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.
ANTIBODY DRUG CONJUGATES - Expansion of Approved Indications Backs 25% Increase in Global Market
Laurie L. Sullivan and Shalini Shahani Dewan, MS, believe technological advancements, the rising incidence of cancer, and an increasing demand for biologic therapies are all factors driving growth in the global ADC market.
THERAPEUTIC FOCUS - Applying the HIV Treatment Model to Hepatitis B – Can a Cocktail Provide a Cure?
James Sapirstein, RPh, says in the ongoing search for a cure to hepatitis B, experts now believe that combining different drugs into a single regimen can work together against HBV and will be the most likely way to achieve a cure.
EXECUTIVE INTERVIEW - BriaCell Therapeutics: Recognizing the Power of Targeted Immunotherapies
Dr. William “Bill” Williams, MD, President and CEO of BriaCell Therapeutics, discusses the value of targeted immunotherapies in the biopharmaceutical industry.
CLINICAL TRIALS - How to Make Clinical Trials Patient Centric: Five Common Sense Steps
Rosamund Round says most companies know they need to make trials more patient-friendly, but few have access to the tools and methodologies to transform their protocol design process. Fortunately, thoughtfully applied common sense practices can create better patient experiences and more robust trials.
AAPS BRIEF - Personalized Medicines for Oral Drug Delivery Devices: Definitely NOT Your Father’s Tablets
Christopher McCurdy, PhD, explains how the incorporation of 3D printing technology, made a reality with the approval of the first 3D-printed pharmaceutical by Aprecia, increased the research and interest around 3D printed formulations, and now, highly sophisticated tablets are being developed.
SPECIAL FEATURE - Injection Devices: As Self-Injection Grows, Drug Delivery Gets Smarter
Contributor Cindy H. Dubin reviews some of the innovative and novel technologies developers are deploying to make self-injection easier and improve patient adherence.
CONTROLLED RELEASE - Informed Selection of Modified-Release Technologies Provides Simpler Oral Dose Regimens
Ronak Savla, PhD, reviews some of the physicochemical and biopharmaceutical characteristics of drugs and how they influence creation of a controlled drug delivery formulation.
DRUG DEVELOPMENT - Cell & Gene Therapies Calling for Innovation in Drug Development
Lev Gerlovin and Pascale Diesel, PharmD, believe there is significant evidence to indicate that we are entering a golden age of gene and cell therapy development, and while industry works to advance these programs, the debate over new approaches in both structuring and financing clinical research is likely to continue.
