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
Noramco & SPI Pharma Announce Availability of New Excipient Compatibility Study
Noramco and SPI Pharma recently announced they have completed work on an excipient compatibility study examining a range of options for the development of….
Catalent Extends Global Commercial Spray Drying Capabilities
Catalent, Inc. recently announced it has significantly expanded the capacity of its global spray drying operations through an agreement with….
Incyte & Zai Lab Announce Collaboration & License Agreement
Incyte and Zai Lab Ltd. recently announced that the companies have entered into a collaboration and license agreement for the development and commercialization of INCMGA0012,…
Amicus Therapeutics & Catalent Biologics Enter Strategic Partnership
Amicus Therapeutics, Inc. has entered into a strategic manufacturing agreement with Paragon Gene Therapy, a unit of Catalent Biologics, for clinical manufacturing capabilities and capacity…
Arcturus Therapeutics Receives Orphan Drug Designation
Arcturus Therapeutics Holdings Inc. recently announced the US FDA has granted Orphan Drug Designation for the company’s lead product candidate………
Athenex Announces Strategic Global Initiatives
Athenex, Inc. recently announced it has strategically expanded its presence in Europe and Latin America to grow its global……
Novavax & Catalent Biologics Enter Strategic Partnership
Novavax, Inc. and Catalent Biologics’ Paragon Gene Therapy unit recently announced an arrangement under which Paragon Gene Therapy will assume the leases to two Novavax product development and manufacturing facilities, giving it immediate access to……..
Designing a CMC Strategy for Accelerated Development of Biotherapeutics
As the pipeline of biologic drugs intended to treat complex disease expands, the typical timeline for drug development seems to be shortening more frequently and with more intensity……..
From ASCO 2019: TILs a Cause for Hope in Melanoma, Cervical & Breast Cancers
As the Spring heat made the light dance around the skin of the largest convention center in America, winners emerged from ASCO last month. One of the most significant announcements (from Iovance Biotherapeutics Inc.) were two first-in-man studies of adoptive T cell therapy (ACT) in patients with melanoma and cervical cancer which had failed to respond to other treatments.
PHASTAR Enters Technology Partnership With Medidata
PHASTAR recently announced today it has entered into a technology partnership with Medidata Solutions, Inc. PHASTAR will deploy several solutions from the Medidata Rave Clinical Cloud, including Rave EDC, Coder, eCOA, and RTSM.
