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EXECUTIVE INTERVIEW - Adare Pharmaceuticals: A Virtual Acquisition is Possible June 3, 2020
Ajay Damani, VP of Pharmaceutical Technologies Business Unit, Adare, and Maria Flynn, President and CEO, Orbis, discuss how both companies will benefit from the acquisition, future product development, and the challenges of a virtual acquisition.
Bormioli Pharma Speeds Up on Innovation With H-FARM March 5, 2020
Fast prototyping and an approach to innovation focused on customer needs are at the heart of the innovation path undertaken...DEVELOPMENT TIMELINES - Drug Development Times, What it Takes - Part 1 January 14, 2020
Josef Bossart, PhD, explains how accurately estimating a product’s clinical development timelines is more than simply adding up the individual timelines, almost always optimistic. You need to “know” the numbers, not just calculate them.
WEARABLE DEVICES - Wearable Drug Delivery Applications: Considerations for Adhesive Material Selection & Wear Testing October 1, 2019
Neal Carty, PhD, MBA, and Deepak Prakash, MS, MBA, discuss the broader healthcare and digital health landscape behind wearable device developments and provide a brief overview of two types of wearable applications — insulin pump therapy/continuous glucose monitoring (CGM) systems and wearable drug injectors.
RISK MANAGEMENT - FDA’s Quality Risk Management Approach to New Drug Applications April 1, 2019
Kaiser J. Aziz, PhD, explains how the FDA emphasizes the Quality Risk Management approach to design of studies by providing oversight and objective review of risk-benefit analysis that guides the use of new drug products by providing patients organized data and appropriate labeling information in support of the new drug’s intended clinical use.
CLINICAL ANALYTICS SOLUTIONS - Reducing Clinical Cost Budget Variations With State-of-the-Art Data Lifecycle Management Solutions January 9, 2019
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.
EXECUTIVE INTERVIEW - BriaCell Therapeutics: Recognizing the Power of Targeted Immunotherapies October 1, 2018
Dr. William “Bill” Williams, MD, President and CEO of BriaCell Therapeutics, discusses the value of targeted immunotherapies in the biopharmaceutical industry.
SPECIAL FEATURE - Injection Devices: As Self-Injection Grows, Drug Delivery Gets Smarter August 28, 2018
Contributor Cindy H. Dubin reviews some of the innovative and novel technologies developers are deploying to make self-injection easier and improve patient adherence.
DRUG DEVELOPMENT - Cell & Gene Therapies Calling for Innovation in Drug Development August 27, 2018
Lev Gerlovin and Pascale Diesel, PharmD, believe there is significant evidence to indicate that we are entering a golden age of gene and cell therapy development, and while industry works to advance these programs, the debate over new approaches in both structuring and financing clinical research is likely to continue.
GLOBAL REPORT - 2017 Global Drug Delivery & Formulation Report: Part 3, Notable Transactions & Technologies of 2017 May 31, 2018
In part 3 of this 4-part series, PharmaCircle in collaboration with Drug Development & Delivery, reviews transactions and technologies that provide greater insight into what we can expect in terms of product development and approvals over the next decade.
INTRABODY DELIVERY - The Feldan Shuttle Technology: A Peptide-Based Method to Deliver Antibodies January 8, 2018
Thomas Del’Guidice, PhD, Nancy Messier, PhD, and David Guay, PhD, present the Feldan Shuttle technology, a peptide-based delivery method that could provide efficient and safe intrabody delivery in mammalian cells.
LIPID-BASED DELIVERY - Are Lipid-Based Drug Delivery Systems in Your Formulation Toolbox? September 29, 2017
Jason M. LePree, RPh, PhD, reviews the causes of poor bioavailability for drugs and provides an introduction to lipid-based drug delivery systems, and how the formulation approach can be used to overcome impediments to good bioavailability of therapeutic actives.
DRUG DEVELOPMENT - To De-Risk Patient Acceptance of Biologic Drugs, Focus Early on Delivery September 11, 2017
Jeannie Joughin, PhD, asks what does a pharmaceutical company do when everyone wants more effective new therapies but no one – including third-party payers – wants to pay the price for their development? De-risk the drug development process, in every possible way.
SPECIAL FEATURE - Prefilled Syringes & Parenteral Manufacturing: A Rise in Biologics & Improved Technology Give Pharma Reasons to Consider Parenteral Delivery May 2, 2017
Contributor Cindy H. Dubin speaks with some of the leading companies in this market to find out about key trends, packaging advancements, safety improvements, and technology developments.
EXECUTIVE INTERVIEW - Vetter: Establishing a Successful Clinical Fill & Finish Manufacturing Site for Biologics April 3, 2017
Dr. Susanne Resatz, President of Vetter Development Services USA, Inc., discusses the many benefits to small biotech companies in utilizing the services of a full-service CDMO, and what advanced services the Chicago-based facility offers its growing customer base.
Avomeen Recapitalizes to Achieve Next Growth Plan Objective January 12, 2017
In an effort to foster growth and reinforce its infrastructure, Avomeen Analytical Services, a fast growing full-service independent analytical and...Avomeen Recapitalizes to Achieve Next Growth Plan Objective January 12, 2017
In an effort to foster growth and reinforce its infrastructure, Avomeen Analytical Services, a fast growing full-service independent analytical and...Pharmaceutical Industry Licensing Deals Soared to Record $46.2 Billion in 2015 June 16, 2016
Licensing deal values in the pharmaceutical industry rose by 37.1% year-to-year, from $33.7 billion in 2014 to $46.2 billion in...Pharmaceutical Industry Licensing Deals Soared to Record $46.2 Billion in 2015 June 16, 2016
Licensing deal values in the pharmaceutical industry rose by 37.1% year-to-year, from $33.7 billion in 2014 to $46.2 billion in...PROTEIN CRYSTALS - Reshaping Traditional Biotherapeutic Formulations June 1, 2016
Don Paul Kovarcik, MBA, and William Wittbold, MS, indicate that while protein therapeutics have enjoyed considerable commercial success throughout the past 3 decades, there still remain formulation and delivery challenges.
Technical Brief: Mucoadhesive Polymers in Pharmaceutical Formulations
This technical brief will cover the use of polymers in a variety of dosage forms (buccal/sublingual tablets, liquid, semi-solid formulations, and oral care products) to impart mucoadhesion. The basic mechanism of mucoadhesion and methods to evaluate it in the context of…
TECH BRIEF – Expedite FDA Approvals With Certified Pure Materials
A key focus of the U.S. Food and Drug Administration’s evaluation of a medical device’s safety and effectiveness is reviewing...WHITEPAPER - Drug Delivery – Recent Trends, Enabling Technologies, In-Vitro-In-Vivo Predictions & Personalized Medicine
Enabling technologies such as Nanotechnology, Amorphous Solid Dispersions, Self-emulsifying/nanoemulsifying drug delivery systems (SEDDS/SNEDDS) or Lipid Nano Particles (LNPs) for oral delivery are key elements for the development of complex and difficult to develop small molecules.
