SPECIAL FEATURE – Outsourcing Analytical Testing: The Gateway to Drug Manufacturing
Contributor Cindy H. Dubin speaks with several leading analytical labs and CDMOs to review their technologies, services, and new strategies to operate in this ever-changing environment.
FORMULATION FORUM – Sophisticated Formulation Approaches for Insoluble Drug Candidates
Jim Huang, PhD, discusses how a sophisticated drug delivery approach involves collaboration, technical experience, and years of working knowledge in drug development at different stages of the process.
TRANSLATIONAL PHARMACEUTICS – Accelerating Early-Stage Drug Development With Integrated CDMO & CRO Services
Peter Scholes, PhD, describes the current challenges and questions faced by drug developers in accelerating molecules to POC and developing optimized and scalable drug products for patient trials.
CLINICAL ANALYTICS SOLUTIONS – Reducing Clinical Cost Budget Variations With State-of-the-Art Data Lifecycle Management Solutions
Srini Anandakumar explores an approach for how sponsor’s operational data, coupled with syndicated data and Real World Evidence data, can enable predictive analytics on clinical cost drivers using a clinical big data and Machine Learning-enabled platform.
EXTRACTABLES & LEACHABLES – A Practical Approach to Extractables & Leachables
Cheryl Johnson says the study of E&L has been evolving for many years, and as pharmaceutical manufacturers, packaging vendors, and regulatory agencies gain more knowledge of extractable compounds, the scope of E&L guidelines grows with it.
TOPICAL DELIVERY – Novel Approaches to Topical Antibiotics Promise Innovation in the Treatment of Acne & Rosacea
Scott Herron, MD, PhD, indicates dermatologists and their patients need a better way to deliver antibiotics effectively without contributing to the resistance problem, and an ideal solution might be a new topical antibiotic formulation.
CLINICAL TRIALS – Spotlight on Quality in Study Startup: Automated Workflows Encourage Upfront Planning & Downstream Improvements in the eTMF
Elvin Thalund, MS, and Craig Morgan say the emphasis on quality is everywhere, but in particular, the study startup portion of clinical trials is a particular hotspot, as it is pivotal to improving study conduct overall.
EXECUTIVE INTERVIEW – Vetter: Insights on Insourcing Versus Outsourcing in the World of Injectable Manufacturing
Oskar Gold, Vetter’s Senior VP, Key Account Management and Marketing/Corporate Communications, offers his insights on aseptic manufacturing and why careful thought and consideration of different criteria must be applied.
DEVICE REGULATIONS – The New Medical Device Regulation & the Applicability of Article 117 to Medicinal Products
Louise Place focuses on the impact of Article 117 in Europe on the combination of a drug and a device, where the primary mode of action is performed by the drug and the two products are combined in a single, integral product that is exclusively for use in the given combination and not reusable.
HUMAN MICROBIOME – Advancing New Frontiers in a Rapidly Emerging Market
Flo Orim, MD, PhD, focuses on biomedical aspects of research, development, and commercial endeavors in the human microbiome space, including essential background information, evolution of the field, and advances in basic research.
REGENERATIVE MEDICINE – Cell Therapy – The Quest for Finding the Cure
Aarti Chitale, MBA, believes as the therapeutic landscape evolves and transitions toward personalized and value-based care, regenerative medicine will play an increasingly important role, and moreover, the success of these therapies offers promising opportunities for previously untreated diseases areas.
GENETIC MODIFICATION THERAPIES – Clinical Applications & Technology Platforms
Laurie L. Sullivan and John Bergin, MS, MBA, say the growing interest on the part of large pharma or biotech companies is driving clinical development of genetic modification therapy candidates, and the rich late-stage pipeline for genetic modification therapy candidates is a driving force of growth.
EXCLUSIVE ONLINE CONTENT
Passage Bio Launches With $115.5 Million Financing to Develop AAV-Delivered Therapeutics
Passage Bio recently debuted with a $115.-million Series A financing led by OrbiMed Advisors and joined by Frazier Healthcare Partners, Versant Ventures, New Leaf Venture Partners, Vivo Capital and Lilly Asia Ventures.
DiaMedica Therapeutics Doses First Patient in Phase 1b Clinical
DiaMedica Therapeutics Inc. recently announced it has initiated dosing patients with chronic kidney disease (CKD) in a Phase Ib clinical study evaluating DM199.
Codexis Announces Nestlé Health Science Exercises Option for Exclusive Global License: Triggers Milestone
Codexis, Inc. recently announced that Nestlé Health Science has exercised its option to obtain an exclusive license for the global development and commercialization of Codexis’ novel, orally delivered enzyme CDX-6114 for the management of phenylketonuria (PKU), an orphan metabolic disorder.
West Annouces Significant Agreements With Swissfillon & scPharmaceuticals
West recently announced it has commenced discussions with two companies regarding the use of West’s proprietary SmartDose drug delivery platform for complex molecules.
uniQure Announces First Patient Treated in Pivotal Trial
uniQure N.V. recently announced it treated the first patient in its HOPE-B pivotal trial of AMT-061, an investigational AAV5-based gene therapy incorporating the patent-protected FIX-Padua variant for the treatment of patients with severe and moderately severe hemophilia B.
Meridian Launches New Range of Lyo-Ready PCR Mixes
Meridian Bioscience, Inc. recently announced that following the successful release of the Lyo-Ready qPCR Mix, Meridian is proud to introduce its next-generation lyophilization-ready mixes for one-step RT-qPCR.
ABITEC Corporation Launches New Versatile Excipient for Oral Dose Applications
ABITEC Corporation, a global manufacturer of specialty lipids, continues to develop products that meet the ever-evolving demands of the pharmaceutical industry.
PCI Pharma Services Announces Bottling Line Expansion to Support Customer Needs
PCI Pharma Services recently announce the expansion of its bottling line capacity at its Commercial Packaging site in Rockford, IL.
AbbVie’s Immunology Pipeline Will Protect it From Biosimilar Erosion
Although AbbVie is feeling the impact of Humira biosimilar launch in Europe, its strong immunology pipeline is likely to protect its hold on the plaque psoriasis (PsO) and rheumatoid arthritis (RA) markets, according to GlobalData, a leading data and analytics company.
First Oral Add-On Treatment to Insulin for Treatment of Certain Patients With Type 1 Diabetes
The EMA’s human medicines committee (CHMP) has recommended for the first time an adjunct treatment to insulin in the form of a tablet for certain patients with type 1 diabetes mellitus.
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