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March 03, 2020___

Today's Rundown

Featured Story

Biogen's early R&D chief Ghosh leaves to take Unity CEO post

Biogen’s head of early R&D Anirvan Ghosh has left the company to take up the CEO position at Unity Biotechnology. The neuroscientist joins the longevity biotech after three years leading a 350-person team at Biogen.

Top Stories

Unum dumps clinical work, slashes 60% of workforce as CSO walks

After a tough few years that saw a bottom-of-the-range IPO and several clinical holds, Unum Therapeutics is now losing more than half of its staff and cutting several clinical assets from development.

Altavant nabs Boehringer, Gilead alum as new CMO

While no longer a member of Vivek Ramaswamy’s Roivant umbrella group, his former Vant company is still able to bring in the big names.

BARDA rejects Pluristem's request for radiation study funding

The U.S. Biomedical Advanced Research and Development Authority has rejected Pluristem Therapeutics’ request for funding to conduct a study. Pluristem wanted the money to show its cell therapy PLX-R18 is better than standard of care at treating acute radiation syndrome.

Senti hires Iglesias, of Abraxane fame, to lead push into clinic

Senti Biosciences has named Jose Iglesias as its chief medical officer. Iglesias joins Senti after a spell as a consultant but is perhaps best known for his work on Abraxane at Abraxis and Celgene. 

Autism discoveries point to potential protein-targeted treatments

Scientists at the Gladstone Institutes discovered a link between the Alzheimer's-associated protein tau and core symptoms of autism, including repetition and difficulty socializing. Separately an MIT-led team liked abnormalities in the protein Shank3 to another symptom, hypersensitivity to sensory stimuli. Both groups believe the findings could inspire new autism treatments.

The most significant FDA warning letters of 2019

Warning letters issued by the FDA in 2019 ran the gamut from small companies to large and OTC drugs to finished pharmaceuticals, but some were significant for a variety of reasons. We present those here.

Digital molecule designer Schrödinger taps Google Cloud for parallel computing

Schrödinger aims to upload its digital drug discovery efforts to Google’s cloud network, with plans to employ thousands of processors to simulate billions of potential compounds per week.

Enrollment Showcase

What's the value of an MBA to healthcare and the life sciences?

Prepare to step up in your career, build the expertise you need to reshape your organization, and explore opportunities worldwide. 

Resources

[Whitepaper] Create A More Compelling Program Development Dossier With Metabolomics

Metabolomics can help you streamline your drug development process by providing the framework to make a stronger, more confident, and more valuable case for a molecule in a shorter timeframe.

[eBook] 9 Ways to Enhance Healthcare Customer Experiences

Download this e-book to learn 9 ways to enhance the customer experience within healthcare marketing.

[Whitepaper] The ROI of Document Delivery

3 ways you may be overspending on scientific literature access, and how to fix them.

[Whitepaper] Manufacturing Cytotoxic and Non-Cytotoxic

When different drug products are produced in shared facilities, potential for cross-contamination needs to be addressed.  Outsourcing to a CMO with experience in multiproduct facilities can be an option.

[Whitepaper] Measure the Right Things at the Right Time: Using A Metric Maturity Model to Optimize Performance Measurement

Ineffective measurement could mean wasting both time and money. This whitepaper showcases a custom-built Metric Maturity Model that helps illustrate and define the process for measuring the right things the right way.

[Whitepaper] Strategies for Improving Software Deployments and Business Processes Adoption Rates

Mediocre adoption rates aren’t due to poorly designed software or lazy users. They’re the result of how skills are trained. Achieve high adoption rates by implementing the right methodology with a focus on behavior change.

[Whitepaper] Navigating Today’s Healthcare Transformation: The Evolution of Payers

Read about the innovative ways payers are making smart moves in the healthcare game.

[Video] FierceBiotech Sits Down With H1

Biopharma companies don't want to go to market with a product no one knows about. H1 has homed in on the often time-consuming research and engagement phases that companies must ace for a successful launch, said Ariel Katz, co-founder of H1.

[Whitepaper] Successful BYOD in Any Phase

Download this free white paper to learn how a BYOD ePRO approach is beneficial to your trial.

[Executive Summary] Strategies for Flexible Manufacturing

This whitepaper discusses the benefits of end-to-end solutions and share case studies on how flexible manufacturing strategies can accommodate the changing landscape of pharmaceutical products and help bring a drug to market.

[Video] FierceBiotech Sits Down With Accenture

Kevin Julian, senior managing director of Accenture’s life sciences practice, recently sat down with FierceBiotech to discuss market trends and Accenture’s new technology platform, INTIENT. 

[Whitepaper] Achieving Differentiation in the Complex Oncology Market

White paper describing how a biopharma company can successfully differentiate an oncology product when the clinical profile alone is not enough to get the job done.

[Presentation] Flexible Manufacturing Strategies

Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible.

[Executive Summary] Overcoming Manufacturing Challenges for Accelerated Drug Development

Regardless of the assigned FDA expedited approval designation and approach, the key action items should be: the assurance of a detail-oriented plan and the adaption of a “forward-thinking” approach that will assist in any future challenges and opportunities for growth of each project.

[Executive Summary] Clinical Supplies - Made to Order

Learn how recent innovations in demand-led supply and direct-to-patient distribution are converging to create a next-generation clinical supply chain that is flexible, lean and most importantly patient-centric.

[Whitepaper] Digital Twins: Creating Digital Operations Today to Deliver Business Value Tomorrow

This whitepaper highlights the challenges of implementing the right digital twin strategy while providing key use cases in the manufacturing domain for which a digital twin is extremely useful and several examples of technology trends that will shape the future.

[Q&A] Embarking Upon the Commercial Manufacturing Journey for a Biologic

In this Q&A, four Catalent Biologics experts share how scale-up, regulatory expectations, demand forecasting and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey.

Events