June 2020

COVER

PFS MANUFACTURING - Prefilled Syringes & Biologics: The Perfect Partnership of Medicine & Delivery

Anish Parikh charts the twin rise of biologics and PFS, outlines some of the common challenges associated with filling and dispensing, and discusses how a patient-centric partnership approach can help biopharmaceutical companies shorten the development pathway and ensure a reliable supply of safe, effective medicines for the people who need them.

FEATURES

SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Specialized Capabilities for Small & Large Molecules

Contributor Cindy H. Dubin interviews key players in the CDMO market who present case studies about how they are helping pharmaceutical and biopharma companies overcome a variety of formulation and manufacturing challenges.

PFS MANUFACTURING - Prefilled Syringes & Biologics: The Perfect Partnership of Medicine & Delivery

Anish Parikh charts the twin rise of biologics and PFS, outlines some of the common challenges associated with filling and dispensing, and discusses how a patient-centric partnership approach can help biopharmaceutical companies shorten the development pathway and ensure a reliable supply of safe, effective medicines for the people who need them.

GENE THERAPY - The Role Viral Vectors Play in Current Gene Therapy Development

Dieter Lingelbach, MBA, discusses the history and science of viral vectors, their current applications, and why they are a vital component in contemporary gene therapy development.

FORMULATION FORUM - Application of Captisol® Technology to Enable the Formulation of Remdesivir in Treating COVID-19

James Pipkin, PhD, Vince Antle, PhD, and Rebecca Garcia-Fandiño, PhD, explain why more Captisol® than ever is required to meet Gilead’s bold goals of making remdesivir available to COVID-19 patients in the US and to hundreds of countries around the world.

FORMULATION DEVELOPMENT - Formulating Immediate-Release Tablets for Poorly Soluble Drugs

Gayatri Khanvilkar, MPharm, Ajit Bhagat, Sangmesh Torne, PhD, Tejas Gunjikar, PhD, and Amina Faham, PhD, present a case study showing that previously unviable APIs can be successfully processed with the right methods, which should give hope to formulators facing similar difficulties.

CHIMERIC COMPOUNDS - “Dopastatins”: One Molecule Targeting Two Receptors for the Treatment of Pituitary Tumors

Heather Halem, PhD, and Michael D. Culler, PhD, believe this novel class of compounds represents a potential treatment for neuroendocrine tumors that are vulnerable to the synergistic dual activation of somatostatin and dopamine receptors.

NEXT-GENERATION TUMOR TARGETING - Leveraging the Tumor Microenvironment to Change the Standard of Care

Vishwas Paralkar, PhD, highlights a unique platform technology that represents the first technology that has successfully been used to target cancer drugs to tumor cells in animal models, while sparing healthy tissue.

FORMULATION FORUM - Rational Design of Oral Nanosuspensions for Insoluble Drugs

Jim Huang, PhD, explains how nanosuspensions are an important class of pharmaceutical dosage forms, particularly for pharmaceutical compounds with solubility and bioavailability challenges.

EXECUTIVE INTERVIEW - Adare Pharmaceuticals: A Virtual Acquisition is Possible

Ajay Damani, VP of Pharmaceutical Technologies Business Unit, Adare, and Maria Flynn, President and CEO, Orbis, discuss how both companies will benefit from the acquisition, future product development, and the challenges of a virtual acquisition.

GLOBAL REPORT - 2019 Global Drug Delivery & Formulation Report: Part 4, The Drug Delivery and Formulation Pipeline

In part 4 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, analyzes the pipeline with an emphasis on clinical-stage products for which there is more product-related information.