APR March 2024 - 25

« FORMULATION AND DEVELOPMENT
healthcare, " said Dr. Biesecker. " Precision healthcare embodies that
simple idea. " 4
Precision medicine shows tremendous promise for impacting the
quality of care and patient outcomes. Then-President Barack Obama
outlined some of the benefits this approach offers in a 2015 address
Figure 1. Clinical trials are the gold standard of research to
advance medical intervention. Through the incorporation of
digital health technologies (DHTs) and statistical analyses,
researchers are making significant strides toward a more
personalized and data-driven approach to the
clinical trial process.
patterns could include genetic variations, biomarker expressions,
or other variables that affect the patient's health or disease status.
Statistical techniques also help pinpoint correlations between
specific variables, and advanced statistical analysis can enable the
exploration of links between genetic mutations, environmental
factors, and disease outcomes.
Regarding predictive modeling, statistical models-including machine
learning (ML) algorithms-rely on patient-specific characteristics to help
predict disease risk, progression, and treatment response. Predictive
modeling also enables healthcare providers to anticipate health issues a
patient might experience and adapt strategies accordingly.
The Promise of Precision Medicine
Historically, medical treatment has taken a one-size-fits-all approach
that doesn't necessarily account for specific differences between
patients-genetics, lifestyle, and environmental factors, for instance.
Also referred to as personalized medicine, precision medicine takes a
different, if not opposite, approach. It uses just this type of information
to classify patients into subpopulations and guide decisions regarding
their medical management. The U.S. National Human Genome
Research Institute has defined precision medicine as " an innovative
approach that uses information about an individual's genomic,
environmental and lifestyle information to guide decisions related
to their medical management. " 3
Leslie G. Biesecker, MD, director
and a National Institutes of Health distinguished investigator at the
Center for Precision Health, stated that the goal of precision medicine
is to use that information to enable a more precise approach for
preventing, diagnosing, and treating disease. " It is common sense that
no two individuals are the same, and so they should not get the same
Figure 2. Precision medicine offers numerous benefits and
shows tremendous promise for impacting the quality of care and
patient outcomes.
announcing the launch of the Precision Medicine Initiative. This was an
" all of government " effort designed to tap the expertise within federal
government agencies to usher in a new era of more individualized
medicine through research, technology, and policies. " The future of
precision medicine will enable healthcare providers to tailor treatment
and prevention strategies to people's unique characteristics, including
their genome sequence, microbiome composition, health history,
lifestyle, and diet, " stated the initiative.5
Precision medicine is already showing its utility in areas such as cancer
care. According to the American Cancer Society (ACS), physicians rely
on personalized medicine to guide their treatment plans for cancer
patients, using precision medicine to determine which tests and
treatment options are most appropriate.6
Precision medicine can help
physicians identify individuals at high risk for cancer, make correct
diagnoses of certain types of cancer earlier, determine which cancer
treatment options are best, and assess the effectiveness of a given
treatment course. Testing cancer cells for specific gene or protein
changes or biomarkers can impact options for treating some types of
cancer. As noted by ACS, " this is often what people mean when they
refer to 'precision medicine. " 6
The benefits of this type of tailored approach are numerous. For
example, personalized medicine reduces the need for readmission
and additional patient visits. Because precision medicine utilizes
genetic and other demographic factors, initial tests are generally more
accurate. Subsequently, patients receiving personalized medicine can
typically avoid additional, unnecessary procedures and prescriptions.
As such, precision medicine has the potential to be a cost-effective
www.americanpharmaceuticalreview.com |
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APR March 2024

Table of Contents for the Digital Edition of APR March 2024

Message from the Editor
Editorial Advisory Board
BIOPHARMACEUTICALS - Getting to GMP-Quality Biotherapeutics From Today’s Bench-Scale Continuous Manufacturing Systems: A Gap Analysis
MICROBIOLOGY - Critical Behavioral Attributes and the Application of COM-B Framework in Aseptic Processing
FORMULATION AND DEVELOPMENT - Use of AUC in AAV Analysis in a GMP Setting
FORMULATION AND DEVELOPMENT - Precision Medicine in Clinical Trials: A Statistical Perspective
An Interview with Dan Smithey, PhD President & CEO, Serán
FORMULATION AND DEVELOPMENT - Still Early Days for AI in Drug Discovery...Says Who?
QC Corner - Enhancing Material and Equipment Availability in Production Isolators
BIOPHARMACEUTICALS - Technologies for Aseptic Filling: The Choice is Clear
Vendor Viewpoint - Data Integrity and Rapid Micro Methods: Transforming to a Modern Microbiology Lab
MICROBIOLOGY - Bacterial Spore Formers in Disinfectant Efficacy Testing
Partner Perspective - Nanoparticle Technologies: Enablers for Ocular Drug Delivery
DRUG DELIVERY - Your Nails and You
DRUG DEVELOPMENT - Battling Exorbitance: High Costs in Sickle Cell Gene Therapies and the Imperative of Global Patient Registries for Equity
FORMULATION AND DEVELOPMENT - How Pharma Companies Are Solving Regulatory Challenges with AI-based Technology
Event Preview - CPHI North America
Event Preview - Excipient World 2024
P.I.N. Points
Advertiser's Index
APR March 2024 - CoverTip01
APR March 2024 - CoverTip02
APR March 2024 - Cover1
APR March 2024 - Cover2
APR March 2024 - 1
APR March 2024 - 2
APR March 2024 - 3
APR March 2024 - 4
APR March 2024 - 5
APR March 2024 - Message from the Editor
APR March 2024 - Editorial Advisory Board
APR March 2024 - BIOPHARMACEUTICALS - Getting to GMP-Quality Biotherapeutics From Today’s Bench-Scale Continuous Manufacturing Systems: A Gap Analysis
APR March 2024 - 9
APR March 2024 - 10
APR March 2024 - 11
APR March 2024 - 12
APR March 2024 - 13
APR March 2024 - MICROBIOLOGY - Critical Behavioral Attributes and the Application of COM-B Framework in Aseptic Processing
APR March 2024 - 15
APR March 2024 - 16
APR March 2024 - 17
APR March 2024 - 18
APR March 2024 - FORMULATION AND DEVELOPMENT - Use of AUC in AAV Analysis in a GMP Setting
APR March 2024 - 20
APR March 2024 - 21
APR March 2024 - 22
APR March 2024 - 23
APR March 2024 - FORMULATION AND DEVELOPMENT - Precision Medicine in Clinical Trials: A Statistical Perspective
APR March 2024 - 25
APR March 2024 - 26
APR March 2024 - 27
APR March 2024 - An Interview with Dan Smithey, PhD President & CEO, Serán
APR March 2024 - 29
APR March 2024 - 30
APR March 2024 - FORMULATION AND DEVELOPMENT - Still Early Days for AI in Drug Discovery...Says Who?
APR March 2024 - 32
APR March 2024 - 33
APR March 2024 - QC Corner - Enhancing Material and Equipment Availability in Production Isolators
APR March 2024 - 35
APR March 2024 - BIOPHARMACEUTICALS - Technologies for Aseptic Filling: The Choice is Clear
APR March 2024 - 37
APR March 2024 - 38
APR March 2024 - 39
APR March 2024 - Vendor Viewpoint - Data Integrity and Rapid Micro Methods: Transforming to a Modern Microbiology Lab
APR March 2024 - 41
APR March 2024 - MICROBIOLOGY - Bacterial Spore Formers in Disinfectant Efficacy Testing
APR March 2024 - 43
APR March 2024 - Partner Perspective - Nanoparticle Technologies: Enablers for Ocular Drug Delivery
APR March 2024 - 45
APR March 2024 - 46
APR March 2024 - 47
APR March 2024 - DRUG DELIVERY - Your Nails and You
APR March 2024 - 49
APR March 2024 - 50
APR March 2024 - 51
APR March 2024 - DRUG DEVELOPMENT - Battling Exorbitance: High Costs in Sickle Cell Gene Therapies and the Imperative of Global Patient Registries for Equity
APR March 2024 - 53
APR March 2024 - 54
APR March 2024 - 55
APR March 2024 - FORMULATION AND DEVELOPMENT - How Pharma Companies Are Solving Regulatory Challenges with AI-based Technology
APR March 2024 - 57
APR March 2024 - Event Preview - CPHI North America
APR March 2024 - 59
APR March 2024 - Event Preview - Excipient World 2024
APR March 2024 - 61
APR March 2024 - P.I.N. Points
APR March 2024 - 63
APR March 2024 - Advertiser's Index
APR March 2024 - Cover3
APR March 2024 - Cover4
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