The Top 10 PharmTech Videos of 2025

A look back at the top 10 PharmTech videos of 2025 reveals several overarching themes dominating the pharmaceutical industry landscape, primarily centered on advancing complex therapeutic modalities, navigating stringent regulatory environments, and accelerating development through technological integration. A significant focus across these videos was on specialized medicines, including gene therapies using adeno-associated virus (AAV) vectors, the challenges of high-concentration biologics formula tion, and the promise of radiopharmaceuticals for targeted cancer treatment. These advanced therapies necessitate novel manufacturing strategies, such as the adoption of the "CGT 2.0" paradigm for cell and gene therapy (CGT), which emphasizes flexibility, scalability, automation, and data analytics to overcome bottlenecks and ensure commercial viability.

Crucially, these advancements are underpinned by a strong emphasis on quality systems, regulatory compliance, and digital transformation. Discussions throughout the year addressed common regulatory hurdles, such as responding effectively to FDA warning letters regarding insufficient Quality Control units, and the complexity of ensuring drug safety by performing rigorous extractables and leachables studies. Furthermore, the industry is increasingly leveraging artificial intelligence (AI) and machine learning to optimize various workflows, including in silico compound screening, predictive manufacturing controls, and accelerating discovery by generating novel hypotheses. This dual focus—on cutting-edge biological science and the application of modern data technology—reflects the industry’s push toward faster, safer, and more personalized medicine in 2025.

Let’s take a look back at our top 10 videos of 2025:

1. Behind the Headlines Episode 24: Surging Implementation of Sequence Event Reporting in CMC Analytics, Billion Dollar Deals Push Further Consolidation or Collapse, and an Analytics Wish List

Episode 24 of Behind the Headlines investigated the latest trends and factors driving pharmaceutical news, including a round of "mega-deals" fueled by “big Pharma” patent cliffs and the necessity of acquiring diverse technological expertise for manufacturing complex advanced therapy medicinal products. Panel discussions focused on major acquisitions, such as AbbVie's purchase of Bretisilocin and the collaboration between Enlaza Therapeutics and Vertex Pharmaceuticals. Significant time was spent analyzing the $17.5 billion Waters-Becton Dickinson deal, concluding that Becton Dickinson’s recurring revenue and regulatory knowledge in diagnostics and precision medicine were the main attractions.

2. Advancing Radiopharmaceutical Development

In this interview, Juliana Maynard, PhD, head of Translational Imaging, at Medicines Discovery Catapult (MDC), discusses what makes radiopharmaceuticals unique and how MDC’s collaboration with Crown Bioscience can help developers of these treatments for cancer. Radiopharmaceuticals are a unique class of medicines that incorporate a radioisotope for both diagnosing and treating cancers, known as a "theranostic" approach, Maynard explained. These treatments offer precision by targeting radiation directly to tumors, significantly reducing the radiation dose to the rest of the body compared with traditional cancer therapies, thus sparing healthy tissue and lowering side effects, she noted. However, development faces challenges, including securing a reliable global supply of radioisotopes, complying with high regulatory and quality standards, and managing the logistics of manufacturing products with short half-lives that often require same-day injection.

3. PharmTech Weekly News Roundup – Week of September 29, 2025

This roundup of all our news from the week ending on Oct 3, 2025, covered pharma news on AI's role in drug development, new FDA/EMA guidance, clinical advances, MFN pricing agreements, and ongoing quality control challenges. The news items discussed included:

• White House, Pfizer Agree on MFN Pricing
• FDA Draft Guidance’s Impact on Clinical, CMC Strategies
• EMA to Include More Patient Perspectives
• FDA’s Remibrutinib Approval and the Future of BTK Inhibitors
• ‘Behind the Headlines’ Episode 26, looking at clinical trial progress for multiple myeloma and breast cancer, Merck's FDA approval for a subcutaneous formulation of Keytruda, and Pfizer's acquisition of Metsera to enter the weight-loss drug market.
• How AI Is Accelerating Pharmaceutical Development

4. Drug Digest: Patient Preference Drives Solid Dosage Trends

This Drug Digest video features Lonza’s Adi Kaushal summarizing the current market state and emerging trends in oral solid dosage (OSD) formulation. The discussion confirms that patient preference is the driving force behind solid dosage trends. A major theme was how contract development and manufacturing organizations leverage their experience and expert techniques to overcome key challenges for developers, particularly focusing on improving OSD bioavailability.

5. PDA Regulatory Conference 2025: Wrap Up

In the wrap-up of the 2025 Parenteral Drug Association (PDA) Regulatory Conference, Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates, joined PDA CEO Glenn Wright and Melissa Seymour, Executive Vice President, Global Quality, Eli Lilly and Company to highlight several "hot topics," including quality culture, import alerts, artificial intelligence, and transparency. Wright noted that the topic of complete response letters proved exceptionally popular and required an extended session, underscoring the substantial industry interest in the number and percentage of these letters being issued.

6. PharmTech Weekly News Roundup – Week of October 6, 2025

This roundup of all our news from the week ending on Oct 10, 2025, covered the pharmaceutical industry’s recent developments and current regulatory landscape. The news items discussed included:

1. Building in Flexibility and Commercial Viability Early in CGT Scaling
2. AstraZeneca’s US Expansion Highlights AI, Automation, and Policy Pressure
3. Collaborating on the Development of Radiopharmaceuticals
4. Schreiner MediPharm Launching RFID-Embedded Label at CPHI Frankfurt
5. DemeRx’s Neuroplastogen Candidate Signals New Alcohol Use Disorder Approach
6. RedHill's $1.8M Middle East Deal Signals Global Demand for Effective H. pylori Treatment

7. AAPS National Biotechnology Conference 2025: High-Concentration Biologics

The formulation of high-concentration biologics presents significant challenges, despite the growing need for patients to administer these drugs at home using devices like pre-filled syringes or autoinjector cartridges, according to Lun Xin, associate director at WuXi Biologics, in this video interview. Biologic drugs typically require higher dosages than small-molecule drugs, he noted, adding that since the subcutaneous volume limit is approximately two milliliters, developers must concentrate protein therapeutics to several hundred milligrams per mL to deliver the necessary dose.

8. Ask the Expert: Studies for Extractables and Leachables

In this episode of the Ask the Expert video series, Schniepp talked to Piet Christiaens, PhD, scientific director, E&L expert at Nelson Labs, and Dennis Jenke, PhD, principal consultant for Nelson Labs and chief executive scientist, Triad Scientific Solutions, about extractables and leachables and the testing required for each.

9. Ask the Expert: Quality Control Units

In this Ask the Expert episode, Schnieep and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how to address an FDA warning letter citation for a failure to establish a quality control unit. Schmitt explains that receiving a warning letter means the company's initial response to the observations on Form 483 was considered inadequate or incomplete by FDA. The essential response strategy involves admitting the shortcoming and providing a complete and convincing remediation plan that the authorities will accept.

10. AAPS National Biotechnology Conference 2025: AAV Vector Production

Noah Kopcho, field application scientist at Gyros Protein Technologies, addresses the challenges involved in the production of Adeno-associated virus (AAV) vectors, which are commonly used in gene therapies. A key difficulty is that AAV often exhibits lower titers compared with other vectors, creating problems for scalability, he says. The workflow for production and purification must maintain strict purity, requiring careful monitoring of several different contaminants.