ORAL SOLIDDOSE FORONCOLOGYACCELERATE THE DELIVERY OF
YOUR LIFE-SAVING THERAPYTABLE OF CONTENTS
4

Streamline your supply chain andaccelerate development

5

Avoid rework and costly delays in early development
by getting your formulation right from the start6

Navigate the complexity of handling andcontaining high-potency compounds

7

Solve solubility and bioavailability challenges
before they become long-term issues

8

Gain access to a broad range of dosage forms
to meet your molecule’s unique needs

8

Accelerate time to phase I clinicaltrials with Quick to Clinic™

9Continuous manufacturing: Reduce API
usage and total cost of supply

9

Optimize your regulatory process

10Technology transfer: Strategic investment
for long-term advantage

10

Commercial packaging provides assurance
and simpler logistics in your supply chain

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Clinical trial solutions: Optimize yourchances for approvalIntroduction
Fifty-eight percent of medications in development today are small molecule drugs, and many of them are earmarked for oncology
drug products. Worldwide, the market demand for oncology products is attributed to regional and environmental factors. Yourability to navigate a complex regulatory environment, handle high-potency materials, overcome bioavailability challenges, andoptimize the supply chain is vital to the success of your oncology drug product. Thermo Fisher Scientific provides a range ofsmall molecule solutions that you can leverage to address your oncology program’s unique needs and challenges, while being
backed by a global network of technical, quality, and customer engagement teams and industry experts.

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Streamline your supply chain and accelerate development
Thermo Fisher Scientific’s small molecule offerings include
robust drug substance, drug product, and clinical trial
supply solutions that enable you to scale your project withspeed and agility under one roof. Our global integrated
network of 65+ sites comprises technical, quality, andcustomer engagement teams with the skills and expertiseto help you resolve complex challenges through every
phase of your small molecule’s lifecycle.

In drug development, working with and coordinating
multiple vendors requires additional time, resources, andexpertise, and often results in delays in development andmiscommunication among vendors. Our Quick to Care™
single-vendor solution streamlines the supply chain andaccelerates the development timeline so that you can bringyour new oncology medication to market safely, quickly,and efficiently.

Integrated global network of technical, quality, and customer engagement teams to support the journeyof your oncology drug product• API• Biologics• Viral vector• Drug product manufacturing• Clinical trial supply• Specialty distribution centers~17,000
colleagues at 65+ sites~3,500experts with deep
knowledge of science,engineering, and technology~3,000quality specialists“Exceptional speed and responsiveness.”—Biotechnology company focused on oncology, USA4

Avoid rework and costly delays in early development bygetting your formulation right from the start
Speed and quality are essential in the development andmanufacture of your cancer-fighting small molecule API.
While you must reach several milestones along the way, you
do not have to navigate this journey alone—Thermo Fisher
offers a full range of services to help you quickly andefficiently bring your oncology project to clinical trial andfurther accelerate your path to commercialization.
Take advantage of the expertise of our world-class chemists
and our state-of-the-art solutions that span all phases ofdevelopment:• Route scouting• Solid-state chemistry and crystallization• Commercial supply manufacturing• Micronization• Physical characterization

Getting your formulation correct in the early development
stage can help you save time and money as your productadvances through each phase and on to commercialization.
Our scientists and experts in early development formulation
are here to support every phase of your oncology program.
Gain access to an integrated drug formulation program forflexible and tailored solutions to:• Evaluate your formulation options• Accelerate your project to first-in-human(FIH) studies• Overcome formulation challenges (e.g.,bioavailability, stability, and solubility)• Gain a clear view of your path through preclinicaland clinical studies• Develop and manufacture fit-for-purpose, earlyphase clinical materials• Design, validate, and implement analytical andprocess methodologies• Generate the data required for IND filings

5Navigate the complexity of handling and containing
high-potency compounds
Since about 60% of all HPAPIs are being developed for cancer, a high-potency strategy is critical to the safety and successof your oral solid dose.1 At Thermo Fisher, we ensure that the environmental health and safety (EHS) risks related to theproducts we manufacture are minimized and appropriately managed. The most effective way to do this is to have a robust
EHS management system in place that can anticipate hazards before a process is introduced, recognize any existinghazards, and evaluate and control the risks associated with the presence of the hazard. Our categorization bands will
ensure that your oncology program is being developed and manufactured to meet safety standards.

High potency: Pharma services categorization bands
CATEGORY 1

CATEGORY 2

CATEGORIES 3A AND 3B

CATEGORY 4

Compounds are
typically very wellstudied; have minor,reversible effects; andare generally innocuous.

Compounds typicallyhave more serious,
reversible health effects,
which occur at moderate
to high doses.

Compounds have serious toxic effects
at lower doses and include sensitizers,teratogens, carcinogens, and drugs withirreversible health effects. Based on thelack of sufficient data, drugs underdevelopment may be included in the
category by default.

Compounds have
exceptional toxicity andoften cause severe,irreversible effects withvery small exposures.

Capabilities to support growth of highly potent products
The number of highly potent molecules in the development pipeline is growing.

High potency (potent)

Low potency (non-potent)

CAT 1
Occupational
Exposure Limits
(OEL)

CAT 2

CAT 3A

1 mg/m 3

10 ug/m 3

CAT 3B
1 ug/m 3

CAT 4
10 ng/m 3

General cutoff forhigh potency
SAFEBRIDGE TOXICITY CATEGORIZATION SYSTEM

CAT 1
Occupational
Exposure Limits(OEL)CAT 2
0.5 mg/m 3

CAT 310 ug/m 3

CAT 430 ng/m 3

Solving your high-potency needs for API, drug product, and clinical services.
1 Switzerland joins major players as home to high containment API manufacturing facilities, GlobalData Healthcare, July 25, 2019
Note: Illustration not to scale
Source: Pharma Services Strategic Business Intelligence Pipeline Analysis August 2019; likely potency determined by Patheon EH&S, J. Galati (2019)6Solve solubility and bioavailability challenges before they
become long-term issues
Poorly soluble compounds often demonstrate lower
bioavailability, which can reduce the efficacy of the drug
substance or product. Our solutions will ensure that youroncology product isn’t hindered by these common challenges.
The need to quickly provide life-saving cancer drugs topatients doesn’t correlate with a trial-and-error approach
to formulation that is time-consuming and costly. Our
Quadrant 2™ program is an in-silico formulation
development approach that saves time and reduces cost by
avoiding the more traditional, empirical trial-and-error
approach. This model analyzes the molecular structure andthe physical and chemical characteristics of a compound,and then predicts the solubility enhancement technology
and excipient combination that are most likely to succeed
based on:Spray drying is a strategic solution that addresses thebioavailability and crystallization challenges that arecommon across many drug substances and drug products.
Thermo Fisher provides spray drying strategies that can beleveraged from early development to commercialization.

“Technical strength in spray drying
solid dispersion.”—Emerging biopharmaceutical company focused on
autoimmune diseases, USA• Physicochemical properties

Hot melt extrusion (HME) is a strategy for manufacturing
amorphous solid dispersions (ASDs). Leveraging Thermo
Fisher’s HME solutions results in solvent-free processing,
reduced cost of goods (COGs), and continuous manufacturing.

• Full-scale molecular modeling• Throughput rates from 20 g/hr up to 2.5 kg/hr• Exclusive excipient descriptor database developedby Thermo Fisher• Throughput rates of 5 to 25 kg/hr• API chemical structure

We have analyzed

250+

molecules using
Quadrant 2 forbioavailability
challenges“Reliable, responsive, transparent.
They always deliver and do notpromise what they cannot deliver.”—Emerging biotechnology company focused on rarediseases, USAWe have extensive expertiseand experience in spraydrying thermodynamics,
having spray-dried

120+ molecules7Gain access to a broad range of dosage forms to meet yourmolecule’s unique needs
Access to a wide range of conventional and specialized dosage forms, both simple and complex, can create an integrated
drug formulation program that is customized to your oncology drug product’s unique properties. We will work with you toensure that your oncology discovery has a proof of concept with built-in speed and efficiency to accelerate your molecule’s
journey to FIH studies. When working with Thermo Fisher, you’ll have access to a broad selection of dosage forms andrelease profiles.

Accelerate time to phase I clinical trials with Quick to Clinic™
Quick to Clinic for small molecules is an integrated approach that can expedite your product to phase I milestones andlay the groundwork required for phase II. Our comprehensive early development solutions solve complex molecule
challenges by creating the most efficient route for your small molecule to reach FIH trials. Quick to Clinic allows you to savetime, simplify your supply chain, and make investments for future milestones to deliver life-saving oncology products topatients quickly.

Fast• Qualified Person (QP)–released
product to the clinic in as little
as 14 weeks from API receipt

FlexibleFull• Range of dose forms• One-month IND/IMPD stability• Seamless project management• QP release to clinic• Phase-appropriate formulation• Technical expertise, fast
problem-solving• Seamless manufacture, packing,and QP services• Reactive scheduling8

Continuous manufacturing: Reduce API usage and total costof supply
Encapsulation
Weigh andDispense

PowderTransferMultiple
Feeder Units

ContinuousMill/Blender

Encapsulator

PolisherIntermediate andto Packaging

Continuous manufacturing is an innovative solution
providing flexibility and cost savings within your oncology
drug manufacturing program by:• Minimizing API usage• Shortening development timelines• Improving quality and consistency of products• Reducing total cost of ownership• Increasing control over manufacturing parameters• Requiring a smaller manufacturing footprint• Increasing process control for higher yields andless batch rejection

Optimize your regulatory process
The demand for oncology products today is high, so you don’t have time to waste filing your IND. In a recent study of newly
emerging and established pharmaceutical companies, leveraging a CDMO that has regulatory experience was an importantattribute. We understand that getting your CMC strategy right from the start of your oncology molecule’s journey can help savetime and money as you advance through each phase and proceed to commercialization. Our regulatory experts will help you:
• Build a robust and flexible regulatory strategy for the short and long term
• Outline your options so that you can make the best decisions for your project• Understand and evaluate trade-offs to ensure that they align with your goals and strategy• Plan best practices for your product’s lifecycle• Optimize your submission to help you reach the next phase with efficiency

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Technology transfer: Strategic investment for
long-term advantage
Whether it’s for scaling up or moving to another facility,
technology transfers are part of the normal course ofbusiness. Our dedicated global experts ensure:

In 2019, wesuccessfully completed

119• Process validation is in accordance with regulatory
and cGMP guidelines

technology transfers• Speed and agility so that your project stays on
track and your product supply is preserved• Seamless execution for right-first-time (RFT) delivery• Access to a robust system to manage theproduct lifecycle• Insight to all stage gates required for each phase• Access to stability studies, analytical data, release
testing, and other regulatory documentation

4460

15

commercial

drug
substancedevelopment

Commercial packaging provides assurance and simpler
logistics in your supply chain
Thermo Fisher offers you flexible, integrated, end-to-end solutions and technical expertise in clinical and commercial
packaging combined with other important value-added services.
Our breadth and depth of capabilities are designed to accommodate both small and large volumes to ensure that yourproduct can be packaged in the most cost-effective way possible. Our commercial packaging can help:• Simplify your logistics• Provide reliable service levels and focus on quality• Enable flexibility for both small and large volumes• Streamline timelines with an end-to-end solution
from development to commercialization• Allow flexibility for changes in capacity for productgrowth or contingency planning“Knowledgeable, flexible, understoodthe needs of a small biotechnology
company, experienced scientists.”—Small biotechnology company focused on rarediseases, USA

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Clinical trial solutions: Optimize your chances for approval
Thermo Fisher offers experience, reliability, and a broad range of fill/finish commercial capabilities. We have an enviable
record of success in oral solid dose commercialization.
Leveraging our commercial production and clinical trial solutions will give you access to our extensive network of global
technical experts as well as supply chain and transportation capabilities. Our solutions span:• Global clinical trial packaging and storage• Clinical supply optimization• Clinical labeling• Distribution and logistics• Global clinical ancillary management

Contact us to learn more about how we can help you get youroncology therapy to patients with speed and agility.

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+1 919 226 3200

• thermofisher.com/patheon • pharmaservices@thermofisher.com© 2022 Thermo Fisher Scientific Inc. All rights reserved.
Published 2/2212