Articles By Ed Miseta

  1. Pets, Perseverance, And Manufacturing Facility Bring Biotech Success 10/30/2020

    Patricia Lawman, cofounder and CEO of the biotech firm Morphogenesis, explains the company’s unlikely genesis and different approach to animal testing.

  2. How Flexion Pivoted To Become A Commercial Biotech 9/1/2020

    Unfortunately, Flexion’s incorporation coincided with the financial crisis of 2007-2008, and the assumption that large pharma’s would pay premiums for successful proof of concept assets came under pressure.

  3. Why Is Antibiotic Development In The U.S. Disappearing? 7/1/2020

    Today, 95 percent of antibiotics in development are being studied by smaller biotechs, including Paratek Pharmaceuticals. Today, the company is on a strong trajectory, but its ups and downs show why antibiotic companies fail and few new antibiotics reach patients.

  4. DIA And CRO Leadership Awards Go Virtual 7/1/2020

    The team behind DIA’s Annual Meeting was able to put together an event that was as informative and engaging as past years, despite the short and very hectic time frame. More than 200 sessions took place virtually, with 120 of those being on demand.

  5. The Benefits & Challenges Of Head-To-Head Trials 7/1/2020

    In Lilly’s immunology portfolio, eight different H2H clinical trials have been conducted thus far. Four of those trials were conducted in parallel with a Phase 3 trial and four were conducted after it. Although the benefits are attractive to a sponsor company, H2H trials can present some unique risks.

  6. A Quick Transition From Research Firm To Clinical-Phase Biotech 7/1/2020

    Since Oct. 2018, Anne Whitaker had to figure out how to transition Aerami Therapeutics from a research firm to a clinical-phase company. It’s been a complicated and challenging journey.

  7. COVID-19 & The Virtual Trial Rush: Front-Line Insights 5/19/2020

    The COVID-19 pandemic caught many sponsor companies and sites unprepared. Clinical trial participants were told to stay home for their own safety and to relieve the burden on site personnel. For companies that had millions invested in trials that required data from those patients, panic set in and the rush was on for new technology solutions.

  8. Lilly Slams The Brakes On New Clinical Trial Activity 3/24/2020

    Conducting clinical trials during the COVID-19 pandemic is no easy task. Recognizing this unfortunate change in events caused by COVID-19, Eli Lilly and Company has made the difficult decision to delay most new clinical study starts and pause enrollment in most ongoing studies.

  9. A Biopharma That Had To Pivot Twice To Forge Ahead 2/28/2020

    Not many thriving companies experience disappointing clinical trial results, jump into an entirely new therapeutic area, and emerge with investor support and renewed hope for an entirely different class of patients. Millendo has done it twice.

  10. A Small Biopharma That Doesn't Use CROs 12/30/2019

    When it comes to conducting clinical trials, most emerging companies choose to access external resources through partnering with CROs. That is what makes Martin Lehr, CEO of Context Therapeutics different. He prefers to bypass CROs and take part in Investigator-Sponsored Trials (ISTs).