Flex-filling and Temperature Controlled Distribution Solutions for Your Injectable Drug Product

Clinical Trials, Life Sciences, Pharma Manufacturing & Supply Chain, Pharmaceutical,
  • Wednesday, September 18, 2019
All small-, mid-size or virtual pharma companies bringing a new biotech drug candidate through clinical trial will be challenged by a myriad of complex technical, regulatory and logistical obstacles on their journey to commercialization.

In this webinar experts from Sharp Clinical and Berkshire Sterile Manufacturing will outline the optimal flow in that process, from sterile manufacturing and filling of vials, cartridges and syringes through to packaging and distribution solutions for small-, mid-size and virtual pharma companies.

Attendees will receive an overview of the various multi-container, flex-fill options for product candidates and the unique advantages of utilising 100 percent isolator technology, which removes the risk of human contamination from the filling and formulation process.

The speakers will discuss some of the complexities of shipping and distribution of clinical trial product, highlighting some of the potential risks — and the associated mitigations — to allow clinical professionals to plan the optimal movement of their temperature-controlled clinical supply.

In this webinar, attendees will learn about:

  • An overview of the optimal flow of drug products from manufacture through to distribution
  • Utilising a 100 percent isolator sterile filling solution for drug products
  • Multi-container options
  • Flex-fill process overview
  • Unique technical advantages
  • The potential risks & mitigations faced in shipping & distributing temperature-controlled drug products such as:
    • Transfer of materials under quarantine
    • Supply chain custody
    • Shipper and monitor qualifications

Speakers

http://Eric%20Sahns,%20Sharp%20Clinical%20Services

Eric Sahns, Distribution Manager, Sharp Clinical Services

Eric Sahns has over 20 years of management experience in everything from operations to logistics, the last four of which he has spent as Distribution Manager for Sharp Clinical Services. During his time at Sharp, Eric has successfully developed and managed a winning team that has achieved year-on-year improvements in both quality and on-time delivery for their clients.

Prior to joining Sharp Clinical Services, Eric served as Vice President of Operations for a leading third-party medical device company. He also has operational experience in roles including Value Stream Manager at a global medical device company. Eric is a graduate of Widener University in Philadelphia.

Message Presenter
http://Shawn%20Kinney,%20Berkshire%20Sterile%20Manufacturing

Shawn Kinney, PhD, MS, CEO, Berkshire Sterile Manufacturing

Dr. Shawn Kinney is a seasoned chief executive with a technical background and 30 years of experience in sterile drug manufacturing. He has expertise in developing safe and efficient filling of pre-filled syringes, vials and custom containers. At Berkshire Sterile, Dr. Kinney designed the first isolators to incorporate flexible fillers for small-batch manufacturing. Prior to establishing Berkshire Sterile Manufacturing, Inc. (BSM) in 2014, Dr. Kinney was the Founder and CEO of another contract manufacturing organization (CMO) that was purchased by AMRI in 2010.

Dr. Kinney holds a Doctorate in Analytical Chemistry from the University of Massachusetts at Amherst, an MS in Medicinal Chemistry from Northeastern University and a Bachelor of Science from Southeastern Massachusetts University.

Message Presenter

Who Should Attend?

This webinar is intended for VPs, Directors and Managers of:

  • Clinical Supply Chain
  • Clinical Logistics
  • Clinical Operations
  • Clinical Outsourcing
  • Project Management
  • Vendor Management
  • Clinical Research and Development
  • Manufacturing
  • Formulation
  • CMC Regulatory Affairs

What You Will Learn

In this webinar, attendees will learn about:

  • An overview of the optimal flow of drug products from manufacture through to distribution
  • Utilising a 100 percent isolator sterile filling solution for drug products
  • Multi-container options
  • Flex-fill process overview
  • Unique technical advantages
  • The potential risks & mitigations faced in shipping & distributing temperature-controlled drug products such as:
    • Transfer of materials under quarantine
    • Supply chain custody
    • Shipper and monitor qualifications

Xtalks Partner

Sharp Clinical Services

As a division of UDG plc., a global healthcare services company with a market cap of over €1 billion, Sharp Clinical Services is committed to helping our customers achieve clinical trial success. Our customized and tailored approach to your program is what makes Sharp different than the other clinical trial manufacturers and packagers in the industry. Our global project management process links our sites in Bethlehem, PA and Rhymney, UK and is focused on a tailored and flexible approach to your clinical trial through dedicated project management. At Sharp we are committed to serving our customers with the highest levels of excellence with on-time delivery rates of 99.9% and a global depot network of over 30 depots in every major region of the world. Our Clinical services include:

  • Analytical & Research
  • Formulation Development
  • In House Label Design & Printing
  • Clinical Manufacturing
  • Packaging & Labeling
  • IRT
  • Storage & Distribution

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