Pharmaceutical packaging capabilities are often constrained by the capital costs in rolling out new equipment and meeting flexible packaging production schedules. This is especially problematic when scaling up packaging activities from clinical to commercial as forecasts become more sophisticated and flexibility, collaboration and communication is necessary.

The journey from clinical operations to commercialisation possess a slew of challenges such as package design, documentation preparedness, capacity issues, general growth complications, internal culture, management maintenance, and standardizing a complicated operation for the mass market. Avoiding these pitfalls, in order to achieve efficiency and alleviate delays, requires subject matter expertise, a lean and continuous improvement mindset and the ability to form strategic partnerships.

This presentation will examine these scale-up challenges and suggest ways to best overcome them.

Keywords:

Speakers

John Hogan, Projects/Commercial Manager, Sharp

John started out his career in the medical device industry managing product lifecycle and new product introductions. From design and development lifecycles through feasibility, validation and eventually full production and ‘End of Life’ with companies such as Depuy, J&J and Boston Scientific.

John then ventured into the Oil and Gas industry, managing large scale construction and commissioning projects of LNG (Liquified Natural Gas) facilities. From FEED (Front End Engineering Design) right through to RFSU (Ready for Start-Up).

John has since returned to the life sciences industry with Sharp and has led the commercial expansion project to a successful conclusion and now manages the commercial portfolio for Sharp Clinical Services UK. With a background heavily influenced by projects, John sees the importance of a structured and planned approach, which is key to moving projects through lifecycle phases seamlessly.

Message Presenter

Nick Seibert, Account Executive, Sharp

Nick has worked within the pharmaceutical packaging industry for 10 years, working at Sharp for the entirety and holding different roles within the company. He started off in the quality department as an inspector, as well as responsible for investigating and authoring non-conformity reports. He transitioned to a supply chain role where he was customer-facing and responsible for daily account activities. Nick’s current focus as an Account Executive is B2B sales, new business development and relationship management. His experiences touching on the entire lifecycle of a product at Sharp has helped him to provide a holistic viewpoint for customers to benefit from in the short and long term.

Message Presenter

Who Should Attend?

Small/virtual, medium & large pharma
Trial sponsors, particularly those at late stage II-III of trial
Clinical and commercial teams

Managers, directors, leads or heads of:

Packaging development / design
Supply chain / Supply chain planning / Supply chain management
Program management
External supply
Operations / Manufacturing operations / External operations
Outsourcing / Purchasing / Procurement
Vendor management

CMC
Clinical project managers
Clinical Outsourcing
Clinical trial design

What You Will Learn

The internal & external forces impacting the scaling of clinical and commercial drug and how to alleviate these issues
The different aspects to consider at the clinical stage that will save time and money at commercial scale up
What key technologies to consider to help complement clinical trials on the path towards commercialisation.

Xtalks Partner

Sharp

Sharp, part of UDG healthcare, is a global leader in contract pharmaceutical packaging and advanced clinical supply chain services. Offering solutions and support to pharma and biotech clients from phase I trials all the way through to rapid launch and commercialization. The organisation has state-of-the-art facilities in the United States, United Kingdom, Belgium and the Netherlands and over 32 clinical depots globally, covering every region of the world.

Our full complement of integrated services includes: analytical, formulation development, clinical manufacturing & packaging, clinical IRT, blister packaging, bottling, secondary assembly and labelling of injectable presentations, compliance packaging, as well as storage and distribution. Sharp also offers Qualified Person (QP) services for European distribution.