SPECIAL FEATURE - Outsourcing Analytical Testing – Timelines, Regulations & Biologics Drive the Sector
Contributor Cindy H. Dubin interviews leading CDMOs to discuss not just their analytical service offerings, but their strategies for meeting regulatory challenges and ensuring faster project timelines.
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.
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.
