Invitation - How To Rescue Your Clinical Trial When at Risk to Fail
A conversation with Heike Schön
Did you know that almost 90% of all product ideas fail in clinical trials? And most of them not because of lack of efficacy?
Some of the best industries to work in are pharmaceutical, diagnostics, and medical devices. Why? The products developed in these industries help to save and improve lives all over the world. The process of developing
new ideas that have the potential to change people's lives,
testing the hypothesis in the first preclinical studies,
pushing it through clinical trials,
raise capital for the whole process
and finally, bringing it to the Market to improve patients' and their families' lives is exciting.
It takes the ability to bring a lot of expertise and many different players together:
Scientific creativity during the concept phase at research organizations
The ability to translate scientific results into product ideas in the ideation phase
Pushing through preclinical development
Clinical expertise to move the product ideas through the clinical development pathway and
Regulatory and Market access skills on an industrial scale
Did you know that almost 90% of all product ideas fail in clinical trials? The most obvious reason that a clinical trial fails is lack of efficacy. Efficacy is one of the core goals of a clinical trial. Based on the results, a trial can be successful or fail.
Surprising to me was that lack of efficacy doesn't seem to be the main reason why clinical trials fail in the first place. Other factors are at play, and most of them are manageable risks when the right team is at work.
The problem with failing trials is that it becomes a costly endeavor for sponsors and investors. Taking out manageable sources of failure during the clinical trial can help gain speed, save expenses and increase the probability of success.
The big questions are:
Why do clinical trials fail?
What factors are manageable risks in clinical trials?
What can a sponsor do to manage them?
After reading some studies on this topic, I asked Heike Schön to join for a podcast recording to explore this area further to find out what sponsors can do to make clinical trials successful and reduce the risk of failure.
Expert in this episode:
Heike Schön is the Managing Director and Co-Founder of Lumis International GmbH and Lumis Life Science Consulting GmbH.
She has more than 25 years of experience in leadership positions in international clinical research and drug development. She has profound knowledge of the clinical drug development processes and regulatory requirements from first in human to market access.
She is experienced in developing strategies and concepts for biopharmaceutical and medical device companies covering clinical operations, clinical research, outsourcing, vendor management, and oversight management.
Lumis International and Lumis Consulting
Lumis International GmbH was founded in 2013 with the goal to act as a bridge to Europe for clinical research activities. The company is specialized in providing legal and data representation services and regulatory consulting for biopharmaceutical and medical device companies who intend to develop their product in the European Market but are located outside of Europe
.
Lumis Life Science Consulting GmbH was founded in 2020 as an independent subsidiary of Lumis International to provide customer-tailored consulting and solutions for clinical vendor selection and management, clinical trial oversight, quality management, and training.
Flexibility and empathy are core to the Lumis brand.
Questions we will discuss:
Strategic considerations for setting up a clinical trial
Inhouse vs Outsourced Clinical Study Management
Why do some clinical trials fail?
Steps to getting your clinical trial back on track
Future trends of clinical trials
and much more
When?
March 23, 2:00 pm CET
Noteworthy Articles
What is going on in the world of Life Science, AI, and other Deep Tech?
Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review Clinical trials are time consuming, expensive, and often burdensome on patients. Clinical trials can fail for many reasons. This survey reviews many of these reasons and offers insights on opportunities for improving the likelihood of creating and executing successful clinical trials. Literature from the past 30 years was reviewed for relevant data. Common patterns in reported successful trials are identified, including factors regarding the study site, study coordinator/investigator, and the effects on participating patients. Specific instances where artificial intelligence can help improve clinical trials are identified. Read more…
90% of drugs fail clinical trials – here’s one way researchers can select better drug candidates It takes 10 to 15 years and around US$1 billion to develop one successful drug. Despite these significant investments in time and money, 90% of drug candidates in clinical trials fail. Whether because they don’t adequately treat the condition they’re meant to target or the side effects are too strong, many drug candidates never advance to the approval stage. Read more…
7 Reasons Why Clinical Trials Fail Why Clinical Trials Fail? To answer this question, we surveyed a number of clinical research specialists and analyzed best practices publications by the EMA and FDA. When zooming in on the project management side, the skill set of project managers seems to be a critical source of error according to the industry experts. Does that surprise you? Read more…
2 Podcasts from this week
Base Editing with Beam Therapeutics CEO John Evans
Base editing, and gene editing as a broader industry, are a major focus of our research at ARK, and a major piece of DNA Sequencing, one of our 5 technology platforms. To dive deeper into the world of base editing, Analyst Ali Urman sits down with industry expert, Beam Therapeutics CEO John Evans. Evans was previously a Venture Partner with ARCH Venture Partners and an early employee and member of the leadership team at Agios Pharmaceuticals. At Agios, he helped develop IDHIFA and TIBSOVO, two IDH inhibitors for the treatment of acute myeloid leukemia (AML), helped initiate and lead Agios’ landmark alliance with Celgene, and co-led Agios’s expansion into rare genetic diseases. On this episode, Ali and John discuss the falling costs of medicine, the convergence of 3D Printing and Base Editing, Base Editing’s applications for chronic illness, the total opportunity of the gene editing space and much more!
Key Points From This Episode:
John’s favorite poet, Wallace Stevens
Medicine’s cost declines and what that means for patients
The efficiency of of Multiplex Gene Editing (MGE)
The convergence between and potential of 3D Printing and Gene Editing
The many colors of CRISPR Gene Editing
Base editing applications for chronic illnesses
The intersection between Base Editing and Prime Editing
Beam Therapeutic’s partnerships with Pfizer and Verve
Measuring the opportunity in the Base Editing space
The potential total market opportunity in the gene editing space
The CRISPR patent ruling and its impact on the genomics field
What John finds interesting about Twitter and why he is so active on the platform
#69: Prof. Collin Ewald - Molecular Mechanisms of Healthy Ageing
1 Youtube Takeaway from this week
Books I am reading this week
Sell or Be Sold: How to Get Your Way in Business and in Life (English Edition)
Whether it’s selling your company’s product in the boardroom or selling yourself on eating healthy, everything in life can—and should—be treated as a sale. And as sales expert Grant Cardone explains, knowing the principles of selling is a prerequisite for the success of any kind.
In Sell or Be Sold, Cardone breaks down the techniques and approaches necessary to master the art of selling in any avenue. You will learn how to handle rejection, turn around negative situations, shorten sales cycles, and guarantee yourself greatness. Cardone will also teach you the success essentials of
•Selling in a bad economy
•Overcoming call reluctance
•Filling your pipeline with new business
•Staying positive, despite rejection
With the experience of a seasoned sales vet at the helm, Sell or Be Sold will change the way you perceive the sale—and life.
Sell or Be Sold: How to Get Your Way in Business and in Life (English Edition)
Best Quote From This Week
“Treat people as if they were what they ought to be and you help them to become what they are capable of being.”
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Check out the full podcast episode here: https://beginnersmind.buzzsprout.com/779930/10333467-71-heike-schoen-how-to-rescue-your-clinical-trial-when-at-risk-to-fail