Jeffrey S. Buguliskis, PhD

ARTICLES BY JEFFREY S. BUGULISKIS, PHD

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• BIOSECURE Act And The 8 Supply-Chain Lessons Sponsors Can't Ignore

  5/26/2026

  For sponsors rethinking China-exposed supply chains, BIOSECURE is less a warning label than a stress test for redundancy, oversight, data control, and operational resilience.

• At INTERPHEX 2026 A Smarter Outsourcing Playbook Comes Into Focus

  4/28/2026

  From AI explainability to geopolitical sourcing strategy, the Contract and Outsourcing Exchange Stage at Interphex 2026 delivered a clear message for drug sponsors: the days of passive, transactional CDMO relationships are over.

• Choosing The Right Outsourcing Model (CRO vs. CDMO vs. FSP)

  3/18/2026

  There are various outsourcing models in pharma—from CDMOs (for formulation/production) to CROs (for clinical trials) to FSPs (supplying specialized talent). Which is the right fit, and how do you choose? In this episode, editorial board member Tom Holmes talks about how to choose the right outsourcing model, balance speed-to-clinic, manage blended models, and course-correct midstream.

• Globalization vs. Localization: Where To Outsource In A Changing World

  3/18/2026

  Geographical strategy for outsourcing is a pressing issue: balancing historical global supply chains with current pressures to reshore/nearshore parts of operations. In this fireside chat, editorial board members Lynn Cinelli, and Kent Pryor help us navigate the geographical pressures of modern outsourcing, the root causes of global supply chain breakdowns, the hardest assets to move across regions, and whether time-sensitive sponsors should simplify their chain or hunt for best-in-class partners globally.

• Strategic CDMO Partnerships: From Vendor To Collaborative Partner

  3/18/2026

  Many pharma companies are shifting from one-off, fee-for-service deals to deeper long-term partnerships with their CDMOs, emphasizing shared goals and transparency. In this episode, editorial board members Doug Bakan and Kim Burson discuss how to transform the sponsor-CDMO dynamic.

• Six Specialized Modalities Testing CDMO Readiness In 2026

  2/27/2026

  As biopharma pipelines shift toward more complex therapies, sponsors are finding that CDMO readiness now depends less on general capacity and more on highly specific technical capabilities.

• End-To-End ADC Manufacturing Works Best With Active Sponsor Oversight

  2/6/2026

  ADC success is less about perfect execution and more about early signal detection, tight communication, and decisive governance.

• 7 Outsourcing Behaviors for 2026 That Will Protect Timelines

  12/29/2025

  Protecting manufacturing timelines in 2026 means converting speed from a hope into a contractual commitment through strategic prepayment, integrated partnerships, and formalized accountability.

• The Top 10 Nations Redrawing The Outsourcing Map

  12/8/2025

  There was a time when your outsourcing strategy could be managed with a simple spreadsheet and a focus on cost-per-liter. Those days are gone…

• How AI Is Rewriting Tech Transfer Timelines

  11/26/2025

  By replacing trial-and-error with virtual simulations and predictive analytics, AI is giving even small biotechs the process development capabilities once reserved for Big Pharma—and slashing tech transfer timelines in the process.

• The 9 Fastest-Growing Outsourcing Segments

  10/21/2025

  Capacity isn’t the choke point—capability is; this piece ranks nine fast-growing outsourcing segments and shows sponsors how to win by locking in modality-proven partners early.

• Cell & Gene Therapy Outsourcing's New Paradigm

  10/7/2025

  The industry has flipped from scarcity to surplus, and sponsors now have leverage to set terms, not take numbers.

• Clear The Outsourcing Runway: The 8 Largest Deals In The Past Year

  9/30/2025

  We ranked the past year’s eight biggest pharma–CDMO manufacturing deals and decoded what they signal for your next outsourcing project.

• Green Is The New KPI: Sustainability In Pharma Outsourcing

  9/10/2025

  Sustainability is moving from marketing to metering, as sponsors look for facility-level metrics and contract incentives that drive measurable improvement.