GLOBAL CLINICAL
SUPPLY SOLUTIONSFOR EVERY TRIAL
DELIVERING THE RIGHT DRUG TO THE
RIGHT PATIENT, ON-TIME, IN-FULL,AND WITHOUT COMPROMISE

Holli CarlsonDirector, Commercial Solutions,Pharma Services,Mt. Prospect, IL

HOW SPRING BREAK HAD TO WAIT A LITTLE LONGER,SO A BABY COULD HAVE A BETTER SHOT.
After a long night of packing for her family’s spring break vacation, Holli woke up at 4:40 AM Saturday morning. She
noticed a text message on her phone. A six-day-old baby experiencing violent seizures needed a client’s medication
immediately. Vacation was going to have to wait. By 5:20 AM, Holli was on the phone with the client to identify a solution.
By 7:30 AM, she and her team were at the site (normally closed on Saturdays). The client had received an emergency
Treatment IND from the FDA the night before. Next, through Thermo Fisher’s Total Transportation Management capability,
they were able to arrange same-day shipment from their TSA-certified warehouse. No red tape. No delay. No package
opening at the airport. The package went directly on a commercial flight, and was hand delivered to the hospital 12 hours
after Holli received that text. Best of all, when every moment mattered most, a baby in urgent need could be treated withthe client’s medication in hours instead of days.

2TABLE OF CONTENTS
5

Building a clinical supply chain strategy
as reliable as your discovery program

6Components of a successful clinicalsupply chain strategy

9Streamlining delivery through a single vendor

At the center of every clinical trial is a patient waiting for a treatment toarrive safely and on-time.
In the highly competitive, new drug development market,
biopharma companies face a myriad of challenges—frombalancing cost, time, and quality, to delivering the best
possible outcome for their trial and their patients. Asbiopharma companies move toward an Investigational New
Drug (IND) application and their first human trial, many ofthem find themselves lacking the experience and knowledge
in securing a reliable clinical supply chain strategy. A reliable
clinical supply chain strategy is as essential as a company’s
discovery program—making finding a partner who can help
guide a comprehensive supply chain strategy and manage
day-to-day supply chain activities, paramount.

4Building a clinical supply chain strategy as reliable
as your discovery program
Clinical trial supply chains can be complicated, andone small oversight can significantly slow things down.
Delivering drugs to patients is the top priority and is asignificant milestone as biopharma companies complete
their drug development. A trial cannot begin unless patientsare registered, and both the investigational drug andancillary components are in place.
While building a clinical supply chain strategy, ask yourself:• How do I build my packaging strategy?
• What about labels?
• What if the drug requires temperature-controlledstorage and special handling?

• How do I plan for comparator sourcing?
• Where can I find information about import andexport regulations?
• How should I design my clinical trial to recruit andretain patients?
• Can I outsource my clinical supply chain to onevendor? Or will I need to outsource each piece toa different vendor?
Unfortunately, many biopharma companies may not havethe required capabilities to meet these challenges and findthemselves in need of a partner who can deliver their clinical
trial needs regardless of size, phase, therapeutic area,country, or region.

• When should I plan for ancillaries?

5Components of a successful clinical supply chain strategy
Keep your trial running smoothly with early planningand oversight across the entire process.
Upfront planning has become a critical component toexecuting a streamlined, efficient, and nimble clinical supply
chain. As such, clinical supply partners play a more activerole in overseeing and managing the strategy—this includes
forecasting, comparator sourcing, ancillary sourcing,packaging, labeling, distribution, and logistics.
A successful clinical supply chain strategy should address
the following components:

Covering all phases of development
Project consultation

Phase II

Phase I

Commercial

Phase III

Global distribution

Streamlining the clinical supply chain• Study planning and setup• Over-encapsulation, blinding• Commercial packaging• Regulatory compliance insights• Blister packaging, carding,vials, syringes, auto injectors• Global distribution, with realtime visibility via Global Gateway• Comparator & ancillarymaterial sourcing• Cold chain network for time andtemperature sensitive material• Global biobanking• Global customs andregulatory guidance• End-to-end supply chain andinventory management• IRT integration• Label design andtranslation management• Laboratory services• Clinical trial packaging strategies are often
impacted by changes to the protocol such as
dosage changes, increases or decreases involumes, changes to expiry dates, and inclusion/
exclusion of countries that weren’t part of theoriginal plan.

• Every study requires a label strategy as labels areneeded for every product, comparator, andshipping box. Furthermore, unlike other medicinal
products, every clinical label design is unique toevery patient.

6• Packaging and storage plans need to ensure
the quality of the study’s medicinal products
and placebos meet the needs for temperature,humidity, lighting, and other environmentalcontrols.
• Cold chain management is critical for products
and samples that need to be packaged, picked,
and packed for distribution and stored within
specific regulated temperatures. These highly
controlled areas must follow strict quality
standards before being released for treatment.
• Sourcing clinical trial ancillary supplies is much
more than just procurement. It requires anunderstanding of the study’s design andrequirements, in-depth knowledge of international
regulations, and rigorous, proactive planning toensure the most appropriate equipment andmaterials are purchased. All while acquiring at theright time and at a competitive price.

• With patient pools expanding to remote locations
across the globe, managing the transportation oflife science shipments has become increasinglycomplex. The growth of biologics creates
additional challenges due to cold chain handling,storage, and distribution requirements.
• The traditional clinical trial model isn’t always
convenient for the patient due to their location,schedule, or lifestyle, which leads to underenrolling or high dropout rates. Decentralized
clinical trials enable patients to participate inclinical trials from their homes by providing themwith study drugs and care where they live.

Direct-to-patient options at a glance

Global Capabilities
Clinical Site

Available in US only*
Available in US only*

Depot

Patient’s Home

Central Pharmacy
Patient’s Home

Packaging and Labels

Central Pharmacy

Direct-to-patient solutions accelerate recruitment, providing patients with moreconvenience and reducing dropout rates

7CASE STUDY

Meeting milestones and patient needs through expedited deliveryof Phase I materials.

SUMMARY: Reneo Pharmaceuticals, a clinical-stage pharmaceutical company, focuses on the development oftherapies for patients suffering from genetic mitochondrial disease. The pressure of delivering safe and effective
drugs to patients, in a timely manner, is critical—as the quality of patient lives depends on it.
CHALLENGE: Reneo needed a way to expedite early testing in order to make informed proof of concept decisions
and complete their regulatory submissions. They were looking for a partner that could provide both productdevelopment and clinical packaging services.
SOLUTION: Reneo took advantage of Thermo Fisher Scientific’s Quick to Clinic™ program for Oral Solid Dose. This
program delivers an oral solid dose product along with labeling and packaging for Phase I clinical trial in as little as
14 weeks from API supply, including one-month stability data.
IMPACT: By developing phase-appropriate formulations for oral solid dose forms, Reneo was able to save both timeand money because the speed at which they were able to get to clinic, allowed them to generate a proof of concept
a lot quicker. In addition, Reneo was able to eliminate multiple quality agreements and master service agreements byworking with Thermo Fisher Scientific under a single contract.

“Working with a CDMO is more about a partnership than a customer-supplier
relationship. And I feel that’s what we have between Reneo and Thermo
Fisher Scientific.”— Helen Barker, Senior Director, Head of Pharmaceutical Development at Reneo Pharmaceuticals

8

Streamlining delivery
through a single vendor
From Phase I to Phase III, domestically or globally, youneed a partner to collaborate with you at every step of
the way to serve the ultimate beneficiary—the patient.
Thermo Fisher Scientific prides itself on making yourtherapies, timelines, and patients as much of a priority as
you do. Whether you need primary or secondary packagingof your clinical drug for storage, distribution, logistics,
labeling, comparator sourcing, ancillary sourcing, andclinical supply chain management through to returns, ourglobal team can meet the needs of every trial. Regardless ofsize, phase, or therapeutic area, our attention to quality,

global capacity, and depth of expertise will help provide a
better clinical trial experience. As a partner who specializes
in clinical supply chain management, we can demonstrate ahistory of successful collaboration, knowledge of industry
best practices, a track record of innovation, and a solutionthat adds value.
With more than 55 locations globally, we provide our clientswith integrated, end-to-end capabilities through all
development phases—including API, biologics, viral vector
services, cGMP plasmids, formulation, clinical trial
solutions, logistics services, and commercial manufacturing.
Our 29 purpose-built GMP/GDP compliant facilities, supportedby over 38 partner depots—located across five continents—
provide the global presence, information systems, and quality
standards giving clients the flexibility, access, and assurance
needed for clinical trials.

>15 million

31M+

samples in freezers & LN2 tankslabels printed in 2019

~413,000

6,000+

clinical shipments completed in 2019clinical trial projects supported in 20199

Global footprint, local expertise, breadth of service offering

Stevenage, UK
Bishops Stortford, UK

Moscow, Russia
Allentown, PAHorsham, UKFranklin, MA

Mt Prospect, IL
Vacaville, CA
Indianapolis, IN

Weil am Rhein & Rheinfelden, Germany
Basel, Switzerland

Bohemia, NY

Beijing, China

Rockville, MD

Suzhou, China

Frederick, MD

Ahmedabad, India

Mexico City, Mexico
Bogota, Colombia

Clinical Supply
Distribution

Seoul, Korea
Tokyo, Japan

SingaporeLima, Peru

Bioservices

São Paulo, Brazil

Cell Therapy
Santiago, Chile

Pretoria, South Africa

Buenos Aires,
Argentina

Distribution• Total Transportation
Management• Regional hubs toincrease flexibility &mitigate risk
• Importer-of-record
capability in20+ countries• Local inventory
management andpackaging services• Real-time visibility
to inventory &distribution data

• ~400,000 clinical supply
shipments annually• 2 million samples
shipped andreceived annually• Cold chain material
management

Global footprint• 29 purpose-built cGMP facilities• Qualified Person (QP) release• 80+ primary packaging rooms• Local subject matter expertise• 135+ secondary packaging rooms• 3,500+ employees• Project managementexpertise w/single pointof contact• Global logistics
help desk

Strategically locatedin emerging regions
Integrated global IT systems& quality networks

With our global reach and local care, we can meet your unique requirements,
no matter where in the world you’re conducting your trial. Contact us to learn
how we can help with your next clinical trial.
10

+1 919 226 3200

• thermofisher.com/patheon • pharmaservices@thermofisher.com© 2021 Thermo Fisher Scientific Inc. All rights reserved.
Published XX/21