Amsterdam, 21st October 2019: CPhI Worldwide – the world’s largest pharma event taking place in Frankfurt (5th-7th November 2019) – has released the first part of its eponymous 2019 Annual Report. Experts Bikash Chatterjee, President and Chief Science Officer at Pharmtech Associates and Girish Malhotra, President of EPCOT International discuss how manufacturing could be revolutionised by new technologies, but warn, that regulators must change to prevent hindering future innovation.
Bikash Chatterjee forecasts a positive outlook for the medium and long-term future of the industry, foreseeing that Pharma 4.0, the Internet of Things, and Artificial Intelligence could ultimately deliver huge shifts in how we discover and develop medicines – even if the short term applications may not bring the results people are striving for.
“There is no doubt we will see broader adoption of IoT on the shop floor and in the distribution portion of the supply chain in the short term. The biggest impact operationally, I believe, will be seen in the clinical trial management stage of the drug development lifecycle, over the next five years. However over the next decade, AI could have a transformational impact on molecular selection and design,” commented Chatterjee.
Despite the call for these advances, Chatterjee emphasizes that such improvements within the industry will not come about unless they are used in the right way, and address the right questions. He forewarns, “the focus on technology in the absence of understanding the basic question to be answered can derail a cross-functional initiative in the blink of an eye”. Chatterjee also calls for both AI and pharmaceutical companies to gain a better understanding of each other’s fields in order to expedite the process of disruptive technology adoption.
Malhotra explores the cost of manufacturing globally and the still high levels of regulatory infringements, postulating that regulators should use powers to remove ANDAs for repeat offenders. “With USFDA being short staffed, even the use of ‘risk-based inspections’ may be insufficient to catch less than quality/cGMP producers” speculated Malhotra. Adding “repeated non-compliance to FDA’s requirements and guidelines should be a cause to forbid shipments to the United States.”
Additionally, he suggests a 90-day approval process, which will necessitate that companies filing applications have complete command of every facet of manufacturing, product quality, and labeling. Taking this a step further, he also advocates enforcing mandatory deposits (circa $200,000) for first deviation from FDA’s expectations, with forfeiture of the deposit and, ultimately, being barred from importing into the United States should further problems occur.
More information can be found at CPhI’s 2019 annual industry report webpage.
