The deadline to comment on FDA's generative AI paper is Oct 19, 2026. We explain why professionals in pharma manufacturing should weigh in.
|Podcasts|July 30, 2021
The Integrated Approach to Drug Development
Author(s)Piramal Pharma Solutions
Efficiency, speed-to-market, and access to unique expertise are among the key benefits of partnering with a contract development and manufacturing organization (CDMO) offering integrated, end-to-end services. Applying a fully integrated approach to drug discovery, development, manufacturing, packaging, and more, all with a single project manager as the primary point of contact and a single plan across multiple scientific disciplines, provides pharmaceutical and biotech innovators with tangible benefits. PPS has a superior record of delivering successful product launches with the seamless transfer of technology, documentation, and materials across global sites. Regulatory know-how and deep experience across a spectrum of projects and categories further solidify the company’s standing as an elite integrated CDMO.
Related to this article
The FDA expanded Anktiva to BCG-unresponsive papillary-only NMIBC using existing CIS trial data, a precedent with implications for development timelines and supply planning.
AI accountability, faster FDA pathways, rare disease CMC review, and next-gen GLP-1 formulation lead this week’s PharmTech roundup.
Ishani Maharaj of Ingredients + Specialties from Univar Solutions explains how to stabilize GLP-1 multi-agonists, weigh delivery formats, and qualify novel excipients and suppliers.
MASH and cardiomyopathy AI collaboration: AstraZeneca pays insitro $40M upfront for target discovery, then leads clinical development and CMC planning.
Boyang Wang, Immortal Dragons, discusses how the FDA’s Expedited IND Pilot must prove efficiency as sponsors chase the fastest route to valid first-in-human data.
Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.
The FDA’s Rare Disease Framework Initiative brings risk-based CMC review and pre-approval inspections into scope for sponsors, CDMOs, and quality teams.
Trending on Pharmaceutical Technology
1
Formulation Strategies for Next-Generation Multiagonists
2
Clinical Trial Delays: FDA’s Expedited IND Pilot vs China’s 818 Decree
3
Rare Pediatric PRVs: Manufacturing Strategies for Expedited Approval, Part 1
4
NVIDIA’s $250M Agentic AI Safety Bet: What GMP Gains
5