Powered by Ideal Cures, the event witnessed leading scientists and R&D heads from pharma organisations and top biotech companies congregate and initiate discussions on key issues in formulation development and drug delivery
Following the successful launch of Formulation and Drug Delivery (FDD) Conclave last year, Express Pharma hosted its second edition at Novotel Airport, Hyderabad, recently.
This year, under the theme, ‘Expanding Horizons of FDD Research: Embracing complexity’, FDD Conclave 2018 addressed several pivotal issues which are to crucial to FDD scientists’ role as one of the key gatekeepers of a company’s future reputation and market leadership.
The two-day event got off to an auspicious start with a lamp-lighting ceremony, followed by the release of the FDD Leaders Handbook, which covers over 35 leading scientists from the formulation development and drug delivery segment.
Next, an industry veteran, Dr Praveen Khullar, Dy Head of Industrial Development Centres EP+Gx (EM), GEM, IA Platform & Head of Global Development Centre, Group Sanofi, Goa delivered a Key Note Address. His talk revolved around the topic, ‘Embracing complexity through drug delivery systems & innovation’.
He spoke on the global pharma market and the Indian pharma industry; highlighted the current challenges for companies and drew attention to the windows of opportunities in the sector. He also emphasised on the role of novel drug delivery and formulation technologies to meet unmet needs, maximise efficacy, fuel product pipelines, improve patient compliance, simplify therapeutic processes etc.
The subsequent speaker, Ranjit Barshikar, QbD/cGMP Consultant & Member of Editorial Board, Journal of Generic Medicines, England gave a detailed and comprehensive presentation on the steps to implement Quality by Design in formulations. He detailed the importance and role of QbD in formulation development and drug delivery to ensure better product quality and thereby patient compliance.
The next session was on Capsule-based Inhalation Drug Delivery – Expanding Horizons. The speaker for this session, Dr Jnanadeva Bhat, General Manager, Product Development and New Product Offerings, ACG Capsules expounded on the application of inhalation drug delivery systems and the advancements in this sphere. His session focussed on dry powder inhalers with an emphasis on capsules-based dry powder inhalers, their usage and advantages.
Alok Chandorkar, Market Development Manager-India, West Pharmaceutical Packaging India, the succeeding speaker, also presented another product in injectables, AccelTRA. He explained how the product could help generic pharma manufacturers with injectables gain an edge with his company’s offering.
The first day of FDD Conclave 2018 also comprised an insightful panel discussion on a very pertinent issue, Regulatory Pathways for Specialty/Complex Generics.
The eminent panel for this discussion comprised Dr Vinay Nayak, Executive Director, Marksans Pharma; Dr Rakeshkumar Bhasin, Vice President-Generic Formulation, Biocon; Dr Raveendra Pai, Vice President, Formulation Development, Glenmark Pharma; Munish Talwar, Vice President, Pharma Research, Lupin; and Dr Pawan Bhat, Executive Vice President, Technical Operations, Natco Pharma.
The panelists discussed and deliberated on what the term ‘complex generics’ and informed that actually they refer to generic drugs where it is difficult to establish therapeutic equivalence as defined in the Orange Book. They also highlighted that complexities actually arise through complex formulation, complex route of administration, complex drug device combination etc. Discussing strategies to become successful in the development of these formulations they urged innovation, creativity, and a multiple disciplinary approach in obtaining a successful path to approval.
Examining the growth opportunities for India Pharma Inc in this segment, they also explored R&D strategies to deliver on key complex/specialty generics, with an emphasis on successfully navigating through the regulatory challenges. The panelists also deliberated on the approaches that should be adopted by R&D teams of pharma companies to provide value and gain a leadership position through this segment.
The final segment on the first day of FDD Conclave was a very interactive and interesting product launch. Suresh Pareek, Managing Director, Ideal Cures and Sanjay Negi, Deputy General Manager – Technical Services, Ideal Cures gave an effective demonstration of how their coating systems, INSTACOAT QD and INSTACOAT T2F enable fast release and thereby increase the efficacy of the drugs. The audience got a chance to check out the benefits of these products first-hand through a small experiment.
The first day’s conference came to an end with this segment. After a short break, the delegates reconvened for FDD Leadership Awards, an initiative to laud leading professionals and their exemplary work in formulation development and drug delivery.
( Read: http://bit.ly/ep-fddawards-2018 )
The audience received a lot of food for thought on the first day of the FDD Conclave.