Meeting Modern Needs: Top Insights from Drug Development and Delivery Insights for 2025 Day
As the complexity of drug molecules evolve and patient expectations grow, industry leaders reveal why the next generation of drug delivery must balance cutting-edge science, flexible manufacturing, and patient-centric design.
The global population is aging and the incidence of chronic diseases is rising, leading to an increased need for safe and effective therapies that are also convenient to take and affordable. However, development pipelines are becoming more complex, giving rise to more challenges for drug development and delivery.
During the Drug Development and Delivery Insights for 2025 Day (1), hosted by Fierce Pharma in partnership with Orientation Marketing, industry leaders and innovators tackled some of the most pressing questions facing modern drug development: How do we address the rising scientific complexity of novel molecules and therapeutic modalities to meet the demands of modern patients? In this summary article, the key takeaways and contrasting perspectives from senior executives across leading CDMOs, drug delivery specialists, and biotech innovators who participated in the event are highlighted. Although approaches differ, the consensus is clear: success will rely on solutions that deliver measurable improvements in therapeutic performance and patient experience, while ensuring scalability and compliance in a competitive market.
Drug Delivery: A Strategic Lever
A rapid-fire panel session, hosted by Elliot Berger, Board of Directors and Strategic Advisor, Orientation Marketing, and former Chief Marketing Officer at Catalent, together with senior leaders from Terumo, Nanoform, and Oregon Freeze Dry Life Sciences (OFD), kicked off proceedings for the exclusive event. During the session, the most pressing trends reshaping drug delivery today and the practical solutions now gaining traction were discussed. Despite the experts having contrasting viewpoints and technical focus, one message came through loud and clear: drug delivery has moved from being a technical afterthought to a strategic lever for clinical success, market differentiation, and patient impact.
“I think patient centricity is really at the top of everyone’s mind currently [and] enhancing the patient experience and patient centricity in everything we do,” said Philippe Lauwers, Technology Development Director, Terumo Pharmaceutical Solutions Division. “This is also fueled by the hospital-to-home care transition.”
By way of example of patient centricity, Lauwers described his company's work on tailored release formulations, microencapsulation, and 3D printing. Terumo’s integrated approach allows for drug release profiles to align precisely with patient and disease needs, creating customized dosage forms that improve convenience — particularly for pediatric and geriatric patients, he added.
The consensus amongst the panel was that science is becoming more complex, yet patients increasingly demand simplicity — bridging this gap is where drug delivery technologies add real value. Breakthroughs in AI-driven molecule design, bioengineering, and novel therapeutic classes are rapidly expanding the treatment landscape (2); however, these advances bring significant industry-wide challenges - from complex formulation requirements to the need for entirely new delivery technologies.
Dan Peizer, VP of Business Development at OFD spoke about modernizing an established technology — lyophilization. By building their own chambers and controls, OFD fine-tunes freeze-drying for complex biologics to enhance stability and reduce cold chain reliance. The company is also developing discrete lyophilized dose forms that bypass the gut and liver, crossing the mucosal barrier in the mouth that could simplify administration and improve absorption.
“[Innovators] really need to explore new ways to preserve and stabilize these ingredients and deliver them effectively,” Peizer said. “Lyophilization is definitely a tool that can help [to] deliver new and innovative ways to help those drugs be delivered [and] improve the bioavailability of a variety of different drugs.”
Another point of agreement was the challenge of polypharmacy (3) - the simultaneous use of multiple medications by a single patient. With patients living longer, it’s not uncommon for them to receive medication for multiple chronic conditions which can increase the risk of drug interactions, side effects, and treatment non-adherence.
Christian Jones, Chief Commercial Officer at Nanoform, explained how they’re using proprietary nanocrystalline platforms to boost bioavailability and shrink pill sizes. For example, compressing multiple oncology tablets into a single, smaller dose not only tackles the polypharmacy burden but also extends intellectual property protection and product life.
“Polypharmacy is a real burden on many patients,” asserted Jones. “Tablets can be quite large and difficult to swallow, and injections might be numerous. If there are opportunities to reduce the number of injections [or tablets], these are areas where drug delivery and smart formulations can play a role.”
Finally, the panelists highlighted the competitive, cost-constrained market environment. In therapeutic areas like biosimilars (where first-to-market often wins), companies need drug delivery strategies that reduce risk, shorten timelines, and protect product value long after launch.
While each company emphasizes different technologies and areas of focus, the panel agreed on the same fundamental point: successful drug delivery must combine scientific performance with patient-centric design and commercial value. Technologies that simplify dosing, improve stability, and enable new ways to deliver therapies will define the next generation of accessible, effective treatments.
Aligning New Modalities with Innovative Solutions
As new therapeutic modalities emerge, new formulations and technologies will determine what is successful or not. To meet the evolving needs of complex therapeutic pipelines, Adare Pharma Solutions is advancing tailored release technologies.
“Tailored release is selected with the clinical purpose in mind. Whether the goal is to match symptom timing, deliver the drug at the disease site, or reduce dosing frequency, or even respond to physiological triggers, the release profile is aligned with the therapeutic objective,” said Dr. Srinivasan Shanmugam, Executive Director of Pharmaceutical Services, Adare, during one of the tech talk sessions from the Drug Development and Delivery Insights for 2025 Day (1). “Tailored release isn't just a formulation choice anymore; it's a strategic tool to optimize outcomes in real world clinical scenarios.”
To achieve tailored release, Adare is pioneering the use of 3D printing to create easy-to-swallow, highly personalized dosage forms with precise control overdose, release kinetics, and physical design. This technology enables multi-compartment systems and combination therapies tailored especially for pediatric, geriatric, and patients managing complex treatment regimens.
When discussing innovation in topical and mucosal drug delivery, Jon Lenn, PhD, Chief Scientific Officer at MedPharm spoke about the benefits of combining scientific rigor with patient-centric design. Of particular note are MedPharm’s advanced in vitro and ex vivo skin models, which allow extended viability to enable detailed studies of drug delivery, efficacy, and barrier repair across multiple epithelial barriers to de-risk clinical development.
Emphasizing patient acceptance, Lenn highlighted how sensory attributes, such as cosmetic feel and ease of application, are critical for consistent use. “Some of these products are applied daily for long periods of time, [with] a huge sensory component to these formulations. We can use a series of in vitro and ex vivo models to develop and optimize these formulations and also support the claims,” he explained. “These preclinical models can be really used to de-risk [development] before you get to the clinic to minimize some of those clinical failures, or they can also be used to support the claims on the cosmetic side.”
Regarding formulation design, Lenn states: “Our formulation approach is going to be similar across the different epithelium. We just really build that formulation around the compound. Then the formulation becomes specific to the barrier of the route of delivery.”
Flexible CDMO Solutions
Developing new formulation technologies for advanced modalities is only half the battle — the next challenge is translating laboratory-scale innovation into robust, scalable manufacturing processes that can reliably deliver quality and consistency at commercial volumes.
For CDMOs, offering flexible, integrated solutions across different molecule types, batch sizes, and regulatory environments is no longer a differentiator but a necessity. Regional supply chains, such as “U.S. for U.S.” and “Europe for Europe” models, are becoming the norm to build resilience and redundancy (4). For smaller biotech's, partnerships with trusted CDMOs are critical to maintain supply continuity and de-risk scale-up in an unpredictable market.
To ensure flexibility and regionalization, Recipharm has invested in pilot-scale equipment across all its sites, enabling rapid scale-up from clinical to commercial production regardless of location, explained the company’s CEO, Greg Behar. “We’ve implemented this pilot scale capability across every single site that is in our network,” he explained. “That basically allows us to go very quickly from a process that has been designed by the customers to our pilot scale and then very quickly also to scale from pilot to commercial.”
This infrastructure, combined with a deliberate regionalization strategy, allows Recipharm to offer clients both speed and security in bringing products to market. The collaborative approach — characterized by real-time data sharing and integrated project management — fosters transparency and agility, ensuring that projects can pivot quickly in response to changing circumstances or client needs.
Behar highlighted how this mindset shapes their operations: “We try on the CDMO side to be fast and flexible and agile,” he said, noting that the evolving CDMO model demands “the speed, the agility, the flexibility that you need.”
Integrated CRDMOs (Contract Research, Development, and Manufacturing Organizations), which offer end-to-end services for innovators under one roof, are becoming increasingly popular. By combining discovery, development, manufacturing, and regulatory support, these partners reduce vendor handoffs, enable parallel workstreams, and improve communication through a single quality system and point of contact.
BioDuro is a leader in this integrated model. The company offers a comprehensive suite of services, including drug substance and product development, analytical and quality control, and regulatory management. Such an integrated approach allows for parallel workflows, unified quality systems, and seamless communication, which together significantly accelerate development timelines and reduce risk.
As Jim Lee, President of Global CMC Solutions at BioDuro noted in his tech talk from the Drug Development and Delivery Insights for 2025 day (1): “One of the solutions is to find a large CRDMO who can do the integrated service from hit identification to lead optimization, all the way to API and CMC development work that can be done in one organization. Because that integrated service will be more efficient.”
“With an integrated CRDMO, you can do many work [streams] in parallel and that will save a lot of time, speed up your program, and also [provide] a single contact point to help you quickly manage the progress of the project,” Lee summarized “[Additionally, customers benefit from] one systematic unified quality system to make sure every part of the study follows FDA guidelines and GMP quality guidelines.”
Smarter Formulations
Flexible manufacturing and regionalized supply chains address the physical production and logistics risks. But as drug development and manufacturing become increasingly complex, so does the regulatory and analytical support required to enable success.
This is especially true as new modalities and novel formulations introduce more variables; increasing the stakes for consistent quality, data integrity, and timely approvals across multiple markets. "Modern biology has identified difficult-to-drug targets,” said Rod Ketner, Vice President, Business Operations, Serán Bioscience, in a fireside chat from the Drug Development and Delivery Insights for 2025 day (1). “These complex molecules and the difficulty to deliver them are requiring innovative technologies and the application of existing technologies in new ways.”
Serán Bioscience integrates physiologically based pharmacokinetic (PBPK) modeling (5) with dissolution data, to predict and optimize bioavailability and inform the design of dosage forms to maximize clinical performance. The company’s expertise in high-concentration subcutaneous injections further improves bioavailability, reduces injection volume and frequency, and supports patient-friendly, scalable dosage forms that enhance adherence in chronic therapies. “This approach of using science upfront to identify the right formulation from the start is an area where we specialize in — to bring our clients’ medicines to patients faster,” Ketner remarked.
Recipharm is another company accelerating progress with digital transformation. Their ReciPredict platform (6) combines material science simulation with predictive modeling to optimize formulation and tech transfer, reducing development cycles, API usage, and costs. This digital-first approach streamlines both development and manufacturing, helping clients meet aggressive timelines and regulatory requirements by using real-time data sharing and integrated project management throughout projects. This enables agile responses to regulatory feedback and ensures submissions are tailored to the specific requirements of each market.
“We developed [ReciPredict] to better foresee how we would set up a tech transfer successfully and increase the success rate and reduce the speed,” Behar commented. “It gives our development team and our customers a clear understanding of how formulation will behave, which means fewer trials, fewer cycles, and faster decisions. The first projects we implemented with ReciPredict have been very successful — we saw a reduction of the tech transfer time by about half and reduced API usage by up to 70% in some cases. For companies with tight budgets, that makes a lot of sense.”
What This Means for the Future
The insights shared throughout the Drug Development and Delivery Insights for 2025 Day make one thing evident: drug delivery and innovation are no longer peripheral considerations, but fundamental to how companies will achieve clinical, commercial, and patient success in an increasingly competitive market.
The range of solutions being developed highlights the industry’s determination to bridge the gap between scientific complexity and patient-friendly, scalable treatments. But while some organizations are clearly leading the way, others risk being left behind if they fail to adapt to the practical realities of new modalities, global supply chains, and rising patient expectations.
Drug developers that are willing to combine scientific rigor with patient-centric design, backed by robust manufacturing and regulatory capabilities, will be best placed to deliver the next generation of therapies. For an industry under constant pressure to do more with less, this balance may prove the decisive factor that sets future market leaders apart from companies that fail to adapt.
References
Fierce Pharma. Drug Development and Delivery Insights for 2025 Day. Virtual Event, May 14, 2025.
Vamathevan, J.; Clark, D.; Czodrowski, P.; et al. Applications of Machine Learning in Drug Discovery and Development. Nat. Rev. Drug Discov., 2019, 18, 463–477.
WHO. Medication Safety in Polypharmacy. Technical report, June 2019.
Stanfield, M.; Horan, S.; St. Sure, S; Wildish, S. Building Resilience in a Commercial-Stage Pharma Company’s Supply Chain. LEK.com, Case Study, April 2025
Deepika, D.; Kumar, V.; The Role of “Physiologically Based Pharmacokinetic Model (PBPK)” New Approach Methodology (NAM) in Pharmaceuticals and Environmental Chemical Risk Assessment. Int. J. Environ. Res. Public Health. 2023, 20 (4), 3473.
Recipharm. Introducing ReciPredict: Revolutionising Drug Product Development and Manufacturing. Press Release, Sept. 4, 2025.