The increasing aging population and the rise in chronic conditions are driving a higher demand for bio/pharmaceutical products. However, developing these therapies is a lengthy and costly process, often ending without commercial success. Research shows that the attrition rate for drug candidates remains high, with about 90% of those reaching Phase I trials failing to progress.

Transformative Technologies

Digitalization and robotics are key trends impacting various industries, including bio/pharmaceuticals. These technologies are expected to enhance drug formulation by improving efficiencies and reducing the risk of failure.

“Digital enablement is gaining momentum, with around 75% of business-to-business customers preferring digital platforms over in-person interactions,” says Shahrzad Missaghi, senior manager at Colorcon. “Intuitive digital platforms help companies make better decisions early in the process, reducing formulation iterations.”

Sibaji Biswas, executive director at Syngene International, highlights the potential of machine learning (ML) and artificial intelligence (AI) in improving the formulation process and avoiding failures. “AI and ML technologies are increasingly used to predict drug–excipient interactions, allowing for rapid selection of optimal formulations,” he explains. “These models also forecast the properties of drug products based on development data.”

Himanshu Gadgil, CEO of Enzene, agrees that ML and AI offer significant advantages by improving efficiency and effectiveness. “ML uses historical data to predict outcomes and identify trends,” he says. “AI can anticipate the properties of new formulations and validate them before costly lab testing, reducing the risk of failures.”

Platforms like FormulationAI are being developed to enhance formulation development. Vincent Levet, director at Ardena, notes that these platforms help review literature quickly, evaluate compounds through predictive models, and support the formulation process by generating design of experiments (DoEs) studies. However, he cautions that AI adoption brings concerns about intellectual property protection and data breaches.

Challenges with Data Sets

“AI is only as good as the data used to train it,” warns Hanns-Christian Mahler, CEO of ten23 health. He emphasizes the need for expert knowledge and understanding of specific liabilities and challenges of molecules or therapeutic modalities. “Large data sets of well-characterized molecules, combined with expert knowledge, can effectively guide and train AI,” he says. Unfortunately, most companies lack such data sets, necessitating cross-company initiatives.

Bernard Sagaert, CEO of etherna, agrees that large datasets seen in other industries are not yet available in bio/pharmaceuticals. “Structuring data to make it accessible for AI and ML has already helped limit screening efforts and predict pathways,” he says.

Future Focus

Vinay Patil, product development manager at Sharp Services, believes AI and ML tools will focus on gaining efficiency in target identification. “Formulation development can only begin once a target compound is identified and characterized,” he says. “As AI/ML technology matures, more efforts will be made in the drug formulation process.”

Gary Watts, senior manager at Abzena, adds that AI and ML are used to predict formulation stability over long-term storage using early-stage data. “This model has been validated with multiple formulations and is beneficial for projects with tight timelines,” he says.

David Ferrizzi, director at Colorcon, notes that ML and AI allow companies to prototype quickly and cost-effectively. “This capability helps tackle previously insurmountable challenges,” he says. “Personalized medicine and a focus on speed and lower costs are enhanced by ML and AI.”

Personalized Approaches

“Patient-centricity is crucial in formulation design and market success,” says Biswas. “An integrated strategy creates optimized products for patients, considering clinical conditions and therapy requirements.”

Biswas explains that patient-centric approaches are shifting towards personalized medications, where formulations are tailored to individual needs. “New chemical entities are being formulated with advanced technologies to minimize side effects and reduce dosing frequency,” he says.

Sagaert emphasizes the importance of considering all aspects of the platform and product for patient-centric formulations. “For RNA-LNP-based products, ensuring RNA is non-immunogenic and highly expressed in target cells is key,” he says. “The route of administration should be convenient for the patient.”

Mahler adds that understanding patient preferences and needs is essential. “For modern therapeutics, subcutaneous administration using syringe or cartridge solutions with high concentration formulations offers significant benefits,” he says.

Watts notes that personalized medications are a hot topic, with efforts to understand differences in patient sub-groups. “Formulation strategies must focus on the target patient population and align with the final drug format,” he says.

Asma Patel, vice president at Quotient Sciences, highlights the need for age-appropriate and palatable dosage forms for pediatric patients. “Liquid and solid dose formulations that are easier for children to swallow are preferred,” she says. “These forms are also beneficial for the elderly and those with disabilities.”

Missaghi emphasizes the importance of patient compliance and convenience in formulation design. “Understanding patient preferences informs the design of the dosage form,” she says. “Factors like taste, size, shape, color, dosing frequency, and swallowability help with patient satisfaction and compliance.”

Patil adds that companies should solicit patient input throughout the development process. “Flexible dosage forms and minimizing the burden on clinical trial participants are important,” he says.

Levet suggests using quality-by-design principles to define target product profiles and identify critical quality attributes (CQAs) that focus on patient safety and clinical efficacy. “Choosing safe excipients and fast-tracked development approaches allow quicker patient access to efficient treatments,” he says.

The Role of Partners

“Selecting the right development partner can be crucial for clinical and commercial success,” asserts Patel. “Integrated CMC and clinical research services streamline drug development processes.”

Missaghi confirms that partners play a crucial role in early development. “Partners enhance the process with technical capabilities, regulatory knowledge, and understanding of the formulation landscape,” she says.

Levet points out that outsourcing partners guide customers towards efficient and cost-effective formulations. “Phase-appropriate development helps expedite the process, essential for small and virtual companies,” he says.

Biswas concurs, emphasizing the importance of phase appropriateness in expediting drug candidate evaluation. “Outsourcing partners provide a solid platform for quicker delivery of milestones,” he says.

Gadgil adds that outsourcing partners should offer comprehensive solutions and embrace innovations like AI and real-time data integration. “Effective partners leverage modern technologies for integrated, forward-thinking solutions,” he concludes.