In this webinar, Sharp and BSM will offer their combined experience in optimizing supply chains during the process of bringing a biologic drug product through formulation to clinic. Panelists will give an overview of each of the steps involved, as well as give guidance and advice in what pitfalls to avoid. Harmonizing processes between supply chain partners is critical to success. Panelists will discuss each step on the journey to clinic, from formulation, fill and lyophilization through to quality testing, stability, primary and secondary packaging as well as distribution and QP release.
Speakers
Sascha Sonnenberg, Global Head of Business Development, Sharp Clinical Services
Sascha Sonnenberg joined Sharp Clinical in September 2019 as Global Head of Business Development supporting Sharps strategy for growth in the Clinical Trial market. Before joining Sharp, he held management positions at Marken and Faubel Pharma Services overseeing global operations and business development activities.
Sonnenberg is an active member of the ISPE Community of Practice on Investigational Products where he is a co-author of the Good Practice Guide for Booklet Labels in Clinical Trials and currently leads a task team developing a Good Practice Guide on Patient Centric Logistics/direct to patient Services.
Sascha Sonnenberg is the author of various articles such as “Managing the Complexity of the Supply Chain for Cell & Gene Therapies” and “Preparing Clinical Trial Logistics for a No-Deal-Brexit”.
Sonnenberg studied economics at the University of Kassel in the field of marketing and completed his MBA with Summa Cum Laude at the Kassel International Management School with an emphasis on international business and management.
Message Presenter
Andrea Wagner, PhD, Senior Vice President of Business Development, Berkshire Sterile Manufacturing
Dr. Andrea Wagner is a cofounder of Berkshire Sterile Manufacturing. She successfully grew the company to an industry leader in small batch sterile fill finish by effectively developing unique isolator based flexible fillers to fulfill an unanswered demand in the market. Her role today involves closely monitoring the coordination of engineering, quality, manufacturing and project management teams to meet the constantly changing customer requirements and critical deadlines, managing sales and client relationships, and effecting pivotal decisions to the growth of the company to meet market needs.
Dr. Wagner holds a Doctorate in Environmental Health and Toxicology from the State University of New York at Albany (SUNY), an MS in Analytical Chemistry from the University of Vermont and a Bachelor of Science from Northern Arizona University.
Message PresenterWho Should Attend?
Managers, Directors, Leads or Heads of:
- Clinical Operations
- Clinical Outsourcing
- Clinical Supply/Planning
- Clinical Research
- Clinical Trial Design
- CMC
- Label Development and Regulatory Vetting
- Local and Global Distribution
- Logistics
- Program/Project Management
What You Will Learn
In this webinar, the panelists will discuss challenges to overcome when setting up a clinical supply chain for biological drug products, including:
- Mapping out the supply chain
- What areas need to be covered
- How to identify the right vendor(s) and how can they best be supportive
- Pitfalls to avoid
Xtalks Partner
Sharp Clinical Services
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
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