From The Editor

1. 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.

2. 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.

3. 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.

4. Inside KKNA’s Uncommon D&I Success 9/1/2021

   How Kyowa Kirin North America is strategically leveraging an incredible growth spurt to fuel its diversity & inclusion initiatives, attracting and retaining biotech talent that’s as diverse as its therapeutic portfolio.

5. Resetting The Immune System With Protein Therapeutics 8/26/2021

   Revolo Biotherapeutics is reaching for its share of the massive autoimmune disorder and allergy markets with novel protein-based therapies designed to reset the immune system. CEO Jonathan Rigby sat down with us on the heels of an IND approval for Revolo’s fourth Phase 2 clinical trial.

6. Alzheimer’s Therapy Takes A Cue From Oncology 8/19/2021

   INmune Bio CEO RJ Tesi, M.D. shares strong opinions on the Agency’s Aducanumab ruling, his belief in the promise of protein biologics that decrease neuroinflammation by targeting TNF, and why his company is mimicking the oncology space in its R&D and clinical approaches.

7. Cell Therapy Logistics: Challenged By COVID-19 8/18/2021

   Kite Pharma was in the midst of a global cell therapy manufacturing expansion initiative when the first wave of the COVID-19 pandemic hit. This conversation with Charles Calderaro covers challenges faced scaling cell therapy manufacturing and accessibility worldwide and how Kite is developing competitive advantage in a nascent space.

8. The Precarious Promise Of Biopharma PR 8/4/2021

   Matt Middleman, MD has made a career and built a company out of guiding emerging biopharma companies to the public relations promised land. On a recent episode of the Business of Biotech podcast, he discussed the value of the good, the peril of the bad, and offered insight for biopharma PR rookies.

9. Physics To Genetics: New Treatments For Hereditary Heart Disease 7/28/2021

   As CMO at gene therapy startup Renovacor, Dr. Marc Semigran is adding another layer to a deep career spent addressing physical, pharmacological, and now genetic approaches to treating cardiac disease.

10. Developing A Cure For Diabetes Type 1 7/21/2021

    Ulf Hannelius, Ph.D. is leading a charge at Diamyd Medical with a singular mission: curing type 1 diabetes. The Business of Biotech caught up with him for deep dive into the company’s progress.