EXTRACTABLES & LEACHABLES - Detecting the Unknown With Extractables & Leachables Analysis
Derek Wood, Xiaochun Yu, PhD, and Aaron Lamb review how a new generation of extraction, identification, and quantification tools, now recognized as approved methods by regulatory bodies, are changing the E&L testing landscape.
CLINICAL TRIALS - New Technology & the Global COVID Pandemic Drive the Need for More Decentralized Trials
Suhas Gudihal, MS, MBA, explains how the COVID-19 pandemic has accelerated the ongoing shift to remote clinical trial monitoring, and remote site access and monitoring platforms are now an essential element of the clinical trial process and a vital connection between the sponsor, CRO, and research site.
PAN-VARIANT INHIBITORS - How Pan-Variant Inhibition Can Outsmart Cancer Treatment Resistance
Tim Clackson, PhD, says the goal in targeted oncology is to achieve pan-variant inhibition and, ideally, pan-variant inhibition should be accomplished with a single agent, avoiding the potential complications and toxicities of drug combinations.
(e-Book) Finally, a Complete Guide to Aseptic Manufacturing
Get ready to elevate your aseptic manufacturing game with this complete guide! All the info you need is within this must-have e-Book.
MARKET REPORT - Survey Suggests Global Innovation to Recover Much More Quickly Than Expected in 2023
After a brief fall in 2022 to a score of 6.5 – the first decline since its inception in 2018 – the index has surged to a record score of 7.4. This sudden recovery in scores over a little more than 8 months bodes extremely well for device and packaging manufacturers in the year ahead, suggesting a strong global recovery in industry outlook and confidence.
(e-Book) Lyophilization Trends in Pharma & Biopharma Drug Development
This 30-page eBook is exactly what you have been looking for. Find out what is driving the lyophilization market and how working with a CDMO will save time and money and help you comply with increasing regulatory requirements.
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.
