EPM conducted a roundtable with several pharma experts to learn what industry trends to watch out for in 2023, from AI drug discovery through to the rise of decentralised trials.

Tim Guilliams, CEO and co-founder, Healx:

"Thanks to improvements in software and computing, the field of drug discovery is being completely reimagined with life changing effects for the hundreds of millions of people living with rare diseases worldwide. In 2023 we will increasingly see AI used across the entire drug discovery and development pipeline. From de novo design of molecules and treatment combination predictions, to preclinical validation, right up to the running of clinical trials for precision medicine. We will also see greater collaboration between industry, technologists, academics and patient groups to progress more novel rare disease treatments towards clinical trials."

Christian Dowdeswell, vice president, head of Commercial Development, Small Molecules, Lonza:

"The ongoing trend of new drugs becoming ever more complex is sure to continue. The number of synthetic steps for making small molecule APIs has grown by two-thirds in the past 20 years, as has the number of chiral centres. Average molecular weights continue to rise, and maybe three-quarters have poor solubility. With so many NMEs being approved via some form of expedited approval pathway, there is bound to be continued high demand for CDMO services, and a demand to meet ever-shorter timelines. Innovation will be vital, and digital tools that support the development of robust processes will be increasingly important.

Ambitious targets have already driven significant sustainability advances, many of them remediating older processes developed when it was less of a concern. We now embed sustainability into our process design for chemical synthesis, and specific projects look to eliminate toxic materials from a process, or replace environmentally damaging chlorinated solvents in spray drying. I fully expect this will become a key area of differentiation in the CDMO industry."

Kyle Cunningham, chief product officer, Greenphire:

“Clinical trial sites face a host of challenges when it comes to keeping trials moving along. While technology is designed to benefit sites, they often feel overwhelmed by the sheer number of technologies that are required for a given trial. In 2023, I believe we will see a concerted effort from sponsors, CROs and solution providers to integrate technology platforms and workflows. For example, sites will benefit from data-driven processes, such as participant payments being automatically triggered via EDC data or completion of participant activity within their ePRO. Through the integration of site platforms, we can eliminate administrative burdens, increase efficiency and empower sites to provide better care and support for their participants.” 

Jim Murphy, CEO, Greenphire:

“Over the past few years, we’ve heard a great deal about the rise of decentralised trials (DCT). In 2023, I predict that the industry will focus less on DCTs and place a heavier focus on strengthening the site-patient relationship. The site will remain the central stakeholder of a clinical trial but with a greater emphasis placed on the notion of heightened flexibility for the participant. We will see further adoption of innovative tools that offer options related to receiving care and completing trial activity while keeping the site in control and enabling them to maintain and even increase efficiency. By empowering sites to better support their participants through versatility of care, we as an industry can drive towards stronger recruitment efforts, greater engagement and improved retention, resulting in overall trial optimisation.”

Jim Lehane, global leader of Life Sciences Manufacturing, Cognizant:

"Biopharma manufacturers are constantly creating an abundance of data. The sheer volume of data can be a blessing and also a curse. In order to create actionable insights and proactive decision making, data strategies need to be in place to capture, analyse, utilise and protect it throughout the integration of technology. When handled correctly, insights can become extremely valuable intellectual property (IP) that can drive significant business innovations and give a competitive advantage.

The adoption of new technologies into manufacturing processes is the crux of major innovation across the sector. Integration of digital technologies and shared interoperable platforms are helping the biopharma industry improve operational efficiency in supply chain management post-pandemic. A big part of this trend is the engagement of automation across the enterprise, merging data from information technologies and operational technologies (OTs), connecting systems and processes to create a seamless transition from drug discovery to commercial batch release.

The life science industry of yesterday kept data siloed within different parts of the business, effectively keeping it  “locked up” and limiting its value. Now, the industry is trying to release the intrinsic power of data from the IT and OT layer utilising cloud technologies – with data strategies built in at design, creating a single source of truth. This approach means data can be leveraged to deliver real-time insights and improved business outcomes through efficiency, reduced supply costs, and increased quality.

But this desire for digital transformation has raised a prominent challenge: technology is becoming increasingly complex and many companies lack the experience and expertise needed to ensure the security, efficiency, and success of any digitalisation or automation initiative.

Relevant experience within the industry and the technology-based evolution of manufacturing will therefore be increasingly necessary to ease biopharma’s transition into the digital age and provide flexibility as industry requirements change. Manufacturers throughout the life science industry that successfully integrate advanced digital and automation technologies, with a clearly defined data strategy will be well-positioned to ensure patients continue to have access to critical medicines."

Sara Lesina, MBA, general manager Business Unit Europe, Sirio Europe:

"Nutritional science is advancing its understanding of the chemistries and therapeutic potential of a myriad of different nutritional compounds and extracts. But it is important to remember the entire category is driven primarily by consumers, who are increasingly selective about the supplements they buy. Consumers want their nutraceuticals to possess five fundamental things: taste and texture, health benefits, be free from additives, environmentally friendly and non—GMO. They also want them to be easy to chew and swallow and affordable.

There was a time when tablets and capsules were perfectly suited to the vast majority of products on the market, but consumer preferences and science continue to move the industry away from an overreliance on traditional oral solid dose forms. Increasingly that means delivering products in ways that people prefer. Softgels and the rising champion, the gummy, are two forms gaining significant ground with product designers and consumers. One look down any nutritional supplement aisle in any grocery store or pharmacy in the world will support that assertion.

For consumers, dose form really matters. Pill fatigue is a real phenomenon especially among older patients. No matter how effective the active ingredient may be, it will never deliver its therapeutic effect if it is not taken as prescribed or as recommended. To attain those mass-market product goals and meet consumer demands, the industry will be increasingly prompted to access more application science from its external pharmaceutical-grade manufacturing partners."

Tony Page, SVP Insight Analytics, Within3:

“As we look to the year ahead, companies must lean further into what worked. Be wary of complacency – organisations that are content with the status quo will be outperformed by those who prioritise areas where they can see the most acceleration. This means elevating insights management to a main strategic pillar. Whether it’s cutting through masses of data or reducing the time it takes to analyse data sets, creating efficient workflows and solving the life science insights gap is critical. In the year ahead, we’ll also see life science leverage artificial intelligence even more strongly, with AI supporting tech-enabled team members rather than replacing them.”

Chuck Miller, director of Solution Consulting, AspenTech:

"What good is taking operations digital if the existing data streams offer limited value? Today’s operating units generate a richness of process data, but this data is not always deemed sufficient for critical monitoring, control and release workflows, especially in the case of legacy operating lines. The effectiveness and reliability of Process Analytical Technology (PAT) has improved greatly in the past several years. Taking advantage of this to enrich operations data streams enables faster commercialisation, more cost-efficient production and reduced supply lead time."

Cathy O’Brien, vice president for International Sales, UPS Healthcare:

“Sustainability is, and will continue to be, a critical issue for the industry. Nearly three quarters of the industry’s emissions come from Scope 3 – activities like transport and packaging – which sit outside of the pharma company’s direct control.

A further challenge is the need to balance the availability of energy and the ongoing inflationary costs with quality of supply, in what will be a very dynamic macroeconomic and geopolitical environment.

Public-private partnerships will continue to be crucial, much like we saw for Covid vaccine development and distribution, to create the scalable, sustainable and cost friendly solutions that can work across the industry.

80% of pharma products in Europe already require temperature-controlled transportation, and that number is only going to grow. With that growth comes the need for next-generation products and services to suit the transport and storage of next-generation healthcare treatments. This means innovation throughout the supply chain to ensure every pharma company has an end-to-end solution that offers unprecedented control, visibility, and reliability. The fragility and high value of these new drugs, like biologics, means that it’s now more important than ever that the industry knows where a shipment is at all times and that it will arrive on time and at the right temperature."

Terry Lo, president and CEO, Vizgen:

"We’ve already seen an explosion of AI approaches being utilised for drug and biomarker discovery. I anticipate this trend will only continue in 2023. With new platform technologies emerging, there is an increasing density of the data generated from a single sample. The payoff in using AI and more efficient analysis tools before entering clinical trials will become even more dramatic because of the richness of the starting data.

Also, massive amounts of data being a challenge in 2023 is a pretty safe prediction. The increasing amount of data is not just the addition of multi-omics, but the combination of high parameter content alongside high resolution imaging. Spatial genomics is a great example, where you can detect the precise location of over a billion transcripts in a single square centimeter of tissue sample. The challenge here is terabytes of data are generated from that single sample."

Karan Singh, managing director, ACG:

“2023 will continue to pave the way towards sustainable manufacturing, with a growing number of organisations placing focus on creating long-term solutions.

Now is the time for new manufacturing sites to adopt and implement new technologies; to transform pharma manufacturing from being reliant on costly legacy processes. Digital technology will speed up processes by enabling early detection of wear and tear on machinery lines. It will also help to reduce wastage and recalls by effectively tracking defective batches, allowing for timely interventions.

Placing digital ‘Industry 4.0’ technologies – such as AI, machine learning, IoT, Augmented and Virtual Reality – at the heart of manufacturing can further improve R&D and speed up testing, compliance and efficiency. Adopting Industry 4.0 technology and new delivery models can help to build a more self-reliant and robust pharmaceutical supply chain to keep up with changing and increasingly complex healthcare needs. Our focus is on creating high-performing and quality driven manufacturing units that can support smart, connected, and intelligent systems. Reams of data converts into actionable intelligence, improving several supply chain aspects such as inventory management, trend analysis, forecasting and predictive equipment maintenance.

The growth of digital health technology and telemedicine will continue to drive healthcare innovations in 2023. Developments such as medical device integrations and software monitoring will be centred around at-home and remote diagnosis, ultimately aimed at improving clinical outcomes and pre- and post-consultation care for more ‘informed’ patients.

Inclusion, innovation, and integration will be keywords for the pharmaceutical industry in 2023.”

Source: https://pharmaceuticalmanufacturer.media/