Mike Hennessy Jr. is the Chairman and CEO of 

Mike Hennessy Jr.

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Each new chapter in pharmaceutical innovation underscores a simple truth: the path from molecule to medicine is never linear. Scientific discovery, technological evolution, and market demands constantly reshape the landscape, requiring both agility and vision from every stakeholder. This issue of 

® captures the state of that journey, one that is as much about mastering fundamentals as it is about embracing new tools and approaches.

Our cover story, “The Evolving Science Behind Formulation Development,” explores strategies across the drug product lifecycle. Vaibhav Sihorkar, PhD, of Aragen Life Sciences, offers insights into problem solving, the role of digital tools, and how geopolitical change is influencing formulation decisions from a CRDMO’s perspective. The complex area of drug formulation is further explored in Cynthia Challener’s “Personalized and Patient-Centric Administration of Oral Medicines,” which highlights how individualized therapies are moving forward despite the challenges of scalability and regulation.

Ensuring product quality remains at the forefront. In our Ask the Expert feature, Michelle Heiter and Susan J. Schniepp outline best practices for implementing contamination control strategies that safeguard patient safety and regulatory compliance. Meanwhile, the Pharma Fundamentals article by Evonne Brennan reinforces the essential skills professionals need to thrive in this rapidly changing field.

At the critical stage of technology transfer, “Emerging Tools, Integrated Controls Impact Tech Transfer” highlights how smarter systems can streamline the transition from lab to production. In advanced therapies, “Optimizing Testing in Cell and Gene Therapy” underscores the need for agile, compliant testing methods that can keep pace with accelerated development timelines. On the manufacturing front, Susan Haigney’s “Keys to Navigating the Complex Drug Supply Chain” shows how digital tools help manufacturers adapt to ongoing global volatility.

As a whole, this issue reveals an industry strengthening its foundation while embracing innovation. Success now demands not just advanced tools and processes, but collaboration, resilience, and a focus on improving outcomes for patients worldwide.

Mike Hennessy Jr is Chairman and CEO of MJH Life Sciences®.

When referring to this article, please cite it has Hennessy, M. Building Resilience and Precision in Pharma Development. 

Articles

Pharmaceutical innovation is a complex journey shaped by scientific discovery, technological evolution, and market demands. This issue examines the evolving science of formulation development, emphasizing problem-solving, digital tools, and geopolitical influences. Personalized oral medicines face scalability and regulatory challenges. Contamination control strategies are crucial for product quality and regulatory compliance. Technology transfer benefits from integrated controls, while cell and gene therapy testing requires agile methods. Digital tools aid in navigating the drug supply chain amid global volatility. Success in the industry hinges on collaboration, resilience, and patient outcome improvement.

Scientific discovery, technological evolution, and market demands are constantly reshaping the landscape.

Building Resilience and Precision in Pharma Development

As you read this note, pharmaceutical development and manufacturing are being redefined by collaboration, innovation, and the urgent need for agility. The throughline across this issue of 

® is unmistakable: success now depends on integration of systems, data, partnerships, and people.

Our cover story, “Customizable Relationships Enhance Speed to Market,” underscores this reality. As drug modalities become more complex, sponsor companies and CDMOs are moving away from traditional, transactional relationships. The new model is one of shared risk and long-term collaboration, driven by mutual investment in speed, quality, and innovation.

This spirit of innovation is reflected in the development space, where ocular drug delivery continues to challenge formulation scientists. As Cynthia Challener reports in “Advanced Solutions for Sustained Delivery of Ocular Therapies,” sustained-release technologies for eye care are gaining traction, improving compliance and outcomes in an area in which frequent dosing has long been a barrier.

“In-line UV Spectrometry Monitoring in Cleaning Validation” offers a timely look at how Pharma 4.0 principles are reshaping validation. The integration of in-line analytical tools enables real-time monitoring, greater data reliability, and stronger alignment with quality-by-design and digital manufacturing goals.

On the analytics front, “Overcoming PK/PD Modeling Challenges” explores how AI and machine learning are transforming PK/PD modeling. These tools enable faster, more accurate predictions of drug behavior, helping teams avoid costly delays and unnecessary experimentation.

We also examine the realities of small-batch fill/finish operations, including the technologies and process solutions emerging to meet the demands of low-volume, high-value production.

Finally, in “ICH Q12 and Post-Approval Changes,” Siegfried Schmitt sheds light on why streamlined post-approval change management remains elusive, and why it’s crucial for maintaining supply resilience.

Taken together, these articles offer a clear view of where pharmaceutical manufacturing is headed: toward smarter tools, deeper partnerships, and a renewed focus on compliance and quality at every stage of the product lifecycle.

®
Vol. 49, No. 6
July/August 2025
Page: 8

When referring to this article, please cite it as Hennessy, M. The Future of Pharma: Connected, Continuous, and Compliant. 

Pharmaceutical development and manufacturing are evolving through collaboration, innovation, and agility. Success now hinges on integrating systems, data, partnerships, and people. The shift from traditional, transactional relationships to shared risk and long-term collaboration is crucial, especially as drug modalities grow more complex. Innovations in ocular drug delivery, in-line UV spectrometry for cleaning validation, and AI-driven PK/PD modeling are reshaping the industry. Small-batch fill/finish operations and streamlined post-approval change management are also critical for maintaining supply resilience and ensuring quality throughout the product lifecycle.

Pharma manufacturing is headed toward smarter tools, deeper partnerships, and a renewed focus on compliance and quality at every stage of the product lifecycle.

The Future of Pharma: Connected, Continuous, and Compliant

Progress in biopharmaceutical science is happening at a pace that challenges even the most seasoned professionals to keep up. This issue of Pharmaceutical Technology® brings that momentum into sharp focus, offering readers a roadmap through scientific breakthroughs, operational innovation, and the cultural shifts required to deliver tomorrow’s medicines.

Our cover story, “Advancements in Biopharma Spur Industry-Wide Innovation,” looks at how messenger RNA platforms, cell and gene therapy pipelines, multispecific antibodies, and extracellular vesicle therapeutics are reshaping the commercial landscape. Thought leaders predict a future in which no single modality dominates; instead, diverse targeted options will coexist, forcing manufacturing and regulatory models to evolve quickly.

Building on that science, the Development feature, “Achieving Targeted Delivery with Nanoscale Systems,” details how lipid, polymeric, and biomimetic nanocarriers are boosting bioavailability and enabling combination therapies.

Downstream on the factory floor, our Manufacturing Q&A with ACG Packaging Materials’ Sheikh Akbar Ali, PhD, illustrates how digital printing techniques, solvent-free adhesives, and advancements in single-use packaging are helping manufacturers meet productivity goals and prioritize sustainability.

As always, quality and compliance remain front and center. Our Pharma Fundamentals feature, “ICH Q6B for Analytics” translates the quarter-century-old guideline into today’s high-resolution mass spectrometry workflows, clarifying expectations for primary sequence confirmation, glycan profiling, and disulfide mapping. Meanwhile, the Outsourcing feature delves into how artificial intelligence and “hybrid” contract and development organzanizations are redefining sponsor relationships amid geopolitical supply chain pressures.

This issue’s Ask the Expert series dives into the PDA/ANSI Standard 06-2025, offering practical advice for embedding leadership accountability, employee engagement, and technical excellence into an enterprise-wide quality culture.

Together, these articles underscore a central message: success in 2025 demands not only cutting-edge science, but agile operations and a values-driven culture that keeps quality at its core.

When referring to this article, please cite it as Hennessy, M. Driving Advancement Through Scientific and Operational Innovation. 

Scientific breakthroughs, operational innovation, and cultural shifts are driving tomorrow’s medicines.

Driving Advancement Through Scientific and Operational Innovation 

As the pharmaceutical industry moves through a new era of complexity and precision, one truth remains constant: the foundation of every successful therapy is built on quality, consistency, and thoughtful innovation. From raw materials to regulatory harmonization, every link in the supply chain plays a critical role in ensuring that medicines reach patients safely and efficiently.

In this issue’s cover story, “Poor API Quality Threatens a Healthy Supply,” we highlight a pressing vulnerability in the supply chain. As global demand grows and supply networks stretch across borders, even minor lapses in API quality can ripple into major disruptions—slowing production, triggering shortages, and ultimately impacting patient care. Ensuring API integrity is no longer just a manufacturing concern; it’s a business-critical priority.

Product formulation is another key decision point in development. In “Parenteral Formulation: Deciding When to Go Frozen or Freeze-Dried,” we explore how technical performance, cost, and logistics influence formulation strategies. Whether opting for frozen storage or lyophilization, the choice has long-term implications for stability, transport, and scalability.

As in previous issues, sustainability continues to be a recurring and essential theme. “Sustainability by Design” reviews a renewed focus on how early integration of green practices into process development can optimize performance and long-term viability.

We also turn our attention to cleanroom practices, as “Evolving Cleanroom Procedures and Sterility Challenges” outlines how the rise of personalized and small-batch therapies is pushing the boundaries of existing protocols. In a world where every patient may receive a unique formulation, traditional sterility approaches must adapt.

Meanwhile, the future of pharma workforce development takes center stage in “Authentic Intelligence: Finding Diverse Talent in the AI Age.” The industry is at a crossroads—embracing AI while also addressing longstanding gaps in workforce diversity and retention.

Finally, our Ask the Expert column compares European vs. US GMPs, reinforcing the importance of navigating regional nuances even in an increasingly globalized landscape.

Collectively, this issue captures a pharmaceutical sector focused on strengthening its foundation, embracing innovation, and future-proofing its path forward.

Mike Hennessy Jr is president and CEO of MJH Life Sciences®.

When referring to this article, please cite it as Hennessy, M. Quality, Resilience, and Reinvention in Pharma Manufacturing. 

The pharma industry is focused on strengthening its foundation, embracing innovation, and future-proofing its path forward.

Quality, Resilience, and Reinvention in Pharma Manufacturing

The bio/pharma industry is not unfamiliar with “patent cliffs”; however, the current one being faced is notably steep and, in combination with other factors, is set to negatively impact revenues significantly in the near future. A similarly steep patent cliff was experienced by the bio/pharma industry during the 2000s, but at that time industry had the benefit of pricing tailwinds in the United States, helping industry to overcome the related revenue slump (1).

Over the course of the next five years, the bio/pharma industry is expected to see the patents of multiple blockbuster drugs expire, impacting some key industry players and potentially leading the industry to lose up to $400 billion (2). For example, Merck’s humanized antibody therapy, pembrolizumab (Keytruda), is scheduled to lose its patent in 2028; Regeneron/Bayer’s anti-vascular endothelial growth factor therapy, aflibercept (Eylea), is expected to lose its patent either in 2025 or 2026; and Eli Lilly’s glucagon-like peptide-1 receptor agonist, dulaglutide (Trulicity), is set to lose patent protection in 2027 (3).

Furthermore, while this hefty patent cliff is ongoing, industry is also facing a raft of other issues that are straining profit margins. Issues such as newer and more complex therapeutic modalities are trending, which are more expensive for companies to develop and are targeted at smaller patient populations; various geopolitical tensions are causing supply chain concerns; new legislation is shortening the exclusivity period for drugs; and investment being heavily placed on trending disease areas and specific technologies (1).

However, while the patent cliff will need companies to strategically pivot to negate revenue losses, potential opportunities may open up for other companies seeking to develop a generic or biosimilar form of the blockbuster drugs. According to research, many of the biologic therapies that are set to lose their patent exclusivity in the coming years have no biosimilars in development (4). Such a gap in the market could be a lucrative opportunity indeed.

Möller, C.; Kristic, S.; Walker, G.-C.; Aguilar, J.; Chandran, P. Biopharma’s Patent Cliff Puts Costs Front and Center. BCG, Article, Feb. 18, 2025.

DeAngelis, A.; Feuerstein, A. With a Major Patent Cliff Coming, Will JPM Play Host to Some Serious Deal-Making? STAT, Jan. 8, 2025.

Burke, H. Top 10 Drugs with Patents Due to Expire in the Next Five Years. Proclinical, Feb. 16, 2024.

Jeremias, S. The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars. AJMC, Feb. 5, 2025.

Mike Hennessy Jr is President and CEO of MJH Life Sciences®.

When referring to this article, please cite it as Hennessy, M. Facing the Latest Patent Cliff. 

Over the course of the next five years, the bio/pharma industry is expected to see the patents of multiple blockbuster drugs expire, impacting some key industry players.

Facing the Latest Patent Cliff

Technological advances are continuing to push boundaries for global industries. Artificial intelligence (AI) is one such advancement and is being increasingly employed in research and scientific work across multiple disciplines as a result of its ability to improve efficiencies.

A recent example of how AI is improving efficiency at the research stage has been demonstrated by co-scientist, Google’s new AI research tool, which solved a complex problem about superbugs—that had taken microbiologists a decade to work out—in a mere 48 hours (1). Google’s AI tool, built on Gemini 2.0, has been created to help scientists generate novel hypotheses and research proposals, which it does through a combination of specialized agents based on scientific methodology (2).

“The AI co-scientist represents a promising advance toward AI-assisted technologies for scientists to help accelerate discovery,” said Juraj Gottweis, Google Fellow, and Vivek Natarajan, Research Lead, in a blog post (3). “This project illustrates how collaborative and human-centered AI systems might be able to augment human ingenuity and accelerate scientific discovery.”

On the theme of collaboration, earlier this year, in January 2025, accelerated computing company, NVIDIA, announced new partnerships with IQVIA, Illumina, Mayo Clinic, and Arc Institute, to transform the healthcare and life sciences industry with AI (4). Using AI agents, NVIDIA’s partners are seeking to accelerate clinical trials, advance drug discovery, and support industry growth.

Looking a little further along the development lifecycle, towards the larger-scale commercial manufacturing end, the benefits of smarter technology and AI implementation are also being seen. However, as highlighted in this issue’s Focus piece, which can be found on pages 10–13, while technological advances are accelerating progress, there are still hurdles to overcome. “Plenty of challenges stand in the way, including cost of implementation, regulatory compliance, and more. We have heard from experts who anticipate that fully automated, ‘lights-out’ biomanufacturing facilities could become a reality within the next five to 10 years,” explains Anthony Christopher, commercial manager of bioprocessing at Kent Elastomer Products (5).

Gerken, T. AI Cracks Superbug Problem in Two Days that Took Scientists Years. 

Haigney, S. Google Launches AI Co-Scientist System. 

Gottweis, J.; Natarajan, V. Accelerating Scientific Breakthroughs with AI Co-Scientist. Blog Post. Google Research. Research.google. Feb. 19, 2025.

NVIDIA. NVIDIA Partners with Industry Leaders to Advance Genomics, Drug Discovery, and Healthcare. Press Release, Jan. 13, 2024.

Mirasol, F. Accelerating Adoption of Smart Tools to Advance Manufacturing. 

Mike Hennessy Jr is President and CEO of MJH Life Sciences®

When referring to this article, please cite it as Hennessy, M. Pushing Tech Boundaries. 

Artificial intelligence, among other technological advances, is pushing innovation boundaries.