Drug research, development, and manufacturing are tough areas to work in any year, but many would agree that 2021 had more than its fair share of mountains to climb. Still, as the industry experts Outsourcing-Pharma connected with in its coverage over the past 12 months frequently mentioned, the year was not without opportunities.
Our editorial team recently connected with a group of professionals from across the spectrum of industry specialties. Read on to hear their informed perspectives on what the most formidable challenges were in 2021, a few of the proudest achievements, and what likely lies on the horizon in the coming year.
Dago Caceres, global strategy manager, IFF Pharma Solutions
The excipient industry is continuously challenged by the complexities involved in getting novel excipients approved – since there is no viable regulatory pathway for new excipients today. Luckily, steps are being made in the right direction. For example, the Center for Drug Evaluation and Research recently launched an excipient review pilot program, which will enable faster approval.
IFF is encouraged by programs that help accelerate and respond to customer needs, helping to unlock the benefits of novel excipients more broadly. At the same time, the industry struggles with approving and commercializing new excipients within a shorter timeframe. Typically, a new excipient can take anywhere from two to 10 years to develop. Then, they must go through pre-clinical and clinical phases, along with the drug candidate. If these phases are successful – and adopted by the industry – it can take several more years to reach maturity. To drive advancement and innovation for excipients, close collaboration with industry, academia, and key stakeholders is required.
Patrick Hughes, CCO and co-founder, CluePoints
I think our biggest challenge has also been our most significant opportunity. Like professionals in every other sector, those of us working in the life sciences industry have had to adapt to a remote world over the last two years. The inability to travel to speak to our customers and stakeholders face-to-face has been a challenge. As a result, we have had to find new ways of working that suit us and our teams and the people and organizations we work with.
This adaptation has demonstrated that it is possible to make long-overdue changes to how we conduct clinical trials. But, of course, a proportion of what we do has to be done in person. Still, remote approaches have a vital role, such as central statistical monitoring, letting technology do some of the heavy lifting. As a sector, we have known this for some time, but the pace of change has been slow. Now, we know digital transformation is feasible and how to do it.
Caroline O’Connor, CCO, Xperiome
Clinical research recruitment has always been a major pain point for sponsors, particularly for orphan drug research where patient numbers are low and individuals are geographically dispersed. Therefore, while the rare disease community is often keen to participate in studies, the distance and frequency of travel may not be workable given the realities of their condition, or the complexities of managing travel around home and work commitments. The move towards decentralized, often hybrid, trials will open up opportunities for pharma to reach a broader audience and, importantly, help reduce the burden of participation for the rare disease community.
Jerry Gross, CEO, and co-founder, Vytal
The pandemic created an increase in demand for pharmacy delivery, as more and more patients wanted to receive prescriptions directly at home to avoid a potentially-risky trip to the pharmacy. This made it critical for supply chains to experience minimal disruption so that medications were delivered safely and efficiently. That was easier said than done. Supply chains across all industries experienced hiccups; however, the pharma industry may have seen one of the biggest hits with the limited availability of materials, limited access points, and delays and challenges that stressed the supply chain severely.
Ivan Jarry, CEO, ObvioHealth
Technology alone is not enough. We’ve seen that adherence to protocols and participant compliance increases significantly when there is support from a virtual or hybrid team. The combination of technology and humans is essential.
We’ve also recognized the need to give patients choices. Different people will have different preferences, and studies need to be designed to provide options. Some people don’t want to be visited at home. So, the model of replacing a physician visit on-site with an at-home visit by a nurse is not always the right solution.
One misperception on the part of some sponsors was that DCTs would always be more cost-effective. But, in cases where the virtual study is overlaid on top of a multi-site study, the costs can sometimes go up rather than down, because sponsors have to pay the CRO fees plus the sites, as well as the software platforms that enable DCTs. The most significant cost savings are obviously when it is possible to eliminate the need for a CRO and/or for traditional sites and run the full study virtually.
Finally, we have learned a lot about the need to do everything to help patients remain compliant and engaged. When you run a decentralized model, you are shifting the burden of collecting outcomes from the physician and nurses at the sites to the patients at their homes via apps and devices. This means that patients need to be informed and trained because they’re playing a more active role in the trial. Here too, UX becomes extremely important. The tasks and the technology need to be simple and intuitive to encourage compliance and ensure you are capturing the correct assessments.
Bernard Vrijens, CEO and scientific lead, AARDEX Group
COVID-19 threw a spanner in the works for clinical development. As travel bans and infection control measures were imposed, recruitment was postponed, and studies were delayed or canceled in their thousands. This has increased development timelines, which were already sitting at more than a decade, and severely impacted industry pipelines. All this has happened at a time when developers were already faced with spiraling development costs, with the latest estimates placing the price of bringing a new drug to market at $1.3b [USD]. It is clear, then, that the last two years have jeopardized the industry’s future revenues – and its very business model.
Patrick Boyle, head of Codebase, Ginkgo Bioworks
New tools and automation are making it easier to generate large and complex datasets, but the data science tools being developed for other fields don’t necessarily match up well to biological data. While there’s a lot of excitement about applying AI/ML to biological challenges, we’re seeing the most progress in areas that have a lot of available training data, like protein folding. Many companies are interested in leveraging AI/ML for their needs, but the corresponding datasets to accomplish this don’t exist. We’re investing a lot in automation in order to better generate that sort of data for our programs.
Christina Smolke, CEO and cofounder, Antheia
Pharma supply chains remain a big priority. There is strong momentum toward reviewing existing vulnerabilities or challenges in pharma supply chains across the world. In particular, gaps in all models of biomanufacturing are the center of discussion. This includes a shortage in biologics and vaccine manufacturing, lack of large-scale microbial fermentation facilities for API/KSM manufacturing, and issues with new therapeutic modalities like CAR-T. We have seen some initial investments from public and private sectors (e.g., Canada investing $2.2b to biomanufacturing; WuXi Biologics opening up its state-of-the-art 12,000-square-meter facility) – this is not nearly enough to close the gap and we expect to see more in 2022 and beyond.
Henry McNamara, senior vice president and general manager, Oracle Health Sciences
Throughout the COVID-19 pandemic, we have seen the life sciences industry adapt and evolve rapidly. In an industry traditionally slow to embrace new technologies and approaches, people, organizations, and industries came together, got creative, and worked together to mobilize. Drug developers and their research partners had to adjust to support alternative ways of monitoring and caring for clinical trial participants in a world where in-person methods were no longer an option.
The forced adoption of decentralized clinical trial models has helped the industry understand when and how to implement new approaches to improve clinical research. Moving forward, the industry has an opportunity to expand trial access to more patients and improve the overall patient experience.
A recent Oracle Health Sciences study found 61% of respondents believe allowing patients’ choices will have a positive impact on clinical research and well over half (58%) said that their organizations plan to give patients the option to choose how they participate in clinical trials moving forward. For example, community sites such as retailers like CVS and Walgreens could become more popular as trial locations. They have been successfully operating as community vaccination sites across the US for flu, COVID-19, and other vaccines. By teaming up with these locations, sponsors can expand opportunities for patient recruitment by offering patients the convenience and comfort of visiting sites they are familiar with and that might be located closer to patients than a hospital or other medical facility.
Vincent Keunen, CEO, Andaman7
The combination of mobile technology with the availability of internet communication has played a huge role. Not only can we now envisage collecting quality data directly from patients, but we can also engage patients because we can offer them direct benefits by contributing to research. Patients with health conditions seek access to - and control over - their health data and health records – and that opens a big door for patient-mediated research such that the Andaman7 platform offers. Patient-mediated research opens more gates to quality data than ever before and, at the same time, it aligns with global regulations on access to data. Most importantly, it is for the benefit of patients which is ultimately why our industry exists.
Andrew Rut, CEO and founder, MyMeds&Me
One of the biggest advances I’ve seen in 2021 is the ability – and willingness – of pharma to introduce different modes of communication for patients. Clearly, the pandemic caused a sea change in approaches to patient communication as a whole, but the industry has also recognized the importance of capturing information directly from patients.
Pharma is now successfully implementing technologies that are new to the industry, such as chatbots and voice interaction to provide consumer-like experiences that engage the user while ensuring information is gathered in a meaningful way. I’ve also seen an enormous shift in data analytics capabilities over the past few years. The combination of these advances means pharma now has the ability to capture more data and do so in a structured format so that it needs minimal human intervention and then leverage the power of analytics to make meaningful assessments more accurately and rapidly than ever before.
Tarquin Scadding-Hunt, CEO, MDGroup
The real-time uptake of mobile health (home visits) is creating a growth area with assent from clinics and hospitals. Over the past year, our business has transformed to accommodate the industry-wide adoption of decentralized clinical trials: we’ve grown our mobile health team by 144% since June 2020.
The uptake of decentralized clinical trials which leverage available technology like smartphones and wearables to reduce the burden of time, travel, and expenditure for patients has been transformational. This is helping us recruit a more representative participant population, inclusive of a wide variety of races, genders, ages, incomes, abilities, and locations – which will produce findings that are more representative of the true patient population, and in turn, lead to better clinical outcomes.
What to look out for in 2022
Rich Christie, chief medical officer, AiCure
One area slated for growth is the use of open-source data platforms to advance AI. Video and audio digital biomarkers are an untapped resource for accurately measuring patient behavior and improving a clinical trial’s objectivity, but currently, the proprietary nature of digital biomarker algorithms keeps researchers from exercising them to their fullest potential, hindering their clinical validation and refinement. As an industry, we need to continue encouraging open-source platforms so the scientific community can gain access to algorithms, jointly contribute to their advancement, and further validate digital biomarkers as a legitimate means to understanding disease.
Serge Bodart, CCO, IDDI
Precision medicine or getting the right treatment to the right patient at the right time is the biggest opportunity currently facing the life sciences sector. It is the logical next step for our industry, and, at IDDI, we believe it has the potential to revolutionize the medicines landscape in the near future. Our mission is to help make that happen. We will continue to innovate, using new applied methodologies, to make it easier, faster, and safer to develop new drugs and biomarkers that improve patient health. We want to go beyond precision medicine and enter a new era of personalized medicine in which patients can choose the treatments that suit them best.
Vincent Keunen, CEO, Andaman7
Patient-mediated care gives an important role to patients and motivates them to contribute to research. And this level of involvement has been accelerated by the pandemic: according to the Health Research Authority (HRA), by August 2020 the rate of public involvement declared in COVID-19 research applications was 85%. This shift to patient-centric care also has significant implications for the care sector, as patients increasingly become health consumers who can wield their spending power.
We will see both the care and research industries begin to communicate better as a result, to align with patients’ needs. This is where patient empowerment platforms (PEPs)can bridge the gap between patients and care and research stakeholders.
Bas van Driel, CEO, DFE Pharma
The pandemic has really highlighted pharma’s need for patient-centric solutions. In 2022, the trend of personalized medicine will grow significantly. This approach aims to ensure a drug is tailored for optimal effectiveness and patient outcomes, and it has demonstrated a higher level of effectiveness for specific patient populations with unmet needs.
However, drug manufacturers need to adapt their processes to enable specialized medicines to be produced in smaller volumes than the norm until now. This type of production requires technology and facilities that allow more flexibility. Continuous manufacturing (CM) has already shown it can address these challenges.
Oliver Technow, CEO, Biovectra
Over the past 18 months, we have witnessed the emergence of new types of commercial vaccines – mRNA and viral vector – that have helped battle COVID-19. However, both the mRNA and viral vector platforms go far beyond vaccines in terms of potential applications, with uses in oncology and autoimmune disorders popular growth areas.
We will see tremendous financial and manufacturing resources focused on moving these products, currently in the clinical phase, towards commercialization. I also believe that we will see manufacturing concepts evolve for these mRNA therapies, for example, targeting personalized medicines with batch sizes of one. This would be a complete reversal of what we are currently seeing with respect to manufacturing mRNA vaccines for the entire world population.