Discussion Group Report

Inhaled Biologics Discussion Group Report 

By Oliver Picken |
09 December 2021
This November, our Formulation Series discussion group focused on the formulation and delivery of inhaled biologics. Oxford Global’s discussion groups bring together a select group of 15-20 key industry leaders for approximately one hour for in depth knowledge sharing and conversation.

This November, our Formulation Series discussion group focused on the formulation and delivery of inhaled biologics. Oxford Global’s discussion groups bring together a select group of 15-20 key industry leaders for approximately one hour for in depth knowledge sharing and conversation.  

Biologic based therapies have soared in popularity and now account for approximately 12% of the pharmaceutical market. Hundreds of biologics have been approved for a wide range of conditions, including cancer. It is estimated that around 40% of drugs currently in trials and development drugs are biologics. Inhaled delivery of biologics has long been a subject of interest, but it has not proved easy to create efficacious drugs. 

Opening this month’s discussion group was David Cipolla (Vice President of Research, Insmed) with a presentation titled “The Development Opportunities and Challenges of Oral Biologics”. David has over thirty years of experience working on inhaled drugs and was the part of the team that worked on Pulmozyme® rhDNase which gained approval for the management of cystic fibrosis in 1993.  

 Key topics covered included the history of inhaled biologics with a focus on how and why inhaled insulin failed to meet expectations, potential applications inhaled biologics could treat such as COVID-19, Cystic Fibrosis and obesity. A substantial portion of the presentation focused on the challenges that face inhaled biologics, including comparison to other forms of delivery, bioavailability and regulatory approval.  

Joining him to lead the discussion were Carsten Erdhart (Professor in Pharmaceutics and Biopharmaceutics, Trinity College Dublin), Francesca Buttini (Associate Professor, University of Parma, Pavan Muttil, (Associate Professor, University of New Mexico) as well as attendees from several pharmaceutical companies and academics universities such as iPharma Lab INC and Istanbul University.  

Patient Centricity & Inhaled Biologics: Smart Inhalers / Digital Inhalers 

‘Smart’ inhalers are inhalers are designed to simplify inhalation by including extra digital features such as dose tracking, connected phone apps and environmental awareness for altered dosing levels. There are many such devices currently in development, but they are not widely available to patients at this point. The difficulty comes with the increased cost of such devices.  

David Cipolla explains that “Technology can provide a lot of benefits to inhaled devices to make them more uniform in delivery, and have patients use them more consistently. The question is always who pays for that? Patients don’t want to pay for that. Insurance companies don’t want to pay for it. No one wants to pay for it.  

I think you have to be selective in opportunities where it makes sense. It’s got to be an area that really requires very precise delivery, maybe because of a narrow therapeutic window, or where the therapy is very expensive, and the disease indication can tolerate it. 

Pavan Mutti agreed with this sentiment but argued that they can still have a place for long term illnesses, saying “I was just talking to one of the clinicians who treats asthma patients with regards to the smart inhalers and her point was straightforward. It’s very expensive. With that said, you want to target a smart digital device for a chronic disease, right? So, you’re looking at asthma, COPD, or even diabetes, where patients are supposed to take medication lifelong.” 

Making The Choice: Local vs Systemic Delivery 

Another question the group wished to answer was whether focus should be given to local or systematic delivery.  

Ayca Yildiz Pekoz states that “I prefer to target local locally. Why? Because we have so many local diseases, so many lung diseases, that we haven’t got proper drugs for. So first of all, I think we have to prioritize these kind of lung diseases, we have to find good, ethical, efficient therapies.”  

Another reason that local delivery is favoured over systematic is that delivery through the lung for systematic release is still relatively poorly understood. When asked about the relationship between molecular weight and blood absorption for systematic delivery Carsten Erdhart explained that “we did studies using cell models back in the days and gathered some ex vivo data and there isn’t really a good correlation between molecular size and high bioavailability mainly because of the stability issues. And I think pulmonary metabolism, not just as far as biologics are concerned, but generally I think has really been a very understudied area.” 

Pavan also explained that the need for systemic delivery has decreased as “needles are getting so much better, so the whole fear of needles is sort of going away. We need to be very sure that if you are developing something it is better and has a purpose.” 

Conclusion 

The discussion group concluded with a discussion on the work ahead of us for inhaled biologics to become more viable and the various opinions and innovations in the industry for biologic targeting.  

At Oxford Global, we couldn’t have been more pleased with the turnout for our second Formulation & Delivery discussion group. The conversation was engaging, the debate stimulating, and the event provided the perfect setting for exchanging ideas.  

We will continue our monthly discussion group series next month when we focus Formulation & delivery for Innovative Delivery Routes. Learn more about Oxford Global’s discussion group series and our other events here

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