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.
DRY-POWDER THERAPEUTICS - Respiration Inspiration: Local Treatment of Lung Cancer by Dry-Powder Inhaler
Philip Kuehl, PhD, and Kimberly B. Shepard, PhD, describe the formulation and manufacturing considerations for development of dry-powder therapeutics for local treatment of lung cancer. Two case studies are presented in which two approved drugs are successfully formulated for DPI administration to the lung.
EXECUTIVE INTERVIEW - Micropore: Innovation in Drug Delivery
Dai Hayward, CEO at Micropore, discusses his company’s expertise and underpinning technology in the development of safe, efficient, and scalable continuous manufacturing of drug delivery solutions.
PRODUCT DEVELOPMENT STRATEGY - ESCP, Estimating Product Performance Part 3 – Mind the Axle
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.
EXECUTIVE INTERVIEW - Lexaria Bioscience Corp.: Stretching Its Legs
John Docherty, President of Lexaria, discusses how the company’s recent uplist to the NASDAQ has resulted in its largest capital injection to date, which will allow it to focus on preclinical and clinical testing programs for DehydraTECH formulations across three main areas of interest.
INJECTABLES MANUFACTURING - Manufacturing Injectable Devices: Why Modern Means Modular
Raffaele Pace, MMe, MBA, reviews how today’s drug delivery devices must be more mobile, less intrusive, and simpler than ever before – all while remaining cost competitive.
EMULSIFICATION TECHNOLOGY - Microspheres for Sustained Release
Alex Kerr, Sam Trotter, and Poppy Maley explain how recent advances in biopolymers and manufacturing technology now enable formulation of injectable drug products to be tailored at will to achieve a target bioavailability in a shorter development time with robust and low cost of manufacture.
SPECIAL FEATURE - Excipients: Far From Inactive
Contributor Cindy Dubin speaks with several innovative excipient companies that assert novel excipients – agglomerated, co-processed, and multifunctional – actively and safely affect formulation stability, solubility, and bioavailability as well as foster faster drug disintegration.
GLOBAL REPORT – 2020 Global Drug Delivery & Formulation Report: Part 2, Notable Drug Delivery and Formulation Product Approvals of 2020
In part 2 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on notable drug delivery and formulation product approvals.
FORMULATION FORUM - Understanding of Amorphous Solid Dispersions & Their Downstream Development
Jim Huang, PhD, discusses how understanding the properties of ASDs and their relationship to downstream product scale up, stability, and in-vivo performance is critical to successfully utilize them for drug delivery of insoluble drugs in early development and commercialization in a timely and cost-effective manner.
INHALATION DELIVERY - Inhaled Drug Development: Optimizing Delivery
Sandy Munro, PhD, Nikki Willis, and Geraldine Venthoye, PhD, believe selecting the delivery device/platform on the basis of patient needs, nature of disease, and opportunities for accelerating the proof-of-concept or early clinical stages by using fast-to-clinic approaches can help to accelerate the project through later-stage development by combining the approach with seamless scalability, designing in manufacturability, and an appropriate manufacturing strategy.
BIOSIMILAR DEVELOPMENT - Guidance on Biosimilar Interchangeability: The Debate Over Drug Delivery Devices
Darren Mansell says as early experience in following this guidance has recently matured, some issues have arisen that may impede best available outcomes for patients, one of which is the question of whether “interchangeability” guidance may stifle innovation (and therefore improved patient experience) in drug delivery devices.
OPEN INNOVATION PLATFORM - Incentivizing Drug Delivery Research Using an Open Sharing Platform
Keith R. Horspool, PhD, Shirlynn Chen, PhD, and Markus Koester, PhD, discuss an open innovation platform to stimulate scientific understanding, and development of potential new technologies, for delivery of compounds with challenging solubility by offering a set of more contemporary poorly soluble drugs free-of-charge for independent research activities.
PRODUCT DEVELOPMENT STRATEGY - ESCP, Estimating Product Performance Part 2 – Choosing a Seesaw
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.
EXECUTIVE INTERVIEW - Celanese: Better Therapeutic Outcomes From Better Drug Delivery
Laura Brand, Vice President of Celanese’s Medical & Pharmaceutical Business, discusses her company’s drug delivery platform and the value it brings to the industry.
NUCLEAR β-CATENIN INHIBITOR - TBL1 - A Novel Target for Safe & Effective Blockade of the Nuclear β-catenin Signaling Pathway
Ruolan Han, PhD, explains how targeting TBL1/TBLR1 enables specific silencing of oncogenic Wnt target gene expression without affecting other necessary cellular functions that are disrupted when targeting higher up the Wnt pathway.
CLINICAL TRIALS - Considering Recurrent Events in Clinical Trials Statistical Analysis
Jennifer Rogers discusses how non-fatal recurring events, such as asthma attacks, epileptic seizures, and hospitalization for heart disease, have a certain manner in which they should be handled in clinical trials.
