Drug Development Executive: Amit Patel, President of Capsugel’s Dosage Form Solutions business unit, speaks about the formulation challenges facing the industry and the increasing pressure on companies to remain competitive in today’s dynamic marketplace.
Mark Perkins, PhD, reviews some of the important factors involved, and highlights the advantages of including recombinant human albumin to stabilize protein therapeutics with reference to a recent case study.
BIOAVAILABILITY ENHANCEMENT – Navigating a Broad Spectrum of Solubilization Technologies: Part I of III
In the past two columns, The Second Quadrant focused on excipients and the roles they play in the quest to overcome bioavailability challenges of poorly…
Stefan Hellbardt, PhD, and Degenhard Marx, PhD, focus their review on the trends in topical skin medication, the impact on primary packaging, and possible dispensing solutions.
SPECIAL FEATURE – Transdermal, Topical & Subcutaneous Drug Delivery: Extending Pipelines & Improving Self-Administration
Contributor Cindy H. Dubin explores how the movement of home care and self- administration is pushing the development of this growing sector in drug delivery.
In June’s edition of The Second Quadrant, we heard from leading excipient providers about challenges faced directly related to formulating with excipients for greater bioavailability.…
FORMULATION DEVELOPMENT – Amorphous Dispersion Formulation Development: Phase-Appropriate Integrated Approaches to Optimizing Performance, Manufacturability, Stability & Dosage Form
John Baumann, Dan Dobry, and Rod Ray, PhD, review the development and use of amorphous SDDs and the testing methodologies used to optimize the formulation and spray-drying process for performance, manufacturability, stability, and incorporation into final dosage forms.
GENOMIC BIOMARKERS – EGFR Mutations, Apoptosis & Gefitinib Response: A Model for Integrating Genomic Biomarkers Into Successful Precision Medicine
Sirosh Bokhari, PhD, says by not recognizing the importance of integrating biomarkers early in drug development and not considering companion diagnostics as an ultimate goal, companies would not be ready to select a companion diagnostic partner and negotiate agreements with long-term implications.
Shunji Haruta, PhD, examines a dry-powder carrier technology and line of delivery devices that help formulations meet the criteria for rapid action and successful delivery of pain therapies.
THERAPEUTIC FOCUS – Evaluation of a Needleless Injection Technique for Treatment of Peyronie’s Disease: a Feasibility Case Study
Jeffrey Marotte, MD, FACS, presents a proof of concept that the Madajet may be a suitable instrument to inject medication into Peyronie’s plaques.
EXCLUSIVE ONLINE CONTENT
Kymab & LifeArc Enter Strategic Partnership to Discover New Medicines Using Kymab’s IntelliSelect Technologies
The agreement will enable LifeArc to enhance its antibody drug discovery capabilities into new medicinal products with Kymab’s proprietary IntelliSelect technology platforms.
Loxo Oncology, Inc. recently entered into a strategic partnership agreement with Amoy Diagnostics Co., Ltd. and PREMIA Holdings (HK) Ltd.
Aclaris Therapeutics, Inc. recently announced positive results from a Phase 2 open-label clinical trial of ATI-502 (AGA-201), an investigational topical Janus Kinase (JAK) 1/3 inhibitor, in patients with androgenetic alopecia (AGA), a condition commonly known as male/female-pattern baldness.
iBio, Inc. recently announced the activation of its new cGMP sterile fill-finish services operation via the signing of a supply agreement with a clinical-stage biopharmaceutical company developing breakthrough gene and cell therapies.
Gilead Sciences, Inc. and Nurix Therapeutics, Inc. recently announced a global strategic collaboration to discover, develop, and commercialize a pipeline of innovative targeted protein degradation drugs for patients with cancer and other challenging diseases.