Getting to First-in-Human Clinical Trials: A Make-or-Break Milestone for Small Biopharmas

June 7, 2018

"Faster and better” has become the mantra for biopharmaceutical companies as they face intense pressure to get therapies to market faster. Quickly proving efficacy in first-in-human (FIH) trials is a make-or-break milestone for these cash-strapped companies whose hopes hinge upon one or two molecules. Speed and revenue are also intertwined at Large Pharma as they struggle with R&D productivity and the pressure to fill pipelines with promising options. Speed to market takes on even greater urgency when you consider how critical it is to get these new treatments to the patients who need them. Read how CDMOs are responding to the mounting pressure.

Spotlight

Omega Therapeutics

Omega Therapeutics is a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as programmable epigenetic medicines

OTHER WHITEPAPERS
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A Cornerstone in the Supply Chain of Cell-based Therapies

whitePaper | February 15, 2023

The diverse therapeutic attributes of mesenchymal stromal cells (MSCs) lend to their rapid development as cellular therapeutics. These unique attributes include potent immu nomodulatory properties [1,2], the potential to differentiate into multiple cell lineages.

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Liposomal and Nanoparticle Technology at Pfizer Melbourne

whitePaper | November 22, 2022

Specializing in oncology, anti-infective and complex formulations, Pfizer Melbourne provides end-to-end services from development through to commercial manufacture of sterile dosage forms.

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Covid-19 Vaccine Distribution System

whitePaper | April 14, 2021

Delivering Covid-19 vaccines to 7.8 billion people is a daunting challenge that will stretch supply chains past their limits. Even if all the needed doses were ready today, vaccine manufacturers still must find solutions to deliver multiple doses of those vaccines to most people on the planet. To read more, please download this free white paper.

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Use of PS-DVB Columns and Matched Buffers in the Purification and Scale-Up of mRNA Drug Candidates

whitePaper | August 24, 2022

The validity of mRNA as an approved pharmaceutical is now largely accepted, with the historic launch and administration of billions of doses of mRNA Covid vaccines (1).

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The EU Clinical Trials Regulation − What You Need to Know

whitePaper | March 22, 2022

The Clinical Trials Regulation has retained some definitions and refined others. For example the definition of “clinical study”: “Any investigation in relation to humans intended: (a) to discover or verify the clinical, pharmacological or other pharmacodynamic.

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Automated Extraction of High Molecular Weight DNA

whitePaper | November 14, 2019

SmartExtraction significantly simplifies the entire automated workflow of DNA extraction, setting new standards with regard to efficiency, yield and quality of the DNA.

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Spotlight

Omega Therapeutics

Omega Therapeutics is a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as programmable epigenetic medicines

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