European Pharmaceutical Review podcast

This episode covers the emergence of nitrosamine impurities in the pharmaceutical industry and what action is being taken to address it, including the latest guidance, across pharma companies as well as regulators.

Brown opens the conversation by summarising the current landscape of nitrosamine impurities since the initial discovery around five years ago. He explains that industry response has continually evolved, due to new data being released and informing best practice for companies looking to mitigate and prevent formation of these impurities in medicines.

He explains that last year, the issue of nitrosamines moved from a toxicological problem to a wider industry concern. Now, “we are starting to get a good idea of how many products on the market could be affected”.

When it comes to preventing nitrosamine formation in drug products, key challenges manufacturers are facing include knowing exactly what active pharmaceutical ingredients (APIs) can form nitrosamines, Brown explains. He specified that there is a lack of alignment on this issue between regulatory agencies and experts.

Having the right laboratory standards, equipment and personnel who are adequately informed is important in working to address the issue of nitrosamines”

Another major challenge is getting through the initial risk assessment for nitrosamines. There is still a “fundamental lack understanding…what exactly should be included in that risk assessment, and what it looks like,” Brown asserts, highlighting the importance of an inclusive risk assessment.

Having the right laboratory standards, equipment and personnel who are adequately informed is important in working to address the issue, Brown continues.

He also shares how technologies are “critical” to detecting nitrosamine impurities and recommends the best approaches in this area. Furthermore, he emphasises the importance of collaboration, spanning decisions made in quality to regulation, as well as considerations for reformulation strategies.

Finally, Jason looks ahead to the future and suggests how the industry can work to navigate nitrosamine impurities, for instance, over the next five years.

The post EPR Podcast Episode 26 – Navigating Nitrosamine Impurities – Jason Brown, Adare Pharma Solutions appeared first on European Pharmaceutical Review.

In this podcast, Giovanni Nisato, project manager at the Pistoia Alliance discusses data integrity and the FAIR data principles. In this role, he coordinates FAIR Community of Experts, which created the FAIR Maturity Matrix.

Giovanni starts the conversation by defining data integrity and explaining why it is ‘mission critical’ for the pharmaceutical industry. 

Next, the podcast introduces FAIR (Findable, Accessible, Interoperable, Reusable) data principles and explores how their adoption have evolved over the past decade.

“This year we celebrated the 10-year anniversary of the first workshop where those FAIR data principles were reformulated. And they were then published in 2016,” Giovanni says.

Since then, the pharmaceutical industry has seen a “move towards data centricity as a way of thinking.” But adoption of the FAIR data principles is not mainstream yet. 

Additionally, while the principles are increasingly recognised in academia and R&D, their implementation in the clinical domain is lagging behind.

While the principles are increasingly recognised in academia and R&D, their implementation in the clinical domain is lagging behind”

“I would say that the implementation of FAIR data principles is perhaps starting, but there’s a lot of room for improvement in the clinical space,” Giovanni reflects.

This is one area the Alliance has focused on, producing the FAIR4Clin guide that gives a comprehensive overview on FAIR resources in the clinical domain.

Giovanni also explains the FAIR Maturity Matrix, a framework developed to help organisations benchmark and assess their systemic level of FAIR maturity. The FAIR Maturity Matrix was co-created by members of the FAIR Community of Experts of the Pistoia Alliance. Giovanni presents seven key dimensions that make up the matrix: data, leadership, strategy, roles, processes, knowledge, and tools. He also introduces the six maturity levels of the framework.

Finally, Giovanni looks ahead, outlining two priorities that are needed to accelerate adoption of FAIR data principles in the industry.

Giovanni Nisato is an expert in collaborative innovation management across organisations at the international level. He has over 20 years of experience in the industrial and public-private deep tech sectors. As a Project Manager with the Pistoia Alliance, he has facilitated the FAIR Community of Experts since 2022. Its aim is to co-create and maintain pre-competitive resources to foster the implementation of FAIR data principles in the life sciences ecosystem for the benefit of pharmaceutical companies, CROs, technology providers, and ultimately, patients.

The post EPR Podcast 25 – FAIR Data in Pharma – Giovanni Nisato, Pistoia Alliance appeared first on European Pharmaceutical Review.

Ocugen is utilising the modifier gene therapy technology approach to treat retinal diseases. The therapy can be used to treat both inherited disorders, such as retinitis pigmentosa (RP), Leber congenital amaurosis, and Stargardt disease, but also multifactorial diseases like dry age-related macular degeneration and angiographic atrophy.

The company’s lead candidate in modifier gene therapy, OCU400, is in Phase III trials for treatment of RP and Phase I/II for treatment of Leber congenital amaurosis.

In this episode, Dr Neena Haider, Faculty member at Harvard Medical School and founder of biotech company Shifa Precision and Dr Arun Upadhyay CSO of Ocugen discuss the development of modifier gene therapy.

Neena starts by discussing the complexity of retinal diseases where multiple genes are involved.

About two to 3,000 genes – so about 10 percent of the genes in the genome – are involved in helping us see, Neena explains. “If there are mutations… in any one of these, it impacts how the retina functions.”

Modifier genes… have been identified and used to suppress or treat or attenuate disease.”

“If we look at retinitis pigmentosa, it’s known as a rare disease – affecting one in 4,000. However, there’s over 200 different roadmaps to get to this disease, meaning either different mutations in known genes or hundreds of different genes,” Neena says.

Modifier genes, which are “normal genes that modulate clinical outcomes by interacting with disease-causing genes,” have been identified and used to suppress or treat or attenuate disease.

Arun and Neena discuss the benefits and challenges of the modifier gene therapy approach, including the manufacturing considerations. 

The speakers also share their predictions for the gene therapy space. They anticipate a trend towards more gene agnostic approaches, combination therapeutics and alternative delivery technologies.

“What I see is the gene therapy approach is going to expand into the non-genetic area, primarily focused on metabolic disorders, neurological disorders, and other chronic disorders,” says Arun.

Neena adds: “We have already started on [an] upward trend. What I predict is that [the gene therapy] space is going to really explode in the most fascinating way … so we’re going to see better, more effective and sustained therapeutics.”

Dr Neena Haider is Faculty at Harvard Medical School; Founder of Shifa Precision and Science Advisor in Congress. She was part of the human genome project and is an internationally recognised leader with over 50 publications, 3000 citations and a US patent issued for her invention of modifier gene therapy as a potentially curative therapy.

Dr Arun Upadhyay is Chief Scientific Officer and Head of Research & Development at Ocugen, where he leads R&D across the company’s gene, cell therapy and vaccines platforms. With over 20 years of experience in biotech, academia, and government, he’s known for innovative ocular drug delivery system development with 40 publications and 15 patents.

The post EPR Podcast 24 – Developing modifier gene therapy – Ocugen appeared first on European Pharmaceutical Review.

Dr Kylie Bromley is Vice President and Managing Director, of Biogen UK and Ireland

In this episode, Dr Kylie Bromley, Vice President and Managing Director of Biogen UK and Ireland, talks about her career journey in the pharmaceutical sector, sharing personal experiences and lessons, and discussing industry efforts to inspire inclusion in the workplace. 

After obtaining a PhD in pharmacology from the University of Melbourne, Australia, Kylie started her career in a clinical-research role in the pharmaceutical industry. In her 20+ year career she has held a number of diverse roles at several pharmaceutical companies before joining Biogen in 2016. 

During her time at Biogen, Kylie has been involved in several initiatives that support women in their careers. In this podcast, she discusses her involvement in Biogen’s Women’s Impact Network (WIN), an employee resource group dedicated to supporting and empowering women within the organisation. She also reflects on her role as a founding member of Pharma Australia Gender Equity (PAGE), now the Pharma Australia Inclusion Group (PAIG).

Reflecting on her experiences, Kylie acknowledges both the progress made and the ongoing challenges, including the underrepresentation of women in senior leadership roles.

Citing data from a recent LinkedIn survey, Kylie states that, overall, female representation in the workforce globally is around 42 percent. However,  this drops down to 32 percent for ‘senior leaders’ and then to 25 percent for C-suite.

“You’re getting more and more inequity as you…get to the more senior levels,” Kylie says.  “I think there is a lot of work to be done, there’s no question.”

When considering how opportunities drive great equality in the industry, Kylie notes the importance of investing in development, fostering allyship and promoting inclusive practices.

Organisations must ensure access to development, networking, and career opportunities – across the board – to create a truly equitable environment”

“We have two themes for International Women’s Day. There’s the UN theme, ‘Invest in women: accelerate progress,’ and then the International Women’s Day theme ‘Inspire Inclusion’,” says Kylie.

Organisations must ensure “access to development, networking and career opportunities – not just for women, but across the board – to create a truly equitable environment,” she explains. 

Allyship is also fundamental in inspiring inclusion, but it cannot be achieved by one company alone. 

“How do we come together as an industry to keep striving to lead the way? Because I do think that that’s the opportunity that this industry has…to be seen as absolute leaders on creating the most inclusive environment that we can.”

The post EPR Podcast 23 – Inspiring inclusion in pharma – Kylie Bromley, Biogen appeared first on European Pharmaceutical Review.

In this episode, Caroline speaks to Manu Kittanakere, Associate Director of Packaging Engineering at Gilead, about the pharmaceutical packaging landscape. Manu reflects on the changes he has witnessed in pharmaceutical packaging over his 17-year career.

“There is a lot of dynamic change happening with supply chain regulations, which has a direct impact on packaging,” Manu says.

He also explains how pharmaceutical packaging sector has evolved significantly over that period, with the growth of contract manufacturing/packaging organisations and an increased emphasis on sustainability, automation, and innovation.

Packaging plays a crucial role in preserving medications and ensuring patient adherence. Manu speaks about a range of packaging options on the market, including the use of bottles, blister packs, vials, and pre-filled syringes/autoinjectors.

In the oral solid dose (OSD) space, the bulk of pharmaceuticals rely on HDPE bottles or blister packaging”

In the oral solid dose (OSD) space, the bulk of pharmaceuticals rely on HDPE bottles or blister packaging. However, regional and company preferences do vary.

“What I have observed is that…in the US, bottles are preferred compared to blisters. But in Europe and Japan, blisters are preferred,” Manu says.

“Vial kits, pre-filled syringes and auto injectors are also gaining a lot of traction with biologics being one of the main focuses in the coming years,” he adds.

Finally, there have been advancements in the cold chain packaging to meet the needs of cell and gene therapies and other biologics.

Looking to the future, Manu predicts that sustainability will be a major focus in the pharmaceutical industry in 2024.

Additionally, packaging developers and engineers will increasingly leverage virtual simulation and smart software to support packaging design.

Looking further ahead, Manu projects innovations in desiccants, materials, and smart packaging. Listen to the full podcast to find out more!

Manu Kittanakere, MS is Associate Director, Packaging Engineering at Gilead Sciences. He Joined Gilead in October of 2022 and is responsible Gilead’s clinical programmes from a packaging development perspective. Manu and his team support about 20+ Gilead clinical programmes and manage the packaging CMOs and vendors.

Manu has over 17 years of experience in Pharmaceutical and Medical Device Packaging. He joined Gilead Sciences following tenures with Kala Pharmaceutical, Alnylam Pharmaceutical and bluebird bio where he held roles in multiple facets of packaging including QA pack & label, external manufacturing focused on Packaging & Labelling and head of packaging technologies department. Manu holds a patent in Glass vial packaging design for Valor glass WIP packaging.

Manu obtained his academic training at Visveswaraya Technological University, India (BS, Printing Technology), Rochester Institute of Technology (MS, Packaging Science) and Cornell University (Executive Leadership).

The post EPR Podcast 22 – Pharmaceutical packaging – Manu Kittanakere, Gilead appeared first on European Pharmaceutical Review.

Biosimilars are similar to reference biological medicines and must demonstrate no clinically meaningful differences in terms of efficacy, safety, and quality.

In this episode, Dr Salim Benkhalifa, Medical Affairs Lead for Celltrion Healthcare France, discusses the benefits of using biosimilars, how the adoption challenges can be overcome and looks ahead to future innovations in the industry.

The main benefit of using biosimilars is cost savings, Salim explains, noting this can “increase patient access to treatment and allow for investment in innovation.”

Having biosimilars can also help prevent shortage of medication, for example if one pharmaceutical company faces supply chain issues, there is an alternative allowing continuity of access to patients. 

Industry is working to overcome challenges through standardised regulatory guidelines, education campaigns, and improved reimbursement processes”

Salim highlights three main challenges facing biosimilars: regulatory barriers, lack of understanding and procurement challenges.  The industry is working to overcome these challenges through standardised regulatory guidelines, education campaigns, and improved pricing and reimbursement processes.

Discussing the regulatory framework, Salim points out different approaches by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) in their assessment of biosimilars. He shares an example of how Celltrion had to follow different pathways for approval of its subcutaneous formulation of biosimilar infliximab in these two markets.  

He also shares how Celltrion’s healthcare professional outreach campaign – launched 10 years after the first monoclonal antibody biosimilar was approved in Europe – is helping to improve awareness. 

“There is still an education [piece] to explain to healthcare providers and to the patient… the importance of biosimilars, why we need biosimilars and to reassure also on their… quality, efficacy and safety,” Salim notes. 

Future innovations…may include expanded therapeutic areas”

Future innovations in the biosimilar space may include expanded therapeutic areas, improved administration methods, and reduced immunogenicity.

“Budget savings remain one of the key objective of payers,” says Salim, noting that innovation of biosimilars can lead to improvements for patients. “Due to technological advances, further innovation in biologic development has resulted in medicines that offer benefit [beyond] those offered by a reference product.”

Developing subcutaneous formulations, for example, can reap benefits for both patients and healthcare systems, giving patients the ability to self-administer at home, rather than travelling to hospital for IV infusions. 

Listen to the full podcast to learn more!

Dr Salim Benkhalifa is Medical Affairs Lead for Celltrion Healthcare France. With university degrees in immunology and IBD, Dr Salim Benkhalifa is a medical doctor with an MBA. He has previous experience at Pfizer, as medical manager at local and international level in rheumatology and IBD, as well as global medical director in dermatology. Dr. Salim Benkhalifa also held a post at Abbvie as Medical affairs lead for France in IBD and Rheumatology.

The post EPR Podcast Episode 21 – Biosimilars – Salim Benkhalifa, Celltrion Healthcare France appeared first on European Pharmaceutical Review.

RNA interference (RNAi) medicines that can ‘silence’ or turn off the production of specific genes that cause or contribute to disease, are one of the exciting emerging modalities in drug development today.

In this episode, EPR Editor Caroline Peachey catches up with Dr Paul Nioi, Vice President of Discovery and Translational Research at Alnylam Pharmaceuticals to explore clinical development and manufacturing of RNAi medicines for large patient populations.

Paul Nioi, Vice President of Discovery and Translational Research at Alnylam Pharmaceuticals

Founded in 2002, Alnylam Pharmaceuticals is developing around a dozen investigational RNAi therapeutics, in the areas of genetic medicines, cardio-metabolic diseases, infectious diseases, and central nervous system/ocular diseases.

Paul reflects on the evolution of RNAi therapeutics in the pharmaceutical landscape. Initially, few companies were working on RNAi, but interest and activity have grown significantly, with both startups and established pharmaceutical companies now exploring its potential, Paul explains.

The technology has primarily focused on rare diseases, but there is growing momentum to apply RNAi to more common conditions.

“When we began on this journey, there was a very, very solid focus on rare disease,” Paul says.

In contrast, today you can see “a crop of medicines for more common conditions [like hypertension and Type 2 diabetes] starting to come through the pipeline.”` Since this podcast was recorded Alnylam and Roche have agreed to jointly develop and commercialise an RNAi therapeutic as a treatment for hypertension. 

The main benefit of RNAi medicines is their ability to target potentially any gene in the genome, including targets that are “undruggable” by small molecules and antibodies, explains Paul. The duration of action can extend from six to 12 months with a single subcutaneous injection.

“We hope this translates into better outcomes because you have consistency in silencing the gene as opposed to taking the pill one day, forgetting the next,” Paul says.

The liver has been a successful target due to its involvement in various diseases, but expanding delivery to other tissues remains a challenge,

One major challenge discussed is the delivery of RNAi therapeutics to specific cells and tissues. The liver has been a successful target due to its involvement in various diseases, but expanding delivery to other tissues remains a challenge. Different approaches have been explored, including encapsulating RNA in lipid nanoparticles for intravenous delivery and modifying nucleotides to enhance stability and enable targeting to specific cells, notes Paul.

Looking ahead, Paul envisions advances in delivery methods to target a wider range of tissues, making RNAi medicines more routine in clinical practice and the emergence of related technologies like gene editing and mRNA delivery.

Listen now to this exclusive podcast to learn more!

Paul Nioi, PhD is Vice President, Discovery and Translational Research at Alnylam Pharmaceuticals. He joined Alnylam in March 2018 and is responsible for leading the Discovery and Translational Research function. He has overall responsibility for new target identification/validation, biomarkers and all preclinical drug discovery programmes.

Paul has over 18 years of biotech and pharma experience. He joined Alnylam following a tenure at Amgen and deCODE genetics where he held roles of increasing responsibility. Most recently he was Director of the Translational Systems Biology group and led a large team that was focused on making discoveries from human genetics to influence target selection.

Paul obtained his academic training at the University of Edinburgh (BSc, Pharmacology) and the University of Dundee (PhD, Molecular Biology).

The post EPR Podcast 20 – RNAi Therapeutics – Paul Nioi, Alnylam Pharmaceuticals appeared first on European Pharmaceutical Review.

The Modern Microbial Methods Collaboration or M3 Collaboration brings together participants from across industry with the goal of modernising pharmaceutical microbiology.

In this episode, Alison Scott, Lynn Johnson, and Miriam Guest, introduce the work of the group and discuss how it is working to address common challenges facing industry.

Established in 2021, the M3 collaboration consists of a steering committee and three sub-teams. The steering committee helps guide the group, and the sub-teams focus on specific topics such as biofluorescent particle counting, understanding baseline counts and setting alert levels, and developing communication tools for modern methods.

Allison Scott is Principal Scientist, MicronView. M3 Collaboration Steering Committee and Sub-Team #3 Facilitator

The collaboration supports industry by promoting knowledge sharing and learning among participants. It allows for open dialogue and problem-solving, facilitates the adoption of modern microbial methods, and provides a platform for communication and collaboration across different companies and backgrounds.

“From our perspective at AstraZeneca, we are really valuing the cross-industry collaboration that we’re seeing in the non-competitive space,” says Miriam Guest, Principal Microbiologist,

Pharmaceutical Technology & Development, AstraZeneca, who initially joined as a member of the Online Water Bioburden Analyzer (OWBA) Working Group.

“We’ve got hundreds of years of [combined] experience across all of the members of this collaboration and so many different backgrounds,” adds Allison Scott, M3 Collaboration Steering Committee and Sub-Team #3 Facilitator.

Another benefit is that there are no costs associated with joining the M3 Collaboration “it’s truly just people volunteering their time, sharing ideas”, explains Lynn Johnson, Senior Scientist, Microbial Control and Viral Safety, National Resilience, Inc and Member of M3 OWBA working group.

Miriam Guest, Principal Microbiologist, Pharmaceutical Technology & Development, AstraZeneca

The M3 collaboration listens to what’s happening in industry to help form or influence what it’s working on.

“Adoption of new technologies has always been a challenge in this industry,” explains Allison. As modern methods can take a lot of time and be expensive to adopt, seeing other companies succeed can be ‘very beneficial’ – they can share their success, they can share the challenges that they’ve overcome, and this really helps lead the industry forward.

Data integrity is seen as an emerging issue. “We are certainly seeing trends with our auditors and regulators looking at data integrity across the whole quality control platform. And when you review the published warning letters on the FDA [US Food and Drug Administration] website, you know data integrity in the microbiology lab is a real issue,” says Miriam.

“There is definitely more adoption of modern microbial methods,” adds Lynn. “I think it’s a critical time right now to be able to share our ideas, how we’re getting things moving forward and implementation strategies.”

Lynn Johnson, Senior Scientist, Microbial Control and Viral Safety, National Resilience, Inc is member of the M3 OWBA working group

Another area where the collaboration is supporting industry is in developing a holistic contamination control strategy,” adds Lynn, noting that the collaboration is working to provide tools and templates to help address some of these challenges.

The M3 collaboration has made progress in several areas, including on developing a User Requirement Specification template, working on several articles and presenting at industry events.

Through this work it is contributing to the advancement of modern microbial methods and driving innovation in pharmaceutical microbiology through industry collaboration and knowledge exchange.

Allison Scott is Principal Scientist, MicronView. M3 Collaboration Steering Committee and Sub-Team #3 Facilitator

Lynn Johnson, Senior Scientist, Microbial Control and Viral Safety, National Resilience, Inc and Member of M3 Online Water Bioburden Analyzer Working Group

Miriam Guest, Principal Microbiologist, Pharmaceutical Technology & Development, AstraZeneca and former member of the M3 OWBA Working Group. 

The post EPR Podcast 19 – Collaboration in microbiology – Allison Scott, Lynn Johnson and Miriam Guest, M³ Collaboration appeared first on European Pharmaceutical Review.

Continuous manufacturing (CM) is recognised industry wide as a more efficient and flexible manufacturing approach than batch manufacturing. Yet, despite encouragement from regulators and being standard in many industries, the pharmaceutical sector has been quite slow to adopt continuous manufacturing techniques.

In this episode, Patricia Hurter, CEO, Lyndra Therapeutics, explores the potential of continuous manufacturing, discussing some of the benefits, challenges and lessons learned.

Dr Patricia Hurter serves as CEO of Lyndra Therapeutics.

Prior to joining Lyndra in 2019, Trish spent 15 years at Vertex, where her team designed and built the world’s first fully continuous drug product manufacturing plant, approved by the US Food and Drug Administration (FDA) in 2015.

Reflecting on this project, Trish highlights the importance of designing a machine that is “flexible enough to make multiple products,” as well as the importance of being “all in” if choosing to adopt a CM approach. She also talks about Lyndra’s pipeline, developments in process analytical technology (PAT) and the how CM is expected to change in future.  

“This is not your average tablet, so you can’t manufacture it using typical manufacturing methods”

Lyndra’s lead product is oral weekly risperidone for schizophrenia and bipolar disorder. Trish describes this as a ‘star-shaped dosage from that folds up into a capsule’.

Once this capsule reaches the stomach, the dosage form unfolds into a flat, flexible, star-shaped structure that resists passage out of the stomach while the drug contained in each of the arms diffuses out. After drug release, linkers that connect the arms to the core soften and disintegrate, allowing the dosage form to break down and be excreted.1

“This is not your average tablet, so you can’t manufacture it using typical manufacturing methods,” explains Trish, noting how assembly of the dosage forms has transitioned from ‘humans and tweezers’ to ‘robotics and automation’’ since she joined the organisation in 2019. 

“We have pilot scale machines right now that do what I would call discontinuous continuous operations. Each part of it is continuous, but humans take the product from step A to step B,” Trish stated. She adds that a fully automated machine is being built in Germany, scheduled for delivery later this year.

“Now regulatory bodies have made expectations clear, I think the pharmaceutical industry will switch over to CM,”

Despite perceptions, Trish does not believe that regulation is a barrier to adoption of continuous manufacturing.

Citing a recent paper published by the FDA in the International Journal of Pharmaceuticals, she notes how CM applicants had shorter times to approval and market as compared to similar batch applications. Products of CM tended to reach the market sooner after regulatory filing, leading to potential $171–537 million in early revenue benefit, this research found.2

“People worry a lot about the regulatory stuff. That was one of the reasons why bigger pharmaceutical companies didn’t jump [into continuous manufacturing] with both feet,” says Trish.

Now regulatory bodies have made expectations clear, she believes the pharmaceutical industry will switch over,” she adds. 

One question for pharmaceutical companies is whether to switch legacy batch manufacturing to continuous.

“If you’ve got a legacy product and you’re only making a few batches a year, the additional effort to go back and turn that into continuous is probably just not worth it,” Trish notes. “I would argue that for new products, however, it makes a lot of sense to start off by doing manufacturing continuously.”

This is even an option for smaller companies, as several contract manufacturers now have continuous manufacturing capabilities in-house.

With International Women’s Day in March, Trish reflects on her career in pharma and offers advice for those looking to enter the sector.

“Being in the science and engineering field is an exciting place for women to be these days. But you have to find companies and leaders that will help you thrive,” says Trish.

Her other top tips for success include staying connected, informal mentoring and ensuring you make time for yourself.

“Divide your time not only between your family and work, but make sure you also devote some time to doing something that you really love for yourself,” she adds.

The post EPR Podcast Episode 18 – Embracing continuous manufacturing – Trish Hurter, Lyndra Therapeutics appeared first on European Pharmaceutical Review.

Antimicrobial resistance (AMR) is a growing concern worldwide and is recognised as one of the leading health challenges by the World Health Organization (WHO).1 With drug resistant infections contributing to nearly 5 million deaths every year2 and costing the European Union (EU) an estimated €1.5 billion per year3 in healthcare costs and productivity losses, AMR is both a scientific and economic issue. 

In this episode, Dr Boumediene Soufi, Head of Antimicrobial Resistance at Sandoz, discusses the challenge of AMR and some of the actions being taken by Sandoz and the wider pharmaceutical industry to address this issue.  

Boumediene (‘Bo’) starts by explaining what antimicrobial resistance is and the main factors that contribute to AMR. He also highlights the key virulent antibiotic resistant pathogens that are of concern today.

“Antimicrobial resistance is causing an unprecedented global public health threat,” Bo says.  

He reflects on how antibiotics “brought about a whole new level of healthcare and quality of living,” describing them as the “backbone” of modern medicine. 

A 2021 report published in the Lancet2 estimated, based on 2019 data, that there are 1.3 million deaths worldwide every year that can be directly attributed to AMR. Putting that in perspective, Bo explains “that means…drug resistant infections are killing more individuals than HIV or malaria.”

“It’s going to require a multi-sectoral, multi-collaborative effort to be able to address antimicrobial resistance,” Bo stresses. 

“If we do not…[we could] be approaching what’s known as the post-antibiotic era,” he warns. The potential repercussions – risks to routine surgeries, as well as the economic burden – would be ‘astronomical.’

Boumediene Soufi holds the position of Global Head Antimicrobial Resistance at Sandoz.

There are two major challenges related to antimicrobial resistance: the scientific challenge and the economic challenge.

“From the scientific point of view…bacteria are evolving rapidly. It’s very difficult to predict how they are going to evolve their resistance patterns,” Bo explains.

Using antibiotics too much (over prescription), not having access to antibiotics or sub-optimal use (ie, not using the ideal antibiotic for a particular infection), also need to be addressed. 

Another big issue is the lack of robust diagnostics for antimicrobial resistance. “We need surveillance programmes to understand the biggest problems of resistance, and then to respond to them in the correct way,” Bo states. 

“The first thing is to acknowledge the threat and to be able to respond,” says Bo. He believes this is being done already, with growing awareness that the issue of antimicrobial resistance needs to be addressed “very, very quickly.” 

The industry response can be divided into two parts: action to develop innovative drugs and efforts focused on existing antibiotics. 

“Of course, new antibiotics are a solution to the problem but I cannot stress enough, what we currently have is…of equal importance,” Bo says. 

“Strong stewardship programmes are absolutely needed to make sure that [we use] the right drug for the right bug,” he adds. The WHO’s Access, Watch, Reserve (AWaRe) tool that helps support antibiotic monitoring and stewardship activities across sectors, is one mechanism assisting with this. 

Another key effort is related to responsible access: “ensuring that — regardless of where a patient may be — they have access to the right drug.”

Looking to innovation, Bo highlights the importance of collaboration to support late stages of drug development. Initiatives such as the AMR Action Fund and the Global Antibiotic Research and Development Partnership both aim to help innovator companies overcome the technical and funding barriers faced during late-stage antibiotic development.

On the generic side, Sandoz follows a “balanced approach” addressing the four pillars established by the AMR Industry Alliance: Innovation; access; responsible use; and responsible manufacturing , Bo says. 

When asked why it’s important to act to tackle antimicrobial resistance now Bo concludes: “AMR is happening. Whether we like it or not, [AMR] is going to continue to happen based on the ability of bacteria to constantly mutate, but we can curb it significantly.”

“The most important thing is to recognise that it’s not too late…The next thing we need to do is realise that in order to curb AMR, it is going to require collaboration across multiple sectors. That’s what needs to happen in the next five years.”

To learn more about recent efforts to address antimicrobial resistance, listen to the full episode! Please join the conversation and leave your thoughts in the comments – we love hearing your feedback!

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