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COMBINATION CORNER - Keys to Avoiding Common Pitfalls in the Development of Product Requirements for Drug Combination Products
Jerzy Wojcik says it is more important than ever to bring the right team together early in a project to capture product requirements correctly. The cost of missing needs or requirements goes up exponentially as development proceeds, and many of these requirements can be identified early in the project if the right individuals are at the table.
AAV VECTOR MANUFACTURING - Challenges & Opportunities in the Manufacturing of AAV Vectors Used in the Delivery of Gene Therapy Treatments
Daniel C. Smith, PhD, indicates there remains a clear need for improved process productivities, and the need to develop manufacturing processes that can be applied to a wide number of AAV-based viral vector therapeutic candidates.
BIOMARKERS - FDA’s Design Control Requirements for Biomarkers in Drug Development
Kaiser J. Aziz, PhD, says the availability of validated biomarker-drug companion products will enable the molecular diagnostics and pharmaceutical industries to develop and rely on new genomic biomarkers in order to elucidate disease pathways, stratify patient populations, and monitor safe and effective use of these products.
CELL THERAPY - PLX-R18: Cell Therapy for Treatment of Acute Radiation Syndrome & Bone Marrow Failure Diseases
Racheli Ofir, PhD, and Noa Sher, PhD, report on studies showing that PLX-R18 is a strong candidate for the treatment of H-ARS as well as a plethora of bone marrow failures with similar symptomatology.
PATIENT-CENTRIC TECHNOLOGY - How Technology Can Impact Patient Adherence: Increasing Patient Engagement & Education to Save the Healthcare Industry Billions
Andrew W. Dunning provides several examples of technologies that specifically cater to pharmaceutical brands that want to leverage a patient-centric marketing strategy to increase their market share and boost patient adherence rates.
EXECUTIVE INTERVIEW - AmerisourceBergen: Partnering With Orphan Product Manufacturers to Drive Commercialization Success
Amy Grogg, Senior Vice President of Strategy and Commercialization at AmerisourceBergen Specialty Group provides her perspective on the barriers orphan drug manufacturers face and the solutions available to them through strategic partnerships with distributors.
THERAPEUTIC FOCUS - GSNOR Inhibition to Stabilize & Improve Mutant CFTR Processing
Steven Shoemaker, MD, reviews how cavosonstat represents a safe and effective option for patients with CF with at least one copy of the F508del-CFTR mutation; and that when used with correctors and potentiators, improves patient outcomes including lung function.
EXTERNAL DELIVERY - The Rodney Dangerfield Effect
John A. Bermingham learned a long time ago that respect has to be earned, it is never given freely. While everyone wants to be respected, the odds are that you will eventually run into someone who is in a management position that “gets no respect.”
SPECIAL FEATURE - Analytical Testing: Market Drivers, Growing Demand & Client Needs
Contributor Cindy H. Dubin spoke with several testing providers to find out what services they offer, trends they identify, and how they have specifically addressed clients’ needs throughout the past year.
ORALLY DISINTEGRATING TABLETS - Patient-Centric Dose Design, Developments in Orally Disintegrating Tablets
Leon Grother, MS, and Mathias Bayru, MS, MBA, indicate recent developments in ODT technology have widened the range of actives that can be formulated and product types that are possible. In particular, the promise of formulating biologics and ODT vaccines is hugely exciting.
FORMULATION DEVELOPMENT - Optimizing the Spray-Drying Parameters for a Formulation of Nanoparticles-In-Microparticles System of Acetazolamide
Parijat Pandey, MPharm, and Harish Dureja, PhD, examine the consequence of spray-drying parameters that are inlet temperature and feed rpm on entrapment efficiency, loading capacity, percentage yield, and particle size.
ADVANCED DELIVERY DEVICES - Disruptive Delivery Technology Partnerships Are Key to Pharmaceutical Life Cycle Management
Michael D. Hooven, MSME, believes in the challenge to deliver innovative therapies that address unmet patient needs while delivering profitable growth, and the industry is responding by embracing disruptive technology that can concurrently help on both fronts and also speed time to market for pharmaceutical products and services.
CNS DELIVERY - Bypassing the BBB: Drug Delivery From the Olfactory Mucosa to the CNS
T.R. Shantha, MD, PhD, FACA, explores and explains how therapeutic and non- therapeutic agents can reach the brain, bypassing through the formidable BBB based on the unique microanatomic and physiologic characteristics of the nasal olfactory mucosal route and its CNS connections that allow transportation directly into the CNS.
EXECUTIVE INTERVIEW - Viral Gene: Protein-Targeting Cancer Vaccine Could Boost Survival Rates
Harry A. Arena, MBA, President & CEO of TDT, Chris Kim, President & General Counsel, Viral Gene, Inc., and Dr. Scott Waldman, Professor & Chair of Sidney Kimmel Medical College’s Department of Pharmacology & Experimental Therapeutics at Thomas Jefferson University, discuss the unique characteristics of the vaccine, the patients who will benefit the most, and how a research team captured the attention of investors.
COMBINATION PRODUCTS - 6 Guidelines to Follow When Developing Combination Products
Winston Brown explains how companies can reduce the risk and impact that regulatory uncertainty can play by, in advance of pursuing development, understanding the regulatory landscape and then developing a regulatory compliance strategy that is appropriate and suitable for the combination product as a system.
EXECUTIVE INTERVIEW - Avista Pharma Solutions: Experience, Responsiveness & Expanded Capacity Driving Growth
Patrick Walsh, CEO of Avista Pharma Solutions, talks about his company’s range of capabilities and what is driving growth in this dynamic industry.
NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025
Cai Xuan, PhD, and Volkan Gunduz, PhD, GlobalData Analysts, estimate that by the end of the forecast period in 2025, NSCLC sales will rise to $26.8B in the 8MM, at a moderate CAGR of 15.7%.
HCV MARKET - Recent Success in HCV Treatment Brings Relief to Patients but Challenges to Companies
Mirco Junker, PhD, GlobalData Analyst, says high cure rates exceeding 90% are now achievable for most patients suffering from chronic hepatitis C, and as a result, the industry is reaching a new phase in the fight against this deadly infectious disease.
ACS MARKET - Acute Coronary Syndrome Market 2015-2025
Michela J. McMullan, PhD, GlobalData Analyst, reports that although the ACS market is set to grow at a CAGR of 4.6%, reaching $12.1B by 2025, the potential for the market to be even more lucrative exists, especially in the sizable lipid-targeting arena.
DNA SEQUENCING MARKET - Emerging Technologies & Applications
Laurie L. Sullivan and John Bergin, MS, MBA, BCC Research Analysts, indicate that NGS has matured into an essential life science tool for genetic studies in a range of applications, and the industry is on the cusp of a second growth phase, powered by new applications in clinical diagnostics.


















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