Upstream and downstream process, structural characterisation, functional characterisation and processes are all major CMC related steps that need to be considered by emerging and biotech companies early in their developm...
Biotech
Developing transformative therapies with small & mid-sized biopharma companies requires a flexible approach
PlayDriving biotech success at every milestone
Biotech companies are pioneering the future of medicine from genomic breakthroughs to first-in-class immunotherapies. With focused pipelines and bold ambitions, many biotechs operate without the full infrastructure of larger organizations, making speed, precision, and strategic support essential.
ICON delivers the expertise, technology, and global reach to turn biotech innovation into impact. Our empowered structure enables fast decision-making and flexible engagement, backed by the scale of one of the world’s most innovative CROs.
With 8,000 professionals dedicated to biotech, our teams are built to understand your unique pressures and priorities, collaborating closely, sharing ownership, and delivering results at every stage of development.
Our four-pillar approach, Patients, People, Process, and Partnership, is designed to transform biotech ambition into real-world impact. By combining patient-centric strategies, expert talent, streamlined operations, and collaborative engagement, ICON empowers you to deliver life-changing therapies faster.
Behind Biotech
Our experts bring more than scientific knowledge - they bring purpose, perspective, and a commitment to partnership.
Partnering with biotechs to transform ideas into life-changing therapies.
ICON provides end-to-end capabilities, from early-phase design to market access; ensuring agility, scalability, and scientific excellence throughout the development journey.
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Тailored clinical development
8,000 professionals dedicated to biotech delivering agile, customized solutions built around your needs.
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Consulting and advisory services
Strategic guidance from early development through to commercialization.
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Therapeutic expertise
Deep experience across therapeutic areas, from first-in-human to late-phase trials.
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Tools and technologies
Innovative platforms that accelerate research and enhance data-driven decisions.
Emerging biotech, empowered for investment
ICON partners with biotech innovators to sharpen funding strategies, align with investor expectations, and drive value across every stage of development.
Emerging biotech funding
As new funding models and investor priorities reshape the biotech landscape, companies must navigate a dynamic environment with agility and foresight to secure the capital needed for innovation.
Optimising biotech funding whitepaper series
In this two-part whitepaper series on biotech funding, we firstly share insights on how biotechs can secure funding in a highly competitive market, and then shed light on the opportunities available to utilise these funds more effectively and efficiently.
Early phase challenges for biotechs
This whitepaper explores the growing challenges facing biotech during early phase drug development, and how these can be navigated to ensure the best possible outcomes.
Case studies
Explore our biotech case study library showcasing real-world success stories where bold ambition meets ICON’s expertise.
Empowering biotech innovation at every stage of development.
Through advanced analytics, global trial expertise, and strategic partnerships, ICON enables biotechs to streamline processes and achieve faster, smarter outcomes.
Early, precise and efficient
The methods and technologies advancing Alzheimer’s and Parkinson’s R&D
In this CNS whitepaper, which includes extracts from our survey of over 120 neurodegenerative therapeutic developers, we examine how innovative methodologies and technologies are being implemented to improve the success rate of clinical trials across a range of neurodegenerative disorders.
2023 biotech sector survey
The biotech industry stands at a pivotal moment, navigating funding challenges with resilience and adaptability. After a period of remarkable growth and investment, the landscape shifted abruptly in 2022, and 2023 continued to present its own set of challenges.
De-risking clinical development of precision medicines in oncology
This whitepaper reviews the most pressing challenges and opportunities facing the oncology therapeutic landscape in the emerging era of precision medicine, and reports on how those opportunities and challenges vary by organisational size and region.
Digital disruption
The clinical research industry is making strides in technological innovation, with small but steady increases to the percentage of companies implementing and piloting digital technologies. However, our 2024 digital disruption survey conducted with Citeline shows a slower pace of innovation than predicted by the 2019 survey. Why is this the case?
Obesity and beyond
Embracing multi-indication potential during clinical development
This whitepaper explores the strategic rise of multi-indication drug development for obesity and its comorbidities, offering insights into clinical trial design, regulatory pathways, and commercial opportunities based on recent industry trends and survey data.
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Building strong foundations: regulatory insights for biotechs.
Through early engagement strategies, deep procedural expertise, and global regulatory insight, ICON equips biotechs to anticipate challenges, streamline submissions, and accelerate access to key markets worldwide.
Procedural and regulatory know-how for China biotechs in the EU
Learn how to navigate the European Medicines Agency registration and regulation procedures and gain access to a potential patient pool of 500 million people.
Early engagement and regulatory considerations for biotech
Gain insight into the common questions small and emerging biotech companies face, and the importance of early engagement and regulatory affairs when developing an asset and considering a drug development partner.
Biotech insights and media contributions
Media article: Insights and projections shaping the biotech industry
This article summarises the main findings from the biotech sector survey and outlines the key implications for biotech including strategic collaboration, innovation and cost optimisation.
Media article: Shaping the future of novel therapy development
In this article from Citeline, we discuss how drug innovation has the potential to benefit everyone, but it cannot exist in a vacuum. Today’s novel therapies are conceived and developed in a payer-patient- and value-oriented environment, one in which the gap between ambition and uptake is wider than ever.
Blog: Crafting a competitive biotech funding pitch
Biotechs can hone their pitch with the guidelines provided in this blog and through early engagement opportunities with strategic partners.
Blog: Optimising biotech trial designs to stretch your cash runway
Read this blog to learn a few key considerations to help optimise and de-risk your trial design.
Blog: The importance of developing rTPP to build biotech asset value
Discover how Biotechs can build value into their asset by developing a reimbursable Target Product Profile (rTPP).
Blog: Uncertainty to opportunity - Recent trends in the biotech funding environment
In this blog, discover more about how the biotech sector is transforming uncertainty into opportunity.
Blog: Exploring the benefits of biotech partnerships
The biotechnology sector is leading the way in developing innovative therapies that will address the unmet needs of many challenging diseases.
Media article: Moving Beyond a Buzzword
How small- to mid-sized biotechs can adopt patient centricity in their oncology trias.
Media article: Due diligence and beyond
Dr. Sandra Eagle outlines how due diligence has evolved from a discrete standalone technical assessment, to now being an integrated part of the holistic development continuum of an asset.
Media article: Europe’s emerging biotechs
John Macdonald, Vice President, Venture & Financial Alliances, examines the European biotech sector – its expertise and opportunities, and potential for growth.
Start the conversation
Start the conversation with our biotech team to explore how ICON can accelerate your clinical development and deliver investor-ready trial strategies tailored to your goals.
