Featured Articles
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.
2023 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
MACHINE LEARNING - Applying Machine Learning Techniques: Gaining Meaningful Life Sciences Insights From Genomics Data
Lucas Glass explains how the predictive capabilities offered by ML solutions can help pharmaceutical and biotech companies shift focus onto additional experiments — providing an opportunity to catch or generate potential options.
ARMED ONCOLYTIC VIRUSES - Instant Messaging Cancer With a TGF-Beta Trap Carrying Oncolytic Adenovirus
Bryan Oronsky, MD, PhD, says cancer is a systemic disease, the eradication of which heavily depends on immune responses. In his opinion, to overcome impaired immune cell function and, hence, to increase the responsiveness to CIs likely requires a 3-in-1 therapy.
DRUG DISCOVERY - Leveraging the Human Gut as a Drug Discovery Tool
Bridget Ann Martell MA, MD, says leveraging a patented technology that uses the human gut as a drug discovery tool has led to a new class of transformative precision therapeutics that disrupt inflammatory disease triggers — gut exclusive microbial metalloprotease inhibitors (GEMMI).
DRUG DELIVERY - Using the IPEG™ Delivery System to Topically Treat Rare Diseases in Dermatology While Limiting Systemic Absorption
Zachary Rome, Jessica Raiz, MPH, and Alan M. Mendelsohn, MD, are advancing innovative clinical research that is evaluating high-potential, low-risk treatments for rare dermatologic diseases using unique topical vehicles combined with established medications that enable the targeted delivery of therapies to the epidermis and dermis while minimizing systemic absorption.
EXECUTIVE INTERVIEW - Ajinomoto Bio-Pharma Services: Giving You the Power to Make
Dr. Nobu Shimba, CEO and President of Ajinomoto Bio-Pharma Services US, discusses the company’s recent areas of focus as well as current plans for expansions.
EXECUTIVE INTERVIEW - Alcami: Unlocking the Potential of Transformative Medicine for 40 Years
Mike Babics, Vice President, Parenteral Services at Alcami, discusses the company’s recent expansions in formulation and analytical development, manufacturing, release testing, and biostorage of clinical and commercial drug products for both solid dosage and parenteral products.
PLATFORM TECHNOLOGY - Versamune®: A New Generation of Cancer Immunotherapies
Dr. Joe Dervan says the unique ability of Versamune® to modulate and enhance numerous critical steps required for an effective clinically relevant immune response and to be combined with targeted antigens found on tumor cells offers several exciting opportunities to treat a variety of cancers.
FORMULATION FORUM - Lipid Nanoparticles: Tackling Solubility Challenges With Lipid-Based Technologies for Oral & Injectable Formulations
Jim Huang, PhD, and Shaukat Ali, PhD, believe as more hydrophobic or brick dust and/or lipophilic or waxy molecules come out of discovery, amorphous solid dispersions (ASDs) and lipid based self-emulsifying microemulsions, nanoemulsions, liposomes, and nanoparticles are ideal for oral and injectable formulations.
EXTRACELLULAR VESICLES - Engineering Extracellular Vesicles to Create Next-Generation Therapeutics
David Lowe, PhD, Justin Hean, PhD, Dave Carter, PhD, and Antonin de Fougerolles, PhD, say EVs exhibit key properties that make them extremely attractive as therapeutics, particularly their safety profile and potential for low immunogenicity. In order to effectively unlock this potential, some key challenges remain, such as the development of EV product manufacture and characterization methodologies and rapid pharmacokinetics.
MEDICAL DEVICE TESTING - Chemical Characterization & the Non-Targeted Analysis of Medical Devices
Luminita Moraru, MSC, MRSC, says the medical devices industry is in continuous growth, and the development of new reliable and accurate approaches in order to assess the safety of the products should constantly be reviewed.
EXECUTIVE INTERVIEW - Owen Mumford & Stevanato Group: Collaborating to Produce Aidaptus® Auto-injector
Michael Earl, Director of Pharmaceutical Services at Owen Mumford, and Steven Kaufman, Vice President for Drug Delivery Systems at Stevanato Group, discuss their collaboration in producing the innovative Aidaptus auto-injector.
EXCIPIENT COMPACTION STUDY - Developing a Reliable Controlled-Release Polymer Using a Compaction Simulator
Gopeshkumar Singh, MS, and Ajit Bhagat provide study results showing that through polymer chemistry, it is viable to effectively manufacture matrix tablets via a simple direct compression method; and Hypromellose has impressive compatibility at various compression forces.
CLINICAL TRIALS - Quality Matters in an Evolving Clinical Trial Landscape
John Buchan reviews best practices for achieving quality by addressing challenges focused on the all-important but growing complexity of managing the distribution of critical safety documents and the processing of Individual Case Study Reports and aggregate reports to sites, Ethic Committees (ECs), IRBs, and others in the reporting chain.
