Outsourced Pharma Webinars

1. Key Considerations When Outsourcing An Aseptic Fill/ Finish Project To A CMO Partner 9/8/2020

   In this presentation, we discuss key elements to consider when choosing to outsource drug production. We will cover the importance of seeking the right partnerships to help overcome complex challenges and Samsung Biologics’ responsibility to leverage capabilities, optimize process efficiency, assure successful delivery, and provide the assurance of secure commercial product supply.

2. Get To IND Faster 9/1/2020

   Expediting development timeline is directly related to obtaining IND clearance and starting phase 1 study faster. This webinar describes how you can get to IND faster through our accelerated & high performance proprietary cell line. We will present our 3 month cell line development timeline and high quality cell line with outstanding productivity. We hope to share how our Faster & Better approach, which can be applicable to your molecule's successful development path to IND.

3. Taking Digital Control Of Cell Therapy Logistics: An Advanced Therapy Treatment Centre Network Case Study 8/4/2020

   Within the manufacturing workflow there are two critical logistics steps 1) transport of the starting material to the manufacturing site and 2) return of the finished product to the treatment center. In this case study we describe work to establish and test a cryogenic logistics pathway for an allogeneic Advanced Therapy Medicinal Product (ATMP).

4. The Product Development Superhighway: Leveraging End-to-End Solutions For Market Success 7/24/2020

   Pharmaceutical and biotechnology companies value streamlined services from early-phase development to clinical supply services to commercialization. Get insights on how contracting with a single service provider can offer significant benefits to the customer through integrated expertise between the formulation development teams, the manufacturing teams, clinical supply specialists, and the packaging teams.

5. Gene To IND In 12 Months Without Increased Risk 7/23/2020

   Financial pressures, competition and current global healthcare events are driving the emphasis to move as quickly as possible into the clinic. Learn how to achieve speed while minimizing risk. 

6. Supply Chain Models For Global Trials: Singapore As The APAC Gateway To The World 7/21/2020

   With an increasing number of clinical studies being conducted in the Asia-Pacific (APAC) region, there is a growing need for streamlining import and export strategies and clinical supply support. Multiple factors, including positive changes in clinical research regulations, reduced costs to run trials, and large urban-centered populations are attracting sponsors to the region. Watch this webinar to get expert insight on using Singapore as a clinical supply hub.

7. Perceptions, Myths And New Thinking On Direct-To-Patient Clinical Supply 7/21/2020

   Direct-to-patient (DTP) distribution of clinical supplies provides trial sponsors with the opportunity to support improved recruitment and retention rates for their studies by removing or reducing the travel and time commitments that can otherwise inhibit patients’ willingness and ability to participate. Watch the webinar to learn about the results from a recent industry survey that sought to gain insight on trial sponsors’ perspective on offering a DTP option and their current level of awareness and understanding of any factors that may influence their ability to do so.

8. Innovative & Flexible Solutions For An E2E Patient Centric, Lean Clinical Supply Chain 7/21/2020

   For sponsors who are embracing the promise of patient-centric trials, new challenges are emerging, including how to transform the clinical supply chain from one that is relatively fixed and site-centric to one that has the flexibility to respond to changes in patient demand. This webinar will explore how recent innovations in forecasting, supply pooling, decentralized processing, labeling, demand-led supply, and direct-to-patient distribution are converging to create a next-generation clinical supply chain that is flexible, lean and most importantly patient-centric.

9. Beyond Brexit: What Now For Clinical Supply Across Europe? 7/10/2020

   After 3 years of Brexit withdrawal negotiations, the UK is officially no longer a member of the European Union. Clinical sponsors with active and planned studies in the EU and UK can be reassured that the UK will remain part of the current trade arrangements, customs union and single market until the end of the transition period on December 31, 2020. This panel presentation will explore the early analysis of potential Brexit challenges that sponsors face and the strategic solutions that can support sponsors in a post-Brexit world.

10. The Art Of Recognizing Clinical Supply Risk Factors 7/10/2020

    No two studies are the same and each clinical supply project carries unique risks. Experienced supply chain managers know that certain study characteristics are often leading indicators that they can anticipate a supply project will be complex in nature. Watch the webinar to learn about aspects of the study protocol that can directly influence clinical supply strategy.