Friday, November 11, 2022

Cell and Gene Therapy Roundup: What the Road to Success Looks Like

Today’s guest post comes from Lung-I Cheng, Vice President of Cell & Gene Therapy at AmerisourceBergen.

Lung-I discusses advancements in cell and gene therapy and explains how to tackle the challenges facing manufacturers, providers, and patients.

Click here to learn about AmerisourceBergen’s Cell and Gene Therapy solutions for biopharma companies, providers, and patients.

Read on for Lung-I’s insights.

Cell and Gene Therapy Roundup: What the Road to Success Looks Like
By Lung-I Cheng, Vice President, Cell & Gene Therapy, AmerisourceBergen

We’re entering an exciting time for cell and gene therapy (CGT). While 2021 had already been a banner year, 2022 is slated to become a record year for approvals of new CGTs to treat debilitating diseases, with six CAR-Ts in the US and the EU, and continued advances in gene editing, per the Alliance for Regenerative Medicine (ARM). The future is bright, and the pipeline looks promising, but as science continues to advance, challenges of bringing these transformative medicines to market remain.

Over the last few weeks, our team members at AmerisourceBergen participated in some of the sector’s most-attended conferences, including Meeting on the Mesa, Cell and Gene Therapy USA 2022, and the 7th Annual CAR-TCR Summit, where we shared insights with biopharma companies and other partners on market access, innovative payment models, cell orchestration journey, and overcoming logistical challenges associated with data management within the supply chain. We also interacted with many of our customers and listened intently to what problems they were trying to solve. While the challenges vary, what is clear is that we need to join forces and keep bringing value to the complex CGT ecosystem by providing out-of-box thinking and creating innovative solutions.

Among the highlights of these events was the consensus around the most urgent hurdles surrounding CGT commercialization: pricing, harmonization of approval requirements, early access, and global equity, to name a few. To tackle these challenges, it is critical to have a shared purpose, adopt the right processes, keep the patient at the center of everyone’s efforts, ensure data accuracy, and build the right partnerships.

As Timothy Hunt, the new CEO of ARM, stated in his opening remarks at Meeting on the Mesa: “The concerns of payers, policymakers, ethicists, and others are no longer theoretical—it is here and it's real. […] We're going to need to meet these important stakeholders not where we are but where they are, and really listen to their questions and concerns.” Expectations have always been there but now efficacy, affordability, compliance, planning, and trust, have been moved to the forefront.

As I reflect on the discussions over the last few weeks, I want to share key takeaways.

The macroeconomic environment is uncertain, and borrowing cost is high in the near term. Without the necessary actions, the lack of funding could slow the pace of innovations benefiting patients and healthcare systems.

Successful therapy launches will depend on lowering barriers to market access. This includes patient access, medication affordability, and reimbursement, and this is where partners like AmerisourceBergen can help.

Patient access is never a straightforward challenge. It is a complex, nuanced, and layered issue that requires solutions as diverse as the people affected. It can only be secured by understanding and anticipating all the hurdles in a comprehensive and integrated manner.

As a convener, AmerisourceBergen is the intermediary between payers, manufacturers, and providers. We help optimize patient engagement and streamline the financing and data management critical in the early stage of commercialization.

Focusing on value and cost-effectiveness, our teams have recently created a new concept around offering outcomes-based agreements (OBAs) to operationalize the contract and enable payers/employer groups to pay for clinical outcomes. This helps optimize access and affordability while reducing the administrative burden for all stakeholders.

Lastly, as regulators and payers become more adept and efficient at evaluating CGTs, the requirements for data robustness and availability will only increase, necessitating careful planning on data strategy.

This is why trust is essential. The path to success relies on ensuring early dialogue and early planning to get a chance to build trust and understand each party’s responsibilities and priorities.


Bringing a new therapy to market can be a long and challenging journey. And finding the right commercialization partner means looking for more than an aggregator of disparate services. True partnership and integration are rooted in seeking solutions for today’s and tomorrow's healthcare challenges and making investments where gaps exist.

As AmerisourceBergen continues to provide robust CGT end-to-end solutions tailored to the specific needs of biopharma companies, providers, and patients, we look forward to guiding, delivering, and supporting even more cell and gene therapies to markets around the globe.

Sponsored guest posts are bylined articles that are screened by Drug Channels to ensure a topical relevance to our exclusive audience. These posts do not necessarily reflect our opinions and should not be considered endorsements. To find out how you can publish a guest post on Drug Channels, please contact Paula Fein (

No comments:

Post a Comment