SPECIAL FEATURE – Prefilled Syringes & Parenteral Manufacturing: Flexibility for Faster Development
Contributor Cindy H. Dubin interviews several contract manufacturers and device developers who are responsible for creating next-generation parenteral drug delivery.
DRUG DELIVERY – ENHANZE (®): An Efficient Way to Optimize Biologic Therapies for Subcutaneous Administration
Michael J. LaBarre, PhD, discusses how the ENHANZE drug delivery technology has the potential to improve the pharmacokinetic profiles of co-administered drugs through increased dispersion, absorption, and bioavailability.
TOPICAL DEVELOPMENT – Fast Tracking Your Way to Success
Marc Brown, PhD, Jon Lenn, PhD, and Jeremy Drummond, PhD, believe it is essential the lead (and potentially a back-up formulation depending on any risk factors identified) has been optimized and characterized to demonstrate it will maintain its quality and performance as well as provide the best chance of measurable success in the clinical setting.
CHECKPOINT INHIBITORS – Novel Targets & Global Markets
Laurie L. Sullivan and Cheryl L. Barton, PhD, say as manufacturers expand the clinical utility and healthcare professionals become more familiar with their efficacy and safety profiles, the checkpoint inhibitor market will continue to expand, becoming the cornerstone of many cancer treatment regimens.
DRUG DEVELOPMENT – Softgel Technology for Fast-Tracked Development Programs
Jeff Browne, PhD, and Ronak Savla, PharmD, PhD, believe given the accelerated timelines associated with expedited programs, lipid-based drug formulations, encapsulated in softgel capsules, provide an attractive option for addressing the challenges facing formulators.
FORMULATION FORUM – Formulation Development From Preclinical to First-In-Human
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.
EXECUTIVE INTERVIEW – PAREXEL: Advancing Patient-Centric Drug Development to Improve Clinical Trial Success
Sy Pretorius, MD, Senior VP, Medical & Scientific Services at PAREXEL, discusses the new Patient Innovation Center and how it is helping to improve the patient experience, enhance study recruitment and retention, reduce costs, and deliver better data.
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.
AMORPHOUS SOLID DISPERSIONS – Increasing Solubility From API to Tablets
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.
SMART DEVICES – Add-On Connectivity Facilitates New Generation of Smart Inhalers
Contributor Cindy H. Dubin reviews how the addition of electronic and connectivity to inhalers may improve patient adherence and, consequently, treatment efficacy.
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.
DRUG DISCOVERY – Zebrafish in Preclinical Drug Development – A Small Fish With Big Returns
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.
EXCLUSIVE ONLINE CONTENT
WuXi STA & Dizal Pharmaceutical Sign Agreement
STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – and Dizal Pharmaceutical, a biotechnology company, recently announced a strategic partnership.
Mercia Invests in Transdermal Drug Delivery Specialist
Medherant Limited, the clinical-stage developer of innovative transdermal delivery products for pain and CNS diseases using its unique TEPI Patch technology, recently announced a new $2.5-million investment.
Catalent to Launch OneBio Suite for Integrated Biologics Development, Manufacturing & Supply
Catalent (Booth 3101) recently announced it will launch its new OneBio Suite for the integrated development, manufacturing, and clinical supply of biologic drugs at the…
Bayer Launches PHAB Awards With up to $1 Million in Grants
Bayer U.S recently announced the launch of the PHAB Awards to support clinical research in pulmonary hypertension, with a focus on pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.
At-a-Glance, a New Way to Visualize Market Data
Tim McLean, Senior Editor, Life Sciences BCC Research, say his company’s new type of market research report is far shorter — but hopefully it delivers the bigger picture.
Bone Sci Bio Presents Breakthrough Solutions for Bone Healing
Bone Sci Bio introduces PeptOss, a novel solution for bone treatment. The new product promotes formation and repair of bone tissue and enables controlled delivery of drugs, such as antibiotics or chemotherapy, directly to the bone, for various orthopedic and dental applications.
Cybrexa Therapeutics’ alphalex Platform Enables Tumor Targeting of Multiple PARP Inhibitors
Cybrexa Therapeutics recently announced preclinical data supporting the potential of its proprietary alphalex technology platform.
HOOKIPA Achieves Research Milestone in Collaboration & License Agreement With Gilead
HOOKIPA Pharma Inc. recently announced it has achieved a further research milestone in its collaboration and license agreement with Gilead Sciences, Inc. for development of a therapeutic hepatitis B virus (HBV) vaccine.
RedHill Biopharma Submits NDA for for H. Pylori Infection Drug
RedHill Biopharma Ltd. recently announced that, following a positive pre-NDA meeting held recently with the US FDA, it has submitted a New Drug Application (NDA) to the FDA for Talicia (RHB-105) for the treatment of H. pylori infection.
Akcea & Ionis Announce European Union Drug Approval for Ultra-Rare Disease
Akcea Therapeutics, Inc. and Ionis Pharmaceuticals, Inc. recently announced that WAYLIVRA has received conditional marketing authorization from the EC as an adjunct to diet in adult patients with genetically confirmed FCS and at high risk for pancreatitis, in whom response to diet and triglyceride-lowering therapy has been inadequate.
