Chandler discusses how life sciences companies are navigating the current climate.
Cencora recently completed its name change from AmerisourceBergen. President of global pharma services Willis Chandler spoke with Pharmaceutical Executive about the company’s goals and how it’s navigating the current biopharma environment.
Pharmaceutical Executive: Can you describe your work at Cencora?
Willis Chandler: We deliver integrated support and solutions across the pharmaceutical development and commercialization journey to help our pharma and biopharma partners overcome challenges and achieve their goals. While we are well-known for our distribution capabilities, we also offer a portfolio of commercialization solutions and services—which range from regulatory affairs and pharmacovigilance to market access, patient services and field solutions—to help companies efficiently bring products to global markets, maximize commercial success and reduce barriers along the treatment journey.
PE: How are supply chain issues impacting cell and gene therapies?
Chandler: Cell and gene is an emerging market, and its growth has really accelerated over the last five years. The wonderful part is that these therapies have the potential to offer life-extending and potentially curative benefits to patients. In the US, there will be regulatory decisions on about 10 cell and gene products by the end of 2023. The robust pipeline and the sector’s upward trajectory offer substantial potential, but the path to commercialization is complex and lined with challenges—from patient access and manufacturing complexities to unique logistics requirements and market access.
For example, cell and gene therapies introduce uniquelogistics challenges, requiring a heightened focus on three key elements: time criticality, chain of custody and identity, and temperature control storage and transport. Another key component is distribution. In order to ensure a smooth transition from clinical to commercial, it’s critical to make the right choice in channel strategy and create a distribution network that can evolve and scale as needed.
We believe the next half-decade holds tremendous promise for the CGT sector and we remain focused on providing developers the support they need to overcome potential barriers and bring products to market. At Cencora, we offer integrated support throughout the development and commercialization journey—from development consulting and clinical trial logistics to market access, patient services and commercial distribution—to help developers navigate the market and unlock the potential of their therapy.
PE: How are companies using new technologies like AI to bring new drugs to the market?
Chandler: We see companies embracing all sorts of innovative technology, but I would say that AI is certainly front and center and well-documented in the news. We see it both from helping with drug discovery, along with the development process and bringing new therapies to market more efficiently.
We also recognize the value it can offer and, like our partners, continue to apply digital solutions and technology, like AI, to deliver enhanced support across the product lifecycle. For example, our electronic benefit verification (eBV) solution—which is powered by machine learning—accelerates the benefit verification process, allowing patients to start on the prescribed therapy sooner.
PE: What challenges or benefits are companies facing considering the inflation reduction act?
Chandler: The changes that were brought forward through the Inflation Reduction Act, including the Medicare Drug Price Negotiation program (MDPN), introduce new considerations and challenges for biopharma companies.
Some of the challenges are already being played out as companies survey the evolving landscape and makeR&D decisions based on the legislation. In late August, CMS unveiled the first 10 drugs covered under the MDPN. With the October 2 deadline for participating companies to submit data to CMS for consideration in negotiations, companies had to work quickly to leverage data from dossiers and economic modeling to help demonstrate the effectiveness of their products against competitors.
The impact of the negotiation program – and the broader Inflation Reduction Act – extends well beyond the first 10 drugs that were listed. Some of the most significant changes won’t take effect until 2025 (full Part D reforms) or 2026. But biopharma companies need to prioritize their planning now to ensure they understand the law’s provisions and how it will impact their portfolios, including market access engagement, pricing strategies and patient assistance programs.
For example, companies should devise a robust strategy for the Part D benefit redesign, with a focus on the financial impact on their company, contracting strategy with Part D plans and patient assistance program changes. Ultimately, we anticipate the implementation of the IRA provisions will lead to change across the industry, including an adverse impact on pipeline products. But by developing a strategy that extends through 2025, they’ll be better positioned to anticipate and overcome challenges throughout the implementation process while continuing to support patients.
PE: What do companies looking to launch in Europe need to consider—how does it differ than the US?
Companies looking to expand their reach or enter new markets should run through an internal checklist which includes: have you considered your global commercialization strategy and sequence to market? Have you started thinking about 3PLs? Do you have an HTA strategy for each market?
That last question, in particular, is relevant for companies looking to launch in Europe. While the US market is complicated by the sheer number of payers and reimbursement designs, Europe is complicated because companies have to navigate varying regulations and requirements across the different countries. For example, the criteria used to assess the clinical value of new pharmaceuticals varies widely across countries in Europe, adding complexity to biopharma companies’ global launch plans. As part of a new Health Technology Assessment (HTA) regulation, the EU will implement a Joint Clinical Assessment (JCA) to create more standardization across the 27 member states. HTAs play a vital role in determining whether a product is reimbursed and accessible in the market. Pharmaceutical companies need to understand and be prepared for the JCA process to avoid potential delays or setbacks.
Our team of experts work with pharma companies to help them navigate the complex HTA processes, optimize pricing and reimbursement strategies and develop and communicate a differentiated value story.