The demand for outsourcing pharmaceutical formulation development and manufacturing is on the rise for drug developers at all levels, especially in emerging markets like India. Frost & Sullivan estimates the global contract research organization (CRO) market will reach $64.58 billion by 2021. Many formulators from CROs who support pharmaceutical and biotechnology industries told us they feel pressure from U.S. and European clients to deliver solutions for oral medications (such as chewable tablets) and topically administered medications. Formulation challenges with these and other drug delivery systems include API solubility and absorption once administered.
Last December, more than 150 formulations scientists and information professionals from pharmaceutical, biotech, agrochemical and cosmetics companies – including CROs and generics firms – came together in Mumbai, Hyderabad and Bangalore, India to talk with CAS about their challenges. During the events, we discussed formulating, product development and export challenges, product development pipelines, and research activities.
During our visit to India, we introduced the attendees to Formulus®, a new solution from CAS that supports product development research and reduces the number of iterations in the lab. The dialogue between CAS and India-based formulators illuminated key challenges they face and the importance of efficient workflow solutions.
In this blog post, I will share more about what we learned during our week in India and discuss the many challenges faced by formulators around the world.
Formulators working to increase efficiency in development process
Formulators want to spend their time innovating – not troubleshooting supply chain issues or being surprised by increased or new regulatory burdens. For formulators, the ingredient supply chain goes from experimental sample size to manufacturing scale for products that make it to market.
Formulators also face increasing complexity with ingredients. Incorporating multiple active ingredients, increasing regulations, changing social and consumer preferences, and environmental implications impact product production, as does usage and eventual decomposition. Formulators are concerned with how their products help patients and consumers, as well as their overall environmental impact.
Financial pressures are always present. R&D investments can be large, with costs accounting for 35% of overall product-to-market expenditures in the pharma sector. What if there was a way to reduce these costs with faster iterations and more efficient ingredient research to identify suppliers and regulatory information?
Coupling formulations data with information about ingredients, regulations, sources
Formulators must address many competing needs as they develop products: Is it effective? Is it safe? Is it easy for a consumer/patient to use? Answering these questions in one place rather than many increases efficiency in the research process. For example, many pharmaceutical companies in India are large exporters to Latin America, North America, EMEA and other Asian countries. Having regulatory information for many geographic regions in one place supports the need to quickly check drug approvals across many export destinations.
For contracted formulators, knowing if a drug has marketing approval by the U.S. or by the regulatory body in the export locale is critical. If approved, formulators also need to be aware of approvals regarding delivery routes, strengths, physical forms and the exact chemical composition of the active ingredient. This is especially important for generics because a different salt form of an active ingredient may be considered a different drug. Formulators also need to be aware of regulations regarding excipients. Exporters in India were especially concerned with regulations in Latin America and the U.S.
Ingredients go in, out of favor with consumers
In both the domestic and export markets, consumers have increasing preferences about ingredients – both active and inactive. With social media and increased transparency, consumers have easy access in layman’s terms to others’ experiences with medications, and they form their own opinions based on what they see, hear and read. The pharma industry must respect these quickly changing trends and adapt their products to meet consumer demands, while still adhering to regulations and maintaining effectiveness.
Sharing data throughout product development pipeline
The product development process is not linear! Formulators work continuously in a large ecosystem of synthetic chemists, IP professionals and attorneys, marketers, physicians, regulatory specialists, and toxicologists, sharing information early and often to help the pipeline move efficiently and reduce pitfalls. Within this ecosystem, formulators have a strong role. Feedback from others in the ecosystem aids the pipeline, such as patient-experience information from physicians that goes beyond drug efficacy. This can inform future innovations and ways to deliver a more positive experience for patients.
During our visit to India, we helped formulators learn new ways to share information electronically and in ways that everyone can access the same information. Formulations are not just the ingredients that make the drug – they are the delivery system, the absorption system and the physical form. The manufacturing process impacts formulations and formulation affects the manufacturing process. Manufacturing challenges can result in the need to re-formulate. Formulators must be mindful of these early on in the product development cycle to mitigate this risk, though sometimes it is unavoidable. A formulator’s work is never done, but the more they are equipped with information and research tools early in the product development cycle, the more time they have to develop the next product versus iterating.
Schedule a demo of Formulus, a new solution from CAS aimed at getting innovations to market faster by addressing the unique information needs of formulation scientists.