Jill Murphy

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A key political decision from 2023 that will undoubtedly impact the scientific communities of both the United Kingdom and European Union has been the allowance of the UK to re-enter the Horizon Europe research programme (see 

) (1). After voting to depart from the EU in 2016 and finally severing from the union in 2020, the UK has been excluded from full membership of certain EU projects, such as Horizon Europe. However, in March 2023, after the implementation of the Windsor framework (2,3), discussions commenced between the regions with the aim of getting the UK reinstated into the Horizon Europe research programme (4).

On 7 Sep. 2023, the UK and EU agreed upon a new bespoke deal, allowing the UK to participate in the Horizon Europe programme as well as the EU’s Earth observation programme, Copernicus (5,6). UK scientists were able to apply for grants and could bid to participate in projects from the date of the deal announcement (7 Sep. 2023), and from 1 Jan. 2024 are able to formally participate in Horizon Europe on par with EU counterparts with access to funding (6).

“The EU and UK are key strategic partners and allies, and [this] agreement proves that point. We will continue to be at the forefront of global science and research,” specified Ursula von der Leyen, president of the European Commission (EC) in a press release about the deal (6).

Horizon Europe is the European Union’s (EU’s) seven-year research and innovation funding programme that has succeeded the Horizon 2020 programme. Across seven years, researchers and innovators can apply to receive a grant from the programme’s budget which is worth a total of €95.5 billion, making it the largest civil research and innovation programme.

Consideration of funding for the programme is split into three main pillars: excellent science; global challenges and European industrial competitiveness; and innovative Europe. Any EU member state and associated countries can participate in the programme.

More information can be found on the European Commission’s website: 

https://research-and-innovation.ec.europa.eu/funding

Many in the scientific research communities of both the UK and Europe have been grateful to see this deal finalized. “[The] announcement on the UK’s association to Horizon Europe and Copernicus is a cause for celebration on both sides of the channel,” said Dr. Michael Spence, president and provost of University College London, in a news release (7). “Association to Horizon Europe will enable research, which makes a positive difference to people’s lives, supporting vital research and innovation networks and strengthening the UK’s position as an attractive destination for talent.”

The deal is a particular boon to those in the UK’s scientific community who were facing uncertainty due to limited funding opportunities for research. “The lack of agreement to allow the UK to continue to play a full role in the EU Horizon funding programme severely threatened [UK science] continued success,” explained Professor Liam Smeeth, director of the London School of Hygiene and Tropical Medicine, in a news release (8). “My concern was particularly for the long term. With no new partnerships and collaborations being formed, there was a very real risk of the UK becoming isolated and insular.”

Mayer Schreiber, CEO of Discovery Park, emphasized the importance of collaboration in the science community. “Collaboration is vital to successful science and innovation and the funding and partnership opportunities the programme offers will bring considerable benefits to the UK and Europe,” he said in a press release (9).

Now that the UK is fully reinstated into the Horizon Europe programme, reforging research relationships that have been lost in the interim will be vital. According to Thomas Jørgensen, director for Policy Coordination and Foresight at the European University Association, trying to get the level of cooperation back to where it was prior to the UK’s removal from the programme will be the biggest challenge (10).

Adding to this challenge will be issues such as the UK and EU’s divergence in regulations and standards, such as the rules around digital platforms, and the European view on certain sensitive subjects, such as the development and sharing of strategically important technologies, asserted Jørgensen (10).

However, on a positive note, the hiatus from the programme has finally come to an end, and UK-based researchers are once again able to receive funding and lead research projects involving multinational consortia. “Joining the Horizon Europe programme is a huge win for the scientific research community, who have been pushing for resolution over the past few years,” specified Janet Valentine, executive director of the Association of the British Pharmaceutical Industry, in a response to the deal. “UK innovation and research depends on international collaborations, which are crucial for driving advancements in all areas of science, including the discovery and early development of new medicines and vaccines. The UK accession to Horizon enables the two sides to reinvigorate their longstanding partnership in R&D, and directly contributes to UK growth and competitiveness in the life sciences sector by making the UK an attractive destination for talented researchers” (11).

. Policy Paper, 27 Feb. 2023.
3. European Commission. Protocol on Ireland and Northern Ireland: The Windsor Framework. 

 (accessed 10 Jan. 2024).
4. Gallardo, C. Britain and EU Agree Draft Horizon Deal. 

, 5 July 2023.
5. UK Gov. UK Joins Horizon Europe Under a New Bespoke Deal. 

, Press release, 7 Sep. 2023.
6. European Commission. EU-UK Relations: Commission and UK Reach Political Agreement on UK Participation in Horizon Europe and Copernicus. 

, Press Release, 7 Sep. 2023.
7. UCL. Rejoining Horizon Europe is a ‘Cause for Celebration’. News Release, 7 Sep. 2023.
8. LSHTM. Expert Comment—UK Rejoins Horizon Programme. News Release, 8 Sep. 2023.
9. Discovery Park. Discovery Park Welcomes Decision to Re-Join EU Horizon Science Programme. 

, 7 Sep. 2023.
10. Jørgensen, T. So the UK is in Horizon Europe—Now What? Research Professional News, 19 Sep. 2023.
11. ABPI. ABPI Response: UK Joins Horizon Europe. News Release, 7 Sep. 2023.

Felicity Thomas is the European/senior editor, and Jill Murphy was the former editor for Pharmaceutical Technology Group


Vol. 36, No. 1
January 2024
Pages: 32–33

When referring to this article, please cite it as Thomas, F.; Murphy, J. Bringing Collaboration to the Horizon Once More. 

Articles

UK scientists are once again able to participate in the Horizon European research programme thanks to a deal struck in 2023.

Bringing Collaboration to the Horizon Once More

In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Tom Fletcher, director of Research and Development at FUJIFILM Irvine Scientific; and Bob Newman, PhD, chief scientific director at FUJIFILM Irvine Scientific, about formulation, specifically with how to prepare culture media for use, single use technologies, and automations to create closed systems in cell/gene therapies.

 is Director of Research and Development at FUJIFILM Irvine Scientific, a company that specializes in the development, manufacture and supply of cell culture media for Bioprocessing and Cell and Gene Therapy applications. As a part of the Bioproduction division, Tom leads the company’s efforts to provide relevant solutions for the various and frequent challenges presented by upstream process development. He has over 30 years of experience serving the biopharmaceutical industry, mostly by developing cell culture media solutions for large-scale production processes. Tom has previous experience in protein chemistry research at the University of California, Irvine School of Medicine and working at Becton Dickinson & Co.

 is Chief Scientific Officer at FUJIFILM Irvine Scientific. In this role, Robert leads scientific strategy, drives global product development, and expands R&D capability for the company. He was previously Senior Director for R&D at ATCC and R&D Manager Stem Cells at BD, and holds a PhD in Biochemistry and Molecular Biology from Georgetown University.

 presents the Drug Solutions podcast, where the editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.

Podcasts

Tom Fletcher, director of Research and Development at FUJIFILM Irvine Scientific; and Bob Newman, PhD, chief scientific director at FUJIFILM Irvine Scientific, discuss formulation, specifically with how to prepare culture media for use, single use technologies, and automations to create closed systems in cell/gene therapies with former Pharmaceutical Technology editor Jill Murphy. 

Drug Solutions Podcast: Staying on Track with Formulation of Cell Culture Media

Girl pours liquid from a test tube into flask | ©madhourse - stock.adobe.com

Operational excellence relies heavily on an organization being staffed with the adequate amount of properly trained personnel. The pharmaceutical industry has seen an increase in new modalities over the past few years, partially because of the COVID-19 pandemic. There has also been a 20% increase in demand for science, technology, engineering, and mathematics (STEM)-related talent (1).

Pharma digital talent is lower than what is needed, and recruitment of talent is challenging (1,2). Strengthening hiring and retention efforts is crucial. “A recent wave of tech-company layoffs offers the pharma industry an opportunity to scoop up critical skills and talent to drive their digital and analytics ambitions,” according to Golub et al. (2). “Pharma companies that need to upgrade their capabilities quickly can also look to M&A deals for digital, AI [artificial intelligence], and healthcare-technology talent. Given the rapid evolution of technology, acquiring tried-and-tested talent allows the company to meet the demands of innovation faster than upskilling” (2).

“Both demand for and development of novel biologic drugs continue to expand at a rapid pace. At the same time, the need for training in the biopharmaceutical industry has increased dramatically in recent years due to this and several other factors,” says Hugues Bultot, CEO Univercells. “As biopharma companies and biologics contract development and manufacturing organizations [CDMOs] have added significant capacity to meet the growing demand, this has created the need for a larger workforce at a time when there is a shortage of skilled/educated/experienced people seeking careers in the biopharma sector.”

Bultot also points to good manufacturing practice and operator training requirements that increase demand for skilled pharmaceutical personnel. “Simultaneously, deployment of single-use technologies at a commercial scale is creating the need for training on these new systems,” he states.

The increased demand for skilled workers in development and manufacturing creates a challenge for an already complicated industry. What can pharmaceutical companies and CDMOs do to address the situation and maximize operational efficiency? Empowering employees, managing burnout, and innovative training technologies may offer solutions.

Finding the right person for the right job is imperative, says John Roosenberg II, PhD, site director, Dr. Reddy’s Laboratories, Shreveport and Middleburgh. “One of the key strategies is to focus your hiring practices on finding people with the right abilities who can learn the skills they need to do the job. It will also be critical for pharma organizations to work with local educational organizations (community and local colleges) to develop classes and educational tracks that ensure there is a local talent pool for hiring,” he says.

Once the right employee is hired, onboarding new employees is where training usually begins. But training should be an ongoing process. Also, companies should be careful not to overload new employees with too much training when starting a new job can be stressful enough.

To avoid overloading employees when training, Michael Tsaconas, vice president Operations and general manager, BioCina, recommends spreading training for new staff over time to avoid too much training in a short time period. He also suggests using “on-the-job methods to facilitate the transfer of practical skills, troubleshooting techniques, and real-time problem-solving” for critical and complex tasks. Automated and flexible training is also important, according to Tsaconas, such as online training and exams. “Ensure regular check-ins with new staff members to solicit valuable feedback, monitor training effectiveness and address gaps, as needed,” he says.

Samantha Hadfield, FSP business segment lead, PPD clinical research business, Thermo Fisher Scientific, comments that streamlining and expediting onboarding for FSP engagements can be done by pairing new hires with current staff. “[We also] employ close line manager oversight and just-in-time function-specific training that combines in-person and online support. Through this ‘ready now’ risk-based approach, we’ve achieved an average of just 22 days from candidate identification to full operational capability,” she explains.

“Interactive learning makes it easier to retain information by separating book learning from hands-on experience. Going into the lab and watching something they will have to make at a commercial scale eases the learning curve. That way a new hire can understand the process and see the equipment they’ll be using. It decreases the amount of information that has to be retained at once,” says Ted Dolan, chief operating officer, Complex Chemistry, BIOVECTRA.

Empowering employees with a greater understanding of the tasks they are performing can be an effective training tool. “Operators are more likely to retain their training and make more informed decisions when they understand the science as well as the equipment,” continues Dolan.

By way of example, Dolan points to a recent approach taken at his company where a group of operators were given more interactive training for a new process—witnessing online batch reading at the bench scale and then following up with a walk-through of the equipment. “This approach emphasizes background learning, so the operators will be better prepared and empowered to make decisions during manufacturing. Traditionally, training is managed by the operators themselves but, in this case, we also included our continuous improvement (CI) and quality groups and created a video to document this novel approach for future training. The CI group will assess whether this approach trained our employees more efficiently.”

Interactive training that includes real-life scenarios can be helpful, according to Dolan. “A new employee can get dozens of training modules during the first week of their new job. They need to read the SOPs [standard operating procedures], then get tested on them,” he notes. To aid in retention of the SOPs, Dolan reveals that interactive training sessions with animations and real-life examples have proven to be useful at BIOVECTRA.

Sometimes switching tasks up can keep employees engaged. “There’s something to be said for taking a good worker who’s been in the same position for 15 years and giving them the opportunity to learn new skills and become excited about their job again. [This can be promoted] through cross-training, which leverages what someone already knows, while providing them with additional insights as to how that can be applied to different products and processes. For example, cross-training allows people [to be brought] from [a] complex chemistry division into biomanufacturing or from biomanufacturing into biologics,” says Peter Ercoli, chief operating officer, Biologics, BIOVECTRA.

However it is accomplished, training is an important and necessary task, and Bultot highlights that companies have to find solutions for providing it. “There are a few examples of universities adding centers focused on biopharmaceutical manufacturing, not only to provide graduates with a higher level of manufacturing skills, but to support training of existing industry personnel. Companies are beginning to leverage these centers to meet training needs they cannot provide internally. Others are, as mentioned earlier, leveraging computer-based and virtual training solutions that reduce the demand for training personnel and other resources. Some of these solutions are being developed through partnerships between manufacturers and equipment vendors. An industry-wide collaboration along these lines would be a great step towards overcoming the issue of training shortages,” he says.

Once the right employees are hired and trained, how do companies keep those people long term? One solution is being aware of the stress employees face. Managing burnout can be a challenge for both staff and management. Burnout, which can be caused by a variety of factors, may lead to high turnaround in staff and, therefore, loss of expertise. “Unfortunately, attracting new graduates continues to be a challenge, as many are drawn to trendier occupations such as those in the software industry. Given the high workload for operators who have remained in the industry, it is not surprising that some reach a point of ‘burnout’,” says Bultot.

According to Melissa El Khouri, head of Quality at BioCina, poor training can be one part of burnout in pharma employees. She recommends that all staff members be fully trained on systems and procedures before starting their defined roles. Managers should also ensure that workloads are reasonable. Teamwork and shared responsibility are also important, according to El Khouri, so workloads become lighter. “Implementing company policies that help staff members to have sufficient control over their work-life balance, for example generous time-off options, flexible hours,” she says.

BIOVECTRA has added additional staff to combat burnout. “The recognition of mental health—which includes stress or burnout—is much more in the daily vernacular than ever and has led to improve[d] communication among staff,” says Dolan. One such approach being employed by BIOVECTRA is regular “lunch-and-learns”, Dolan states. These sessions allow employees a forum for open discussion, and the company can listen to any concerns raised about the work environment, which ultimately has a positive impact as it takes away “unnecessary stress and fear of the unknown,” he reveals.

Denise Bell, director, Product Management, LabVantage Solutions cautions that inefficient operations and an unmanageable number of manual tasks can cause burnout for laboratory personnel. “One effective way to address this is by introducing a laboratory information management system (LIMS),” she says. “LIMS can drastically streamline lab processes by automating time-consuming tasks, such as data entry and report generation. Not only does it ensure regulatory compliance and easy documentation, but it also organizes and manages data for effortless access and analysis. Moreover, LIMS can manage consumables in an efficient manner, further relieving the load on hardworking lab staff and reducing stress.” Through integration of a well-structured LIMS, it is possible to free-up staff time as the tools being used operate smoothly, Bell explains. In turn, with more free time, employees can then focus on other tasks, such as important scientific explorations, which “can significantly mitigate the burnout and subsequent shortages in the industry,” she says.

LIMS can also offer automation of routine tasks, guided workflows, compliance control, and management of permission control, says Bell. “This not only enhances efficiency but also helps address the challenges faced by those who are still gaining training and experience within the industry,” she states.

Roosenberg points to schedule disruptions that cause last-minute changes, overtime work, and a lack of flexibility in working hours to possible stressors for pharma employees. “It is important to develop a relationship [with] team members and find ways to work with each of them as individuals to ensure the success as a whole. This may mean ensuring team members get off for family activities and having others provide coverage. This requires a very balanced approach,” he says.

Unexpected situations can put undue stress on employees, according to Ercoli. “The best way to address this is through clear communication. What [employees] have to do may not change, but their perception of it may have changed. Another cause of burnout is a feeling of loss of control,” he says.

Equipment and resources. Having the proper resources for employees can help manage burnout. “Designing equipment that is easier to use, such as single-use systems that have simple processes for installing and removing the ready-to-use reagents and disposables, as well as for running processes, is one approach and a goal at Univercells. Cross-functional training is another that enables operators to continue learning and keep their interest level high while reducing fatigue and the grind of performing the same tasks day after day,” says Bultot. “It should also be noted that retraining is required on an ongoing basis to refresh operator understanding and ensure that manufacturing personnel are familiar with any new systems.”

Aging facilities and equipment, or equipment that doesn’t work properly, are additional stressors that can contribute to staff burnout. “An equipment problem that results in schedule delays, and the potential to have a batch under investigation, creates extra work. The happiest operators are the ones who run well-functioning equipment,” says Dolan.

“Handling aging equipment is sometimes mitigated with excessive SOPs, overwhelming operators. And, as soon as it breaks down, stress levels go way up,” Ercoli agrees. Investing in technology-driven facilities with new equipment that is continuously improved is advised, he notes, and also avoids operators having to repair old equipment.

Roosenberg offers that older equipment has the benefit of fewer skills requirements and less training. “If you don’t have to train employees on new equipment and deal with many of the challenges of new software upgrades etc. Also, many of the older equipment is more manual in operation so trouble shooting it is more straightforward.”

Innovation and digital enhancements have been entering all types of industries. Automation is becoming more and more prevalent in various areas of the pharmaceutical industry, and staff will need training on these new innovations. But with innovation comes change.

Augmented reality may offer the ability to run simulations on routine issues, specifies Roosenberg. And new training enhancements can offer better engagement with personnel. “It would also be great to have manufacturers of equipment generate a digital training platform. This way changes in the training can be done in real time to the changes in the operations of equipment,” he says.

“The risk is that, with automation, operators will no longer need to understand what equipment does and could become button-pushers as opposed to manufacturers,” warns Ercoli. “This has the potential to separate workers emotionally from what they’re making—essential medicines for people. Also, from a regulatory perspective, [it will be necessary] to prove the control of systems that are intelligent enough to make a series of decisions very quickly.”

Whilst in agreement, Dolan also points out that with processes being run by humans then it is imperative that these operators are trained properly to ensure safety. “There’s so much potential value in using AI, in terms of time management and efficiency, but the concern is how to manage it,” he emphasizes. 

Digitalization of training may be the key to more efficient training. Tsaconas reveals that some of the “most forward-looking ways” of increasing operational efficiency and reliability he has experienced is through digitization and automation of key workflows. Developing interactive e-learning modules offers flexibility and convenience for operators. “These methods can also significantly reduce traditional training requirements and the accompanying investment of time and resources they demand,” he summarizes.

Dukart, H.; Lanoue, L.; Rezende, M.; and Rutten, P. Emerging from Disruption: The Future of Pharma Operations Strategy. 

Golub, A.; Lewis, J.; Tinkoff, D.; Van der Veken, L. and Zhu, D. Rewired Pharma Companies Will Win in the Digital Age. 

®
Vol. 47, No. 12
December 2023
Pages: 12-15

When referring to this article, please cite it as Haigney, S. and Murphy, J. Training for Operational Excellence. 

The bio/pharmaceutical industry is struggling with the challenge of staffing and training.

Training for Operational Excellence

Bourji Mourad, Director of Global Logistics & Partner Management at Sonoco ThermoSafe

 has spent the last 22+ years in the air cargo temperature management and cold chain logistics sector for safer transportation of time and temperature sensitive pharmaceutical products. Bourji is building a global network of stations for handling and repair of Pegasus ULD the first in market with aircraft certified temperature-controlled container as a Unit Load Device launched during 2022.

Bourji is also creating partnerships with selective Airlines and Freight Forwarders at corporate level making it possible for customers gain access to the Pegasus ULD fleet available around the world and offered by Sonoco under a rental program for shipping Pharmaceutical & Life Sciences products. Prior to joining Sonoco in late 2019, Bourji was with Envirotainer for 18 years as their Global Head of Partner Management & Compliance; also has 20 years-experience in the Shipping & Freight Forwarding industry prior to joining Envirotainer.

In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.

Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain

Key highlights from the CPHI Pharma Survey were announced as of Oct. 13, 2023, and the full findings will be published at CPHI Barcelona as part of the CPHI Annual Report. These results will provide insights from more than 250 global pharma executives, including discoveries such as pharma confidence dipping below the record scores of 2022, although it has remained extremely resilient despite wider macro uncertainly, according to the press release.

Further, the CPHI Pharma Index reported its second highest ever total, which was 2.5% down on the 2022 all-time high. These results highlight the medium-term trajectory of the industry and the strength of market fundamentals. The United States remained the top overall ranked nation, with India also continuing to make year-on-year inroads for significant growth in 2024. India did, however, remain at the top of the “growth” category for the second year in a row, scoring 7.8 out of 10. It also saw improvements in the score for “biologics quality” and finished behind the United States for “overall competitiveness”. According to the report, India is predicted to undergo a fast transformation from a generics hub to an innovation-focused pharma economy, driven by the incremental steps of large contract development and manufacturing organizations.

One of the more startling discoveries, according to the press release, is that the report predicts that an “India plus one” strategy will be adopted in the next five years. “When you look collectively at the data points in the Annual Survey, you see that after a reset from record scores in 2022—when many reported record profits—the industry is now well positioned for growth in 2024,” said Tara Dougal, Content Director–Pharma, in a press release.

The report also identified that many of the industry’s growth drivers that were seen in 2019 are still present but are now supplemented by the breakthroughs in microbiome therapeutics, while artificial intelligence now looks like the next efficiency used in the industry over the next five years.

“Our analysts predict outsourcing will continue its growth trajectory in 2024 and beyond—which is obviously a tremendously positive message for the industry as we approach CPHI Barcelona,” Dougal said in the press release. “It is also why we have ensured that ‘outsourcing strategies’ are a central theme of this year’s content, and the overall takeaway is of quiet and confident optimism. In fact, this will remain an ongoing theme for CPHI content, helping our audience to meet their objectives around partnering and supplier selection year-round.”

These results will provide insights from more than 250 global pharma executives, including discoveries such as pharma confidence dipping below the record scores of 2022, although it has remained extremely resilient despite wider macro uncertainly, according to the press release.

CPHI Annual Survey Finds Global Pharma Resilient with India the Chief Beneficiary of Macro Changes

When considering manufacturing and the growth of drug formulation, it is evident that there has been change and many new advancements introduced to make processes more efficient. However, in terms of formulating highly potent drugs, their specific release requirements and poor aqueous bioavailability make them challenging to produce and analyze (1).

Although there may be difficulties seen with analytical challenges, the strength of oral solid dosage (OSD) forms and the manufacture of all pharmaceutical finished dosage forms continues to be prominent. According to research, the OSD market outlook is expected to continue growing and have low production costs, even with the knowledge of how unpredictable formulation may become (2).

Trends in Formulation for Highly Potent Drugs

 discussed new formulation trends with Shailesh Vengurlekar, senior VP of Quailty and Regulatory Affairs at LGM Pharma, and how the industry can go forward with these advancements, despite any challenges that may arise.

Read this article in the Trends in Formulation 2023 eBook

When referring to this article, please cite it as J. Murphy, "Trends in Formulation for Highly Potent Drugs," 

's Trends in Formulation eBook (October 2023).

When considering manufacturing and the growth of drug formulation, it is evident that there has been change and many new advancements introduced to make processes more efficient. 