Contract Services
CDMO CASE STUDY – AJILITY: Streamlining Drug Product Manufacturing
Dustin Campbell says the AJILITY platform takes the burden off clients and allows his company to drive, manage, and support their drug product manufacturing, maximizing speed and success, while prioritizing these programs are driven to completion.
DEVICE DEVELOPMENT – Designing Devices for Inhaled Drugs
Andreas Meliniotis explains how there is plenty of opportunity for the development of new, improved devices to ensure inhaled drugs can be accessible for a wide range of patients and can treat various diseases and conditions effectively.
OVER-ENCAPSULATION CAPSULES – Double-Blind, Zero Bias: Over-Encapsulation — The Right Tool for Blinding Studies?
Julien Lamps believes that while many blinding options are available to drug sponsors and external clinical research partners, over-encapsulation remains a popular choice for its dosing simplicity, trial efficacy, patient accessibility, and cost-effectiveness.
OSD FORMULATIONS – Dissolving Bioavailability & Solubility Challenges in Formulation & Development
Vinod Patil, PhD, says many of the innovative and novel formulations introduced throughout the past decade have had to cope with poorly water-soluble APIs. Considering the pace of development, overcoming solubility issues will remain problematic, and this is especially true for important new classes of pharmaceuticals entering the market.
IMMUNOGENICITY TESTING – Regulatory Updates for Immunogenicity Assessment of Therapeutic Proteins
Leon Shi, PhD, Lan Li, MS, and Jing Shi, PhD, provide a high-level analysis of the significant changes to the guidance compared to the immunogenicity draft guidance released in 2016, and the implications for drug development programs.
SPECIAL FEATURE – Injection Devices: Will COVID-19 Deliver Growth to the Market?
Contributor Cindy H. Dubin interviews several leading companies and highlights trends in autoinjectors, pen injectors, wearable devices and connectivity, and prefilled syringes.
DRUG DEVELOPMENT – Bringing New Drugs to Patients Faster by Integrating Traditionally Separate Pharma Development Functions
Nutan Gangrade, PhD, says reducing R&D project timelines saves on overhead in development while increasing the likelihood of primacy in the marketplace (which engenders significantly more sales) and describes new approaches drug developers are taking to streamline drug development.
DEVICE DEVELOPMENT – Mapping the Regulatory Strategy to Better Navigate Electronic Drug Delivery Device Development for Patient Safety & Security
Ahmed Mallek, Hadrien Gremillet, and Audrey Chandra say that along with technology advancement in the medical industry, the behaviors and needs of different stakeholders also evolve, resulting in a clear interest in electronic drug delivery devices for a variety of reasons.
COMBINATION PRODUCTS – Development Challenges & Solutions
Tom McLean says combination drug development pipelines continue to rapidly expand and diversify with differentiated molecules and formulations, which can call for nuanced as well as significant packaging and delivery system requirements.
EXECUTIVE INTERVIEW – Nuritas Pharma: Life Changing Peptide Drug Discoveries for a Changing World
Nora Khaldi, PhD, Founder and Chief Executive Officer of Nuritas, discusses the company’s innovative approach to accelerating the discovery of novel therapeutic peptides that address unmet patient needs in multiple disease areas.
EXCLUSIVE ONLINE CONTENT
AzurRx BioPharma Engages PPD to Manage Clinical Trial for Niclosamide as Treatment for Grade 1 Immune Checkpoint Inhibitor-Associated Colitis
AzurRx BioPharma, Inc. recently announced it has entered into an agreement with PPD, Inc. for its planned Phase 1b/2a clinical trial evaluating proprietary formulations of micronized….
Moderna & Catalent Announce Long-Term Strategic Collaboration for Dedicated Vial Filling of Moderna’s COVID-19 Vaccine & Clinical Portfolio
Moderna, Inc. and Catalent, Inc. recently announced the expansion of their strategic collaboration to dedicate a new high-speed vial filling line for the manufacture of the Moderna COVID-19 Vaccine and potentially other….
Ascendia Pharmaceuticals Secures Growth Equity Investment From Signet Healthcare Partners
Ascendia Pharmaceuticals, Inc. is a specialty CDMO dedicated to developing and manufacturing enhanced formulations for pre-clinical, clinical-stage drug candidates, and marketed drug products. The investment was made by Signet Healthcare Partners….
Syneos Health Partners With Science 37 to Transform Clinical Trials
Syneos Health and Science 37 recently announced a strategic partnership to enable enhanced decentralized clinical trial delivery…..
Ajinomoto & Bright Peak Therapeutics Enter Research Collaboration & License Agreement
Ajinomoto Co., Inc. and Bright Peak Therapeutics Inc. recently announced a research collaboration and exclusive license agreement to incorporate AJICAP, Ajinomoto Co.’s proprietary….