Jennifer Rogers discusses how non-fatal recurring events, such as asthma attacks, epileptic seizures, and hospitalization for heart disease, have a certain manner in which they should be handled in clinical trials.
David J. Bearss, PhD, Chief Scientific Officer and Global Head of Research at SDP Oncology, discusses his company’s unique structure that has supported its robust research in the tumor immune microenvironment as well as its investigational assets being studied in this space.
Contributor Cindy H. Dubin speaks with several innovative companies to discuss novel approaches to improving bioavailability and solubility that have one commonality: they treat each molecule as an individual.
FORMULATION FORUM – Considerations in Development & Manufacturing of Complex Injectables for Early Phase Studies
Jim Huang, PhD, explains how a niche CDMO, which has specialized technologies in complex injectable development and adopts GMP practice with a “laboratory setting,” will have greater flexibility regarding changes, timing, and cost for successful manufacture of complex injectables in early phase development of therapeutic drugs.
In part 1 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on a global review of 2020 product approvals.
CELL & GENE THERAPY – End-to-End Cell & Gene Therapy – From Development to Commercialization – Buy or Build?
Aldo Romano and Emily Moran, MBA, discuss how the life science industry must bring technology solutions to the table while at the same time securing the capacity to develop and manufacture groundbreaking cures so patients and society can tap the benefits of cell and gene therapies.
Michael Snape, PhD, says when identifying promising therapeutic targets for any disease or condition, including developmental disorders such as Fragile X syndrome, PMS, CDM1, and Rett syndrome, it is critical researchers work to understand the mechanism of disease and disease pathways as well as the unmet need and patient experience.
Sridhar Krishnan, Pii’s Senior Vice President, Operations and Strategic Initiatives, discusses how manufacturing is not solely where Pii wanted to be, so the company made a concerted effort to get back to its CDMO roots.
IMMUNE ACTIVATORS – Enhancing Cell Adhesion to Safely Improve Effectiveness of Vaccines & Cancer Immunotherapies
Siddhartha De, PhD, and Peter Vanderslice, PhD, present their research on the use of proprietary, orally available compounds that can activate the immune system to enhance the effectiveness of vaccines as well as immuno-oncology therapies for cancer, especially in patient populations that are most vulnerable to disease.
MICROFLUIDIC ENCAPSULATION TECHNOLOGY – Achieving Reliable siRNA Drug Delivery for Inflammatory Diseases & Tumor Targeting by Nanoencapsulation
Olivia Merkel, PhD, and Christoph Zimmermann, PhD student, discuss the benefits of microfluidic encapsulation technology for gene silencing applications in cancer immunology and inflammatory diseases, where siRNA can potentially be used to downregulate genes associated with these pathologies.
EXCLUSIVE ONLINE CONTENT
This e-Book showcases the various types of services that leading testing companies offer and how they are helping industry comply with regulations to get their products approved and commercialized.
EXECUTIVE INTERVIEW – Oasmia Pharmaceutical: Commercializing Technologies While Pursuing the US Market
Julian Aleksov, Executive Chairman of Oasmia Pharmaceutical, discusses his company’s efforts to enter the US market, its strategy to increase commercial adoption, and why it believes its underlying drug delivery system technology is significant not only within the oncology sector, but the entire pharmaceutical industry.
Hywel Williams, PhD, Annabel Igonin, PhD, David Vodak, PhD, and Hassan Benameur, PhD, believe lipophilic salts are being explored in a number of different areas and one interesting application is their potential to boost API loading in lipid formulations.