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February 19, 2020___

Today's Rundown

Featured Story

Gilead poaches Bristol-Myers oncology executive to lead research biology

Gilead has a new head of research biology: Michael Quigley, Ph.D., an alum of MedImmune, Johnson & Johnson and Dana Farber, who joins from Bristol-Myers Squibb. Most recently, he was a vice president and head of the Big Pharma’s Tumor Microenvironment Modulation Thematic Research Center.

Top Stories

Ex-PixarBio CEO sentenced to 7 years for defrauding investors

A judge has sentenced former PixarBio CEO Frank Reynolds to seven years in prison for defrauding investors. The judge also ordered Reynolds to pay $280,000 in forfeiture and around $7.5 million in restitution as punishment for his crimes. 

Israeli biotech NeoTX lands $45M series C for combo I-O cancer trials

NeoTX Therapeutics has nabbed a healthy $45 million third funding round as it looks to continue work on its early-stage cancer combo test and in-license new tech.

[Sponsored] Executive Interviews at J.P. Morgan 2020

FierceBiotech sits down with some of the most informative industry leaders at JPM 2020.

Incyte hits endpoint in 2nd pivotal atopic dermatitis trial

A second phase 3 trial of Incyte’s ruxolitinib cream in atopic dermatitis has met its primary endpoint. The back-to-back pivotal successes tee Incyte up to talk to regulators about bringing the JAK inhibitor to market.

Five Prime Therapeutics' pancreatic cancer combo with Opdivo a bust

Wedding Five Prime Therapeutics’ experimental CSF-1 receptor inhibitor cabiralizumab to Bristol-Myers Squibb’s checkpoint inhibitor Opdivo has proved a bust in pancreatic cancer.

Grail kicks off its first study to provide doctors with real-world results from its multi-cancer blood test

After gathering tens of thousands of people to participate in its clinical research studies, Grail says it’s got at least one more to do—an interventional trial of its multi-cancer blood test, where it will be used for the first time by oncologists to help guide a patient’s care.

Audentes investing $109M in gene therapy manufacturing facility with 200 jobs

With a gene therapy nearing the finish line and $3 billion in hand from its buyout by Astellas, biotech Audentes is ready to start work on its $109 million gene therapy manufacturing facility that will employ 200.

Resources

[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] Science-based Training Ensures 90%+ Adoption Rates for Software Deployments and Business Processes

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 for Veeva, Workday, Microstrategy or any software platform by implementing the right methodology with a focus on behavior change.

[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.

[Whitepaper] Regulatory agencies provide insights and concerns for eConsent study

To conduct a successful trial, do you need to understand the global eConsent Regulatory landscape?

[Whitepaper] Computer Software Assurance: What You Need to Know About FDA’s Upcoming Guidance

Details on the FDA’s upcoming Computer System Validation guidance

[Whitepaper] Fusing Specifications and Design for Data Collection Casebooks with Veeva Vault EDC

Learn how data management teams at ICON, Bioforum, and Vertex Pharmaceuticals are creating the spec and casebook in a single step, reducing study build times and effort by over 50%.

[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