News

• CDMO Selection: Can We Eliminate the On-Site Audit?

  December 2020

  On-site capability assessments are an indispensable part of the CDMO selection process.Travel restrictions brought about by the pandemic makes us rethink this step. Ray Sison evaluates the trade-offs in virtual vs. on-site capability audits which may change the way audits are done in the future.

  
  
  

• Pfizer, Moderna Ready Vaccine Manufacturing Networks

  November 2020

  As expedited regulatory review of COVID-19 vaccines based on mRNA technology gets underway, Peter Bigelow warns that ramping up production to meet demand in the months ahead will prove challenging.

  
  
  

• Pharmaceutical Services Firm Resilience Debuts, With Questions

  November 2020

  Peter Bigelow comments on the launch of a venture-backed biopharmaceutical manufacturing services firm.

  
  
  

• One Stop Shop or Best of Breed

  September 2020

  Ray Sison outlines three case studies and offers a detailed analysis of the best-of-breed and one-stop-shop outsourcing models.

  
  
  

• 2 Things Every Emerging Biopharma Needs to Know About Supply Chain

  May 2020

  Ray Sison advises that clinicians and development-stage companies looking to transform their organization need to design a framework to integrate supply chain operations into a business strategy.

  
  
  

• CDMO Selection: How to Kick-Off A Game-Winning Project

  November 2019

  Ray Sison explores the execution phase of outsourcing with a focus on the context and planning of the kickoff meeting where the handoff from the existing procurement team to the operations team will require close attention.

  
  
  

• Negotiating Quality Technical Agreements

  August 2019

  Of the four critical documents that must be negotiated and executed by both sponsor and CDMO, the QTA is often the least-prioritized by the procurement team. Yet, in practice, Ray Sison believes the QTA will be the most useful because it provides a framework for operations and a road map for building quality systems.

  
  
  

• How to Ace Your Next CDMO Capabilities Audit

  June 2019

  A capabilities audit is an integral part of a sponsor's due diligence in vendor procurement according to Ray Sison. It is often the sponsor’s first exposure to a CDMO’s operations, and the primary objectives are to evaluate the facility, equipment, quality systems and the expertise of each functional team.

  
  
  

• CDMO Selection: 3 Questions to Save Time and Reduce Stress When Reviewing an MSA

  April 2019

  Ray Sison advises that you must first understand that an MSA is not a novel, read from front to back. It is a functional legal document that provides operational, financial and legal guidance that will be referenced throughout the term of the agreement.

  
  
  

• Supplier Selection in the Time of Brexit: How to Get It Right

  February 2019

  Ray Sison reminds us that the best way to mitigate disruption is to more heavily weigh finding alternate ex-U.K. suppliers versus waiting it out.

  
  
  

• Early Formulation Development RFPs Made Easy

  November 2018

  Ray Sison cautions that 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.

  
  
  

• Clinical Packaging RFPs Made Easy

  September 2018

  Managing clinical supplies is hard according to Ray Sison.

  Clinical supplies management sits at the intersection of multiple disciplines, each with its unique perspectives and priorities. Clinical packaging is critical to the success of a program and a company, and an effective request for proposal (RFP) will guide you to the right packaging partner for your journey to product approval.

  
  
  

• 3 Easy Questions Every Pharma Outsourcing RFP Should Answer

  July 2018

  Ray Sison believes that 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?

  April 2018

  Ray Sison, discusses why 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.

  
  
  

• Compelling Reasons to Partner with CDMOs

  February 2018

  The past decades have seen a maturation of the Contract Development and Manufacturing Organization (CDMO) business and an increased level of collaboration between pharmaceutical companies and CDMOs.  Peter Bigelow explains why. 

  
  
  

• 10 Simple Steps to Selecting the Right CMO

  November 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, Ray Sison believes that exactly the opposite is true.
   

  
  
  

• Building Strong CDMO Contracts

  July 2017

  Peter Bigelow offers up sound advice  on how to build strong CDMO contracts. He believes a strong personal relationship, backed by a legal framework that clearly lays out the rules and expectations, results in business arrangements that meet the needs of both parties in the long run.

  
  
  

• Bigelow Presents at CPhI Conference

  October 2016

  Peter Bigelow, President, presented "Assessing Risk and Building Supply Chain Reliability or The 8 Habits of World Class Supply Chains" at the 2016 CPhI Conference held in Barcelona, Spain, October 4 - 6.  Principals Ray Sison and Balu Balasubramanian also attended the industry event, which brings together more than 36,000 pharma industry professionals from over 150 countries.

  

  
  
  

• Bigelow Predicts 2017 to be a Break-Out Year for CDMOs

  December 2016

  Peter Bigelow, President, predicts that the CDMO industry will continue to consolidate and mature, which will drive pharmaceutical companies to be receptive to partnering. He forecasts that 2017 will be a break out year for the types of partnering contracts that are signed. Read his industry insights in the December 19, 2016 issue of Outsourced Pharma.

  
  
  

• Principals Play Integral Role on ISPE Drug Shortage Prevention Steering Committee

  November 2015

  xCell Strategic Consulting members are key players on the ISPE Drug Shortage Steering Committee and were document review contributors to the comprehensive tool for assessment of preparedness for preventing drug shortages of important medicines recently released by the organization’s Drug Shortage Prevention Task Force.  This tool builds on the ISPE Drug Shortage Prevention Plan and has had input from many members of the ISPE and regulators worldwide.  The document is free to ISPE members.

  
  
  

• Executives Moderate Sessions at Outsourced Pharma West

  November 2015

  Peter Bigelow, President, and Balu Balsubramanian, Principal, of xCell Strategic Consulting served as panelists at the second annual Outsourced Pharma West Conference held in San Francisco. This meeting brought together many drug development companies with CROs, CDMOs and industry experts to discuss partnering best practices and industry trends.  Bigelow moderated two panels – “Project Management and Your Outsourcing Partner” and “Strategies for Getting to Your First GMP Batch.”  Balasubramanian served as a panelist on a session titled, “Getting Real: How Much is Outsourcing My Project Going to Cost.”

  
  
  

• President to Serve as PBOA Chairman of the Board of Trustees

  October 29, 2014

  Peter Bigelow, President of xCell Strategic Consulting, has been elected to serve a two year term as Chairman of the Board of Trustees of the Pharma & Biopharma Outsourcing Association (PBOA).

   

  The PBOA is a non-profit trade association that will help advance the regulatory, legislative and business interests of Contract Manufacturing Organizations and Contract Development and Manufacturing Organizations (CMOs/CDMOs).  Members represent large and small molecules, APIs to finished dosage forms, and cover the gamut from single-site to multi-national companies.

   

  In his role as Chairman of the Board of Trustees, Peter will work with the Board and with PBOA President Gil Roth to develop the PBOA’s agenda, represent the association in its regulatory, legislative and business mission, and serve as liaison between the Board and member companies.

  
  
  

• Executives Attend Ground Breaking Event in United Arab Emirates

  September 17, 2014
  Life Pharma, FZE, a privately held pharmaceutical company based in the United Arab Emirates, breaks ground on a new oncology product manufacturing facility in Kizad, U.A.E. The groundbreaking ceremony represents an exciting milestone for the growth of Life Pharma. Peter Bigelow and Balu Balusubmaranian serve on the Board of Directors of Life Pharma, FZE and as advisors to the company. They attended the groundbreaking ceremony along with a number of Life Pharma executives and United Arab Emirates government officials.
   

  

  
  
  

• Principal Honored at Daiichi Sankyo in Bethlehem, PA

  August 13, 2014
  Jim Robinson, Principal, and Peter Bigelow, President, xCell Strategic Consulting, participated in a ceremony to welcome Hal Lewis as new Plant Director for Daiichi Sanyo Bethlehem Operations.  Jim Robinson was honored for his service as Interim Plant Director.  A celebration was held to honor Jim at an all-hands meeting that included employees and executives of Daiichi Sankyo Bethlehem.

   

  

  
  
  

• Executives Conduct Webinar

  July 22, 2014
  Peter Bigelow, CEO, and Craig Seyfried, Principal, xCell Strategic Consulting, conducted a Webinar sponsored by the Life Science Training Institute titled: The Seven Characteristics of World Class Supply Chains.

  
  
  

Events