issues

March 2020

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COVER

SPECIAL FEATURE – Improving Bioavailability & Solubility: Understand Your Molecule

Contributor Cindy H. Dubin asked several leading companies about how they are currently overcoming today’s most pressing bioavailability and solubility challenges for their pharma clients.

FEATURES

SPECIAL FEATURE – Improving Bioavailability & Solubility: Understand Your Molecule

Contributor Cindy H. Dubin asked several leading companies about how they are currently overcoming today’s most pressing bioavailability and solubility challenges for their pharma clients.

CLINICAL TRIALS – Leaning Into Investigator Sponsored Trials

Martin Lehr, MA, says given the capital and intellectual capacity constraints within large pharmaceutical companies and start-ups, ISTs provide an important path to unlocking the therapeutic value of developmental and marketed drugs.

INTRATUMORAL DELIVERY – Combining Local & Systemic Treatments: Could Immuno-Oncology Finally Enable Local Intratumoral Delivery?

Lewis H. Bender, MA, MBA, says cancer is a local and systemic disease, and new forms of local treatment, such as intratumoral dosing coupled with systemic immunotherapy, are being explored.

DEVELOPMENT TIMELINES – Drug Development Times, What it Takes – Part 2

Josef Bossart, PhD, reviews the Development and Review Times associated with new molecular entity (NME) approvals throughout the 2010 to 2018 period.

CONTAINER CLOSURE INTEGRITY – Mitigating Risk in Pharmaceutical Manufacturing With Visually Inspected Components

Olga Laskina, PhD, discusses visible particles and manufacturing defects of the packaging components as well as the impact these defects can have on container closure integrity and functional characteristics.

EXECUTIVE INTERVIEW – Noxopharm: Introducing a Novel & Potentially Transformative Drug Candidate in the Treatment of Cancer

Graham Kelly, Founder, Executive Chairman, and CEO of Noxopharm, discusses the company’s innovative approach to cancer treatment.

BIOSIMILAR DEVELOPMENT – Biosimilar Biological Products: Development & Applications

Kaiser J. Aziz, PhD, provides an in-depth overview of biosimilar products development and the evaluation criteria for FDA approval.

GLOBAL REPORT – 2019 Global Drug Delivery & Formulation Report: Part 1, a Global Review

In part 1 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on a global review of 2019 product approvals.

HIGH PURITY EXCIPIENTS – A Simple Solution to a Complex Problem

William Small, PhD, and Arsalan Khan say drug degradation can have toxicological effects in many instances, and it is imperative that this mechanism be minimized as much as possible. The best solution to this is to ensure that appropriate ingredients, both high in quality and purity, are chosen and used throughout the entire drug product lifecycle.

FORMULATION FORUM – Rational Design & Development of Long-Acting Injectable Dosage Forms

Due to the advantages of parenteral sustained-release drug delivery (also known as long-acting injectables, LAIs) different types of sustained-release injectable delivery systems have been....