George Clinical Recruits More than 5,000 Patients in the Global Kidney Patient Trials Network October 25, 2022

FORMULATION FORUM - Lipid Nanoparticles: Tackling Solubility Challenges With Lipid-Based Technologies for Oral & Injectable Formulations October 10, 2022

Jim Huang, PhD, and Shaukat Ali, PhD, believe as more hydrophobic or brick dust and/or lipophilic or waxy molecules come out of discovery, amorphous solid dispersions (ASDs) and lipid based self-emulsifying microemulsions, nanoemulsions, liposomes, and nanoparticles are ideal for oral and injectable formulations.

EXTRACELLULAR VESICLES - Engineering Extracellular Vesicles to Create Next-Generation Therapeutics October 3, 2022

David Lowe, PhD, Justin Hean, PhD, Dave Carter, PhD, and Antonin de Fougerolles, PhD, say EVs exhibit key properties that make them extremely attractive as therapeutics, particularly their safety profile and potential for low immunogenicity. In order to effectively unlock this potential, some key challenges remain, such as the development of EV product manufacture and characterization methodologies and rapid pharmacokinetics.

SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Understanding Critical Attributes Earlier in Development Leads to a More Robust Drug Product June 1, 2022

Contributor Cindy H. Dubin speaks with industry leaders on how drug sponsors and CDMOs are collaborating earlier, and highlights how third-party contractors are navigating material shortages and how the industry is shifting to address different therapeutic targets and molecules, such as mRNA.

Cocrystal Pharma Selects Two Lead Antiviral Drug Candidates for its COVID-19 Oral Drug Program January 27, 2022

Cocrystal Pharma, Inc. has selected two investigational novel antiviral drug candidates for further development as oral treatments for SARS-CoV-2, the virus that causes COVID-19…..

Recce Pharmaceuticals Announces Update on Phase 1/2 Clinical Trial for the Treatment of Burn Wound Infections December 7, 2021

HUMAN FACTORS STUDIES - Human Factors Studies During a Pandemic: How One Company Adapted to Covid-19 Restrictions October 4, 2021

Miranda Newbery says although it is possible to carry out use risk assessments, expert reviews and device comparisons – which do not require contact with end users – these cannot fully replace first-hand user feedback.

EXECUTIVE INTERVIEW - Micropore: Innovation in Drug Delivery May 3, 2021

Dai Hayward, CEO at Micropore, discusses his company’s expertise and underpinning technology in the development of safe, efficient, and scalable continuous manufacturing of drug delivery solutions.

BIOSIMILAR DEVELOPMENT - Biosimilars: The Process & Quality System Approach to Clinical Applications January 13, 2021

Kaiser Aziz, PhD, addresses biosimilar developments and future innovations with an emphasis placed on quality system approaches to the development and availability of new biosimilar products.

Catalyst Pharmaceuticals Announces Strategic Plan for Product Portfolio Expansion January 7, 2021

EXECUTIVE INTERVIEW - Adare Pharmaceuticals: A Virtual Acquisition is Possible June 3, 2020

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.

Bormioli Pharma Speeds Up on Innovation With H-FARM March 5, 2020

DEVELOPMENT TIMELINES - Drug Development Times, What it Takes - Part 1 January 14, 2020

Josef Bossart, PhD, explains how accurately estimating a product’s clinical development timelines is more than simply adding up the individual timelines, almost always optimistic. You need to “know” the numbers, not just calculate them.

WEARABLE DEVICES - Wearable Drug Delivery Applications: Considerations for Adhesive Material Selection & Wear Testing October 1, 2019

Neal Carty, PhD, MBA, and Deepak Prakash, MS, MBA, discuss the broader healthcare and digital health landscape behind wearable device developments and provide a brief overview of two types of wearable applications — insulin pump therapy/continuous glucose monitoring (CGM) systems and wearable drug injectors.

RISK MANAGEMENT - FDA’s Quality Risk Management Approach to New Drug Applications April 1, 2019

Kaiser J. Aziz, PhD, explains how the FDA emphasizes the Quality Risk Management approach to design of studies by providing oversight and objective review of risk-benefit analysis that guides the use of new drug products by providing patients organized data and appropriate labeling information in support of the new drug’s intended clinical use.

CLINICAL ANALYTICS SOLUTIONS - Reducing Clinical Cost Budget Variations With State-of-the-Art Data Lifecycle Management Solutions January 9, 2019

Srini Anandakumar explores an approach for how sponsor’s operational data, coupled with syndicated data and Real World Evidence data, can enable predictive analytics on clinical cost drivers using a clinical big data and Machine Learning-enabled platform.

EXECUTIVE INTERVIEW - BriaCell Therapeutics: Recognizing the Power of Targeted Immunotherapies October 1, 2018

Dr. William “Bill” Williams, MD, President and CEO of BriaCell Therapeutics, discusses the value of targeted immunotherapies in the biopharmaceutical industry.

SPECIAL FEATURE - Injection Devices: As Self-Injection Grows, Drug Delivery Gets Smarter August 28, 2018

Contributor Cindy H. Dubin reviews some of the innovative and novel technologies developers are deploying to make self-injection easier and improve patient adherence.

DRUG DEVELOPMENT - Cell & Gene Therapies Calling for Innovation in Drug Development August 27, 2018

Lev Gerlovin and Pascale Diesel, PharmD, believe there is significant evidence to indicate that we are entering a golden age of gene and cell therapy development, and while industry works to advance these programs, the debate over new approaches in both structuring and financing clinical research is likely to continue.

GLOBAL REPORT - 2017 Global Drug Delivery & Formulation Report: Part 3, Notable Transactions & Technologies of 2017 May 31, 2018

In part 3 of this 4-part series, PharmaCircle in collaboration with Drug Development & Delivery, reviews transactions and technologies that provide greater insight into what we can expect in terms of product development and approvals over the next decade.

TECH BRIEF – Expedite FDA Approvals With Certified Pure Materials