Tag: drug development

Observations: CNS Summit Conference 2021

The CNS Summit, a year-round community with an annual in-person Summit was held at the Encore Resort Boston Harbor. It was very well-attended with over nine hundred registered. There was a feeling of pent-up need for networking and reconnecting. It is quite apparent that participants at this meeting are enthusiastic to be attending in person. The joy and happiness of seeing friends, colleagues (past and current) and being able to freely move about and make new connections was palpable. There is such a willingness to hear about what each other is up to, has learned and is doing different since the last time we gathered in person.

Rapid antigen testing was conducted rapidly for Covid-19, and  a negative test result (within about 15 minutes) indicated by a wristband provided, allowing access to the Summit.  The testing was provided by CNS Summit in partnership with Care Access. The process went off flawlessly, a great testament to the Care Access and CNS Summit staff involved.

There were many exhibitors, patrons and sponsors. To see which companies participated, I recommend you go to the website: https://cnssummit.org/

Digital Biomarkers, Artificial Intelligence, Machine Learning, Big Data, Patient Diversity, Real World Data were among many Spotlight topics. As an example, Sharecare and UCB presented real-world data on patients with Myasthenia Gravis. The insights learned, the new endpoints discovered and the capabilities of the smartphone in such trials was impressive.

Below is the expanding list of companies that define themselves as DCT clinical trial service providers.  Go to https://www.dtra.org/  Decentralized Trials & Research Alliance to fully appreciate the expansion of companies and organizations in and/or getting into the decentralized research segment of our industry.

Curebase Circuit Clinical
Medable Science 37
TrialBee Thread
CaptureProof Care Access
Clinical Ink DataCubed Health
Medocity Medidata
ShareCare (SmartOmix) Science 37
SiteRx

If you are interested in the CNS Summit community and the opportunity for interacting within it year round, you can apply at the organization website, which is listed above in  paragraph 3.

And on a sad note, Medidata co-founder, Glenn DeVries who attended and presented at the conference passed away November 11 in a private plane crash in New Jersey.

 

FOCM Networking Person of the Year for 2020

Without a doubt the work done by the pharmaceutical, biotech, clinical research, drug development industry and the Food and Drug Administration is worthy of this distinction for 2020. What was accomplished is just short of miraculous.

The federal government (FDA) and the corporations cut no corners. I have no doubt that everything was done according to established good clinical principles. What was done was the speeding up of the regulatory processes; decreasing the workflow processing time. Turn around time on data review and decision making was the focus. The researchers and the reviewers of the data had Covid-19 treatments and vaccines at the forefront of their priorities.

The typical time for vaccine development to get approved is 4 years. The first two approved were done within 12 months!! There are several more in development.

We are now beginning to see the impact the vaccine is having in the decline of daily new cases. Many people have now received their second dose.

The United Kingdom began vaccinating their population one week earlier than the US and you can see the impact to their daily new cases as well. This has me very encouraged. I’m hopeful that by Memorial Day, we’ll be back to dining out and meeting in person, traveling to conferences, vacations, etc.

Benefits of Capitalism in Drug Discovery

Nathan Yates has spinal muscular atrophy and is a professor or economics and finance. Here’s an excerpt of his article on the price of a new drug to treat his condition. The bold in the text below is mine. The

The full article is here:
https://www.statnews.com/2019/05/31/spinal-muscular-atrophy-zolgensma-price-critics/

As someone who has lived with spinal muscular atrophy for all 30 years of my life, I was perplexed and disappointed that the recent approval of Novartis’ gene therapy Zolgensma was immediately overshadowed by outrage over the drug’s price: $2.125 million.

The Food and Drug Administration’s decision was a pivotal day for those of us in the SMA community. Zolgensma, approved for children under 2, is the only one-dose treatment option for any category of SMA patients and has been highly effective in clinical testing so far.

Sure, it’s the world’s priciest drug. But instead of debating the level of financial profit that is appropriate for Novartis, let’s focus on the needs of patients. How are we going to get treatments for rare diseases if there’s not a financial incentive for doing it? Therapies are being developed because people think they can sell them for a profit. We don’t like to talk about it, but pharmaceutical companies exist to make money. Don’t we realize, though, that all of society profits from each disease we cure and each baby that is saved from SMA and other deadly diseases?

As a professor of economics and finance, I believe that the cost-related complaints being thrown around social media are short-sighted. Shortly after Zolgensma’s price was announced, I even told a friend, “This is a good problem to have.” Why? It’s a twofold answer:

  1. Competition – drives cost down
  2. Long term value – each successive drug that’s approved will be an improvement – whether that’s injected by IV once instead of into the spinal column every 4 months or made into a pill for once a day dosing. drug

LaunchBio NC Networking

LaunchBio (LaunchBio) holds events on the first Thursday of the month in Durham, NC.  They are held in the Chesterfield Building in the downtown area.  The building was formerly a cigarette manufacturing building.  It has now been converted and there is incubator lab space for drug discovery and development.

It is a great opportunity for networking with people involved in the clinical research industry.  Here I am enjoying a Durty Bull Lager beer and conversation with Peter Weiman and David Holland (they’re drinking the IPA that was being served).

LaunchBio_August_2018_Web-10