Featured Articles
PRODUCT DEVELOPMENT STRATEGY - ESCP, Estimating Product Performance Part 4 – Building Playgrounds & Fences
Josef Bossart, PhD, introduces, in a series of short articles, a qualitative model to help understand and visualize the potential of a product with prescribers, patients, and payors. This simple model can help weed out product ideas that may at first glance seem attractive but offer little potential in the real world.
GENE-EDITING TECHNOLOGY - Expanding the CRISPR Toolbox for Genome Editing
Ashley Jacobi says while there are many ever-improving tools available to scientists performing ground-breaking research, and the potential of CRISPR genome editing appears limitless, there remain challenges that need to be overcome to realize the technology’s full potential.
ORAL THIN FILMS - The Quest for a Magic Pill May Not Be a Pill at All
Robert Davidson says there have been significant advances in clinical development of this novel drug delivery system, and the technology is rapidly moving from just a theory to practical real-world application.
CLINICAL TRIALS - Statistical Challenges in Preserving Integrity of Ongoing Clinical Trials During the COVID-19 Pandemic
Karen Ooms, Msc, believes the consequences of this pandemic on ongoing clinical trials can be objectively assessed, and with the correct mitigation strategies put in place, study integrity can be preserved, optimizing use of the available resources for both patients and sponsors.
PRECLINICAL TESTING - Expanding Opportunities in Implantable Medical Devices With Optimized Preclinical Studies
Jaleel Shujath outlines the growing importance of implantable devices in clinical settings and our daily lives, highlighting the current state of preclinical testing and the regulatory barriers faced by device developers.
DRUG DEVELOPMENT EXECUTIVE - Quotient Sciences: Breaking Down the Silos Between Drug Substance & Drug Product
Mark Egerton, PhD, CEO of Quotient Sciences, discusses how integrating these capabilities cuts through functional silos, simplifies drug development, and affirms Quotient’s belief that molecules need to become cures, fast.
GLOBAL REPORT - 2020 Global Drug Delivery & Formulation Report: Part 4, The Drug Delivery and Formulation Pipeline
In part 4 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, provides pipeline snapshots and comparisons for a number of parameters that are of most interest to drug delivery and formulation professionals – Disease Area, Molecule Type, and Delivery Route.
SPECIAL FEATURE - PFS & Parenteral Manufacturing: How COVID-19 Changed the Market
Contributor Cindy Dubin explores how device developers and parenteral contract development and manufacturing organizations (CDMOs) are addressing current challenges, as well as advancements in customized device design, the continuous effort to incorporate safety and human factors, and how COVID-19 is shaping the future of the market.
FORMULATION FORUM - Considerations in Formulation Development of Injectable Solutions
Jim Huang, PhD, reviews how injectable solutions offer an attractive alternative to oral dosage form due to fast onset, reproducible PK/efficacy profile, high bioavailability as a result of bypassing the oral absorption barrier, and suitability of administration under hospital setting.
GLOBAL REPORT - 2020 Global Drug Delivery & Formulation Report: Part 3, Notable Drug Delivery & Formulation Transactions & Technologies of 2020
In part 3 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on several notable drug delivery and formulation transactions and technologies.
EXCLUSIVE ONLINE CONTENT
Unicycive Therapeutics Announces Orphan Drug Designation Granted for UNI-494 for the Prevention of Delayed Graft Function in Kidney Transplant Patients
Unicycive Therapeutics, Inc. recently announced the US FDA has granted orphan drug designation (ODD) to UNI-494 for the prevention of Delayed Graft Function (DGF) in kidney….
2019 Analytical Testing in Drug Development eBook - Regulations Help Propel Testing Market
This e-Book showcases the various types of services that leading testing companies offer and how they are helping industry comply with regulations to get their products approved and commercialized.
EXECUTIVE INTERVIEW - Oasmia Pharmaceutical: Commercializing Technologies While Pursuing the US Market
Julian Aleksov, Executive Chairman of Oasmia Pharmaceutical, discusses his company’s efforts to enter the US market, its strategy to increase commercial adoption, and why it believes its underlying drug delivery system technology is significant not only within the oncology sector, but the entire pharmaceutical industry.
LIPOPHILIC SALTS - Opportunities & Applications in Oral Drug Delivery
Hywel Williams, PhD, Annabel Igonin, PhD, David Vodak, PhD, and Hassan Benameur, PhD, believe lipophilic salts are being explored in a number of different areas and one interesting application is their potential to boost API loading in lipid formulations.