Post-Event Report

Innovations and Challenges: Formulation and Drug Delivery Europe

By Oliver Picken |
27 August 2021
Advancement is accelerating but are we ready to face the challenges? 

On the 20th and 21st of April 2021, Formulation and Delivery Europe Online and the co-located Inhalation & Respiratory Drug Delivery Europe Online events bought together some of the leading minds in the rapidly evolving field of drug delivery research and application, as well as the technological processes and strategies for fast-tracking drug product development. Across the events, there were more than 50 presentations, as well as over 14 hours of interactive sessions, including Q&A’s, panel discussions and workshops. Of course, the opportunity to network was especially important this year; live interactive discussions, panels, and roundtables, as well as the opportunity for one-to-one virtual meetings, were a key focus, bringing people together even in the most difficult of times to do so.  

Key speakers included Janet Halliday (Associate Vice President at Ferring Pharmaceuticals), Jonathan Kingsbury (Senior Director, Head of Developability & Preformulation Science at Sanofi), Ildiko Terebesi (Managing Director at INVITE GmbH), Christian Dechant (Director, Primary Packaging Development Biologicals at Boehringer Ingelheim), Mark Milton Edwards (Head of Health Solutions – Digital Health at Teva Pharmaceuticals) and Olivia Merkel (Professor of Drug Delivery at Ludwig-Maximilians-Universität München).  

About The Events 

Formulation and Delivery Europe Online is home to the latest developments in both biopharmaceutical and small molecule drug formulation and delivery. This crucial event included a range of new dosage forms and novel delivery modalities, as well as the latest in devices and combination products. This year’s congress also covered the challenges of improving patient adherence and patient-centric design for various target groups.

Inhalation & Respiratory Drug Delivery Europe brought together the premier experts working on the formulation and delivery of inhaled therapeutics, including preclinical development and characterisation, the latest case studies for novel therapeutics and the formulation strategies for respiratory drugs. This year, the event included presentations from world leaders in novel delivery devices and combination products and discussions on the patient-centric, regulatory and commercial challenges faced by inhaled and respiratory therapies.

Topics Overview 

With four tracks spread across two days, this Formulation and Delivery: Europe event attracted over 600 delegates and held over 50 presentations, discussions and case study reports from industry experts and respected academics.  

This year “Track 1: Small Molecule Drug Formulation” hosted presentations ranging fromsuccessfully developing amorphous solid dispersion formulations to the challenges of formulating oral solutions. There were also a range of roundtable discussions and live question and answer panels, in which patient centricity and risk assessment were key topics.  

With the increasing importance of biologics, it was no surprise that “Track 2: Advances in Biologics Delivery” proved popular, focusing on the challenges and potential of adeno-associated virus vectors and liquid nanoparticles. 

“Track 4: Innovation in Biotherapeutic Formulations” centred on dosing with a focus on patient-centricity, viral vectors, and advances in characterisation, with Rene Holms’ presentation “Formulation for Innovative Delivery Routes” drawing the most views, which we will be summarising in an article soon.

“Track 5: Innovations in Drug Delivery & Delivery Technologies” sawpresentations on combination products, nanomedicine and cancer targeting. The live Q&A session for this track was particularly popular this year. 

Moving over to the collocated Inhalation & Respiratory Drug Delivery event, “Track 3: Development & Formulation of Inhaled Therapies focusedon current and future trends, with Peter Barnes’s presentation on COPD inhalation treatments (which we posting a condensed version of on this portal soon) drawing close to 100 delegates.   

Finally, “Track 6: Inhalation Combination Devices Development & Combination Products” was a chance for industry leaders to share advancements in nebulisers and dry powder inhalers. The panel discussion for this track focused on overcoming industry challenges and various pathways for regulatory and product development success.  

Formulation and Delivery Europe Online: Market Trends 

Advances in the Delivery of Biologics 

The most popular topic and panels of the event centred around biologics delivery. Biologics have revolutionised the treatment of various conditions, such as diabetes, inflammatory diseases, and cancer. Oral delivery of peptides was a key topic throughout the presentations and discussions. Poor absorption of peptides received orally has long been a barrier for delivery, but advancements are being made, and new methods are currently in trial. There has been something of a divergence in the industry regarding peptide delivery, with many companies abandoning it. Those that continue argue that the benefits are too high. By making peptide delivery less invasive and more convenient and catering to the large percentage of the public who are needle phobic, treatment can reach more people. While bioavailability of drugs will always be lower when taken orally, in many cases, the higher dosage requires can be offset by the lower cost of production. This is an area that will continue to divide opinions, but it’s all the more interesting for that very reason.  

The Acceleration of Spray Drying 

Spray drying is a process in which a liquid feed is atomised into droplets inside a hot drying gas, creating solid particles. These particles can then be separated from the drying gas. In essence, spray drying converts liquid feed into powder, with excellent control of the properties of the resulting drug.  Spray drying is currently the fastest-growing formulation method to tackle poor bioavailability and is also used for the reformulation of existing drugs. 

Drivers for the increased use of spray drying in the pharmaceutical industry include producing inhalable drugs and microcapsules for controlled-release formulations. Spray drying has also been used to make more advanced forms of powders, including readily wet-able and direct compressible. New dry powder formulations are constantly making it to market, and this trend is only expected to accelerate in the future. 

mRNA Delivery to the Heart

Exciting developments have been made in the treatment of myocardial infarction. Modified mRNA is currently in phase two testing for use in cardiac regeneration. The therapeutic effect is long-lasting, as shown by significantly improved survival rates after myocardial infarction with a single administration of the mRNA given under 48 hours after a heart attack. The long-term effect appears to be based on changing the outcome of heart stem cells from creating more cardiac fibrotic scar tissue to generating new cardiovascular tissue. Delivery is the key challenge with this new treatment as keeping the effect localised is essential, however, results currently looking promising.  

Inhalation & Respiratory Drug Delivery Europe Online: Market Trends 

mRNA Therapeutics For Pulmonary Diseases

Shrirang Karve (Translate bio) presented his companies work on the first inhaled mRNA inhaled therapeutic to reach the clinical stage. This is the first time that mRNA has been delivered to the lungs of people with cystic fibrosis via nebulisation in a multiple-dose fashion, a proof of concept that has positive implications for future research.

mRNA can be packaged in a delivery vehicle, for example, a lipid nanoparticle and delivered to the cell, where it is internalised through endocytosis. Eventually, it is released from the lipid nanoparticle allowing the free mRNA to travel through the cell as our own natural mRNA would. This is where the patient’s body steps in and begins the process of making healthy proteins. Just as naturally produced mRNA would engage the ribosomal machinery and initiate protein synthesis, so does the synthesised version. The desired protein is then created, which can be intracellular, secreted, or transmembrane. In essence, using the cell’s own machinery to produce the desired protein may be used to treat pulmonary diseases previously considered untreatable.

SiRNA: A New Weapon Against COVID-19?

The first siRNA-based therapeutic approval in 2018 was at as much of a boost for the field of RNA delivery as the rapid approval of the COVID-19 mRNA vaccines. However, the critical difference between siRNAs and miRNAs is that the former is highly specific, whereas the latter can target multiple areas. The therapeutic approaches of siRNAs and miRNAs are consequently very different. Olivia Merkel’s (University of) presentation on siRNA Pulmonary delivery Against SARS-CoV-2 was of great interest to many for its potential to be an alternative to vaccine injections against the current pandemic.

Key Challenges Facing Formulation & Delivery 

Patient Centricity and Modified Release Drugs

Modified release dosage forms present an opportunity to improve patient centricity and user-friendliness for patients. Immediate-release drug doses are often easier to administer, but with drugs that have to be taken several times a day or at particular intervals, patients can easily forget doses, which lowers efficacy. In addition, immediate-release drugs have an increased risk of unwanted side effects caused by high-peak blood concentrations straight after administration. Finally, they can also help secure extended market authorisation. Currently, many organisations are faced with imminent patent expirations, the re-development of drugs into more patient-centric modified-release products can be helpful for life cycle management.

Challenges of Nanomedicines: Complex Drugs and Complex Problems 

Nanomedicines have led to several treatment breakthroughs and have great potential for the future; however, they face many challenges that traditional small-molecule formulation does not. For example, their complexity means that current tools cannot fully characterise them, which has knock-on effects, making it impossible to create completely identical copies. This means that proving pharmaceutical equivalence and bioequivalence for generic versions of nanomedicines, a regulations requirement, is further complicated. 

Nanomedicines also share many of the same issues as biologics, with instability and sensitivity to external conditions a significant concern. Finally, creating nanomedicines with the intended effects requires rigorous processing conditions as even small changes to temperature or PH levels can lead to safety and efficacy issues in the final product as well as batch variability.  

Key Challenges Facing Inhalation & Respiratory Drug Delivery 

Fundamental Obstacles For Pulmonary Delivery

Despite being a key driver for improving delivery and patient adherence, Inhaled devices suffer from mechanistic problems concerning delivery and absorption.  In essence, pulmonary drug delivery faces challenges related to the very nature of the respiratory tract. Unfortunately, our ventilatory systems have developed to be incredibly efficient at removing or deactivating foreign particulate matter, thus creating a barrier to overcome for efficient drug delivery. As a result, most inhalers deposit less than 20% of the inhaled dose into the lungs. In addition to these mechanical, chemical, and immunological barriers, pulmonary drug delivery is adversely affected by the behavioural barriers of poor adherence and poor inhaler technique. Strategies to mitigate these barriers include inhaler devices and formulations that deliver drugs to the lungs efficiently, appropriate inhaler techniques, and improved education of patients. 

Inhaled Biologics: Flawed or The Future? 

The delivery of biotherapeutic molecules (antibodies, proteins, peptides) and nucleic acids via the respiratory route has presented challenges for regulatory approval due partly to a lack of understanding of the expected pathology, mechanisms of toxicity, and immunogenicity induced by the inhalation route. The major challenge in developing inhalable compounds is limited understanding of the relationship between pharmacokinetics and pharmacodynamic effects in the lung.

Most biologics are also much more expensive to manufacture than small molecules. In addition, the low systemic bioavailability of the nasal and pulmonary routes requires much higher doses than injections, which for costly biologics may render these administration modes less attractive. In contrast, delivering biologics directly to the sites of therapeutic action in the respiratory tract makes these routes very attractive not just from the cost-of-goods perspective but also to reduce the potential for systemic side effects.

Conclusion 

This year’s Formulation and Delivery: Europe and Inhalation & Respiratory Drug Delivery: Europe events showcased various novel innovations and promising in-development projects. If you are interested in formulation or delivery and would like to attend one of the next events in this series, please take a look at our upcoming Formulation & Delivery Series US: In-Person, taking place in Q1 2022.

Join leaders, experts and researchers at Formulation & Delivery US: In-Person, connecting global pharma, biotech and academia for high-level discussions on the latest innovations for biopharmaceutical development

Speaker Biographies

Janet Halliday, Associate Vice President at Ferring Controlled Therapeutics and External Technology

Dr Halliday has worked in Drug Delivery in pharmaceutical Research and Development for 30 years. Starting with a PhD in Pharmacy, she has worked on a novel drug delivery technology that spun out from a university and ultimately reached the market, some technologies that never made it and somewhere work continues in the clinic.

Janet’s role in Ferring is to scout out, evaluate and move along drug delivery technologies that support Ferring’s mission of Helping People Live Better Lives. Janet and her colleagues in Drug Delivery in Ferring work in partnership with university technology laboratories, small start-ups and established drug delivery groups. Her focus is on Reproductive Medicine and Maternal Health. Urology and Gastroenterology therapeutic areas are also of interest. The aim is to evaluate drug delivery solutions for small molecules, peptides, and monoclonal antibodies.

Jonathan Kingsbury, Head of Developability and Preformulation Sciences, Biologics Development at Sanofi

Jonathan has over ten years of experience in the biopharmaceutical industry in analytical and drug product development. He currently leads the Developability & Preformulation Sciences group within Biologics Development, supporting Sanofi’s exciting biologics pipeline at the transition of research to development. Jon received his PhD from Boston University School of Medicine and MS and BS degrees from the University of New Hampshire.

Ildiko Terebesi, Managing Director of INVITE

Ildikó is a pharmacist by training, holding a PhD in pharmaceutical technology. She has more than 15 years of experience in the pharmaceutical industry. Focusing on specialised drug delivery technologies, she led with increasing responsibility clinical development projects from clinical phase 1 up to production scale-up. Later, Ildikó was leading a group for early drug delivery to preclinical projects, including developing new molecular entities and recommending the preferred formulation approach for clinical development. Since August 2020, Ildikó is the managing director of INVITE GmbH, a public-private partnership of BAYER AG with the Heinrich-Heine-University in Düsseldorf and Technical University in Dortmund. Among other research areas, INVITE is also leading the Drug Delivery Innovation Center (DDIC), an open consortium with academic and industrial partners for pre-competitive research on drug delivery.

Christian Dechant, Director Primary Packaging Development Biologicals Pharmaceutical Development Biologicals at Boehringer Ingelheim Pharma GmbH&Co. KG

Christian Dechant brings more than 19 years of experience in various roles to the primary packaging development at Boehringer Ingelheim. At BI microParts GmbH, he started working in research & development of microfluidic systems and was later responsible for the implementation and running of clinical trial manufacturing for Devices (e.g. Respimat)

In 2010 he started working at Boehringer Ingelheim as a primary packaging engineer with focus on liquid formulations for parenteral and oral solutions. Since 2014 he is responsible for the primary packaging development group for parenteral solution within Pharmaceutical Development Biologicals. He established the primary packaging development group with focus on NCE and NBE development. In this role he is responsible for the selection of suitable container closure systems to ensure the stability of the formulation and the functionality within a combination product like an autoinjector.

Mark Milton-Edwards, Head of Product & Health Solutions – Digital Health at TEVA Pharmaceuticals

Mark is responsible for the Product & Health Solutions within Digital Health at TEVA Pharmaceuticals. Over ten years with TEVA and prior to that sixteen with AstraZeneca Mark has held various positions including R&D Project Leader, VP Sales & Marketing, Strategic Planning & Business Development, and Global Brand Lead. Graduated in Aeronautical Sciences and completed his MBA at Durham University, UK. During his career he has led technology & especially inhaler development teams through engineering, CMC characterisation, clinical evidence generation, registration within US, EU and International Markets and ultimately to successful global launch. Total Brand Leadership value >$2.5bn. Mark has numerous patents granted and pending in electronic communications, sports technologies, inhaled pharmaceutical development, and respiratory physiological function & predictive AI. Mark is the inventor of Digihaler®, the first FDA approved digital inhaler with built-in sensors.

Olivia Merkel, Professor of Drug Delivery, LMU Munich

Olivia Merkel has been a Professor of Drug Delivery at LMU Munich since 2015. She is a Registered Pharmacist, received an MS in Pharmaceutical Technology in 2006 and a PhD in Pharmaceutical Technology in 2009 and has obtained numerous awards, including an ERC Starting Grant, the APV Research Award and the Carl-Wilhelm-Scheele-Award. Merkel is the author of over 85 articles and book chapters. She served as NIH reviewer from 2014-2015, SNF reviewer since 2018, is an Editorial Board member for JCR, EJPB, Molecular Pharmaceutics and 3 other journals as well as the President of the German Controlled Release Society and the Chair of the CRS Focus Group on Transdermal and Mucosal Delivery.

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