The CDMO Roundtable at CPHI North America featured industry experts in a panel discussion which covered the newest developments in outsourcing, including industry trends, technological advancements, regulatory considerations and strategic partnerships.
 
Speakers included:
 

• Anil Kane, Executive Director, Global Head of Technical Affairs, Thermo Fisher Scientific
• Dave Powell, Vice President of Business Development, Grand River Aseptic Manufacturing
• Tim Quinn, Vice President & General Manager Pharmaceuticals, Actylis

 
The interactive roundtable was hosted by Jim Miller, Independent Consultant in the Bio/Pharma industry.
 
Revisit some of the topics covered in the panel below:

Novo Nordisk Acquisition of Catalent

Earlier this year, Catalent Inc., a global CDMO, and Novo Holdings, a holding and investment company responsible for managing the assets and wealth of the Novo Nordisk Foundation, entered into a merger agreement under which Novo Holdings will acquire Catalent in an all-cash transaction that values Catalent at $16.5 billion on an enterprise value basis.
 
As part of the deal, Novo Nordisk has agreed to acquire three fill-finish sites from Novo Holdings for $11 billion—the sites are in Italy, Belgium, and Bloomington, IN, in the U.S.
 
Catalent is a top-tier supplier of outsourcing services to the industry. It provides skills to hundreds of clients with whom it is contracted as a supplier. So, this current news represents a situation where the industry is watching very closely to understand how this acquisition of Catalent will ultimately affect and influence all of these contract client relationships in the long run.
 
The acquisition will force companies currently making their drugs in Catalent facilities to find new facilities and could therefore create some bottlenecks in the industry.
 
Furthermore, this acquisition in addition to Annex-1 regulatory requirements in Europe could cause disruptions to total capacity for making drugs in the industry.
 
According to Powell, change is hard to adapt to and will take time, but he predicts that the industry will end up with new technologies and better capacity down the road, which is a benefit in the long-term.
 
Kane also anticipates short-term disruptions in the supply chain. He says that Thermo Fisher is discussing with partners how to meet their needs.
 
“We think the industry is more on a ‘wait and watch’ mode and monitoring how changes will impact them,” he remarks.

Reshoring Supply Chains

The next topic of discussion was investment in domestic drug manufacturing capacity. After the supply chain disruptions that Covid-19 wrought, having proximity to desired markets is key, however, it’s difficult to change overnight. Reshoring requires infrastructure and teams of experienced experts.
 
It’s a complex market and it’s up to companies to decide where to invest, says Quinn.
 
For example, in the U.S., Congress has passed 10 legislative actions to try and address reshoringand there several bills in discussion focusing on Buy-American and reshoring. Recently, the Biden administration announced a taskforce to look at developing a U.S.-based supply chain for 50-100 critical drugs on the essential medicines list.

Other Trends in the Industry

The speakers also discussed the increased interest in antibody drug conjugates (ADCs) and the drivers behind this trend, including improved efficacy, reduced toxicity, more effective payloads and the role they may potentially play in the future of anti-cancer.
 
ADCs are a type of drug therapy produced by conjugating a monoclonal antibody to a cytotoxic payload, which is designed to be able to specifically target cancer cells, and then deploy the payload directly to the target, reducing off-target effects and systemic exposure to the cytotoxic molecules. ADCs represent one of the fastest-growing regimes of oncology drugs, owing to their effectiveness in vivo.
 
The speakers also noted more interest in oligonucleotides. Due to their rapid development cycle, impressive success rate, low side effects, and lasting effectiveness, oligo drugs are now being applied far beyond rare diseases. They’re tackling chronic conditions like hyperlipidemia, hepatitis B, and diabetes, with over 1500 research pipelines around the globe.
 
However, turning oligo drugs into commercially available products requires technology accumulation and validation, presenting high barriers in quality control and production processes. Due to the lack of industrialization and factory construction experience, large-scale production faces considerable challenges.
 
Lastly, the speakers examined artificial intelligence (AI) and how it’s being used in drug development and manufacturing.
 
Thermo Fisher Scientific has been utilizing predictive modeling tools and machine learning from drug development through commercialization. In manufacturing, the company applies machine learning to data to predict what should go right/wrong.
 
The applications are nearly limitless, from drug research through API processing and more. Actylis has started utilizing route analysis in facilities, which saves the company time and money, however, Quinn makes a point to emphasize that human intelligence remains crucial. None of these companies will stop depending on humans anytime soon.