Featured Articles
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.
SYRINGE PLUNGER – Exploring How the Functional Properties of the PremiumCoat® 1-3-mL Plunger Facilitate its Implementation on Filling Lines & Enable the Delivery of Sensitive Vaccines & Biotech Drugs
Sebastien Cordier, Laure-Hélène Guillemot, PhD, and Audrey Chardonnet explain how the PremiumCoat 1-3-mL syringe plunger combines a pure Bromobutyl formulation with a market-proven ETFE film that acts as a barrier to limit the transfer of rubber leachables into the drug product.
EXECUTIVE INTERVIEW – Emergent CDMO: Making the Impossible, Possible for Biopharma Innovators
Catherine Hanley, Vice President & Interim CDMO Business Unit Head at Emergent BioSolutions, discusses the company’s plans for current and future CDMO operations and client partnership opportunities.
EXCLUSIVE ONLINE CONTENT
Unicycive Therapeutics Announces Orphan Drug Designation Granted for UNI-494 for the Prevention of Delayed Graft Function in Kidney Transplant Patients
Unicycive Therapeutics, Inc. recently announced the US FDA has granted orphan drug designation (ODD) to UNI-494 for the prevention of Delayed Graft Function (DGF) in kidney….
2019 Analytical Testing in Drug Development eBook – Regulations Help Propel Testing Market
This e-Book showcases the various types of services that leading testing companies offer and how they are helping industry comply with regulations to get their products approved and commercialized.
EXECUTIVE INTERVIEW – Oasmia Pharmaceutical: Commercializing Technologies While Pursuing the US Market
Julian Aleksov, Executive Chairman of Oasmia Pharmaceutical, discusses his company’s efforts to enter the US market, its strategy to increase commercial adoption, and why it believes its underlying drug delivery system technology is significant not only within the oncology sector, but the entire pharmaceutical industry.
LIPOPHILIC SALTS – Opportunities & Applications in Oral Drug Delivery
Hywel Williams, PhD, Annabel Igonin, PhD, David Vodak, PhD, and Hassan Benameur, PhD, believe lipophilic salts are being explored in a number of different areas and one interesting application is their potential to boost API loading in lipid formulations.