CPHI Pharma Awards 2023 – Supply Chain Excellence Winners: Catalent Case Management Services

After another year of impressive nominations for the CPHI Pharma Awards our winners were announced at CPHI Barcelona in October. In this series of interviews, we speak to the people and teams behind the award-winning projects, concepts, and technologies. 

Please can you give some background to Catalent and the aims and goals of the company?

Catalent is the global leader in enabling pharma, biotech, and consumer health partners to optimise product development, launch, and full life-cycle supply for patients around the world. With broad, deep-scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred Contract Development and Manufacturing Organisation (CDMO) partner for personalised medicines, blockbuster drugs and consumer health brand extensions. Catalent helps accelerate over 1,000 partner programmes and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply over 80 billion doses of nearly 8,000 products annually. Its rapidly growing expert workforce exceeds 18,000, including more than 3,000 scientists and technicians. Headquartered in Somerset, New Jersey, Catalent, Inc. (NYSE:CTLT), is an S&P 500® company, and generated nearly $5 billion in revenue in its 2022 fiscal year.

You won the ‘Supply Chain Excellence’ prize for the Catalent Case Management Services – please can you tell us a little more about this offering?

Catalent’s Case Management Services enable cell &gene therapy companies to overcome complex supply chain management challenges to support the timely delivery of advanced therapies to patients. This service provides continuous, seamless 24/7 supply chain coordination and support from initial cell collection through manufacturing and ultimately delivery. Catalent understands that every project is different, which is why our Case Management Services are available as a menu of services so customers can get exactly what they need.

Have you encountered any challenges in developing this service, and how did you overcome them?

Yes, since our Case Managers are overseeing the coordination and delivery of potentially life-saving therapies, conducting extensive due diligence was critical in the development of this service. In addition to engaging a cross-functional internal team spanning operations, supply chain, legal and other areas we additionally sought advice from outside counsel to ensure compliance with US and global regulations.

By providing assistance with shipment handling, manufacturing and supply chain integrity, how will this lead to a more secure and sustainable supply chain? 

Case Managers can enable companies to focus on science and innovation by eliminating strain on internal resources, mitigating supply chain risk and improving their ability to scale-up in the future to reach more patients and/or add indications or new therapies.

How can this be used to help companies adhere and adapt to changing regulations globally? 

A key responsibility of our Case Managers is to ensure that proper documentation including full COI and COC is maintained for the therapies that we are overseeing and managing. And while our Case Management Services do not offer direct regulatory support, advice or guidance beyond these specific responsibilities, we comply with all applicable regulations in the countries in which we operate and/or perform services. As such, our regulatory, trade compliance and operational teams all play a crucial role in ensuring that Catalent is in compliance with all applicable regulations as well as actively monitoring proposed and pending changes in the regulatory environment so we can conduct impact assessments and plan accordingly. 

What does winning the award mean to you and how will it help you as a company?

We are honoured to be recognised and win the prestigious Supply Chain Excellence award at CPHI this year. At Catalent we take our commitment to being a “Patient First” focused company into everything that we do. Developing Case Management Services to complement our world-class cell and gene therapy manufacturing services was a natural extension to ensure that patients receive their potentially life-changing advanced therapies. And because the patient is at the centre of all that we do, our Case Management Services are made available even if Catalent is not manufacturing the therapy, because professional management of these complex supply chains is critically important, and we are more than happy to use our deep expertise in supply chain management to support patients.   

What does the future hold for Catalent? What further initiatives do you have in the pipeline?  

As a publicly traded company, we do not disclose pending capital investments, facility expansions or new services in advance. However, at Catalent, we strive to continually innovate and deliver outsourced services that support the changing needs of the biopharmaceutical market. We accomplish this through a combination of expanding or modifying our existing facilities and in-market services and introducing innovative solutions that address emerging market needs. Recent examples include the addition of cryogenic storage and a specialised packaging area for cell and gene therapies in our world-class Philadelphia, USA facility, and of course, the introduction of our award-winning Case Management Services in support of the critical cell and gene therapy supply chain. 

Meet Trish Demko, Director, Case Management Services

Trish has over 15 years of experience in Case Management facilitating bone marrow and stem cell transplant coordination across a global network, overseeing team productivity, quality, and maintaining excellence in customer service. Throughout the course of her career, she has acquired significant leadership experience, relationship management, programme and project management experience including Lean Six Sigma Green Belt certification. Currently working at Catalent, she launched and oversees Case Management Services, a patient-first focused supply chain offering to support cell and gene therapy customers.