ARTICLES BY RAY SISON

• 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. 

• 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.

• 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.

• 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.

• 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.

• 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. 

• 3 Easy Questions Every Pharma Outsourcing RFP Should Answer

  7/10/2018

  In pharma outsourcing, RFP templates are a time-saving and efficient tool to initiate and control a bidding process. They allow sponsors to collect comparable proposals that create leverage for negotiation.

• CMO Selection: Are You Qualified?

  4/3/2018

  Proactive companies and professionals tasked with procuring CMO services for difficult-to-place projects must become advocates to overcome barriers with a strategized approach and compelling narrative.

• 10 Simple Steps To Selecting The Right CMO

  11/28/2017

  Contrary to how it sounds, controlling information is not about withholding key documents or facts that are relevant to the CMO bidding process to see how the bidders react, or only supplying pertinent information if requested. In fact, it is exactly the opposite is true.