Chris Spivey

This inaugural edition of the Pivotal Paper series features leading vaccine experts discussing a groundbreaking study on next-generation self-replicating RNA (srRNA) vaccine technology. The panel explores the study’s key findings, highlighting srRNA’s potential for lower-dose, single-dose vaccines with enhanced immune response, expanding the applications beyond infectious diseases.

Vector Bioscience Cambridge is developing highly porous nanomaterials that can help reduce toxicities due to the small amount of vehicle material.

William Oh, MD, led a panel discussion during which the practicalities of incorporating AI tools into the daily workflow of busy clinicians were discussed.

Eswar Iyer, MS, PhD, CEO and co-founder at Aikium Inc., describes a tool to overpower the data paucity problem in proteins.

Hood, a pioneer of systems biology and systems medicine, shared his personal interest in starting a new peptide-based, informational-driven pharmaceutical company that would address wellness and longevity during an interview with BioPharm Internaltion at the Precision Medicine World Conference.

Jane True, Dr Andreas Kuhn, and Dr Andy Geall discuss mRNA risks, costs, effectiveness, manufacturing logistics, public messaging, and regulatory challenges.

Jane True, Dr Andreas Kuhn, and Dr Andy Geall discuss mRNA risks, costs, effectiveness, manufacturing logistics, public messaging, and regulatory challenges.

Jane True, Dr Andreas Kuhn, and Dr Andy Geall discuss mRNA risks, costs, effectiveness, manufacturing logistics, public messaging, and regulatory challenges.

Vanessa Almendro, Elliot Berger, Benjamin McCloud, and Turna Ray go behind the headlines to discuss their ‘wish list’ for the progression of trends in the bio/pharmaceutical industry.

Sustained investment, technological innovation, and collaboration are essential to future pandemic preparedness.

Strategies to combat vaccine hesitancy and ensure equitable global vaccine distribution are explored amidst declining confidence.

Advances in surveillance, including AI and wastewater monitoring, are critical to detecting and responding to emerging pathogens.

Sustaining pandemic readiness requires investment in workforce, infrastructure, and scalable manufacturing practices.

Empowering the public with balanced information and enhancing agency alignment are central to navigating public health crises effectively.

The panel covers the benefits and challenges of a unified government pandemic response, focusing on transparency and trust-building.

Lessons from the COVID-19 response highlight regulatory collaboration, research expansion, and challenges in vaccine access and preparedness.

The panelists introduce themselves and outline key aspects of pandemic preparedness, emphasizing global collaboration and coordinated responses.

Addressing manufacturing at scale for ATMP’s. Reducing costs through reducing batch failures and shrinking footprints, and targeting more focused critical quality attributes for potency but also patient efficacy. Reducing regulatory uncertainty in an uncertain environment to increase patient access to life saving cures.

Optimizing analytics, including laser force cytology, with a goal to delivering adaptive manufacturing, full automation and standardized processes, products and patient outcomes.

Looking ahead 5-10 years for in vivo practice. Combined platform and modalities marriages, to bring CGT up to first relapse or consolidation therapies.

Repairing nucleotide abnormalities for rare disease populations as pivotal proving grounds for transformative therapies.

Popular new delivery vectors, and some not fully appreciated like Non-AAV parvoviruses or Herpes Simplex virus. Are we in a transition state, where there is a growing a trend away from Viral Vectors? How do we best regulate CRISPR?

Standardization leading to CGT therapies becoming a standard of care. Importance to outcomes of high-quality starting materials, to reducing batch-to-batch quality, and the possibilities of allogeneic chimeric antigen receptor therapy (CAR-T) successes.

Success and Challenges (Potholes) in Cell and Gene Therapy: automation, regulatory certainty, and standardizing manufacture processes such as vector constructs or Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) steps.

Frontage Laboratories' Marianna Tcherpakov, PhD, director of Business Development, CMC Services, discussed the CDMO’s role in enabling startup biotechs solve complex technical challenges for scale up.

Laks Pernenkil, Brian Feth, and Alex Philippidis go behind the headlines to discuss the impact of recent news, including FDA’s drug shortage list update, Nobel prize winners in microRNA and AI, and a big-potential research win for RNA editing.

Cell and gene therapy experts Fabian Gerlinghaus, Dr. Claudia Zylberberg, and Benjamin McLeod weigh in on hot topics in CGT.

Cell and gene therapy experts Fabian Gerlinghaus, Dr. Claudia Zylberberg, and Benjamin McLeod weigh in on hot topics in CGT.

Cell and gene therapy experts Fabian Gerlinghaus, Dr. Claudia Zylberberg, and Benjamin McLeod weigh in on hot topics in CGT.

During Bio 2024, Aaron Cowley, PhD, chief technical officer and co-founder, Captozyme, discussed the advancement in development of microbiome-derived therapeutics.