INSIGHTS ON DRUG DEVELOPMENT

• Can’t Afford A Head Of Clinical And CMC? Think Again

  Brian James of Rondaxe, and Joanne Beck of Aerium Therapeutics, consider the basic “org chart” needed to ensure development and manufacturing success at your CDMO.

• How Much Do You Need To Pay Your CDMOs … And When?

  Striking a balance between must-haves, and thus must-pay-fors, with the need for development speed and budgetary constraints, was a serious subject for our outsourcing professionals.

• How Much Can You Actually Rely On Your CDMO?

  At our recent Outsourced Pharma Live, “How Can CMC Keep Up With The Rush To The Clinic?”, our panel of professionals draw the line on how much you can count on your CDMO to do for you, even if you are a virtual biotech.

• “Relentless Transparency” Needed Between CDMO And Biotech Customer

  Vincent Kosewski, VP, Manufacturing & Supply Chain Management, Kala Pharmaceuticals, explains his phrase for how outsourcing communication needs to be handled.

• Speed To Clinic, Cost To Get There, And FDA Expectations

  5/15/2024

  GSK’s Ben Stevens provides an indepth analysis of the variables regulatory bodies and developers need to balance when considering fast track designations, and the overall rush to get to the clinic.

• When Outsourcing, Get The Right Professionals On Your Internal Team

  5/15/2024

  In our Outsourced Pharma Live titled “How Can CMC Keep Up With The Rush To The Clinic?”, our speakers all agree: Hire strategically internally for the best results.

• A New Acronym – CBMC? Put “Biology” In CMC? Our Panelists Think Not.

  5/15/2024

  Chief Editor Louis Garguilo asks our panel if CMC – chemistry, manufacturing, and controls – might be outdated, and whether biology should be added to the acronym.

• Consultants Know: Emerging Biotechs Have Outsourcing “Disconnects”

  5/15/2024

  Missing an analysis of all the pieces involved in development outsourcing, and a loose connection between the C-suite and reality, can slow down a biotech’s program.