Career progression is rarely linear, and there is no single path to leadership. In our latest blog, Sinéad McKeon discusses what drove her move from the lab bench to project management. She reflects on the capabilities...
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Mechanism of action in pediatric research
Discover how EMA’s proposed MoA-based PIP requirements mirror the US RACE for Children Act and how sponsors can prepare for pediatric regulatory changes.
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Behind Biotech: Bojana Mirosavljevic
When companies seek support with rare disease patient advocacy, ICON Biotech’s Bojana Mirosavljevic brings hard won insights. As an embryologist and mother of a rare disease patient, she sees patient advocacy from the dual perspectives of science and caregiver.
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Pushing boundaries in idiopathic pulmonary fibrosis clinical research
The landscape of IPF research is evolving and early-stage biopharmaceutical teams need a new roadmap to success. We offer strategies to meet the challenges to develop new treatments.
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Cross-border initiative to empower rare disease researchers
ICON joins new EU initiative to boost cross-border collaboration.
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Beyond awareness: Driving progress on the Rare Disease journey
ICON employees share their experience with Rare Diseases.
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Rare disease trials require effective participation support strategies to succeed
ICON is leading the way in rare disease clinical research having supported 778 rare disease clinical trials in the past five years. Every day, thousands of colleagues at ICON work tirelessly to support the success of rare disease clinical research – because patients can’t wait.
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Strategies for de-risking rare disease programmes during research and development
Difficulties in research and development for rare disease therapeutics have been compounded by a historically challenging market for biotechs. ICON experts share how biotechs can maximise funding for rare disease therapeutic development in our blog.
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Patient-centric best practices for improved diversity
In this blog, we share best practices for a more patient-centric approach to trials as discussed in our webinar to improve accessibility, inclusion and diversity.
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Rare diseases and orphan drugs regulatory framework in Canada
This blog details initiatives that are being taken by the Government of Canada to promote a health care system that works for those with rare disorders.
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Rare Disease Day diversity and inclusion
This event aims to raise awareness about the diversity of individuals affected by rare diseases. Find out how virtual events can be made more accessible and inclusive.
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Filling the gaps for rare and orphan diseases
Read the blog to learn more about the benefits and challenges of Rare Disease natural history studies.
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A rare partnership: collaborating with patient advocacy organisations for rare disease registries
Rare disease registries: practical ways to build trust and collaboration with patient advocacy groups.
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Clinical development challenges faced by advanced therapies for rare disease
Advanced therapies are a class of products based on genes, tissues or cells used to treat or deliver treatment to patients.
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Advanced therapies for rare disease - a regulatory roadmap
Navigating advanced therapy development for rare diseases is challenging from many perspectives and requires a customised development strategy.
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Rare disease patients and advocates drive change in public policy
Learn how patient advocacy organisations and rare disease communities are driving change in US public policy to make safe and effective treatment options available to all patients.
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Sharing my rare disease story - Hayley Christensen
ICON's Hayley Christensen shares her personal experience with Cystic Fibrosis.
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Sharing my rare disease story - Tamie Joeckel
ICON's Tamie Joeckel shares her personal experience with Type 3 Hereditary Angioedema.
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Sharing my rare disease story - Amanda Huber
ICON's Amanda Huber shares her personal experience with Alpha-1 Antitrypsin Deficiency (Alpha-1).
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Sharing my rare disease story - Julia Tonge
ICON's Julia Tonge shares her personal experience with Amniotic Band Syndrome (ABS).
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Effective patient recruitment for rare disease research
With 350 million people affected worldwide, rare diseases represent a major unmet medical need. However, the timely recruitment of eligible participants is a challenge for any rare disease clinical trial.
In this section
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Digital Disruption
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Clinical strategies to optimise SaMD for treating mental health
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Digital Disruption: Surveying the industry's evolving landscape
- AI and clinical trials
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Clinical trial data anonymisation and data sharing
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Clinical Trial Tokenisation
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Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
- mHealth wearables
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Personalising Digital Health
- Real World Data
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The triad of trust: Navigating real-world healthcare data integration
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Decoding AI in software as a medical device (SaMD)
- Software as a medical device (SaMD)
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Clinical strategies to optimise SaMD for treating mental health
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Patient Centricity
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Accelerating clinical development through DHTs
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Agile Clinical Monitoring
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Capturing the voice of the patient in clinical trials
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Charting the Managed Access Program Landscape
- Representation and inclusion in clinical trials
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Exploring the patient perspective from different angles
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Patient safety and pharmacovigilance
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A guide to safety data migrations
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Taking safety reporting to the next level with automation
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Outsourced Pharmacovigilance Affiliate Solution
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The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
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Sponsor and CRO pharmacovigilance and safety alliances
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Understanding the Periodic Benefit-Risk Evaluation Report
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A guide to safety data migrations
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Patient voice survey
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Patient Voice Survey - Decentralised and Hybrid Trials
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Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
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Using longitudinal qualitative research to capture the patient voice
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Prioritising patient-centred research for regulatory approval
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Accelerating clinical development through DHTs
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Regulatory Intelligence
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Accelerating access
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Meeting requirements for Joint Clinical Assessments
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Navigating the regulatory landscape in the US and Japan:
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Preparing for ICH GCP E6(R3) implementation
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An innovative approach to rare disease clinical development
- EU Clinical Trials Regulation
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Using innovative tools and lean writing processes to accelerate regulatory document writing
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Current overview of data sharing within clinical trial transparency
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Global Agency Meetings: A collaborative approach to drug development
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Keeping the end in mind: key considerations for creating plain language summaries
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Navigating orphan drug development from early phase to marketing authorisation
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Procedural and regulatory know-how for China biotechs in the EU
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RACE for Children Act
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Early engagement and regulatory considerations for biotech
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Regulatory Intelligence Newsletter
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Requirements & strategy considerations within clinical trial transparency
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Spotlight on regulatory reforms in China
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Demystifying EU CTR, MDR and IVDR
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Transfer of marketing authorisation
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Exploring FDA guidance for modern Data Monitoring Committees
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Streamlining dossier preparation
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Accelerating access
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Therapeutics insights
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Endocrine and Metabolic Disorders
- Cardiovascular
- Cell and Gene Therapies
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Central Nervous System
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A mind for digital therapeutics
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Challenges and opportunities in traumatic brain injury clinical trials
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Challenges and opportunities in Parkinson’s Disease clinical trials
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Early, precise and efficient; the methods and technologies advancing Alzheimer’s and Parkinson’s R&D
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Key Considerations in Chronic Pain Clinical Trials
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ICON survey report: CNS therapeutic development
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A mind for digital therapeutics
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Glycomics
- Infectious Diseases
- NASH
- Obesity
- Oncology
- Paediatrics
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Respiratory
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Rare and orphan diseases
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Advanced therapies for rare diseases
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Cross-border enrollment of rare disease patients
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Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
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Diversity, equity and inclusion in rare disease clinical trials
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Identify and mitigate risks to rare disease clinical programmes
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Leveraging historical data for use in rare disease trials
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Natural history studies to improve drug development in rare diseases
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Patient Centricity in Orphan Drug Development
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The key to remarkable rare disease registries
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Therapeutic spotlight: Precision medicine considerations in rare diseases
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Advanced therapies for rare diseases
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Endocrine and Metabolic Disorders
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Transforming Trials
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Accelerating biotech innovation from discovery to commercialisation
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Demystifying the Systematic Literature Reviews
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Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
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From bottlenecks to breakthroughs
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Linguistic validation of Clinical Outcomes Assessments
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More than monitoring
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Optimising biotech funding
- Adaptive clinical trials
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Best practices to increase engagement with medical and scientific poster content
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Decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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Decentralised and Hybrid clinical trials
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Practical considerations in transitioning to hybrid or decentralised clinical trials
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Navigating the regulatory labyrinth of technology in decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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eCOA implementation
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Blended solutions insights
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Clinical trials in Japan: An enterprise growth and management strategy
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How investments in supply of CRAs is better than competing with the demand for CRAs
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The evolution of FSP: not just for large pharma
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Embracing a blended operating model
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Observations in outsourcing: Survey results show a blended future
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Clinical trials in Japan: An enterprise growth and management strategy
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Implications of COVID-19 on statistical design and analyses of clinical studies
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Improving pharma R&D efficiency
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Increasing Complexity and Declining ROI in Drug Development
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Innovation in Clinical Trial Methodologies
- Partnership insights
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Risk Based Quality Management
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Transforming the R&D Model to Sustain Growth
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Accelerating biotech innovation from discovery to commercialisation
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Value Based Healthcare
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Strategies for commercialising oncology treatments for young adults
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US payers and PROs
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Accelerated early clinical manufacturing
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Cardiovascular Medical Devices
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CMS Part D Price Negotiations: Is your drug on the list?
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COVID-19 navigating global market access
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Ensuring scientific rigor in external control arms
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Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
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Health technology assessment
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Perspectives from US payers
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ICER’s impact on payer decision making
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Making Sense of the Biosimilars Market
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Medical communications in early phase product development
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Navigating the Challenges and Opportunities of Value Based Healthcare
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Payer Reliance on ICER and Perceptions on Value Based Pricing
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Payers Perspectives on Digital Therapeutics
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Precision Medicine
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RWE Generation Cross Sectional Studies and Medical Chart Review
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Survey results: How to engage healthcare decision-makers
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The affordability hurdle for gene therapies
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The Role of ICER as an HTA Organisation
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Integrating openness and precision for competitive advantage
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Strategies for commercialising oncology treatments for young adults
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