Featured Articles
MARKET BRIEF - Allergic Rhinitis Immunotherapy: Opportunity Analysis & Forecasts to 2028
Rose Joachim, PhD, indicates that while a wide variety of OTC therapies exist for the temporary abatement of AR symptoms, allergen-specific immunotherapy is the only truly disease-modifying therapy available for AR.
STANDARD OPERATING PROCEDURES - How Writing an Effective SOP Can Influence Compliance & Build a Better Organization
Heidi Stuttz provides a common outline used in many companies and explores the essential elements of a well-written SOP that can be effective whether developing one from scratch or remediating a current system of SOPs that will foster success in every area of your company in which it is implemented.
CLINICAL STUDY REPORTING - Assessing the Value of Interim Analyses in Clinical Trials
Paul Stark, MS, ScD, reviews how and when an interim analysis would be valuable and how, with examples and outcomes, it can be applied in a clinical trial setting.
GLOBAL REPORT – 2019 Global Drug Delivery & Formulation Report: Part 2, Notable Drug Delivery & Formulation Product Approvals of 2019
In part 2 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on notable drug delivery and formulation product approvals.
SPECIAL FEATURE - Improving Bioavailability & Solubility: Understand Your Molecule
Contributor Cindy H. Dubin asked several leading companies about how they are currently overcoming today’s most pressing bioavailability and solubility challenges for their pharma clients.
CLINICAL TRIALS - Leaning Into Investigator Sponsored Trials
Martin Lehr, MA, says given the capital and intellectual capacity constraints within large pharmaceutical companies and start-ups, ISTs provide an important path to unlocking the therapeutic value of developmental and marketed drugs.
INTRATUMORAL DELIVERY - Combining Local & Systemic Treatments: Could Immuno-Oncology Finally Enable Local Intratumoral Delivery?
Lewis H. Bender, MA, MBA, says cancer is a local and systemic disease, and new forms of local treatment, such as intratumoral dosing coupled with systemic immunotherapy, are being explored.
DEVELOPMENT TIMELINES - Drug Development Times, What it Takes - Part 2
Josef Bossart, PhD, reviews the Development and Review Times associated with new molecular entity (NME) approvals throughout the 2010 to 2018 period.
CONTAINER CLOSURE INTEGRITY - Mitigating Risk in Pharmaceutical Manufacturing With Visually Inspected Components
Olga Laskina, PhD, discusses visible particles and manufacturing defects of the packaging components as well as the impact these defects can have on container closure integrity and functional characteristics.
EXECUTIVE INTERVIEW - Noxopharm: Introducing a Novel & Potentially Transformative Drug Candidate in the Treatment of Cancer
Graham Kelly, Founder, Executive Chairman, and CEO of Noxopharm, discusses the company’s innovative approach to cancer treatment.
BIOSIMILAR DEVELOPMENT - Biosimilar Biological Products: Development & Applications
Kaiser J. Aziz, PhD, provides an in-depth overview of biosimilar products development and the evaluation criteria for FDA approval.
GLOBAL REPORT - 2019 Global Drug Delivery & Formulation Report: Part 1, a Global Review
In part 1 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on a global review of 2019 product approvals.
HIGH PURITY EXCIPIENTS - A Simple Solution to a Complex Problem
William Small, PhD, and Arsalan Khan say drug degradation can have toxicological effects in many instances, and it is imperative that this mechanism be minimized as much as possible. The best solution to this is to ensure that appropriate ingredients, both high in quality and purity, are chosen and used throughout the entire drug product lifecycle.
FORMULATION FORUM - Rational Design & Development of Long-Acting Injectable Dosage Forms
Due to the advantages of parenteral sustained-release drug delivery (also known as long-acting injectables, LAIs) different types of sustained-release injectable delivery systems have been….
SPECIAL FEATURE - Outsourcing Analytical Testing: Novel Services Elicit Consistent, Quantifiable, & Faster Results
Contributor Cindy H. Dubin, in her latest report, describes some novel analytical testing services aimed at ensuring quality and safety, and in some cases, speeding the process and saving money.
AUTOINJECTOR PLATFORM - Identifying New, Enhanced Device Delivery Solutions for Chronic Diseases
Karima Yadi, MSc, and Lionel Maritan, MSc, believe identifying enhanced needle solutions and offering integrated system solutions to serve the chronic disease market is a great step toward addressing improved patient outcomes and adherence.
PERSONALIZED MEDICINE - Personalizing Cancer Immunotherapy: Trends in Biomarker Discovery
Emile Youssef, MD, PhD, says due to tumor heterogeneity, the plasticity and diversity of cancer cells, and a multitude of other factors, biomarker development is a challenge, and thus explores four trends in cancer biomarker discovery.
DEVELOPMENT TIMELINES - Drug Development Times, What it Takes - Part 1
Josef Bossart, PhD, explains how accurately estimating a product’s clinical development timelines is more than simply adding up the individual timelines, almost always optimistic. You need to “know” the numbers, not just calculate them.
IMAGE-BASED CHARACTERIZATION - Non-Invasive, Quantitative Characterization of Lyophilized Drug Product Using Three-Dimensional X-Ray Microscopy Analytics
Shawn Zhang, PhD, Johnathan Goldman, PhD, Xiaodong Chen, PhD, et al present a new method that not only characterizes quantitatively the microstructures of the lyophilized drug samples, but also presents the potential to correlate the microstructures with physical properties to optimize parameters in drug formulation, cycle development, process scale-up, stability control, and administration.
BIOPROCESSING - A New Era: Why the Time Has Come for Biopharma to Move to Continuous Bioprocessing
Dr. Martin Smith explains why the pharma industry must embrace continuous processing if it’s to survive and thrive in an era of global personalized medicine.
