Archives: Articles

Applying AI to adverse event case processing: sharpening the impact of pharmacovigilance

6 October 2025 No Comments

As drugs move out of the lab and into the world, vigilance in safety monitoring is paramount not only for regulatory compliance and risk management, but also to maximise the positive impact of products for patients. As the industry diversifies into new therapy areas, and as pharmacovigilance (PV) workloads soar, adverse event (AE) case processing requires a smarter approach, facilitated by AI and advanced automation. Qinecsa’s John Cogan explains.

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Patent strategies for biotech startup companies

6 October 2025 No Comments

The present article focuses on the basics of intellectual property protection strategies that biotech startups should adopt for the purpose of competing in the global marketplace.
The initial step in the decision-making process for a new invention is determining whether to patent it or maintain its secrecy. This decision is followed by the determination of the optimal timing and location for filing a new patent application. The formulation of claims in an application constitutes a strategic element that must be given due consideration to avert the phenomenon of “design-around” by competitors.
For biotech startups, the possession of at least one patent in the portfolio is a crucial asset. This can enhance the valuation of the company and serve as a leverage strategy, facilitating financial investment.
The PCT procedure is regarded as the optimal choice for biotech startups, as it allows for the deferral of the costly national phases of approximately 30/31 months following the priority filing. Furthermore, a PCT confers a provisional protection with a broad scope of geographic protection.

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Advancing Process Analytics in Pharma: Practical Strategies for PAT and QbD Adoption in Resource-Constrained Environments

3 October 2025 No Comments

The pharmaceutical industry has made gradual progress since the FDA’s 2004 initiative to promote Quality by Design (QbD) and Process Analytical Technology (PAT) as enablers of modern manufacturing. Despite regulatory momentum and technological advances, adoption remains uneven, particularly in resource-limited environments. This article presents a practical framework for implementing PAT and QbD in such settings. We examine key technological enablers, organizational barriers, and proven strategies based on industry experience. Through a series of case studies and actionable recommendations, the article aims to support incremental yet impactful progress toward data-driven, resilient pharmaceutical manufacturing systems.

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Reimagining Antibody-Drug Conjugates: The Rise of Novel Targets, Bispecific Antibodies and Dual Payloads

3 October 2025 No Comments

This article explores the evolving landscape of antibody-drug conjugates (ADCs), highlighting innovations in novel targets, bispecific formats, and dual payload strategies. It discusses how these advances are reshaping therapeutic approaches in oncology and beyond, while also addressing the manufacturing and regulatory complexities associated with ADC development.

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Precision as a growth lever for CDMO leaders: Key findings from Simon-Kucher’s 2025 CDMO growth report

3 October 2025 No Comments

This article explores the evolving dynamics of the global CDMO (Contract Development and Manufacturing Organization) market, highlighting key findings from Simon-Kucher’s 2025 CDMO Growth Report, developed in collaboration with PharmaSource. Drawing on insights from over 100 executives across CDMO and pharma companies, the piece outlines how precision – not just scale – will define future market leaders. The report identifies six critical levers for growth: tailored engagement, smart pricing, early capacity planning, value-added services, investment in high-value modalities, and digital innovation. The article advocates for a co creative, partnership-first approach that enables CDMOs to compete with focus and deliver measurable value.

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