Newsletter | June 1, 2021

06.01.21 -- Identifying A Biologics and API Partner To Accelerate Development

Leveraging Infrastructure And Innovation To Accelerate Biologics Development

With a growing pipeline of both traditional and regenerative biopharmaceutical drugs and increasing approvals for novel biologics and biosimilars, there is a need for readily available solutions that will translate the promise of a remarkable discovery into a successful therapy.

First-In-Human Trials: A Make-Or-Break Milestone

Quickly proving efficacy in FIH trials is key for cash-strapped, small companies where success depends on one or two molecules. Large biopharma companies may have several molecules with therapeutic potential, but the challenge is simultaneously screening and determining which to pursue. How can you rapidly move into FIH testing?

In-House Versus Outsource: A Decision-Making Guide

Biopharmaceutical companies are increasingly seeking new strategies to quickly and cost effectively bring biologics to market. Executives must consider how outsourcing fits into their development and production strategy and how to select the best CDMO partner for their business.

The 5 Pitfalls Of API Development

No matter where you are in the API development life cycle, early planning makes a big difference. Every plan should keep these five key milestones — and potential pitfalls — in mind.

Q&A: API Experts — A Small Molecule’s Journey Through API Development

Developing a small molecule API is often a perilous process for new and emerging pharma companies. Three leading API experts discuss the key challenges, what your company needs to succeed, and how partnering with a capable CDMO can make the biggest difference of all.