GENE-EDITING TECHNOLOGY - How CRISPR-Cas9 Technology Will Play a Vital Role in the Future of Human Therapeutics & Drug Discovery
Kevin Holden, PhD, explores how this technology can be utilized in research efforts toward the development of new therapies and how it will play a vital role in the future of biopharma and drug discovery.
ANTIBODY THERAPEUTICS - Teneobio’s Next Generation of Multispecific Antibody Therapeutics
Omid Vafa, PhD, MBA, reviews unique technologies, including a transgenic rat platform expressing human heavy chain antibodies, and a state-of-the-art sequence-based discovery engine, to create novel multispecific antibodies for various therapeutic indications.
PACKAGING - Child-Resistant Features for Container Closure Systems
Stefan Hellbardt, PhD, Guenter Nadler, and Degenhard Marx, PhD, highlight the successful introduction of Aptar’s first CR/SF nasal spray pump and the first dermal dispenser on the US market.
DEVICE REGULATIONS - Early Preparation Will Pay Big Dividends as EU Enacts New EU Device Regulations
Joanne Emmett says current directives are giving way to new regulations that require Class III and implantable devices to undergo clinical investigation to show that they are equal or superior to other products on the market.
CLINICAL TRIALS - Why Are Metrics Important in Starting Clinical Trials?
Craig Morgan believes metrics are indeed critical to efforts to rein in clinical trials that are either poorly initiated or have incurred unforeseen events, which place the original timelines and/or budgets at risk of overages.
TECHNOLOGY-ENABLED HEALTH - Digitally Connected Health Technologies: Blazing Meaningful Trails in Healthcare
Daniel Spors and Kyle Dolbow, PhD, say the overall digital health market is currently $76 billion, and is estimated to grow at 21%, and this space includes life sciences and medical device companies that are incorporating digital technology into their products and services, such as smart inhalers and remote therapy devices.
INTRABODY DELIVERY - The Feldan Shuttle Technology: A Peptide-Based Method to Deliver Antibodies
Thomas Del’Guidice, PhD, Nancy Messier, PhD, and David Guay, PhD, present the Feldan Shuttle technology, a peptide-based delivery method that could provide efficient and safe intrabody delivery in mammalian cells.
EXECUTIVE INTERVIEW - Lonza Pharma & Biotech: Taking on the Next Challenges in Small Molecules
Gordon Bates, Head of Chemical Division at Lonza Pharma & Biotech, shares his perspective about industry needs and how strategic acquisitions are enhancing Lonza’s position as a development and manufacturing partner of choice.
NEXT-GENERATION SEQUENCING - Emerging Clinical Applications & Projections to 2022
Laurie L. Sullivan and John Bergin, MS, MBA, say the growth curve for clinical applications of NGS is approaching an upward trajectory as existing applications gain traction and new ones begin to establish a foothold.
CANCER IMMUNOTHERAPY - Building on Initial Successes to Improve Clinical Outcomes
Allan B. Haberman, PhD, provides an updated discussion of approved and clinical-stage agents in immuno-oncology, including recently approved agents. He also addresses how researchers and companies are attempting to build on prior achievements in immuno-oncology to improve outcomes for more patients.
CENTRALIZED BIOMETRICS - The Backbone of a Global Clinical Data Strategy
Paul Fardy details the steps needed to implement a successful global clinical data strategy and how to approach developing a centralized process that results in transparency, traceability, accuracy, and collaboration.
ONCOLOGY DIAGNOSTICS - Advancements Paving the Way for More Tailored Drugs
Divyaa Ravishankar, MS, says pharmaceutical companies have been subjected to a wide variety of external forces compelling them to get innovative about development of new platforms, liaise with new partners, leverage big data toward precision and predictive diagnosis, and identify new markers.
R&D PARTNERSHIPS - Partnering for Progress: How Collaborations Are Fueling Biomedical Advances
Neil Lesser and Matt Hefner analyze biopharmaceutical partnerships created throughout the past several decades, and based upon a comprehensive database of partnerships formed between 1980 and 2014, they found that R&D-focused partnerships have grown substantially.
CordenPharma Acquires Pfizer API Manufacturing Facility in Boulder, CO
CordenPharma, a leading Contract Development & Manufacturing Organization (CDMO), has entered into definite agreements to acquire the former Hospira Boulder (Colorado) high containment API site…
TABLET FORMULATION - Reformulation of Tablets to Resolve Sticking & Picking Issues Faced on Compression: A Case Study
Smruti P. Chaudhari, PhD, and Anshul Gupte, PhD, successfully reformulated tablets using the potassium-salt form of Compound XY without adding any new excipient. Through the reformulation, they also resolved earlier issues faced during tablet compression.
OPHTHALMIC SQUEEZE DISPENSER - Eliminating the Need for Additives in Multidose Preservative-Free Eyecare Formulations
Degenhard Marx, PhD, and Matthias Birkhoff highlight their company’s Ophthalmic Squeeze Dispenser (OSD), a multi-dose dropper that relies solely on mechanical measures to prevent microbial contamination of the bottle content.
GENE & CELL THERAPY - Its Growing Potential to Disrupt Drug Research & Healthcare Delivery
Jeff Galvin believes as the pace of gene and cell therapies accelerates over this next decade, potential cures for chronic diseases, cancer cures, and autosomal defect cures will result, and the efficacy of new therapeutics may move as much as $500 billion from traditional pharmaceuticals to gene technologies.
ADVANCED DELIVERY DEVICES - The Staked Needle Pre-Filled Syringe: Benefits, Conventional Limitations & a New Approach
Horst Koller and John A. Merhige, MEM, say the advantages of a Staked Needle Pre-Filled Syringe are clear and well documented, but significant risks remain. A new alternative is now available that addresses the known challenges and adds critical usability and safety features while preserving existing components and processes.
SPECIAL FEATURE - Platform Technologies - Derisking & Transforming Drug Development
Contributor Cindy H. Dubin, in this second annual report, speaks with several exciting and innovative companies whose platform technologies are transforming drug development.
EXECUTIVE INTERVIEW - Aptar Pharma: Quality Will Inject Real Growth Into the Injectables Market
Bas van Buijtenen, President of the Aptar Pharma Injectable Division, reviews the past 12 months and assesses what will drive the market in the future.
