Industry Insights

  1. 10 Questions For “Make Vs. Buy” In Drug Development And Manufacturing

    The questions for “make vs. buy" raised by Bristol-Myers Squibb’s Christopher Sinko, SVP and Head of Product Development, are news because of this: Sinko reaffirms for us they remain cemented within the otherwise changing dynamics impacting drug development and manufacturing outsourcing decisions.

  2. Transforming Next-Gen Therapy Supply Chains Into Patient-Connected Value Chains

    Cell, gene, and other emerging therapies are distinctly different from traditional biopharma products. Every lot is for a named patient or small population of patients, and that lot drives direct uplift on the bottom line. Traditional supply chain management does not necessarily create patient value in emerging therapy value chains. Operations should be the backbone of a distribution model that delivers these products efficiently and effectively over the last few yards.

  3. Off-Site Modular Fabrication Of Biopharma Facilities — What You Need To Know

    Measurable benefits of off-site module construction are becoming more evident, and it is emerging as a viable method for delivering a greater degree of predictability. Furthermore, market constraints driven by shortages of craft labor, lagging productivity, project complexity, and competitive forces are contributing to biopharma’s move toward modularization.

  4. Cost Of Healthcare And Biopharma Implications

    The pharmaceutical industry’s success has become something of a double-edged sword, and our healthcare systems are burdened with the costs of lifestyle challenges. Everyday businesses and healthcare professionals must work diligently to improve our quality of life, but pricing and access will continue to be a battle globally that the industry must take note of.

  5. Trends In Single-Use System Adoption In The Biopharma Industry

    Upstream bioprocessing at large and commercial scales is projected to be the fastest growing segment of the single-use equipment market as products now in development using SUS move up to commercial manufacturing. In addition, as cellular and gene therapies emerge, we will likely see SUS technologies created and adapted explicitly for these personalized applications.

  6. 10 Tips For Western Blot Detection Of Phosphorylation Events

    The ability to interrogate protein phosphorylation events and aberrant phosphorylation levels is critical to our understanding of various biological and pathological processes, particularly in the research of diseases, like cancer. However, detection of phosphorylated proteins in western blots can be challenging. Following are ten tips to ensure robust data generation and cleaner blots.

  7. The Parameters That Matter In Cryopreservation And Cell Thawing Process Development

    Which parameters really matter for cell therapy process development? G. John Morris, CEO Asymptote, part of GE Healthcare Life Sciences discusses the evidence in this blog post.

  8. The Current Landscape For Developing Biosimilars In India

    As India’s biosimilar market moves toward a promising future, it is important to gain an overview of the current regulatory and clinical expectations in India for biosimilar products.

  9. Virtual Patient Registries: Real-World Evidence For Cell And Gene Therapies

    In recent years, cell and gene therapies have been generating highly promising results in clinical studies, advancing them toward the market. However, the small number of products launched to date have not been proven commercial successes, with a number of advanced therapies being withdrawn from the EU market and limited sales of CAR-T therapies in the U.S.

  10. Establishing Data Models To Support Cell And Gene Therapy Adoption

    Cell and gene therapy offers extended-term relief from disease states but comes at high cost with a complex reimbursement model. What proportion of intervention costs should be levied up front, and what proportion can be phased into the future (when the patient benefits accrue and are proven)? Separating the payment timeline from the treatment schedule is often referred to as outcome-based costing.