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.
Patient centricity has moved to the forefront of clinical trials. Direct-to-patient (DTP) services provide convenience, and lead to greater participation and retention, addressing two key challenges that face study sponsors Yourway has.
Zack Gurard-Levin, PhD, says with new innovations in assay methodologies, scientists no longer have to make sacrifices to do quality drug discovery research.
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.
Gregory A. Sacha, PhD, describes the devices used for process monitoring and how they can be used to detect end points during the process.
EXECUTIVE INTERVIEW – Tedor Pharma, Inc.: A Strategy Shift to Serve Both Generic & Branded Companies
Doug Drysdale, President & CEO of Tedor Pharma, Inc., discusses the FLEXITAB technology, his strategy for managing a shift in business model, and how Tedor is addressing the needs of small- and medium-size companies developing innovative and repurposed small molecules for unmet medical needs.
NATURAL LANGUAGE PROCESSING – How Life Sciences Companies Are Leveraging NLP From Molecule to Market
Jane Z. Reed, PhD, MA, discusses some of the challenges facing pharma researchers and executives; the benefit NLP can bring; and some specific customer-use cases (covering patent landscaping, gene disease associations, access to safety silos, and more).
STANDARD OPERATING PROCEDURES – How Writing an Effective SOP Can Influence Compliance & Build a Better Organization
Heidi Stuttz provides a common outline used in many companies and explores the essential elements of a well-written SOP that can be effective whether developing one from scratch or remediating a current system of SOPs that will foster success in every area of your company in which it is implemented.
Paul Stark, MS, ScD, reviews how and when an interim analysis would be valuable and how, with examples and outcomes, it can be applied in a clinical trial setting.
EXCLUSIVE ONLINE CONTENT
Vectura Group plc, an industry-leading inhalation CDMO, recently confirmed the announcement made by its partner Hikma Pharmaceuticals PLC, which has received a minor complete response letter (CRL) from the US FDA in….
OXGENE recently announced the launch of its scalable, plasmid-free manufacturing system for AAV. OXGENE’s new TESSA technology addresses….
Hovione recently announced the signing of a partnership agreement with Ligand to significantly ramp up the production output of Captisol, a Ligand product, which is a chemically modified cyclodextrin proven to improve the solubility….
Thomas H. Lee Partners, L.P. and Frazier Healthcare Partners recently announced they have acquired Adare Pharmaceuticals, which will be rebranded Adare Pharma Solutions, a leading specialty contract development….
CombiGene & Cobra Biologics Sign Agreement to Secure GMP Production of Plasmids for Production of Gene Therapy
Cobra Biologics and CombiGene AB (publ) (CombiGene) recently announced they have signed agreements covering Good Manufacturing Practice (GMP) production of two essential….