Articles by Jeffrey S. Buguliskis, PhD

  1. Five Raw Material Assumptions That Can Derail Your Outsourced Program 10/8/2026

    From supplier substitutions to release testing, raw-material decisions deserve the same sponsor scrutiny as the CDMOs that manufacture them.

  2. Calculating Outbreaks Early Through Advanced Surveillance 10/5/2026

    Effective outbreak response begins long before a vaccine or therapeutic enters manufacturing; it relies on early detection of emerging pathogens and continuous surveillance during quiet periods. In this episode of Outsourcing Against the Outbreak, Dr. Al Ozonoff, Associate Professor of Pediatrics at Harvard Medical School and Senior Director of Pandemic Preparedness at the Broad Institute, discusses how biostatistics and mathematical modeling power global disease surveillance. The conversation explores the Sentinel program, an international early-warning framework co-led with Nigeria's Institute of Genomics and Global Health, and how its genomic surveillance model was tested during the 2025 Mpox outbreak in Sierra Leone. Dr. Ozonoff details the logistical and governance realities of expanding surveillance capabilities across Africa, why biopharma developers must engage local partners prior to a crisis, and how transferring technology and source code to national institutions creates long-term, sustainable public health infrastructure.

  3. Your CDMO Can Make It, But Can Your Market Afford It? 10/2/2026

    From formulation and packaging to partner selection, early outsourcing decisions help determine whether a medicine can reach patients at a cost the market can sustain.

  4. Is AI Revolutionizing Outsourced Drug Manufacturing? 9/16/2026

    Is AI REALLY revolutionizing outsourced drug manufacturing, or are we still sorting useful tools from industry hype? In this episode of The Outsourcing Advisor, Bikash Chatterjee, President and Chief Science Officer of Pharmatech Associates and a member of the Outsourced Pharma Editorial Board, joins us for a fast-paced game of “AI Hype, Help, or Hazard?” He puts real-world use cases to the test, from CDMO selection and tech transfer to manufacturing, regulatory work, supply chain decisions, and partner oversight, to see where AI is delivering value today and where sponsors should still proceed with caution.

  5. Expanding Global Access Through Voluntary Licensing and Tech Transfer 8/25/2026

    Turning patented biomedical discoveries into affordable, widely available treatments requires aligned partnerships between innovator pharma and regional generic manufacturers. In this episode of Outsourcing Against the Outbreak, Charles Gore, Executive Director of the Medicines Patent Pool (MPP), breaks down how voluntary licensing models expand access across low- and middle-income markets.

  6. Advancing Academic Vaccine Innovation into Global Access 8/25/2026

    Moving infectious disease programs from promising laboratory discoveries to scalable interventions requires bridging the gap between academic research and commercial manufacturing. In this episode of Outsourcing Against the Outbreak, Dr. Maria Elena Bottazzi, Co-Director of the Texas Children's Hospital Center for Vaccine Development at Baylor College of Medicine, explores how academic teams can navigate this journey successfully.

  7. Great Science Isn't Enough: Solving The Global Health Drug Development Equation 8/25/2026

    Designing infectious disease interventions for low- and middle-income countries requires solving for access, affordability, and delivery from day one rather than treating them as downstream afterthoughts. In this inaugural episode of Outsourcing Against the Outbreak, Dr. Krishnan Ramanathan, Interim CEO of the Gates Medical Research Institute (Gates MRI), explores how to navigate the unique economic and operational realities of global health R&D.

  8. For Bispecific Ab Programs, Measure Twice And Outsource Once 8/19/2026

    Just like inspecting a house before a major renovation, biopharmas must address underlying bispecific structural and analytical flaws before handing their molecule off to a CDMO.

  9. Effective Sponsor–CDMO Collaboration and Communication 7/30/2026

    Effective sponsor–CDMO collaboration relies on clear communication, shared expectations, and proactive problem-solving. In this episode, guest panelists Stella Vnook, Co-founder and Executive Board Chair, Kaida BioPharma, and Allison Vavala, Senior Director for Business Development, Flamma Group, explore what makes these operating relationships work. The discussion covers building strong day-to-day partnerships, establishing practical meeting cadences, and setting transparent goals from the start. The panel also takes a fun look at common industry phrases like "we need flexibility on timelines" and "can you just take a quick look?" in order to help sponsors and CDMOs better align, prevent miscommunication, and solve technical challenges jointly.

  10. Oligonucleotide Scale-Up: Six Things Every Sponsor Needs To Know 6/24/2026

    From impurity control to technology transfer governance, these practical lessons will help sponsors navigate the realities of oligonucleotide manufacturing scale-up.