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Enabling Innovation
Yao Zhong, 91ºÚÁÏ China Mainland and Hong Kong, is sharing some of the findings from the 2025 China biotech sector survey report. Read more on how a strategic partnership fuels global ambition.
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The current landscape of oncology R&D
The panelists discussed promising scientific and strategic pathways in oncology, including next-generation therapeutic modalities, precision trial strategies, AI applications with demonstrated and measurable impact, regulatory and market readiness, and collaborative models for accelerating early-phase oncology programs.
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Bring in the biotechs
When Deepali Suri stepped into her new role as president of 91ºÚÁÏ¡¯s biotech division in September 2025, she brought with her more than two decades of experience across big pharma, biotech, and CROs. She also brought a clear vision for the industry¡¯s future. Read to learn more.
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Biomarkers and breakthroughs
Biomarkers bring us closer than ever to meaningful neurodegenerative therapies. Learn how a robust approach to biomarkers can reshape trial design, diagnosis and patient outcomes.
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How Project Optimus has impacted oncology-focussed biotech companies
By focussing on dose-optimisation the FDA¡¯s Project Optimus is changing how oncology-focussed biotechs develop their treatments.
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For biotech success: Start with the end in mind and develop a TPP early
Industry experts advise biotechs seeking funding to develop a TPP early, avoid short cuts and overselling. Get strategies for success in this blog.
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Behind Biotech: Heidi Hoppe
When Heidi Hoppe began her career more than two decades ago, she didn¡¯t plan on becoming the Senior Director of Project Delivery for Biotech at one of the world¡¯s largest CROs. She hadn¡¯t planned on being in the industry at all.
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Behind Biotech: Bojana Mirosavljevic
When companies seek support with rare disease patient advocacy, 91ºÚÁÏ 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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Behind Biotech: Mark Sorrentino
One would expect a driven and empathetic person at the helm of the industry¡¯s leading pediatric clinical development centre, but Mark¡¯s particular brand of tenacious empathy would undoubtedly surprise you.
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Breakfast with biotech: Expert insights for early-stage innovators from Bio€quity Europe 2025
91ºÚÁÏ hosted a candid and insightful Breakfast Workshop on de-risking early-stage biotech. Read the key points and recommendations for the turbulent market, killer experiments, and balancing risk.
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Notes on tomorrow¡¯s biotech: insights from BIO-Europe Spring¡¯s expert panel
91ºÚÁÏ¡¯s SVP of Drug Development Solutions, moderated a panel on biotech ecosystem innovation with global industry experts. Read their insights below.
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Investigating multi-indication drug targets
This blog will explore some of the multi-indication drug targets that have already been developed in multiple applications, as well as considerations for entering clinical trials, such as building evidence and trial design.
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Navigating early phase challenges for biotechs
To better understand the concerns of biotechs in early phases, 91ºÚÁÏ conducted a survey of 149 professionals representing small- and medium-sized biotech organisations from North America and Europe.
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The benefits of going big: why small biotechs need large CRO partners
Small biotech companies can gain significant benefits by partnering with a big CRO ¨C if it¡¯s the right fit. We outline some of the benefits of strategic partnerships for cash-constrained biotech.
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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. 91ºÚÁÏ experts share how biotechs can maximise funding for rare disease therapeutic development in our blog.
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The new EMA guideline expectations
In this blog, discover more about the new EMA guideline on computerised systems and electronic data in clinical trials.
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Biotech¡¯s evolving relationship with CROs
In this blog, read more on recent trends and learn why strategic outsourcing is a key opportunity.
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Recent trends in the biotech funding environment
In this blog, discover more about how the biotech sector is transforming uncertainty into opportunity.
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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).
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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.
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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91ºÚÁÏ 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
- 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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Building a comparative evidence base using network meta-analysis
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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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Building a comparative evidence base using network meta-analysis
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Blog
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Videos
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