| This week's sponsor is Patheon. | | | In-House Versus Outsource: A Decision-Making Guide
Here’s a step-by-step guide for biopharmaceutical executives to use when considering if outsourcing fits into their strategy, as well as how to select the best CDMO partner for their business. |
Today's Rundown AbbVie halts trial of Stemcentrx-sourced ADC for cancer Lilly hires Leena Gandhi as new look I-O team takes shape After months of mounting pressure amid lurid allegations, OrbiMed’s Isaly steps down [Sponsored] Getting to True Agile IRT: 5 Questions to Ask Your IRT Vendor Kiniksa and Scholar Rock gun for $175M IPOs as 2 other biotechs struggle Proniras launches with BARDA funding to pit migraine drug against nerve agents Just shy of phase 3, Alzheon calls off $81M IPO Crescendo raises $70M to trial bispecific T-cell engager Synthorx reels in $63M to push synthetic cytokines into the clinic [Sponsored] Australia the not-so-secret destination for pharma and biotech clinical trials Jazz grabs Spark’s priority review voucher for $110M Roivant’s Datavant raises $41M, buys data de-identification firm UPK Featured Story | | | Monday, April 30, 2018 AbbVie has terminated an early-stage trial of an antibody-drug conjugate (ADC) for solid tumors, one of the candidates acquired as part of its $9.8 billion takeover of Stemcentrx in 2016. |
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Top Stories Monday, April 30, 2018 Eli Lilly has appointed Leena Gandhi, M.D., Ph.D., to lead immuno-oncology medical development. The thoracic oncologist will head up a team tasked with overseeing the advance of Lilly’s portfolio of immuno-oncology prospects. Monday, April 30, 2018 Sam Isaly has now finally left OrbiMed, the venture capital firm he founded, amid allegations of sexual impropriety. Monday, April 30, 2018 Download the article and better understand the five questions that will help you separate myth from reality when it comes to Agile IRT. Monday, April 30, 2018 It was something of an up-and-down week for IPOs: Two biotechs, Alzheimer’s-focused Alzheon and brittle bone drug company Mereo BioPharma, pulled their collective $161 million Nasdaq attempts. But the week ended with better news for two other biotechs. Friday, April 27, 2018 Accelerator Life Science Partners launched a spinoff company to develop an investigational migraine treatment into a therapy for a variety of seizure disorders and landed an $89.5 million federal contract to explore the drug’s use as a medical countermeasure against the effects of nerve agents. Friday, April 27, 2018 Alzheon had planned to advance its once-failed Alzheimer's drug with the IPO funds, but now its phase 3 ambitions remain on hold. Monday, April 30, 2018 Crescendo Biologics has raised $70 million (€57 million) to take its lead bispecific T-cell engager into the clinic. The financing equips Crescendo to show whether its vision for dialing up T-cell activity in the tumor microenvironment translates into humans. Monday, April 30, 2018 The funding will advance its pipelines of synthetic cytokines, which are designed to improve the efficacy of immuno-oncology treatments without the negative side effects that sometimes come with native cytokines. Monday, April 30, 2018 Supported by generous tax breaks and backed up by strong clinical research and healthcare organizations, Australia has become the not-so-secret destination for both small and large pharmaceutical and biotech companies looking to conduct early stage clinical trials. Monday, April 30, 2018 Spark Therapeutics agreed to sell its priority review voucher, good for four months off an FDA decision date for any product, to Jazz Pharmaceuticals for $110 million—providing Spark a nice bonus on top of the recent approval for what’s been described as the world’s most expensive drug, Luxturna. Monday, April 30, 2018 Datavant has raised $40.5 million and acquired Universal Patient Key (UPK). The takeover gives the Roivant startup control of HIPAA-compliant "de-identification" technology to support its drive to link up sources of health data. | This week's sponsor is ExL Events. | | | |
Enrollment Showcase | | | Sponsored by: Drexel University Online 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. |
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Resources Sponsored by: Veeva Systems Find out how to eliminate regulatory’s tracking spreadsheets for good. Sponsored by: Veeva Systems UCB took a more holistic approach to managing regulatory processes. Read how their efforts are paying off. Sponsored by: Veeva Systems Learn how to reduce change management burden, keep systems current, and maintain compliance by applying a risk-based approach to change management of GxP systems. Sponsored by: Seton Hall Law 4-day interactive educational program trusted by multi-national companies as part of their compliance training for employees. Explore legal, regulatory and ethical issues faced by pharmaceutical, biotech and medical device manufacturers operating globally. Visit event homepage for session topics. Sponsored by: Veeva Systems Learn how leading companies, from the world’s top pharma to emerging biotechs, are empowering their medical affairs teams. Sponsored by: Veeva Systems To deliver value to key opinion leaders, medical affairs needs to tailor their engagement with deeper analytics and insights. Sponsored by: Veeva Systems Explore a new model for events management, and learn how to deliver more value. Sponsored by: WCG Small biopharma companies are conducting almost 50% of the clinical trials in the US today, yet they face unique challenges that large pharma do not. In this paper, we explore some of those challenges, and solutions that can reduce the pressure on small biopharma teams and timelines. Sponsored by: Halo Pharma Why does confidence matter when outsourcing Fixed-Dose Combination products? Download Halo Pharma’s white paper on the importance of product design, technology, and analyticals tools for FDC. Sponsored by: USDM Life Sciences What are the biggest trends in life sciences this year? Presented by: Patheon, part of Thermo Fisher Scientific Patheon's Stephen Lam reviews the formidable challenges and decisions facing biopharma manufacturing executives. Watch as he shares unique insights and perspectives and demonstrates how there is really no one-size-fits-all solution in biomanufacturing, regardless of company size. Presented by: Charles River How do you get your oncology therapy to the clinic? The path isn’t always clear. In vitro, ex vivo, xenograft, syngeneic, PDX, humanized models, immunology considerations, safety regulations – which do you need to plan for and when? Sponsored by: DocuSign Life science companies are experiencing a significant transformation in how they bring new products to market. Sponsored by: WCG Selecting the right sites to conduct your clinical trials will determine the success or failure of meeting your enrollment goals. Presented by: Covance 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. Presented by: Charles River 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. Presented by: Catalent Learn how Catalent Biologics is paving the way for flexible biologics development and manufacturing through advanced technologies and fully integrated multi-product facility. Presented by: Catalent Download the eBook to get articles from various Elsevier journals highlighting developments in ADC technology. Presented by: Catalent Learn how cell development and process scale-up can be optimized for antibodies requiring additional processing. Sponsored by: RTI Health Solutions 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. Drug Approval, Manufacturing Quality & Regulation 2018 | Online Biotech for the Non-Scientist May 2-3, 2018 | San Diego, CA Translational Biomarkers: Advancing Neuroscience Drug Discovery and Development May 14, 2018 | South San Francisco, CA
MIXiii-Biomed 2018 May 15-17, 2018 | Tel-Aviv, Israel Drug Development Immersion May 17-18, 2018 | Boston, MA BIO International Convention June 4-7, 2018 | Boston, MA
FierceBiotech Executive Breakfast at BIO 2018 – CAR-T 2.0: Innovation Never Stands Still June 6, 2018 | Boston, MA BioBasics: Biotech for the Non-Scientist June 13 - 14, 2018 | Toronto, Canada BioBasics: Biotech for the Non-Scientist June 13 - 14, 2018 | West Windsor, NJ Sensors Expo & Conference Conference & Expo: June 26-28, 2018 | Pre-Conference Symposia: June 25, 2018 | San Jose, CA 18th International Biotechnology Symposium and Exhibition August 12-17, 2018 | Montreal, Canada Drug Development Boot Camp® 2018 November 14-15, 2018 | Boston, MA | Register and start preparing Today! | 