SPECIAL FEATURE - Outsourcing Analytical Testing: Novel Services Elicit Consistent, Quantifiable, & Faster Results January 14, 2020

Contributor Cindy H. Dubin, in her latest report, describes some novel analytical testing services aimed at ensuring quality and safety, and in some cases, speeding the process and saving money.

PERSONALIZED MEDICINE - Personalizing Cancer Immunotherapy: Trends in Biomarker Discovery January 14, 2020

Emile Youssef, MD, PhD, says due to tumor heterogeneity, the plasticity and diversity of cancer cells, and a multitude of other factors, biomarker development is a challenge, and thus explores four trends in cancer biomarker discovery.

2019 Analytical Testing in Drug Development eBook - Regulations Help Propel Testing Market September 6, 2019

This e-Book showcases the various types of services that leading testing companies offer and how they are helping industry comply with regulations to get their products approved and commercialized.

SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: CDMOs Shift to Offer More Specialized Services June 5, 2019

Contributor Cindy H. Dubin speaks with several innovative CDMOs to discuss their formulation development and manufacturing capabilities (as well as shifting strategies) for bio/pharma companies of all sizes.

BIOSIMILAR DEVELOPMENT - Approval of Biosimilar Medicines Through Totality of the Evidence June 4, 2019

Hillel Cohen, PhD, outlines the evolution of biosimilar approvals and describes the process of analytical and clinical testing followed in the development of a biosimilar, with use of data from the scientific literature.

EXECUTIVE INTERVIEW - Synteract: Advances in Pediatric Clinical Research & the Promise for the Future June 4, 2019

Dr. Martine Dehlinger-Kremer, Vice President, Pediatric Development at Synteract, reviews current and significant challenges in pediatric clinical research, advancement of regulations surrounding them, and where the industry is headed.

SPECIAL FEATURE - Prefilled Syringes & Parenteral Manufacturing: Flexibility for Faster Development April 30, 2019

Contributor Cindy H. Dubin interviews several contract manufacturers and device developers who are responsible for creating next-generation parenteral drug delivery.

SPECIAL FEATURE - Outsourcing Analytical Testing: The Gateway to Drug Manufacturing January 10, 2019

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.

ONCOLOGY DIAGNOSTICS - Advancements Paving the Way for More Tailored Drugs November 20, 2017

Divyaa Ravishankar, MS, says pharmaceutical companies have been subjected to a wide variety of external forces compelling them to get innovative about development of new platforms, liaise with new partners, leverage big data toward precision and predictive diagnosis, and identify new markers.

SPECIAL FEATURE - Formulation Development & Manufacturing - CDMOs Offer Speed, Advanced Technologies, & the Ability to Handle More Potent APIs April 4, 2017

Contributor Cindy H. Dubin speaks with some of the industry’s leading CDMOs to highlight their capabilities in the areas of speed, quality, technology, and handling of complex APIs.

ELECTRONIC TONGUE INSTRUMENTATION - Improving the Palatability of User-Friendly Dosage Forms Using an Electronic Tongue April 4, 2017

Detlev Haack, PhD, and Martin Koeberle, PhD, believe one exciting alternative starting to gain traction in the industry is assessment via an electronic tongue to detect and analyze all the compounds responsible for taste within a sample.

SPECIAL FEATURE - Analytical Testing: Market Drivers, Growing Demand & Client Needs January 17, 2017

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.

COMBINATION PRODUCTS - 6 Guidelines to Follow When Developing Combination Products January 13, 2017

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.

THERAPEUTIC FOCUS - Adenosine Receptors – The Promise of A3AR Research May 4, 2015

Pnina Fishman, PhD, reports that the A3AR adenosine receptor, expressed in the lungs, liver, brain, aorta, testis, and heart, may hold promise as both a therapeutic target and as a biological predictive marker.

SPECIAL FEATURE - Outsourcing Formulation & Manufacturing Development: Using Data & Unique Approaches to Solve Solubility Issues, Target Profiles & Customize Products March 31, 2015

Contributor Cindy H. Dubin finds that CMOs are embracing development projects in an effort to establish longer-lasting partnerships with their pharma and biotech clients. These contract developers are deploying innovative techniques aimed at improving solubility and fast-tracking products to market.

SPECIAL FEATURE - Analytical Testing: A Critical Element in Drug Development January 8, 2015

Contributor Cindy H. Dubin interviews several industry experts who believe there is intense competition to develop cutting-edge therapies and get them through development quickly to take advantage of patent exclusivity. And one of the critical elements in the drug development process is analytical testing.

MANAGEMENT INSIGHT - Pharmaceutical Innovation in the Second Machine Age January 7, 2015

Derek Hennecke says on one side, we have those who argue that technology is advancing so fast we have achieved a second-derivative rate of change. On the other side are those who claim we haven’t seen true innovation since the 1970s. Which is it?

SPECIAL FEATURE- Analytical Testing of Biologics & Biosimilars March 5, 2014

Contributor Cindy H. Dubin talks with some of the leading experts in the industry about the importance of outsourcing analytical testing in the biologic/biosimilar space, the associated challenges, and how to ensure products get to market safely and quickly.

1/30/2013 January 27, 2013

10/30/2012 October 25, 2012