Product development in health sciences is complex and costly. It can take many years to gain marketing approval for a new drug, device or diagnostic. And while there are many potential potholes along the development highway, there are also numerous opportunities to accelerate development and create benefits for all stakeholders. The Molecule Development Team (MDT) construct at Covance is specifically designed for these tasks! Indeed, programmatic outsourcing to our team can create substantial savings for asset/portfolio development with up to 30% savings in time and/or cost. In this white paper we discuss many of the advantages of programmatic outsourcing to a Covance Molecule Development Team - advantages described not only in terms of time but also in terms of a refined management of burn rate.

1. Creating Value – Compressing
Time – Refining Burn Rate
Forecasts: The Molecule
Development Team (MDT)
Product development in health sciences is complex and
costly. It can take many years to gain marketing approval
for a new drug, device or diagnostic. And while there are
many potential potholes along the development highway,
there are also numerous opportunities to accelerate
development and create benefits for all stakeholders.
The Molecule Development Team (MDT) construct
at Covance is specifically designed for these tasks!
Indeed, programmatic outsourcing to our team can create
substantial savings for asset/portfolio development with
up to 30% savings in time and/or cost. In this white paper
we discuss many of the advantages of programmatic
outsourcing to a Covance Molecule Development Team –
advantages described not only in terms of time but also
in terms of a refined management of burn rate.
Flexibility in the Development
Team Model
Today more than one-half of development activities are
outsourced. This includes nonclinical and clinical studies
and encompasses all therapeutic areas. Furthermore,
clinical studies are becoming more complex and often
incorporate cutting -edge technology – requiring
specialized expertise – all factors contributing to the
increasing cost of drug development. Indeed, the need
for integrating development strategy, specialized trial
execution and quality, has never been higher. Analysis
suggests this trend will continue to grow substantially
through 2025 and beyond. However, the traditional
model of contracting one single-study at a time, as has
been the practice for the last 30 years, is inefficient. For
example, the typical single study outsourcing model
requires transfer of knowledge from sponsor to CRO,
quick scientific learning by the CRO, de novo development
of documents, tools and databases, training of staff and
investigator sites plus many other activities. In essence,
single-study outsourcing causes delays (or white spaces)
between the phases of development. Unfortunately, during
white space periods, when additional studies are being
contracted and discussed, the patent clock continues to
tick – and as we all know, patents don’t get better with age! One goal of the MDT programmatic construct
is, therefore, to remove multiple transactional steps involved in the single-study outsourcing model. With
programmatic outsourcing, transactional activities become centralized across multiple studies and value
inflection points. In essence, the MDT construct reduces white space between development phases, allows
COVANCE:
MDT CONSTRUCT
The Core MDT is a permanent
group of subject matter experts
(SMEs). The Core MDT draws
upon additional SMEs from across
Covance/LabCorp as warranted
(the Extended MDT). This dynamic
MDT design enables the sponsor
to bring in SMEs during the
different phases of development
without having to dramatically
increase in-house head count. The
MDT approach is flexible and can
accommodate entire programs or
specific phases (e.g., Preclinical to
clinical Proof of Concept [PoC®
]
and exit).
SPONSOR
CONSULTANTS/
KOLs
CORE
MDT COVANCE
Extensive
facilities/expertise
of global CRO

2. for rapid course adjustments and keeps the project
on track and on budget.
Programmatic outsourcing via an MDT is a simple
concept that can create value and, if conducted by
experienced drug development experts, compresses
time to create value. While the value of subject
matter experts (SMEs) is easily understandable,
an arguably more important element is trust.
Generating trust at an early stage of engagement is
at the heart of a successful high-performing MDT.
With the operational imperative of building trust
quickly, a small dedicated Core MDT is initially
formed between the sponsor and Covance, and
multiple early engagements are utilized. With
trust we also ensure continuity – the Core MDT
stays with the molecule throughout development.
Whether the plan is to take the product through
to marketing approval and launch, or to seek an
exit strategy at the end of Phase 2, the Core MDT
team stays with the program. The continuity of the Core MDT is not only critical for ensuring the integration
of business and scientific goals, but also crucial for strategic and operational decisions to reduce white space
between phases of development. The MDT model also allows a more efficient use of capital by the sponsor
since there are multiple efficiencies with programmatic outsourcing compared to single-study transactions.
Furthermore, Covance is particularly suited to programmatic outsourcing since we are the only contract drug
development company to cover the entire development process with SMEs in discovery, nonclinical and clinical
testing, central laboratory, marketing approvals and post-licensure activities.
Of course, while membership of the Core MDT remains constant, different stages of the program will require
different types of expertise. For example, for an emerging company seeking funding, the skills brought to bear
by the MDT will be vastly different than the skills required to construct a comprehensive clinical development
plan designed to take the product through to marketing. These differences in the make-up of the MDT will also
be reflected in the costing structure at the various stages of development. So while the Core MDT remains with
the program throughout the lifetime of the asset, there will be periods where additional SMEs must be brought
into the various stages of development. These additional SMEs form the Extended MDT. And while these
Extended MDT members are important to maximize the probability of success, they are not required throughout
the project – an important consideration for controlling costs and managing headcount.
One size does not fit all!
The MDT mantra must be flexibility. Flexibility in structure, functional operation and financial models.
Consequently, it would be foolhardy to try to pair all development scenarios with the advantages of the
MDT. However, there are common generalities for programmatic outsourcing:
Substantial savings to asset/portfolio development costs through decreased cycle times, exceeding
milestone delivery with up to 30% savings in time/cost
Earlier engagement and proactive planning eliminates “white space” and ensures timely resources
Fixed costs more manageable for the sponsor across time points to better predict for asset/portfolio
execution through consolidation and simplified contracting/invoicing
De-risking programs through collaboration with SMEs in multiple scientific disciplines without
increasing headcount
Simplified integration of business and scientific goals during development

3. Flexibility in the Financial Model
Combining strategy and execution effectively
is not an easy task in product development.
The high-performing MDT can coordinate
this process and ensure changes in the
development plan are decided in a rational
manner and executed efficiently to keep the
program on target – or if possible, ahead
of target. Development plans are dynamic
and change over time as new information
becomes available. The MDT approach
is focused on problem solving to flexibly
exploit the changing development landscape.
Similarly, financial models to fund the MDT
must have strong elements of flexibility that
both reward for success and penalize for less than acceptable outcomes. There are many ways to structure
financial models for programmatic outsourcing, but most will likely hinge on continuity and value
inflection points. For example:
Continuity of the program through the MDT leads to the greatest flexibility and opportunity for risk
sharing. As the program progresses various costs can be “credited back” to the sponsor. In other words,
the assessment of costs can be based on a financial model utilizing a sliding scale. This type of model
creates greater benefit to the sponsor and Covance since both benefit from financial projections that
enable certainty over time.
Tie risk/reward to the most time-sensitive activity for each phase of development: (e.g., end of Phase 2
PoC study)
– Agreed date with a confidence range
– Exceed the upper confidence – bonus
– Fail to achieve the lower confidence level – penalty
Make an overall primary reward/penalty associated with the agreed upon major value inflection point
(e.g., Market Authorization Application (MAA) submission date)
– Achieve the date – reward
– Achieve the milestone ahead of time – bonus
– Fail to achieve the milestone date – penalty
Final Analysis
In terms of functionality, the MDT must have all the characteristics of
all high-performing teams: the members must have a clear vision of
where they are headed and what they want to accomplish – they must be a
group of people who share a common vision, goals, and who collaborate,
challenge, trust and hold each other accountable to achieve outstanding
results. The additional attribute for high-performing product development
teams in the health sciences is that they must be experienced in highly
specialized business and scientific disciplines. Covance is the only contract
development company that covers the entire spectrum of development from
early nonclinical activities through to clinical trials, registration and post
marketing activities. With skilled MDTs and flexible financial models, we
have the experience to combine strategic intent with operational excellence.
With our programmatic approach, Covance can provide an enterprise-
wide solution to reduce the white space between phases of development,
accelerate the program and help you reach your desired positive value
inflection point quickly.
Value Inflection Points During Development
An MDT can be constructed to cover the
entire development spectrum or through
well-defined value inflection points
during development (e.g., preclinical
through clinical PoC).
Creative financial models are available
to maximize the advantages of
programmatic outsourcing. The overall
goal is to reduce time, create value and
improve projections of burn rate.

4. Learn more at www.covance.com
Covance is the drug, medical device and diagnostics business segment of LabCorp, a leading
global life sciences company. COVANCE is a registered trademark and the marketing name
for Covance Inc. and its subsidiaries around the world.
The Americas + 1.888.COVANCE (+1.888.268.2623) + 1.609.452.4440
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