TRAINING DEVICES – Best Practices & Considerations in Developing Effective Training Devices for Injectable Healthcare Markets
Joe Reynolds says training devices are often used to create consistent onboarding experiences for patients through the use of novel technologies and mechanisms that fully simulate the mechanical aspects of the injection experience. And while these devices appear to be fairly simple at first glance, numerous design and engineering challenges must be addressed.
Contributor Cindy H. Dubin spoke with some of the world’s leading device developers about their current injection technologies and how their devices are addressing the current trends and opportunities in the industry.
Ronak Savla, PhD, PharmD, and Jeffrey E. Browne, PhD, indicate formulation screening, development, scale-up, and commercial manufacture of LBDDSs require considerable expertise, and choosing an outsourcing partner with experience and a proven track record is critical.
ORALLY DISINTEGRATING TABLETS – Designed With Patients in Mind: The Art of Patient-Centric Drug Formulation
Anthony Recupero, PhD, believes by partnering with an expert in drug delivery technology, whose portfolio features a broad range of proprietary technologies, pharmaceutical companies have the potential to add further value to their products and extend market exclusivity.
GLOBAL FORMULATION REPORT – Notable Technologies, Approvals, Transactions, Pipelines & Inflection Points
This Global Formulation Report is a joint initiative by Drug Development & Delivery and PharmaCircle LLC, covering several areas of significant interest in today’s ever-challenging pharmaceutical and biotechnology industries.
Robert Lins, MD, PhD, believes classical primary respiratory endpoints are far from successful in exploratory and confirmatory studies, and new techniques being developed have most potential in early phase, exploratory, clinical trials, but there may be the opportunity to apply at least some of them in the later stages of development.
Lilli Zakarija, MSME, MBA, explains that in order to conduct a successful V&V on the intended combination product, the key is to understand that the V&V testing is not an isolated activity and task.
Roelof Rongen, MBA, MS, indicates drugs for serious fungal and microbial infections currently require IV administration at doses associated with significant toxicity. Orally administered, encochleated formulations of a broad-spectrum of fungicidal and anti-microbial medications may provide delivery of anti-infective drugs at therapeutic levels while minimizing drug-associated side effects.
EXECUTIVE INTERVIEW – DelMar Pharmaceuticals: Polishing NCI Diamonds in the Rough With Modern Science
DelMar Pharmaceuticals, Inc. was founded to develop and commercialize new cancer therapies in indications where patients are failing or have become intolerant to modern targeted…
SPECIAL FEATURE – Excipients: Manufacturers Look to Co-Processing as a Way of Improving Functionality
Contributor Cindy H. Dubin reports how leading excipient manufacturers are overcoming their own R&D challenges to deliver innovative excipients that address problems associated with both large and small molecules.
EXCLUSIVE ONLINE CONTENT
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.
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.
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.
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