Rick Connell, Vice President and Worldwide Head of External Research Solutions, Pfizer Global research & Development, moderates an expert panel discussion around the emerging realm of risk share in drug discovery, and speaks with Mark Ashton, Executive Vice President of Business Development, Evotec, Bill Farley, Vice President of Business Development, ChemDiv, and Sri Mosur, CEO and President, Jubilant Discovery Services.

1. 20/20 Pharma
Rick Connell, Vice President and
Worldwide Head of External Research
Solutions, Pfizer Global research & Development,
moderates an expert panel discussion around the emerging
realm of risk share in drug discovery, and speaks with
Mark Ashton, Executive Vice President of Business
Development, Evotec, Bill Farley, Vice President of
Business Development, ChemDiv, and Sri Mosur,
CEO and President, Jubilant Discovery Services
OFFER TO
SHARE

2. whitepapers
2
RC: Some companies that work in the risk- sharing discov- then develop to pre-agreed-upon critical success factors in a
drug discovery
ery space with chemistry and biology programs also operate given time period. When the product reaches one of these factors,
in the pre-clinical space; in which case, they essentially take it is nominated to the next stage. Should the project fail to meet
invalidated hits, but they stop before development. Other them, a joint steering committee may extend this investigation
companies take their programs all the way to proof-of-con- period for one to two quarters, at which point the factors are either
cept, at which point, as part of that risk-sharing partnership, met or they’re not. Should the asset proceed to candidate nomina-
they hand them over to their pharmaceutical partners. Most tion, the partner would pay an agreed- upon sum for that asset so
companies will say they can do any service the client wants, that the development would be done on a fee-for- service basis in
but in your experience with clients, where do you tend to Phase I or Phase II.
have that breaking point? SM At Jubilant, we have developed a plug-and-play model from
target or hit generation to Phase II proof-of-concept, leveraging
MA: Some of our collaborations covered by this description our requisite capabilities in the discovery, pre-clinical and develop-
start at the target, so the hits actually come from activities carried ment phase with our global clinical research organization in the
out within Evotec, and they all continue primarily to pre-clinical U.S., India and Europe. Our model has been to work across the
development. We only have one case where we go from post pre- portfolio, with the starting points coming from either Jubilant or our
clinical development through to clinical proof-of-concept. In these collaborators. Typical scenarios include starting with a de-novo
relationships, there are a couple of options for us to continue to design from our side, or a number of hits or optimized leads from
proof-of-concept, but there is a natural break at pre-clinical or clin- collaborators and ending at any point from pre-clinical candidate
ical development. However, having the in-house clinical expertise to Phase II proof-of-concept. At this point, our collaborators can
plus a network or clinical development providers, we are uniquely either bring the pre-clinical candi- date into their development
set up to support our customers from target to clinic and portfolio or allow Jubilant to continue to participate until POC. In
beyond if that is their need. some cases, we also extend some of Jubilant’s own investment
into the development phase. As a policy, we do not do any com-
BF: ChemDiv has taken an approach based on capacity, mercialization, as our entire risk paradigm ends at
resources and knowledge for the discovery processes — from
Phase II in proof-of-concept.
design to hit identifications, re-characterization and candidate
nomination. We have recently added Phase I and Phase II clinical
capabilities in Russia, a process which has been vetted, ordered RC: Let’s look at how these deals are typically structured.
and actualized by several major pharmaceutical companies. Our When you approach a client and you’ve agreed on a
model was simply a cost-plus model, where we constructed a roll- particular target, is the client paying for specific full-time
ing workspace with appropriate assets for a equivalents (FTEs) or planning for a specific outcome? What
small molecule discov- ery enterprise. is the typical business construct for a deal where you’re
We insert those opportunities doing a risk- sharing model?
provided by the client or sug- BF: We would like to provide a significant discount on FTEs to
gested by ChemDiv, and our work vendor. The drug discovery process for a large pharma-
ceutical company to produce a candidate costs about $10 million.
However, if we are able to put together an enterprise,
whether it be in a single target area or in a vari-
ety of different target areas, we believe
we can construct this rolling
workspace. We look at a
given workload and timelines,
which is different from a
large pharmaceutical com-
pany’s approach, and we try to
set those timelines and expecta-
tions with our partners at the on
set. When we reach can didate nomination, we
look at getting paid a milestone, or being made
whole for those efforts. Essentially, we’re
doing a risk share on a cost-plus basis. We are
being paid for our costs, being made whole and
getting a slight bonus for delivering on those
metrics through the discovery process.
RC: Is the typical model to define some
sort of timeline with financial boundar-
ies?
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RICK CONNELL
VICE PRESIDENT & WORLDWIDE HEAD, EX- 3
BF: No, the typical model is based on multiple opportunities. TERNAL RESEARCH SOLUTIONS
drug discovery
Let’s say we’re going to use anywhere from 15 to 25 FTEs per PFIZER
slot. Then what we want to do is create three to five slot opportuni-
ties, whether they be de novo, hits, leads or candidate nomination.
Dr. Connell started his career at Bayer in 1990, then joined Pfizer
We want to mitigate all risk by taking multiple opportunities and
as Head of Cancer Chemistry (1999) and spent a year at the Sand-
keeping those resources moving. It may involve not only screen-
wich, U.K. site before promotion to Executive Director of Discovery
ing, but syntheses of the new compound and development of the
operations. He heads up the global External Research Solutions
current biological assets to interrogate that target. At the critical
(ERS) group. This group manages the network of external research
deci- sion point, a joint steering committee would decide whether
collaborations delivering line-centric (Chemistry, Biology and Drug
or not we have met those criteria for hits. If we were not able to
Metabolism) and integrated services from target identifica- tion
nominate that opportunity to lead, we would want to replace that
through proof-of-concept.
with another de novo, a lead opportunity or something on its way
to being a candidate nomination.
RC: It sounds like the ChemDiv model would start with a set MARK ASHTON
number of FTEs offered at a discounted rate and tracked by EXECUTIVE VICE PRESIDENT, BUSINESS DE-
a joint steering committee. Should a compound advance to VELOPMENT
some milestone triggering event, the financial model would
be that ChemDiv would seek to remain financially whole. How
Evotec
similar is the Jubilant model?
SM: We look at our model like a pre-clinical and a clinical de- Dr. Ashton has been in his current position since 2005 and is re-
velopment engine up to Phase II. What we try to do is break the sponsible for global commercial and marketing activities, discuss-
stages down between hit, lead and optimized lead, candidate, and ing outsourcing needs with the world’s leading pharmaceutical and
Phase I and II. The research- funding decision spans across the biotechnology companies. Prior to this he was President, Dis- covery
whole portfolio, depending on how far a collaborator would like to Services, responsible for the Discovery Division of Evotec: a divi-
go beyond a pre-clinical or a Phase II stage. We set the stage and sion of over 250 chemists and biologists involved in projects ranging
agree to what we call fixed-research funding. We do not drive our from high-throughput screening to parallel synthesis and medicinal
projects purely by number of FTEs, but by the science and flexible chemistry.
staffing that will meet the objectives of a time-bound deliverable.
We prefer to work on research funding that is not tied to a fixed
number of FTEs, but does have the flexibility (which allows us
to use flexible FTEs across all of our components — biology, BILL FARLEY
chemistry and pharmacology) to meet the objectives of a particu- VICE PRESIDENT, BUSINESS
lar stage or milestone. We manage the program as it evolves in its DEVELOPMENT
science at our mutual discretion, while keeping the partner com-
CHEMDIV, INC.
pletely informed. If we reach our milestones within the pre-agreed-
upon timeframe, we get the normal milestone with the possibility
of bonus milestones for accelerated deliveries. If delayed, we Mr. Farley joined ChemDiv in 2000 and has in part been respon-
pur- sue the specific stage at our risk. We facilitate this process in sible for the company’s remarkable growth. He manages sales and
such a way that the collaborator pays more for success. To derive commercial development in North America; overseeing some of the
efficiencies, we prefer to do this in a portfolio of assets and not as most successful chemistry and drug discovery collaborations for the
single programs, as we can manage the attrition more effectively, company, most notably with Schering Plough, Eli Lilly, BMS, Aven-
which is critical to our deal structures. Ideally, with a portfolio of tis and Syndexa Pharmaceutical, as well as many others in academia.
three to five targets or programs, we are able to come out better Mr. Farley has more than 30 years experience in drug discovery and
in the early phases of the collaboration despite the challenges of over 20 years in business development.
science and operational delays.
MA: I think that it is no surprise that Evotec’s approach is similar
to that of Jubilant and ChemDiv. For example, we have a col- SRI MOSUR
laboration with Boehringer Ingelheim, which works on multiple CEO & PRESIDENT, GLOBAL
targets at a time. This is the preferred model, as one can spread
DISCOVERY & DEVELOPMENT
the resources effectively and balance any potential attrition, giving
everyone the confidence that the milestones will be met. Having JUBLIANT ORGANOSYS LTD
said that a number of our customers are single-target deals, but
it is true to say that, we would prefer to work on multiple targets Mosur is the CEO and President of Global Discovery and Develop-
in parallel. For these types of deals, we prefer the term “results- ment at Jubilant Organosys Ltd., a leading Indian pharmaceuti- cal
based” rather than risk sharing. In a results-based structure we vertical focused on global drug discovery and development, manu-
would be willing to discount the FTE or fixed fee in return for suc- facturing, and healthcare solutions. A chemical engineer by training,
cess- based milestones as a program progresses. As mentioned Mr. Mosur develops and directs R&D and healthcare alli- ances
earlier, the preference is for a multi-target relationship where you between mature and emerging markets. He is also a promi- nent
can manage attrition, but in reality that’s not always possible, speaker in international forums and a proponent of globally lever-
so businesses need to be flexible between the two. Most of our aged pharmaceutical R&D and affordable healthcare.
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4. whitepapers
clients prefer the FTE structure, because then they know what
they’re getting in the program. With the fixed fee, there may be
a concern as to whether companies are getting the FTEs they “ESSENTIALLY, WE’RE DOING
4 expect or have been promised. So we have more experience with
the discounted FTE model and subsequent milestones, but this A RISK SHARE ON A
drug discovery
is not to say that we don’t consider all potential business models
when putting together a results-based deal with our partners. COST-PLUS BASIS.”
RC: At Pfizer, we look at two major classes of targets.
First, there are credentialed targets, where we have proof- — BILL FARLEY
of-concept in the clinic and we’re looking for a best-in-class
approach. Then, there are targets without clinical proof-of-
concept, so they’re looking to get a clinical candidate.
Do the clients who approach you typically look at creden-
tialed targets or uncredentialed targets? Does one approach
fit better with your company’s model?
SM: The clients approach us from a mix of fast followers on one dated target is that you have to pick holes through the minefield
end to unprecedented targets on the other. It’s a combination of IP, which can be very difficult, but there are some very cre-
of biological and target validation efforts to include in vivo tools, ative medicinal chemists on those programs at Evotec. With less
with the goal being to find new indications or opportunities in that validated targets, you need some good, innovative technologies
space. We believe it should be a mix of both to create new oppor- that are able to unlock those targets and find some novel chemical
tunities that can sustain a long-term relationship. Early on in the matter. We have a good mix of these.
collaboration until it reaches a steady state, we prefer a balance Let me try to give you some examples. We have put in place
to sustain ourselves with a mix of known and unprec- edented an excellent hit-finding platform that we can use against many
targets in the ratio of 70/30, with the intent to move this from 70/30 different targets. For example, for the highly interesting yet ex-
towards 50/50 or 40/60. While the clients prefer to bring more tremely challenging CNS target, BACE, we’ve used our fragment-
unprecedented targets, a lot of this depends on the scale of the based screening platform to identify some novel chemotypes that
portfolio — three targets, six targets or nine targets — as it posi- we’re taking forward into optimization. Targets such as BACE
tions us for different value propositions. have proven extremely challenging to unlock in the industry, but
The second part of this is the fact that we are building ex- targets such as this fit well with Evotec — where we can bring to
perience with particular expertise in both the translational and bear the power of our diverse, hit-finding platform. We can also
pre-clinical space in differ- ent therapeutic areas. These can be use such tools on fast-follower targets as well. The oncology
utilized for identifying/validating new targets in specific thera- target, HSP-90 is a good example. This is a target for which there
peutic areas, like oncology, CNS/pain, metabolic dis- orders and is a raft of IP published, so the challenge is really finding some-
infectious disease, where our structural biology experience can thing novel. Again, we were successful in achieving this. We did a
play a major role. We would allow ourselves to a mix in ratio that fragment screen on HSP-90 and identified some novel chemical
is appropri- ate to the client’s strategy around development and matter, which we were then able to partner with an Italian biotech
commercialization while also allowing us to keep a sustainable re- company. This program has now advanced in to lead optimization
ward structure. All of our announced collaborations have a range and multiple patents have been filed on the chemical structures.
of validated to low-validated targets. So in summary, we have put the tools in place that can address
both of those aspects, and then we bring them to a collaborator
to establish a bal- anced portfolio with targets that carry good
RC: With high-volume invalidated targets, the methodology, chances of success.
infrastructure and skill sets are the same. When you get into
the fast follower group, there are certain speed components BF: Let’s look at unprecedented targets as well as fast follow-
which differentiate a best- in-class approach as opposed to ers, which are two different opportunities that serve some of our
others and tend to be larger investments. assets. One of our biggest assets is Chemistry on Demand: a
If customers are looking at these un-credentialed targets library of our collaborating systems. We have 1.4 million com-
or fast followers, do your organizations have any particular pounds that are powdered and in vials on the shelf — in all, about
expertise in one class over the other? 13,000 chemotypes, so we have a valid set of chemistry. All this
chemistry being validated makes it easily tractable and scalable,
SM: At Jubilant it’s equally balanced, particularly in the lead gen- so for either unprecedented targets or for follow-up chemistry,
eration area. With unprecedented targets, we perform effectively it provides a rich field to mine for power shooting or getting a
based on the experience we have had with the various tools in quick start on your discovery. This year, we will process probably
the early discovery phase and the technology partnerships that another 200,000 compounds based on 2,000 new chemo types
we continue to establish. We also work on fast followers in the all from rational design. We can accentuate small concentric sets
more validated space, simply because most of these are in the to unprecedented targets and develop those probe sets rapidly
lead optimization phase and serve as a good testing phase for our around fresh, IP-clean compounds to interrogate that target and
collaborative capabilities while ensuring early wins for the model provide us a foothold. Follow-ups take a different set of skills —
to sustain. usually the skill of a medicinal chemist. The medicinal chemist is
MA: It has to be said that for the most part, people don’t out- experiential in nature. Even if someone has a post-doctoral in a
source their easy targets, so Evotec tends to see challenging particular area, they may not have the ability to affect a compound
targets. I think that it would be fair to say that we have an equal physiologically on some axis of opportunity in biology. Those two
mix of more validated targets and less validated targets, and they opportunities are slightly different, and I would put a more skilled
each carry a different risk-reward profile. Most of the risk of a vali- chemist on the hit follow up or the task of trying to uncouple ad-
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5. whitepapers
ditional leads.
RC: Does your typical client portfolio tend to consist primar-
ily of biotech companies? Who do you see as the client of
“WE HAVE AN EQUAL MIX 5
today, and how will that change down the road? OF MORE-VALIDATED TAR-
drug discovery
MA: Firstly, our portfolio consists of companies ranging from vir- GETS AND LESS- VALIDATED
tual bio- techs up to the top 10 pharmaceuticals. However, in the
space of these risk- sharing or results-based deals, we see the
TARGETS, AND THEY EACH
large biotechs plus mid-size and large pharmaceutical companies.
For example — as well as the collab- oration with Boehringer In-
CARRY A DIFFERENT RISK-
gelheim that I mentioned earlier — we also have ongoing collabo- REWARD PROFILE.”
rations with Novartis and Roche. Normally, the smaller biotechs
don’t have the bandwidth in terms of multiple targets to bring to
a collaboration, so the appetite for risk is less. We are, however, — Mark Ashton
seeing more and more deals with biotechs in this field, and there
is currently much hype in the industry around these types of
risk-sharing deals. You have to wonder if some of the business
models being applied are sustainable, but without a doubt there
is increasing interest in these types of models and collaborations.
We are also discussing some potential opportunities with venture-
capital companies. These could be interesting deals that we are
able to discuss a little further in the future.
BF: The drug discovery process and the metrics of it are fairly tical companies, hoping for a lower cost base or a more efficient
well under- stood. It costs about $10 million for a large pharma- R&D process under a risk-reward model. We have gener- ated
ceutical company to produce a hit and go from first principle up leverage for such assets in our joint venture with Lilly in the pre-
to Phase I studies. However, to go from candidate nomination clini- cal to POC space, which will be used for rapid drug develop-
to distribution of the drug, it’s about $990 million. Increasingly, ment expertise. Using the CROs of Jubilant, we have been able to
pharmaceutical companies are concentrating on ways to better attract assets from third parties, as well as companies interested
characterize, understand and model their clinical trial processes. in using this shared risk model to grow their portfolio of assets to
They are looking toward outsourcing those opportunities in a proof-of-concept effectively.
well-characterized fashion and trying to find partners that have
the abil- ity to provide assets that they can monetize further. RC: With academia and some of these hedge funds, there
Large pharmaceutical companies will drive more and more of their is no competition internally. However, in the com- petitive
discovery portfolio externally. For instance, Burke announced in space, most companies will claim they have the “smartest
October that they were going to drive at least 25 percent of their chemists” or the “most experienced biologists.”
portfolio externally in the next five years. When you meet with a large pharmaceutical client, what do
It’s hard for biotech companies to find funding and opportuni- you say differentiates you from other service providers?
ties and to go forward. Several venture-capital people have pre-
dicted that over the next 18 months the number of dated materials
BF: From the perspective of biotech versus large pharmaceuti-
cal compa- nies, we need to work faster, better and smarter. At
that will become available will be over 1,000. Those companies
ChemDiv, one of our advantages is our ability to “have boots
and those assets will be looking for favorable terms, probably with
on the ground,” so we have a critical mass of about 550 people
large pharmaceutical companies, and we will work with them to
working and are able to use U.S.-based project management. We
integrate these discovery opportunities.
have a technology center based in San Diego, Calif., which allows
SM: While major pharmaceutical companies are an important us to do quick response and fast transfer of materi- als. We also
driver of this type of portfolio business, particularly in the risk- have the advantage of working offshore and providing some cost
sharing model, there are other players as well. We not only have advantages of a waiver by working in Russia, where we have a
relationships with large pharma- ceutical companies including Lilly state- of-the-art facility.
and Amgen, but also with mid-size com- panies like Forest. We believe our chemistry library gives us a six-to-nine month
We have partnerships with academia, which is looking at cre- head start. If someone is synthesizing compounds to begin a proj-
ating more value for enabling technologies and assets. We have ect without a library, it puts them behind and doesn’t give them the
a relationship with Duke University, in which we access Duke’s advantage of new IP space. We have successfully done this and
investigator technologies to help go through the pre-clinical phase. have a track record to prove it. In one of our projects, for instance,
Academia is now beginning to use some of its available tech- there were some assets that were not able to be transferred be-
nologies and resources to move opportunities eventually in such cause they were owned by a third party. We were able to take that
partnerships. They see the pharmaceutical companies being the project under our umbrella, manage the third-party pro- vider, and
biggest sponsor, usually at the pre-clinical stage, after complet- integrate that into a seamless drug discovery process that didn’t
ing validation or with someone like Jubilant. consume our partner management assets in the process.
In addition, there are a large number of distressed assets
building into the landscape, from biotech companies running out
of funding to hedge funds trying to pull the money out of the mar-
RC: Three things I’m hearing that stand out are: critical
mass and experience, U.S.-bases with a tightly integrated
ket. We have seen traction here in the last two or three months for
offshore subsidiary, and unique assets.
such partnerships increasing, wherein some firms are willing to
What are these unique assets and differentiators that a com-
invest in a plug-and-play portfolio, in partnership with pharmaceu-
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pany can offer?
SM: Our first and foremost asset is people. We look at this as
being a judgment-driven, portfolio-driven approach, and the busi-
“PEOPLE AND THEIR
JUDGMENT-MAKING
6 ness model is based upon successfully managing the attrition
process. Therefore, people and their judgment-making capabili-
drug discovery
ties become extraordinarily important for us. We have brought
together a group of people who have managed portfolios in a
combination of pharmaceutical, biotech and academic environ-
CAPABILITIES BECOME
ments; people who bring a deep understanding of making the right EXTRAORDINARILY IMPOR-
type of judgment. Our leadership, both at the senior level and proj-
ect level, is based on people who have come back to India from
the West. Instead of trying to make it a U.S.-centric approach,
TANT FOR US.”
we have moved people from the U.S., Europe, Japan and other
places to Bangalore, India, and other sites where we operate.
Our group is not afraid of failing. They make judgments, both
in collaboration and independently, to lead projects successfully.
All of our people have experience in different aspects of discovery, — Sri Mosur
pre-clinical development or development. They also bring a tre-
mendous amount of therapeutic understanding of biology, as we
do not want to confine our strengths toward medicinal chemistry
only. With our bioinformatics platform and our ability to understand
therapeutically aligned clinical and pre-clinical biology, we are able
to generate knowledge in order to be successful in integrating and
delivering the portfolio.
The second differentiator is the technology platforms. In The third area I want to mention is our technologies. Here I
order to enable our people, we provide them access to as many want to go back and use, as an example, the diverse hit-iden-
technology platforms as possible, both internally and through our tification technology at Evotec. Like ChemDiv, we also have an
partners, within limitations. internal library of small molecules that we add to annually. We
The third differentiator is our evolving culture. We have de- also ensure that we routinely analyze all of the compounds to
veloped a culture of transparency and collaboration among our ensure their chemical purity and integrity. We screen them using
people. We don’t try to claim that we could do everything, but our in-house, ultra-high-throughput screening platform that we’ve
rather that we need to col- laborate and access the institutional developed together with our pharmaceutical partners, Pfizer, GSK
knowledge of our partners to be successful. As a young company, and Novartis. In addition, we have a fragment screening platform
we do not have the institutional expertise of someone like Pfizer. that we can use if the target is be amenable to a high-throughput
Operationally, we are a global CRO with facilities in Europe, screening approach. Our fragment screening technology utilizes
the U.S. and India. We have generated great efficiencies in bioassay and NMR- based screening technologies. We are one of
logistics, supply chain, IT infrastructure and communications, and the only companies that is able to access such a diverse platform
our chemistry group can ramp up or down based on the need of of hit-finding technologies. In addi- tion to this, we have a strong
a project. Between our two sites in India, Bangalore and Noida, molecular modeling department that can use virtual screening
we have about 900 people in discov- ery chemistry, biology and methodology also to screen targets for new hits. Our investment in
pre-clinical aspects, with an additional 450 in the translational and our technologies plus our people and track record is part of what
clinical development space. This type of synergy and ability of differentiates us from our competitors.
people with access to technology and platforms makes us more
efficient and differentiated for scale and success.
RC: The risk-sharing model is a relatively new phenom-
MA: There are three areas where Evotec is truly differentiated enon, and it’s difficult to say whether or not this model will be
from other companies in our space: track record, people, and our any more financially or scientifically successful than previ-
platform and technologies. In terms of track record, we know what ous models.
it takes to progress com- pounds into the clinic. For example, we What metrics do you use to monitor the progress of a
are currently running five clinical programs within the CNS space. program so that the client feels their investment is
Outside of that, we’ve taken over 10 compounds into the clinic for worthwhile?
our clients. So we know what it takes to be able to push targets,
push compounds from the target into the clinic.
SM: We built a governance process that involves a more cre-
ative management of the portfolio rather than strictly following
Secondly, people. We have strong expertise in biology and
everything “by the book.” We have a three-tiered structure that
chemistry. We became one of the first CROs in the space to truly
is involved in almost every partnership we have. First tier is the
integrate chemistry and biology when Evotec acquired Oxford
management-level team that meets once every six months to
Asymmetry in 2000. Our scien- tists have experience of taking
understand the collaboration and its impact on the portfolio. It’s a
compounds into the clinic either at Evotec or at pharmaceutical
very objective approach, and all of our partners have also been
companies and in various therapeutic areas. We also recognize
very objective in approaching this. The metrics at the manage-
the need of the industry to access more cost-efficient solutions,
ment level is the impact on the portfolio, which could be defined
so we have a joint venture in India with a company called RSIL,
in multiple ways. What is the most cost-effective and scientifically
where we do all of our parallel synthesis activities. This gives us a
driven portfolio that you can achieve that could be defined by the
unique position of being able to offer to our collaborators a com-
number of candidates you deliver to the portfolio per year? The
bination of experienced drug hunters and access to cost-efficient
approach on this is primarily driven by the fact that we are not
resources.
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competing in the CRO space. been used, but it is more dependent on meeting the objectives of
When we take on any of these collaborations, we look at the the critical success factors and the timeline. The approach here
target or the therapeutic area competing in the global marketplace is also defined by the fact that some of the collaborators are very
that our part- ner would compete with. The management commit- particular about the quality of the science, information, inter- pre- 7
tee would look objectively at the quality of the science relative to tation and judgment capabilities. The raw data is uploaded and
drug discovery
the therapeutic area and the productivity, resulting in a number the interpretation is always discussed to identify and measure the
of candidates impacting the portfolio. We recognize the fact that quality of the people and the science as it is within Jubilant.
attrition can also occur by way of decisions made in our partner’s
portfolio, despite the fact that we reach and meet all of the critical RC: Let’s focus on just the senior level assessment of
success factors. The management group defines and manages decision-making. What are the criteria used to decide if a
the expectations around the quality of science, as well as the particular program isn’t making progress?
impact on the portfolio financially.
The second tier is the scientific steering team that focuses on MA :The focus is very much on quality rather than quantity, and
developing the scientific strategy and leveraging the strengths we don’t work in isolation — everything is done in collaboration
and capabilities within the collaboration. This group also governs with the customer. When we’re looking at the progress of a target,
any of the potential conflicts, issues and variations to the science we’ll review the program in terms of pre-agreed timelines — that
as it develops, and defines the progres- sion of each stage of is, timelines that we set at the beginning of a program. We jointly
any portfolio at any given point. This team meets once per month agree with our collaborators what are the expected timelines to
(mostly via teleconferences), typically for a two-hour review. The the various value inflection points, be they lead optimization, dem-
third is the project team, which executes the projects specific to onstration of in vivo proof of concept or pre-clinical development.
the operational level of the scientific activities that include re- We set expectations, regularly review progress against those, and
sourcing and logistics. This would be managed by the owner of we can clearly see if it’s taking longer than we thought or is ahead
the project at both ends. Of late, the collaborators are building in of schedule.
dedicated teams to manage this process at their end. This project We’ll look at what the key criteria are that we want to achieve
team works closely with the collaborator and produces a combina- throughout a program. If we’re aiming for a pre-clinical develop-
tion of weekly or biweekly reports. There are project meetings that ment candidate, we’ll look at what the therapeutic area is and
take place weekly, and sometimes fortnightly, but typically on an what we want the candidate to look like — for example, its efficacy
as-needed basis as agreed between the project teams. There are or its pharmacodynamic profile. We’ll track criteria against a traffic
different productivity metrics, but ultimately the effectiveness of light system so we can review the progress regularly and clearly
the portfolio determines it. In addition to scientific reports, we have see if we’re addressing the key criteria. We encourage our col-
a transparent approach to providing the number of FTEs that have laborators not to be shy about terminating ineffective programs.
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8. whitepapers
8 That is a strength that we bring to the table: being able to kill
“AND AT PFIZER WE
things quickly is sometimes far better than expending resources
on something that is not going anywhere. Having an objective out-
drug discovery
look, setting goals and timelines, and identifying key asset criteria
for the programs provide a clear focus for the collaboration. LOOK AT TWO MAJOR
BF: We heavily rely on structured collaboration — setting ex-
pectations at the onset and drafting an appropriate research plan
that has the governance of critical success factors. We also have
CLASSES OF TAR-
a flat management structure, so the scientific-portfolio manager
is a stakeholder. He or she reports directly to senior manage-
GETS... CREDENTIALED
ment and is intimately involved with everything that is going on
in the project. We typically sit down with our clients face-to-face
TARGETS AND TARGETS
while creating this workspace and understand the communication
portals and reporting criteria. This allows us to set those expecta- WITHOUT CLINICAL
tions at the onset, so we can critique the process, whether it be
on a weekly, bimonthly or a quar- terly basis, depending on the PROOF-OF- CONCEPT.”
client’s needs. We like to have governance with the joint steering
committee and input from the client, because discovery has to be
a dynamic process. There may be publications or patent filings
— Rick Connell
dur- ing the course of our anticipated collaborations, and we may
have to adjust what we’re doing to reassign resources. Keeping
these processes “flat” and maintaining direct communication with
our partners is key to making profits as transparent as possible,
and helping us understand exactly what the cli- ent needs and
when they need it.
RC: Let’s look into the risk-sharing world of hits to leads
and leads to candidates. If you were a client looking to as- Schering, and Nerviano Medical Science, to name a few. Those
sess the marketplace, what information would you seek from organizations can work on development and we can do the heavy
a service provider that would help inform this decision? lifting for their success. This is a small environment, and nothing
MA: Ultimately, you want to be sure and confident in whom you travels faster than bad news. Focusing on particular target areas
are placing your money with. If I were a client, I would want to see — like CNS, oncology, anti-infective and metabolic — presents
what programs run within the service provider so that I could un- our company in the best light.
derstand how the company has progressed the programs to vari- SM: I would look to the partner who would be aligned to both the
ous decision-gates or critical success factors. Chemistry is easy strategic and operational objectives, including alignment to the
to evaluate alone, but what is the turnaround time of chemistry to market strategy. It’s important because this sort of relationship
biology? Clients want a rapid turnaround of compounds made and does not have any short- cuts or easy exit options once you get
tested, and to be able to understand a company’s experience in into this. Even to demonstrate the first experiment is a potential
evaluating SAR (structure-activity-relationship) data, ADMET data, three-year curve where attrition has to play out in the sponsor’s
and the PK profile of a compound or series of compounds. I would favor, not to mention enabling the provider and the partner at the
want to know the level of experience of their chemists or biologists other end. It’s important to align from a strategic, scientific and
in interpreting such data. Can this experience be demonstrated? operational perspective, and be flexible. The partner should have
I would also want to know what the main challenges are for flexibility to absorb technology, branch out and take risk as ap-
them and how they are going to overcome them. All companies propriate. Therefore, alignment to the strategy, scientific, business
have an Achilles’ heel — areas that are not as strong as others and operational goals is extraordinarily important.
— but the key is how they make progress with their strengths and Secondly, this is a very risky environment. You need to have high-
weaknesses. In some cases, it’s not realistic to try to cover as quality people with a mix of experience, particularly with the ability
many therapeutic areas as possible. Companies have to be brave to make judg- ments beyond lead generation. Strategic, functional
and declare what their area of expertise is, and where they have and operational lead- ership are all important parts of how you
more or less experience. I would want to place my bet with a com- would identify the company.
pany that has the experience in a relevant, specific therapeutic Lastly, you need to look at the partners’ ability not to conflict
area and that has demonstrated success in carrying out integrated with your goals. In this space, you’re not looking at two compatible
chemistry and biology projects in the past. CROs try- ing to compete for efficiency; you are actually creating
BF: Drug discovery is an experiential art form, so I would look at a portfolio that would compete in the marketplace with equal com-
what those companies have done recently, and who they’ve done panies. Therefore, the partners should be devoid of any potential
business with. For example, ChemDiv has announced collabo- conflict in pursuing these tar- gets or relationships. These are the
rations with Schering Plough, Merck, Eli Lilly, Genentec, Bayer three things I would look at if I were to pick a partner in the space.
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