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.
EXECUTIVE INTERVIEW – Pace Analytical® Life Sciences: Delivering Science Better; Advancing Novel Therapies Through the Clinic to Commercialization
Frank Tagliaferri, PhD, Vice President of Pharmaceutical Development at PLS, discusses his experiences with the company and its recent growth.
ORAL MUCOSAL IMMUNOTHERAPY – Oral Mucosal Delivery of Allergenic Proteins for Inducing Tolerance in Food Allergic Individuals
William R. Reisacher, MD, highlights some of the differences between food allergy immunotherapy via the oral mucosal route versus exposure through the stomach and intestines.
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.
SPECIAL FEATURE – Outsourcing Analytical Testing: Innovative Drugs Spike Demand for Advanced Analysis
Contributor Cindy H. Dubin asked some of the key analytical testing providers to describe their offerings in several key areas and what advanced analytical testing techniques they can offer to pharma clients.
Jim Huang, PhD, discusses how understanding key biopharmaceutical properties in relationship to drug absorption and elimination plays a critical role in successful design of CR dosage forms from discovery to first-in-human with a shorter timeline and lower development costs.
Tilman Roedle says variation in tub packaging continues to create financial and operational challenges for the entire downstream supply chain, and it’s time for the industry to align on packaging configuration requirements that make tubs fully processable on automated lines.
MULTI-PARTICULATE MANUFACTURING – How Does Experiment Design Affect Multi-Particulates Manufacturing?
Namrata Vora, MS, Danica Cartwright, Karthikeyan Selvaraj, MPharm, and Ryan Larmon, MS, discuss how the careful application of design of experiment studies is an invaluable tool in proving the design space of complex formulations and manufacturing processes.
REGISTER TODAY! TWO SESSIONS: March 11, 2021 9:00 AM EST and 1:00 PM EST Join us as we explore the unique challenges in oral delivery of…
What life sciences developments will be talked about this year? Who will you meet? There's no telling—well, maybe there is—with the official release of the DIA…
Registration is now open for Advances in Drug Formulation & Delivery Part II--a weekly webinar series with more than a dozen speakers from industry and academia, discussing innovative and…
ProPerma™ uniquely improves both permeability and bioavailability of BCS III and BCS IV compounds by deploying an innovative and bespoke combination of GRAS and novel enhancing excipients…
Developing a new pharmaceutical product is one of the most interesting and rewarding activities to partake in, it is also extremely challenging. It is a given that drug development projects will not….
Considerations in Support of Achieving Successful Double Blinding and Removing Bias With Over Encapsulation
Download the new whitepaper, Considerations in Support of Achieving Successful Double Blinding and Removing Bias With Over Encapsulation, to learn more about these considerations and…
EXCLUSIVE ONLINE CONTENT
Vaccinex, Inc. recently announced the signing of multi-project deals with two undisclosed prominent pharmaceutical companies…..
Stevanato Group has recently launched an Artificial Intelligence platform, based on Deep Learning (DL) models, that leverages the benefits of….
SIRION Biotech & Sanofi Join Forces to Develop Gene Therapies for Multiple Life-Threatening Disorders
SIRION Biotech GmbH recently announced it signed a license and collaboration agreement with Sanofi to develop improved tissue-selective adeno-associated virus (AAV) vectors to realize….
Catalent to Acquire Delphi Genetics & Launch US Plasmid Manufacturing Site to Establish Global pDNA Development & Manufacturing Capabilities
Catalent and Delphi Genetics recently announced they have entered into a final and definitive agreement whereby Catalent will acquire 100% of the shares of Delphi Genetics. Catalent is also….
Halberd Collaborates With GreenBioAZ for the Development of Radio Frequency Technology to Eliminate Disease Pathogens
Halberd Corporation has engaged GreenBioAZ, Inc. to conduct laboratory testing of Halberd’s patent pending Radio Frequency (RF) extracorporeal treatment to eliminate….
SCYNEXIS, Inc. recently announced it has entered into a licensing agreement and strategic partnership with Hansoh Pharmaceutical Group Company Limited…..
Biomunex Pharmaceuticals Signs Strategic License & Co-development Agreement With Onward Therapeutics
Biomunex Pharmaceuticals and Onward Therapeutics SA recently announced the signing of a strategic exclusive worldwide license and co-development agreement for a proprietary….
Altimmune Announces FDA Clearance of Single-Dose, Needle-Free, Intranasal COVID-19 Vaccine Candidate
Altimmune, Inc. recently announced the US FDA has cleared the company’s Investigational New Drug (IND) application for its Phase 1 clinical trial of AdCOVID….
Samsung Biologics recently announced another successful Investigational New Drug (IND) clearance from the FDA for its client to begin clinical trials on a cancer immunotherapy, furthering the….
Maravai LifeSciences, Inc. recently announced the United States Patent and Trademark Office has issued a new patent, United States Patent No. 10,913,768, to the company’s TriLink Biotechnologies subsidiary…..