Respiratory Drug Development eBook – Increased Focus on Respiratory Drug & Device Development Makes Treatment More Personal
This e-Book highlights some of the innovators and innovations in the respiratory sector, addresses the importance of end users in the device development process, and presents recent advancements in improving patient adherence.
SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: CDMOs Shift to Offer More Specialized Services
Contributor Cindy H. Dubin speaks with several innovative CDMOs to discuss their formulation development and manufacturing capabilities (as well as shifting strategies) for bio/pharma companies of all sizes.
PARENTERAL DEVELOPMENT – Considerations in Developing Complex Parenteral Formulations
Iain MacGilp, PhD, says the path to delivering stable, apparently simple solution, suspension, or emulsion formulations is multi-faceted and requires a constant focus on key control measures through pre-formulation development to commercialization.
DEVICE DESIGN – Quality-by-Design Approach to Enable High-Dose Drug Delivery With Autoinjectors
Patrick Le Gal explains how his company deployed a quality by design approach to manage all the unavoidable competing requirements and to propose a solution that balances performance, robustness, and usability.
IN VITRO DDI STUDIES – 2017 FDA Guidance: Many In Vitro DDI Evaluations Should Precede FIH Studies
Brian Ogilvie, PhD, and Andrea Wolff explain the implications of the new timing requirements and best practices for negotiating them efficiently and effectively moving forward.
BIOSIMILAR DEVELOPMENT – Approval of Biosimilar Medicines Through Totality of the Evidence
Hillel Cohen, PhD, outlines the evolution of biosimilar approvals and describes the process of analytical and clinical testing followed in the development of a biosimilar, with use of data from the scientific literature.
MARKET BRIEF – Nothing Degrading About Saving Lives: E3 Ligands Recruiting New Drugs Into the Clinic
Marianna Tcherpakov, PhD, discusses underexploited strategies, traditional approaches that can be optimized, novel techniques beginning to emerge and pay dividends, and results propelling this field toward better clinical outcomes.
FORMULATION FORUM – Amorphous Formulations for Insoluble Drugs: Rational Design & Practical Approaches on Formulation Screening & Development
Jim Huang, PhD, discusses the issues associated with amorphous formulations, including solid state stability, chemical stability, reproducibility of API manufacturing, impurity of API, stability in aqueous solution, in vitro in vivo performance, and process and scale-up.
EXECUTIVE INTERVIEW – Synteract: Advances in Pediatric Clinical Research & the Promise for the Future
Dr. Martine Dehlinger-Kremer, Vice President, Pediatric Development at Synteract, reviews current and significant challenges in pediatric clinical research, advancement of regulations surrounding them, and where the industry is headed.
2018 Global Drug Delivery & Formulation Report: Part 4, The Drug Delivery & Formulation Pipeline
In conclusion of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, reviews and compares current Phase 3 and Registration-stage products with products first approved since 2014 in the United States, Japan, or Europe.
SPECIAL FEATURE – Prefilled Syringes & Parenteral Manufacturing: Flexibility for Faster Development
Contributor Cindy H. Dubin interviews several contract manufacturers and device developers who are responsible for creating next-generation parenteral drug delivery.
DRUG DELIVERY – ENHANZE (®): An Efficient Way to Optimize Biologic Therapies for Subcutaneous Administration
Michael J. LaBarre, PhD, discusses how the ENHANZE drug delivery technology has the potential to improve the pharmacokinetic profiles of co-administered drugs through increased dispersion, absorption, and bioavailability.
EXCLUSIVE ONLINE CONTENT
Cara Therapeutics Enters Commercial License Agreement With Enteris BioPharma
Cara Therapeutics, Inc. recently announced it has entered into a non-exclusive commercial license agreement with Enteris BioPharma, Inc. for oral formulation rights to…..
Viral Vectors Expected to Play Pivotal Role in Gene Therapy Pipeline for Neurology Indications
Viral vectors, such as adeno-associated virus (AAV), are expected to play a pivotal role in gene therapies for neurology indications, as this vector type has been found to be the most…..
Q BioMed & ChemVeda Announce Potential Chemotherapeutic Breakthrough
Q BioMed, Inc. and Chemveda Life Sciences recently announce the successful chemical synthesis of a unique natural compound that has shown remarkable efficacy as a potential………
AC Immune Announces Research Collaboration With University of Pennsylvania
AC Immune SA recently announced a research partnership with leading scientists in the Perelman School of Medicine at the University of Pennsylvania (Penn) focused on studying the pathological mechanisms of…..
CureVac Enters Exclusive Collaborative Research Agreement
CureVac AG recently announced it has entered into a Collaborative Research Agreement with Yale University for discovery research into mRNA-based……
Saama & Comprehend to Form Preeminent Clinical Analytics Platform Company
Saama Technologies, Inc. recently announced it has signed a definitive agreement to acquire Comprehend Systems, Inc. to create an exciting, enhanced suite of………..
Co-Processed Excipient for Direct Compression Designed for Orally Disintegrating Tablets
Developing ODTs is a worldwide trend. In recent years, new excipients and excipient blends have enabled manufacturers to produce ODTs using conventional equipment, ie, blenders and tablet presses. One such product is GRANFILLER-D………
Creating Your Secondary Packaging Strategy – Begin With the End in Mind
Whether it is meeting the needs of a rapidly aging market, blocking drug counterfeiters, or differentiating your pharmaceutical product in the market, a secondary packaging program is an important factor in………
MilliporeSigma Acquires BSSN Software to Accelerate Customers’ Digital Transformation in the Lab
MilliporeSigma has acquired BSSN Software, a Darmstadt, Germany-based laboratory informatics company that makes data more readily accessible for ease of integration, collaboration, analysis and…..
Huge Untapped Potential for Rheumatoid Arthritis Treatment by Targeting OX40
A new study led by experts from the University of Tsukuba first published in Annals of the Rheumatic Diseases in July found that OX40-expressing follicular helper T cells contributed to inflammation by regulating……
