Pharma Experts Deliver Crucial Intel on Industry Trends, Themes | 14 October, 2015

In the second half of the Pre-Connect Congress held a day before the official opening of CPhI Worldwide, experts and attendees gathered again for the afternoon sessions that covered a number of cutting-edge themes and trends that pharma execs need to know: API sourcing and manufacture, new trends in the generic and biosimilar sectors, FDA approval processes, pharma packaging, and the future of mergers and acquisitions.

Kate Kuhrt, Senior Director, Generics and Biotech at Thompson Reuters opened the afternoon sessions speculating on where APIs will be manufactured over the next decade and the challenges producers will face.

“In order for API manufacturers to succeed, they must be able to satisfy customer demand for quality, quantity, and timing. In addition, they must provide products at a competitive price while maintaining attractive margins,” she said. The manufacturer’s success is not only a function of production skills and business savvy, but is also predicated on external factors like demand, regulatory pressures, cost structures, and resource availability.

“We expect the playing field for active ingredient manufacturers will continue to level. Tighter regulations to protect environmental quality and patient safety have increased operating costs, while customers, fearing broken supply lines, are valuing quality over bargain prices,” she explained.

Warning that the pharma industry is undergoing great change as it plunges over the patent cliff with fewer blockbusters on the horizon, R&D productivity down and more molecules aimed at niche markets, Clive Badman, Executive Director Business Engagement Group and Industrial Chairman CMAC described the advantages in continuous manufacturing.

In the face of these changes in the industry, he observed, “we have to ask if we have the correct architecture for manufacturing? To date, we have largely been focused on blockbuster manufacturing with large, often separately located, drug substance and drug product facilities.

“Now is the time to look at new infrastructure with smaller, more agile facilities for end-to-end manufacture and how can pre-competitive collaboration help in achieving this?”

In his address on the continuing rise in contract API manufacturing, Akshay Kant Chaturvedi, the head of corporate IPM & legal affairs at Shilpa Medicare, argued that the increase is making production cheaper which, in turn, is making APIs affordable for the end user and providing excessive flexibility in terms of availability in time besides cost.

“Contract manufacturing shares benefits not only for cost reductions, improvised efficiency levels, flexibility in drive, advanced automated technology and higher throughput, but also provide access to quicker entry in time to market with reliable quality,” he said, adding that CMOs, OEMs and other large generic players are expecting greater science of affordability while not trespassing on third party IP rights.

“There are two main focuses on this perspective which must be discussed—one is R&D in CMOs and IP generation, and the second is the stringent regulatory environment compliance worldwide,” he told participants.