Featured Articles
SPECIAL FEATURE - Analytical Testing Trends in 2022
Contributor Cindy H. Dubin reports on the innovative technologies and techniques that several leading outsourcing providers currently offer for both small and large molecules.
FORMULATION FORUM - Formulation & Process of Lipid Nanoparticles for Delivery of Small Molecules & Biologicals
Jim Huang, PhD, explains how recently, lipid nanoparticles have emerged as a drug delivery system for biologicals, especially for the COVID-19 mRNA vaccines in which LNPs play a vital role in transporting mRNA into the target cells.
ORGAN-ON-A-CHIP - A Novel Way to Accurately Test Delivery of Non-Standard Formulations
David Hughes, PhD, says ultimately, the goal of OOC technology is to improve the translatability of data between the lab and the clinic. Through a lung-on-a-chip approach, it is possible to recreate the histoarchitecture, phenotype, and function of bronchial and alveolar areas of the lung.
EXOSOMES - The Next Evolution in Therapy Delivery Beyond the Cell Membrane: The Promise of Exosomes
Linda Marbán, PhD, says perhaps the best way to get past the cell membrane is to deliver contents the same way that cells send information to each other. And that is by the exosome, which in the case of targeted therapy delivery, has been identified as an alternative that shows powerful promise.
COATING TECHNOLOGY- Combining a State-of-the-Art Bromobutyl Formulation With a Proven ETFE Film for Exceptional Chemical Performance
Julie Suman, PhD, Sebastien Cordier, and Estelle Verger discuss the properties of the ETFE film coating technology used for PremiumCoat(R) vial stoppers and pre-filled syringe plungers. When combined with pure Bromobutyl formulation, the film forms a barrier that can reduce the number of leachables transferred into the solution, and their quantity by up to 98%.
EXECUTIVE INTERVIEW - EyePoint Pharmaceuticals, Inc.: Disrupting Treatment Paradigms
Nancy Lurker, President and CEO of EyePoint Pharmaceuticals, discusses how she is not only working to disrupt treatment paradigms in ophthalmic drug delivery, but also disrupting leadership paradigms as a female CEO of a company with 2020 total revenues of $34.4 million.
CYBERSECURITY - Cybersecurity for Connected Medical Devices: A Holistic Approach During the Entire Product Lifecycle
Nicola Alagia explains why cybersecurity is important for connected medical devices and how to integrate ad hoc activities to tackle cybersecurity in the early phases of product development.
EXECUTIVE INTERVIEW - GATC Health & Liquid Biosciences: Faster, Cheaper, More Effective Drug Discovery
Ian Jenkins, Director of Science, and Jeff Moses, CMO at GATC Health, discuss the combined benefits of their MAT platform and Liquid Biosciences’ Emerge mathematical evolution platform to help identify the right biology sooner and focus on a smaller set of potential compounds early in the pre-clinical development process to enable pharma companies to develop drugs with more efficiency and a higher success rate.
GALECTIN INHIBITORS - Is a Galectin-3 Inhibitor the Answer for Millions of Patients With Cirrhosis & Cancer?
Pol F. Boudes, MD, explains how development of a galectin-3 inhibitor could play a significant role in treating liver diseases, such as non-alcoholic steatohepatitis (NASH) and its complication, liver cirrhosis.
BIOMARKERS - Biomarkers: The Guiding Light for R&D in Heterogeneous Diseases
Thomas Turi, PhD, says while biomarkers have been a long-standing part of R&D and a mainstay of clinical practice for the characterization and diagnosis of disease for decades, they are increasingly playing a crucial role in guiding decisions to improve efficacy and efficiency of clinical trials.
2022 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
FORMULATION FORUM - Amorphous Nanoparticles for Drug Delivery of Poorly Water-Soluble Compounds
Jim Huang, PhD, says a thorough understanding of their amorphous stabilization and nano colloidal properties in relationship to in-vitro and in-vivo performance will help advance this interesting dosage form into human clinical testing and commercialization.
MARKET BRIEF - Navigating the Evolving Landscape of Rare Cancer Trials
Rupa Doshi, PhD, and Sameena Sharif, PhD, explore the landscape of rare cancer clinical trials, from key considerations for study design and the value of biomarkers to the importance of the patient perspective and the options for speeding much-needed therapies to market.
APTAMER TECHNOLOGY - From Postal Codes to GPS: Building Better Drug Conjugates With Aptamers
David Bunka, PhD, and Emily Robinson, PhD, focus on a new breed of affinity binders that can be used as an alternative to antibody therapeutics and has the potential to reshape the industry, delivering new medicines with improved safety and efficacy profiles and reduced healthcare costs.
EXECUTIVE INTERVIEW - Quotient Sciences: Unique Considerations & Challenges When Developing Palatable Pediatric Formulations
Nazim Kanji, Executive Director, Pediatric Services at Quotient Sciences, discusses the unique considerations and challenges when developing palatable pediatric formulations, so that molecules can become cures, fast.
INHALATION THERAPY - An Overview to Drug-Nebulizer Combination Development With Biologics
Hernan Cuevas Brun, MBA, says biologic drugs are increasingly being investigated for delivery with inhalation therapy, which has initiated more in-depth discussions about the implications of formulation development and their pairing with adequate inhaled devices for more efficient treatment outcomes.
TARGETED ONCOLOGY THERAPIES - Harnessing Nature’s “Cues” to Selectively Activate the Immune System to Attack Cancer
Dan Passeri, MSc, JD, reviews a new class of synthetic biologic drugs engineered and designed to leverage the beneficial effect of IL-2 to selectively stimulate the proliferation and cytotoxic activity of disease-relevant T cells against cancer.
DRUG DELIVERY - CAPRO(TM): A New Advance in Polymeric Drug Delivery
Bob Wieden and Chun Wang, PhD, discuss how significant challenges, coupled with the complexity and diversity of new pharmaceuticals, have fueled the development of a novel polymeric drug delivery platform that overcomes a great many bioavailability and delivery obstacles.
DEVICE DEVELOPMENT - Selecting Drug Delivery Systems for Higher Doses, Higher Viscosities & Lower Risk
Nicolas Bralet and Megan Lan, MBA, MA, discuss how companies can de-risk their device selection as they bring this new generation of high-volume, high-viscosity biologics to market.
MANUFACTURING SOLUTIONS - Sterile Drug Product Manufacturing During a Global Pandemic
Ankit Agrawal, MSc, Ronald Aungst, Jr., PhD, Jonothan Hamer, MCIPS, and Barbara Solow, PhD, say with vaccines and treatments now available and yet more on the horizon, the first major manufacturing hurdles have been crossed; however, the finish line is still in the distance.
