Thoughts From Industry Experts Before They Head to Milan
As 3,000 companies and 60,000 attendees finalize plans before heading to Milan for the 35th anniversary of CPHI, you might have started thinking about what’s on offer and who you are going to catch up with next week.
If you’ve read any of our previous editions of The Pharma Navigator, you will be all too aware of the breadth of innovation and trends that are happening within the industry. We spoke with executives from pharma and services companies to ask them what industry developments and trends interest them prior to this year’s event:
Innovation & Trends in Drug Delivery
The drug delivery market is witnessing a surge in innovation and investment as pharmaceutical and biotech companies continue to develop new systems for improved therapeutic outcomes. The sector - traditionally dominated by oral, injectable, and transdermal methods - is rapidly evolving due to recent advancements in nanotechnology, materials science, and biotechnology.
As a result, a diverse array of new delivery technologies have emerged, aimed at enhancing bioavailability, targeting specific tissues, and offering more patient-friendly solutions. The industry’s focus is shifting from merely administering drugs to designing sophisticated systems that optimize how, when, and where drugs are released in the body.
“Based on recent pipeline developments in advanced modalities - ADCs, RNA, MAbs, Cell and Gene Therapies and NCEs - it's clear that personalized medicines are poised to revolutionize the biopharmaceutical landscape,” comments Pratibhash Chattopadhyay of Expert Insights Consulting. “But developing these therapies isn’t easy and demands the production of highly specialized, low-volume batches; often using single-use systems, modular designs, and cutting-edge technologies.”
The Rise of Biosimilars & Generics
Yet the drug development market isn’t all about new innovations and technologies; biosimilars and generic drugs are experiencing rapid growth and strong industry interest thanks to their potential at delivering cost-effective alternatives to branded pharmaceuticals.
As patents for blockbuster biologics and small-molecule drugs expire, there is increasing pressure from healthcare providers and governments to reduce drug costs without compromising quality. This has already led to a surge in both the development of generics and the production of biosimilars, and companies are racing to capture market share in this lucrative sector - presenting significant opportunities for both established players and new entrants.
Srini Paluri, SVP & GM of bioprocessing & purification technologies at Ecolab (stand 3D46) commented on the increased competition between drugs as more come off patent and new targets are discovered, “When a company plans a new drug launch to address an indication that has an established treatment, it must set its product apart - regardless of it being an innovator drug, generic, or biosimilar.”
“Formulation development and manufacturing efficiency are crucial in ensuring a differentiation to marketed drugs, for example through improved bioavailability, extended release, and taste-masking. Paluri also cites improved manufacturing efficiencies as being able to “reduce cost of goods sold (COGS), and enable increased accessibility to more patients.”
“CPHI will be an invaluable platform for executives to engage with experts to help meet their drug product and business needs. At Ecolab Life Sciences will have formulation development and bioprocessing experts onsite at CPHI to discuss customers’ unique challenges of their drug development and manufacturing,” said Paluri.
The Roles of CDMOs & Service Providers
Regardless as to whether you are developing new drug technologies, repurposing patented medication, or developing something else, more pharmaceutical and biotech companies are seeking external partners to support their development and production.
For startups and smaller companies, this often comes as a result to streamline operations, reduce costs, and accelerate time-to-market for new therapies, which often lack the in-house capabilities for full-scale production, whereas larger companies often seek the flexibility and scalability that CDMOs offer.
John Chiminski, a past Chair and CEO of Catalent commented, “After 15 years at the helm of a CDMO, I can tell you that there is one aspect above all others that you should focus on when getting to know any CDMO that you think has the capabilities and the expertise to address your project need: it's their quality culture and track record! How they set the tone for quality, how they operate their quality operating system, how they drive regulatory compliance, inspection readiness and response, how they invest in quality upgrades, personnel, training and resources, and what is their inspection track record. Those are the key aspects or you to be able to confidently place your key project with them with more assurance of reliable high quality delivery day in and day out."
With the CDMO industry thriving, there seems to be more support and specialization available to companies looking to outsource. Elliott Berger from Orientation Marketing said, “In response to rich, but increasingly complex pipelines, many CDMOs have made very substantial investments, sometimes billions of dollars, into their capabilities. The show provides industry executives an opportunity to explore and discuss these new options to improve and advance their pipelines with right technologies and right partners.”
Some of the reasons for significant investment in CDMO services can be partly attributed to the wide variation in services required, as highlighted by Stacey R. Williams, VP Marketing at Alcami (stand 5D17), “Outsourcing storage for pharmaceutical and biotech companies is one of these things that you don’t realize you need until you NEED it. Covid really exposed some of the gaps in capacity to store material at volume but now, post-Covid, we’re seeing that many of the newer, complex medicines, APIs, treatments etc require very customized cold and freezer storage (think liquid nitrogen storage!) Storage isn’t usually at the top of the list of considerations, but it certainly needs to be on a checklist if you are supporting complex medicines or materials. You need a long-term solution that can safely house your most prized possessions.”
Jamie Grabowski, VP of Business Unit Operations, API at Curia (stand 7A18) highlights how specific industries can play an important role, “CDMOs capable of API manufacturing across diverse Western geographies offers key advantages, such as reducing single geographic supply risks and creating stronger, more resilient supply chains. While costs may be higher, the long-term benefits of sustainability and stability far outweigh the potential expense. Industry executives attending CPHI should engage in friendshoring discussions to safeguard drug supply and meet evolving market demands with greater confidence.”
All the executives we spoke with expressed their excitement ahead of the show. Kurt Nielsen, Ph.D., principal at Expert Insights Consulting was positive about the show’s potential, “CPHI will be a great opportunity to discover how targeted drug delivery technologies and advanced manufacturing can unlock their therapeutic potential for patients anywhere in the world.” Chattopadhyay added that he found the prospect of finding out more compelling, asking, “how companies are not only seizing opportunities in this rapidly growing market but also addressing the operational complexities needed to drive sustainable value creation.”
CPHI Milan runs from October 8 – 10, 2024 at the Fiera Milano, Italy.
