OUR EXPERT NETWORK

• Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign

  The compendial 14-day sterility testing window exposes product and patient to numerous risks, but settling on a rapid alternative also presents its own set of challenges.

• Nanosystems And Rare Diseases: Opportunities And Limitations

  Nanosystems offer unique capabilities, enabling researchers to design precise, versatile delivery systems that address key challenges in rare diseases.

• The Potency Chains Of Events For mRNA/LNP Therapeutics

  Potency in mRNA/LNP therapies depends on two chains: manufacturing/cold chain integrity and complex in vivo delivery. Breakdowns at any step — from stability to translation — can limit efficacy and safety.

• How Informal FDA Feedback Is Quietly Driving RNA Capital Allocation

  Subtle FDA signals — especially in pre-IND talks — are quietly shaping RNA investment. Early regulatory feedback on CMC and comparability now drives how investors assess risk and allocate capital.

• From Pandemic Collaboration To Patent Litigation: BioNTech's Case Against Moderna

  BioNTech’s new lawsuit against Moderna highlights the intensifying post-COVID mRNA patent wars, as companies clash over vaccine design, delivery technologies, and the future of RNA therapeutics.