June 2021

COVER

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.

FEATURES

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.

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.