EXECUTIVE INTERVIEW - SDP Oncology: Uncovering New Biology
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.
SPECIAL FEATURE - Improving Bioavailability & Solubility: Each Molecule Is Unique
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.
GLOBAL REPORT - 2020 Global Drug Delivery & Formulation Report: Part 1, a Global Review
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.
DRUG DEVELOPMENT - Understanding & Targeting the Mechanism of Action of Developmental Disorders
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.
EXECUTIVE INTERVIEW - Pharmaceutics International, Inc: Getting Back to its Roots
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.
PRODUCT DEVELOPMENT STRATEGY - ESCP, Estimating Product Performance Part 1 - Playground Physics
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.
FORMULATION FORUM - Oral Controlled Delivery of Poorly Water-Soluble Drugs
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.
TUB PACKAGING - Why Double-Bagged Tubs Are an Issue for High-Speed Filling
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.
EXECUTIVE INTERVIEW - BiologIC Technologies: The Future Microsoft for the Biorevolution
Richard Vellacott, CEO of BiologIC Technologies, discusses his company’s unique technology and its applications in the future of medicine and wider fields of synthetic biology.
FORMULATION DEVELOPMENT - The Role of Excipient Selection in the Development of Orally Disintegrating Tablets
Torkel Gren, PhD, reviews the benefits that orally disintegrating products can bring to patients and developers and assesses the impact that excipient selection can have on the development of successful products.
EXECUTIVE INTERVIEW - Fortress Biotech, Inc.: Looking for the Muffin Tops
Lindsay A. Rosenwald, MD, Chairman, President, and CEO of Fortress Biotech, discusses how his medical and financial knowledge come together to find successful drug candidates, the company’s partnership model, and the inefficiencies he sees in the biotech industry.
TURNAROUND CASE STUDY - A Pharma Industry Outsider’s Perspective - Turning Around the “ABCDMO” Company
Paul Fioravanti, MBA, MPA, presents a case study on how he successfully turned around a failing CDMO that grew rapidly from one production location to eight in just 4 years, but was just few weeks away from running out of cash.
