DCAT Week Innovation Leaders Program Highlights - Contract Pharma

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DCAT Week’s The Innovation Leaders: A Conversation with Aamir Malik, Executive Vice President and Chief Business Innovation Officer, Pfizer, addressed key trends driving innovation.

Learning from the Pandemic
The role of mRNA in vaccines and future drug development: We’ll continue to see the application of mRNA in drug development. For example, new areas leveraging this technology, including the shingles vaccine outlined below, as well as oncology gene editing to enhance design and delivery. Aamir noted that collaborations will be critical to help shave time off development. While this rapid development cannot be applied to everything, we can expect more development like this.

In January, Pfizer and BioNTech SE announced a new research, development and commercialization collaboration to develop a potential first mRNA-based vaccine for the prevention of shingles (herpes zoster virus, or HZV), a disease that impacts about one in three people in the U.S. during their lifetime.

The collaboration builds on the companies’ success in developing the first approved and most widely used mRNA vaccine to help prevent COVID-19. This is the third collaboration between Pfizer and BioNTech in the infectious diseases field, following the influenza vaccine collaboration initiated in 2018 and the COVID-19 vaccine collaboration initiated in 2020.

Under the terms of the agreement, the companies will leverage a proprietary antigen technology identified by Pfizer’s scientists and BioNTech's proprietary mRNA platform technology used in the companies’ COVID-19 vaccine. The parties will share development costs.

Clinical trials are planned to start in the second half of 2022. Pfizer will have rights to commercialize the potential vaccine on a global basis, with the exception of Germany, Turkey and certain developing countries where BioNTech will have commercialization rights. The companies will share gross profits from commercialization of any product.

Comirnaty & Paxlovid
We learned that a vaccine can be developed in record time. This is something that has never been done before and going forward we can expect more agile and robust development. Aamir attributes this to regulatory collaboration. He noted, a big piece is streamlining governments and removing bureaucracy, which allows progression to move quickly. Additionally, Pfizer’s relationships allowed it to scale quickly. Aamir noted a real alignment of goals and trust are key.

Partnerships and M&A
Trends behind partnerships include having the criteria to advance its portfolio, scientific acumen, and where Pfizer is going to be competitively and financially.

To help diversify risk, external innovation will depend on the science being advanced. Pfizer does this in several ways. From venture fund and private equity in smaller companies with early stage assets, and investments of ~$5-$10 million in public companies with more advanced candidates, as well as complementary licensing deals, such as partners gaining access to Pfizer’s capabilities.

Manufacturing plays an important role in product innovation. The role of outsourcing, and the desire to form strategic relationships, are more actional rather than transactional. Dynamics often revolve around the science and the need for advanced capabilities. Aamir noted conversations are happening earlier and offering greater resilience.

With respect to consolidation, Aamir noted, while more capabilities under one roof are good, this needs to be balanced with specialized capabilities.

As far as what Pizer looks for in a partner’s capabilities, according to Aamir, it’s deal specific. For consideration of a licensing deal, with later stage assets, it will depend on a platform technology, scale up and how Pfizer can accelerate a program. Pfizer is currently focused on whether or not there are synergies.

Small Molecules vs. Large Molecules and Future Drug Development
Pfizer’s pipeline going forward will include a large proliferation of modalities. When looking at investments, Pfizer looks at geographies and building scale quickly, as well as leveraging artificial intelligence (AI) and machine learning (ML), which can massively improve patient outcomes and reduce timelines.

These technologies will play a bigger role identifying candidates and in the clinical trial process. In particular, real-time data played a big role with COVID vaccine development, where decisions were informed by AI, and made quickly.

There are big implications with AI and the promise of the technology in identifying targets, which saves time.

In closing, Aamir, is optimistic about the future of drug development. There will be greater collaboration among stakeholders, development timelines will compress, and there will be more real time insight.