12th June 2024 by Mandeep Singh Bhandari | Pharmaceutical
The landscape of drug delivery is shaped by the pioneering contributions of renowned scientists and researchers who have played instrumental roles in advancing various drug carrier formulations. In the realm of liposomal drug delivery, the trailblazing work of experts such as Bob Langer, Gregory Gregoriadis (UCL), Demetrios Papahadjopoulos (UCSF), Shiladitya Sengupta (Harvard), William Charman (Monash), and Scott Diamond (Penn) has been paramount.
For protein-based nanoparticles, including virus-like particles (VLPs), the notable figures include Bob Langer, MG Finn (GATech), Inder Verma (Salk), Angela Belcher (MIT), Steven Dowdy (UCSD), Leaf Huang (UNC), Efrosini Kokkoli (UMN), and David Schaffer (UC-B).
Polymer-based nanoparticles have seen groundbreaking developments spearheaded by leaders such as Bob Langer, Mark Davis (Caltech), Nicholas Peppas (UT Austin), Mizuo Maeda (RIKEN), Patrick Stayton (UW), Dennis Discher (Penn), Frank Caruso (Melbourne), Linda Griffith (MIT Langer Alum), Mark Banaszak Holl (UMich), Miqin Zhang (UW), Ashutosh Chilkoti (Duke), Kam Leong (Duke Langer Alum), Samir Mitragotri (UCSB Langer Alum), Alexander Kabanov (UNC), Daniel Pack (UIUC, Langer Alum), Allan Hoffman (UW), Sangeeta Bhatia (MIT), Paula Hammond (MIT), Darrel Irvine (MIT Griffith Alum), Mark Saltzman (Yale Langer Alum), Theresa Reineke (UMN Davis Alum), Suzie Pun (UW Davis Alum), and Omid Farokhzad (Harvard Langer Alum).
Dendrimers have seen significant advancements thanks to the contributions of Jean Frechet (UC-B), James Baker (UMich), and Steven C. Zimmerman (UIUC). In the domain of carbon nanotubes, notable researchers include Maurizio Prato (UNITS), Hongjie Dai (Stanford), Kostas Kostarelos (UCL), and Vladimir Zharov (Arkansas). This comprehensive network of researchers and their affiliations underscores the collaborative and interdisciplinary nature of drug delivery research, with each expert contributing to the evolution of targeted and effective drug delivery systems. For additional insights, exploring the NCI's Centers of Cancer Nanotechnology Excellence (CCNEs) can provide a broader perspective on current advancements in the field.
The pharmaceutical industry remains at the forefront of patent innovation, fueled by the continuous evolution of treatment paradigms, pressing unmet medical needs, and the increasing integration of cutting-edge technologies. Notably, the adoption of advancements in pharmacogenomics, digital therapeutics, and artificial intelligence has significantly contributed to the surge in patent activity. GlobalData's report on "Innovation in Pharma: Drug Delivery Nanoparticles" reveals that within the past three years, an impressive number of over 787,000 patents have been both filed and granted in the pharmaceutical sector.
This robust level of patent activity underscores the industry's commitment to advancing drug delivery technologies and addressing challenges in medication administration. Drug delivery nanoparticles, as highlighted in the report, play a crucial role in enhancing the efficacy and precision of therapeutic interventions. These nanoparticles, encompassing various formulations such as liposomes, protein-based nanoparticles, polymer-based nanoparticles, dendrimers, and carbon nanotubes, represent a key area of innovation within the broader pharmaceutical landscape.
The convergence of traditional pharmaceutical research with nanotechnology and other cutting-edge disciplines demonstrates a multidimensional approach to drug development. Such innovations not only aim to improve drug delivery mechanisms but also leverage technologies like artificial intelligence to optimize drug discovery processes, enhance treatment personalization through pharmacogenomics, and integrate digital therapeutics for improved patient outcomes.
As the pharmaceutical industry continues to navigate the complexities of healthcare, the substantial number of patents reflects a commitment to staying at the forefront of innovation. This landscape is marked by a collaborative and interdisciplinary effort among researchers, clinicians, and technology experts, all working towards the common goal of developing novel and effective therapies that address the evolving needs of patients worldwide.
In the dynamic landscape of ulcerative colitis (UC) treatment, therapies are continuously evolving to enhance local, targeted therapy for improved patient outcomes. UC, a chronic inflammatory bowel disease affecting the gastrointestinal (GI) tract, manifests with symptoms including diarrhea, blood in the stool, fatigue, loss of appetite, and weight loss. While the exact cause of UC remains elusive, a combination of genetic predisposition and environmental factors is believed to contribute to its onset and prevalence.
Current treatments for UC encompass a range of anti-inflammatory drugs, immunosuppressants, and monoclonal antibodies (mAbs) targeting pro-inflammatory markers elevated in the GI tract of UC patients. However, despite the availability of 49 approved drugs for UC, many exhibits suboptimal efficacy and pose safety concerns related to tissue-specific toxicity. Addressing these challenges, biotechnology company Biora Therapeutics has unveiled its groundbreaking Phase I clinical study of BT-600 in healthy human volunteers. BT-600 represents a novel medical drug-device combination designed to deliver tofacitinib, the active component of Pfizer’s Xeljanz, directly to the colon. This innovative approach employs the NaviCap targeted oral delivery platform, a compact, ingestible device measuring 26mm by 11mm—roughly the size of a fish oil pill.
Upon ingestion, Biora's auto-location technology embedded within the device enables it to navigate the GI tract's anatomy, rather than relying solely on physiological cues, to pinpoint the target site accurately. Subsequently, BT-600 releases the therapeutic dose of up to 500ul locally within the colon, minimizing systemic exposure and maximizing therapeutic efficacy while mitigating potential side effects.
This pioneering approach heralds a new era in targeted, topical drug delivery for UC, offering promising prospects for enhancing treatment outcomes and improving the quality of life for patients grappling with this debilitating condition.
TRANSFERRA Nanosciences Inc., formerly known as Northern Lipids Inc. (NLI), stands as a leading Contract Development and Manufacturing Organization (CDMO) at the forefront of lipid nanoparticle drug delivery systems. Specializing in Chemistry Manufacturing and Controls (CMC) services, TRANSFERRA caters to pharmaceutical and biotechnology companies involved in drug development. The company's expertise lies in the comprehensive development and manufacturing of intricate drug delivery systems utilizing lipid nanoparticle science. Operating within a state-of-the-art cleanroom facility featuring ISO 7 compounding areas and an ISO 5 filling suite against an ISO 6 background, TRANSFERRA is dedicated to manufacturing nanoparticles, particularly liposomes. The company employs custom-designed isolators to ensure operator and manufacturing area protection from potent Active Pharmaceutical Ingredients, adhering to U.S. and European regulations for clinical trial material production.
TRANSFERRA offers full-service Good Manufacturing Practice (GMP) manufacturing, encompassing raw material acquisition, identity testing, master batch record drafting, compounding, filling, inspection, labeling, release testing, and clinical distribution site shipping. The company's analytical support for GMP manufacturing includes in-process testing, release testing, and stability studies. In addition to manufacturing, TRANSFERRA excels in process development and scale-up services, utilizing core technologies such as extrusion, tangential flow filtration (TFF), sterile filtration, and isolator technology for high-potency drug manufacturing. Analytical services provided by TRANSFERRA align with FDA guidance on liposomal drug production, covering crucial measurements for product performance assessment.
TRANSFERRA's formulation development services extend to a diverse range of lipid nanoparticle-based drug formulations, including liposomes, micelles, and emulsions, with experience in polymer-based formulations. The company works across various drug classes, including small molecules, peptides, proteins, mRNA, siRNA, and DNA oligonucleotides. Through pre-formulation studies, prototype development, and manufacturing, TRANSFERRA facilitates the identification and scaling of lead candidates for further testing in animals. Noteworthy programs include synthetic vaccines, lipid nanoparticle formulations for RNA-based and DNA-based drugs, challenging hydrophobic drug formulations, controlled release formulations, and ligand-targeted nanoparticle formulations. TRANSFERRA's dedication to advancing drug delivery systems positions it as a key player in the evolution of pharmaceutical innovations.
The drug delivery field faces significant challenges, both historically and in the present. One glaring issue is the escalating prices of pharmaceuticals, which outpace inflation rates, leading to financial strain on patients in need of crucial medications. Instances of exorbitant price hikes by certain pharmaceutical companies, such as the drastic increase in the cost of Daraprim and the EpiPen, highlight a concerning trend where financial interests supersede patient well-being. Moreover, breakthroughs in drug delivery systems and technologies have been relatively scarce in recent decades. This stagnation raises concerns about the effectiveness of research efforts, leading to a potential erosion of public confidence. As drug prices soar, skepticism about the value of research and its impact on treating conditions like cancer, Alzheimer's disease, and opioid addiction becomes more prevalent.
The narrative also delves into the flawed approaches in nanotechnology initiatives, emphasizing the importance of leadership, authenticity, and radical thinking in scientific endeavors. The report criticizes the current system of research, publishing, and funding, highlighting issues such as self-promotion, redundancy, and a focus on quantity over quality. The document discusses the responsibility of pharmaceutical scientists, urging them to acknowledge mistakes and embrace constructive criticism. It advocates for significant changes in the research funding system, emphasizing the need to promote new ideas and problem-solving skills over the sheer number of publications.
The narrative questions whether the current drug delivery field can continue without substantial changes, given the drop in public support for biomedical and pharmaceutical research. It acknowledges the responsibility of researchers to ensure effective and efficient use of research funds, calling for a reduction in redundancy and duplication. In conclusion, the report stresses the importance of realistic dreams, humility, curiosity, and diversification of drug delivery technologies. It calls for a shift in the mindset of drug delivery scientists, encouraging them to explore new ideas, embrace change, and contribute to making a better system that ultimately benefits global health.
Research Associate
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