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Session 4: The Common Treads Across All Sample Types. Challenges of Sample Management Quality and Compliance [clear filter]
Thursday, November 21
 

1:30pm EST

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 EST
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

1:35pm EST

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 EST
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

1:55pm EST

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 EST
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

2:15pm EST

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 EST
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

2:35pm EST

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 EST
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA