bridging · to an inherent resource gap, however, biotech firms are at a disadvantage right from...
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BRIDGINGBRIDGINGBRIDGINGTHE RESOURCE GAP IN
DRUG DEVELOPMENTDRUG DEVELOPMENTDRUG DEVELOPMENT
4 Ways Biotech Firms Can Keep Pace With Big Pharma - Even On A Startup Budget
WHITE PAPER
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Biotechnology firms
and pharmaceutical
companies alike are
under pressure to develop
new drugs, diagnostics, and
medical devices faster and
faster. Because in the fiercely
competitive drug development
landscape, being first to
market is a top priority.
In an industry where it takes an
average 10-12 years to bring a new
drug to market—with the average
cost per asset hovering around
$2 billion—companies must find
ways to improve efficiencies. Due
to an inherent resource gap,
however, biotech firms are at a
disadvantage right from the start.
Big pharma corporations and
academic institutions have
staff dedicated to helping
researchers and scientists
acquire and manage the
information they need to
focus on scientific research
and development.
On the other hand, even with
increasing financial firepower,
biotech firms are often pressed for
resources due to their small staff
sizes and constrained R&D budgets.
Many small-and medium-sized
enterprises (SMEs) don’t have a
dedicated librarian on staff, much
less a full information management
team. As such, each scientist must
wear many hats.
Those duties that a librarian
would typically handle—such as
facilitating literature acquisition
and management; keeping up with
expanding regulatory requirements;
and navigating reimbursement
hurdles—are instead
handled ad-hoc by the scientists
themselves, depending on who has
the most capacity or greatest needs.
The added burden on scientists slows
down progress.
When a study gets off to a slow
start, the challenges for SMEs will
only continue to build through the
clinical phases and regulatory filing.
It’s a vicious cycle: the longer a study
takes, the more costly it becomes,
which in turn puts an even bigger
strain on the company’s limited
resources and capital.
SMEs that focus on improving efficiency at the earliest stages of discovery—to
identify the best path and minimize wrong turns—can overcome the obstacles
created by their resource deficits. In this white paper, we’ll share four tactics
organizations should consider as they seek new ways to minimize R&D costs,
speed development, and improve research outcomes.
WAYS TO EXTEND THE VALUE OF YOUR R&D SPEND
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Automated TOC alerts combined with intelligent sharing and collaboration can
make the difference for smaller R&D teams. Reprints Desk customer Genomind
set up 80 separate bibliographies in a shared library hub, each for a different
gene or product, preventing duplicate orders and enabling researchers to share
copyright-compliant content.
A new research paper is published
every 4 minutes, adding to an
estimated 50 million papers already
online. The fastest, easiest way to
comb through published research,
without reallocating staff time and
resources? Take advantage of modern
technology to automate repetitive,
time-consuming tasks. To get a head
start on your study right out of the
gate, focus on automating tasks
throughout your literature acquisition
workflow—from search and access
to compliance and invoicing. There
are a growing number of research
platforms and freestanding tools to
help you save time and money. But
many are designed to meet the needs
of large enterprises or academic
groups—with a broad scope of tools
and services. When picking a solution,
it’s important to weigh both the
upfront costs and the return on your
investment in terms of time savings,
convenience, and actual dollars
saved. To minimize your costs, select
a solution that meets the immediate
needs of your firm. You can always
upgrade as your company grows or
your needs change.
� Speed Article Access: Use
seamless document access that
integrates with publisher websites
and preferred discovery portals,
enabling users to order journal
articles on demand, directly from
their search results.
� Facilitate Direct Content
Awareness: Use notification
tools—like topic-specific alerts
and journal table-of-contents
(TOC) feeds—to stay up to date
with newly published research.
� Minimize Acquisition Costs: Use
advanced search filters to obtain
articles at the lowest legal cost
(including Open Access and any
existing holdings or subscriptions).
� Simplify Compliance: Use a
document retrieval solution that
automatically ensures you acquire
the copyright-compliant version
for your intended use.
� Consolidate Invoicing: Take
advantage of monthly billing
or annual subscription options
to control costs and alleviate
the need for time consuming
individual invoices.
� Stay Organized: Many
multipurpose research platforms
include a reference manager.
Make sure you’re getting the
tools that will help most with
your firms’ needs (e.g. advanced
citation management; sharing
and collaboration).
Tips for Automating Literature Search and Acquisition
LITERATURE ACQUISITION TASKS
3
Customer Use Case
� Read Full Case Study
Response Times for On-Demand Article Delivery
Source: Reprints Desk
Return on investment (ROI) is an
important metric for all businesses,
across all industries. But for small and
medium-sized biotech companies
with limited resources, optimizing ROI
must always be top of mind. That goes
for literature acquisition investments,
too. Whether you’re subscribed to
a few scientific journals or more,
auditing your per-article spend and
your holdings will ensure you get top
value from your subscriptions.
Advanced analytics tools make
running an audit quite simple. Via
usage data and reporting, you can
quickly see which subscriptions are in
high demand within your organization.
Armed with this personalized, up-
to-date ROI information, you can
easily identify which scientific content
matters most to your organization’s
researchers, and prioritize accordingly.
On-demand document retrieval
complements your journal
subscriptions and can help you
optimize their value. Automated
duplicate prevention, for example,
streamlines workflows via direct link
outs to an article already included in
your subscription—thereby eliminating
unnecessary individual purchases. In
some circumstances, you may want to
see if there’s a rental option available.
Renting can be useful, for example, if
you want to assess a paper’s relevance
for regulatory submissions before
you make a purchase. If you decide
to buy the article, your rental fees will
typically be applied to the final price.
To further minimize your per-article
spending, keep an eye out for any
publisher programs, partnerships,
or special offers aimed at making
research more accessible to individual
scientists and SMEs.
4
LITERATURE ACQUISITION SPEND OPTIMIZEOPTIMIZEOPTIMIZE
� Sign Up Here
There are a lot of changes going on
in the publishing industry surrounding
Open Access and affordability, and
many publishers are looking for ways
to help even the playing field.
In 2019, for example, the world’s
second-largest publisher, Springer
Nature, launched an article-sharing
pilot project, making articles from 23
of its Nature journals freely accessible
to scientists via ResearchGate.
This year, Springer Nature
announced another pilot program:
Through an agreement with Research
Solutions, companies with up to
100 R&D staff can sign up for Article
Galaxy+, an exclusive subscription
deal for SMEs that includes Springer
Nature’s full collection of journals and
ebooks.
On-demand document retrieval complements your
journal subscriptions and can help you
optimize their value.
Article Galaxy+
One-Click Document
Retrieval with Access to
Content.
2019 2025 (expected)
$302m
2018
$2453m
$463m
Traditional R&D processes associated
with discovery and testing are
evolving. Increasingly, companies are
employing artificial intelligence (AI) to
improve efficiency in various facets of
the drug discovery process, such as
drug repurposing, clinical trial design,
and safety prediction. Within the
United States, the AI spend in pharma
and healthcare increased by 76.6% to
$302 million in 2018 and will continue
to grow at a high compound annual
growth rate (CAGR) of 26.9%.
Although we are still just beginning
to scratch the surface on the promise
of AI for drug development, these
new and emerging technologies are
already helping accelerate discovery
and early stage development.
Pharma is slowly but surely starting
to incorporate the use of machine
learning and big data into many
components of their lifecycle.
In-silico tools and techniques,
for example, can be used to
enhance hypothesis development
and testing, uncover potential
drug development issues,
ADVANCED COMPUTING & AI TECHNOLOGIES
and inform decision-making
about whether to proceed through
to more costly lab studies and
clinical trials. AI technologies are
being used to analyze and interpret
data from previous studies and
published scientific literature to
optimize protocols.
With a growing list of startups
using AI in drug discovery, some
early adopters are already seeing
groundbreaking results. In 2019, for
example, Hong Kong-based startup
Insilico Medicine published research
in Nature Biotechnology showing
that its deep-learning model could
identify promising treatments for
fibrosis in just three weeks. Similarly,
British-based startup Exscientia
teamed up with Japan’s Sumitomo
Dainippon Pharma to accelerate
development using AI algorithms.
In under a year, the companies
developed a clinical
human trial of a
drug treatment
for OCD.
Forecasted AI
Spend in $M
Synthesize Information
� Curate comprehensive
reading lists using keywords
and natural language
� Find hidden connections
from large, diverse datasets
� Transform unstructured clinical
notes into rich, structured data
Repurpose Existing Drugs
� Conduct in-silico screening
prior to experimental screening
� Uncover novel uses for
existing drugs
� Analyze data to find patterns
and non-obvious associations
Develop Novel Drugs
� Build predictive models
� Integrate clinical trial data
with public datasets
� Screen compounds for
multiple properties
Design Clinical Trials
� Increase diagnostic sensitivity
� Model and predict trial success
� Run digital trials end to end
Use Cases for AI in Drug Development
5Source: https://www.researchandmarkets.com/research/prx7rm/artificial?w=4
TRANSLATION GAP THE “VALLEY OF DEATH”
CAPITALIZED COST (US$ MILLIONS)
DURATION (YEARS)
TARGETVALIDATION &
LEAD SELECTIONPRE-CLINICAL
(LEAD) PHASE I PHASE II PHASE III SUBMISSION
314
319
273
674
4.5
2.52.5
1.5
1.0
48
1.5
Over the past decade, thanks to
a rise in venture capital funding,
smaller biotech companies have
become increasingly independent.
Rather than licensing out to their
big pharma counterparts once their
drugs move into Phase 2 or 3 clinical
studies, many SMEs are looking for
ways to maintain control through
later stages of development—or even
all the way to market.
Many biotech companies, however,
do not have the capacity or expertise
to navigate regulatory processes or
efficiently manage production. If
that’s the case with your company,
working with an external partner,
like a contract development and
manufacturing organization (CDMO),
can help take some of the burden
off of your team. A CDMO can
help improve efficiency earlier in
the development cycle, too. Due
to the ‘vicious cycle’ we mentioned
previously, time is not on your
side as an SME. Early stage drug
development—including pre-clinical
studies and the development of
active pharmaceutical ingredients
(APIs)—makes up the bulk of
spending in the drug
development lifecycle.
A CDMO with deep expertise in
these areas can help you accelerate
and enhance API development,
while reducing the daily drain
on your in-house resources. Of
course, not all CDMOs are created
AN EXTERNAL PARTNER
equal. As with any partnership,
finding the right match is critical.
That’s especially true for SMEs,
where a lack of due diligence in
the selection process can lead to
misaligned business objectives and
costly development delays.
Early-stage development makes
up the bulk of R&D spending
Source: https://www.researchgate.net/publication/266969130_Developability_assessment_as_an_early_de-risking_tool_for_biopharmaceutical_development 6
While only 9.6% of drugs that enter
clinical trials are approved by the FDA,
drug development failures account
for 75% of the R&D costs. Companies
that adopt a ‘Fail Fast‘ strategy to
identify dead ends early can avoid
wasting years of time and resources
on late-stage drug failures.
TIP: SAVE MORE BY FAILING FASTER
Research Solutions, Inc. (OTCQB: RSSS) is a pioneer in providing seamless access
to scientific research. Its wholly-owned subsidiary Reprints Desk, Inc., simplifies
how organizations and individual researchers discover, acquire, and manage
scholarly journal articles, book chapters and other content in scientific, technical,
and medical (STM) research. More than 70 percent of the top pharmaceutical
companies, prestigious universities, and emerging businesses rely on Article Galaxy,
Reprints Desk’s cloud-based SaaS research platform, for simplified and lowest cost
access to the latest scientific research and data. Featuring an ecosystem of app-
like Gadgets for a personalized research experience, Article Galaxy offers individual
as well as enterprise plans, coupled with unparalleled, 24/7 customer support.
For more information on
Research Solutions and Reprints Desk,
visit www.researchsolutions.com and
www.reprintsdesk.com.
About Research Solutions and Reprints Desk:
In an industry fraught with massive
R&D costs, low drug approval
rates, and deep-pocketed global
competitors, small- and medium-
sized biotech companies face tough
barriers to success. But for those
who enter into this industry, the
rewards (both in terms of real-world
benefits and bottom-line profitability)
can far outweigh the risks.
To stay competitive,
SMEs must extract top value from
their limited resources.
Companies that find ways to
improve efficiency—especially
during the earliest stages of
development—can drastically
reduce costs, accelerate processes,
and improve clinical outcomes.
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