Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Felicity Thomas

Pharmaceutical Technology® discusses the quality and compliance issues surrounding the use of animal-derived ingredients in the bio/pharma industry with Roger Viney, chief commercial officer of ICE Pharma.

DCAT Week 2025: Quality and Compliance for Animal-derived Products

“There are two main differences in terms of quality and compliance that you have to take into account when you're handling animal-derived products,” explains Roger Viney, chief commercial officer of ICE Pharma. “The first is to have steps in your process that ensure biological inactivation, whether it's of course, removal of bacteria, denaturing of DNA, and particularly viral inactivation.”

Secondly, Viney adds that traceability is important: Knowing the exact origin of the animal-derived material means that should there be any issues in a particular country or with a particular disease, it is easy to identify and segregate the material that will be affected, he remarks.

Looking at regulatory requirements, Viney points out that harmonization is critical and allows for increased security of supply. Furthermore, offering fully integrated services is an added benefit for customers as it provides them with the confidence in traceability of the products, he specifies.

 spoke with Viney about the utility of bile acids as excipients to help improve solubility and bioavailability. The interview can be viewed by following the link below:

https://www.pharmtech.com/view/improving-solubility-and-bioavailability-with-bile-acids

Roger Viney, PhD, is the chief commercial officer for ICE Pharma and is responsible for the global commercial functions. Roger has a 30-year career, starting in R&D and then moving across to sales, marketing, key account management, and business and product management for the pharma market.

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Pharmaceutical Technology® sat down with Tore Bergsteiner from MAIN5 to discuss the most pertinent and impactful bio/pharma industry trends from 2024.

Industry Outlook 2025: Looking at the Mega Trends

The past year, 2024, was a very active one, remarks Tore Bergsteiner, managing partner at MAIN5, a European consulting firm specializing in digitally enabled change for life sciences R&D organizations. “There have been a lot of changes and trends, especially in the political legislative perspective, but also related to new technical trends, influences which are gaining more momentum and maturity,” he says.

Firstly, a key trend for industry, Bergsteiner points out, is artificial intelligence (AI) and the digital transformation that is being seen. “[AI] will become a more and more relevant technique impacting our daily businesses, our overall competitiveness in the industry,” he notes. “And we have to consider that accelerated adoption and processes driven by AI/machine learning or large language models are already reshaping a variety of key processes in pharma.”

The second trend of note for Bergsteiner is the globalization of the supply chain and the monitoring of critical medicines and relevant shortages. “That means diversifying efforts to continue reducing dependency on single regions such as India or China for API, and manufacturing needs to be decreased,” he says.

Continued regulatory reforms and harmonization make up the third key trend from 2024 for industry, emphasizes Bergsteiner. “There are streamlined pathway in the US [United States] and in the EU [European Union], fostering innovation, especially in the area of rare diseases and oncology,” he remarks. “Those [pathways] are pushing companies more and more to continue digitizing their end-to-end processes to remain competitive and regulatory compliant.”

Tore Bergsteiner, Managing Partner at MAIN5

Tore Bergsteiner is Managing Partner at MAIN5, a European consulting firm specializing in digitally enabled change for life sciences R&D organizations. Tore has approximately 30 years of experience in industry and has been a pioneering influence in the field of electronic regulatory submissions and within the management and publishing servicing industry. He previously worked for EXTEDO GmbH, a leading international product vendor of electronic approval systems for publicly owned and private pharmaceutical industry, and IABG GmbH, a major German technology and operating company. Tore graduated in Computer Sciences in 1996 and studied at the University of Bremen, Germany, the University of Texas, Austin, USA, and the Julius Maximilian University of Würzburg, Germany.

Pharmaceutical Technology® chats with Simon Wright from Almac Pharma Services about shifting demand for commercial manufacturing services and how service providers are adapting to meet demand. 

DCAT Week 2025: Recognizing the Value of CDMOs

Therapeutic modalities are diversifying across the bio/pharma industry, explains Simon Wright, vice president of Business Development for Almac Pharma Services. “Whilst there remains a strong demand for traditional small molecules, we see a higher percentage growth in areas such as biologics, vaccines, cell and gene therapies, and I guess, most recently, peptides,” he says. “And these drugs are administered through various formats, ranging from oral to injectables, but with an increasing trend towards drug–device combinations.”

In addition, regulatory and financial incentives are giving rise to increased attention on novel drugs that treat rare and difficult-to-treat diseases that have smaller patient populations, Wright adds. With these trends in mind, contract development and manufacturing organizations (CDMOs) need to offer flexibility as a strategic partner to innovators, he specifies.

“We're really seeing a desire for more of a strategic partnership versus maybe more of that traditional transaction relationship [from sponsor companies],” Wright says. “I truly believe that the evolution of sponsor CDMO relationships reflects how pharmaceutical companies recognize the value of CDMOs within their overall network and ecosystem. I think that the most strategic relationships today are characterized by strategic partnership approach where companies leverage specialist expertise and trust the CDMOs to assume greater responsibility and deliver substantial value.”

Simon Wright, vice president of Business Development for Almac Pharma Services

Simon Wright is Vice President of Business Development for Almac Pharma Services, part of Almac Group. In his role, Simon leads the business development team across both Europe and North America, and he supports the company’s marketing efforts for the business unit. Simon has approximately 30 years’ experience in the CDMO space.

In an interview with Pharmaceutical Technology®, Ian Lafferty from Upperton discusses the trends and challenges facing sterile manufacturing and how partnering with CDMOs can help innovators progress to the market.

DCAT Week 2025: Helping Innovators Progress

“The sterile manufacturing sector is at a real crossroads at the moment,” asserts Ian Lafferty, chief technical officer of Upperton Pharma Solutions. Driven by factors such as the increasing prevalence of chronic diseases, the requirement from industry for sterile manufacturing has been driven upwards at a significantly rapid pace, he remarks. “But, right now, there’s a real deficit in the [sterile manufacturing] capacity, and it is difficult for people to find the right places to go,” Lafferty says.

Difficulties in finding suitable aseptic/sterile manufacturing capacity is particularly prevalent for smaller innovator companies who are looking to develop just one product, Lafferty explains. “They need the CDMO [contract development and manufacturing organization] world to pick up that banner and build facilities,” he specifies. “And it’s not just the facilities; it’s the infrastructure around the appropriate quality management systems, [and] it’s the expertise to support multiple small biotech companies entering into the market.”

For sterile or non-sterile projects, CDMOs can offer some key advantages for innovator companies and the industry in general, Lafferty continues. First and foremost, he adds, having a wealth of expertise and experience in one place is a great help for small innovator companies. Additionally, CDMOs offer facility space for multiple partners, which reduces the need for smaller companies to invest in facilities of their own and provides greater flexibility as multiple projects can be serviced at the same time, Lafferty states.

“Ultimately, [CDMOs are] going to reduce costs [and] reduce timelines while maintaining quality standards,” Lafferty summarizes. “So, it's servicing and giving a place for those small innovator companies to concentrate their efforts on developing the product and the molecules and all the really difficult things they have to do, and then allowing someone else to concentrate on the manufacturing process and the compliance.”

Ian Lafferty, Chief Technical Officer for Upperton Pharma Solutions

Ian Lafferty is Chief Technical Officer for Upperton Pharma Solutions. He has more than 30 years’ experience within the pharma industry and has previously held senior management and executive roles at emerging and growing CDMOs. Ian is a formulation scientist with a background in oral solid dosage, nasal dosage, and sterile dosage forms.

In an interview with Pharmaceutical Technology®, Miguel Forte from ISCT and Kiji Therapeutics talks about the potential impact of a changing European political landscape. 

Industry Outlook 2025: Fostering the Development of Biotech in Europe

During 2024, many European countries held political elections, resulting in shifts in leadership. “First of all, the commission, the member states, and some of the programs have highlighted the commitment to biotechnology,” says Miguel Forte, president of International Society for Cell & Gene Therapy (ISCT), board member of Alliance for Regenerative Medicine, and CEO of Kiji Therapeutics when commenting on how the political shifts may impact the bio/pharma industry. “Obviously, the evolving political landscape gets people worried about it, focused on that, and potentially leading to less attention to other aspects.”

Another potential outcome of a change in leadership for a member state may be their approach to deploying funding and support. “If we look at some more conservative approaches, they may be conducive to certain business perspectives but may be less conducive to certain other practices that would be important in terms of fostering the development of biotech in general, and cell and gene therapy in particular,” Forte explains.

Europe needs to be more competitive on the global platform within the field of biotech, Forte specifies, which has been recognized by relevant authorities across the region. “Take, for instance, [Europe’s stance] on cell and gene therapy, making it less of an exception and more of the mainstream, which I think is a recognition that [these therapies should be] part of our day to day,” he says.

However, it takes time for such changes to be fully realized and implemented, as various checks and balances need to be considered, Forte continues. “The key elements that to be to be considered [are] an investment in biotech and a recognition that we all need to work together to improve the competitiveness of Europe for the sake of the overall business, for the sake of the overall patient, and clearly, for the sake of us in Europe,” he summarizes.

Miguel Forte, president of International Society for Cell & Gene Therapy, board member of Alliance for Regenerative Medicine, and CEO of Kiji Therapeutics

Miguel Forte is president of International Society for Cell & Gene Therapy, board member of Alliance for Regenerative Medicine, and CEO of Kiji Therapeutics—a company developing engineered cell therapies for inflammatory diseases. Miguel holds an MD and a Specialist in Infectious Diseases from the Faculty of Medicine, University of Lisbon, a PhD in Immunology from the University of Birmingham, and a certificate on Health Technology Economics from the Stockholm School of Economics. Additionally, he is Fellow of the Faculty of Pharmaceutical Medicine of the RCP in the UK.

Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments, in an interview with Pharmaceutical Technology®.

Industry Outlook 2025: US Political Motivations and Legislative Discussions

According to Miguel Forte, president of International Society for Cell & Gene Therapy (ISCT), board member of Alliance for Regenerative Medicine, and CEO of Kiji Therapeutics, there are two aspects to consider when assessing the potential impact on industry of the new administration in the United States. “One is a conservative attitude to business, which I think might have some potential positive impact. That's good [because it] will support the economy and give a certain confidence to investment,” he says.

Additionally, Forte specifies that the leadership must impact business positively while also managing to make careful decisions around technological aspects of the industry, allowing organizations, such as FDA, the ability to perform their jobs. “I would also want to see that public health and product considerations are done the right way,” he adds.

A legislative change in the US that will more than likely have an impact on the bio/pharma industry is the introduction of the BIOSECURE Act, which was passed in September 2024. “I can understand some political motivations on how to manage the flow of the data [in relation to the BIOSECURE Act],” Forte says. “Some companies may get impacted, not only the ones that are directly targeted by the BIOSECURE Act, but also the ones that had deals and partnerships and collaborations with those companies, they will have to readjust their businesses again.”

Looking at industry regulations in more detail, Forte specifies that FDA has been keen on engaging in discussions about cell and gene therapy and becoming more comfortable with these novel modalities. “I believe that regulators [are] in a much better position today to make the right decisions and support the field in terms of the development [of cell and gene therapies], and that will translate in legislation, for sure, as well,” he adds. “I think, from a new technology point of view, we saw some good decisions in terms of reimbursement into the US recently, which I think is a good signal to the field.”

Felicity Thomas

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