Industry experts gave insights on what they expect from excipient manufacturers
DuPont organised ‘Health by Design’ symposium in Mumbai and Hyderabad, with the aim of updating the pharma industry about the latest trends and innovations in drug delivery development and productivity enhancement. The event connected industry experts from all different stages of development to discuss pressing development topics, including selecting the right technology partner, how to transform current drug development processes and more.
Chief Guest Shirish Dabhade, retired Assistant Commissioner, Maharashtra FDA, kicked off the day by tapping into his more than 21 years’ experience, reflecting on the time in the late 80’s and 90’s when time-consuming and laborious manual and semi manual tableting techniques were used. He highlighted the role of advanced technologies and increasing dependency on Artificial Intelligence (AI) in pushing current pharmaceutical boundaries, emphasising the necessity of having a skilled staff to optimise the use of new technology. He also briefly touched on more recent innovations, like derma patches and microneedle patches, pointing out how such innovations are improving healthcare in India by offering patient-centric dosage forms that are virtually pain-free to improve the compliance and effectiveness of medication.
Two of DuPont Nutrition and Health’s top executives in the South Asia region – Prashant Chitgopekar, Deputy General Manager, and Sangesh Torne, Application Development Manager—presented on discovering new possibilities to improve productivity and differentiation in the marketplace. Chitgopekar discussed the challenges faced by generic-producing companies and how they have impacted their bottom line, including lower sales growth, lower profitability and value proposition challenges. To help offset the decreasing return on high investments in R&D, he suggested ways by which companies could increase returns on innovation. He challenged attendees to focus on three specific avenues—continuous manufacturing, productivity and differentiation – to expand their footprint both globally and domestically by stretching the pharma product lifecycle to overcome current market challenges.
Taking over from Chitgopekar, Torne emphasised the need to increase productivity by utilising the functionality of a continuous manufacturing process. He focused on the benefits of a continuous process, including fewer process steps, less time and improved process robustness, as well as shared insights on methods to help minimise the pains of switching to the process. While highlighting the advantages of process innovations like Moisture Activated Dry Granulation (MADG) in the wet granulation process, he explained how various excipients in the combined DuPont + Dow+ FMC portfolio could reduce the number of steps and time taken in the production cycle, thus helping companies transition from batch to continuous manufacturing. These products are designed with solubility and controlled release methods for wet granulation process in mind.
Up next, Gopeshkumar Singh, Application Development Manager, South Asia, DuPont Nutrition and Health, shared techniques to help formulators solve bioavailability challenges. Briefing about the challenges faced by the industry in hydroxypropyl methylcellulose (HPMC) process, he discussed novel excipients in DuPont’s portfolio for bioavailability, immediate release and controlled release purposes to help increase the solubility of APIs, simplify processes and improve patient compliance. Singh emphasised the rising demand for novel excipients and explained that this demand could be met by tailor-made HPMC.
Tejas Gunjikar, Application Development Leader, South Asia, DuPont Nutrition and Health, started his presentation by asking the audience to list the challenges they face during regulatory filling. A common pain point that emerged was the need for bridging documents, and the fact that the Inactive Ingredients Database (IID) changes every three months. He shared tips on navigating ingredient database challenges for successful filling, including insights into US FDA’s expectations from pharma companies before ANDA filing and approval. Concluding his presentation, he mentioned how DuPont is able to assist client pharma companies in preparing bridging documents, and urged attendees to provide not just the data, but the justification and context of use of a particular excipient as well.
Besides these scientific power packed sessions, the audience also had a lot to gain from the panel discussion, moderated by Viveka Roychowdhury, Editor, Express Pharma and Express Healthcare. Among the topics discussed were industry trends, technology and process innovations that provide speed to market and flexibility in oral solid dosage formulation. The panel comprised of Pramod Kharwade, General Manager, Formulations, Glenmark; Preeti Raut, Vice President, Formulation Development, Cipla; Raviraj Pillai, Senior Director and Site Head, Pharmaceutical Development, Abbott; Sandhya Shenoy, Associate Vice President, R&D, FDC; and Sanjay Sharma, Head Technology Transfer, Lupin.
Explaining the dynamics of the business, Sharma shared that on certain occasions the business scenario changes over the years from its initial development process to its last mile. As cost plays a key role in the decision making process, choosing the right excipients at the right time becomes crucial.
Concurring with this view, Shenoy said that companies tend to resist change, whether it be new technologies or novel excipients, as they become worried about how these changes would impact regulatory compliance. She explained how choosing the right partner is a key decision to be taken at the early stages of product development to ensure smooth formulation processes that adhere to regulatory standards. She also suggested that vendors or excipients manufacturers should get their novel developments approved and validated by regulators before launching them. This would increase uptake of these technologies as the industry would then be assured that the new technologies are compliant with norms. She also stated that lack of evidence by vendors has created a hurdle in the process of continuous manufacturing and gave an example of how her company had to modify one of its products to conform to IP, though the initial product was USP complaint and more effective.
In the same vein, Raut noted how pharma companies historically take longer to understand newer technologies and suggested that whenever such developments happen, vendors or excipient manufacturers should provide an update to pharma companies.
Kharwade pointed out that pharma companies would not see value in making huge investments in novel technology unless they had a basket of products that could benefit from this investment. Justifying the decision, he said that while the return on investment may not be accomplished with a single product in such a dynamic and competitive market, it could be made more viable across various products.
Pillai opined that the focus should be on identifying an unmet patient need, rather than simply using a novel excipient as a differentiator.He significantly remarked that an unmet patient need could be fulfilled by process modification, rather than a change in excipients or technologies.
Each panelist then shared their experiences in selecting excipients and technologies, and their insights while dealing with regulatory changes. The experts also suggested that excipient manufacturers should first understand the needs of pharma companies and then develop their products accordingly.
While at the symposium, DuPont unveiled the new brand identity of the mega merger of DuPont, Dow Chemicals and FMC Corporation. Savindu Kudrigikar, Business Head, South Asia, DuPont Nutrition and Health, gave a brief overview of the expanded business portfolio after the merger. She also mentioned the role of their channel partners, Signet and Colorcon, in welding DuPont’s global presence with their deep local expertise.
Kudrigikar shared more on the merger following the event, stating, “The alliance between DuPont, heritage Dow and FMC will give our customers access to the largest pharmaceutical portfolio on the market, consisting of solutions, expertise and research from three industry-leading innovators. We will continue to expand our offerings together to ensure our customers are equipped with a supplier’s partner that offers solutions for each of their unique formulation needs.”
The panelists in the Hyderabad edition were Dr Rajeev Singh Raghuvanshi, Senior Vice President & Head, BRaIN, IPDO, DRL; Dr Pavan Bhat, Executive Vice President,Technical Operations – R&D, Natco Pharma; Dr Venkata Ramana Reddy S, AGM – R&D, Formulations, Suven Life Sciences, and Seshnath Chauhan, Director – Global Sourcing (SCM), DRL.
In the course of the panel discussion in Hyderabad, Bhat noted that excipient manufacturers are collaborating with pharma industry and regulators to introduce new excipients which are functional and help address challenges faced in drug development. Giving his views, Raghuvanshi commented that the value delivered by excipients will be the foremost consideration.
Speaking about the adoption of new technologies, Reddy said that process time and sometimes the number of steps would reduce due to some co-processed and ready made excipients, mentioning some examples like direct compressible polymers for matrix system. As the SCM expert on the panel, Chauhan from DRL spoke about how pharma companies can de-risk their supply chains.
Summing up the discussion, Roychowdhury concluded that developing innovative excipients delivering proven value in terms of higher quality, efficacy improvement, cost reduction, and time to market is the need of the hour.
In her closing remarks, Kudrigikar gave an overview of the range of solutions from DuPont, appreciated the discussion and thanked the attendees for their time and insights.