Formulation Development
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.
TRANSDERMAL DELIVERY – Effect of Skin Model on In Vitro Performance of an Adhesive Dermally Applied Microarray – ADAM(TM) – Coated With Zolmitriptan
Hayley Lewis and Mahmoud Ameri, PhD, assessed Strat-M, full-thickness, and dermatomed ex vivo skin on percutaneous delivery of zolmitriptan from innovative drug-coated dermally applied microprojections that target the epidermal/dermal layer for fast and efficient delivery.
ARTIFICIAL INTELLIGENCE – 3Ds Powering AI in Drug Discovery – Domain Expertise, Deep Learning & Data
Liran Belenzon and Simon Smith counter skepticism about AI with concrete data on recent exponential progress, provide examples of companies applying these advances to drug discovery, and show how those combining domain expertise, deep learning, and proprietary data are excelling.
BUCCAL FILMS – Better Drug Release & Patient Experiences With Buccal Films
Robert Davidson and Jessica Rousset explain how buccal administration further represents a better alternative to injections or tablets for those patients who have difficulty swallowing.
EXCLUSIVE ONLINE CONTENT
Soligenix Achieves Significant Enrollment Milestone for its Pivotal Phase 3 Clinical Trial
Soligenix, Inc. recently announced today it has reached a significant milestone in the Phase 3 clinical study (the “DOM-INNATE” study) for SGX942 (dusquetide) in the treatment of oral mucositis in patients with head and neck cancer (HNC).
Paragon Bioservices to be Acquired for $1.2 Billion
Catalent, Inc. and Paragon Bioservices, Inc. and Catalent Inc. recently announced they have entered into a definitive agreement under which Catalent will acquire Paragon for $1.2 billion.
BioAtla & BeiGene Form Worldwide Development & Commercialization Collaboration
BioAtla , LLC and BeiGene, Ltd. recently announced the two companies have entered into a global co-development and collaboration agreement for the development, manufacturing, and commercialization of BioAtla’s investigational CAB CTLA-4 antibody (BA3071).
GeneDesign Joins Ajinomoto Bio-Pharma Services & Opens Oligonucleotide API Development Center
Ajinomoto Bio-Pharma Services, a leading provider of biopharmaceutical contract development and manufacturing services, recently announced that GeneDesign, Inc. has joined the global organization.
CURE Pharmaceutical to Acquire Chemistry Holdings Inc.
CURE Pharmaceutical, an innovative drug delivery and development company, recently announced that it has agreed to acquire Chemistry Holdings Inc., a formulation technology company that is developing innovative delivery systems for a variety of industries, in an all-stock transaction.