Biotech Insights Hub

Roundtable report: Keeping Pace with CGT Innovation

The future is bright for cell and gene therapies (CGTs), driven by recent successes and technological advances as they broaden into areas such as autoimmune, neurodegenerative and cardiovascular diseases. However, overcoming scalability challenges is vital for achieving long-term commercialization growth.

In parallel to the 2024 Meeting on the Mesa in Arizona, ICON and Citeline met with industry experts to discuss the commercial challenges facing CGTs and outline the key strategies for long-term success, including:

• Challenges in clinical development
• Impact of automation and AI on manufacturing
• Importance of early and ongoing regulatory engagement
• Financial viability and payer reimbursement
• Collaboration with academia, biotech and pharma to enhance efficiency

Infographic: Advancing Drug Development in Oncology

The rise of targeted therapies and precision medicine has revolutionized cancer treatment, giving patients renewed hope for faster, more effective outcomes. However, this rapidly evolving landscape demands high levels of adaptability and innovation.

Citeline and ICON Biotech surveyed over 100 global professionals, primarily from biotech companies, to identify the key pain points in the oncology drug development lifecycle - uncovering both the challenges and future advancements aimed at accelerating patient treatments. View the infographic to explore key findings from the survey, including:

• Current therapies in the oncology pipeli
• Clinical vs therapeutic development challenges
• Latest strategies accelerating drug developmen
• The role of AI/ML in advancing R&D
• Emerging trends and predictions

Article: Navigating CAR T Delivery In Autoimmune Indications: Impact & Opportunity

Recent successes of CAR T-cell therapy in oncology have spurred further interest and research into its potential for treating autoimmune diseases, a significant unmet need in life sciences. Yet, to succeed in this highly competitive landscape, biotechs must address challenges in manufacturing and scalability. Explore the impact of CAR T-cell therapies, the obstacles faced, and the future strategies for success, as they discuss: 

• Promising results from a study on CAR T-cell therapy
• Importance of site design, specialist expertise and communication
• Difficulties around manufacturing and scalability
• Vital role of industry partnerships, geographical expansion and community organizations

Advancements in Oncology: A New Wave of Technology-Driven Therapeutics

Expert panellists address the key trends and challenges shaping the future of oncology, as they explore:

• How innovations are shaping how later-line treatments are used, and the impact on the patient experience
• Challenges of CAR T-cell therapies, and the benefits of reviving older therapies such as ADCs and bAB
• Pricing pressures and negotiation
• Strategies for driving operational excellence
• Shaking old habits in patient diversity
• Future uses of AI and ML in oncology, such as predicting the impact of drugs on certain subgroups

Article: Advances and challenges in the development of ADCs

Antibody-Drug Conjugates (ADCs) are notoriously tricky to develop, due to their delicate nature and the barriers facing their delivery. Andreas Dreps, Senior Vice President, Drug Development Services at ICON Biotech, highlights key obstacles in the development of ADCs and why the future remains bright for this targeted therapy, as he explores:

• Tumor heterogeneity, resistance and off-target effects
• Delicate nature of ADCs
• Need for highly refined manufacturing protocols
• Advances in linker chemistry, design and manufacturing of mABs
• ADCs as a neoadjuvant therapy in breast cancer

Roundtable Report: Overcoming Obstacles and Seizing Opportunities in Early Phase Biotech Research

In early stage drug development, biotechs face a multitude of challenges, from protocol development to generate the right scientific data required for further investment, to compliance and regulatory requirements, and the identification of strategic partnerships. In this report, discover insights from leading biotechs on:

• Different challenges of each development stage
• CRO selection criteria and scoring tools
• Additional CRO value vs. traditional value proposition

eBook: Developing innovative treatments for CNS disorders

The CNS therapeutic solutions market is witnessing huge growth, due to the aging global population and a surge in R&D. But it's not all plain sailing - in order to improve patient outcomes, researchers, stakeholders and regulatory bodies must address a range of complex challenges posed by these neurological and psychiatric disorders.

• Role of Digital Therapeutics in Central Nervous System Clinical Trials
• For Psychedelics, US FDA Is Open To Creative Thinking But Firm On Approval Standards
• Schizophrenia, Depression And Neuropathy: What’s Coming In 2024
• CGT Is In Its Infancy For CNS Disorders, But Technical Strides Being Made
• Pioneering Partnerships And Novel Trial Design Are Reshaping Repurposing In The CNS Space

Article: Increasing Rare Disease Awareness Brings Promise To Orphan Drug Innovation 

Orphan drug innovation has gone from strength to strength, propelled by advances in genetic medicine, such as mRNA therapies. However, challenges remain in patient identification and carrying out small-scale complex clinical trials. In this article, Will Maier, VP and Head of Centre for Rare Disease, ICON Biotech, explores the challenges and the necessary solutions to advance rare disease drug development in today’s dynamic landscape.

• Identifying patient populations
• Role of patient advocacy organizations
• Regulatory complexity
• Reimbursement concerns
• CRO partnerships

Whitepaper: A multifaceted risk factor: Addressing obesity’s impact across the disease spectrum

Obesity is a growing health concern worldwide, with at least 2.8 million people dying each year as a result of the disease. Additionally, the number of individuals living with obesity continues to increase annually across age, gender and geographic location. A complex condition, obesity has implications in inflammatory, metabolic and cardiovascular health — which, together, mean that advancing the treatment of obesity also means accounting for its relationships with other physiological systems and health conditions.

• The foundational physiology and drivers of obesity
• How obesity impacts inflammatory, metabolic and cardiovascular health
• Current approaches to treating obesity
• Unique challenges and approaches in participant recruitment and retention for obesity-related clinical trials