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.
CLINICAL ANALYTICS SOLUTIONS - Reducing Clinical Cost Budget Variations With State-of-the-Art Data Lifecycle Management Solutions
Srini Anandakumar explores an approach for how sponsor’s operational data, coupled with syndicated data and Real World Evidence data, can enable predictive analytics on clinical cost drivers using a clinical big data and Machine Learning-enabled platform.
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.
EXECUTIVE INTERVIEW - Vetter: Insights on Insourcing Versus Outsourcing in the World of Injectable Manufacturing
Oskar Gold, Vetter’s Senior VP, Key Account Management and Marketing/Corporate Communications, offers his insights on aseptic manufacturing and why careful thought and consideration of different criteria must be applied.
DEVICE REGULATIONS - The New Medical Device Regulation & the Applicability of Article 117 to Medicinal Products
Louise Place focuses on the impact of Article 117 in Europe on the combination of a drug and a device, where the primary mode of action is performed by the drug and the two products are combined in a single, integral product that is exclusively for use in the given combination and not reusable.
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.
EXECUTIVE INTERVIEW - BD Integrated Systems: From Innovation to Integration
Theresa Bankston, PhD, Director of the Technical Services group for BD Medical – Pharmaceutical Systems, discusses the advantages of using an integrated system for complex drug-device combination products.
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.
WEARABLE INJECTORS - BD Wearable Drug Delivery Devices: An Attractive Proposal
Beth DiLauri sets out the fundamental case for the adoption of wearable injectors, outlines the specific barriers they overcome, and describes how the design and development of the BD Libertas(TM) is an attractive proposal for pharma companies.
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.
EXECUTIVE INTERVIEW - JRF Global: Innovating Drug Discovery & Development Solutions for Your Leads
Sameer Navalgund, Global Director at JRF Global, shares his perspective about the on-going trends, current status, and some of the upcoming biggest challenges in the contract services industry.
MARKET BRIEF - Alzheimer’s Disease Market Report (2016-2026)
Akiko Fukui, MSc, indicates that amid several failures, the AD pipeline is large and consists of many novel mechanisms, which makes it an exciting market undergoing rapid changes despite its high risk.
