Formulation Development
SPECIAL FEATURE – Outsourcing Analytical Testing: The Gateway to Drug Manufacturing
Contributor Cindy H. Dubin speaks with several leading analytical labs and CDMOs to review their technologies, services, and new strategies to operate in this ever-changing environment.
FORMULATION FORUM – Sophisticated Formulation Approaches for Insoluble Drug Candidates
Jim Huang, PhD, discusses how a sophisticated drug delivery approach involves collaboration, technical experience, and years of working knowledge in drug development at different stages of the process.
TRANSLATIONAL PHARMACEUTICS – Accelerating Early-Stage Drug Development With Integrated CDMO & CRO Services
Peter Scholes, PhD, describes the current challenges and questions faced by drug developers in accelerating molecules to POC and developing optimized and scalable drug products for patient trials.
EXTRACTABLES & LEACHABLES – A Practical Approach to Extractables & Leachables
Cheryl Johnson says the study of E&L has been evolving for many years, and as pharmaceutical manufacturers, packaging vendors, and regulatory agencies gain more knowledge of extractable compounds, the scope of E&L guidelines grows with it.
TOPICAL DELIVERY – Novel Approaches to Topical Antibiotics Promise Innovation in the Treatment of Acne & Rosacea
Scott Herron, MD, PhD, indicates dermatologists and their patients need a better way to deliver antibiotics effectively without contributing to the resistance problem, and an ideal solution might be a new topical antibiotic formulation.
CLINICAL TRIALS – Spotlight on Quality in Study Startup: Automated Workflows Encourage Upfront Planning & Downstream Improvements in the eTMF
Elvin Thalund, MS, and Craig Morgan say the emphasis on quality is everywhere, but in particular, the study startup portion of clinical trials is a particular hotspot, as it is pivotal to improving study conduct overall.
HUMAN MICROBIOME – Advancing New Frontiers in a Rapidly Emerging Market
Flo Orim, MD, PhD, focuses on biomedical aspects of research, development, and commercial endeavors in the human microbiome space, including essential background information, evolution of the field, and advances in basic research.
REGENERATIVE MEDICINE – Cell Therapy – The Quest for Finding the Cure
Aarti Chitale, MBA, believes as the therapeutic landscape evolves and transitions toward personalized and value-based care, regenerative medicine will play an increasingly important role, and moreover, the success of these therapies offers promising opportunities for previously untreated diseases areas.
GENETIC MODIFICATION THERAPIES – Clinical Applications & Technology Platforms
Laurie L. Sullivan and John Bergin, MS, MBA, say the growing interest on the part of large pharma or biotech companies is driving clinical development of genetic modification therapy candidates, and the rich late-stage pipeline for genetic modification therapy candidates is a driving force of growth.
THERAPEUTIC VACCINES – Exploring the Potential of Combining Cancer Vaccines With Immune Checkpoint Inhibitor Therapy
Nina Baluja, MD, believes advances in our understanding of tumor immunology are rekindling interest in cancer vaccines, particularly in combination with breakthrough immunotherapies, such as immune checkpoint inhibitors.
EXCLUSIVE ONLINE CONTENT
Passage Bio Launches With $115.5 Million Financing to Develop AAV-Delivered Therapeutics
Passage Bio recently debuted with a $115.-million Series A financing led by OrbiMed Advisors and joined by Frazier Healthcare Partners, Versant Ventures, New Leaf Venture Partners, Vivo Capital and Lilly Asia Ventures.
DiaMedica Therapeutics Doses First Patient in Phase 1b Clinical
DiaMedica Therapeutics Inc. recently announced it has initiated dosing patients with chronic kidney disease (CKD) in a Phase Ib clinical study evaluating DM199.
Codexis Announces Nestlé Health Science Exercises Option for Exclusive Global License: Triggers Milestone
Codexis, Inc. recently announced that Nestlé Health Science has exercised its option to obtain an exclusive license for the global development and commercialization of Codexis’ novel, orally delivered enzyme CDX-6114 for the management of phenylketonuria (PKU), an orphan metabolic disorder.
West Annouces Significant Agreements With Swissfillon & scPharmaceuticals
West recently announced it has commenced discussions with two companies regarding the use of West’s proprietary SmartDose drug delivery platform for complex molecules.
uniQure Announces First Patient Treated in Pivotal Trial
uniQure N.V. recently announced it treated the first patient in its HOPE-B pivotal trial of AMT-061, an investigational AAV5-based gene therapy incorporating the patent-protected FIX-Padua variant for the treatment of patients with severe and moderately severe hemophilia B.