BIG DATA AND ARTIFICIAL INTELLIGENCE IN PHARMACEUTICAL MANUFACTURING

Emerging technologies can lower costs, speed up production and improve research and development

Sean Riley, Senior Director Media and Industry Communications PMMI the Association for Packaging and Processing Technologies

Pharmaceutical companies have heightened concerns about traceability, product quality, and process validation. Companies are embracing big data and remote storage more readily, in order to stay ahead of innovation and more easily comply with regulations.

Billions of dollars are invested every year into the discovery and development of new medicines, but it usually takes 10-15 years for a drug or vaccine to evolve from inception to release. Manufacturers invest a tremendous amount of capital long before seeing any return, which means pharmaceutical companies must allocate a high per centage of the budget to R&D. The fail rate for clinical trials is 92 per cent, and drug companies spend an average of US$2.6 billion developing a single drug.

When a pharmaceutical company invests in Research & Development (R&D), it screens 5,000-10,000 chemical or biological compounds to find one that exhibits potential for treating new or existing conditions, according to the 2018 Pharmaceutical Packaging and Processing White Paper, produced by PMMI, the Association for Packaging and Processing Technologies. There is also risk associated with investing in R&D for a drug if it fails or does not meet regulatory approval.

Using big data to design clinical trials better and predict outcomes can make it commercially feasible to develop drugs for smaller patient populations. Pharmaceutical companies are looking to big data to reduce costs in research and development and manufacturing. With the explosion of health-related data in recent years, the market for artificial intelligence in drug development, valued at US$200 million in 2015, ballooned to US$700 million in 2018 and is predicted to appreciate more than US$5 billion in 2024, according to a report by big data analytics. Artificial Intelligence (AI) and big data have the potential to lower the cost and time of drug trials, to better determine patient outcomes with established drugs and to better design new drugs. Computer software and algorithms can provide better analytics before and during the manufacturing processes and stimulate insights to fuel better decisions in the pharmaceutical industry.

Pharmaceutical manufacturers collect data on patient responses to drugs during the clinical trial process and using that data with AI, will be able to reverse engineer which aspects of a patient sub population are associated with responses to drugs.

AI can also be used to predict protein interactions and better drug design, a practice called insilico medicine. For example, researchers at Carnegie Mellon University were able to better predict clinical outcomes by using algorithms to virtually stimulate how changes in drug structure would interact with different proteins and receptors. Such a process is much more cost-effective than the traditional trial and error on a lab bench.

In another example, researchers at the University of Toronto applied insilico methods to find drugs that interacted with proteins associated with the Ebola virus. Using an algorithm that mapped the virus to predict molecules that could potentially bind to these proteins, they were able to identify solutions that might have been overlooked otherwise.

Data for Regulation

Complexities abound in the pharmaceutical industry. Entry not only requires a high initial capital investment, but there are rigorous regulatory controls that demand adherence. The result is a challenging sector to thrive in, which promotes large multinationals that have the resources to meet financial and regulatory requirements.

In particular, traceability legislation established to stem the threats of counterfeiting and grey market drugs is a present market effector, driving rapid growth in the labelling, coding and decorating machinery market.

In North America, the deadlines imposed for meeting the Drug Quality and Security Act (DQSA) of 2013 will now come into force in 2018 with later deadlines for re-packagers and wholesalers. The regulation requires a transaction document and serialisation of all prescription products, enabling the electronic transfer of specified transaction information and complete supply chain history.

Many counterfeit drugs have originated in China, the largest of the ‘pharmerging’ countries. To combat piracy, it initiated a gradual implementation of its Electronic Drug Monitoring Network as part of the China Food and Drug Administration’s (CFDA) plans to enable traceability of all drug products throughout the supply chain. Serial numbers were to be assigned centrally by the government, requiring reporting of all transactions, from manufacturing to dispensing. The legislation required all drug manufacturers, both domestic and foreign, to be using the network by the end of 2015. Within a few months, however, the law was unceremoniously shelved, confusing pharmaceutical manufacturers.

In July 2016, the CFDA released an update alluding to future serialisation requirements. Possible revisions include alignment with serialisation standards in other regions such as 2D barcodes used in the US and Europe and the ability for companies to generate their own codes instead of having them generated centrally by the government.

The most substantial legislative uncertainties for the global drug industry lie with President Trump’s pledges to bring down US drug prices. This potential for changing healthcare legislation would have a definite but uncertain impact on the pharmaceuticals market, as it calls for draft legislation allowing the US Department of Health and Human Services to negotiate drug prices for Medicare. The proposed legislation is highly controversial, but its details and the impact it may have are unknown.

Regardless, in the last few years, the U.S. Food and Drug Administration (FDA) has encouraged companies toward continuous manufacturing and away from the step-by-step approach of batch processing. By continuously monitoring manufacturing processes and collecting feedback, pharmaceutical companies can monitor factors like temperature and moisture change, therefore reducing variability in the final product and patient outcomes, a method called Process Analytical Technology (PAT).

Continuously testing drugs through the production process using PAT is more efficient and cost-effective than batch testing, mainly when synthesising biological proteins at millions of dollars per batch. By better monitoring pharmaceutical manufacturing process operations, we can continually foresee performance and reduce variability in clinical performance. Applying AI to performance and feedback response data generated with PAT can be used not just to control manufacturing processes, but to improve them through automated machine learning.

Pharmaceutical companies are automating in two major areas as the FDA mandates electronic submissions:

  • The evolution from batch-based production to true continuous production.
  • The collection, management, and utilisation of data.

Batch-based processing will be phased out, eventually replaced with continuous production, with quality checks at each stage. This will be achieved as more physical processes are automated, and production schedules and maintenance schedules are planned out and regulated based on past data.

Pharmaceutical companies have heightened concerns about traceability, product quality, and process validation. Companies are embracing big data and remote storage more readily, to stay ahead of innovation and more easily comply with regulations. CMOs (Contract Manufacturing Organisations) are attracting biopharmaceuticals customers, who typically don’t have in-house manufacturing capabilities.

Automation is playing a role in making lines suitable for several products, supporting the trend of smaller, more responsive facilities that concentrate on flexibility, cost efficiency, and speed. Improvements in the communications infrastructure internally, with business partners, and throughout the supply chain will be the next steps.

Looking Ahead

With all the benefits of big data, incorporating it into manufacturing processes poses some challenges. Companies need to be prepared to handle the volume of data, the speed at which it accumulates and how to organise it best to create a more detailed future.

Researchers recognise that it would be valuable for companies to share data and learning with others who can apply it to improve the safety and reliability of all manufacturing. But the competitive nature of the pharmaceutical industry means that all information is propriety, and an open source system can be complicated as companies use different technology platforms. A standardisation process would have to be developed. Such a solution may be possible, however, as organisations like the Allotrope Foundation, a worldwide coalition of scientists with a mission to improve data access and integrity, are seeking to revolutionise the way we acquire, share and gain insights from scientific data. The industry is at the early stages of using electronic data to understand drug structure & function and ultimately that impact on patient outcomes. Big data, AI and machine learning have the potential to change the way we develop, monitor, manufacture and apply drugs.

A Bigger Healthcare Packaging EXPO in 2019

Healthcare Packaging EXPO (Sept. 23-25; Las Vegas Convention Center), co-located with PACK EXPO Las Vegas 2019, will provide a compelling opportunity for pharmaceutical and medical device manufacturers to converge and address evolving consumer and regulatory demands.

PACK EXPO Las Vegas and Healthcare Packaging EXPO 2017 welcomed nearly 1,000 more attendees than 2015 as post-show numbers revealed 29,500 attendees and 2,000 exhibiting companies convened over almost 900,000 net square feet of the Las Vegas Convention Center.

Our exhibitors and attendees expect PACK EXPO Las Vegas and Healthcare Packaging EXPO to carry out first-class events, and the 2017 show was no exception,” says Jim Pittas, president and CEO, PMMI. “We expect the overwhelming success of PACK EXPO Las Vegas and Healthcare Packaging EXPO, to continue in 2019 with many new and exciting additions to the event.”

While PACK EXPO Las Vegas provides a platform to explore packaging technologies, equipment and materials from 2,000+ exhibitors serving virtually every vertical industry, Healthcare Packaging EXPO brings healthcare suppliers from the pharmaceutical, biopharma, nutraceutical and medical device industries together with attendees that traditionally represent the top 25 pharma companies by global sales.

To keep up with the growing size, PMMI continues to offer the most up-to-date online technologies like My Show Planner both online and via a mobile app which include enhanced Virtual Exhibitor Booths to ensure attendees and exhibitors come to the show prepared to make the most of every minute.

Pavilions are always a unique opportunity to visit targeted exhibitors in one area. New to Healthcare Packaging EXPO 2019 and PACK EXPO Las Vegas and is the Package Printing Pavilion. This 35,000 net square feet pavilion is the perfect place to discover the latest printing and converting technologies, including digital color printing for folding cartons, flexible packaging and corrugated packaging; labeling, coding and marking solutions and smart package printing technologies.

Returning pavilions include Containers and Materials, Confectionery and Reusable Packaging Pavilions. The Containers and Materials Pavilion offers a destination for brand managers and designers seeking solutions to help their products stand out. The pavilion also houses The Showcase of Packaging Innovations, sponsored by Dow. In addition to confectionery solutions providers, the Confectionery Pavilion is home to the Candy Bar networking lounge sponsored by the National Confectionery Association (NCA). Reusable solutions in the Reusable Packaging Pavilion will help buyers achieve supply chain sustainability and cost efficiency.

Other new additions to PACK EXPO Las Vegas and Healthcare Packaging EXPO 2019 include The Technology Excellence Awards, which debuted at PACK EXPO International 2018. After months paring down the many qualified entries, three days of onsite voting allowed PACK EXPO International and Healthcare Packaging EXPO attendees to be the ultimate judge of the most innovative new technologies at the show. The winners included Triangle Package Machinery Co. (Baking and Snack), Volpak (Beverage and Dairy), Evolabel (General Packaging), Bemis Company Inc. (Meat/Poultry/Seafood), Neopac The Tube (Personal Care/Cosmetics), Bausch + Ströbel Machine Company, Inc. (Pharmaceuticals and Medical Devices) and Pearson Packaging Systems (Prepared Foods).

Education is always a big part of the PACK EXPO Las Vegas experience with the return of the Innovation Stage. Integrated on the show floor to allow attendees easy access, the Innovation Stage presents free 30-minute seminars on breakthrough technologies and techniques focused on a wide range of industry-specific solutions. A new addition to the education program within the PACK EXPO portfolio of Trade Shows is The Forum. After successful debuts at PACK EXPO East, Pack EXPO International and Healthcare EXPO and ProFood Tech, The Forum offers free, unique, interactive learning periods featuring 45-minute open sessions on the latest industry trends by the OpX Leadership Network, World Packaging Organisation, Institute of Packaging Professionals,

Contract Packagers Association and PMMI Business Intelligence. Sessions will be interactive, including hands-on activities, small group discussions and Q&A sessions.

For more information on the latest additions to PACK EXPO Las Vegas and Healthcare Packaging EXPO 2019 visit packexpolasvegas.com

--Issue 35--

Author Bio

Sean Riley

Sean Riley is currently PMMI’s Senior Director, Media and Industry Communications. He was Editor-in-Chief for PMMI’s Packaging Machinery Technology Magazine for nearly a decade and has over 20 years of experience working with and as a member of the packaging and processing media.