Jim Huang, PhD, says when a compound enters preclinical development for a GLP tox study from the drug discovery stage, formulators have innovative options on how to develop a tox and clinical formulation that ensures the success of IND and first dose in human.
GLOBAL REPORT – 2018 Global Drug Delivery & Formulation Report: Part 3: Notable Drug Delivery and Formulation Transactions and Technologies of 2018
In part 3 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, offers a short overview of drug delivery and formulation transactions and includes some of the numbers that color the trends of 2018 along with some thoughts on notable transactions and technologies.
Paulo Lino, PhD, and João Henriques discuss the main development goals and present a framework for a streamlined development of amorphous solid dispersion formulations by spray drying.
FORMULATION FORUM – Revitalization of Older Drug Products Using Innovative Formulation Technologies by 505(b)(2) Regulatory Pathway
Jim Huang, PhD, says more than 50% of approved drugs on the market contain poorly water soluble APIs, which typically are associated with poor bioavailability, suboptimal drug delivery, ineffective drug efficacy, and side effects, and this creates a huge opportunity in generating 505(b)(2) products.
Rafael Miñana, PhD, explores the benefits of preclinical outsourcing, the value of zebrafish as an alternative model, as well as the challenges and opportunities of managing a highly diversified portfolio and providing customized solutions.
GLOBAL REPORT – 2018 Global Drug Delivery & Formulation Report: Part 2, Notable Product Drug Delivery and Formulation Approvals of 2018
In part 2 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on how the pharmaceutical industry has harnessed well validated drug delivery and formulation technologies to deliver important product approvals in 2018.
Contributor Cindy H. Dubin speaks with leading excipient companies to discuss the current role excipients are playing in continuous manufacturing, biopharma formulation, and controlled- and immediate-release delivery.
THERAPEUTIC FOCUS – Targeting the Novel LANCL2 Pathway Offers Potential for a Differentiated Treatment Paradigm for Autoimmune Diseases
Andrew Leber, PhD, Raquel Hontecillas, PhD, and Josep Bassaganya-Riera, PhD, say current IBD therapeutics have mediocre efficacy, poor maintenance of response, and damaging side effects, including cancer, infection, and death, resulting in an unmet clinical need for safer and more effective oral therapeutics.
SPECIAL FEATURE – Improving Bioavailability & Solubility: Chemical & Physical Modification vs. Formulation Development
Contributor Cindy H. Dubin speaks with several leading companies to explore chemical and physical modification versus formulation development, and new technologies and techniques for improving bioavailability and solubility.
PRODRUG TECHNOLOGY – Prodrugs for ADHD Treatments: Opportunities & Potential to Fill Unmet Medical Needs
Travis Mickle, PhD, indicates key properties that prodrugs can potentially modify generally fall within one or more of the ADME categories, with the goal being the creation of an NCE that optimizes the performance, utility, and potential life-cycle management of the parent drug.
EXCLUSIVE ONLINE CONTENT
Kymab & LifeArc Enter Strategic Partnership to Discover New Medicines Using Kymab’s IntelliSelect Technologies
The agreement will enable LifeArc to enhance its antibody drug discovery capabilities into new medicinal products with Kymab’s proprietary IntelliSelect technology platforms.
Loxo Oncology, Inc. recently entered into a strategic partnership agreement with Amoy Diagnostics Co., Ltd. and PREMIA Holdings (HK) Ltd.
Aclaris Therapeutics, Inc. recently announced positive results from a Phase 2 open-label clinical trial of ATI-502 (AGA-201), an investigational topical Janus Kinase (JAK) 1/3 inhibitor, in patients with androgenetic alopecia (AGA), a condition commonly known as male/female-pattern baldness.
iBio, Inc. recently announced the activation of its new cGMP sterile fill-finish services operation via the signing of a supply agreement with a clinical-stage biopharmaceutical company developing breakthrough gene and cell therapies.
Gilead Sciences, Inc. and Nurix Therapeutics, Inc. recently announced a global strategic collaboration to discover, develop, and commercialize a pipeline of innovative targeted protein degradation drugs for patients with cancer and other challenging diseases.