From The Editor

1. Nurturing A Nascent Colorado Biotech Hub 4/6/2020

   Jennifer Jones Paton and her teams at the Colorado BioScience Association and Colorado Bioscience Institute are leading a unique education-based approach to the long-term sustenance of a fast-growing bioscience hub in the Mountain states. 

2. Inside FDA’s AI-Based Established Conditions Pilot 4/1/2020

   FDA-CDER’s Geok Yan Loo gave us an inside look at CDER’s application of artificial intelligence to inform and improve pharmaceutical quality systems. The pilot offers good reason to consider how machine learning can improve bioprocessing quality and ease your regulatory burden.

3. New FDA Guidance For Clinical Trials Disrupted By COVID-19 3/19/2020

   During this unprecedented time full of unanticipated challenges for biopharmas, FDA has issued new guidance that offers advice on adjusting clinical trial protocols in the midst of the fast-spreading and ill-understood virus SARSCoV-2 and its resulting COVID-19.

4. Virus Exposes Weak Links In The Biopharma Supply Chain 3/16/2020

   In early March, the life sciences investment firm SVB Leerink hosted a conference call that exposed just how big a problem COVID-19 presents to US biopharma innovators.

5. Is Biopharma’s Response To Coronavirus Off The Mark? 3/4/2020

   As biopharmas aplenty race to develop a vaccine, CureLab’s Alex Shneider says an incorrect approach risks turning the currently insignificant coronavirus threat into a deadly pandemic. He suggests that we instead focus on the development of adjuvants and immunostimulants to protect the elderly.

6. COVID-19: A Case For “Virtual” Biopharma? 2/27/2020

   Work-and-learn from home policies are more than employee perks. They could help thwart a pandemic. Have you adopted procedures and tools that ensure continuity when employees aren’t in the office?

7. The Process Behind The Potential: Therapy For HPV16-Related Malignancies 2/18/2020

   HPV-related malignancies are poised to skyrocket over the next thirty+ years. Here's a look into Cue Biopharma’s engineering-centric approach to in vivo tumor antigen specific T cell activation to treat these cancers.

8. Update On Advanced Rapid Microbiology Methods In Biopharma 2/13/2020

   A BioPhorum survey of biopharma end-users reveals the opportunity—and the challenge—involved in the adoption of advanced rapid microbiology methods. Audrey Chang, global head of development services at BioReliance Merck; Morven McAlister, senior director at Pall Biotech; and Scott Hooper, associate director at Merck & Co Inc. break down the data.

9. The Perilous Development Of A Potential Biologic Blockbuster 2/10/2020

   CytoDyn's leronlimab is under FDA review for Breakthrough Therapy status. Its path from forgotten molecule to near market readiness was riddled with financial and process challenges.

10. CDER-ETP: A Resource For Innovative Biopharma Firms 1/15/2020

    The FDA’s Center for Drug Evaluation and Research’s Emerging Technology Program (CDER-ETP), is yet another step toward removing slow-moving bureaucracy and red tape that stands in the way of innovative new technologies that drive drug development.