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.
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.
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.
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.
EXCLUSIVE ONLINE CONTENT
Catalent to Open Second Clinical Supply Facility; Enables Broader Integrated Solutions for Global & Local Customers
Catalent Pharma Solutions recently announced its plans to invest $2.5 million in a new, second clinical supply facility in Shanghai, China, due to open in early 2019. When completed, the facility is expected to employ 100 people and will double Catalent’s total clinical storage capacity in China.
PCI Clinical Services Announces Site Expansion to Support Growth & Flexibility
PCI Pharma Services, a full-service provider of specialist outsourced drug manufacturing, clinical trial services, and commercial packaging to the global biopharmaceutical industry, recently announced the expansion of its Clinical site at Rockford, IL.
Enable Injections Enters Strategic Partnerships With UCB & Apellis
Enable Injections, Inc., a patient-centric drug delivery combination product company developing advanced wearable devices for subcutaneous delivery of high-volume therapeutics, recently announced it has entered into development agreements with Apellis Pharmaceuticals, and most recently, UCB.
Organovo Partners With IIAM on Multi-Year Clinical Biomaterial Sourcing Agreement
Organovo Holdings, Inc. recently announced it has entered into a cell and tissue clinical sourcing agreement with the International Institute for the Advancement of Medicine (IIAM).
Verona Pharma Completes Enrollment in Phase 2 Clinical Trial
Verona Pharma plc recently announced it has enrolled the last patient in its Phase 2 clinical trial evaluating the effect of nebulized RPL554 as an add-on to dual therapy using long-acting anti-muscarinic/long-acting beta2-agonists (LAMA/LABA) and triple therapy (LAMA/LABA with an inhaled corticosteroid) in the maintenance treatment of patients with moderate to severe COPD.
Sanofi & Denali Therapeutics to Develop Multiple Molecules; $125 Million Upfront
Sanofi plans to collaborate with Denali Therapeutics Inc. on the development of multiple molecules with the potential to treat a range of neurological and systemic inflammatory diseases.
Nemera’s e-Novelia® Ophthalmic Add-On Wins “Excellence in Pharma: Drug Delivery Devices” Award
A team of industry experts awarded Nemera’s electronic add-on for ophthalmic droppers with a prestigious CPhI Award for Best Drug Delivery Device in its category.
Alcami Helps Medicines Development for Global Health Secure FDA Approval
Alcami Corporation recently announced its collaboration with Medicines Development for Global Health (MDGH), a not-for-profit Australian biopharmaceutical company dedicated to the development of affordable medicines and vaccines for neglected diseases prevalent in low and middle-income countries.
Novel Oral Therapies Could Transform the Standard-of-Care for DME & Lead to Preventative Treatment
Verseon, a technology-based pharmaceutical company, is presently developing multiple novel, small-molecule inhibitors of plasma kallikrein for the treatment of DME. Plasma kallikrein is a central mediator in the kallikrein-kinin system (KKS), a well-known pathway addressing an underlying cause of DME.
VistaGen Therapeutics Acquires Worldwide Rights to Develop & Commercialize First-in-Class Intranasally Administered Drug
VistaGen Therapeutics Inc. recently announced it has exercised its option to acquire from Pherin Pharmaceuticals, Inc. the exclusive license for worldwide rights to develop and commercialize PH10, a first-in-class, intranasally administered neuroactive steroid (a pherine), with rapid-onset antidepressant effects for treatment of major depressive disorder (MDD) demonstrated in a Phase 2a study
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