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Editor’s note: Please enjoy our looking ahead issue as well as the biggest stories of the day.
Today's Rundown Looking ahead to a new year and a new decade New leader at FDA, new philosophy? Will we see the world's first approved NASH drug in 2020? [Sponsored] Invitae’s Detect Programs Breakdown Barriers to Genetic Testing Election 2020: What will it mean for R&D? Biogen and the desperation of a need for Alzheimer's drugs Is there a future for pharma in neuro? As promised, Gilead and Galapagos file filgotinib to FDA and get a speedy review Pharma's gene and cell therapy ambitions will kick into high gear in 2020—despite some major hurdles On heels of European nod, Merck scores FDA approval for Ebola vaccine Ervebo Chutes & Ladders—Pfizer's Read to take board seat at Viatris News of Note—Novartis backs out of Akcea/Ionis research deal; Flagship jumps on gene therapy bandwagon Featured Story | | | Friday, December 20, 2019 As we come to the end of 2019 and the twenty-teen era, we look ahead to what we see as the biggest and most pressing issues facing biotech in 2020. |
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Top Stories Friday, December 20, 2019 Stephen Hahn is the next commissioner of the FDA. What that means for the FDA and its attitude to R&D and approval standards is unclear. Friday, December 20, 2019 NASH has been among the closely watched indications in biotech since January 2014, when Intercept Pharmaceuticals lit a fire under the field with midphase data that sent its share price up 500%. Thursday, December 19, 2019 Lack of access to genetic testing delays diagnosis and limits access to clinical trials and approved therapies. Sponsored testing programs can help. Friday, December 20, 2019 The 2016 U.S. election had a big, albeit short lived, effect on biopharma, with Hilary Clinton’s drug pricing tweet sinking stocks and putting a chill on a hot IPO market. Friday, December 20, 2019 Biogen is set to provoke an early pointer of the direction the FDA will take under new commissioner Stephen Hahn. Friday, December 20, 2019 The retreat of big biopharma from neuroscience R&D continued apace in 2019, with Amgen axing its neuroscience unit and Eli Lilly shuttering a U.K. facility. Friday, December 20, 2019 Gilead emerged from a meeting with the FDA this summer confident it would file for approval in the U.S. by the end of 2019: With just over a week to spare, it’s delivered on that promise. Thursday, December 19, 2019 Bristol-Myers Squibb, Pfizer, Biomarin and Sarepta are just a few of the biopharma players expected to make big strides in gene and cell therapies in 2020. But as these companies continue to produce treatments with disease-modifying or even lifesaving benefits for patients, they'll have to address challenges in everything from manufacturing to reimbursement. Friday, December 20, 2019 Merck & Co.'s Ebola vaccine started fighting an ongoing outbreak in Congo in 2018, despite the fact that it wasn't approved by regulators anywhere in the world. Now, though, the shot has its FDA green light—right on the heels of its approval in Europe. Friday, December 20, 2019 Pfizer Chairman Read to take Viatris board seat; Bristol's Biondi bolts; Ipsen CEO Meek takes over new company. Friday, December 20, 2019 Welcome to our pre-Christmas news of note, as we gather up bite-size news from around biotech. Resources Sponsored by: Colorcon Learn more: Best practices for defending supply chain security and compliance by efficiently managing product authentication. Sponsored by: Metabolon Small or emerging pharmaceutical and biotech companies pursuing novel molecules and targets have two important goals: achieve clinical success and attract new rounds of funding. While there’s never a guarantee of either, certain actions can influence the outcome in your favor. Sponsored by: Catalent 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. Sponsored by: Altran 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. Sponsored by: Clarivate Analytics Get your copy of the Q2 2019 Life Sciences M&A notes and trends to understand the mergers and acquisitions (M&A) activity in the life sciences sector which drove 136 new M&A deals and provides a forward look to 2020 activity ahead. Sponsored by: Thermo Fisher Scientific Are you facing costly delays in your API scale-up? Sponsored by: Roche and IQVIA This global landscape study identifies and assesses innovative funding models for cancer and other high-cost chronic NCDs across Africa, Asia, Europe, Latin America and Middle East. The study aims to enable readers to better understand the possibilities that innovative funding models bring to bridge the current and future funding gap, while stressing the key success factors that enable sustainability and success such as stakeholder collaboration. Sponsored by: Catalent Pharma Solutions 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. Sponsored by: Amazon Web Services From IoT to data management to high-performance computing and machine learning, leading life sciences organizations are using Amazon Web Services (AWS) to develop scalable, global, predictable, and secure solutions to modernize clinical trials while mitigating risks Sponsored by: Outer Edge Technology, LLC See why visionaries outsource the design and management of the infrastructure allowing their scientists to innovate. Sponsored by: Eli Lilly and Company in partnership with Xcenda Download this complimentary paper that explores the practice of step therapy and its impact on key stakeholders in the US healthcare system. Sponsored by: Catalent Download the case study to learn about the clinical supply management tools that helped a small sized pharma company during phase III of a multi-arm oncology study. Sponsored by: Catalent Watch a short video on demand led supply model. It is designed to meet the needs of patients, clinical sites, clinical team and sponsors and results in shorter lead time, less waste, less stock out risk and no booklet labels. Sponsored by: Catalent Download the eBook to explore a proactive approach for clinical supply management. Asia-Pacific Healthcare Compliance Certificate Program March 9-12, 2020 FierceBiotech Executive Breakfast at the J.P. Morgan Healthcare Conference 2020 January 14, 2020 | The Fairmont Hotel | San Francisco, CA 11th Annual SCOPE Summit: Summit for Clinical Ops Executives February 18-21, 2020 | Orlando, FL 4th Annual Gene Therapy for Rare Disorders March 30 – April 2, 2020 | Boston, MA Drug Development Boot Camp® 2020 November 18-19, 2020 | Register now and begin Pre-Boot Camp Preparation. | Take your new medicine development skills to the next level. Middle East Healthcare Compliance Certificate Program March 23-26, 2020 | 