Unless you’ve been living on private island (send invite immediately!), it’s no secret that the pandemic has changed the way manufacturers operate and run their businesses in order to survive these challenging times.
At least that’s what we at the National Institute of Standards and Technology’s Manufacturing Extension Partnership (NIST MEP) have heard from manufacturers over 11 virtual listening sessions we call the “National Conversation with Manufacturers.”
When clinical investigators and study coordinators start planning a new study design, speed and efficiency are paramount.
Running a clinical study takes careful planning. Whether this is your 1st clinical study or your 21st, the last thing you probably want to do is waste time and resources on data collection delays that are easy to prevent.
Traditionally, major bottlenecks occur during study startup, eligibility screening, the informed consent period (including assent in pediatric studies), and patient travel to the clinical site(s). Researchers eager to get the ball rolling on their study can save time and ease logistical burdens by stopping data gridlock before it begins.
Though it began like any other year, 2020 has proven to be one of the most difficult and frustrating periods of our lifetime. This was especially true for our business community, which faced numerous new obstacles including shifting consumer needs, new safety requirements and a general uncertainty about what lay ahead.
SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Dec. 9, 2020 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) announced today that the United States Food and Drug Administration (FDA) has granted orphan drug designation to treprostinil for the treatment of patients with idiopathic pulmonary fibrosis (IPF). United Therapeutics intends to initiate a phase 3 study, called TETON, to evaluate the use of Tyvaso® (treprostinil) Inhalation Solution in patients with IPF. FDA recently cleared United Therapeutics’ investigational new drug application (IND) for the TETON study, and the company expects to commence enrollment in 2021. Orphan drug designation is the first step in receiving orphan drug exclusivity following approval, which confers seven years of market exclusivity for the relevant indication. This exclusivity would also benefit Treprostinil Technosphere®, United Therapeutics’ next-generation dry powder inhalation form of treprostinil, upon FDA approval of that product for the IPF indication.
The university licenses its original patent to the company to develop the product and conduct early-stage clinical trials.
Image: Michael Keidar, a mechanical engineer by training, is a professor of engineering at George Washington University. WILLIAM ATKINS
We caught the tide– but just barely. That the Bayh-Dole Act passed was amazing. That it passed in a lame duck session of Congress with its principal author defeated, the US Senate changing hands, and a sitting president thrown out, was a miracle. Even then success was not assured. The bureaucracy was waiting to undermine the implementing regulations. Yet the new law survived, strengthening the economy while improving public health and well-being.
Image: U.S. Senator Birch Bayh (ret.)
The COVID pandemic has certainly forced us to re-think the whole paradigm of conducting clinical trials. From design, site and CRO selection, patient recruitment, data management, to execution, the world of clinical trials has been altered significantly in 2020… and most likely beyond.
Here are some relevant questions you should be asking yourself and that we will be asking our panelists in today’s webinar:
ROCKVILLE, Md., Dec. 14, 2020 /PRNewswire/ — Emmes today announced that it has conducted the data and statistical analysis for the second iteration of the Adaptive COVID-19 Treatment Trial (ACTT-2). The ACTT-2 trial assessed the efficacy and safety of a 4-mg dose of baricitinib with remdesivir, versus remdesivir alone, in hospitalized COVID-19 patients.
Baricitinib, produced by Eli Lilly and Company, has been used to treat adults with moderate to severe rheumatoid arthritis. Baricitinib, in combination with remdesivir for COVID-19 patients, received Emergency Use Authorization on November 19.
AstraZeneca on Saturday said it was acquiring Alexion Pharmaceuticals for $39 billion, marking a significant expansion into the treatment of rare diseases of the immune system.
The deal — a mix of cash and stock — values Alexion at $175 per share, a 45% premium to Friday’s closing stock price.
Image: KRISTOFFER TRIPPLAAR/SIPA/AP
AstraZeneca on Saturday said it was acquiring Alexion Pharmaceuticals for $39 billion, marking a significant expansion into the treatment of rare diseases of the immune system.
The deal — a mix of cash and stock — values Alexion at $175 per share, a 45% premium to Friday’s closing stock price.
Image: KRISTOFFER TRIPPLAAR/SIPA/AP
