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BRIDGING BRIDGING BRIDGING THE RESOURCE GAP IN DRUG DEVELOPMENT DRUG DEVELOPMENT DRUG DEVELOPMENT 4 Ways Biotech Firms Can Keep Pace With Big Pharma - Even On A Startup Budget WHITE PAPER

BRIDGING · 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

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Page 1: BRIDGING · 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

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

Page 2: BRIDGING · 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

2

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

2

Page 3: BRIDGING · 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

available for emaildelivery in minutes

34%

available forimmediate download

58%

scanned from printusually within 24 hours

8%

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

Page 4: BRIDGING · 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

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.

Page 5: BRIDGING · 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

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

Page 6: BRIDGING · 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

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

Page 7: BRIDGING · 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

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.

© 2020 Research Solutions, Inc. All Rights Reserved.