What is AbbVie's approach to partnering in the drug delivery space?
Large pharma pipelines are becoming more diverse in terms of different modalities, product presentations, and challenges with respect to target engagement. Examples include areas like genetic medicines and delivery to the CNS, and the need for long acting and locally delivered therapies. All of that means that advanced drug delivery capabilities are more important than ever to delivering the pipeline.
We and many other large pharma invest internally to build innovative drug delivery capabilities. But partnering is another way we tap into the much larger pool of innovation that happens outside our walls and ensures we gain access to the technologies that best meet the needs of our patients and other stakeholders. My team looks at both formulation as well as med tech-based approaches across a whole range of administration routes, therapeutic areas and development stages.
What drug delivery technologies are you personally excited about?
Delivery is key to genetic medicines, and we have seen a lot of encouraging successes there recently. There is still a lot more to do in terms of being able to access a variety of target tissues throughout the body.
Another space that I’m personally excited about is next-generation technologies to enable long-acting delivery in areas like eye care and neuroscience. We’re now seeing technologies that can address limitations of legacy technologies and open up new areas like long acting delivery of large complex biologics. We’ve done a number of deals in the sustained release space in the past and we’ve recently partnered with MedinCell and Ripple Therapeutics on new programs.
"Strong science is fundamental. We make our decisions on where to focus our partnering efforts based on data."
Do you approach external innovation based on the type of delivery technology you are looking for or based on the therapeutic area that needs a delivery solution?
It’s both. When we can find technologies that can serve as a platform, that is attractive because we have that initial investment in partnering or building the capability and then we can bring that to bear on future programs and really drive speed and predictability.
How do you analyze potential technologies for partnering?
There are a number of things that we look for. They need to be differentiated, they need to solve a clear unmet need with respect to our pipeline, and they need to align to the target product profile (TPP) of the particular asset that we have in mind. They also need to meet business needs, like readiness for supporting clinical stage or ultimately commercial development efforts and be competitive in the commercial landscape we anticipate at the time of launch, which is often many years down the road.
Strong science is fundamental. It is helpful to understand how the technology works at a mechanistic level. We make our decisions on where to focus our partnering efforts based on data. When prospective partners – even at early stage – can bring data like PK, PD and local tolerability, especially in models that can help give us an idea of preclinical to clinical translation risk, it can be very helpful. If there is limited data early on, we often will have a material transfer agreement or a similar approach to generate feasibility data that will help us drive decisions.
We need to understand the limitations of the technology and it is helpful when the potential partner, who knows their technology best, is realistic and transparent about what the technology can and can't do. My team looks at a lot of technologies in a given year, so it can save us a lot of time and make our lives much easier if we have that understanding upfront. It's important to understand the line of sight to clinical as well as commercial manufacturing. We often see gaps there, particularly for early stage technologies.
"Establishing open and transparent communication upfront is very important to ensure success in an eventual partnership."
How do you balance scientific innovation and commercial viability when making partnering decisions?
It ties back to what alternatives are available. If there are multiple ways to get to a given outcome and some of those have a clearer line of sight to some of those practical elements of manufacturing and cost of goods, we would weigh heavily on the technologies that are at a level of readiness that we could move them forward. If there are a lack of solutions, as there are in some of these emerging and more challenging spaces, we have to accept more risk to achieve the goals of the TPP.
How do you analyze potential companies for partnering?
We kind of get a feel for what that relationship may look like as we work through the evaluation process. Building a fundamental understanding of the science of their technologies is really important. Communication is really important. Establishing open and transparent communication upfront is very important to ensure success in an eventual partnership.
What are some of the different types of deal structures you employ?
Our approach is very diverse and flexible depending on the needs of the situation. We have done the full gamut of different deal structures, from collaborations to licenses, option deals and outright acquisitions. It comes down to the specifics of the given situation.
"It's really important to establish upfront a very clear understanding of what success looks like and how it will be measured."
How can drug delivery companies best partner with pharma?
We always try to design these partnerships in a way that best leverages the strengths of each of the individual partners. The drug delivery company obviously knows their technology best. Often, they can be quite agile and innovative in solving problems. Pharma often brings deep disease area expertise and development capabilities across the whole spectrum of CMC, clinical and regulatory. We strive to allow each partner to bring the things they do best to the relationship.
Any advice for pharma companies on best practices when looking for partnerships?
Being plugged into the landscape by attending meetings is a great way to see what people are doing. Obviously, there is the patent literature and scientific literature. Relationships and networks are very important to leverage as well. It’s important to encourage early, open, and regular dialog. Even if the time for either the technologies or prospective partners isn’t quite right, early relationship building, and maintenance is key to success. And reaching back into the academic space is also helpful.
What red flags should companies watch out for in potential partnerships?
Often, the drug delivery companies want to portray their technology in the best light. On my side of the table, when I see an overly rosy picture and they are telling me that this technology can solve all of my problems, that sends some red flags for me. It’s really helpful when there is transparency upfront about where the technology does and does not play. That can save a lot of time in trying to assess how any given technology can best support and enable our pipeline.
Once a partnership is in place, what are the ingredients for success?
It's really important to establish upfront a very clear understanding of what success looks like and how it will be measured. Make sure there's good alignment between the partners on that. It’s helpful on the pharma side to have a good internal champion who can navigate the organization and align internal stakeholders. Open, transparent and frequent communication is also really key to ensure success.
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