APR March 2024 - 27
« FORMULATION AND DEVELOPMENT
treatment plans. For instance, a dearth of standardized formats for
sharing and exchanging healthcare data can hamper interoperability.
In addition, disparate healthcare systems and platforms often rely on
different data structures, which impedes seamless data integration.
Integrating precision medicine's tools and technologies into existing
healthcare systems and workflows is a complex process, but achieving
compatibility and interoperability between different technologies is
critical if clinicians wish to implement them successfully.
Bridging the gap between scientific and clinical practice presents
another barrier, as healthcare providers may face difficulties
incorporating precision medicine into their workflows. Integrating
data from various sources, such as electronic health records (EHRs),
genomic databases, and wearable devices, can present challenges in
creating unified and comprehensive patient profiles. Making precision
medicine approaches part of routine clinical practice can also disrupt
well-established workflows.
These hurdles can be overcome. The complexity of genetic, clinical,
and environmental data associated with precision medicine requires
sophisticated analytical methods, and analyzing and interpreting
large datasets with diverse variables means adopting computational
techniques and expertise. Education and training are necessary to
give healthcare professionals an understanding of precision medicine
tools and technologies. Clinicians will want to see plenty of evidence
and validation of precision medicine interventions before fully
incorporating them into patient care.
These challenges underscore the complex nature of precision
medicine. Addressing these potential issues will require researchers,
healthcare providers, policymakers, and technology providers to work
together to overcome regulatory challenges and ensure precision
medicine is integrated into patient care effectively and ethically.
Ultimately, statistics are pivotal in unraveling the unique genetic,
environmental, and lifestyle factors influencing individual health. This
statistical perspective transforms the treatment landscape, allowing
healthcare to evolve from a one-size-fits-all model to a nuanced,
tailored approach, creating a paradigm shift in how medical care
is viewed and delivered. It's a journey into the future of healthcare,
where statistical precision becomes the cornerstone in developing
more effective, targeted, and patient-focused interventions, heralding
a new era in the evolution of medical research.
References
1.
2.
3.
4.
Statista. Total precision medicine treatment spending worldwide from 2022 to 2027.
Available at https://www.statista.com/statistics/1420946/spending-on-precisionmedicine-treatments-globally/.
Accessed February 12, 2024.
Zlobina K, Jafari M. The role of machine learning in advancing precision medicine with
feedback control. Cell Rep Phys Sci. 2022; 3(11):101-149.
Delpierre C, Lefevre T. Precision and personalized medicine: What their current definition
says and silences about the model of health they promote. Implication for the development
of personalized health. Front Sociol. 2023; 8:1112-1159.
National Human Genome Research Institute (NHGRI). Precision medicine
definition.
Available
at
https://www.genome.gov/genetics-glossary/PrecisionMedicine#:~:text=Precision%20medicine%20(generally%20considered%20
analogous,related%20to%20their%20medical%20management.
Accessed January 30,
2024.
5.
6.
7.
8.
The White House, President Barack Obama. The Precision Medicine Initiative information
page. Available at https://obamawhitehouse.archives.gov/precision-medicine. Accessed
Jan. 30, 2024.
American Cancer Society. Precision or personalized medicine information page. Available
at https://amp.cancer.org/cancer/managing-cancer/treatment-types/precision-medicine.
html. Accessed Jan. 29, 2024.
Johnson K, Wei WQ. Precision Medicine, AI, and the Future of Personalized Health Care. Clin
Transl Sci. 2021; 14(1):86-93.
Zlobina K, Jafari M. The role of machine learning in advancing precision medicine with
feedback control. Cell Rep Phys Sci. 2022; 3(11):101-149.
Author Biography
Shivashankar Thati, M.S., GSTAT, is a clinical statistical
analyst specializing in clinical trials and new drug
development. Shivashankar holds a master's degree in
chemistry from Texas A&M University and is working on
Figure 3. A statistical perspective on the clinical trial process
will transform the treatment landscape, evolving the healthcare
model to a data-driven and patient-centric approach.
a second master's degree in applied statistics at Villanova University.
His contributions to the industry have been recognized by numerous
organizations, publications, and universities. For more information,
contact ssthati@outlook.com.
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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