Contract Services
EXECUTIVE INTERVIEW – Tedor Pharma, Inc.: A Strategy Shift to Serve Both Generic & Branded Companies
Doug Drysdale, President & CEO of Tedor Pharma, Inc., discusses the FLEXITAB technology, his strategy for managing a shift in business model, and how Tedor is addressing the needs of small- and medium-size companies developing innovative and repurposed small molecules for unmet medical needs.
NATURAL LANGUAGE PROCESSING – How Life Sciences Companies Are Leveraging NLP From Molecule to Market
Jane Z. Reed, PhD, MA, discusses some of the challenges facing pharma researchers and executives; the benefit NLP can bring; and some specific customer-use cases (covering patent landscaping, gene disease associations, access to safety silos, and more).
STANDARD OPERATING PROCEDURES – How Writing an Effective SOP Can Influence Compliance & Build a Better Organization
Heidi Stuttz provides a common outline used in many companies and explores the essential elements of a well-written SOP that can be effective whether developing one from scratch or remediating a current system of SOPs that will foster success in every area of your company in which it is implemented.
CLINICAL STUDY REPORTING – Assessing the Value of Interim Analyses in Clinical Trials
Paul Stark, MS, ScD, reviews how and when an interim analysis would be valuable and how, with examples and outcomes, it can be applied in a clinical trial setting.
CLINICAL TRIALS – Leaning Into Investigator Sponsored Trials
Martin Lehr, MA, says given the capital and intellectual capacity constraints within large pharmaceutical companies and start-ups, ISTs provide an important path to unlocking the therapeutic value of developmental and marketed drugs.
CONTAINER CLOSURE INTEGRITY – Mitigating Risk in Pharmaceutical Manufacturing With Visually Inspected Components
Olga Laskina, PhD, discusses visible particles and manufacturing defects of the packaging components as well as the impact these defects can have on container closure integrity and functional characteristics.
SPECIAL FEATURE – Outsourcing Analytical Testing: Novel Services Elicit Consistent, Quantifiable, & Faster Results
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.
IMAGE-BASED CHARACTERIZATION – Non-Invasive, Quantitative Characterization of Lyophilized Drug Product Using Three-Dimensional X-Ray Microscopy Analytics
Shawn Zhang, PhD, Johnathan Goldman, PhD, Xiaodong Chen, PhD, et al present a new method that not only characterizes quantitatively the microstructures of the lyophilized drug samples, but also presents the potential to correlate the microstructures with physical properties to optimize parameters in drug formulation, cycle development, process scale-up, stability control, and administration.
BIOPROCESSING – A New Era: Why the Time Has Come for Biopharma to Move to Continuous Bioprocessing
Dr. Martin Smith explains why the pharma industry must embrace continuous processing if it’s to survive and thrive in an era of global personalized medicine.
CYBERSECURITY – Why Pharmaceutical Companies Are Vulnerable to Cyberattacks & What You Can Do to Protect Your Company
Andrew Douthwaite says having a comprehensive cybersecurity strategy in place to safeguard digital assets has become an essential part of any company’s security protocols, and not doing so leaves valuable data vulnerable.
EXCLUSIVE ONLINE CONTENT
Saama Makes State-of-the-Art Clinical Analytics Platform Available to Integrate Data From All Organizations Investigating COVID-19 Treatments
Saama Technologies, Inc. recently announced it will contribute its AI-powered Life Science Analytics Cloud (LSAC) technology platform to establish the EndPandemic National Data Consortium…..
Covid-19 Outbreak in China Threatens Biopharma In-House Manufacturing
With several mega cap biopharma companies having their vital manufacturing steps in Chinese facilities, the novel coronavirus (Covid-19) outbreak is putting the complicated global biopharma industry’s supply….
Considering a Technology Transfer? Start by Making Sure You Have the Right Partner
Simply put, a technology transfer is the moving of a product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve project realization…..
Pfizer & BioNTech to Co-develop Potential COVID-19 Vaccine
Pfizer Inc. and BioNTech SE recently announced the companies have agreed to a letter of intent regarding the co-development and distribution (excluding China) of a….
Exagen Inc. Partners With Sonora Quest Laboratories to Offer AVISE Testing for Patients Suspected of Autoimmune Disease
Exagen Inc. recently announced it has entered into a strategic partnership with Sonora Quest, the nation’s largest integrated…