SPECIAL FEATURE – Injection Devices: Wearables, Connectivity & Patient-Centric Designs Empower Self-Administration
Contributor Cindy H. Dubin highlights the innovation in injection devices – from wearables to connectivity to varied dose administration – that have occurred in the past year.
DEVICE DESIGN – Autoinjector Design Adjustment to Control Needle Insertion & Initial Injection Speed – Could This Positively Impact Drug Delivery?
Pascal Dugand, Thomas Megard, and Séverine Duband explain how controlling the needle insertion speed can reduce the shock on the prefilled syringe, which can reduce the risk of glass breakage, and will allow a smooth transition to syringe emptying.
BIOLOGICS DELIVERY – Enabling Biologic Drug Delivery of Volumes Beyond 1 mL
Megan Lan, MBA, MA, and Patrick Le Gal say delivery system manufacturers need to use methodologies and tools to manage conflicting requirements and to offer delivery solutions that balance performance, robustness, and usability while delivering higher volume or viscosity biologics.
INTRATUMORAL DELIVERY – Arming the Immune System; Turning Cold Tumors Hot
Daniel J. O’Connor believes a trigger mechanism that can turn cold tumors hot can help researchers set their focus on delivering potentially life-saving drugs directly to core of a cancerous tumor.
ON-TARGET DELIVERY – Lipid-Based System Introduces a Novel Approach for an HIV Vaccination
Fabrice Navarro, PhD, summarizes recent disappointing clinical trial results for HIV vaccines and reports on CEA-Leti’s new approach based on engineered lipid nanoparticles that deliver p24 (a viral protein that optimizes the CpG adjuvant’s effect) with pinpoint accuracy.
THERANOSTICS – The Outlook for the Theranostic Radionuclide Approach to Neuroendocrine Tumors & Other Cancers
Eric P. Krenning, MD, PhD, and Rachel Levine provide a review of the evolution and development of theranostics, in general, citing the theranostic radionuclide approach to the management of neuroendocrine tumors to highlight this evolving modality.
EXECUTIVE INTERVIEW – Eloxx Pharmaceuticals: Developing Rare Disease Drugs for Nonsense Mutations
Bob Ward, Chairman and CEO at Eloxx Pharmaceuticals, discusses nonsense mutations and how his company’s goal is to bring safe and effective therapies to children and adults suffering from genetic diseases as quickly as possible.
Respiratory Drug Development eBook – Increased Focus on Respiratory Drug & Device Development Makes Treatment More Personal
This e-Book highlights some of the innovators and innovations in the respiratory sector, addresses the importance of end users in the device development process, and presents recent advancements in improving patient adherence.
SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: CDMOs Shift to Offer More Specialized Services
Contributor Cindy H. Dubin speaks with several innovative CDMOs to discuss their formulation development and manufacturing capabilities (as well as shifting strategies) for bio/pharma companies of all sizes.
PARENTERAL DEVELOPMENT – Considerations in Developing Complex Parenteral Formulations
Iain MacGilp, PhD, says the path to delivering stable, apparently simple solution, suspension, or emulsion formulations is multi-faceted and requires a constant focus on key control measures through pre-formulation development to commercialization.
DEVICE DESIGN – Quality-by-Design Approach to Enable High-Dose Drug Delivery With Autoinjectors
Patrick Le Gal explains how his company deployed a quality by design approach to manage all the unavoidable competing requirements and to propose a solution that balances performance, robustness, and usability.
IN VITRO DDI STUDIES – 2017 FDA Guidance: Many In Vitro DDI Evaluations Should Precede FIH Studies
Brian Ogilvie, PhD, and Andrea Wolff explain the implications of the new timing requirements and best practices for negotiating them efficiently and effectively moving forward.
EXCLUSIVE ONLINE CONTENT
Analytical Testing in Drug Development eBook – Regulations Help Propel Testing Market
This e-Book showcases the various types of services that leading testing companies offer and how they are helping industry comply with regulations to get their products approved and commercialized.
Accenture Announces Collaboration With Bayer
Accenture recently announced a collaboration with Bayer to implement the Accenture INTIENT Clinical platform to help simplify and speed its……
Sanofi & Abbott Partner, Changing the Way Diabetes is Managed
Sanofi and Abbott are partnering to integrate glucose sensing and insulin delivery technologies that would help to further simplify how people with diabetes……
AC Immune Receives Milestone Payment in Connection with Initiation of a Phase 2 Trial
AC Immune SA recently announced it has received a milestone payment from its partner Life Molecular Imaging in connection with the initiation of….
InveniAI Launches Suite of Products Powered by Artificial Intelligence Platform
InveniAI Corporation recently announced the expansion of its flagship AI- and ML-driven innovation monitoring platform, AlphaMeld. This expansion will provide…..
DURECT Earns $10-Million Milestone Payment From Gilead
DURECT Corporation recently announced that further development of a long-acting injectable HIV investigational product utilizing DURECT’s SABER technology has triggered a $10-million milestone payment from Gilead Sciences, Inc. to…….
Pfenex Earns $11-Million Development Milestone
Pfenex Inc. recently announced it has earned an $11-million development milestone under its development and license agreement with Jazz Pharmaceuticals. The milestone is associated with…….
FUJIFILM Irvine Scientific Launches BalanCD Gal Supplement for Biotherapeutic Development
The new formula has been developed to increase galactosylation in biotherapeutic development, to help achieve….
Kaleido Biosciences to Collaborate with Gustave Roussy Cancer Center
Kaleido Biosciences, Inc. recently announced plans to develop Microbiome Metabolic Therapies (MMT) to enhance the effects of cancer immunotherapies under a new…….
Nkarta Therapeutics Raises $114 Million in Series B Financing to Advance Multiple Programs Into Clinical Trials
This financing is intended to support two clinical trial programs of NKX101, Nkarta’s allogenic NK cell therapy targeting NKG2D, in patients with either…..
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