In this third annual Drug Development & Delivery Respiratory eBook, several companies discuss what they are currently working on to propel the respiratory sector.
WEARABLE PLATFORM – Next-Generation Wearable Drug Delivery: Prefilled Devices Provide a Truly Patient-Centric Solution
Mindy Katz says with increasingly positive expectations for the wearable device market to provide an intuitive and user-friendly drug delivery experience, her company continues to optimize its wearable platform solution, investigating new technologies and processes to improve the offerings for patients and providers.
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.
In this month’s column on formulation development challenges, Jim Huang, PhD, discusses nanosuspensions prepared via the top-down process, ie, the wet milling process.
OPEN INNOVATION PLATFORM – Beyond the Rule of Five: Scouting for Novel Formulation Approaches to Enable the Subcutaneous Application of Molecules With Poor Drug-Like Properties in Preclinical Research – Facilitated Through opnMe.com
Ines Truebenbach, PhD; Menorca Chaturvedi, PhD; Markus Koester, PhD; and Achim Grube, PhD, are looking for proposals that would provide innovative formulation approaches to facilitate the subcutaneous application of bRo5 molecules in a preclinical setting.
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.
PRODUCT DEVELOPMENT STRATEGY – ESCP, Estimating Product Performance Part 4 – Building Playgrounds & Fences
Josef Bossart, PhD, introduces, in a series of short articles, a qualitative model to help understand and visualize the potential of a product with prescribers, patients, and payors. This simple model can help weed out product ideas that may at first glance seem attractive but offer little potential in the real world.
Ashley Jacobi says while there are many ever-improving tools available to scientists performing ground-breaking research, and the potential of CRISPR genome editing appears limitless, there remain challenges that need to be overcome to realize the technology’s full potential.
Robert Davidson says there have been significant advances in clinical development of this novel drug delivery system, and the technology is rapidly moving from just a theory to practical real-world application.
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.
GLOBAL REPORT – 2020 Global Drug Delivery & Formulation Report: Part 4, The Drug Delivery and Formulation Pipeline
In part 4 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, provides pipeline snapshots and comparisons for a number of parameters that are of most interest to drug delivery and formulation professionals – Disease Area, Molecule Type, and Delivery Route.
Contributor Cindy Dubin explores how device developers and parenteral contract development and manufacturing organizations (CDMOs) are addressing current challenges, as well as advancements in customized device design, the continuous effort to incorporate safety and human factors, and how COVID-19 is shaping the future of the market.
Jim Huang, PhD, reviews how injectable solutions offer an attractive alternative to oral dosage form due to fast onset, reproducible PK/efficacy profile, high bioavailability as a result of bypassing the oral absorption barrier, and suitability of administration under hospital setting.
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 Rule of 5 suggests that, for oral bioavailability, a better chance for oral absorption is obtained when the molecules are within the parameters of the Rule of 5’. However, the pharmaceutical industry is achieving oral efficacy with drugs that exceed….
Bespak by Recipharm Webinar: Learn How To Overcome Viscous Formulation Challenges For Parenteral Delivery
There have been many challenges holding back widespread adoption of self-administered injectable formulations. One of the most pressing is the need to develop an auto-injector with a fine enough needle for….
With the development of ILC Dover’s new Aseptic Isolator system new opportunities have opened up for many organizations who were previously able to conduct fill finish activities due to facility restraints or expensive closed barrier systems. This new technology….
Access our webinars on solubility strategies & pediatric drug development….
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.
This white paper describes the use of PVA-based Parteck® SRP 80, a functional excipient specifically developed for matrix-based sustained release oral solid dose formulations.
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.
FORMULATION FORUM – A Quick Approach for Evaluation of Drug-Excipient Compatibility: Case of Acetylsalicylic Acid
In this study, the authors monitor acetylsalicylic acid (ASA) hydrolysis in different formulations using UPLC and TAM with the objective of comparing these methods for agreement, speed, and efficiency in predicting drug stability. In parallel, they assess the impact of the excipient choices on the stability of the ASA.
Outsourcing Drug Development & Production: Technology-Driven Drug Delivery Systems for Small Molecules at Losan Pharma
Due to the increasing demand for drug delivery systems that are able to improve the properties of low soluble, poor permeable, or highly dosed new and existing drug substances, technology-driven CDMOs can offer a wide range of technology platforms to overcome such challenges….
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….
Brickell Biotech Announces Final Patient Completed in First US Phase 3 Pivotal Clinical Study & Patient Enrollment Completed in Second US Phase 3 Pivotal Clinical Study
Brickell Biotech, Inc. recently announced the final patient has completed the Phase 3 pivotal Cardigan I study, and that all planned patients have been enrolled in the Phase 3 pivotal Cardigan II study…..
BioAegis Awarded BARDA Contract to Advance Development of a Novel Host-Directed Human Protein for Patients With Sepsis & Severe Infection
BioAegis Therapeutics Inc. recently announced it was awarded a contract from Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, to further….
Apellis Pharmaceuticals, Inc. and Beam Therapeutics Inc. recently announced an exclusive 5-year research collaboration focused on the use of Beam’s proprietary base editing technology to discover new….
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….
LEXEO Therapeutics recently announced the US FDA has granted Rare Pediatric Disease designation and Orphan Drug designation to LX2006 for the treatment of….
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….
eTheRNA immunotherapies & Quantoom Biosciences Announce Strategic Collaboration for the Development of a Novel RNA Production
eTheRNA immunotherapies NV and Quantoom Biosciences S.A. recently announced they are to collaborate on the development of a revolutionary RNA production system (RPS) for both research and GMP-grade material…..