To view this email as a web page, click here

   Home

Subscribe

Advertise

 

 

 

 

January 15, 2018

Today's Rundown

Featured Story

Message to Trump: Alnylam CEO proud to be a ‘shitholer’

Describing a country as a ‘shithole’ isn’t going to endear you to anyone, but President Trump’s latest alleged outburst has struck a nerve with one particular biotech leader.

Top Stories

Biofrontera files for IPO to run skin cancer clinical trials

Biofrontera has filed for a Nasdaq IPO. The German company is seeking $22 million (€18 million) to support a clutch of clinical trials designed to expand use of Ameluz in types of skin cancer and other dermatological conditions.

Hikma names ex-Fresenius scientist as global R&D chief

Hikma Pharmaceuticals has named Surendera Tyagi, Ph.D., as its CSO and global head of R&D. Tyagi joins Hikma with a brief to stimulate noninjectable R&D activity at a time when the company's generic drug unit is suffering.

[Sponsored] Contract Execution Timelines: An Important Factor in Site Selection

The impact of protracted contracting timelines can be felt throughout the study start-up process. Coupling predictive enrollment analytics with contract execution timelines of a site decreases time to Last Patient First Visit by up to 25%.

Charles River buys immunology player KWS BioTest for $20M

Charles River Laboratories has snapped up British CRO KWS BioTest for about $20 million, a deal that will enhance its offerings in immuno-oncology and inflammatory and infectious diseases.

Merck's Keytruda nabs new data to rival Bristol-Myers' Opdivo at fending off melanoma's return

Merck & Co. and Bristol-Myers Squibb have been head-to-head competitors in melanoma ever since their two immuno-oncology treatments, Keytruda and Opdivo, both won their first FDA approvals. Now, with its latest data, Keytruda can play catch-up with its rival for another new use.

Enrollment Showcase

Online Graduate Programs Designed for Your Career

Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more.

Resources

[Whitepaper] Streamline your mAb Intact Protein Characterization: Download App Note

This Agilent intact protein analysis includes:

[Marketplace] Asia-Pacific Compliance Training for Life Sciences Professionals

Don’t miss this educational program trusted by multi-national companies as part of their employee’s compliance training. Explore legal, regulatory and ethical issues faced by pharmaceutical, biotech and medical device manufacturers operating in the Asia-Pacific region. Visit event page for session topics.

[Whitepaper] Is Your In-House Strategy Ready For The Uncertainties Of Biologic Drug Development?

Download Patheon’s whitepaper to discover two main areas where a drug developer can face significant obstacles during biologics development and how by evaluating these capabilities, it can answer the critical question of whether its in-house strategy is ready for these uncertainties.

[Webinar] How to Prevent, Identify, and Implement a Clinical Trial Rescue

What do you do when timelines are missed, data is dirty, and everyone is pointing fingers? Join this webinar to learn how to prevent, identify, and implement a successful clinical trial rescue.

[Whitepaper] Key to regulatory transformation is unified RIM

Expanding into new markets places a spotlight on inefficient processes.

[Whitepaper] Best Practices for Managing Regulatory Processes 

Regulatory leaders share challenges and best practices from a lack of standardization, manual processes, and fragmented systems.

[Whitepaper] Choosing the Right Solution: Improving the Site Feasibility Process

Selecting the right sites to conduct your clinical trials will determine the success or failure of meeting your enrollment goals.

[Whitepaper] 5 Steps to Managing Quality Globally

Read this guide if you’re a global life sciences company - conducting clinical trials across several countries, or manufacturing and distributing products in multiple regions - to learn five steps to align and improve quality oversight, as well as avoid common mistakes in harmonization initiatives.

[Whitepaper] How Do Sponsors Ensure Quality in Global Clinical Trials?

Global clinical trials are the trend and gaining in popularity, but running a global trial is not a straightforward process. This white paper explores some of the challenges associated with global clinical trials and considerations for ensuring that the collected data comply with the trial's overall objectives.

[Webinar] Validating a 7 Day Membrane Filtration Sterility Test using Celsis®

Join us as we discuss how Charles River Celsis® helped Labor L+S AG validate a 7-day membrane filtration sterility test using existing protocols.

[Infographic] Evolution of Flexible Commercial Biologics Manufacturing

Learn how Catalent Biologics is paving the way for flexible biologics development and manufacturing through advanced technologies and fully integrated multi-product facility.

[eBook] Developing Site-specifically Modified ADCs: Using a Chemoenzymatic Approach

Download the eBook to get articles from various Elsevier journals highlighting developments in ADC technology.

[Article] Optimizing titer and use of a specific enzyme for generating a fully processed antibody

Learn how cell development and process scale-up can be optimized for antibodies requiring additional processing.

[Webinar] Within-Subject Clinical Trials: Intro to New Methods & Stat. Models

In this webinar, we will introduce the rapidly-evolving within-subject clinical trial (WSCT) methods for early phase evidence generation that require fewer people, less time, and usually less funding than traditional early phase methods.

Events

.