• IPSCs For Democratized Cell Therapy

    Dr. Daniel Teper and his team at Cytovia Therapeutics have developed a unique combination of candidates designed to improve access to safe and affordable "off-the-shelf" cell therapies. Founded just four years ago, the company is preparing multiple clinical trials of IPSC-derived therapies, which Dr. Teper says lend to a consistent, scalable manufacturing process. 

Differentiation Via Developmental Difficulty

By way of its business strategy, Context Therapeutics willfully embraces difficult breast, ovarian, and endometrial oncology development projects. That’s what creates differentiation and value in a therapeutic area that’s desperately lacking both, says VC-turned-CEO Martin Lehr.

Will Anellovirus Vectors Solve Immunogenicity Challenges?

Ring Therapeutics is building a first-of-its-kind viral vector platform based on a commensal virus that flies under the immune system’s radar. If its odds-beating CEO is any indication of its success, the company just might beat the immunogenicity challenge.

Engineering Antibodies To Suppress Severe Allergic Reactions

Dr. Jessica Grossman’s life’s work has been dedicated to women’s health, maternal health, family health, and inspiring the advance of female leadership in life sciences. She’s paving that path in her current role as CEO at IgGenix, which is pioneering genomically-engineered antibodies for the treatment of severe allergies.

How To Build A Genomic Medicine Biotech

SparingVision CEO Stephane Boissel took the reins of a fledgling, single-asset gene therapy company born of academic research and quickly built a well-funded startup with a deepening pipeline of ocular disease candidates. He told the Business of Biotech how it happened.


  • FDA Updates Guidance For Investigating OOS Test Results for Pharma Production

    FDA's CDER has released a guidance sharing the agency's recommendations on how to evaluate out-of-specification (OOS) test results, including the responsibilities of lab personnel, the lab phase of the investigation, additional testing that may be necessary, when to expand the investigation outside the lab, and the final evaluation of all test results.

  • Why Russia's Invasion Of Ukraine Threatens Our Life Science Ecosystem

    I posit that only pluralistic democracies committed to the rule of law can support the kind of investment and innovation our industry requires to thrive, while autocracies can’t make the same claim.

  • FDA Proposes Benefit-Risk Considerations For Product Quality Assessments

    The FDA recently released for public comment Benefit-Risk Considerations for Product Quality Assessments: Guidance for Industry. Mark Durivage breaks down the guidance and how the FDA considers and assesses risks, sources of uncertainty, and possible mitigation strategies for product quality-related issues and how unresolved product quality issues may be addressed.

  • How To Navigate The Patenting Challenges Of AI-Assisted Drug Discovery

    With “low hanging fruit” drugs already in the market, biopharma companies are finding it more difficult to discover the next blockbuster treatment. Artificial intelligence (AI) has become a new arrow in the drug discovery quiver. But how do you patent AI-assisted drug discovery? Attorneys from Haynes Boone provide recommendations.

  • 2022 Outsourcing Trends In Biopharmaceutical Manufacturing

    The continued focus on productivity and efficiency is moving manufacturers to increasingly consider outsourcing activities. Biomanufacturers are spending more, demanding better technologies, and expressing greater optimism. This article shares the trends in outsourced activities, percentages of activities outsourced, outsourcing destinations, and offshoring.

  • FDA Publishes Guidance For Biopharma Container And Carton Label Design

    The scope of this new FDA guidance includes prescription drug products marketed under an approved NDA or ANDA, prescription drugs marketed without an approved application, and biological products marketed under an approved BLA, but the principles may apply to OTC, compounded, or investigational products.

  • How To Test Master Cell Banks As A Starting Material For Gene Therapies

    BioPhorum’s Cell and Gene Therapy Raw Materials team suggests a platform approach for testing a critical starting material for gene therapies – master cell banks (MCBs). This can ultimately influence and/or aid regulatory agencies when developing guidance or policies around gene therapy development and manufacturing.

  • Assessing Extractables & Leachables In Parenteral Drug Products

    Therapeutic complexity increases the potential risks associated with chemical composition of materials used for drug packaging. Leachables in drug or biological products are chemical compounds that originate from components that are used to store and deliver medicines. Extractables should be considered as potential leachables.





From setting up and implementing a QRM program to objectively measuring your risk appetite and risk tolerances to proving sound risk management through factory and site acceptance testing (FAT and SAT), this e-book offers a collection of fresh insights from biopharma risk mitigation experts to help guide your risk management strategy.

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