FORMULATION FORUM - Rational Design & Development of Lipid-Filled Hard Capsules
Jim Huang, PhD, says with ever increasing percentage of water-insoluble or low permeable new therapeutic entities among drug pipelines, lipid-based delivery systems, together with other main delivery technologies, have become an important tool for the development of those compounds.
THERAPEUTIC PEPTIDES - Continuous Manufacturing of Peptides Could Speed Up Development, Reduce Costs & Improve Quality
Jens Bukrinski, PhD, MSc, says the high-quality, high-process consistency between manufacturing runs and the in-line PAT analytics of the μLOT platform will enable unprecedented robustness of the manufacturing process, significantly retiring the risk of failure to supply due to non-scalability of the manufacturing process.
CANNABINOID THERAPY - NeuroDirect Effects(TM) CBD: Non-Systemic Cannabidiol for Autism Spectrum Disorder
Ronald Aung-Din, MD, says NeuroDirect Effects Technology CBD is particularly attractive in this population as it utilizes the body’s own ECS, and in utilizing a non-systemic therapeutic mechanism, there is less likelihood for long-term negative effects in developing brains of children.
ORAL THIN FILMS - Misconceptions, Advantages & Limitations About an Emerging Drug Delivery System
Srinivasan Shanmugam, PhD, says due to advancements in the science behind OTF design, as well as the predicted increase in OTF market valuation, this drug delivery system is becoming increasingly popular.
EXECUTIVE INTERVIEW - Tedor Pharma, Inc.: A Strategy Shift to Serve Both Generic & Branded Companies
Doug Drysdale, President & CEO of Tedor Pharma, Inc., discusses the FLEXITAB technology, his strategy for managing a shift in business model, and how Tedor is addressing the needs of small- and medium-size companies developing innovative and repurposed small molecules for unmet medical needs.
NATURAL LANGUAGE PROCESSING - How Life Sciences Companies Are Leveraging NLP From Molecule to Market
Jane Z. Reed, PhD, MA, discusses some of the challenges facing pharma researchers and executives; the benefit NLP can bring; and some specific customer-use cases (covering patent landscaping, gene disease associations, access to safety silos, and more).
DEVELOPMENT TIMELINES - Drug Development Times, What it Takes - Part 3
Josef Bossart, PhD, analyzes the development and review times of the US FDA’s new drug approvals (NDA and BLA) for the period of 2010 through 2018.
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.
