Anymore, the luxury of having a little time at the beginning of each year to come up to speed on all the new trends influencing and reshaping industries has become a thing of the past. The pharma industry is no exception and has clearly been gathering no moss going into 2020.
Before we’ve even flipped over the first calendar page of the year, initiatives involving the use of artificial intelligence (AI) and machine learning (ML) in drug development continue to gain momentum based on a report published in December 2019 by the U.S. Government Accountability Office (GAO).1 Also, the U.S. Food and Drug Administration (FDA) recently announced it will formally launch its Drug Risk Management Board (DRMB). Among its many responsibilities, the DRMB will facilitate the modernization of the Center for Drug Evaluation and Research’s (CDER) framework for safety surveillance of marketed products, according to CDER Director Janet Woodcock.2
The operative word in these and numerous other trends springboarding 2020 is “modernization.” The impetus of many initiatives pursued by the pharma industry’s governing bodies is to make transformative and disruptive advances in health care a possibility. A new MasterControl Trend Brief, “Top 5 Pharmaceutical Manufacturing Trends in 2020” discusses the emerging trends that will have a notable impact on pharma manufacturing this year.
While the FDA is in favor of innovation and advancing public health, the regulatory watchdog isn’t wavering on its prime directive of product quality, safety and efficacy. Data integrity is still the undisputed leader in reasons for receiving a warning letter. Recent violations effectuated by high-profile companies have touched a nerve, compelling the agency to ramp up its enforcement of data management protocols. The trend brief spells out some of the critical aspects of data integrity, including:
Overall, more attention and technology resources will need to be applied to data governance.
As long as there have been health care scientists, there has been an earnest desire to develop more discoveries and achievements their predecessors could never have imagined. New scientific advances in areas such as cell and gene therapies and nanotechnology are creating unprecedented possibilities for medical professionals. The ability to target previously untreatable diseases and cases where traditional medicines have not been effective is becoming more within reach.
That said, with new approaches to health care diagnosis and treatment comes new methodologies for developing, regulating and distributing the associated products. This trend will largely impact product manufacturing, particularly involving:
None of us needs reminding that there is a growing sense of urgency in the pharmaceutical industry to address issues such as recalls, delayed product releases and product shortages. To keep up with the industry’s already rapid pace, more pharma companies are looking to expand their use of contract manufacturing organizations (CMOs), contract packaging organizations (CPOs) and contract development manufacturing organizations (CDMOs).
Employing external facilities might help keep product schedules intact, but adding more operational appendages can take a toll on a company’s ability to properly oversee the supply chain. The FDA recognizes that there are differences between outsourcing facilities and conventional drug manufacturers. Still, the agency has further enunciated the importance of protecting patients from the risks of contaminated or otherwise substandard drug products in a new guidance outlining the current good manufacturing practices (CGMPs) for outsourcing facilities.3 The document is intended to serve as an interim guidance for outsourcing facilities, covering CGMP topics ranging from facility design to release testing, while the agency develops and publishes more specific regulations.
Data is becoming a greater asset to companies. Advanced technology is making data more abundant, robust and accessible. However, these advantages are only useful if a company can gather, store and analyze large amounts of data fast enough to make it worthwhile. That said, data management processes that rely on paper reports and spreadsheets are no longer up to the task. Manually inputting and distributing data can be detrimental to production because stakeholders don’t have the data they need until it comes to them. In the meantime, the supply chain could experience obstacles, such as:
The ability to gather and process large amounts of data quickly and closer to the point of origin is a tremendous advantage. To avoid perpetual and costly production issues, companies are evolving toward smart manufacturing environments, which include portable smart devices. Ultimately, this will enable organizations to be more proactive and keep errors to a minimum.
A common denominator among the latest pharma manufacturing trends is establishing a more agile business model. The demand for more complex products and unprecedented manufacturing methods is increasing. Pharma companies aiming to expand their footprints by accommodating these unique scenarios will need the advantage of effective predictive analytics, which involves using both historic data combined with new data in order to derive more insight, make more confident strategic decisions and accelerate development life cycles.
This concept is made possible by advancing technologies such as the internet of things (IoT) and ongoing progress with the convergence of information technology (IT) and operational technology (OT). Pharma companies can gain a significant competitive advantage by:
Find out how your organization can easily adapt to the new pharma industry trends and comply with the updated regulatory guidelines by downloading the trend brief “Top 5 Pharmaceutical Manufacturing Trends in 2020.”
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