In the era of seamless drug development, reducing time to
the clinic and getting rapid regulatory approval has become the goal of
nearly every early drug development sponsor. Handling drug
development, manufacturing, and clinical supply efficiently can help
sponsors save costs and provide maximum benefit for patients. To
improve the efficiency of the drug development continuum, integrated
solutions have become an effective option for sponsor companies to
streamline the transition from early development to the clinic, in
addition to providing timely clinical supplies to help keep study
timelines and budgets on track. Along with a discussion, examples of
real-life tactical and operational decisions involved in the integrated
approach to drug development will be presented.
Boehringer Ingelheim licenses six preclinical ADC and T-cell engager programs from Sino Biopharmaceutical in a deal worth up to $7 billion, Spyre Therapeutics drops anti-TL1A antibody SPY072 in rheumatic diseases after phase 2 misses and turns to hidradenitis suppurativa, and Biora Therapeutics gets ethics approval for a first-in-human trial of its BioJet oral adalimumab capsule.
As access to low Earth orbit expands, space-based research is opening possibilities in drug discovery, formulation, and manufacturing. In Part 1, the authors look at how microgravity changes biology and chemistry in ways that can’t be reproduced on Earth and where it fits from target discovery to life cycle management.
The half-life-extended antibody failed its primary endpoints in two Phase 2 SKYWAY sub-studies, so Spyre is dropping it in rheumatic diseases and moving it into a combination trial in hidradenitis suppurativa.
Boehringer Ingelheim will pay Sino Biopharmaceutical $358 million upfront and near-term for options on six biologic oncology programs, deepening a partnership that began in 2024.
A former CIA officer, Pacific Research Institute economists, and industry groups say Treasury's proposed COINS Act biotechnology restrictions are too broad, while the National Security Commission on Emerging Biotechnology backs the move. Comments are due December 7, 2026.
