12PePersonalization

Find your missing element with
Thermo Fisher Scientific.

Quick to careprogramTM

Learn how we can support your drug development journey
through to delivery.

Mike Pearson
Staff Program Manager,
Pharma Services,Bend, OR

How leveraging a global network delivered big results
Mike’s team in Bend, OR was only supposed to optimize the spray drying process for a particular medication while
another, much larger, facility would handle the large-scale manufacturing. However, the other facility’s equipment wouldn’t
be available in time to meet the client’s aggressive IND filing schedule. It was time to leverage the power of the Thermo
Fisher Scientific global network and Quick to CareTM program to offer the client their best chance at success. Throughincredible effort and intensely coordinated activities, the team in Bend delivered an order nearly double in magnitude
compared to typical projects before transferring the product to other Thermo Fisher sites to test, fill, and deliver topatients. Despite the change in plans, the right team stepped in to ensure all deadlines were met, and the client got a
critical medicine to the patients who needed it most.

2

Streamlining supply chain andaccelerating development
In 2022, the average cost to develop an asset was $2,3B,
an increase of $298 million from 2021. The number ofterminated assets doubled, from 15 in 2021 to 30 in 2022,
including six that were forecasted to be “blockbuster”
assets. The average cycle times — the time it takes for a
new drug to progress from starting clinical trials to approval— increased to 7.09 years in 2022 from 6.9 years in 2021,
the second longest average cycle time since the study
began.¹ A single vendor solution that streamlines the supply
chain and accelerates the development timeline is criticalto ensuring that these new medicines are brought to market
on time. Coordinating with multiple vendors requires
additional time, resources, and expertise to manage
the various projects and timelines associated with drug
development. This often leads to delays in development
and miscommunication between vendors.
In 2015, Thermo Fisher Scientific introduced our Quickto Care™ program, the industry’s first-of-its-kind, endto-end, integrated, and customizable solution covering
all development phases. The program streamlines andaccelerates your discovery by combining drug substance anddrug product development, clinical trials supply solutions
including packaging, labeling, storage and distribution,regulatory services, transportation management, andcommercial manufacturing and packaging.
In 2021, with the acquisition of PPD, a leading provider ofclinical research services to the biopharma and pharma
industry, Thermo Fisher added clinical research services tothe Quick to Care™ program.
This addition expanded its comprehensive suite of services
across the clinical development specturm, and enabled
portfolio management from early development throughclinical research and to commercialization.

Quick to Care™ program — comprehensive, flexible, integrated solution
Start here, stay here
Pre-IND

Phase I

Phase II

Phase III

Commercial

Clinical supply optimization
Drug substance (small and large molecule and viral vectors)
Drug product (OSD, softgel, and sterile injectables)
Clinical research (PPD)
Clinical packaging and labeling
Clinical supply distribution
Regulatory services
Total transportation management (TTM)
Commercial packaging“Thermo Fisher Scientific has the right expertise, great team, and flexibility to meetcostumers’ needs.”— Biotechnology company focused on cancer medicines, USA3

Meeting our customers’ drug development andclinical service needs
With a complex drug development path, many challenges
can occur in the form of detours and roadblocks, leading
to unexpected disruptions, missed milestones, anddelayed timelines. We understand these challenges andour dedicated global team of experts can provide youwith the experience and guidance needed to develop aprogram designed to find synergies to save time and get
you to commercial success, faster. Our solution to thesechallenges is the Quick to Care™ program, which integratesour broad, industry-leading capabilities into a single solutionthat is tailored to the needs of your program and covers all
development phases and commercial manufacturing.

Tailored solutions just for you
Whether your goal is out-licensing at Phase IIb or taking
your molecule to full commercialization, it requires
a dedicated, trusted, and experienced partner that
understands your complex program needs. Our team ofglobal experts provides unified program management,scientific and technical insight, and reduces redundancies
to ensure success in your drug development journey. By
partnering with us, you’re able to create and customize
your own flexible integrated offering based on your specificneeds, all while working alongside our team of experts tofind a solution tailored just for you. We take a patient-centric
approach and offer customizable solutions that include:

Keybenefits
Key Benefits
Simplicity
ü Streamlined processes and communications, activelycoordinated by a global program manager
ü Single MSA and harmonized quality agreements
ü Consolidated invoicing

Supply chain
optimization

Regulatory
services

Cold chain
storage

Clinical Su

Viral Vecto& Manufac

Clinical trials
manufacturingEfficiency
ü Integrated timelines, enabling savings
ü Cross-site collaboration
ü Elimination of duplicative workr
Reduced Risk
and improved scalability
ü Collaborative expertise across network to proactively
identify and solve issues before they ariseü Integrated global networks to support commercial
scale standards and volumes

Transportation
management

Patient-centric
Patient-Centric
focus
Focus

Drug Subs& Manufac

Drug Produ& Manufac

Clinical Tria& Labeling

Analyticaltesting

Clinical Ma& Logistics

Transporta

Distributionand logistics

Commercia& Packagin

Packaging, labeling,
comparator sourcing4Benefits of partnering with us
We understand the unique needs of small companies—
more than 78% of our clients are emerging and mid-size
pharma/biopharma organizations. The Quick to Care™
program was designed with you in mind, and combines
world-class drug substance, drug product, and clinicalsupply development and manufacturing services into asingle, customizable, integrated program for your molecule,and further reduces the amount of effort you put into
managing the supply chain. Benefits include:• Simplification• Time savings• Reduced risk
The program provides a customizable solution designedto fit your journey. Our single vendor solution integrates
drug substance and drug product development, clinicalmanufacturing, clinical supply forecasting, demand planning,and clinical trial supply services—all of which are designed
to accelerate your discovery. We provide you with access toa vast global network of scientific experts and technicians
as well as a dedicated program manager assigned to yourproject, all united by with one shared commitment to yourdrug development success. This connected and accessible
team brings deep experience in their specialties to solve
your challenges faster—all while simplifying and accelerating
the development of your molecule into commercial
manufacturing.

experience guiding new and emerging clients through eachphase of drug development has resulted in time and costsavings.Our integrated network of technical, quality, andcustomer engagement teams are ready to support your drug
development journey. The Patheon pharma services networkhas 60+ sites across five continents and employs ~3,000
scientists, technicians, and engineers with deep technicalexpertise, plus ~3,700 quality professionals, all working
together to ensure the success of your molecule. Wecurrently offer manufacturing locations in the United States,
Europe, and Australia, which provides you with simplified
logistics and R&D tax advantages.
We offer a broad range of solutions that include:• Clinical labeling services• Demand planning and supply optimization• Clinical trial packaging and storage• Cold chain storage and logistics• Distribution and logistics• Clinical ancillary management“ For a small company, having atechnically competent,
customer- focused team supporting us
is critical to our success ”— Pharmaceutical company focused on
women’s health, USA

Delivering global excellence
Our client-focused mindset and global expertise combine toprovide a best-in-class, integrated offering to position yourmolecule for greater therapeutic and financial success. Our5

Integrated global network of technical, quality, and customer engagement teams to support yourdrug development journey• API• Biologics• Viral vector• Plasmids• Drug product manufacturing• Clinical trials supply• Specialty distribution centers~18,000
colleagues in 60+ sites~3,000scientists, technicians,and engineers with deep
technical expertise~3,700quality specialists

6Accelerating development timelines
The path through drug development is marked bydetours, roadblocks, and very few shortcuts. Unexpected
delays can lead to missed milestones, rework, anddelayed timelines — all setbacks that no one wants to
explain to their investors. Working with multiple vendors
means that there are varying levels of hand-offs involved
between vendors, which can lead to operational silos,

workflow and process inefficiencies, and productknowledge gaps, as well as potential timeline delays and“whitespace.”
By partnering with one single vendor, the Quick to Care™
program enables you to accelerate your time to market.

“Thermo Fisher Scientific provides exceptional speed and responsiveness”— Biotechnology company focused on oncology, USA7

Dedicated project management
The Quick to Care™ program begins with a dedicatedprogram manager who is assigned to your program fromthe outset. The program manager is the integrator thatpulls together our broad, industry-leading capabilities
into a single, integrated solution. They are responsible forreaching across our extensive network to pull together ateam of technical experts to focus on your program. Your
program manager is your advocate who establishes andmanages the governance process.
Our experienced and dedicated global program managers
have the knowledge necessary to provide clients with aproactive, timely, and seamless approach to position yourmolecule for greater therapeutic and financial success.
We provide a global network integrated by program
managers to deliver coordination, commitment, andaccountability across the entire supply chain. Our
managers are the human connector that integrates thesites and capabilities into a single network, by having:• A “one team” approach• Harmonized global practices and procedures• Decreased administrative tasks• Streamlined and focused communications• Integrated governance model• Proactive risk mitigation and clear escalation
pathway• Access to global leadership and executive
sponsors

Single, comprehensive, integrated plan enabled by communication and coordination

Global network:
Expertise and capabilities• Involved from concept
to delivery• Leveraged across
supply chain

Key client contact

Governance• Client advocate
integrating andcoordinating overall
program• Global framework tomake decisions andescalate issues• Network of technicalexperts solving
your challenges

Global communication• Communicationand visibility acrossnetwork provides
complete viewof program• Positioned toidentify and respondto obstacles“The Thermo Fisher Scientific team always delivers quality results rapidly.”— Biotechnology company focused on innovative therapeutics, USA

8

Shaping outcomes
From drug development to commercial manufacturing,packaging, labeling, distribution, and clinical trials,
the Quick to Care™ program is a premier integrated
offering solution that is comprehensive and flexible. The
biopharmaceutical industry’s new business model that

Case study

focuses on the unmet needs of smaller patient populations
has diversified today’s pipelines and brought new hope topatient care. By offering multiple services in one solution,
the program gives you an opportunity to improve efficiency
in delivery and, as a result, bring drugs to patients faster.

How Quick to Care™ program accelerated the delivery of a breakthrough
COVID-19 treatment to patients in less than 12 months

Summary: A large, multi-national company, with a potential breakthrough treatment for COVID-19, needed to partnerwith a CDMO with the capacity and expertise to meet their current drug development needs, and the ability to significantly
scale up operations, in a short timeframe.
Challenge:• Support drug development needs of potential breakthrough COVID-19 treatment in capsule format• Transfer process and scale up drug substance at one site, and drug product at two sites• Produce 20+ metric tons of drug substance and manufacture >200 million capsules in 12 months• Once EUA granted, supply product to US, EU, China, and Japan
Solution:
Quick to Care™ program with dedicated overall program management and coordinated efforts across network,established governance systems, and clear visibility into end-to-end processes
Strategic coordination of production materials:
Pooled materials requirements across both drug product sites
Leveraged purchasing power with suppliers through global procurement teamUpfront commitment to production slots of critical materials
Technical expertise addressed scale-up challenges with drug substance
Results:
52-week lead time for critical material avoided with purchasing power and upfront purchasing commitment
Drug product raw materials were on hand at start of manufacturing campaign at both sites
Drug substance and drug product processes scaled up, and drug product produced at both locations in under 11months
Potential breakthrough treatment for COVID-19 became a reality

9Our proven track record of quality, reliability, and expertise can support yourdrug development journey

109 NDA
approvals,
3X moreEmerging and mid-size biotechs

85%

of our customers in 2022

Active Q2C studies in 2022

34
Phase I projects

29

25

than our closest competitor3

Phase II projects Phase III projects

2Commercial
Thermo Fisher Scientific is your global partner of choice for
an integrated solution to streamline your drug development
program. We understand the complex journey ahead and areexperienced in working with new and emerging clients. In
2022, 85% of our customers were from emerging and midsize biotech companies. We had 90 active Quick to Care™
programs, including 34 Phase I projects, 29 Phase II projects,
25 Phase III projects and two commercial projects. From 2013
to 2022, Thermo Fisher received more NDA/BLA approvals
than the next two CMOs combined.²

With our breadth of experience, vast access to scientificexperts, and a global integrated network, we can provideyou with a customizable solution that works to reduce
your development timeline. We apply a science-driven,risk-based approach to every step of the development
and manufacturing process. Our harmonized quality
processes combined with our logistics experts across ourextensive global footprint ensures your discovery makes
it to the patients who need it most. We have one sharedcommitment—your drug development success.

1

Deloitte Centre for Health Solutions - Seize the digital momentum, measuring the return from pharmaceutical innovation
2022

2

PharmSource, A GlobalData Product, Trend Report – New Drug Approvals and Their Contract Manufacture – 2023 Edition

3GlobalData Pharma Intelligence Center, New Drug Approvals and Their Contract Manufacture - 2023 Edition10

+1 919 226 3200 • thermofisher.com/patheon • pharmaservices@thermofisher.com
Published 01/24 © 2024 Thermo Fisher Scientific Inc. All rights reserved.