From The Editor

1. 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. 

2. A Disruptive Approach To Oncology Therapy Development 1/9/2020

   CureLab Oncology CEO Alex Shneider’s lament is a biopharma industry that exhibits little appetite for those discoveries made while coloring outside the lines. We caught up with him for an update on the maverick path of lead candidate Elenagen.

3. Biosimilar Industry Advancements To Watch In 2020 1/8/2020

   Multi-biosimilar competition in the U.S. oncology space, as well as the FDA’s regulatory progress toward a more competitive insulin market were popular topics among the whole group. But these are hardly the only big events to note in this progressing industry.

4. How BlueWillow Biologics Is Pioneering Mucosal Vaccine Tech 1/2/2020

   CPA-wielding business and finance executive Dave Peralta is leading a pioneering intranasal nano vaccine developer through the advent of next-generation immunotherapies.

5. The Top 7 Biosimilar Developments of 2019 12/30/2019

   I normally only do the top five developments for the biosimilar industry in this annual column. But it turned out, upon reflection, that 2019 was an even more eventful year than it may have seemed as we were making our way through. So, you’re getting a whopping seven this year.

6. Alternative Funding For Startup Biotechs 12/13/2019

   Tough competition for traditional funding has led creative biotech entrepreneurs to seek alternative and diversified sources. Chad Dehmer, senior manager of business development at UPMC Enterprises, walks us through one such alternative.

7. International Reference Pricing: The Answer To Rising Drug Costs? 11/20/2019

   Political leaders on both sides of the aisle are mulling government-mandated international reference pricing as means of controlling the spiraling cost of biologics and other prescription medicines. Here's what that might look like, and why it's unlikely to happen in short order.

8. Early-Stage Biopharma Funding Advice From A Leading VC 11/13/2019

   5AM Ventures Senior Associate Jason Ruth, Ph.D. dished some insider advice to biotech fund seekers in the Pittsburgh LifeX Labs community, and BioProcess Online was there to catch his talk. Here are the highlights.

9. How The Medical Innovation Act Could Stifle Medical Innovation 11/12/2019

   The reincarnated bill targeting big pharma is exemplary of congressional inefficiency and over-legislation. Instead, congress should get better at negotiating and appropriating settlements in the existing system.

10. Outsourcing Insights From A Tech Transfer Veteran 10/29/2019

    Explore tech transfer expert Anthony Grenier's opinions on the most common mistakes he sees, how to avoid them, and planning ahead to beat the CMO capacity crunch.