It seeks to provide a platform for formulation development scientists to gain applicable applicable insights on technologies and innovations in a rapidly evolving segment
According to a recent report from rating agency ICRA, R&D spends of top domestic companies moderated to 8.6 per cent during 9mFY2018 but are expected to remain at 8.4-8.6 per cent. There will be a growing focus both on regulated markets and complex molecules/ therapy segments such as injectables, inhalers, dermatology, controlled-release substances and bio-similars.
With a projected moderation in R&D spends, it becomes all the more imperative that formulation and drug delivery scientists sharpen their skills and keep up to date to remain flexible to evolving market demands.
Expanding Horizons of FDD Research: Embracing Complexity
The main role of an R&D formulation and drug delivery scientist is to research, develop and optimise product formulations to fulfill the company’s market strategy. However, a crucial part of this role is to ensure these formulations adhere to regulatory mandates for patient safety, efficacy and quality.
Meeting internal expectations of a differentiated product as well as fulfilling external mandates is thus the balancing act that FDD scientists have to perfect.
A third factor is time. FDD scientists are often working against time, keeping in mind the competitive nature of the pharma sector. Delays could mean a loss of market share while poor quality could mean batch recalls and loss of reputation.
Which is why the Indian Express (P) Ltd and Express Pharma, India’s leading Pharma Business Magazine, launched the Formulation and Drug Delivery Conclave (FDD Conclave) in June 2017, with the message: Staying Ahead of the Curve.
FDD Conclave 2017 had insightful sessions on Ensuring Successful Development of Complex Generics, regulatory perspective of Lipids as Excipients in Pharmaceutical Formulations, Advances in Film Coating Technology, Dry Enteric Coatings as a Superior Polymer Technology to Meet Emerging Drug Delivery Demands, and panel discussions touching pertinent issues like FDD strategies to increase compliance in special population segments, and the need to expand India’s FDD talent pool.
FDD, in its second edition, will take a deeper dive into evolving regulations which are fundamental to the FDD scientist’s role one of the key gatekeepers of a company’s future reputation and market leadership.
Some proposed topics:
- Product Development Through Integrated Project Management
- 505(b)2: Avenues for Development
- Regulatory Pathways for Specialty Generics
- Impact of Brexit on EU submissions
- The Potential of Specialised Injectables
- Advances in Powder Processing Technologies