Artificial intelligence in pharma: utilising a valuable resource

SYDNEY TIERNEY | March 11, 2020

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The pharmaceutical industry is set to greatly benefit from the use of artificial intelligence (AI), due to its wide range of applications. Sydney Tierney discusses how machine learning can enhance marketing, manufacturing and drug trials. Artificial intelligence (AI) can be applied to nearly every aspect of the pharmaceutical and healthcare industry, to enhance data processing. Adopting the technology will reveal the astonishing potential of the healthcare sector, with success rates flying higher than ever before – especially in the research and development of crucial, life-changing drugs.

Spotlight

Rational Vaccines

Rational Vaccines (RVx) was formed in 2015 for the purpose of offering better solutions to stop the spread of herpes and alleviate the problems faced by people suffering with unrelenting, chronic disease. Based on the life work of Dr. Bill Halford, Associate Professor, Southern Illinois University Medical School, who studied herpes simplex virus 1 and 2 (HSV-1 and HSV-2) in a laboratory setting for 25 years, RVx has developed the world’s first line of rationally-engineered live HSV-1 and HSV-2 vaccines that have been shown across 10 years of pre-clinical studies to be safe and highly immunogenic. RVx has also developed a novel type-specific diagnostic method, the ABVIC test, for serological testing of patients for HSV-1 and/or HSV-2 infection, which greatly improves upon the existing standard of care. Through the development of rationally-engineered live viral vaccines and a more accurate and reliable HSV diagnostic test, RVx is forging the path ahead to a brighter future.

OTHER ARTICLES

A pharma outsourcing mission

Article | August 18, 2021

In a way, getting through the initial stages of a complex pharmaceutical project that is being outsourced to a contract development and manufacturing organization is like getting a rocket off the ground. Many drug developers express frustration with the time it often takes during the initial stages of working with a CDMO — from the time they first reach out to a CDMO for help until they receive a proposal. Some have described it as months of silence from when they send a request for proposal (RFP) until they have a proposal in hand. The initial stages of a relationship between drug sponsor and CDMO often do not get the attention it deserves, and valuable time is lost, delaying projects and delaying delivery of therapeutics to patients. The quick scheduling of the ACT meeting with the right attendees can deliver immediate answers to key questions needed by the drug sponsor for effective planning and can help propel projects to a successful launch.

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Artificial intelligence in pharma: utilising a valuable resource

Article | March 11, 2020

The pharmaceutical industry is set to greatly benefit from the use of artificial intelligence (AI), due to its wide range of applications. Sydney Tierney discusses how machine learning can enhance marketing, manufacturing and drug trials. Artificial intelligence (AI) can be applied to nearly every aspect of the pharmaceutical and healthcare industry, to enhance data processing. Adopting the technology will reveal the astonishing potential of the healthcare sector, with success rates flying higher than ever before – especially in the research and development of crucial, life-changing drugs.

Read More

New Dimensions of Clinical Trial Optimization

Article | April 20, 2021

For much of the past three decades, even as methodologies for clinical trial design have advanced and refined, the idea of the optimized clinical trial has centered on optimal patient samples, target enrollment rates, and generally the most efficient uses of scarce resources in the form of patients. Yet anyone who has had to design and optimize a clinical trial, knows that trial optimization occurs within an ecosystem of choices; a series of choices that stretch from the time it takes to implement a clinical trial and submit clinical data for analysis, to general concerns about the cost and power of a clinical trial. A true clinical trial optimization process would try to unify a number of these choices into a single framework for trial optimization. The complexity of clinical trial optimization comes from the need to align priorities on the one hand, and to understand opportunities on the other. We know that at a very general level, clinical operations specialists benefit from simplicity in clinical trial design, and that commercial teams prefer shorter clinical trials to longer ones. We also know that the statistical design of a clinical trial can influence both simplicity and duration. Yet how many sponsors have their clinical operations and commercial teams, sit with their R&D teams to review various statistically nuanced design options? For many sponsors, the reason this process does not occur as often as it should, is because the nuanced statistical parameters of a clinical trial design are very difficult to communicate to non-statisticians. Yet a trial optimization tool like Solara, equipped with data visualizations and the ability to see tradeoffs intuitively, can overcome this challenge. The real challenge is often convincing the non-statistician that they have a stake in clinical trial design. Cytel recently had a client that thought it needed a sample size re-estimation design, because it had a very strict limit on the number of patients it could enroll. After a few hours of working with Solara, though, a statistician discovered that a much simpler Group Sequential Design would deliver comparable power using about the same number of patients. The gains from the more complex design were minimal from the optimization perspective, when understood as the eco-system of choices. Similarly, most commercial teams pressure their clinical trial designers to have the most accelerated clinical trial imaginable, but as we all know, the longer the clinical trial the more likely there will be a higher number of events that demonstrate the effectiveness of a new medicine. So commercialization teams have a stake in longer clinical trials, even when their rule of thumb is to shorten them. Therefore, it is absolutely essential to communicate the benefits of various statistical designs to multiple stakeholders in a way that makes tradeoffs clear. Aligning on priorities early during the clinical trial design process is essential to selecting the optimal clinical trial. Yet for this statisticians need to be equipped for both a strategic and communicative role in the R&D process.

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What to Watch in 2020: Non-Specialty Drugs

Article | March 1, 2020

Pharmaceutical manufacturers are constantly working to develop new and improved medications. Join us as we explore the non-specialty drugs you should be watching in 2020. If you missed last week’s article about the most important upcoming specialty drugs, be sure to check it out here. Approximately 40 new medications are approved by the Food and Drug Administration (FDA) every year.1 (Please note: If you’re curious about what it takes to develop a drug and bring it to market, check out our previous article). Why should you care about these new medications? Because they can affect both your organization’s pharmacy spend and your members’ cost share. For non-specialty drugs, we will focus on medications that may come to market this year, including ones that are currently being reviewed by the FDA, or that are in the last clinical trial (Phase III) stage.

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Spotlight

Rational Vaccines

Rational Vaccines (RVx) was formed in 2015 for the purpose of offering better solutions to stop the spread of herpes and alleviate the problems faced by people suffering with unrelenting, chronic disease. Based on the life work of Dr. Bill Halford, Associate Professor, Southern Illinois University Medical School, who studied herpes simplex virus 1 and 2 (HSV-1 and HSV-2) in a laboratory setting for 25 years, RVx has developed the world’s first line of rationally-engineered live HSV-1 and HSV-2 vaccines that have been shown across 10 years of pre-clinical studies to be safe and highly immunogenic. RVx has also developed a novel type-specific diagnostic method, the ABVIC test, for serological testing of patients for HSV-1 and/or HSV-2 infection, which greatly improves upon the existing standard of care. Through the development of rationally-engineered live viral vaccines and a more accurate and reliable HSV diagnostic test, RVx is forging the path ahead to a brighter future.

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