Contributor Cindy H. Dubin reports on the innovative technologies and techniques that several leading outsourcing providers currently offer for both small and large molecules.
FORMULATION FORUM – Formulation & Process of Lipid Nanoparticles for Delivery of Small Molecules & Biologicals
Jim Huang, PhD, explains how recently, lipid nanoparticles have emerged as a drug delivery system for biologicals, especially for the COVID-19 mRNA vaccines in which LNPs play a vital role in transporting mRNA into the target cells.
David Hughes, PhD, says ultimately, the goal of OOC technology is to improve the translatability of data between the lab and the clinic. Through a lung-on-a-chip approach, it is possible to recreate the histoarchitecture, phenotype, and function of bronchial and alveolar areas of the lung.
Linda Marbán, PhD, says perhaps the best way to get past the cell membrane is to deliver contents the same way that cells send information to each other. And that is by the exosome, which in the case of targeted therapy delivery, has been identified as an alternative that shows powerful promise.
COATING TECHNOLOGY- Combining a State-of-the-Art Bromobutyl Formulation With a Proven ETFE Film for Exceptional Chemical Performance
Julie Suman, PhD, Sebastien Cordier, and Estelle Verger discuss the properties of the ETFE film coating technology used for PremiumCoat(R) vial stoppers and pre-filled syringe plungers. When combined with pure Bromobutyl formulation, the film forms a barrier that can reduce the number of leachables transferred into the solution, and their quantity by up to 98%.
Nancy Lurker, President and CEO of EyePoint Pharmaceuticals, discusses how she is not only working to disrupt treatment paradigms in ophthalmic drug delivery, but also disrupting leadership paradigms as a female CEO of a company with 2020 total revenues of $34.4 million.
CYBERSECURITY – Cybersecurity for Connected Medical Devices: A Holistic Approach During the Entire Product Lifecycle
Nicola Alagia explains why cybersecurity is important for connected medical devices and how to integrate ad hoc activities to tackle cybersecurity in the early phases of product development.
Ian Jenkins, Director of Science, and Jeff Moses, CMO at GATC Health, discuss the combined benefits of their MAT platform and Liquid Biosciences’ Emerge mathematical evolution platform to help identify the right biology sooner and focus on a smaller set of potential compounds early in the pre-clinical development process to enable pharma companies to develop drugs with more efficiency and a higher success rate.
GALECTIN INHIBITORS – Is a Galectin-3 Inhibitor the Answer for Millions of Patients With Cirrhosis & Cancer?
Pol F. Boudes, MD, explains how development of a galectin-3 inhibitor could play a significant role in treating liver diseases, such as non-alcoholic steatohepatitis (NASH) and its complication, liver cirrhosis.
Thomas Turi, PhD, says while biomarkers have been a long-standing part of R&D and a mainstay of clinical practice for the characterization and diagnosis of disease for decades, they are increasingly playing a crucial role in guiding decisions to improve efficacy and efficiency of clinical trials.
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
Jim Huang, PhD, says a thorough understanding of their amorphous stabilization and nano colloidal properties in relationship to in-vitro and in-vivo performance will help advance this interesting dosage form into human clinical testing and commercialization.
Rupa Doshi, PhD, and Sameena Sharif, PhD, explore the landscape of rare cancer clinical trials, from key considerations for study design and the value of biomarkers to the importance of the patient perspective and the options for speeding much-needed therapies to market.
David Bunka, PhD, and Emily Robinson, PhD, focus on a new breed of affinity binders that can be used as an alternative to antibody therapeutics and has the potential to reshape the industry, delivering new medicines with improved safety and efficacy profiles and reduced healthcare costs.
EXECUTIVE INTERVIEW – Quotient Sciences: Unique Considerations & Challenges When Developing Palatable Pediatric Formulations
Nazim Kanji, Executive Director, Pediatric Services at Quotient Sciences, discusses the unique considerations and challenges when developing palatable pediatric formulations, so that molecules can become cures, fast.
The need for flexible solutions for potent product handling is increasing. We’ll discuss the proven benefits of aseptic isolator systems in sterile environments and take a look at real feedback from real customers of ours in an upcoming webinar on Tuesday, November 16th at 11:00 AM EST.
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….
SHL Medical has redefined the conventional platform model by adding modularity to its proven Molly® autoinjector technology. This white paper outlines SHL’s predictive response to market imperatives in the….
WHITE PAPER – A Safe & Efficient Analytical Method for Identity Determination of Oligonucleotides is Now Available
Drs. Alexandra H. Heussner and Melanie Zerulla-Wernitz believe it is essential that the ID specified by the API manufacturer is confirmed before use since it forms the basis for successful drug production.
Bora’s Technology Transfer Whitepaper will help you discover key strategies to successfully transfer and scale Rx & OTC drugs.
WHITEPAPER: Lonza Engine® & Xcelodose®: Accelerating Preclinical & Clinical Trial Pathways With Target Dosing Technologies
Learn how Lonza helps developers quickly assess new drug candidates while minimizing API consumption through efficient excipient screenings, encapsulation and early-phase clinical development technologies. Drug…
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.
EXCLUSIVE ONLINE CONTENT
Mind Medicine (MindMed) Inc. recently announced the US FDA has cleared MindMed’s Investigational New Drug application, allowing the company’s Phase 2b dose-optimization trial of….
Lyra Therapeutics Announces Initiation of LYR-210 Pivotal Phase 3 ENLIGHTEN Program in Surgically Naïve Chronic Rhinosinusitis Patients
Lyra Therapeutics, Inc. recently announced the initiation of the Phase 3 ENLIGHTEN I clinical trial of LYR-210 in adult, surgically naïve chronic rhinosinusitis (CRS) patients, with trial sites open for….
Starton Therapeutics Successfully Demonstrates Continuous Drug Delivery of Lenalidomide From a Transdermal Patch in an In Vivo Nonclinical Study With STAR-LLD
Starton Therapeutics Inc. recently announced it successfully obtained promising results in a non-GLP rabbit pharmacokinetic (PK) and skin irritation study of….
Soleno Therapeutics, Inc. recently provided an update following recent interactions with the US FDA regarding the development of once-daily DCCR (diazoxide choline) extended-release tablets for….
Kura Oncology Receives FDA Authorization to Proceed With Phase 1b Study of KO-539 in Acute Myeloid Leukemia
Kura Oncology, Inc. recently announced the US FDA has lifted the partial clinical hold on the KOMET-001 Phase 1b study of KO-539 in patients with…
Enteris BioPharma, Inc., a biotechnology company developing innovative drug products based on its proprietary delivery technologies, and a wholly-owned subsidiary of SWK Holdings Corporation (Nasdaq: SWKH), recently announced the launch….
F-star Announces Issuance of US Patent Protecting FS118, a Bispecific Antibody Targeting PD-L1 & LAG-3
F-star Therapeutics, Inc. recently announced the USPTO has granted a patent protecting the composition of matter of FS118, F-star’s tetravalent bispecific antibody which blocks PD-L1 and LAG-3 receptors…..
Spero Therapeutics Awarded up to an Additional $12.9 Million by BARDA to Support the Development of Orally Administered Tebipenem Pivoxil in Pediatric Patients
Spero Therapeutics, Inc. recently announced the company and the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the US….
Kinnate Biopharma Inc. recently announced the US FDA has cleared the company’s Investigational New Drug (IND) application for KIN-3248, a next-generation….
Revive Therapeutics Ltd. recently provided an update on the company’s US FDA Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine, an oral drug with….