From The Editor

  1. Adaptive, Precision Trials Change The Clinical Paradigm 11/8/2021

    Allan Shaw doesn’t just lament the incredible cost and encumbrance of traditional randomized, controlled trials. He has strong opinions on a path forward that’s more efficient for biopharma businesses and more effective for patient populations.

  2. Navigating CDMO Capacities & Capabilities 11/3/2021

    There’s never been more outsourced manufacturing capacity in play and in process, and it’s still not nearly enough to meet advanced therapeutic manufacturing demand. It’s an awfully tricky time to pick outsourcing partners and meet timelines.

  3. AION Labs’ Challenge To AI Drug Development Innovators 11/1/2021

    AstraZeneca, Merck, Pfizer, The Israel Biotech Fund, BioMed X Institute, Teva Pharmaceuticals, and Amazon Web Services are teaming up to support the AION Labs mission to inspire innovation in AI-enabled drug discovery and development. Here’s how the consortium created collaboration among fierce competitors.

  4. Developability: Making Better Bets On Biologic Winners 10/25/2021

    Developability assessments are objective analyses of a molecule’s therapeutic potential, but their execution is as much art as it is science. AltruBio VP of Technical Development Gene Lee, Ph.D. shares his insight into when, why, and how to go about assessing CMC developability.

  5. Slippery Slope: Competitive Differentiation In Biopharma 10/12/2021

    When is it time for an emerging biopharma company to truly emerge, and what goes into its competitive positioning? Biopharma industry veteran Allan Shaw shares insight into developing a differentiation strategy on an increasingly crowded, and evermore complex playing field.

  6. Inside Aruvant’s Gene Therapy Manufacturing Strategy 10/7/2021

    To in-source or to outsource? That’s the question many a formative cell and gene therapy company faces, and it’s one that seldom yields a definitive or absolute answer. Aruvant Chief Technology Officer Palani Palaniappan, Ph.D. shares his company’s strategy, along with color commentary from Project Farma EVP Tony Khoury.

  7. mAb 2.0 For Psoriatic Arthritis 9/30/2021

    With its lead candidate AbGn-168H (Neihulizumab), AltruBio is also engaging T cell-mediated diseases and indications including solid organ transplant, acute graft versus host disease, steroid refractory acute graft versus host disease, and ulcerative colitis.

  8. Big Bio: Inside SILS’ New Stake In Biocon 9/18/2021

    The sum of government vaccine mandates and a pandemic that’s turning endemic make simple math out of a $5 billion big bio deal.

  9. 4 Keys To Winning FDA Breakthrough Therapy Designation 9/14/2021

    Agency filings require accuracy, dialog, order, and precision. We caught up with two biopharma regulatory experts who have seen breakthrough therapy designation success to get their firsthand advice on how to get it done.

  10. New ADC Linker Tech Shows Efficacy, Safety Advantages 9/8/2021

    Araris Biotech AG CEO and co-founder Dr. Philipp Spycher says his company’s linker technology eliminates the antibody engineering requirement, is more stable and efficacious, and requires far less drug payload than those currently in use. Now it’s building a pipeline and seeking partnerships.