When finding the fastest path between discovery and delivery, pharmaceutical companies are increasingly looking toward Contract Research Organizations (CRO s). As the face of the industry changes, 2020 Pharma (Ph) sits down with two CRO experts to discuss these trends.

1. as the
CRO
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Flies

2. case studies
as cros go, charles river is one of the largest, with 9,000 employees worldwide and
over 60 facilities in 15 countries. We talk with two Charles River vice Presidents,
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stephanie Wells and Nancy gillett, about the current trend of outsourcing by pharma-
ceutical and biotechnology companies
drug discovery
When finding the fastest path between discovery and delivery,
pharmaceutical companies are increasingly looking toward
contract research organizations (cros). As the face of the particularly the mid-development area around the
industry changes, 2020 Pharma (Ph) sits down with two regulatory required studies. They are no longer
CRO experts to discuss these trends. maintaining the expertise in specific areas where
they used to. For example: reproductive toxicology.
Ph: Are Contract Research Organizations of the cases, it’s a much deeper partnership. We’re That expertise is very specialized, requiring a strong
(CROs) in greater demand today than in past looking at taking on whole programs and we have historical control base and unique scientific exper-
years, and if so, why? a deeper expertise around the effects of particular tise. also, these studies typically are conducted late
sW: We are definitely seeing an increase in classes of molecules. it feels much more like an in the development process. so we’re seeing more
demand from our clients for outsourcing services, equal partnership than in previous years. it is also a companies choosing not to maintain that expertise
despite the fact that the overall pharmaceutical and more fun business model and gives us opportuni- internally and to rely instead on cros. That builds
biotech industry is somewhat depressed from a ties to evolve and integrate with our customers. efficiency into the process, because instead of
research and development (r&d) point of view. a fixed infrastructure with costs of both people
This is because there is a changing business model Ph: How can CROs affect the R&D process of and facilities that are doing these studies only
occurring out there: our clients are increasingly major pharmaceutical companies? occasionally, you’re getting into a situation where
looking to strengthen their pipeline while manag- sW: Historically, the larger companies have specific people are doing these studies routinely for
ing, or even decreasing their internal resource lacked agility — and connecting all of the multiple a variety of companies — making it more efficient
base and their capital expenditures. This means operating functions within the corporation has for everyone.
they’re focusing on defining core competencies always been a challenge. With the current move sW: increasingly, because of the need for effi-
and predominantly directing these to early pipeline toward reinventing the r&d process to acceler- ciency, the large corporations are looking for
development, compound qualification and so on. ate pipeline development and time-to-market, it’s standardization globally — although there is an
From the cros, these companies are there- causing a lot of internal tension in the companies, understanding that there are different regulatory
fore looking for operational efficiencies to stand- and there are clearly some political issues going on. standards. in many cases, these companies have
ardize procedures and processes; the facilitation of also, management direction seems less clear than it built their portfolios through acquisition of smaller
the drug development pathway; and expert advice was in the past, due to the speed of change. cros companies or licensing in compounds; they have
on study types and compound classes that can help can help by breaking down some of those internal lots of different processes and ways of doing things.
improve the design and implementation of the barriers that previously separated departments, We’re being seen as a way to help standardize some
study. consequentially, we’re seeing a change in functions and capability sets in the r&d process of this across their organization, and at least pro-
that relationship in many different dimensions, but within large corporations. We can facilitate that vide guidance about best- practice approaches.
the trend is definitely moving toward deeper part- process and replace parts of it as well. in the past, they’ve been able to deal with
nerships rather than supplier- vendor relationships, Ng: in previous years, major pharmaceutical the volatility of fluctuation in the pipeline and
and there is a lot more consultation and dialogue companies wanted complete control along every matching their workforce requirements with that.
between the two parties. step of the pipeline — from early discovery to However, the days of being able to have 20 percent
Ng: From my perspective, we definitely see that development to marketing. With the current extra capacity in any dimension is really over, given
change. i’ve been working in cros since 1994, challenges of identifying new therapeutics and the financial-performance requirements of many of
and it used to be just a vendor relationship with controlling cost, they’re finding that they need our clients. as a result, utilizing external resources
pharmaceutical companies. For instance, we’d get a to focus on their core competencies, which are helps balance the workload/workforce issues.
study and many times we wouldn’t know the nature more in the early stages of drug discovery and then
of the compound and so forth. during those years, again in the post-market stage of distribution, sales Ph: Do CROs specialize in new tools and tech-
cros were regarded as a ittle bit second-class in and marketing. We’re seeing them more willing nology to accelerate drug development? If so,
terms of the level of science. Now, in the majority to outsource, or relinquish control, in key areas, which ones are being focused on currently?
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3. case studies
Ng When i talk to new scientists in the cro models within oncology and inflammation. We’re development to get to approval of a product. We
business about safety assessment, i characterize us very pleased with our recent acquisition are particularly proud of the fact that we have
as being one step behind the cutting edge, so we’re of a company called Mir (Molecular imaging the Navigators, a group of individuals within the
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not necessarily the group that would want to be research) that has expertise in imaging across company, who have previously worked at the Fda
drug discovery
using brand-new technologies that haven’t been a variety of different technologies working with and know what a reviewer is looking for in terms of
validated. We’re experts at taking technologies that laboratory animals. so we do see it continuing to safety and risk assessment for humans. They’re able
have been determined to be useful and using them be expanded in the early discovery arena, but also to actually sit down with these clients when design-
to advance the decision-making process, because imaging is going to increase in the field of pathol- ing the studies, discussing the particular compound
that’s what it’s really all about: How quickly can ogy, where it becomes an easy, quick way to share class and what the intended use is.
you decide if this compound is likely to make it to images across different geographies — both with The Fda has differing requirements in terms
being a drug or not? clients and with different sites. of the studies that are necessary, based on the in-
We want to be able to say, “This technology is sW: The example of acquiring Mir is a good tended use of the compound. For instance, expec-
one that’s being used by a number of key players way for us to demonstrate supporting research in tations will vary for a drug intended for children,
in drug discovery or drug development.” Then it’s the discovery space, along with developing dis- as opposed to that for a terminal cancer patient.
something that we can put in an offering to our ease-specific models. This is a great example of a often, it may be that some of the studies wouldn’t
clients. We can do it in a regulatory compliant man- complimentary technology that is really state- of- be appropriate in a particular animal model to
ner, which in many cases, as with something com- the-art in offering multiple modalities for in vivo determine if there’s an unknown toxicity. What our
ing out of academia, wouldn’t necessarily be done imaging. These services permit a lot of new types of people are able to do is design an efficient package
in that way. We certainly are always looking for new investigation, particularly in oncology and inflam- of studies. We will then also be able to sit down
tools and technologies to add to our offerings to mation studies. it is also a great example of a strate- with the client, discuss the intended program with
the client. We do get many opportunities to look gic add-on that enhances our portfolio but still very the Fda, and be a partner for them. it’s increasing-
at new tools, and many are very interesting and fun much focuses on supporting the drug development ly important to be able to provide the expertise in
from a science perspective — and i am a scientist process. That’s an area that perhaps we are unique regulatory strategic design, not only for the bigger
— but they don’t always change the decision point. in as a cro: We can add incremental value with companies who want to offload an entire program,
some new technologies, where cros do par- our portfolio of tools to help in the discovery but for the small companies that may have never
ticularly excel, are developed during the evolution phase — we can aid in identifying the right target taken a molecule down the development path.
of new, specific therapeutic classes. For example, compounds before more money is invested in later sW: The cro experience level is obviously built
there is a lot of work going on in stem cells, ribo- stages, and more expensive development activities. over time, and is something that can be shared with
nucleic acid interference and oligonucleotides. less- experienced companies or even in shaping
in many cases, we are the ones that do the initial Ph: With frequently reported FDA “crack- newer markets as a whole. With trends and ex-
efficacy and safety work, and we therefore end downs” in an often changing compliance land- pectations moving toward global standardization,
up being more knowledgeable about the classif- scape, how can CROs help navigate the world of this is especially important. We’re hearing that,
fects of specific therapeutic areas than individual FDA regulations? wherever a product or drug might come from, the
companies. That’s one place where growth of our Ng: cros do of course provide help to the global consumer is expecting the standards to be
knowledge and expertise accumulates more rap- major pharmaceutical companies, but many times the same. so setting standards high and implement-
idly than for companies individually. our work is coming from the smaller biotechnol- ing, albeit in a collaborative way, Western standards
transitioning to more innovative areas, imag- ogy companies, or the almost virtual companies in emerging markets is essential to ensure quality
ing technology will be very important in the future, with very few people, that don’t have the expertise processes and outcomes, particularly in an area as
and no one yet has fully grasped all of the ways in terms of regulatory requirements. They need sensitive and important as drug development. as
in which it can be applied, although there is cer- assistance in understanding what it takes to get a cro, we are highly focused on compliance and
tainly a lot of imaging that is being applied to early through the set of studies in order to proceed to the meeting regulatory goals; everything we do is in
discovery, particularly in some of the early efficacy first-dosing stage in humans, or the path of that domain.
stePHaNie Wells is senior vice President and chief Marketing officer at charles river. as cMo, Ms. Wells is charged with
developing and implementing a brand and marketing strategy that enhances the company’s ability to meet customers’ evolving needs.
Born in the uK, she has more than 25 years of international experience in the healthcare industry. this expertise, coupled with a clinical
biochemistry background, enables Ms. Wells to successfully spearhead initiatives that appeal to the global scientific community. Ms. Wells
holds the equivalent of a bachelor’s degree in Medical laboratory sciences and clinical chemistry from Paddington college, london,
england.
NaNcy gillett d.v.M, PH.d., is the corporate executive vice President and President, global Preclinical services at charles river.
she has more than 23 years of experience as an acvP board-certified pathologist and scientific manager. Her deep understanding of the
scientific community helps ensure that charles river provides a unique portfolio of products and services to help accelerates clients’ drug
development programs. dr. gillett received her d.v.M. degree from Washington state university and her Ph.d. degree from the univer-
sity of california, davis. in May 2006, dr. gillett received an Honorary doctor of science degree from Purdue university.
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