In European Pharmaceutical Review’s first podcast, Deputy Editor Victoria Rees discusses the current and future states of pharmaceutical supply chains with Richard Daniell, Executive Vice President of European Commercial at Teva Pharmaceuticals.  
“Today, India and China dominate where active pharmaceutical ingredients (APIs) come from,” says Daniell, explaining how the pharmaceutical market in Europe is supported by a global supply chain. However, he emphasises that a key aspect is balance – ensuring that a global supply chain is in place without being too reliant on one particular area is the ideal scenario. 
Daniell also discusses the COVID-19 pandemic and how this has impacted supply chains; for example, when certain factories were shut down, the flow of medicines such as paracetamol was disrupted worldwide. He says that a new challenge arose as a result of the pandemic, creating medicine nationalism with restrictions. Daniell explains why countries need to instead work together to ensure that medicines are delivered to the patients that need them. 
We also explore how disruptions to pharmaceutical supply chains can impact patients and thus why it is important to mitigate these as much as possible. As a result, we discuss how policy makers can work to diminish any issues in the medicine supply chain – for example, through collaboration and digitalisation. Daniell highlights that pharmaceutical companies are also responsible for the undisrupted flow of medicines, alongside governments: “we’ve absolutely got our part to play to play in tackling and preventing shortages or any interruption in supply chains.” 
Listen to all this and more in our first podcast.

European Pharmaceutical Review Podcast

EPR Podcast Episode 1 - Richard Daniell, Teva Pharmaceuticals

In this episode Lonza’s Dr Deanna Mudie explains the importance of bioavailability, how to achieve desired bioavailability and top tips for how to select the correct dissolution media for your testing needs.
“For oral drugs, bioavailability is the fraction of the administered dose that actually reaches your systemic circulation unchanged,” explains Deanna, continuing that it must be high to ensure all or most of the drug can reach its site of action for the best therapeutic effect. She went on to explain how dissolution and solubility both factor into how much drug reaches the circulation and some of the key drug properties that affect them, including particle size and lipophilicity.
Deanna also outlines the various methods for improving bioavailability, including reducing the particle size of a crystalline drug or using a salt form, as well as formulation techniques like creating amorphous solid dispersions (ASDs). “Another method which is generally more challenging… is by improving the permeability of the drug,” which she states can be done by creating a pro-drug or by including permeation enhancers or utilising nano-sized drug species.
She also goes into more depth about ASDs specifically, adding that they work by using the amorphous form of the drug instead of the crystalline one, as it has a higher solubility, and outlining their various benefits and a few examples currently on the market.
Deanna discussed how, with any drug product, drug developers need to make sure that they not only achieve high performance in the body but that they also remain stable over the drug product shelf life. To ascertain this, they use a kind of in vitro analysis called dissolution testing, which simulates the gastrointestinal environment, using different fluids and other physical properties to determine how fast and how much of a drug would transition from the gastrointestinal tract to the bloodstream.
However, the diverse range of potential medias can be challenging, so Deanna explained Lonza’s three step approach for selecting the right media: determine the testing goal, ascertain the target population of interest (eg, human, canine, etc) and select the dissolution apparatus and media that selects the key features of the properties that may affect the drug in this species. “When you use a dissolution medium selection approach like this it can be really powerful because it combines the knowledge of key physiological properties with the drug formulation properties… this can enable ‘right first time’ development and reduce the costs and increase the development speed of medicine,” states Deanna.
Find out about all of this and more in this podcast, supported by Lonza.

European Pharmaceutical Review Podcasts

EPR Podcast Episode 2 - Bioavailability enhancement with Dr Deanna Mudie, Lonza

Join Dr Bill Williams as he discusses formulation for inhaled and intranasal drug delivery and goes into detail about thin film freezing, a novel powder formulation technique he developed.
Inhaled and intranasally delivered drugs and vaccines have garnered a lot of attention since the dawn of the COVID-19 pandemic, with the desire to reduce the likelihood of side effects by delivering therapeutics and prophylaxis specifically to their site of action in the respiratory system. To find out more about inhaled and intranasal drugs and vaccines, and their formulation, I spoke to Dr Robert  O. “Bill” Williams III – the Division Head and Professor of Molecular Pharmaceutics and Drug Delivery at the University of Texas at Austin. We also explore the thin film freezing (TFF) technique he helped develop, which is currently being used to formulate more stable biologic drugs, such as a shelf-stable messenger RNA vaccines for COVID-19 and Takeda’s norovirus vaccine, among others.
If you want to hear about all this and more – listen to the episode!

EPR Podcast Episode 3 - Inhaled and Intranasal drug delivery - Dr Bill Williams, University of Texas

With their success in the fight against COVID-19, messenger RNA (mRNA) vaccines have taken the world by storm. However, despite existing in the literature for years, the pandemic was the first time an mRNA vaccine had been granted regulatory approval, and thus, for much of the industry, this is the first time manufacturing and ensuring the quality of mRNA vaccines. With Pfizer revealing >50 percent of its COVID-19 vaccine's production time being devoted to testing and quality assurance, what techniques enable mRNA vaccine quality to be assessed at each stage?
In this podcast, Dr Hans-Joachim Muhr, Head of SPG UV/VIS at Mettler Toledo GmbH, Analytical, explains the key QA/QC considerations for mRNA vaccines, and how ultraviolet–visible (UV/Vis) spectrophotometry can be applied synergistically with other analytical techniques throughout the vaccine development and production lifecycle to ensure quality.
To access free additional resources accompanying this podcast, please visit the podcast tab on European Pharmaceutical Review's website.

Episode 4 – mRNA vaccine QC - Dr Hans-Joachim Muhr, Mettler Toledo

Join Rey Mali and Félix Montero-Julian as they discuss the challenges facing the manufacture and QC of advanced therapy medicinal products (ATMPs) and potential solutions.
Cell and gene therapies, types of advanced therapy medicinal products (ATMPs), are an exciting emerging class of therapeutics offering potentially huge therapeutic benefit. So far, more than 100 cell and gene therapies have been approved in markets worldwide and many more are under development.
Cell therapies have shown promise in treating diseases such as cancer, where chimeric antigen receptor (CAR) T-cell therapies have already transformed care for haematological malignancies, and gene therapies offer a potentially one-time curative treatment for genetic disorders.
Yet despite their potential, there are challenges facing cell and gene therapies. In this podcast, Rey Mali, Vice President Sales and Marketing, Accellix, and Félix Montero-Julian, Healthcare Scientific Director, bioMérieux discuss the difficulties in manufacturing and ensuring the quality of cell and gene therapies, why speed is particularly important in their quality control and some of the key technologies involved in these quality assessments.
Find out about all of this and more in this podcast, supported by bioMérieux.

EPR Podcast Episode 5 – ATMP Manufacturing And QC - Accellix and BioMérieux

Why are precision medicines important? What challenges face their development and manufacture? Where could they be in 10 years? Discover all this and more in this podcast with Janssen!
With the market for precision medicine in oncology anticipated to value almost $150 billion by 2030 and the incidence of cancer only rising with the world's aging population, European Pharmaceutical Review's Hannah Balfour sat down with industry experts Laetitia Guilloux, Vice President EMEA Commercial Strategy Lead, Oncology, and Edmond Chan, EMEA Therapeutic Area Lead, Haematology, both from the Janssen Pharmaceutical Companies of Johnson & Johnson to find out more about this exciting field.
"Precision medicine is of particular interest because cancer is not homogeneous... precision medicine allows us to more effectively target specific tumour types based on genetic factors," explains Laetitia, adding that there has been significant growth in precision medicine research over the past decade, particularly for haematology, since it has huge transformative potential. Ed added that there are three elements to precision medicine: 1) identifying the correct patients for the treatment - precision in diagnosis, 2) giving each patient the best therapy - precision in treatment, and 3) how to monitor patient response - precision in outcome measurement. "I believe precision medicine is a combination of these three pillars and cannot be thought about one without the others," says Ed.
Laetitia and Ed went give examples of the cancers currently being targeted with precision medicine by Janssen, including non-small cell lung cancer (NSCLC) and multiple myeloma, as well as prostate cancer. "If we want, one day, to be able to tackle those cancers [that are difficult to treat]… or even intercept it so early that we can be potentially curing them, and solid tumour is a little bit further away for that, precision medicine and especially the biomarker driven approach will be key," states Laetitia, enforcing the importance of treatments such as chimeric antigen receptor (CAR) T-cell therapy.
To hear all about this and find out about Janssen's work in the field of precision medicine, what Laetitia and Ed believe precision medicine could look like in the next five to 10 years and more – listen to the episode!

EPR Podcast Episode 6 – Precision Medicine With Laetitia Decroix Guilloux And Edmond Chan, Janssen

How important is collaboration in ATMP development? What can be done to expedite ATMP manufacturing and release? Find out about all this and more in this podcast with bioMérieux.Collaboration has been a huge part of the COVID-19 pandemic response, but it is also hugely important in the development of various other therapeutics. In the second episode in our advanced therapy medicinal products (ATMPs) series Jérôme Larghero, Director of the Department of Biotherapies and the MEARY Center for Cell and Gene Therapy in the Hôpital Saint-Louis, AP-HP, and Julien Textoris, Vice President of Global Medical Affairs, Immunoassays and host response at bioMérieux, discuss the importance of collaboration between academia and industry in the development of ATMPs.
To learn about all this and more, tune in to this podcast!
Please leave your thoughts in the comments – we love hearing your feedback – and look out for our next episode coming soon!

EPR Podcast Episode 7 – Collaboration In ATMP Development - Jérôme Larghero And Julien Textoris

How close are we to oral biologic drug delivery? Will biomedical devices be essential in overcoming drug delivery challenges? 
In this episode, we discuss one of drug delivery's greatest challenges: how to orally administer biological therapies, such as antibodies and hormones. To address such an important topic, we are joined by Giovanni Traverso, Assistant Professor in the Department of Mechanical Engineering at MIT, and a gastroenterologist at Brigham and Women’s Hospital (BWH), Harvard Medical School.
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