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Page 6 of 16 Fetro. Rare Dis Orphan Drugs J 2023;2:7 https://dx.doi.org/10.20517/rdodj.2023.06

Various reasons may explain the poor cooperation between industry and academia. These reasons need to
be properly understood if we want to orient efforts in appropriate directions. Key questions may be
addressed: why, when, and how to implement a relevant collaboration. They deserve clear answers through
a broader and more structured debate involving all stakeholders. In the meantime, some suggestions can be
made, and some existing initiatives at European (for some of them) and international levels can be reported
to encourage and stimulate new opportunities.

WHY
Why get academia and industry to work together? There are many reasons to support such collaborations.
Even if they have different expectations and constraints, academia and industry may be complementary and
bring added value to each other in a highly regulated environment.

Academia as a source of innovation
Pharma’s business model fundamentally depends on product innovation to create value. Patent expiry and
generic competition approximately every 10 years are real challenges for pharmaceutical companies which
[20]
look to academia for valuable knowledge and innovation . The contribution of academia is crucial in terms
of basic research, identification and validation of new targets, and also in terms of clinical trials to evaluate
the efficacy and safety of drug candidates. Academia and industry may be caricatured as the alpha and the
omega as they have complementary enterprises throughout the drug value chain, from innovation to
[21]
validation. Research for rare diseases starts in academia , development is shared between stakeholders, and
commercial launch is managed by the industry.

Different expectations and constraints but working towards the same goal of improving the health
of patients
It has become commonplace to highlight the gap between academia and industry in terms of cultures and
practices. Although patenting is key for them both, the value of secrecy for pharma continues long after
patent filing and grant. Pharmaceutical companies still consider results collected from clinical trials to be
confidential information or trade secrets, even after submission to regulatory agencies. Academics, for their
part, are under pressure to increase their publication count. The “publish or perish” culture is a well-known
practice existing within academic institutions. But once the patent has been filed, the invention may be
published. It is then crucial for a researcher to present his/her work at conferences, exchange with peers,
and win grants.

Highly regulated drug development process
Academic researchers have neither the capacity nor the finance to develop a drug candidate until the launch
of the finished product. Moreover, they are often unaware of what evidence needs to be submitted as part of
an application for marketing approval or which complex drug development challenges will have to be
addressed. Pharmaceutical companies operate in a very highly regulated area, from key nonclinical studies,
Phase I-III clinical trials, chemistry, manufacturing and controls (CMC), and formulation activities to
[7]
regulatory submissions, commercial launch activities, and life-cycle management . Drug development
requires a comprehensive and well-thought-out development strategy with a detailed roadmap.

Drug development is a risky and costly process
The time required for a new drug to be developed is about 10-15 years and the cost is around $ 2 billion.
Despite such significant investments in time and money, approval rates for a new drug are about 10%. DR
has been proposed as an interesting strategy with fewer risks, lower costs, and shorter timelines. Indeed,
repurposed drugs are generally approved sooner (3-12 years), at reduced (50%-60%) cost and lower risk:
approval rates for repurposed drugs are close to 30% . However, in some cases, DR may be an expensive,
[22]