Formulation Development
FORMULATION FORUM - Sterile & Non-Sterile Formulation Capabilities - A CDMO Perspective
Jim Huang, PhD, and Shaukat Ali, PhD, explain how their company is expanding its footprints in sterile manufacturing to handle innovative molecules and leverage its services to emerging and specialty and biopharma companies requiring cGMP materials for preclinical tox and clinical studies.
DRUG-ELUTING IMPLANTS - Sustained-Release Implants - A Targeted Approach to Drug Delivery
Tom Quinci, MSc, believes oncology requires new treatment modalities that are better for patients, and it is time technologies like drug-eluting implants, offering real, achievable advantages, are more widely considered.
ROUNDTABLE DISCUSSION - Which Trends Will Have the Most Impact on Drug Development in 2023?
Contributor Cindy H. Dubin posed this question to life science leaders during a recent roundtable discussion, and one common theme is the focus on sustainability in pharmaceutical development.
FUNCTIONAL EXCIPIENTS - Improving the Water Solubility of Oral Drugs With Amorphous Solid Dispersions (ASDs)
Liliana Miinea, PhD, says with certain polymers, it is possible for drug formulators to take full advantage of the benefits of ASDs, enabling them to overcome formulation challenges to deliver more effective novel drug products capable of transforming the lives of patients.
CLINICAL TRIALS - Historical Controls in Rare Disease Drug Development: Using RWE to Overcome Key Challenges
William Maier, MD, PhD, says the utility of HCs based on RWE should be evaluated for potential applications to increase speed of product approval, reimbursement, and clinical practice adoption.
DISCOVERY PLATFORM - Reverse-Engineering Targeted Immunotherapy
Bob Lechleider, MD, explains how by applying a patient-first technology and looking for clues in the immune system, a powerful tool can be harnessed – the human body – to identify and produce new molecules to make medicines for cancer patients.
EXECUTIVE INTERVIEW - TC BioPharm: Developing Platform Allogeneic Gamma-Delta T Cell Therapies for Cancer
Bryan Kobel, CEO of TC BioPharm, discusses his company’s upcoming plans, therapeutic clinical trials, and the biotech landscape.
FORMULATION DEVELOPMENT - Understanding CBD Formulation Versus Dosage Format
Gerry McNally, PhD, says there are many misconceptions when it comes to considering the best way or format to consume CBD and get the maximum benefit. Formulation scientists need to consider several factors when developing new formulations of nutraceutical ingredients, especially botanical ingredients and natural materials from various sources.
THERAPEUTIC FOCUS - Addressing the Unmet Need for Improved Treatments of Female Cancers
Martin Lehr, MA, explains how his company is advancing a pipeline of innovative products designed to address treatment resistance in breast, ovarian, and endometrial cancer, which, if approved, could provide patients with a much-needed new treatment options.
CLINICAL TRIALS - The Mission to Increase Diverse Clinical Trial Participation
Lauren Chazal, MBA, and Keidra Gaston, MBA, believe clinical trials are critical to advancing medical knowledge and new therapeutics; however, it is important that participants in clinical trials represent their entire communities and the potential recipients of new treatments.
PATIENTS-ON-A-CHIP - Why Artificial Intelligence Will Be the Tipping Point to Remove the Faulty Reliance on Animal Testing in Drug Discovery
Isaac Bentwich, MD, believes Advanced Bio-AI platforms that integrate artificial intelligence and machine learning with patients-on-a-chip, real-time nano-sensing, and stem cell genomic diversity technologies are the future of drug discovery and development.
Lonza Completes Expansion to Solid Form Services Facility at Oregon Site
The offering complements Lonza’s API development services and first-in-human services, aimed at the rapid advancement of small molecules….
Ethicann & Catalent Sign Development & License Agreement for New Fast-Dissolve Cannabinoid-Based Treatments
Catalent and Ethicann Pharmaceuticals Inc. recently announced the companies had executed a development and license agreement to develop Ethicann’s clinical drug pipeline using Catalent’s….
Global CDMO Adare Pharma Solutions Harmonizing Quality With Veeva Vault Quality Suite
Adare Pharma Solutions recently selected Veeva Vault Quality Suite to harmonize quality systems across the organization. By replacing legacy systems with modern connected applications, Adare can…
Pheno Therapeutics Announces Worldwide License From UCB to a Novel Program for Neurodegenerative Disease
Pheno Therapeutics Limited. recently announced it has entered into an exclusive worldwide license agreement with UCB. The agreement grants Pheno Therapeutics access and rights to….
Emerald Health Pharmaceuticals Receives Safety Review Committee Approval to Proceed to Final Cohorts of EHP-101 Phase 2a Systemic Sclerosis Trial
Emerald Health Pharmaceuticals Inc. recently received a positive safety review following a pre-specified interim analysis by the Safety Review Committee (SRC) of its Phase 2a…
BioXcel Therapeutics Announces Promising Top-Line Results from Phase 2 Trial of BXCL701 in Aggressive Form of Rare Prostate Cancer
BioXcel Therapeutics, Inc. recently announced promising top-line data from its Phase 2 trial of BXCL701, the company's investigational, oral innate immune activator, in combination with…
Sterling Pharma Solutions Completes Acquisition of API Manufacturing Facility in Ireland
Sterling Pharma Solutions recently announced the completion of its acquisition of an active pharmaceutical ingredient (API) manufacturing facility in Ringaskiddy, Ireland, from Novartis, in a…
Ajinomoto & Exelixis Enter License Agreement to Discover & Develop Novel Antibody-Drug Conjugates for the Treatment of Cancer
Ajinomoto Co., Inc. recently announced a license agreement with Exelixis, Inc. to incorporate AJICAP, Ajinomoto Co.’s proprietary site-specific bioconjugation and linker technologies, in the development of….
SAB Biotherapeutics Successfully Concludes IND-Enabling GLP Toxicology Study for Novel Immunotherapeutic for Type 1 Diabetes
SAB Biotherapeutics recently announced the successful completion of an IND-enabling GLP-tox study for SAB-142, further progressing the therapeutic as a way to prevent and/or delay onset…
