Pharma Articles
Renowned pharmaceutical firm executives and other experts from around the world write articles on current topics in the industry. The section of articles on the pharmaceutical sector focuses on contemporary and expanding challenges in fields such as pharmaceutical R&D, drug discovery, clinical trials, pharmaceutical production, biopharmaceuticals, and information technology.
The Commercial Future of Personalized mRNA Cancer Vaccines
There is no such thing as a batch in this therapeutic class An individualized neoantigen vaccine begins with a fragment of one patients resected tumor is designed against mutations that exist nowhere else and is manufactured released and shipped for a single person who is already on the calendar
Adaptive Clinical Trials: Building Flexibility into Modern Drug Development
For two decades adaptive design was sold to pharmaceutical boards as a promise In it is closer to standard vocabulary few protocol synopses reach a development committee without some flexible element written into them What has not kept pace is execution Adaptation remains concentrated in the cheape...
Strategic Capacity Planning for Biologics and Next-Generation Therapeutics
Almost every major decision a pharmaceutical chief executive makes can wait for evidence Capacity cannot A largemolecule facility takes somewhere in the region of five years to move from board approval to validated commercial
Quality in Pharmaceutical Manufacturing
Quality is the cornerstone of pharmaceutical manufacturing and directly influences patient safety product efficacy regulatory compliance and organizational reputation Pharmaceutical products are consumed by patients whose health depends on the consistent quality of every manufactured batch
AI-Powered Clinical Data Management: Improving Quality, Speed, and Regulatory Compliance
A latephase pharmaceutical trial is in operational terms a data business wearing a clinical coat Research from the Tufts Center for the Study of Drug Development puts the average Phase III study at roughly million data points about three times the volume collected a decade earlier
Analytical Testing in Pharma and Biotech: Applications, Challenges, and Future Perspectives
Analytical testing is a fundamental component of the pharmaceutical and biotechnology industries and serves as the scientific basis for assessing product quality throughout the product lifecycle It provides reliable data to demonstrate that raw materials
Digital Twins in Pharma Manufacturing: Optimizing Process Performance
For most of the last decade the digital twin occupied an awkward position in pharmaceutical manufacturing intellectually attractive operationally optional Engineering teams built simulations quality teams ignored them
Cosolvency as Drug Delivery: PEGs, Glycerin and Polysorbates
Poor aqueous solubility remains one of the defining constraints of pharmaceutical development Around per cent of marketed drugs and a still larger share of pipeline candidates
Generative AI in Clinical Operations: Optimizing Protocol Development and Site Selection
The pharmaceutical industry has industrialised almost every part of drug development except the part that consumes the most money Target identification is computational Molecule design is computational Manufacturing is instrumented to the batch record Yet the clinical protocol the single document t...
Next-Generation RNA Therapeutics: Expanding the R&D Landscape Beyond Vaccines
For most of the pharmaceutical industry RNA walked into the boardroom in wearing a vaccine badge The badge has proved difficult to remove and it has become a strategic liability It encourages executives to treat RNA as an infectiousdisease capability attached to a pandemicshaped demand curve to be...
