CASE STUDYUNITEDWITHQUALITY & QUICKNESS

Cost savings and speed: The untapped value of asingle-source solution
In the current drug development pipeline, smalland emerging companies are being credited
as the drivers of innovation. And although themajority of new drugs in today’s pipelines comefrom these types of companies, there are still
significant challenges they must overcome due
to limited funding and resources.1
These resources include R&D productivity, experienced in-housestaff, capacity, and access to advanced technology. To avoid
interrupting the flow of these novel drugs into the market, small
biopharmaceutical companies must find a competent partnerthat can help them commercialize their products and/or develop
the asset to the phase defined by the company’s business model.
There are a growing number of CDMOs in today’s market available
to assist with all phases of the drug lifecycle and to provide
support for any capabilities a company is lacking. However,contracting a partner for each need requires a significant amountof time and resources to negotiate terms and conditions as wellas to oversee the project from development to proof of concept(POC) and beyond. Most small companies do not have that kindof bandwidth. This calls for an alternative solution to help small
companies achieve success. One option is a single-source
solution, a nontraditional approach that aligns all services throughone CDMO to accelerate drug development. This eliminates
the silos that can often exist in today’s outsourcing paradigm,increasing both communication and speed.
In a recent interview,2 Anil Kane, Executive Director, Global
Head of Technical and Scientific Affairs at Thermo Fisher
Scientific, describes how this solution can actually benefit
pharma companies of all sizes. “Medium and large pharmacompanies are consolidating to focus on higher-priority products
and portfolios and reducing the staff that manages outsourced
products and services,” he explains. “Thus, the single-vendor
concept is becoming increasingly beneficial to medium and large
pharma companies, too.” Kane adds pharma still questions theeffectiveness of integrating drug substance and drug productmanufacturing in a single-source solution. However, looking to acompany’s experience and history can speak volumes about its
service and capabilities.
This alignment of the entire drug development process wascertainly a concern of one emerging biopharma company as it
pursued the commercialization of its highpotency, small moleculedrug. The CMC team of less than five people relied on Thermo
Fisher’s Quick to Care™ solution for the capabilities and standards
needed for clinical manufacturing. This approach gave the small
biopharma an opportunity to streamline its drug development andexpedite the path of idea to reality.

One path, one team, with Quick to Care™
As a very small startup, the company did not have in-houseformulation capabilities, nor other capabilities for late-stage
development. It was important the company they partneredwith had not only manufacturing experience but also the ability
to understand regulations and quality requirements. They also
wanted project management expertise. “In other partnering
scenarios, it is sometimes the experience that you need a large
volume of product to get people to listen to you. This can meaneven having to show up on-site, which is not an efficient process,”says the company’s current senior director of manufacturing. “Weneeded someone who would oversee the project and not push it
off on us instead. Thermo Fisher presented us with their Quick toCare™ program, which was a new initiative being implemented toprovide a better soup-to-nuts experience for customers.”
With Quick to Care™, clients have a dedicated program
manager who provides seamless coordination throughout drug
development. “One of the first deliverables we were given by
our project manager was an overarching timeline across all ofthe sites. Often in this industry, it is difficult to stick to timelines.
However, in this case, the oversight of an independent party
helps to keep all individuals on track,” he explains. “Our program
manager conducts monthly meetings with members from eachsite to go over that timeline and make sure each site understands
its responsibilities within the project and the deliverables
expected from them. As a result, the joint activities between sites
have resulted in more efficient solutions to some of our greatestchallenges.” The other role their program manager has played,which he says has been an essential benefit, is to be an advocate
for them as a client. “If there is a lapse somewhere that is affecting
or might affect the overall timeline of the product, our program
manager is the single point of contact we go to because theyknow who to go to and have a discussion with.”someone who knows the players inside the organization andis able to show up on-site or make a phone call to solve thesepotential setbacks and let people know the importance of thespecific deliverable is a key differentiator for us between Thermo
Fisher and other CDMO experiences.” Aaron Williams, Program
Manager, Quick to Care™, adds, “As program managers, we visit
and establish good working relationships with each of our site’s
leadership teams. When needs arise with my clients’ molecules,
I am able to react quickly to leverage the capability, capacityand expertise of a global network.” Today, the two companies
continue to work together using the Quick to Care™ program, andthe molecule is continuing to progress through clinical trials.
To determine the benefits of a single supplier, Tufts Center for
the Study of Drug Development (CSDD) recently analyzed asampling of drug development timelines of Thermo Fisher’s
Quick to Care™ clients. The results of the analysis determined thatthese customers reduced their timelines by 9-18 weeks, equating
to an average of $36.8 million in development time costs. In anindustry where time is money, these savings go well beyond thebottom line. Kane describes the true value of cutting both costs
and timelines. “Any delays in bringing a product to market mean
lost opportunity from a business perspective and lost benefits topatients,” he says. “By accelerating the development process, asingle vendor can deliver better healthcare to patients faster andbring business benefits to the sponsor.”

References
1. 1 New England Journal of Medicine, Drug-Development Challenges for Small
Biopharmaceutical Companies — http://www.nejm.org/doi/full/10.1056/
NEJMra1510070#t=article
2. Drug Discovery Online, New Resource Saves Drug Developers Timeand Money — https://www.drugdiscoveryonline.com/doc/
new-resource-saves-drug-developers-time-and-money-0001

He recalls a time when there was a specific need that was central
to the advancement of the molecule and the solution was notavailable at one of Thermo Fisher’s sites. Without a resolution,
it could have potentially been a major stumbling block for theproduct. “Through direction from the program manager, Thermo
Fisher was able to tap into its network and identify a site thatcould keep the molecule on its critical path,” he explains. “Having+1 919 226 3200 • thermofisher.com/patheon • pharmaservices@thermofisher.com© 2021 Thermo Fisher Scientific Inc. All rights reserved.
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