Compound Management - Pharma IQ Report 2011

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

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 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 organisation's 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 firm's 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 company's 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.


Matt Hamilton, vice-president of Hamilton Storage Technologies, said: "Many users feel chained
to a more expensive, less flexible automation platform because no other system could cherry-pick
their punch-type tubes.

"We've developed an entirely new method for punching tubes to a destination rack, so customers
can now switch to the more full-featured Hamilton platform or add us as they expand their
existing library management systems."

Hamilton is just one of a number of companies that have carved a niche out of providing
technology 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 as
sealing and capping, and software for use with such solutions.

According to the company: "We recognised the need for vigorous environmental controls during
processing 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 and
develop new products for compound management purposes. Any equipment that can help
scientists to improve the efficiency of their logistics, as well as their handling of compounds, is
likely 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 to
underestimate the importance of compound management. Its prominence in the pharmaceutical
industry is only likely to grow over the next few years.


Constructing an Integrated Chemical and Test Data Management
System 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-l'Alleud. 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.


Obviously all the project members, everybody that’s involved in the compounds library and who
inputs 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 same
data notwithstanding where that data has been generated, since they are working together towards
a common goal. So building such a compounds facility comprises two main aspects: the
compounds storage and handling as such, and the data management without which nowadays
nothing is possible anymore.

Now where things become intricate is when you start considering the IP. As I mentioned briefly a
bit earlier all the parties who entrust their compounds with the compounds library want to make
sure that their IP is protected, that is making sure that their structures and data remains
confidential, but at the same time also avoiding any IP contamination.

So, firstly, the structures and all related information must be protected against unauthorised
access. Nobody who’s not working for a particular project for which the compound has been
synthesised 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 is
not 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 related
information, 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. And
once this is in place, you want to make sure that the data system allows for professional
registration and storage of information which is generated in a standards compliant and stable
application 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 and
test data management system to industrial standards. What would you say are the key challenges
involved, Reiner?

R Dieden: In practice, working in a consortium like this implies that the project groups are
composed from members from different backgrounds; some of them are from industry, others
from academia; and both located either at universities or in industry, and they’re working together
in order to discover new drugs. So we need to make sure that all the project members, wherever
they are sited physically, can have access to the most recent data gathered by their different
colleagues at the different institutions.


However, we must not forget that we’re using two or more different systems, informatics
systems. At UCB we have our own home-built data management system with its inherent
complexities and our business rules; on the other hand, at the University a new system is being
conceived to local requires, with a different architecture and maybe less stringently enforced
business 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 into
the local system, all the time making sure that only the data for the specific projects that the two
exchange partners are involved in is actually transmitted over the internet using standard, secure
data transmission protocol.

So, in practice the way we are ensuring this is through generating on both sides a full dump of the
records of the project under scrutiny, which are in the data base as a standard SD file. These are
then 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 problems
due to the different complexities inherent to the system which then must be handled by the
Registrar. A feature which helps us with that is data flash modification for each data item, which
can 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 synchronisation
between academia and industry. Next, I’d like to talk about the advances that you foresee in the
next two to three years.

R Dieden: The pharmaceutical industry is developing more biologicals, so managing biologicals
is an obviously trend with which more and more colleagues have to cope, so I would see that as
one development in future years. Besides that, I think we would see in the future a continuing
tendency to more collaboration with external partners, be it industry or academia. Most
biopharma companies that I can see are working with CROs in either India or China for
compound synthesis. I think that in the future you might also see more risk or library sharing
ventures.


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 GSK's 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
weren't 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.


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 material
also want the ability to measure these factors for bioassay output – which is no easy task, she
observed.

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 to
optimise their sample libraries and take drug discovery to the next level.

Another major compound management issue is maintaining sample quality and this was
addressed by Dave Harding, sales and marketing director at RTS Life Science, based in
Manchester.

He told Drug Discovery and Development that a big problem with compound libraries is
precipitation of the compound, as this means the concentration of the sample is different to what
firms 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 auditor
which works without removing the tube's cap – something Mr. Harding said is simplifying the
process considerably.

When it comes to biological samples, Ian Yates, global sales support manager for automation
solutions at Agilent Technologies, said that long-term quality often requires lower storage
temperatures, though automation for managing biological samples is generally less advanced than
chemical storage.

"It's an up-and-coming area. Lots of biological samples must be stored at –80 degrees Celsius and
below," the expert explained.

.


However, Matt Hamilton, vice president at Hamilton Storage Technologies, said that many firms
make automated –20 degrees and –80 degrees Celsius sample storage systems.

He explained: "For example our automated storage systems require minimal or no infrastructure
changes and work well in distributed and satellite labs. In addition, our –80 degrees Sample
Access Manager storage systems include integrated sample management software that supports
chain 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 simplify
compound 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, and
leverages our purchasing power."


Additional Resources

INTERVIEW: Building a Compound Management Facility – The Integration
Challenge
With 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 Pfizer
With 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 Compound
Management Activity
With 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.


Evaluating Compound Management Strategies
and Technologies From Around the World Glossary

Event
8 successful years of real-world conferences, the annual Compound Management & Highlights
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 How it Works
experts to you in a series of expert-led interactive webinars beginning October 31,
2011. FAQ’s

Never fear: you don’t need to bid the real-world CM event (and the networking Agenda
opportunities it provides) farewell. If you have the time, we’d love to see you at our
Meet Your
CM events in London, Germany and the US. But if you can’t attend – or need some
Speakers
CM insights between now and next year’s event – join us online this autumn!
Pricing
True to form, Compound Management & Integrity Online delivers the hard-hitting,
technical content you need to consider when managing, optimising and building a Register
successful sample collection for drug discovery research. In these interactive webinars, Today
CM experts will demonstrate how to tackle challenges such as the ongoing trends of
downsizing and outsourcing, and will help you identify tools and develop strategies for
ensuring the quality of your processes, collaborating with partners (including CROs
and academic research organisations) and improving your automation systems for
increased efficiency.

In order to accommodate your schedule, we have spread this event over the course of 5
weeks so that you may attend at your convenience. Presentations will also be available
on demand so if you miss a session, you will always have an opportunity to catch up at
a time that is convenient!

Get your Early
Bird discount Now

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