EXECUTIVE INTERVIEW - Synteract: Advances in Pediatric Clinical Research & the Promise for the Future
Dr. Martine Dehlinger-Kremer, Vice President, Pediatric Development at Synteract, reviews current and significant challenges in pediatric clinical research, advancement of regulations surrounding them, and where the industry is headed.
2018 Global Drug Delivery & Formulation Report: Part 4, The Drug Delivery & Formulation Pipeline
In conclusion of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, reviews and compares current Phase 3 and Registration-stage products with products first approved since 2014 in the United States, Japan, or Europe.
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.
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.
SPECIAL FEATURE - Excipients: Formulators Want Excipients for Solubility & Beyond
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.
EXECUTIVE INTERVIEW - PCI Synthesis: Acquisition by Seqens Expands its Pharmaceutical Offerings
Ed Price, President and CEO of PCI Synthesis, reflects on the trends fostering the CDMO industry consolidation and the positive impact it augurs in addressing sponsors’ needs to enter the clinic more quickly and safely.
DRUG DEVELOPMENT - Rapid Preparation of Gadolinium & Protamine Complexes With Aurintricarboxylic Polysalicylates: Implications for Drug Development
Timothy J. Smith, RPh, PhD, reviews how derivatives of aurintricarboxylic acid (ATA), a commercial reagent for aluminum ion determination, are under consideration for drug development in view of ATA’s diverse pharmacological spectrum.
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.
REAL ESTATE - Four Ways Firms Are Advancing Innovation With Real Estate
Roger Humphrey, MBA, says as companies pursue various and unique collaborative platforms, their real estate needs are changing — with profound implications for how and where life sciences companies choose to operate.
