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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
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

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
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





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

10:20am

10:40am

Enabling Drug Discovery- 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

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

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-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, Analytical Development, Biogen

Chairs

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

11:45am

Vendor Snapshots
Wednesday November 20, 2019 11:45am - 12:15pm
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

12:15pm

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

12:15pm

Posters in Exhibition
Wednesday November 20, 2019 12:15pm - 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
Chairs

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
avatar for Matthew Boeckeler

Matthew Boeckeler

Associate Director, Astrazeneca
Matt is an innovative visionary with 18 years of successive career advancement in the life sciences industry, focused on automated platform development, process improvement, and value chain optimization.Before joining AstraZeneca in 2007, he held posts at other pharmaceutical companies... Read More →

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- Navigating the Expanding Horizon of External Collaborations

The Drug Discoveryprocessis becoming increasingly more collaborative as Pharma, Academia, CRO’sand Biotechs collaborate to identify transformational medicines.This collaboration often involves the transfer of materials between organizations particularly small molecules. This poster will describe the issues and problems associated with the transfer of compounds and provide some examples of approaches to navigate the customs, compliance and IP issues that often accompany the process.

Speakers
avatar for Sara Grab

Sara Grab

Investigator, GSK
Member of the Sample Management organization at GlaxoSmithKline (GSK) for 13 years.Has experience in small molecule processing, shipping, compliance, automation, liquid handling and helpdesk.

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

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 →

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

3:30pm

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

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

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

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, Scripps Research
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

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

5:00pm

Vendor Snapshots
Wednesday November 20, 2019 5:00pm - 5:30pm
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

5:30pm

Networking Reception
Wednesday November 20, 2019 5:30pm - 8:00pm
TBD
 
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
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

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

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

9:55am

10:15am

10:35am

11:00am

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

11:30am

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

1:00pm

Vendor Snapshots
Thursday November 21, 2019 1:00pm - 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

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

GlaxoSmithKline
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

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

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

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

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