Featured Articles
SPECIAL FEATURE - Injection Devices: Designing Simplicity, Safety & Adherence Into One Delivery System
Contributor Cindy Dubin, in this annual report, speaks with industry innovators and takes a deep dive into the myriad injectables that are currently in development or recently introduced to the market.
DELIVERY DEVICE - Aerosol Deposition Characterization of Innovative PureHale® Technology Targeting the Upper Airways
Degenhard Marx, PhD, Fotos Stylianou, PhD, and Stavros Kassinos, PhD, explain how PureHale provides a modern device option for the delivery of a fine mist for a variety of solutions to only the upper respiratory tract without significant deposition in the lungs and lower airways.
FORMULATION DEVELOPMENT - A Quick Approach for Evaluation of Drug-Excipient Compatibility: Case of Acetylsalicylic Acid
Masumi Dave, PhD, and Rollie Fuller monitor in this study ASA hydrolysis in different formulations using UPLC and TAM with the objective of comparing these methods for agreement, speed, and efficiency in predicting drug stability. In parallel, they assess the impact of the excipient choices on the stability of ASA.
GENE THERAPY - Solving the Puzzle: Aligning the Pieces of Gene Therapy & Creating Success for Patients
Sue Washer, MBA, reviews the various elements that must come together in developing safe, effective, and commercially viable viral-based gene therapies.
NASAL SPRAY BIOEQUIVALENCE - Between-Batch Bioequivalence (BBE): An Alternative Statistical Method to Assess In Vitro Bioequivalence of Nasal Product
Jonathan Bodin, Stéphanie Liandrat, Gabriel Kocevar, and Céline Petitcolas explain how one way to prove equivalence, without long and expensive clinical trials, is to conduct in vitro bioequivalence evaluation between the Innovator (Reference product) and the proposed generic (Test product).
DRUG DEVELOPMENT EXECUTIVE - Poseida Therapeutics: Creating the Next Wave of Cell & Gene Therapies With the Capacity to Cure
Eric M. Ostertag, MD, PhD, CEO of Poseida Therapeutics, discusses the company’s innovative approach to develop safer, more effective, accessible and affordable cell and gene therapies for patients.
DIGITAL CUSTOM PLATFORM - PCI Pharma’s Digital Transformation: Reaching New Levels of Customer Experience
Wayne Hull and Rebecca Coutts, PhD, explain how incorporating digital transformation as core to their company’s business strategy was a decision based on increasing evidence that investment in digital solutions provides real and measurable returns.
HOT MELT EXTRUSION - API Bioavailability: Suspending Hydrophobic Drugs in a Solid Solution
Ameya Deshpande, MS, says for APIs that are compatible with HME, careful attention to the formulation quality attributes that include excipient selection, dosage form design, analytical testing, and stability are required to maximize the efficacy and quality of the final product.
ADVANCED STOPPER SOLUTION - PremiumCoat®: Proven Compatibility With Current Vial Standards
Sebastien Cordier, Bruno Morchain, and Estelle Verger review how PremiumCoat combines state-of-the art elastomer formulation with market-proven film-coating technology to create a highly advanced stopper solution.
WEARABLE PLATFORM - Next-Generation Wearable Drug Delivery: Prefilled Devices Provide a Truly Patient-Centric Solution
Mindy Katz says with increasingly positive expectations for the wearable device market to provide an intuitive and user-friendly drug delivery experience, her company continues to optimize its wearable platform solution, investigating new technologies and processes to improve the offerings for patients and providers.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Meeting Demand for Biologics & Specialty Drugs
Contributor Cindy Dubin highlights the formulation development and manufacturing offerings from some of the leading CDMOs to address a myriad of challenges – from complex compounds to poor solubility to dual-release profiles.
FORMULATION FORUM - Nanosuspension Dosage Forms: Product Development & Scale Up
In this month’s column on formulation development challenges, Jim Huang, PhD, discusses nanosuspensions prepared via the top-down process, ie, the wet milling process.
OPEN INNOVATION PLATFORM - Beyond the Rule of Five: Scouting for Novel Formulation Approaches to Enable the Subcutaneous Application of Molecules With Poor Drug-Like Properties in Preclinical Research – Facilitated Through opnMe.com
Ines Truebenbach, PhD; Menorca Chaturvedi, PhD; Markus Koester, PhD; and Achim Grube, PhD, are looking for proposals that would provide innovative formulation approaches to facilitate the subcutaneous application of bRo5 molecules in a preclinical setting.
DRUG DEVELOPMENT EXECUTIVE - Enteris BioPharma: How to Build a Preferred CDMO Partner
Dr. Paul Shields, COO of Enteris BioPharma, discusses the changing face of the CDMO industry and how his company plans to leverage its newly expanded CDMO operations to take advantage of a variety of growth opportunities to build deeper partnerships.
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.
