11 episodes

European Pharmaceutical Review’s podcasts interview some of the leading experts and scientists about the latest developments in the pharmaceutical and life science sectors.

European Pharmaceutical Review podcast European Pharmaceutical Review

    • Science

European Pharmaceutical Review’s podcasts interview some of the leading experts and scientists about the latest developments in the pharmaceutical and life science sectors.

    Developing vaccine technologies

    Developing vaccine technologies

    Why is vaccine manufacturing becoming more biological? How could Generalized Modules for Membrane Antigens (GMMA) enhance vaccinology? What developments have there been in adjuvant systems? Discover all this and more in this podcast with GSK experts.

    With COVID-19 having intensified focus on vaccine development over the past few years, in this podcast we are exploring how manufacturing and formulation of vaccines has advanced and some promising technologies for the future. For this episode, European Pharmaceutical Review's Hannah Balfour is joined by two representatives from GSK: Giulia Giordano, PhD, Vaccine Development Leader, and Professor Mark Doherty, Senior Manager of Global Medical Affairs, Vaccines.

    • 33 min
    3D printing pharmaceuticals – Sheng Qi, Simon Gaisford, Clive Roberts

    3D printing pharmaceuticals – Sheng Qi, Simon Gaisford, Clive Roberts

    The idea of personalised medicine has been gaining interest in recent years as the drug development and healthcare industries seek to reduce side effects, improve adherence, and thus patient outcomes. As a potential enabler of personalised oral solid dosage forms (OSDs), three-dimensional (3D) printing has garnered significant interest. But despite a surge in research over the last decade, following patents for 3D printers expiring in 2009, so far just one pharmaceutical manufactured using 3D printing has been approved by regulators, Spritam® (levetiracetam), back in 2015. To find out about recent developments in the field, the major hurdles stalling the widespread implementation of 3D printing in commercial manufacturing and more, European Pharmaceutical Review's Hannah Balfour spoke with Sheng Qi, Professor of Pharmaceutical Material Science and Technology at the University of East Anglia, Simon Gaisford, Professor of Pharmaceutics in the University College London (UCL) School of Pharmacy, and Clive Roberts, Chair of Pharmaceutical Nanotechnology at the University of Nottingham.

    • 40 min
    Future of ATMPs

    Future of ATMPs

    In our previous advanced therapy medicinal products (ATMPs) episode 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, discussed the importance of collaboration in developing cell and gene therapies and the processes and quality controls that support their manufacture. In this final episode they join us once again to explain what makes these challenges worth overcoming and the key areas of development expected to shape the future of these critical treatments.

    • 29 min
    EPR Podcast Episode 8 – Oral biologic drug delivery with Giovanni Traverso, MIT

    EPR Podcast Episode 8 – Oral biologic drug delivery with Giovanni Traverso, MIT

    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 Massachusetts Institute of Technology (MIT), and a gastroenterologist at Brigham and Women’s Hospital (BWH), Harvard Medical School. His research focuses on the development of next generation drug delivery systems and biomedical devices to support new modes of drug administration.

    Biologic therapies are growing in popularity, accounting for 13 of the 53 new drugs the US Food and Drug Administration (FDA) approved in 2020. Though promising, these therapeutics present several drug delivery challenges, including that their composition makes them liable to damage in the gastrointestinal (GI) tract, requiring them to be delivered intravenously or subcutaneously. While manageable for infrequent treatments, for those who must be injected regularly, such as diabetes patients, being able to simply swallow a pill may seem much more desirable.

    Giovanni explained that, when discussing the delivery of biologic drugs, he splits the mechanisms into two broad categories: non-physical and physical modes of delivery. “From a non-physical perspective, what I mean is molecules or additives that enhance transport across the mucosa/protective layer in the GI tract… for example, there are a couple of smaller peptides or proteins that actually do exist in an oral formulation and those apply either an additive that transiently enhances transport or the drug has somehow been modified to stabilise it to facilitate its transport,” he explained. These systems are limited by the size of the molecule with smaller peptides, proteins and even insulin able to be delivered in this fashion, but not monoclonal antibodies and other larger molecules.

    Physical techniques, he described as those that involve some kind of intervention such as a medical device, eg, a hypodermic needle for injections, or ultrasound at certain frequencies to propel drugs into tissue. “On the physical side we have actually been able to deliver a very broad set of molecules, including monoclonal antibodies,” stated Giovanni.

    We went on to discuss his team’s recent work on the development of gastric autoinjectors and how, during the process, they broke it up into three challenges: a. ensuring the sharp needle is always in contact with the desired tissue, b. how to autonomously trigger the drug delivery event/injection, and c. how to fit enough drug within a blueberry-sized device, a safe capsule size for oral administration. They addressed orientation challenges in a paper published two years ago and reviewed materials that could hold energy from a compressed spring, with brittle fracture mechanics, that could sense a humid environment. They eventually designed sugar cylinders that had these elements and could be adjusted to control the rate of dissolution and drug release through the needle.

    To overcome the challenge of size and ensure they could deliver enough drug, they developed solid formulations of biologic drugs, such as insulin. However, a fluid dose was more desirable, and in a recent paper published in Nature Biotechnology they displayed the development of a self-orientating gastric autoinjector system able to release a liquid. The research was done in collaboration with Novo Nordisk and demonstrated that the system could deliver insulin, a GLP-1 receptor analogue, adrenaline and adalimumab, a monoclonal antibody.

    Then we explore other issues surrounding the oral delivery of biologics, including that future developments into miniaturising these device sy...

    • 29 min
    EPR Podcast Episode 7 – Collaboration in ATMP development – Jérôme Larghero and Julien Textoris, bioMérieux

    EPR Podcast Episode 7 – Collaboration in ATMP development – Jérôme Larghero and Julien Textoris, 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.

    What is the MEARY Center?

    The MEARY Center for Cell and Gene Therapy is the ATMP manufacturing centre of the Assistance Publique – Hôpitaux de Paris (AP-HP) – the university hospital trust operating in Paris and its surroundings. AP-HP includes 39 hospitals and is the largest hospital system in Europe. The MEARY Center offers the services, skills and contract development and manufacturing organisation (CDMO) capacities to develop cellular immunotherapies and regenerative medicine. “The centre is first an academic centre dedicated to cell and gene therapy, and to collaboration for projects that are run both with academic and industrial partners,” explains Jérôme. He added that the role of the centre is to develop processes for the manufacturing and QC of cell and gene therapies of various types and for different indications, to allow collaborators to conduct clinical trials of investigational products. 

    With several hundred cell and gene therapies currently under development worldwide, what limitations are hindering the development and application of cell and gene therapies?

    Jérôme explains that many of the manufacturing and QC problems faced by pharmaceutical and biopharmaceutical developers are also faced by cell and gene therapy developers: “we face exactly the same issues when we have to think about which kinds of quality control, when we have to put in place this quality control and how we have to perform both the manufacturing, quality control and the release of product.” He continued that as with any pharmaceutical, manufacturing for ATMPs must be based on ensuring that, at the end, they deliver a safe product for patients. 

    Jérôme goes on to explain that because ATMPs have huge heterogeneity, they require specialised manufacturing and QC, which is a challenge. “We all know that two healthy donors are different, because their cells are different. Regardless, at the end, we are supposed to have robust, reproducible processes… much is based on how you qualify your product, and thus which kind of quality control you will put in place,” he remarks. 

    Another challenge limiting ATMP development and manufacturing is the sheer number of quality control tests required and the time taken to perform these processes, as well as the cost of such testing and its impact on product pricing and accessibility. Jérôme describes how both virologic and microbiological testing are required to ensure products are safe, but microbiological test results take seven to 10 days to come back. Additionally, cellular attributes must also be assessed. The result is that, dependent on the type of product and its specifications, between five and 15 different QC tests are needed with five or 10 in-process controls. Jérôme noted that gene therapies typically requiring a larger number of QC tests than cell therapies.

    He also explained how this impacts product cost, using chimeric antigen receptor (CAR) T-cell therapy as an example: “It is more complex than saying for one batch it is 10 percent of global manufacturing cost, because we forget that when you perform one QC,

    • 26 min
    EPR Podcast Episode 6 – Precision Medicine with Laetitia Decroix Guilloux and Edmond Chan, Janssen

    EPR Podcast Episode 6 – Precision Medicine with Laetitia Decroix Guilloux and Edmond Chan, 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 and Edmond Chan 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. Edmond 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 Edmond.

    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.

    She adds, “We are seeing continuous innovation across the precision medicine spectrum, so many of these technologies are incredibly exciting, and though we’ve made great strides, there are still challenges to overcome and things we can improve on to make them as effective as possible for patients.” For precision in monitoring, Edmond gives the example of developing blood tests, as an alternative to the more invasive bone marrow tests, for assessing minimal residual disease in multiple myeloma patients following treatment. 

    As we discussed the challenges when developing and implementing precision medicines in healthcare, Ed explained the importance of collaboration, particularly with patients: “If we take CAR T for example, CAR T is not the typical off the shelf medicine – it is a process involving many, many steps. The patient journey starts with finding the right patient, then the patients must be referred to a certified CAR-T centre, then blood must be taken for a T-cell extraction, these T-cells must be manufactured or trained to recognise the cancer, then the T cells must be reinfused back to the patient, and then monitoring afterwards. It is a process involving many, many steps and a huge time commitment from patients and their carers.”

    When questioned about the challenges in terms of manufacturing precision medicine, Laetitia explained that by their very nature, personalised therapies have an impact on manufacturing “this is due to the fact that they have different requirements than more one-sized-fits-all treatments, so they can require additional expenditure on manufacturing infrastructure.” However, she emphasised that in future precision medicines may also help to optimise the use of healthcare resources and reduce cost overall as a result; “to reach this po...

    • 24 min

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