In this third annual Drug Development & Delivery Respiratory eBook, several companies discuss what they are currently working on to propel the respiratory sector.
SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: Meeting Demand for Biologics & Specialty Drugs
Contributor Cindy Dubin highlights the formulation development and manufacturing offerings from some of the leading CDMOs to address a myriad of challenges – from complex compounds to poor solubility to dual-release profiles.
Securing your API supply chain is key when managing the manufacture and delivery of your products, and a minor delay can derail a whole project. Learn what to look out for and how to prevent it happening to you.
Dr. Paul Shields, COO of Enteris BioPharma, discusses the changing face of the CDMO industry and how his company plans to leverage its newly expanded CDMO operations to take advantage of a variety of growth opportunities to build deeper partnerships.
CLINICAL TRIALS – Statistical Challenges in Preserving Integrity of Ongoing Clinical Trials During the COVID-19 Pandemic
Karen Ooms, Msc, believes the consequences of this pandemic on ongoing clinical trials can be objectively assessed, and with the correct mitigation strategies put in place, study integrity can be preserved, optimizing use of the available resources for both patients and sponsors.
PRECLINICAL TESTING – Expanding Opportunities in Implantable Medical Devices With Optimized Preclinical Studies
Jaleel Shujath outlines the growing importance of implantable devices in clinical settings and our daily lives, highlighting the current state of preclinical testing and the regulatory barriers faced by device developers.
DRUG DEVELOPMENT EXECUTIVE – Quotient Sciences: Breaking Down the Silos Between Drug Substance & Drug Product
Mark Egerton, PhD, CEO of Quotient Sciences, discusses how integrating these capabilities cuts through functional silos, simplifies drug development, and affirms Quotient’s belief that molecules need to become cures, fast.
Celanese and ThermoFisher Scientific have partnered together to present the value of the VitalDose® EVA drug delivery platform and manufacturing through Hot Melt Extrusion (HME) on September 9, 2021.
The transition from preclinical to clinical development is one of the most crucial stages in the life cycle of a drug product. Decisions made during this stage lay the groundwork for a compound’s success at many key downstream milestones, from regulatory submission, to commercial scale-up, and beyond.
DRY-POWDER THERAPEUTICS – Respiration Inspiration: Local Treatment of Lung Cancer by Dry-Powder Inhaler
Philip Kuehl, PhD, and Kimberly B. Shepard, PhD, describe the formulation and manufacturing considerations for development of dry-powder therapeutics for local treatment of lung cancer. Two case studies are presented in which two approved drugs are successfully formulated for DPI administration to the lung.
EXCLUSIVE ONLINE CONTENT
A pioneer in biotechnological medicines in Brazil, BIOMM is launching Nemera’s Advapen under the trade name Lifepen® for the administration of….
Recipharm Signs Memorandum of Understanding (MOU) for the Fill Finish of Vaccines & Biotherapeutics in Morocco
Global contract development and manufacturing organization (CDMO) Recipharm has recently signed an MOU, along with His Majesty the King of Morocco, Mohammed VI, the Moroccan Government and….
Genedata recently announced that Encoded Therapeutics has chosen Genedata Bioprocess to digitalize their proprietary gene therapy R&D technology…..
Evonik offers an innovative green technology that enables the large-scale synthesis of active pharmaceutical ingredients in water. The “Chemistry in Water” technology has the potential….
InMed Pharmaceuticals Signs Non-Binding Letter of Intent to Acquire BayMedica, a Commercial Manufacturer of Rare Cannabinoids
InMed Pharmaceuticals Inc. recently announced it has entered into a non-binding letter of intent to acquire BayMedica Inc., a private company based in Nevada and California that specializes in the manufacture and commercialization of….