After reaching a certain point in development, Biogen decided it wanted those compounds back and acquired Stromedix in a $562.5 million deal, said Michael Gilman, who headed up Stromedix and now serves as senior vice president of early stage research at Biogen

Obviously we've got money so any deal would have to be good, but we would consider early stage deals if they were lucrative enough," Young said.

Obviously we've got money so any deal would have to be good, but we would consider early stage deals if they were lucrative enough," Young said

Within its National Center for Accelerating Translational Sciences, the NIH has established the Therapeutics for Rare and Neglected Diseases program, "established with this sort of situation in mind, although I think it was geared toward the earlier stage of clinical research, and not waiting until you're in Phase III," McCleary said

That timeline was tossed out the window due to CMS' 15-month delay in finalizing the rule. (See BioWorld Today, Oct. 5, 2011, and Jan. 24, 2013.) FDA Wants Input The FDA is seeking comment on draft guidances released last week on immunogenicity assessment of therapeutic protein products and the development of drugs to treat early stage Alzheimer's...Intended as a conversation starter, the other draft guidance addresses the clinical development of drugs to treat early stages of Alzheimer's disease

In addition to solidifying its MM presence with Pomalyst, Celgene is placing bets on early stage contenders

With much of the early stage discovery and development effort now delegated to third parties, "the skill sets needed are for people who can oversee and manage" these projects, Franco said. (See graph, The life sciences industry is looking for new skills among scientists.) Biopharmas "need people who have a broader perspective," so they understand how each piece of data flows together "to tell a complete story," Franco explained

In order to accomplish that, the company will reduce its overall cost structure, particularly in early stage programs

Celldex largely eschewed early stage partnerships after it was spurned by New York-based Pfizer Inc...The company also has earlier-stage assets that could add value in the coming years, including the monoclonal antibody vaccine CDX-1401 targeting solid tumors, CD27-targeting candidate CDX-1127 and CDX-301, a recombinant human FMS-like tyrosine kinase 3 ligand

The overall approach allows the firm to "take account of liquidity requests" but also to capture the potential for higher returns from earlier-stage, riskier ventures...it can be difficult to finance early stage, and you need to do a decent job to raise the next round," Litzka said

Janssen Research & Development LLC, of Titusville, N.J., a unit of Johnson & Johnson, said its San Diego-based Janssen Labs added a Concept Lab, a shared laboratory to offer entrepreneurs access to bench spaces for early stage research, and an Open Collaboration Space, an open-plan office setting designed to provide companies and individuals with desk space

Similarly, CDRC provides expertise and infrastructure to researchers at Canada's leading health research institutions so they can advance promising early stage drug candidates, de-risk them and transform them into viable investment opportunities for the private sector...The centers recognize that they won't rescue every early stage therapeutic program

He and his colleagues have created a mouse with a reporter gene that appears to light up at the earliest stages of tumor development, regardless of the tissue type in which the tumor is developing "We said all along that Zerenex was the only phosphate binder that had the potential to transcend into another dialysis category – in this case, anemia management – and generate some benefit." – Ron Bentsur, CEO, Keryx Biopharmaceuticals Inc

Many are allied with other research institutions to advance early stage drug candidates and provide gap funding...Es Sabar hopes the work of the alliance will strengthen early stage biopharma licensing deals and create stronger, more sustainable biotechs

Ceptaris Therapeutics Inc., of Malvern, Pa., said results of a pivotal trial comparing its gel formulation of mechlorethamine hydrochloride 0.02 percent to pharmacy-compounded mechlorethamine ointment for the treatment of early stage mycosis fundoides were published in JAMA Dermatology

Early stage data are expected late this year

That would both provide an advance in terms of the care of people with the disease and in enabling drugs to be tested in the earlier stages of the disease when there is a greater likelihood of showing a significant clinical effect...If they are, we need to get them to patients at an earlier stage of disease

By Anette Breindl Science Editor Researchers have created a mouse with a reporter gene that appears to light up at the earliest stages of tumor development, regardless of the tissue type in which the tumor is developing...It really does seem to work in every malignancy we've tested," Norman Sharpless told BioWorld Today, which makes the mouse in question a broadly useful tool to study the earliest stages of tumor development

In addition to late-stage advancements, Biogen also inked several early stage deals in 2012, including a microRNA agreement with Regulus Therapeutics Inc