GLOBAL REPORT – 2021 Global Drug Delivery & Formulation Report: Part 1, A Review of 2021 Product Approvals
In part 1 of this 3-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on a global review of 2021 product approvals.
Jim Huang, PhD, says it is of the utmost important task to utilize a phase-appropriate formulation development approach for early and later-stage commercial development of oral dosage forms.
John Swift believes each medical device manufacturer will discover different patterns of risk as a result of COVID-19. It is therefore imperative that businesses carry out an in-depth and urgent re-appraisal of their supply chain, as failing to do so may cause commercial damage.
Prabu Nambiar, PhD, Founder and CEO Syner-G, discusses the company’s evolution, its approach to CMC, and the future of the organization.
PLATFORM TECHNOLOGY – Predictive Medicine, Biomarkers & the Multiple Unmet Needs in Acute Respiratory Distress Syndrome
Joe G.N. Garcia, MD, and Stan Miele believe the unmet need in ARDS is to identify reliable, validated ARDS biomarkers that minimize ARDS heterogeneity and allow for stratification of subject selection for enrollment in clinical trials of tailored therapies. Combined with a more streamlined drug-approval process, biomarker- and genotype-based treatment of specific ARDS endotypes has never been as within reach as it is today.
Aparna Seksaria reviews how for pharmaceutical companies — and pharma supply chains — to bring safe, commercial-ready products to market quickly and profitably, and for them to meet growing demand for highly personalized, batch-size-one types of products, it’s critical that they take steps to de-risk and speed up processes like batch release, and do so without compromising quality, safety or the bottom line.
Fabio Gratton, CEO of inVibe, discusses patient-focused drug development (PFDD), his company’s language model, and the value this technology brings to a patient’s treatment journey.
PERMEABILITY STUDIES – Onion Epithelial Membrane as a Model for Predicting Intestinal Absorption of Drugs
Antoine Al-Achi, PhD, Mounika Nangineedi, MS, Chaitali Koli, MS, et al, study 19 drugs with varying partition coefficient, water solubility, and molecular weight values to compare their diffusion through the middle epithelial membrane of onion with that of their Caco-2 cell line.
Contributor Cindy H. Dubin interviews several leading companies on how they are using innovative technologies, such as lipid nanoparticles to achieve a high drug loading, combining anti-solvent continuous crystallization with micro-mixing technology to control crystallization and reduce crystal size, and how a robotic capsule can improve bioavailability in the range of 47% to 78%.
Andrew Thomson, Brian Carpenter, and Robert Broadnax focus on how developers must strategically address and overcome specific challenges to successfully drive development and eventual adoption of microbiome-based therapies.
EXCLUSIVE ONLINE CONTENT
This e-Book showcases the various types of services that leading testing companies offer and how they are helping industry comply with regulations to get their products approved and commercialized.
EXECUTIVE INTERVIEW – Oasmia Pharmaceutical: Commercializing Technologies While Pursuing the US Market
Julian Aleksov, Executive Chairman of Oasmia Pharmaceutical, discusses his company’s efforts to enter the US market, its strategy to increase commercial adoption, and why it believes its underlying drug delivery system technology is significant not only within the oncology sector, but the entire pharmaceutical industry.
Hywel Williams, PhD, Annabel Igonin, PhD, David Vodak, PhD, and Hassan Benameur, PhD, believe lipophilic salts are being explored in a number of different areas and one interesting application is their potential to boost API loading in lipid formulations.