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Bikash Chatterjee, president and chief science officer at Pharmtech Associates and Girish Malhotra, president of EPCOT International, touch upon how manufacturing could be revolutionized by new technologies if regulators evolve to prevent hindering future innovation.
CPhI Worldwide released the first part of its 2019 Annual Report on Oct. 21, 2019. The report features experts Bikash Chatterjee, president and chief science officer at Pharmtech Associates and Girish Malhotra, president of EPCOT International, who touch upon how manufacturing can be revolutionized by new technologies if regulators evolve to prevent hindering future innovation.
In the report, Chatterjee expressed his confidence in Pharma 4.0, the Internet of Things, and Artificial Intelligence (AI) to change the way medicines are discovered and developed. In order to achieve positive results from these new advances, Chatterjee emphasized the need for AI and pharmaceutical companies to gain a better understanding of each other’s fields in order to expedite the process of disruptive technology adoption.
“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,” he said. “The challenge with anything new in our industry is that the organizations selling into life sciences don’t know drug development, and the drug sponsors interested in AI don’t really understand AI, so they cannot direct the solution provider very effectively. As this knowledge gap dissipates through experience on both sides, more effective pilot projects and solutions will be developed and brought to term.”
Chatterjee predicted AI will be used regularly by 2040 for drug therapies and personalizing dosing and drugs regimens designed around each patient’s genetic markers and circumstances.
Additionally, Malhotra discussed the cost of manufacturing globally and the high levels of regulatory infringements by suggesting that regulators use power to remove abbreviated new drug applications (ANDAs) for repeat offenders. He proposed a 90-day approval process which requires companies filing applications to have control of all sections of manufacturing, product quality, and labeling. He also suggested a mandatory $200,000 fine for the first FDA violation and a possible ban from importing into the United States if the violations continue.
“With [FDA] being short staffed, even the use of ‘risk-based inspections’ may be insufficient to catch less than quality/cGMP producers,” he said. “Pharma has not explored increased profitability through continued process improvements, and my conjecture is that the regulators are the obstacle to this. [FDA] should refrain from suggesting to companies what types of manufacturing processes (batch or continuous) they need or practice, instead they should concentrate on helping ensure manufacturing processes are repeatable using continuous improvement principles.”
CPhI Europe Brand Director, Orhan Caglayan, emphasized the importance the annual report has on the industry, specifically on CPhI itself, which is hosting the 30th anniversary of CPhI Worldwide on Nov. 5–7, 2019 in Frankfurt, Germany.
“This year is CPhI Worldwide’s 30th anniversary, which provides us with an opportunity to reflect on both how far the industry has come during this time, as well as where it is heading in the years to follow,” he said. “With over 45,000 executives attending, our event is designed to help meet new partners and drive forward innovation. By bringing the supply chain together-from APIs and FDF [finished dosage form], to machinery, packaging, outsourcing and, biopharma,-we enhance the industry’s ability to find new cost-effective solutions and learn about new developments that will sustain growth in the year ahead.”