Keeping It Simple: Collaborating for Success in Drug Delivery

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The history of the pharmaceutical industry is filled with examples of brilliant product ideas that ultimately failed. In the case of Pfizer’s revolutionary product, Exubera inhaled insulin, an innovative drug and delivery concept resulted in a drug-delivery form that failed to gain acceptance. Stories like this are not uncommon. The right approach to thinking about drug-delivery options, however, can help ensure success, especially when working with contract partners.

Pharmaceutical Technology asked 3M Drug Delivery Services team members Richard Beesley, global business development manager; Louise Righton, global marketing operations manager; and Ross Errington, sales manager, to share some best practices.

Drug-delivery trendsPharmTech: What trends are becoming most important in drug delivery today? Which forms do you expect to be dominant in 5 to 10 years?

Beesley: As payers around the world continue to focus on cost reduction alongside improvements in health outcomes, stakeholders need to be open to the possibilities afforded by new digital technologies. On the surface, these options are more expensive, but connected devices allow the payer and the clinician to track usage and, in some cases, disease state, allowing real-time condition management. New technologies to drive patient compliance and adherence will be the future of drug delivery.

Choosing a drug-delivery platformPharmTech: What are the biggest mistakes that pharma companies make when deciding on a drug-delivery platform? What do they typically fail to consider?

Beesley: Pharmaceutical manufacturers generally always prefer to start with a tablet, but that doesn’t mean it’s the most efficacious or convenient way to deliver a drug. It’s really important to think about how a drug is going to be administered, by the patient themselves or by a caregiver. Pharma companies need to look at all aspects of drug delivery and consider whether there might be better options.

It can be easy to get caught up in thinking about ‘how quickly?’ a commercialization can occur, but that approach may overlook key opportunities for differentiation. Take an injectable, for instance. If you broaden the search, you might decide on microneedle technology, because it can have a far easier supply chain, no cold storage, no needles to dispose of, no glass, patients can administer themselves, and, ultimately, to the end user and payer it could be cheaper and more convenient. Now, if the decision on delivery is made too quickly without considering the bigger picture, it’s either too late or too costly to make a change.

PharmTech: Please outline the ‘ideal’ best practices for deciding on a drug-delivery platform for a new drug. When should the choice be made and based on what criteria? How does this process differ when one is repurposing an off-patent drug for a new indication and new delivery system?

Errington: The short answer is as early as possible so you can assess all options. Use your decision tree to take it all the way to the end user. Who is the end user? You don’t necessarily want to have elderly patients having to remember whether or not they took their pills. In this case, a visual identifier might be needed. Does the therapeutic area have common side effects to be aware of? If you’re developing an anti-nausea medication, patients probably don’t want to swallow one more thing. A transdermal patch might be better. There are a lot of considerations to be weighed.

Of course, certain drugs for specific therapeutic areas have already established best practices. If you’re dealing with chronic obstructive pulmonary disease (COPD), the obvious delivery choice is an inhaler; so the decision becomes what features do you want to add to the inhaler (i.e., dose counter, breath-actuation, and so on).

An experienced company with a culture of learning and continuous improvement will leverage past experiences in understanding what can work, early in the process.

PharmTech: How should patient and healthcare professional preference be factored in? How about issues of pricing and payer acceptance?

Righton: Recent research conducted by 3M highlights three themes that ultimately drive success:

• Patient-centric approaches. A growing consumer mindset is being applied to the healthcare world. Devices that are difficult to use or that don’t satisfy the needs of the patient as a consumer will struggle. In addition, recognizing--and addressing--the complex reasons for non-adherence and non-compliance will appeal to payers and clinicians alike.

• Electronic integration. Devices are becoming smaller and smarter. Many new developments build on existing devices such as smart phones, helping to make them more cost effective and holistic. New integrated products enable us to move from ‘disease treatment’ to ‘condition management’.

• Low cost. With continued austerity measures and generic competition, it is likely that the focus on cost will continue.

This leads to the following product development lessons:

• Keep it simple--new devices need to be robust to accidental, or willful, misuse.

• Make it intuitive--minimize training to reduce costs.

• Ensure it provides improved health outcomes, including quality-of-life measures.

• Find a way to provide added-value services that better match the patient and the condition.

• Ensure all of the real-world health economic benefits can be proven to a payer.

The primary challenges facing the industry are to develop a product that allows patients to adhere to their medication regimes and to comply with their use, optimizing delivery of the drug, resulting in improved patient outcomes and minimizing utilization of healthcare resources.

Furthermore, we need to be able to measure positive patient outcomes in a real-world environment and demonstrate that they are real to the payer and healthcare professional. Finally, the industry needs products that are differentiated in today’s competitive landscape, and that also enable protection against generic competition.

The role of contract partnersPharmTech: How should pharma sponsors work more successfully with contract partners to ensure that they are not leaving anything out of the decision process?  What internal groups need to be involved?

Beesley: Pharmaceutical companies will maximize the contribution of their contract partners if they recognize and leverage their areas of expertise and experience. A contract manufacturer should be able to take a product from start to finish, no matter at what stage they get involved. By far the most important part of this process is the sharing of information. Share as much information as you possibly can. Often, during the bidding process, pharmaceutical sponsors don’t give CMOs all the information they need. A ‘more is less’ mentality can be helpful. More information up front tends to mean fewer surprises down the line, later in development. 

Article DetailsPartnerships in Outsourcing Supplement 
Vol. 40, No. 13
Pages: 20–21

Citation:
When referring to this article, please cite it as A. Shanley, “Keeping It Simple: Collaborating for Success in Drug Delivery," Pharmaceutical Technology Partnerships in Outsourcing Supplement 40 (13) 2016.