DCAT Value Chain Insights’ “5 Minutes With,” part of the new DCAT Member Community section, features interviews with industry leaders on issues impacting the bio/pharmaceutical manufacturing value chain and other business leaders. 

This “5 Minutes With” features John Ratliff, Chairman and CEO, Curia.  

Q: From an industry view, what key trends and/or market dynamics are most significantly impacting the CDMO/CMO sector? 

Ratliff (Curia): Clearly the COVID-19 pandemic remains a major factor with CMDOs and CMOs playing a significant role in the societal response. From supporting the development of treatments and vaccines to the production of billions of doses of these products to treat and prevent COVID-19 cases, I’m proud of how our entire industry stepped up and stood out. But we’re not done yet. We still need billions more vaccine doses globally. Scalable treatments are still needed with more in development. We must not take our eye off the ball. 

At the same time, scientific and technological innovation continues to advance. Biologics make up an increasing percentage of large pharma’s pipeline as well as biotech’s. That is driving substantive growth across the CDMO/CMO industry and creates greater operational complexity for us. Biologics make up more and more of the discovery, development, and analytical efforts, and I anticipate that growth to continue. 

Q: For CDMOs/CMOs, what are the greatest challenges and opportunities in responding to these issues? 

Ratliff (Curia): I’ve been fortunate to work across different industries over the course of my career, and I’ve seen how things we might label as ‘disruption’ can set a new standard of expectations that become the norm. Think about Uber and Netflix. The pandemic has set a new standard for agility and innovation for CMDOs. Consider how the industry responded with mRNA, lipids, even sterile fill–finish.  

We must continue to add breadth and depth across the industry to meet customers’ increasing needs and expectations. We need breadth of capabilities and the girth to scale, so we can deliver velocity—volume at speed. At the same time, we must provide the depth of scientific, technology, and engineering expertise needed to navigate the complexity associated with the advances in customers’ pipelines. No small feat. 

Much also has been said about supply chains. They are currently headline news in the US and around the world. Previously a back-office discipline, supply-chain management is now widely recognized for the critical role it plays, particularly in our industry. Our supply-chain professionals have shown remarkable foresight, speed, and sophisticated relationship management by enabling us to be responsive when the world needs us. We need continued dedicated focus on this function to incorporate the pandemic learnings and advances. 

Q:  From a drug-development view, direct-to-patient/remote clinical trial practices came into use during the pandemic. Do you see that trend continuing, and what will be the impact on clinical trial material supply? 

Ratliff (Curia): Decentralized clinical trials (DCT) have been evolving over recent years but really came to the forefront during the pandemic by enabling important clinical development to continue safely at a time when people couldn’t travel to sites. It was impressive to see how sponsors, providers, and regulators pulled together in the interests of patients during the pandemic. I don’t think we’re going back.  

My view is that DCT are here to stay, and CDMOs are an important part of the DCT ecosystem. Looking to the future, the drug-development community needs to scale its ability to meet DCT needs by ensuring that clinical trial materials can reach patients in ways that are safe, compliant, efficient, and convenient for patients. It will take agility in terms of development and manufacturing—from grams to metric tons— as well as a fresh look at the supply-chain management, particularly packaging and distribution. It’s likely we can leverage what’s already in place. It’s an important opportunity for CDMOs and one that I think is integral to drug development of the future. 

Q:  How has project management evolved over the past year overall and in response to the pandemic? What new approaches (such as remote audits) or adjustments have come into play, and how will they be applied going forward? How have sponsor companies’ expectations changed? 

Ratliff (Curia): CDMOs and CMOs pivoted quickly when the pandemic emerged and put safety precautions in place that protected employees and safeguarded ongoing operations. We had to. While we still have many of these precautions in place, we’re seeing certain trends emerging, and I think we’ll end up in a better place than we were pre-pandemic, with a mix of remote and in-person strategies. We’ve been calling it a ‘back to better’ way of working.  

In-person audits, inspections, or visits will still be important, but we’ve determined what can be managed equally effectively in a remote setting. The technology has been available for years, and the pandemic has caused the behavioral change needed to adopt the new practices. In this new setting, program- and project-management skills and systems take on increased significance to weave remote and in-person activities for optimized delivery.  

Q: In taking a longer-term view, how do you see drug development and bio/pharmaceutical outsourcing five or 10 years from now? What issues or practices may emerge not currently on the industry’s radar? 

Ratliff (Curia): As a relative newcomer to the CDMO and CMO industry, I’m still learning, but I would say I’m motivated about the opportunities ahead of us. The fast pace of scientific and technological innovation means that the products of the future will need a combination of chemists and biologists to develop and manufacture. It will be complex. Companies that can combine these disciplines and provide agile capabilities from grams to metric tons will increasingly be seen as partners to customers. They will be positioned to play an increasing role in the success of products by creating meaningful value for customers and making a bigger impact for patients. 

Patient centricity has long been discussed in drug development and is increasingly factored into development programs and approaches. In the coming years, I’m confident that CDMOs and CMOs will move beyond discussions and explorations of patient centricity and actually take action to alter how we operate. We already mentioned DCT, which is a great example of a patient-centric methodology that will be an integral part of drug development in the coming decade. 

While our potential future is exciting, actually making the necessary changes can be achingly slow. It needs to go faster because patients need us to go faster. I’m focused on driving specific changes to accelerate the possibilities. At Curia, we talk about advancing from idea to patient impact. There’s honestly nothing else I’d rather be doing.  

John Ratliff is Chairman and CEO of Curia, formerly AMRI, a contract research, development and manufacturing organization. Prior to joining Curia in December 2019, he served as CEO of LabCorp’s drug-development business, Covance. Previously, he was President and CEO of HUYA Bioscience International. His healthcare industry experience also includes almost 10 years at Quintiles, where he served as Chief Financial Officer before becoming President and Chief Operating Officer. Overall, he has more than 25 years of executive management experience.