May 2020

COVER

SPECIAL FEATURE - Prefilled Syringes & Parenteral Manufacturing: Innovations, Challenges & Solutions

Contributor Cindy H. Dubin features several leading companies’ innovations in delivery devices as well as how contract parenteral manufacturers are addressing the ever-demanding challenges, issues, and opportunities related to delivering biologics and small molecules.

FEATURES

SPECIAL FEATURE - Prefilled Syringes & Parenteral Manufacturing: Innovations, Challenges & Solutions

Contributor Cindy H. Dubin features several leading companies’ innovations in delivery devices as well as how contract parenteral manufacturers are addressing the ever-demanding challenges, issues, and opportunities related to delivering biologics and small molecules.

DRUG DISCOVERY - Disrupting Drug Discovery From Assay Development to Lead Compound

Zack Gurard-Levin, PhD, says with new innovations in assay methodologies, scientists no longer have to make sacrifices to do quality drug discovery research.

ANALYTICAL SERVICES - Applying Innovative Thinking & Techniques to Reduce Time-to-Market

Ramesh Jagadeesan, PhD, says that while CDMOs have the capacity to support pharmaceutical companies with their analytical requirements for both small and large-scale projects, the opportunity exists to increase speed to market with innovative thinking.

RISK-BASED MONITORING - Making the Move to RBM: Improving Patient Safety & Data Quality With Real-Time Insights

Crystal Stone and Amanda Coogan indicate that in an era in which the time- and resource-intensive business model of developing blockbuster drugs has been supplanted by a push to move drug candidates through the pipeline with greater speed, accuracy, and quality, RBM and real-time data analytics are becoming a must-have for clinical trials.

LYOPHILIZATION - Process Monitoring During Freeze-Drying

Gregory A. Sacha, PhD, describes the devices used for process monitoring and how they can be used to detect end points during the process.

FORMULATION FORUM - Application of Nano-Emulsion Technology to Address Unmet Medical Needs: A Case Study of Clopidogrel IV by 505(b)(2) Pathway

Jim Huang, PhD, presents a case study on how the EmulSol technology produces stable, optically clear nano-emulsions without the use of organic solvents and with minimal use of surfactants using a high-pressure or microfluidic homogenization process.

EXECUTIVE INTERVIEW - FSD Pharma Inc.: Is Ultra Micro-PEA the Best Untold Story in Pharma?

Raza Bokhari, MD, CEO of FSD Pharma, discusses how acquiring Prismic will benefit FSD, what makes the ultra-micronized platform unique, and how ultramicro-PEA could be the answer to ending the opioid epidemic.

GLOBAL REPORT - 2019 Global Drug Delivery & Formulation Report: Part 3, Notable Drug Delivery & Formulation Transactions & Technologies of 2019

In part 3 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on several notable drug delivery and formulation transactions and technologies.