Vaibhav Patel

Jan 16, 2025 | biosimilardevelopment.com | ajaz Hussain |Yadnyesh Patel |Vaibhav Patel

With a third wave of biologics patents expiring, the race is on to seize the booming opportunities in the fast-evolving biosimilars field. What’s driving the patent scramble? What hurdles in manufacturing, regulation, and market access must be cleared for biosimilars to thrive? And how are global industry leaders carving out strategies to dominate the market? Don’t miss Bioprocess Online Live happening February 4th.

Jan 15, 2025 | outsourcedpharma.com | Louis Garguilo |Yadnyesh Patel |Vaibhav Patel |Yves Massicotte

Transitioning Your Product from Phase 1 to Phase 2 Clinical StudiesTransitioning oral solid dosage (OSD) forms from Phase 1 to Phase 2 clinical studies demands effective strategies and solutions to overcome formulation and development challenges. This whitepaper explores practical techniques to refine formulations, manage Phase 1 outcomes, and optimize timelines.

Nov 11, 2024 | insights.bio | Vaibhav Patel

Cell & Gene Therapy Insights 2024; 10(10), 1397–1405 DOI: 10.18609/cgti.2024.160 Phase-appropriate analytical controls are critical to ensure the safety, efficacy, and quality of cell therapy products throughout the drug development lifecycle. In the early stages of development, analytical strategies focus on essential attributes that define the product while maintaining the flexibility to adapt to evolving regulatory requirements.

Oct 21, 2024 | pharmaphorum.com | Vaibhav Patel

The pharmaceutical landscape is experiencing a paradigm shift with the rise of gene therapies, cell therapies, and personalised medicine. These innovative treatments hold the promise of tackling previously incurable diseases, providing hope for patients with rare or complex conditions. However, as groundbreaking as these therapies are, they also pose unique challenges for the drug development process, particularly regarding quality assurance (QA).

Oct 12, 2024 | pharmaceuticalonline.com | Vaibhav Patel |Tim Sandle

SEPTEMBER'S BEST FEATURED EDITORIALFDA Issues Revised Guidance On Controlling Nitrosamine Impurities In PharmaceuticalsThe FDA has issued a revised version of its guidance, Control of Nitrosamine Impurities in Human Drugs. This article explores the agency's recommendations, root causes of nitrosamines, and strategies for mitigating their presence in pharmaceuticals.