BioSpace Insights
The BioSpace Insights team performs research and analysis on industry trends for BioSpace and clients, producing industry reports, podcasts, events and articles.
Latest from Insights
Single-trial approvals are raising the bar on trial design and execution. The new paradigm is pushing sponsors to plan earlier, step up their data and risk‑based quality management and use modeling and AI to generate one compelling, regulator‑ready evidence package.
Listen to Denatured
Unravel the business of science with BioSpace.
In this episode of Denatured, you’ll listen to Oxana Iliach, senior director of regulatory strategy at Certara and Vera Pomerantseva, director of product management for risk-based quality management at eClinical Solutions. We speak about how the FDA’s latest decision to have one, rather than two pivotal studies, for new drug applications raises the bar for data collection and risk-based management.
In this episode of Denatured, you’ll listen to Ram May-Ron, managing partner at FreeMind Group, and Ravi Kiron, managing director at Biopharma Strategy Advisors. We’ll be speaking about how to combine nondilutive funding and family office money into a unified strategy that gets companies through the drug development valley of death.
In this episode of Denatured, you’ll be listening to Indu Navar, CEO and founder of EverythingALS and Dr. Olga Uspenskaya, chief medical officer at VectorY Therapeutics. We’ll be speaking about patient-pharma collaborations accelerating trials and hope, advances in ALS biology understanding and biomarker-driven endpoints.
Upcoming Events
Artificial intelligence is rapidly reshaping the life sciences, from automating repetitive tasks to enabling advanced scientific and safety assessments across drugs, biologics, and devices. As adoption grows across regulators, pharmaceutical companies, technology developers, nonprofits, and collaborative consortia, the need for clear, risk-based frameworks for validation, governance and human oversight becomes increasingly critical.
Tuesday, March 17, 2026 1–2pm EDT
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Virtual
Every biopharma R&D and investment decision could be guided by connected intelligence. Join us to hear firsthand how agentic workflows and enterprise-scale data are helping drug developers move faster from molecule to market with greater confidence.
Wednesday, March 18, 2026 11am–12pm EDT
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Virtual
Join us for this critical discussion on how regulators and biotech companies can bridge the expectation gap during the regulatory review process to ensure novel therapies reach patients in a timely manner—because patients don’t have time to wait.
Thursday, March 26, 2026 2–3pm EDT
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Virtual
BioSpace at 2025 SCOPE Summit
- Meeting on the Mesa: October 6-8, 2025 | Phoenix, AZ
Events
In this live panel discussion, speakers focused on the EU AI Act’s global regulatory implications for medical devices & QARA’s future. An executive summary is available.
FROM BIOSPACE INSIGHTS
The U.S. Congress greenlit a historic $315 million in federal ALS research funding for 2026 amid Rare Disease Month, spotlighting biotech progress like VectorY Therapeutics’ first patient dosing in its TDP-43-targeting PIONEER-ALS trial and EverythingALS’ pharma consortia driving biomarker innovations and trial alignment.
In this episode of Denatured, you’ll be listening to Jane Hughes, President of R&D and Co-founder of Verdiva Bio, and Jon Rees, CEO and Co-founder of MitoRx Therapeutics. We’ll discuss next-generation obesity solutions tackling GLP-1’s muscle loss and adherence challenges, through innovative muscle preservation, oral administration and combination therapy.
Muscle Preservation, Tolerability and Alternative Administration Routes Define Obesity’s Drug Future
In the incredibly hot obesity drug space, with more than 700 clinical trials ongoing, Verdiva Bio and MitoRx leaders discuss how next-generation therapies are targeting lean muscle preservation, extended efficacy and better safety profiles to enable lifelong weight management.
In this episode of Denatured, Jennifer C. Smith-Parker speaks with Dr. Rob Monroe and Jennifer Fakish at Danaher Corporation. They discuss how antibody drug conjugates (ADCs) are transforming cancer care. With AI-powered pathology, doctors can now measure HER2 more precisely to match patients with the best treatments.
As next-generation antibody-drug conjugates reshape cancer care, digital pathology and artificial intelligence are transforming how HER2 is measured. The advances aim to help clinicians identify low and ultra-low expressors, match patients to the right therapies and make more precise treatment decisions.
In this episode of Denatured, Jennifer C. Smith-Parker speaks to Erik Digman Wiklund, CEO of Circio and Jacob Becraft, Co-founder and CEO of Strand Therapeutics. They discuss how post-COVID, emerging platforms like circular and logic circuit RNA are expanding the field’s therapeutic horizons.
Investor enthusiasm and evolving FDA pathways are accelerating rare disease drug development, with ultrarare conditions like MPS II moving into the spotlight.
After years of contraction, investors see biotech reentering a growth cycle driven by scientific progress, asset quality and renewed conviction in oncology, obesity and neuroscience innovation.
In this episode of Denatured, Jennifer C. Smith-Parker speaks with RTW’s Rod Wong and Stephanie Sirota how shifting JPM deal timing masks record M&A potential; why oncology, obesity, psychedelics, and neuroscience are attracting fresh capital; and how “alpha stacking” shapes their investment edge in an age of chronic uncertainty. They cover topics discussed in RTW’s new book, “Innovation is the Best Medicine.”
BioSpace’s 2026 U.S. Life Sciences Employment Outlook examines the state of the biopharma workforce amid ongoing funding pressure, elevated layoffs and cautious hiring sentiment, while highlighting early signals of stabilization and cautious optimism for the year ahead.