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Compound Management and          Integrity Online                                 Industry Overview                       ...
Contents          3. Compound Management Becomes Big Business          5. Constructing an Integrated Chemical and Test Dat...
Compound Management Becomes Big Business   In the world of pharmaceuticals, few issues are more important than compound ma...
Matt Hamilton, vice-president of Hamilton Storage Technologies, said: "Many users feel chainedto a more expensive, less fl...
Constructing an Integrated Chemical and Test Data ManagementSystem Dieden PhD, AnalystStandards   Reiner          to Indus...
Obviously all the project members, everybody that’s involved in the compounds library and whoinputs his compounds into the...
However, we must not forget that we’re using two or more different systems, informaticssystems. At UCB we have our own hom...
Making Compound Management Simpler     For many organisations in the pharmaceutical sector, the area of compound managemen...
The expert said that there is still much more to do in the field of sample management, however,such as integrating quality...
However, Matt Hamilton, vice president at Hamilton Storage Technologies, said that many firmsmake automated –20 degrees an...
Additional ResourcesINTERVIEW: Building a Compound Management Facility – The IntegrationChallengeWith Reiner Dieden PhD, A...
Evaluating Compound Management Strategies  and Technologies From Around the World                                         ...
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Compound Management - Pharma IQ Report 2011

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After 8 successful years of real-world conferences, the annual Compound Management & Integrity series of events is going online! With travel restrictions tighter than ever and a growing interest in compound management (CM) around the world, we’re bringing the experts to you in a series of expert-led interactive webinars beginning October 31, 2011.

Key topics inlcude:

How to develop successful collaborative relationships with external partners, including academic research facilities and CROs
Ensuring quality in both your materials and your processes
Addressing the “why” of compound libraries: how to prioritise what compounds are stored, bearing in mind the realities of storage and management requirements, but keeping your likely future needs in sight as well

Navigating the challenges of collaborating with international partners, including the Asian markets
Assessing available automation options and augmenting (and improving) your facility's systems for increased efficiency

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Compound Management - Pharma IQ Report 2011

  1. 1. Compound Management and Integrity Online Industry Overview Pharma IQ Sector Report & Resources July 2011 Compound Management and Integrity Online Pharma IQ Sector Report & Resources 2011
  2. 2. Contents 3. Compound Management Becomes Big Business 5. Constructing an Integrated Chemical and Test Data Management System to Industrial Standards 9. Making Compound Management Simpler 11. Additional Resources 12. Compound Management and Integrity Online Pharma IQ 2010 - 2011 Compound Management and Integrity Online Pharma IQ Sector Report & Resources 2011
  3. 3. Compound Management Becomes Big Business In the world of pharmaceuticals, few issues are more important than compound management facilities. Selecting the best options for the storage, handling and retrieval of key samples is often a vital part of drug development, so having the right solutions in place has risen up the agenda for many firms recently. The concept has also spawned a big industry. Businesses have been quick to realise both the benefits of developing new technology to aid the practice, as well as the potential economic boost that outsourcing the concept to specialist bodies can provide them. One company that has enjoyed much success thanks to the growth of outsourced compound management is BioFocus. As a global firm with offices in the US, UK and other parts of Europe, the company has become a well-known name in the world of biotechnology and pharmaceuticals. Its compound management services also appear to have a strong reputation, as the company has wrapped up two major deals in the sector during the past six months. A three-year agreement with the Global Alliance for TB Drug Development, which is best known as the TB Alliance, will see BioFocus take control of the organisations chemical library collection at its San Francisco-based compound management facility. Scott Snyder, senior director of compound management of BioFocus, said the company would be joining "prestigious" names, including the National Institutes of Health, on the firms portfolio. "This collaboration leverages our full suite of compound management services and further expands our client base of not-for-profit discovery organizations to a global level," he added. Another chemical library based at the companys San Francisco facility is that of Procter & Gamble. Back in August, BioFocus agreed a similar three-year deal with the global pharmaceutical firm which, along with the TB Alliance agreement, shows that compound management outsourcing appears to be a hot trend at present. However, there is more to compound management than just outsourcing. Like many parts of the pharmaceutical industry, attempts to improve the technological aspect of the field are ongoing. One of the latest innovations to be seen has come from Hamilton Storage Technologies, which has added an integrated tube processing module to its -20C and -80C Sample Access Manager systems. Called the SAMple Puncher, the technology allows drug developers to automatically punch tubes from their storage trays; a flexible add-on that makes the system ideal for use with REMP labware. The company has suggested that its capabilities make it useful for both compound management and biobanking applications. Compound Management and Integrity Online Pharma IQ Sector Report & Resources 2011
  4. 4. Matt Hamilton, vice-president of Hamilton Storage Technologies, said: "Many users feel chainedto a more expensive, less flexible automation platform because no other system could cherry-picktheir punch-type tubes."Weve developed an entirely new method for punching tubes to a destination rack, so customerscan now switch to the more full-featured Hamilton platform or add us as they expand theirexisting library management systems."Hamilton is just one of a number of companies that have carved a niche out of providingtechnology for industries based around life sciences, particularly the pharmaceutical industry.Founded in 2007, the business has a hand in tube and plate management technology, as well assealing and capping, and software for use with such solutions.According to the company: "We recognised the need for vigorous environmental controls duringprocessing to ensure compound integrity and increase data quality and operational effectiveness."Such concerns are likely to lead a number of firms continuing their efforts to embrace anddevelop new products for compound management purposes. Any equipment that can helpscientists to improve the efficiency of their logistics, as well as their handling of compounds, islikely to meet with much approval from the world of pharmaceuticals.As work to combat a range of illnesses and conditions continues at pace, it is difficult tounderestimate the importance of compound management. Its prominence in the pharmaceuticalindustry is only likely to grow over the next few years. Compound Management and Integrity Online Pharma IQ Sector Report & Resources 2011
  5. 5. Constructing an Integrated Chemical and Test Data ManagementSystem Dieden PhD, AnalystStandards Reiner to Industrial and Physical Chemistry and Logistics Director from UCB, joins Pharma IQ to discuss the development of a Compound Management Facility at the University of Bonn. Pharma IQ: Could you give us a brief overview of your role? R Dieden: As you mentioned in the introduction, I’m responsible for Analytical and Physical Chemistry, as well as Logistics, which is the local term for compound management here at UCB’s Belgian site in Braine-lAlleud. We’re hosting the central UCB test compound archives as well as the main UCB screening deck, because of the high throughput screening facility being located here as well. Pharma IQ: Now at the conference you’re going to be talking about building a compound management facility at the University of Bonn within the Neuro-Alliance consortium, so, first of all, could you talk a little bit about managing compounds with different IP situations in one place? R Dieden: UCB is part of the Neuro-Alliance consortium which is an initiative which is financed in part by the German Government and which is aimed at strengthening pharmaceutical research in Germany and making innovative therapies for neuro degenerative disorders available to the public. One of the sub-projects, the one my talk is covering, is to build a compound library at the University of Bonn. The goal of this compound library is twofold: first of all, it’s to store and manage in a professional fashion, whilst in a university setting, the compounds synthesised within the projects that are part of the Neuro-Alliance consortium. So the compounds library facility must provide adequate storage conditions and also be able to serve as a central compound despatching platform in order to be able to send the compounds for local testing or external testing facilities. The second goal is to serve as a repository for compounds originating from outside of the consortium. These latter are, for example, generated at the University of Bonn with non Neuro- Alliance affiliated projects, but again also originate from other academic groups and institutions. For example, classically whenever an academic leader or professor retires, the compounds that have been generated, isolated or synthesised during his career are just lost or destroyed. The idea here is to salvage these, which are sometimes precious or rare compounds, and be able to use them for future projects. Compound Management and Integrity Online Pharma IQ Sector Report & Resources 2011
  6. 6. Obviously all the project members, everybody that’s involved in the compounds library and whoinputs his compounds into the library, wants to make sure that his IP is respected and guaranteed.At the same time, all the people working in a particular project need to have access to the samedata notwithstanding where that data has been generated, since they are working together towardsa common goal. So building such a compounds facility comprises two main aspects: thecompounds storage and handling as such, and the data management without which nowadaysnothing is possible anymore.Now where things become intricate is when you start considering the IP. As I mentioned briefly abit earlier all the parties who entrust their compounds with the compounds library want to makesure that their IP is protected, that is making sure that their structures and data remainsconfidential, but at the same time also avoiding any IP contamination.So, firstly, the structures and all related information must be protected against unauthorisedaccess. Nobody who’s not working for a particular project for which the compound has beensynthesised should have the right to see or to access the structures and the relevant data.Secondly, the same is true in reverse. By all means we must avoid being able to see data which isnot ours, so which is not part of the projects we are involved in.As far as the data management system is concerned, beside the strictly compound relatedinformation, we also need to manage the access rights to the data and this enforced access control,both on a physical, that is, directly to the compounds as such, but also at the electronic level. Andonce this is in place, you want to make sure that the data system allows for professionalregistration and storage of information which is generated in a standards compliant and stableapplication that’s usable at the University, even beyond the duration of the consortium.Pharma IQ: Now next I’d like to discuss the challenges in constructing an integrated chemical andtest data management system to industrial standards. What would you say are the key challengesinvolved, Reiner?R Dieden: In practice, working in a consortium like this implies that the project groups arecomposed from members from different backgrounds; some of them are from industry, othersfrom academia; and both located either at universities or in industry, and they’re working togetherin order to discover new drugs. So we need to make sure that all the project members, whereverthey are sited physically, can have access to the most recent data gathered by their differentcolleagues at the different institutions. Compound Management and Integrity Online Pharma IQ Sector Report & Resources 2011
  7. 7. However, we must not forget that we’re using two or more different systems, informaticssystems. At UCB we have our own home-built data management system with its inherentcomplexities and our business rules; on the other hand, at the University a new system is beingconceived to local requires, with a different architecture and maybe less stringently enforcedbusiness rules. Therefore the data from these two different systems must be synchronised,checked against errors or business rule violations for the other system, and then be merged intothe local system, all the time making sure that only the data for the specific projects that the twoexchange partners are involved in is actually transmitted over the internet using standard, securedata transmission protocol.So, in practice the way we are ensuring this is through generating on both sides a full dump of therecords of the project under scrutiny, which are in the data base as a standard SD file. These arethen checked for differences with the data which is already present in the local data bases.Differences can be due to either new data that must be incorporated or they can identify problemsdue to the different complexities inherent to the system which then must be handled by theRegistrar. A feature which helps us with that is data flash modification for each data item, whichcan help us distinguish between data handling errors and amendments.So the process needed some fine tuning in the beginning, but now almost a year into the project,it’s running almost seamlessly, which does not yet mean as well as we would like it.Pharma IQ: So you’ve outlined some of the challenges in ensuring secure data synchronisationbetween academia and industry. Next, I’d like to talk about the advances that you foresee in thenext two to three years.R Dieden: The pharmaceutical industry is developing more biologicals, so managing biologicalsis an obviously trend with which more and more colleagues have to cope, so I would see that asone development in future years. Besides that, I think we would see in the future a continuingtendency to more collaboration with external partners, be it industry or academia. Mostbiopharma companies that I can see are working with CROs in either India or China forcompound synthesis. I think that in the future you might also see more risk or library sharingventures. Compound Management and Integrity Online Pharma IQ Sector Report & Resources 2011
  8. 8. Making Compound Management Simpler For many organisations in the pharmaceutical sector, the area of compound management can be a problematic one due to all the potential complexities involved. Simplifying this process is high on the agenda for many organisations and this was recently recognised by Dr. Mike May in an issue of Drug Discovery and Development, which observed that organisations are seeking more efficient ways of keeping track of libraries of compounds and biological samples as they expand. One thing which can help to address this problem is improved automation, he stated, particularly as some libraries hold in excess of a million samples. This statement was echoed by Dr. Sue Holland, site director for sample management technologies and molecule discovery research at GlaxoSmithKline (GSK), who said that such automation systems must not only provide environmental control, but also facilitate rapid access. She advised: "Analyse the project and then adjust the automation accordingly. In high- throughput screening, for instance, compromise between the best storage conditions and rapid access." The expert pointed to GSKs own custom system, which he said can meet this balance by providing several million samples for high-throughput screens in just a few days. Dr. Holland also pointed out that these systems need to work well together, as even the best technology can suffer from labware issues which will undermine the whole system. She added: "IT systems underpin all of this. Only a few years ago, most of the information technology was developed in-house at GSK. The commercial offerings werent out there, but now that has changed." In the case of many organisations, chemical library management is more advanced than biological samples and so anything learned from this can help companies to make better choices for biological issues. At GSK, the firm uses the existing chemical library automation with biological samples, Dr. Holland pointed out. Compound Management and Integrity Online Pharma IQ Sector Report & Resources 2011
  9. 9. The expert said that there is still much more to do in the field of sample management, however,such as integrating quality assurance of samples into the entire process.Many companies which have the ability to measure the purity and concentration of stock materialalso want the ability to measure these factors for bioassay output – which is no easy task, sheobserved.As the issue of compound management becomes more and more pressing in the months ahead,questions such as these are the ones which pharmaceutical firms will need to answer if they are tooptimise their sample libraries and take drug discovery to the next level.Another major compound management issue is maintaining sample quality and this wasaddressed by Dave Harding, sales and marketing director at RTS Life Science, based inManchester.He told Drug Discovery and Development that a big problem with compound libraries isprecipitation of the compound, as this means the concentration of the sample is different to whatfirms expect and can lead to screening errors.In order to try and detect precipitate in a tube and the liquid level, RTS introduced a tube auditorwhich works without removing the tubes cap – something Mr. Harding said is simplifying theprocess considerably.When it comes to biological samples, Ian Yates, global sales support manager for automationsolutions at Agilent Technologies, said that long-term quality often requires lower storagetemperatures, though automation for managing biological samples is generally less advanced thanchemical storage."Its an up-and-coming area. Lots of biological samples must be stored at –80 degrees Celsius andbelow," the expert explained.. Compound Management and Integrity Online Pharma IQ Sector Report & Resources 2011
  10. 10. However, Matt Hamilton, vice president at Hamilton Storage Technologies, said that many firmsmake automated –20 degrees and –80 degrees Celsius sample storage systems.He explained: "For example our automated storage systems require minimal or no infrastructurechanges and work well in distributed and satellite labs. In addition, our –80 degrees SampleAccess Manager storage systems include integrated sample management software that supportschain of custody and 21 CFR Part 11 requirements."Consistency is perhaps the most important factor in compound management, according to Dr.Holland.Beyond flexibility, consistency is key for companies such as GSK which are aiming to simplifycompound management without compromising quality.She noted: "If we put a new system at one site, it goes into all of our sites for the same purpose.That minimises costs in terms of integration, reduces our repair and maintenance burden, andleverages our purchasing power." Compound Management and Integrity Online Pharma IQ Sector Report & Resources 2011
  11. 11. Additional ResourcesINTERVIEW: Building a Compound Management Facility – The IntegrationChallengeWith Reiner Dieden PhD, Analyst and Physical Chemistry and Logistics Director from UCB Reiner Dieden discusses the challenges faced by the NeuroAllianz Consortium – including managing compounds from with different intellectual property situations in one place; the principal steps in constructing an integrated chemical and test data management system to industrial standards; and the difficulties involved with ensuring secure data synchronisation between academia and industry. The interview closes with Dieden’s projections of how the industry is to develop over the next few years.INTERVIEW: Rose Gonzales, Director Compound Mgmt & Distribution at PfizerWith Rose Gonzales , Director at Pfizer The role of CROs in the drug discovery process is constantly evolving, and as data management and distribution efforts improve, there is increased opportunity for leveraging CROs within drug discovery research. In this podcast, Rose Gonzales, who is a director at Pfizer, joins us to talk about the ever-changing role of CROs as well as the effective utilisation of strong compound management within the drug discovery process.INTERVIEW: Essential Tips for Successful Outsourcing of Your CompoundManagement ActivityWith Dr. Sylviane Boucharens, Section Head of Molecular Pharmacology Department at MSD In this exclusive interview, Dr. Sylviane Boucharens, Section Head of Molecular Pharmacology Department at MSD, speaks to Andrea Charles from Pharma IQ, about the current hurdles to accurate compound management and integrity, and the benefits of outsourcing all or part of your compound management activity. Compound Management and Integrity Online Pharma IQ Sector Report & Resources 2011
  12. 12. Evaluating Compound Management Strategies and Technologies From Around the World Glossary Event8 successful years of real-world conferences, the annual Compound Management & HighlightsIntegrity series of events is going online! With travel restrictions tighter than ever and agrowing interest in compound management (CM) around the world, we’re bringing the How it Worksexperts to you in a series of expert-led interactive webinars beginning October 31,2011. FAQ’sNever fear: you don’t need to bid the real-world CM event (and the networking Agendaopportunities it provides) farewell. If you have the time, we’d love to see you at our Meet YourCM events in London, Germany and the US. But if you can’t attend – or need some SpeakersCM insights between now and next year’s event – join us online this autumn! PricingTrue to form, Compound Management & Integrity Online delivers the hard-hitting,technical content you need to consider when managing, optimising and building a Registersuccessful sample collection for drug discovery research. In these interactive webinars, TodayCM experts will demonstrate how to tackle challenges such as the ongoing trends ofdownsizing and outsourcing, and will help you identify tools and develop strategies forensuring the quality of your processes, collaborating with partners (including CROsand academic research organisations) and improving your automation systems forincreased efficiency.In order to accommodate your schedule, we have spread this event over the course of 5weeks so that you may attend at your convenience. Presentations will also be availableon demand so if you miss a session, you will always have an opportunity to catch up ata time that is convenient! Get your Early Bird discount Now Compound Management and Integrity Online Pharma IQ Sector Report &the Speakers << Meet Resources 2011

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