November 2023 Issue Table Of Contents

From The Editor

• A Family Affair

Feature Articles

• The Power Couple Behind Krystal Biotech
• Building A Business Suma Model For Novel Antibiotics

Companies To Watch

• Freya Biosciences

Industry Research

• CDMO Engagement Timeline For Gene Therapy

Podcast Summary

• Data-Driven Biopharma Leadership

Inside The Industry

• AI & ML: A Review Of EMA And FDA’s Approach
• Heading Back Home To The Heart
• 4 Ways To Gain A Competitive Edge In This Bio/Pharma Talent Shortage
• AI Predictions From The CPHI Annual Report  
• The Power Of Decision Planning
• Understanding The FDA’s Current Focus On REMS
• An Overview Of The 9 FDA Special Designations For Pipeline Drugs
• Navigating The Complexities Of Research In Private Practice
• Patent Term In Peril
• Pfizer To Provide Individual Participant Data At Scale

Industry Leader

• How Prioritizing OpEx Can Raise Sinking Biopharma Valuations

Ask The Board

• What New Technologies Offer The Most Promise For Improving Global Supply Chain Operations?
• In September, You Testified Before Congress On The Inflation Reduction Act’s (IRA) Real-World Impact On Rare Disease R&D And Small Molecule Therapies. Can You Summarize The Key Points?