Articles by Ray Sison

1. CDMO Selection In Our Post-COVID World 10/28/2022

   In a post-pandemic world, we need to explore a broader view of our new reality. This article shares some of the concepts currently playing out in bio/pharmaceutical outsourcing that will impact your CDMO selection strategy. Additional discussion touches on how new outsourcing players will fit in and the path forward.

2. CDMO Selection: Can We Eliminate The On-Site Audit? 12/15/2020

   On-site capability assessments are an indispensable part of the CDMO selection process. But, due to travel restrictions brought about by the ongoing pandemic, supply chain professionals, as well as development and clinical stage biotech companies that outsource, have no choice but to rethink and re-evaluate this step of the process. 

3. One-Stop Shop Or Best of Breed? 3 CDMO Selection Case Studies 9/8/2020

   Following last week’s editorial by chief editor, Louis Garguilo, Ray Sison, xCell Strategic Consulting, has prepared three case studies and a detailed analysis of the best-of-breed and one-stop-shop outsourcing models. Learn to define a strategy that best fits your product requirements and aligns with your corporate objectives.

4. 2 Things Every Emerging Biopharma Needs To Know About Supply Chain 5/8/2020

   For clinicians on the front lines with potential effective therapies who are exploring how to develop new drug products, as well as development-stage companies looking to manage clinical supply chains and transform their organization for product launch, a basic framework is needed in order to integrate supply chain operation into a business strategy.

5. CDMO Selection: How To Kick Off A Game-Winning Project 11/1/2019

   This article explores the execution phase of outsourcing with a focus on the context and planning of the kickoff meeting. At this meeting, the handoff from the existing procurement team to the operations team will require close attention.

6. Negotiating Quality Technical Agreements: Strategies for Non-Quality Professionals 8/20/2019

   Of the four critical documents that must be negotiated and executed by both sponsor and CDMO (NDA, quotation, MSA/SA, and QTA), the QTA is often the least-prioritized by the procurement team. Yet, in practice, the QTA will be the most useful for development- and clinical-stage companies, because it provides a framework for operations and a road map for building quality systems.

7. How To Ace Your Next CDMO Capabilities Audit 6/18/2019

   Site visits require a significant investment of resources on the part of both a sponsor and its prospective CDMO, so swapping out the time required to prep, travel, meet, and follow up in favor of a two-hour teleconference is understandable … to a limited extent.

8. 3 Questions To Save Time And Reduce Stress When Reviewing A CDMO MSA 4/9/2019

   Whether because of unfamiliarity or lack of resources, master service or supply agreement (MSA) execution can be time consuming and difficult. 

9. Supplier Selection In The Time Of Brexit: How To Get It Right 2/14/2019

   Negotiating deals and supply agreements takes time, as does the logistics of tech transfer and moving materials. So risk management, timing, and terms are key success factors.

10. Early Formulation Development RFPs Made Easy 11/20/2018

    RFPs for early formulation development are different from tech transfers, clinical supplies, and other RFP strategies because the scope requirements need more flexibility to accommodate the unknowns of R&D.