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
TrakCel & Quick Partner to Provide Industry-Leading Digital Supply Chain IT Solution for Cell & Gene Therapies
TrakCel and The Quick Life Science Group recently announced a partnership to offer an integrated IT logistics orchestration platform.
MilliporeSigma & Roche Renew Global Distribution Agreement
MilliporeSigma and Roche recently announced they have agreed to renew their current distribution agreement for the Biochemical Reagents and Kapa Biosystems product portfolios, as well as select qPCR & Nucleic Acid Purification products.
Bavarian Nordic Announces Exercise of $44-Million Option by BARDA
Bavarian Nordic A/S recently announced the US Biomedical Advanced Research and Development Authority (BARDA) have exercised another option under the ongoing contract for freeze-dried MVA-BN smallpox vaccine.
Lonza & Takeda Partner in Development & Manufacture of Cancer Treatment
Lonza recently announced another major milestone in its multiproduct partnership with Takeda.
MedPharm Announces Expansion of US Center of Excellence
MedPharm Ltd recently announced the expansion of its US Center of Excellence in Durham, NC, in response to increasing service demand for its topical and transdermal formulation development and performance testing services.
PCI Pharma Services Announces $20-Million Expansion of Biotech Technologies, Including Advanced Injectable Delivery Forms
Leading global biopharmaceutical services provider PCI Pharma Services (PCI) has announced a momentous investment in support of biologic medicines and advanced injectable delivery forms, totaling more than $20 million.
Catalent Makes Significant Investment to Expand Biologics Capacity & Capabilities
Catalent, Inc. recently announced it has commenced a $200 million capital investment in its Biologics business to expand drug substance manufacturing capacity and drug product fill/finish capacity due to projected growth among existing and future customers.
Bristol-Myers Squibb’s Acquisition of Celgene Could Position Company Amongst Top Five Most Profitable Pharma Giants
Following Bristol-Myers Squibb’s (BMS) announcement that it will acquire Celgene in a cash and stock deal with an equity value of approximately $74 billion, Edit…
Cybrexa Therapeutics Selects Lead Clinical Candidate to Treat Various Solid Tumors in Combination With Chemotherapy
Cybrexa Therapeutics recently announced it has selected CBX-11 as its lead clinical development candidate for the treatment of patients with various solid tumors.
Fujifilm Commits to Further Research on Nucleic Acid-Liposome Drug Delivery System
FUJIFILM Corporation recently announced that it is working toward improving the development of nucleic acid therapeutics by using liposomal drug delivery systems.
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