfast with fellow participants prior to the beginning of the symposium.
Sponsored by Frontier Scientific Solutions

Sponsors
avatar for Frontier Scientific Solutions

Frontier Scientific Solutions

Frontier Scientific Solutions
Frontier Scientifics' core competency of Outsourced Materials Management and Sample Preparation Services supports multi-industry Compound Management, R&D Screening and Chemistry groups.  Frontier performs sample reformatting, analysis, and full compound management and repository... Read More →


Wednesday November 20, 2019 8:30am - 9:00am
Essex Ballroom Foyer (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

9:00am

Opening Remarks/Welcome
Chairs
M

Marybeth Burton

Executive Director, Discovery Sample Management, Merck


Wednesday November 20, 2019 9:00am - 9:15am
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

9:15am

Keynote Address- Enhancing Drug Discovery and Development Through the Application of Machine Learning
Artificial intelligence (AI), and more specifically machine learning (ML) methods have been used in drug discovery for several decades.  However, a convergence of technologies and recent advances and breakthroughs have generated a renewed level of interest.  As with any technology, exuberance can lead to over use or misapplication.  In order to maximize the impact and avoid misuse, a clear understanding of the requirements for generating robust predictive models and their application is critical.  Choices around featurization, suitability of the data, and the algorithms themselves are important for achieving the desired outcomes.  At present, ML is having a meaningful and expanding impact across many of the drug discovery and development stages and workflows, from target identification, through preclinical optimization, and into process development and clinical investigation, and has the potential to transform the way we discover new medicines in the future.

Speakers
avatar for Juan Alvarez, Merck and Co.

Juan Alvarez, Merck and Co.

AVP Computational and Structural Chemistry, Merck and Co.
Dr. Juan Alvarez is the AVP of Computational and Structural Chemistry at Merck Research Labs, leading the computational chemistry, cheminformatics, and protein structure determination groups.  Prior to Merck, Juan was at Alkermes from 2010-2017, where he established and led biologics... Read More →


Wednesday November 20, 2019 9:15am - 10:00am
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

10:00am

Coffee Break
Join exhibitors in the exhibition hall for coffee.

Wednesday November 20, 2019 10:00am - 10:15am
Essex Ballroom Foyer/Exhibition (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

10:15am

Enabling Drug Discovery:Target Validation to PreClinical- Introduction
Sample management in the drug discovery space continues to evolve with the introduction of both non-small molecule modalities and new screening technologies . This session will provide case studies and outline best practices for tackling these new sample types and enabling downstream processes.

The following topics maybe covered in this session:
• Cell and gene therapy
• Biologics and peptides
• Automation and informatics challenges
• Workflow optimization
• Repurposing existing tools/processes




Chairs
M

Marybeth Burton

Executive Director, Discovery Sample Management, Merck


Wednesday November 20, 2019 10:15am - 10:20am
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

10:20am

Enabling Drug Discovery:Target Validation to PreClinical- Trends in Screening and Compound Profiling
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.

Speakers
avatar for Jeff Gross

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... Read More →

Chairs
M

Marybeth Burton

Executive Director, Discovery Sample Management, Merck


Wednesday November 20, 2019 10:20am - 10:40am
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

10:40am

Enabling Drug Discovery:Target Validation to PreClinical- Establishing Small Molecule Discovery at the Cleveland Clinic Lerner Research Institute
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.

Speakers
avatar for Shaun Stauffer, Ph.D.

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... Read More →

Chairs
M

Marybeth Burton

Executive Director, Discovery Sample Management, Merck


Wednesday November 20, 2019 10:40am - 11:00am
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

11:00am

Enabling Drug Discovery:Target Validation to PreClinical- Building on the Past and Preparing the Future of Lead Discovery through Screening and Compound Logistics at Roche pRED
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.

Speakers
avatar for Nicolas Zorn, Ph.D.

Nicolas Zorn, Ph.D.

Head Compound Library Enhancement and Logistics, Hoffmann La Roche
Nicolas Zorn received his Ph.D. in Organic and Synthetic Chemistry from the University of Paris 6 and worked in the industry for ten years as a medicinal and then computational chemist across several disease therapeutic areas. He joined Roche in 2014 in the Computer Aided Drug Design... Read More →

Chairs
M

Marybeth Burton

Executive Director, Discovery Sample Management, Merck


Wednesday November 20, 2019 11:00am - 11:20am
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

11:20am

Enabling Drug Discovery:Target Validation to PreClinical-Pursuit of the One Day Turnaround: Expediting Process Support through Automated Sample Logistics
The development of monoclonal antibody (mAb) therapeutics requires fast turnaround of testing results to drive decision making during process development. Through the automation of routine testing assays, turnaround time has been reduced from 2 weeks to 1, yet laboratory processes are still hindered by preparative steps where samples are received, organized, and handled manually. By introducing new equipment, labware, and automated data handling, samples can be quickly processed through a myriad of product quality tests. These tools have further streamlined testing, reducing post-purification sample logistics to 1 hour and assay preparation to 30 minutes. These newfound efficiencies empower 1- to 2-day turnaround times, which further promote study design and impact in cell culture development.

Speakers
SJ

Sean Johnston

Sr Associate Scientist, Biogen

Chairs
M

Marybeth Burton

Executive Director, Discovery Sample Management, Merck


Wednesday November 20, 2019 11:20am - 11:40am
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

11:45am

Vendor Snapshot - From Development into Production – The AcoustiX™ Tube Solution
Speaker: Evelyn Stevenson- Brooks Life Sciences

Sponsors
avatar for Brooks Life Sciences

Brooks Life Sciences

Brooks Life Sciences
We partner with these scientists and support the search for cures with the industry’s most complete portfolio of sample management solutions. Our products, services, and technology are empowering advancements and creating hope for the delivery of healthier and brighter tomorrows... Read More →


Wednesday November 20, 2019 11:45am - 12:00pm
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

12:00pm

Vendor Snapshot - Mosaic to Track Any Sample Anywhere, Easily and on a Budget
Speaker: Anne Vergnon

Sponsors
avatar for Titian Software

Titian Software

Titian Software
Titian Software was founded in 1999 and specialises in sample management. We offer software products and consultancy services that help our clients to improve the supply of samples (compounds, biologicals and reagents) to their vital research processes. Using our Mosaic software... Read More →


Wednesday November 20, 2019 12:00pm - 12:15pm
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

12:15pm

Lunch in Exhibition
Enjoy a hot lunch buffet in the exhibition over conversation with exhibitors and fellow participants.  
Sponsored by Evotec.

Sponsors
avatar for Evotec

Evotec

Evotec
Evotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups and venture capitalists. We operate worldwide and our more... Read More →


Wednesday November 20, 2019 12:15pm - 2:00pm
Essex North & Center (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

1:00pm

Poster Presentation: A Case Study in Implementing High Throughput Assay Plate Preparation Solution
Service Organizations within R&D face a unique challenge of having to be flexible to accommodate the varying needs of several customers requesting their services, yet agile enough to operate at a higher speed and efficiency. This is the guiding principle for Compound Management, which is a critical backbone to the functioning of several labs involved in Drug Discovery and Development. Compound Management Groups interact with many internal and external teams receiving, storing and managing of compounds of al modalities from Chemists, Biologists, CROs and Vendors and dispersing, plating and shipping of compounds to various groups such as High Throughput Screening, DMPK, External Labs.    In this presentation, we talk about our experience in implementing a High Throughput Assay Plate Preparation solution for a top 10 Bio Pharmaceutical company. The solution combined many capabilities needed for Assay Plate Preparation such as a Preordering, Ordering, Reordering, Fulfillment, Plate Map Reporting, Label Printing, Liquid Handler Integration under a unified User Experience. The solution was implemented through a combination of Robotic Systems, Informatics Solution and Business Process Changes. The primary goals of the project were to increase throughput and efficiency and reduce wastage of compounds/tips/plates.    The project was implemented in under 6 months with the ability to deliver Assay plates for High Throughput ADME assays with a Turn Around time of less than 2 days from Compound Registration to Fulfillment. The solution supports creation of 96/384/1536 well Assays plates for Single Point, Dose Response and Mixture/Cassette Assays. Over a period of 1 year, the solution was expanded to support more than 70 Discovery and Development assays run by 20 labs (internal and external) across 2 continents. Today, more than 50K compounds are requested and fulfilled through the solution.     The presentation aims to highlight the critical elements - Risks, Opportunities, Challenges, Learnings –for success as seen from the perspective of the Compound Management Group, its Customers and the Informatics Team.

Speakers
S

Sujeegar Jeevanandam

Principal Consultant, Zifo RnD Solutions
Sujeegar Jeevanandam (SJ) is a Principal Consultant with Zifo RnD Solutions.SJ has over 15 years’ experience and is leads Zifo US Consulting Services team for Life Sciences Customers. Some of his focus areas include Medicinal Chemistry, Compound & Bio-specimen Management, DMPK... Read More →


Wednesday November 20, 2019 1:00pm - 1:30pm
Essex North & Center (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

1:00pm

Poster Presentation: Sample Management & Informatics on a Global Scale – a Small Biotech’s Approach
2018 ushered in over one hundred new biotech companies globally [1]. The hallmark of a small biotech is its ability to make quick decisions while maintaining a small footprint. In order to accomplish this, access to real-time data and access to the samples that generate the data are critical. Building groups from scratch and outfitting them with equipment takes time and is costly, thus creating a need for outsourcing R&D to a certain extent. In this global environment where companies choose to seek the services of specialized CROs optimal sample and data management become critical for success. To accomplish this fit for purpose informatics and automation that can coordinate samples and compounds into their respective assays are pivotal. This talk highlights how a small company tackles these challenges by incorporating some of the latest tools in informatics and automation while remaining nimble and cost effective.
1. 2018 Biotech Startups. West Virginia Biotech, Pharma & Medical Device Company List Available at: https://biopharmguy.com/links/company-by-name-2018.php. (Accessed: 21st February 2019)

Speakers
CJ

Chatura Jayakody

Manager, Research Operations, Accent Therapeutics


Wednesday November 20, 2019 1:00pm - 1:30pm
Essex North & Center (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

1:30pm

Poster Presentation: Management of Non Traditional Samples and or Workflows
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.

Speakers
MB

Monica Betancur

Senior Scientist, Merck
Born in Colombia, South America. Graduated from Universidad del Valle, Cali, Colombia in 1992. Worked at Schering Plough from 2000-2010 and at Merck since 2010.


Wednesday November 20, 2019 1:30pm - 2:00pm
Essex North & Center (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

1:30pm

Poster Presentation: The PrepCell - Leveraging Scheduling Software for Automated Sample Processing
Merck Discovery Sample Management leverages Brooks Sprint software and custom in-house software packages to enhance sample preparation workflows and improve downstream liquid handling efficiency and reliability.

With the scheduling functionality of Sprint and a custom automation platform collectively known as the "PrepCell", Discovery Sample Management automates many of the previously manual processes to prepare samples for downstream liquid handling. These processes include thawing samples from their -20C storage temperature to room temperature, centrifuging, stock volume verification, and reformatting into required well-maps.

Custom software from Brooks allows returning samples to be intercepted and redeployed prior to returning to frozen storage, increasing throughput, and eliminating unnecessary freeze-thaw cycles.

 Additionally, custom in-house software provides tools to compare tube volume verification results (from Brooks Tube Auditor device) with the recorded volume data from our Titian Mosaic Sample Management system, allowing users to identify potential pipetting errors and stock volume deviation errors before liquid handling. This process will improve the quality of plates delivered to our customers and provides remediation tool for inventory discrepancies.

Speakers
DM

Duncan McNicol

Associate Director, Merck
Duncan McNicol has been working in compound management for 24 years, with extensive experience in Storage and Liquid Handling Automation, Inventory Management systems, and developing custom software solutions to facilitate and enhance integration between these systems.


Wednesday November 20, 2019 1:30pm - 2:00pm
Essex North & Center (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

2:00pm

Panel: Sample Management as a Career, Not a Job
Speakers
MG

Michelle Galante

Group Leader, Operations, Evotec

Chairs
SC

Sue Crimmin

Vice President Sample Management Technology, GlaxoSmithKline


Wednesday November 20, 2019 2:00pm - 2:30pm
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

2:30pm

Lightning Poster Session- Volumetric Quality Control for Sample Management Automated Applications Using Low Coherence Interferometry
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.

Speakers
DC

David Calle

AstraZeneca

Chairs

Wednesday November 20, 2019 2:30pm - 2:40pm
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

2:40pm

Lightning Poster Session- Management of Non Traditional Samples and or Workflows
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.

Speakers
MB

Monica Betancur

Senior Scientist, Merck
Born in Colombia, South America. Graduated from Universidad del Valle, Cali, Colombia in 1992. Worked at Schering Plough from 2000-2010 and at Merck since 2010.

Chairs

Wednesday November 20, 2019 2:40pm - 2:50pm
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

2:50pm

Lightning Poster Session- 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
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.

Speakers
avatar for Carla Alpert

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... Read More →

Chairs

Wednesday November 20, 2019 2:50pm - 3:00pm
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

3:00pm

Coffee Reception / Exhibition
Get caffeinated and energized for the afternoon with coffee and snacks in the exhibition.  

Wednesday November 20, 2019 3:00pm - 3:30pm
Essex North & Center (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

3:30pm

Innovative Technology and Process Optimization- Introduction
Chairs
CG

Christina Glazier

Senior Research Operations Manager, Amgen


Wednesday November 20, 2019 3:30pm - 3:35pm
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

3:35pm

Innovative Technology and Process Optimization- Living in a Simulation
The Amgen research environment is distributed around the world with a combination of staff and contract organizations. The Research Materials Management (RMM) organization is the hub in a hub-and-spoke model connecting compound producers with the consuming organizations. Discrete event simulation software was used to model current and proposed RMM processes and the resulting interaction with the downstream functions. In this talk I will discuss the lessons learned in simulation projects ranging from counting minutes in an automation heavy process to modeling the annual cost of outsourcing a specific task.

Co-Author: Julia Dookran, MS,  Engineer, Amgen

Speakers
avatar for Mark Gulbronson, MS, MA

Mark Gulbronson, MS, MA

Director Research Operations, Amgen
Mark Gulbronson, Director Research Operations, is head of Amgen’s Research Materials Management organization. With operations in California and Massachusetts, his team is responsible for the curation and worldwide distribution of Amgen’s small molecule and biologics collections... Read More →

Chairs
CG

Christina Glazier

Senior Research Operations Manager, Amgen


Wednesday November 20, 2019 3:35pm - 3:55pm
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

3:55pm

Innovative Technology and Process Optimization- Digital Innovation in Discovery Labs
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

Speakers
VV

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... Read More →

Chairs
CG

Christina Glazier

Senior Research Operations Manager, Amgen


Wednesday November 20, 2019 3:55pm - 4:15pm
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

4:15pm

Innovative Technology and Process Optimization- Development and Implementation of a Business Process Management Platform to Transform High Throughput Biomolecule Production and Sample Management Workflows
Gene and protein production workflows are essential to the discovery of both small and large molecule therapeutics and a host of other research activities.  In order to keep pace with ever increasing requests to produce, manage and track large numbers of these critical reagents across multiple groups, the need arose to replace manual workflows and siloed informatics systems with a unified, automated request management and fulfillment platform able to be integrated with our registration and sample inventory management systems.  In this talk we will share how, through a highly collaborative effort between scientists and bioinformatics colleagues, we are developing an end-to-end request, workflow, registration and sample management solution which will increasingly enable a more efficient, high-capacity biomolecule discovery and production pipeline.

Speakers
KN

Kristen Nailor, B.S. Biochemistry

Scientific Manager, Genentech
Kristen Nailor holds  a degree in Biochemistry from Indiana University. She spent 7 years as a  medicinal chemist at GlaxoSmithKline. She then accepted a position as the  head of compound management at Vanderbilt University where she built a robust  compound management facility... Read More →

Chairs
CG

Christina Glazier

Senior Research Operations Manager, Amgen


Wednesday November 20, 2019 4:15pm - 4:35pm
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

4:35pm

Innovative Technology and Process Optimization- Optimizing Processes Using In-House Engineering to Innovate Automation and Sample Management
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.

Speakers
avatar for Pierre Baillargeon

Pierre Baillargeon

Senior Robotics Engineer, The Scripps Research Institute
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... Read More →

Chairs
CG

Christina Glazier

Senior Research Operations Manager, Amgen


Wednesday November 20, 2019 4:35pm - 4:55pm
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

5:00pm

Vendor Snapshot - Compound Management Strategy Update: A New Access to the Acoustic Tubes Technology
Speaker: Olivier Casamitjana

Sponsors
avatar for Evotec

Evotec

Evotec
Evotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups and venture capitalists. We operate worldwide and our more... Read More →


Wednesday November 20, 2019 5:00pm - 5:15pm
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

5:15pm

Vendor Snapshot - New Developments in Sample Management
Speaker: Jerry Ferentinos

Sponsors
avatar for Scigilian

Scigilian

Founder, Scigilian Software Inc
Scigilian is focused on simplifying drug discovery informatics. Our software enables collaboration in the same lab or across the globe. Request™ optimizes the pharmaceutical R&D model by tightly integrating CRO partners into the discovery process. By integrating with Store™, Request's... Read More →


Wednesday November 20, 2019 5:15pm - 5:30pm
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

5:30pm

Networking Reception in Exhibition
End the day with drinks and heavy hors d'oeuvres in the exhibition.
Sponsored by Labcyte

Sponsors
avatar for Labcyte

Labcyte

Labcyte
 Labcyte, now a part of Beckman Coulter Life Sciences, is revolutionizing liquid handling. Echo Liquid Handlers use sound to precisely transfer liquids without contact, eliminating the use of pipettes. Our customers work across a wide spectrum of research, including drug discovery... Read More →


Wednesday November 20, 2019 5:30pm - 7:00pm
Essex North & Center (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA
 
Thursday, November 21
 

8:00am

Registration Open
Thursday November 21, 2019 8:00am - 3:30pm
Essex Ballroom Foyer (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

9:00am

Breakfast in Exhibition
Start the morning off right with breakfast and coffee in the exhibition.

Thursday November 21, 2019 9:00am - 9:30am
Essex North & Center (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

9:30am

Enabling New Medicines: From Candidate to the Clinic- Introduction
As new chemical entities go through the later stages of drug discovery to become new medicines, the management of different kinds of samples are encountered.  The following topics maybe covered in this session:
• Drug product supply
• Clinical supply chain considerations
• Clinical biosample management innovation
• Ensuring integrity of the medicine supply chain

Chairs
RG

Rose Gonzales

Director, Pfizer


Thursday November 21, 2019 9:30am - 9:35am
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

9:35am

Enabling New Medicines: From Candidate to the Clinic- Clinical trial biospecimen management: A clinical lab perspective
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.

Speakers
avatar for Jean-Claude Marshall

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.

Chairs
RG

Rose Gonzales

Director, Pfizer


Thursday November 21, 2019 9:35am - 9:55am
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

9:55am

Enabling New Medicines: Sampling and Consent Management to Support Complex Biomarker Research in CAR T Cell Clinical Trials
This talk will review complexity of CAR T cell clinical trials, with focus on the biomarker and exploratory research that is inherent to such trials and sampling required to support such research.  In the context of allogeneic CAR T trials, there is interest in understanding patient, tumor and T cell donor attributes that are associated with efficacy or safety.  Thus sampling and research plans are quite complex.  In trials with complex biomarker endpoints, the ability to achieve a globally acceptable informed consent is a challenge, and one that must be addressed so as to preserve the ability to generate robust data across the entire trial population.  The ICH E18 Guidance was developed in part to harmonize guidance and expectations on the conduct of genomic research within clinical trials.   Some elements of this Guidance will be discussed.

Speakers
avatar for Rebecca Blanchard, Ph.D.

Rebecca Blanchard, Ph.D.

Vice President, Translational Pharmacology, CRISPR Therapeutics, Cambridge, MA
Dr. Blanchard’s career in academia and industry has spanned basic, translational, and clinical research and development across multiple therapeutic areas.  She is currently Vice President of Translational Pharmacology at CRISPR Therapeutics where she is responsible for Safety Toxicology... Read More →

Chairs
RG

Rose Gonzales

Director, Pfizer


Thursday November 21, 2019 9:55am - 10:15am
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

10:15am

Enabling New Medicines: From Candidate to the Clinic- A Path To Accreditation – Implementing ISO 20387 in a Cornell Biobank
Biobanks play an integral role in research and precision medicine
by collecting, processing, storing, and distributing high-quality biological material and associated
data. Through the adoption and implementation of standards, biobanks can ensure the integrity,
authenticity, and traceability of their products to enhance reproducibility in research. In
preparation for ISO 20387 (ISO 20387:2018, Biotechnology – Biobanking – General Requirements for
Biobanking) accreditation by the American Association of Laboratory Accreditation (A2LA), the
Cornell Veterinary Biobank (CVB) developed and implemented a quality management system
(QMS) in compliance with this standard, and the information was compiled into a quality
manual. Procedures describing the control of documents and records were implemented first to
provide a foundation on which to build the QMS, followed by procedures for documenting the
identification of risks and opportunities, improvements, and corrective actions following
nonconforming outputs. Internal audit and management review programs, consisting of both
procedures and a schedule, were developed and implemented. Procedures for the governance and
management of the CVB were generated, including: confidentiality and impartiality policies;
facilities and equipment maintenance, calibration and monitoring; staff training and
competency; and evaluation of external providers. All processes on scope were described, along
with the validation and verification of methods to ensure its reproducibility, robustness, and the
fitness-for-purpose of the biological material and data produced. Training sessions were held during implementation to ensure all staff were familiar and would conform to the procedures. In
April of 2019 the CVB was assessed by A2LA for compliance with ISO 20387, and became the
first biobank to receive accreditation to this standard.

Speakers
avatar for Marta Castelhano

Marta Castelhano

Cornell Biobank Director, Cornell University
Dr Castelhano is the Director of the Cornell Veterinary Biobank (CVB) and has 13 years of experience in biobanking, particularly in the standardized collection, processing, storage, and distribution of high-quality biospecimens and associated data. She has been a member of the Education... Read More →

Chairs
RG

Rose Gonzales

Director, Pfizer


Thursday November 21, 2019 10:15am - 10:35am
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

10:35am

11:00am

Vendor Snapshot - The Echo – An Introduction
Speaker: Maureen Stone - Labcyte

Sponsors
avatar for Beckman Coulter Life Sciences

Beckman Coulter Life Sciences

Beckman Coulter Life Sciences develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. For more than 80 years, our products have been making a difference in people’s lives by improving the productivity of scientists by supplying... Read More →
avatar for Labcyte

Labcyte

Labcyte
 Labcyte, now a part of Beckman Coulter Life Sciences, is revolutionizing liquid handling. Echo Liquid Handlers use sound to precisely transfer liquids without contact, eliminating the use of pipettes. Our customers work across a wide spectrum of research, including drug discovery... Read More →


Thursday November 21, 2019 11:00am - 11:30am
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

11:30am

Lunch in Exhibiton
Fuel up your afternoon with a hot buffet lunch in the exhibition.
Sponsored by HighRes Biosolutioons

Sponsors
avatar for HighRes Biosolutions

HighRes Biosolutions

HighRes Biosolutions
We love lab automation! We provide innovative laboratory automation systems, dynamic software solutions, and lab automation devices with superior technology to accelerate and streamline discovery. We offer highly flexible, modular and mobile solutions that provide you the ability... Read More →


Thursday November 21, 2019 11:30am - 1:00pm
Essex North & Center (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

12:00pm

Poster Presentation: Evaluation of Low mg Solid Dispenses to Support Acoustic Tube Platforms
In preparation for a new workflow, Sample Management Boston identified a Tecan Fluent automation friendly tube for preparing DMSO solutions from neat stock. After evaluating the tube, it was determined that dry solid could be accurately dispensed to plastic tubes. The next part of the evaluation was to determine if small mg amounts could be dispensed to the tube accurately (between 0.15mg and 1.0 mg).
Nine AZ compounds were used in testing. They were a diverse mix of materials, ranging from powders to gums. On five place balances, each sample was dispensed 10 times to FluidX tubes. The dry dispenses were then solubilized to 10 mM and the solutions were measured by LCMS (10 mM + or – 10%) for concentration accuracy. Any solid dispense with a subsequent concentration between 9 - 11 mM was deemed accurate.

 The Achievement: The team demonstrated small amounts of solid compound can be accurately dispensed into the FluidX tube. Over 88% of all dispenses were accurate with concentrations between 9-11 mM (see table 1) The accuracy of dispenses around 0.35 mg of less was variable. Having the ability to dispense small amounts of dry sample accurately will allow AZ to conserve it’s solid compound collection.

Speakers
JA

Jeff Andrews

Sr Scientist, AstraZeneca
I've worked with the Sample Management Group at AstraZeneca since 2003. Some of my strengths within Sample Management are Customer Service and communications, Delivering on SLA’s (a focus on delivery customer requests correctly and on time) and Creative problem solving skills


Thursday November 21, 2019 12:00pm - 12:30pm
Essex North & Center (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

12:00pm

Poster Presentation: Volumetric Quality Control for Sample Management Automated Applications Using Low Coherence Interferometry
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.

Speakers
LB

Lindsey Bonicki

Astrazeneca


Thursday November 21, 2019 12:00pm - 12:30pm
Essex North & Center (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

12:30pm

Poster Presentation: Evaluation of FluidX External Thread Tubes for Potential Leachable Compounds
Plastic storage tubes are used in laboratories worldwide to store biological and chemical samples. As most plastics are supplied sterile, pyrogen- and DNAse/RNAse-free, it is generally accepted that this guarantees product integrity. Few researchers ever consider that despite these apparent guarantees, plastic ware can still provide a potential source of error. Evidence shows that bioactive compounds can diffuse into solutions that come into contact with the surface of the plastic 1,2. These compounds, typically referred to as “leachables” or “extractables”, are used during the manufacturing process to improve product stability and durability. However, these compounds can have a significant impact on scientific experiments and pose a likely source of error in many assay systems. Examples of leachable interference include inhibition of enzyme activity and falsification of nucleic acid quantification. The aim of this evaluation was to determine if “extractables” could be detected in solvent solutions stored in FluidX external thread tubes and to compare the performance against competitor tubes.

Speakers
ES

Evelyn Stevenson

Senior Product Manager, Brooks Life Sciences


Thursday November 21, 2019 12:30pm - 1:00pm
Essex North & Center (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

12:30pm

Poster Presentation: 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
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.

Speakers
CA

Carla Alpert

Merck & Co. Inc
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... Read More →


Thursday November 21, 2019 12:30pm - 1:00pm
Essex North & Center (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

1:00pm

Vendor Snapshot - Automated Labeling Solutions
Speaker: Wes Proffer - Scinomix

Sponsors
avatar for Scinomix

Scinomix

Scinomix provides laboratory automation solutions to customers in the Life Science Industry. The initial creation of the company is rooted in our passion to create customized solutions for labs which over the last 18 years, evolved into a standard product line that can be configured... Read More →


Thursday November 21, 2019 1:00pm - 1:15pm
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

1:15pm

Vendor Snapshot - Operational Informatics
Speaker: Thomas Frech

Sponsors
avatar for Uwe Schey

Uwe Schey

CEO & President, Xavo USA Inc.
Xavo provides a single cloud native product: Xavo Professional Suite (XPS) which is designed to meet the complex challenges of end-to-end Sample Management. XPS enables informed decision making since it is the only available system combining planning, scheduling and execution capabilities... Read More →


Thursday November 21, 2019 1:15pm - 1:30pm
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

1:30pm

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

New medicines are originating from multiple modalities and as such drug discovery requires the management and use of many different sample types. Some of associated risk and compliance and quality activities are common and some are different.  


Chairs
SC

Sue Crimmin

Vice President Sample Management Technology, GlaxoSmithKline

Sponsors
avatar for Hamilton Storage

Hamilton Storage

Hamilton Storage
Hamilton Company specializes in the development, manufacturing and customization of precision measurement devices, automated liquid handling workstations, and sample management systems. Hamilton's processes are optimized for quality and flexibility. Whether it's a custom needle with... Read More →


Thursday November 21, 2019 1:30pm - 1:35pm
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

1:35pm

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
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.

Speakers
NT

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... Read More →

Chairs
SC

Sue Crimmin

Vice President Sample Management Technology, GlaxoSmithKline

Sponsors
avatar for Hamilton Storage

Hamilton Storage

Hamilton Storage
Hamilton Company specializes in the development, manufacturing and customization of precision measurement devices, automated liquid handling workstations, and sample management systems. Hamilton's processes are optimized for quality and flexibility. Whether it's a custom needle with... Read More →


Thursday November 21, 2019 1:35pm - 1:55pm
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

1:55pm

The Common Threads Across All Sample Types. Challenges of Sample Management Quality and Compliance- Controlled Substance Compliance in Drug Discovery and Clinical Supply
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.

Speakers
avatar for Jessie Bin Song, BS

Jessie Bin Song, BS

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... Read More →

Chairs
SC

Sue Crimmin

Vice President Sample Management Technology, GlaxoSmithKline

Sponsors
avatar for Hamilton Storage

Hamilton Storage

Hamilton Storage
Hamilton Company specializes in the development, manufacturing and customization of precision measurement devices, automated liquid handling workstations, and sample management systems. Hamilton's processes are optimized for quality and flexibility. Whether it's a custom needle with... Read More →


Thursday November 21, 2019 1:55pm - 2:15pm
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

2:15pm

The Common Threads Across All Sample Types. Challenges of Sample Management Quality and Compliance- Advocating Change: One Synthetic Cannabinoid at a Time
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

Speakers
avatar for Zofia Jordon

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... Read More →

Chairs
SC

Sue Crimmin

Vice President Sample Management Technology, GlaxoSmithKline

Sponsors
avatar for Hamilton Storage

Hamilton Storage

Hamilton Storage
Hamilton Company specializes in the development, manufacturing and customization of precision measurement devices, automated liquid handling workstations, and sample management systems. Hamilton's processes are optimized for quality and flexibility. Whether it's a custom needle with... Read More →


Thursday November 21, 2019 2:15pm - 2:35pm
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

2:35pm

The Common Threads Across All Sample Types. Challenges of Sample Management Quality and Compliance-Total Quality Management within a Sample Logistics Lab
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.

Speakers
JC

Jefferson Chin, B.Sc, MBA

Senior Scientist, Pfizer
Jefferson Chin is a Senior Scientist in the Sample Logistics group at Pfizer.

Chairs
SC

Sue Crimmin

Vice President Sample Management Technology, GlaxoSmithKline

Sponsors
avatar for Hamilton Storage

Hamilton Storage

Hamilton Storage
Hamilton Company specializes in the development, manufacturing and customization of precision measurement devices, automated liquid handling workstations, and sample management systems. Hamilton's processes are optimized for quality and flexibility. Whether it's a custom needle with... Read More →


Thursday November 21, 2019 2:35pm - 2:55pm
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

3:00pm

Closing Remarks
Thursday November 21, 2019 3:00pm - 3:15pm
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA