CLINICAL TRIALS SOLUTIONS - Cracking Down on the Rising Costs of Drug Development: How Pinpointing the Complexity of Individual Patients Can Improve Success Rates
Dominique Demolle, PhD, and Erica Smith, PhD, say taking a more holistic, patient-centric approach by considering patients’ individual psychology, perceptions, and beliefs provides drug developers the opportunity to quantify these interpersonal differences between patients and address this source of variability in data analysis and interpretation.
SYNTHETIC ANTI-INFECTIVES - Synthetic Polymers Offer a New Class of Anti-Infectives
James Graham believes synthetic anti-infectives offer a potential solution to the obstacles encountered by naturally derived antibiotics in the constant arms race against antimicrobial resistance.
SPECIAL FEATURE - PFS & Parenteral Drug Delivery: Self-Injection is Very Much the “New Normal”
Contributor Cindy H. Dubin showcases how leading CDMOs and drug delivery developers are responding to current market trends to create ergonomic technologies that are patient friendly, easy to use, reduce needle anxiety, and feature improved packaging materials.
GLOBAL REPORT – 2021 Global Drug Delivery & Formulation Report: Part 2, Notable Drug Delivery and Formulation Product Approvals and Technologies of 2021
In part 2 of this 3-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on notable drug delivery and formulation product approvals.
ARTIFICIAL INTELLIGENCE - Modernizing Your Clinical Development Safety Practices With Artificial Intelligence
Updesh Dosanjh, MS, says by continuing to explore the ability of these technologies to deliver better and safer treatments, pharmaceutical companies can benefit not only the advancement of the medical community, but the quality of life of patients around the world.
EXECUTIVE INTERVIEW - Adare Pharma Solutions: The Journey to Become a Full-Service Provider
Tom Sellig, CEO at Adare Pharma Solutions, discusses his expectations for Adare and how he can leverage his 30-plus years of pharma experience to put Adare in a competitive position to address complex formulation and development challenges.
FREEZE-DRYING MICROSCOPY - Unravelling the Complexities of Freeze-Drying Pharmaceuticals With Advanced Microscopy Techniques
Paul Matejtschuk, PhD, Prof Yvonne Perrie, and Robert Gurney, PhD, say FDM is being used to analyze the most challenging formulations that require sophisticated stabilization methods. By altering and adapting the three main freeze-drying stages to specific formulations, researchers are providing the tools needed for the pharma industry to improve its drug development processes and maintain drug stability when scaling up to production.
REGENERATIVE MEDICINE - Delivering on the Promise of Regenerative Medicine in Type 1 Diabetes
Thomas Donner, MD, explains how advances in stem-cell engineering, immune-evasion technologies, and vascularization of implanted cells have the potential to generate novel therapeutics that could lead to reduced treatment burden for patients with T1D and infuse new energy into efforts at finding a cure.
EXECUTIVE INTERVIEW - PCI Pharma Services: Broadening Our Biologics Footprint, Together
Shawn Cain, SVP Development & Manufacturing at PCI Pharma Services, discusses the recent acquisition, the opportunities this presents to Biopharma companies, and the current trends in the sterile fill-finish industry.
MEDICAL DEVICE UX DESIGN - Bridging the Divide Between People & Products: How UX Design Can Improve Medical Device Product Development
Aditya Jagannathan explains how human factors and industrial design can bridge the divide between people and products to maximize the likelihood that new medical devices will be safe and effective for the intended uses, users, and use environments.
AUTOMATION SOLUTIONS - The Future of Lab Tech Will Combine Automation, Accuracy & Agility
Rich Ellson and John Fuller, PhD, say accelerating development comes down to designing and using flexible automation solutions along with smarter instruments and new consumable paradigms to help meet researchers’ needs.
CELL & GENE THERAPY - State of the Industry – Where is C> Headed?
Bill Vincent believes if the industry wants to keep moving up the steep growth curve, then capacity and raw materials must be readily available. The innovations in therapies, platforms, and processes will all come with time, money, and increasing availability of resources.
SPECIAL FEATURE - Excipients: Exciting Expansion & Innovation
Contributor Cindy H. Dubin speaks with several companies and presents a unique look at how excipients are being used to support current and future innovative active pharmaceutical ingredients.
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.
FORMULATION FORUM - Oral Formulation Approaches for Different Stages of Clinical Studies
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.
SUPPLY CHAIN MANAGEMENT- Are Supply Chains Up for the Post-Pandemic Challenge?
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.
EXECUTIVE INTERVIEW - Syner-G BioPharma: A Track Record of CMC Excellence
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.
BATCH RELEASE - The Business Case for Reinventing Batch Release
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.
EXECUTIVE INTERVIEW - inVibe: Changing the Research Game With Voice
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.
