Xconomy: Xpertise

CMC in Drug Development and Life Cycle Management

This white paper provides biotech companies an overview of the considerations for Chemistry, Manufacturing and Controls (CMC) in asset development. There are a multitude of complexities and points to consider when... Read more »

PRA Health Sciences

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CMC in Drug Development and Life Cycle Management
This white paper provides biotech companies an overview of the considerations for Chemistry, Manufacturing and Controls (CMC) in asset development. There are a multitude of complexities and points to consider when... Read more »
PRA Health Sciences
Sponsored · Whitepaper
Decentralized Trials: Reshaping the Rare Disease Landscape
A decentralized clinical trials model is especially important for patients with rare, genetic, or complex diseases. Learn how this model increases access to trials, bringing new therapies to rare disease patients... Read more »
PRA Health Sciences
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Biotech & Early Engagement Considerations: What Companies Must Consider When Developing an Asset
Learn how small biotech companies can navigate the complexities of asset development and selecting a drug development partner

Emerging biotech companies are a significant and burgeoning sector of... Read more »
PRA Health Sciences
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Bridging the Diversity Gap with Decentralized Trials
How a patient-centric, technology-driven approach can broaden access to research and reach patients regardless of geography, ethnicity, sex, or gender

The current drug development research paradigm is flawed... Read more »
PRA Health Sciences
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Oct. 28 – Accelerating COVID-19 Drug Discovery: Qualified Assays for Proinflammatory Cytokines
How Functional Cell-based Assays Support Clinical Programs Managing Proinflammatory Cytokines Associated with High Mortality

The high mortality rate in COVID-19 patients has been linked to cytokine release syndrome,... Read more »
Eurofins DiscoverX
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Nov. 12 – High-Throughput Assessment of Compound-Induced Cardiotoxicity Using Human iPSC-Derived Cardiomyocytes
Provide an in vitro drug-induced proarrhythmia assessment & strengthen pharmacological safety profiles of drug candidates

Drug-induced QT interval prolongation and Torsades de Pointes (TdP) arrhythmias are the leading... Read more »
Eurofins DiscoverX
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How Healthy Are Your Market Access Programs?
A Guide to Performing Check-ups on Pharmaceutical Distribution & Patient Access Programs

Pharmaceutical manufacturers invest countless resources to develop product distribution and patient access programs to maximize product... Read more »
Archbow Consulting
Xconomy Insight · Special Report
Biotech Startups: How to Succeed in a COVID-19 World
Download our latest startup e-book today for a deep dive into the biotech world during these unprecedented times. Notably, the trend toward digital and virtual that had already begun has been... Read more »
From Our Editors · Special Report
Xcelerating Life Sciences San Francisco: Special Report
The AI, Big Data, and R&D Boom
Learn what’s fueling San Francisco’s boom in AI, big data, and R&D, explore promising investment and partnership opportunities, and align the latest trends and... Read more »
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Sept. 15 – Challenges of Implementing Innovation in Drug Discovery & Development
Phenotypic Screening & Profiling to Understand a Compound’s Disease Impact

While you missed the live webinar, you can still watch a recording by following the link below.
... Read more »
Eurofins Discovery
From Our Editors · Podcast
Xcelerating Life Sciences San Francisco: The Highlights Podcast
The AI, Big Data, and R&D Boom
Learn what’s fueling San Francisco’s boom in AI, big data, and R&D; explore promising investment and partnership opportunities, and align the latest trends and... Read more »
From Our Editors · Special Report
Xcelerating Life Sciences Philadelphia: Special Report
Becoming the Cell & Gene Therapy Hub
Learn what’s fueling Philadelphia’s growing cell and gene therapy ecosystem, explore promising investment and partnership opportunities, and align the latest trends and technologies with... Read more »
From Our Editors · Podcast
Xcelerating Life Sciences Philadelphia: The Highlights Podcast
Becoming the Cell & Gene Therapy Hub
Learn what’s fueling Philadelphia’s growing cell and gene therapy ecosystem, explore promising investment and partnership opportunities, and align the latest trends and technologies with... Read more »
Sponsored · Webinar
Aug. 19 – Next-Generation Drug Discovery: Leveraging E3 Ligases for Targeted Protein Degradation
The Next Dimension of Precision Medicine?

While you missed the live webinar, you can still watch a recording by following the link below.

E3 ligases... Read more »
Eurofins Discovery
From Our Editors · Special Report
Xcelerating Life Sciences Boston: Special Report
Biopharma’s Future in Digital Health
Learn what’s fueling Boston’s biotech investment and partnership opportunities by reading our special report packaging the highlights from the recent Xcelerating Life Sciences Boston event.
... Read more »
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The Bay Area and Beyond: Biocom Talks Innovation and COVID
Xcelerating Life Sciences Fireside Chat

Joe Panetta, president and CEO of Biocom, speaks with Xconomy Managing Editor Dan Stanton about the Bay Area’s special place in the life... Read more »
Biocom
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Fish & Richardson: Patent Law in Regards to AI and Machine Learning
Xcelerating Life Sciences Fireside Chat

Teresa Lavoie, principal at Fish & Richardson, speaks with Xconomy Managing Editor Dan Stanton about the legal complications of using machine learning and... Read more »
Fish & Richardson
From Our Editors · Special Report
Biopharma and Tech Innovators Summer 2020
Even during the most difficult of times, the life science sector continues to push forward with innovation. The recent rapid progression of drug development, diagnostic tests, and healthcare tools has propelled... Read more »
Sponsored · Webinar
The Need for Manufacturing Execution Systems (MES) in Cell and Gene Therapy
While you missed the live webinar, you can still watch a recording by following the link below.
The presentation will provide an understanding why manufacturing execution systems (MES) should be considered... Read more »
Global OT/IT Quality Services
From Our Editors · Podcast
Xcelerating Life Sciences Boston: The Highlights Podcast
Learn what’s fueling Boston’s biotech investment and partnership opportunities by listening to our podcast packaging the highlights from the recent Xcelerating Life Sciences Boston: Biopharma’s Future in Digital Health event. Hosted... Read more »
Sponsored · Video
The Importance of Early Planning for Biotechs & Engaging with a CRO for Molecule Development
Xcelerating Life Sciences Fireside Chat

David Horton, director of Regulatory Affairs at Medpace, sits down with Xconomy Managing Editor Dan Stanton to discuss the importance of early planning... Read more »
Medpace
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Digitization of the Regenerative Medicine Supply Chain
While you missed the live webinar, you can still watch a recording by following the link below.
The presentation will provide an overview of the evolving regenerative medicine supply chain and... Read more »
Global OT/IT – Quality Services
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Using Enzyme Fragment Complementation (EFC) Technology to Quantify Reporter Gene Activity
While you missed the live webinar, you can still watch a recording by following the link below.
Simple Signaling Reporter Assays – Easily Quantify Activation & Inhibition of Cellular Pathways
Cell-based... Read more »
Eurofins DiscoverX
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Applying Cell-based In Vitro Assays to Improve In Vitro Hepatotoxicity Assessment Challenges
While you missed the live webinar, you can still watch a recording by following the link below.
Screening Approaches for Reducing Attrition Due to Drug-induced Liver Injury (DILI) Early in Drug... Read more »
Eurofins Discovery
From Our Editors · Special Report
Xcelerating Life Sciences San Diego: Special Report
Learn what’s fueling San Diego’s biotech investment and partnership opportunities by downloading our special report packaging the highlights from the recent Xcelerating Life Sciences San Diego: Biomedical Breakthroughs in Precision Medicine... Read more »
Sponsored · Whitepaper
Navigating Challenges & Advancing Clinical Development: A Toolkit for Emerging Biotechs
Emerging biotechs are a force to be reckoned with. In 2018, approximately 70% of clinical pipelines belonged to emerging biotechs, who were also responsible for nearly 64% of new active substances... Read more »
Medpace
From Our Editors · Podcast
Xcelerating Life Sciences San Diego: The Highlights Podcast
Learn what’s fueling San Diego’s biotech investment and partnership opportunities by listening to our podcast packaging the highlights from the recent Xcelerating Life Sciences San Diego: Biomedical Breakthroughs in Precision Medicine... Read more »
Sponsored · Whitepaper
Decentralized Clinical Trials: The Call for a New Paradigm
The existing framework around modern clinical trials is antiquated and inefficient. The foundations for clinical development date back to the 1938 US Food, Drug, and Cosmetic Act which gave the FDA... Read more »
PRA Health Sciences
Sponsored · Special Report
As the Commercial Real Estate Market Slumps, Look for a More Tenant-Friendly Future
The story of the “canary in the coal mine” is an advanced warning of danger. The metaphor originates from when miners used to carry caged canaries while at work; if the... Read more »
Hughes Marino
Sponsored · Video
WellMarker Bio Accelerates the Development of Predictive Biomarker-based Anticancer Drugs
Dong-Hoon Jin, Founder and CEO of WellMarker Bio Co., Ltd (WMBIO), speaks at BIO-Europe 2019 in Hamburg about their programs focused on predictive biomarker-based anticancer drugs to identity novel targets. WMBIO... Read more »
WellMarker Bio
Sponsored · Whitepaper
How Big Is the US Market for Medical Devices & Technologies?
This white paper is designed to demonstrate the utility of using the MarketScan® Inpatient View and Outpatient View (now known as IBM® MarketScan® Inpatient View and Outpatient View) online tools to... Read more »
IBM Watson
Sponsored · Whitepaper
IBM Watson Health Data in Action – Epidemiology Studies
For several decades, IBM® Watson Health™ researchers have been conducting epidemiology and outcomes research, consultation, and collaboration on the execution of pre- and post-launch research agendas. Our researchers and our databases... Read more »
IBM Watson
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The Importance of Early Key Opinion Leader Outreach in the Biologics & Biosimilars Marketplace
Over the past several years, the pharmaceutical industry has witnessed significant growth in the biologics sector, with biologics representing more than $150 billion in global sales in 2013. By 2020 they... Read more »
IBM Watson
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TILT Bio’s Oncolytic Virus-Enabled T-Cell Therapy Is Ready for Clinical Trials
Akseli Hemminki, Founder, CEO, and Chairman of the Board of TILT Biotherapeutics, discusses how TILT is different from other immune-therapy companies. Their approach is based on human observations during trials, for... Read more »
TILT Biotherapeutics
Sponsored · Video
Incysus Enters Clinical Trial for Genetically-Modified T Cells for Treating Glioblastoma
Lawrence Lamb, Executive VP and Chief Scientific Officer at Incysus Therapeutics, tells an inspirational story about the impetus behind the immuno-oncology company’s formation to advance a unique and innovative approach to... Read more »
Incysus Therapeutics
Sponsored · Whitepaper
How to Approach Life Sciences Fundraising
One of the biggest challenges for life sciences companies is finding sources of funding to keep research and development moving forward. In this guide, we’ll explore the different sources of funding... Read more »
Brex
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PRA Health Sciences Leverages Technology & Data to Reinvent Clinical Trial Practices
PRA Health Sciences executives Sol Babani, Senior VP for Drug Development and Scott Schliebner, Senior VP for the Center for Rare Diseases and Digital Therapeutics, spoke at Biotech Showcase 2020 about... Read more »
PRA Health Sciences
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What’s Next in Neuroscience Therapies
Brain and neurological disorders are among the toughest conditions to diagnose and treat, but new approaches and technologies are on the horizon that could change how researchers and clinicians approach them.... Read more »
Sponsored · Video
Fidelta Focuses on Drug Discovery in Infection & Inflammation
Fidelta’s Managing Director, Adrijana Vinter, speaks at BIO-Europe® 2019 in Hamburg about her company’s excellence in integrated drug discovery services, from target validation to early preclinical development. The CRO is able... Read more »
Fidelta
Sponsored · Whitepaper
Potency Assay Development for Cell and Gene Therapy Products
The Issue: Approved biological products are required to be accompanied by analytical tests to demonstrate safety, purity, and potency that are validated and performed under current Good Manufacturing Processes (cGMP)... Read more »
Absorption Systems
Sponsored · Video
BWB TV: Synthego aligns with “Young Innovator” award at the 2019 Xconomy Awards Boston
Synthego’s Brian Schneider, Territory Account Manager, chats with Xconomy Publisher Brian Caine just before the company presented the “Young Innovator” award at the 2019 Xconomy Awards Boston. He explains the company’s aim... Read more »
Synthego
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Bioceros develops monoclonal antibodies as a division of Poland’s Polpharma Biologics Group
Dr. Louis Boon is Chief Scientific Officer of Bioceros, based in the Netherlands, a division of Poland’s Polpharma Biologics Group, a one-stop-shop CDMO offering novel technologies on their own platform generating... Read more »
Bioceros
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Mundipharma’s success rests on valuable like-minded partnerships
Marco Cerato, Senior VP of Business Development and Strategic Partnerships at Mundipharma, speaks at BIO-Europe® 2019 in Hamburg about how his company’s successes in the market are resulting from a shift... Read more »
Mundipharma
Sponsored · Video
Rousselot Biomedical’s X Pure® is changing the game in purified gelatins
Jeff Daelman, Business Development Manager at Rousselot Biomedical, speaks at BIO-Europe® 2019 in Hamburg about X-Pure®, an innovative range of purified gelatins and collagens designed explicitly for (bio)medical applications and backed... Read more »
Rousselot Biomedical
Sponsored · Video
PharmAbcine Makes Great Strides in Immune-Oncology Cancer Treatments with Successful Trials
PharmAbcine’s CEO, Dr. Jin-San Yoo, speaks at BIO-Europe 2019 in Hamburg about the South Korean clinical stage immune-oncology company’s several successful and upcoming clinical trials in Melbourne, Australia, and elsewhere. PharmAbcine... Read more »
PharmAbcine
Sponsored · Video
Rgenix Cancer Therapeutics Company Focuses on RNA to Identify Novel Targets
Co-founders of Rgenix, CEO Masoud Tavazoie and COO David Darst, speak at BIO-Europe® 2019 in Hamburg about their clinical-stage cancer therapeutics company that focuses on the RNA space to identify novel... Read more »
Rgenix
Sponsored · Video
Nimble Therapeutics Greatly Accelerates Development of Peptide-Based Therapeutics
Jigar Patel, CEO of Nimble Therapeutics, speaks at BIO-Europe® 2019 in Hamburg about the spin-out last April of Nimble from Roche to accelerate the development and discovery of peptide-based therapeutics, and... Read more »
Nimble Therapeutics
Sponsored · Whitepaper
What to Include in Your Life Sciences Company Fundraising Pitch Deck
The actual pitch deck you use when pitching biotech investors probably won’t matter quite as much as the delivery of your fundraising pitch. Still, creating that deck is a critical part... Read more »
Brex
Sponsored · Video
Polaryx Therapeutics Boosts Lysosome Biogenesis to Treat Neurodegenerative Disorders
Hahn-Jun Lee, President and CEO of Polaryx Therapeutics Inc., speaks at BIO-Europe® 2019 in Hamburg about how the company accelerates the availability of treatment options for underserved patients, and what the... Read more »
Polaryx Therapeutics
Xconomy Insight · Webinar
Digital Healthcare Revolution Webinar Series
While you missed the live webinar, you can still watch a recording by following the link below.
Register Now for Free
Wednesday, Nov.... Read more »
Sponsored · Video
BWB TV: BREX aligns with “Secret Weapon” award at Xconomy Awards Boston
Hours before presenting the “Secret Weapon” award at the 2019 Xconomy Awards Boston, BREX’s Matt Henkel, Manager of Business Development and GTM Lead, chatted with Brian Caine, Xconomy’s Publisher. They... Read more »
BREX
Xconomy Insight · Webinar
The New Era of Emerging Therapies Webinar Series
While you missed the live webinar, you can still watch a recording by following the link below.
Register Now for Free
Potential cures... Read more »
From Our Partners · Webinar
The Digital Health Revolution
While you missed the live webinar, you can still watch a recording by following the link below.
Register Now for Free
Prepare for... Read more »
Xconomy Insight · Special Report
How to Jump 5 Unforeseen Hurdles to Biotech Success – Startup Sourcebook
This guide goes deeper than the last and gathers advice to help entrepreneurs solve some of the toughest—and often unexpected—challenges of creating a life sciences startup. Where possible, we also provide... Read more »
Sponsored · Video
Mass General has success with strategic alliances initiative for research
Gabriela Apiou, Director of Strategic Alliances at Mass General Research Institute in Boston, explains that the mission of strategic alliances for biomedical research and patient care is the essential retraining of... Read more »
Massachusetts General Hospital Research Institute
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Staatz Business Development & Strategy offers high-level consulting
Dr. Irina Staatz-Granzer, Founder and President of Staatz Business Development & Strategy, describes her biotech and pharma consulting company as having two main areas of expertise, business development and market access.... Read more »
Staatz Business Development & Strategy
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Exicure’s CEO describes unique SNA™ technology now in clinical trials
Dr. David Giljohann, CEO of Exicure, outlines the company’s unique spherical nucleic acid (SNA™) technology and how this three-dimensional arrangement of nucleic acid will solve the delivery challenge to get into... Read more »
Exicure
Sponsored · Video
Biotech Showcase™ 2019: Barc Lab expanding globally to bring personalized approach to more clients
Sofie Vandevyver, Head of Business Operations and Marketing at Barc Lab, highlights the lab’s goal to help every unique client find the right therapy for the right patient within the... Read more »
Barc Lab
Sponsored · Video
Biotech Showcase™ 2019: Tools4Patient aims to reduce effect of placebo response in clinical trials
Tools4Patient was founded by a group of industry veterans of clinical trials to accelerate the launch of drugs to patients by developing predictive algorithms to focus on the detrimental placebo response... Read more »
Tools4Patient
Sponsored · Video
Biotech Showcase™ 2019: Barc Lab expanding globally to bring personalized approach to more clients
Sofie Vandevyver, Head of Business Operations and Marketing at Barc Lab, highlights the lab’s goal to help every unique client find the right therapy for the right patient within the... Read more »
Barc Lab
Sponsored · Video
BIO-Europe® 2018: Life Biosciences aims to solve for aging
Life Biosciences is the world’s leader in longevity research addressing age-related decline. During BIO-Europe, Sree Kant, Head of Business Development at Life Biosciences, talked with Dr. Cora Kaiser about the company’s... Read more »
Life Biosciences
From Our Partners · Special Report
Robert Langer reveals secrets to early-stage biotech success
Download this exclusive profile of Bob Langer—one of 13 Institute Professors at MIT—which features his advice for obtaining funds to get promising technologies from lab to clinic, and where he sees... Read more »
From Our Partners · Whitepaper
Cell and Gene Therapies – State Of The Industry Report
Download from our partner, KNect365 Life Sciences
It is an exciting time to be involved in the cell and gene therapy industries. There are both opportunities and challenges around analytical testing,... Read more »
Sponsored · Video
Big Data in Clinical Trials with Oracle’s MaryAnne Rizk
PCT TV recently sat down with Dr. MaryAnne Rizk, Global Vice President of Biopharma Partnerships at Oracle, to discuss the biggest challenges facing clinical trials today and how technology can combat... Read more »
Sponsored · Video
Interview with Willie Muehlhausen, Head of Innovation, ICON
PCT TV recently sat down with Willie Muehlhausen, Head of Innovation, ICON to discuss transforming patient trials and patient recruitment. Muehlhausen explored the challenges to patient recruitment in clinical trials and... Read more »
From Our Partners · Video
Interview with Nadine Ritter from Global Biotech Experts
Cheryl Scott, Senior Scientific Editor, BioProcess International Magazine, recently sat down with Nadine M. Ritter, Ph.D., Global BioTech Experts for an interview on the increasing importance of sound product characterization and... Read more »
From Our Partners · Video
Interview with Kavita Ramalingam Iyer from Merck Sharp & Dohme
Anne Montgomery, Editor In Chief, BioProcess International Magazine, recently sat down with Kavita Ramalingam Iyer, PH.D., Associate Director, Global Regulatory Affairs and Clinical Safety – CMC Vaccines at Merck Sharp &... Read more »
Merck Sharp & Dohme
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Interview with Jarrod Medeiros from IDBS
Brian Caine, Publisher, BioProcess International Magazine, recently sat down with Jarrod Medeiros, Product Manager, IDBS at BioTech Week Boston in September to discuss data management and challenges in the pharmaceutical and... Read more »
IDBS
Sponsored · Video
Interview with Jonathan Royce from GE Healthcare
Brian Caine, Publisher, BioProcess international Magazine, recently sat down with Jonathan Royce, Business Leader Chromatography Resins, GE Healthcare at BioTech Week Boston in September to discuss market trends impacting Monoclonal antibodies.... Read more »
GE Healthcare
From Our Editors · Video
Interview with Lita Nelsen on the Future of Technology Transfer
Lita Nelsen recently retired as the long-time director of MIT’s Technology Licensing Office. She and Xconomy’s Corie Lok recently sat down for an interview during Biotech Week Boston in September. Nelsen,... Read more »
From Our Editors · Video
Interview with David Edwards on the Future of Food
David Edwards is a professor at Harvard University. He sat down with Xconomy’s Corie Lok during Biotech Week Boston in September to share his vision for the future of food and... Read more »
From Our Editors · Video
Interview with David Berry on Microbiome Therapeutics
David Berry is a general partner with venture capital firm Flagship Pioneering. In recent years, he has co-founded companies that are developing microbiome products for both human therapeutics and agricultural applications.... Read more »
From Our Editors · Podcast
Xconomy Voices 02: Christopher Ahlberg of Recorded Future
Christopher Ahlberg, the CEO of Recorded Future, a cybersecurity startup based in Somerville, MA. Recorded Future has an intriguing approach to solving some of the biggest problems in data and network... Read more »
From Our Editors · Podcast
Xconomy Voices 01: Mary Lou Jepsen
Mary Lou Jepsen is a fearsome samurai when it comes to the design and manufacturing of electronics, especially displays. Her latest venture is Openwater, a San Francisco-based startup that’s using LCDs—the... Read more »
Xconomy Insight · Special Report
Trending in Healthcare
An exploration of the science, technologies and trends with potential to radically change how, when and where people receive healthcare
Johnson & Johnson Innovation
From Our Editors · Special Report
The Sacramento-Davis Corridor: Seeding an Innovation Cluster
Xconomy presents a two-part series on efforts to transform the Sacramento region into a major new innovation cluster. Part 1 looks at changes in Sacramento that could make the city more... Read more »
From Our Editors · Special Report
Madison’s Healthtech Cluster
Healthcare, agriculture, and manufacturing remain the bread and butter of the private sector in Madison, WI, and the surrounding region, but healthcare IT has arguably become the area’s most buzz-worthy industry.... Read more »
From Our Editors · Special Report
Boston Cybersecurity Map
It’s no secret that the Boston area is home to a formidable group of companies related to cybersecurity. Just how big is the local cluster? Xconomy surveyed the landscape and found... Read more »
From Our Editors · Slideshow
12 San Diego Tech Startups to Watch in 2017
A little more than a year ago, amid a resurgence in San Diego’s software sector, Xconomy identified a baker’s dozen of local tech companies to watch in 2016. The results were... Read more »
From Our Editors · Special Report
Xconomist Report: The Future of Education
For young people today, the view to the future is arguably cloudier than it has been in several generations, thanks to breakneck technological change and increasing economic uncertainty. What kinds of... Read more »
From Our Editors · Special Report
Innovation in Santa Cruz
Wade Roush’s three-part exploration of Santa Cruz’s innovation ecosystem, its history of launching successful companies and entrepreneurs, and its efforts to reverse perceptions that it is anti-business.
Santa Cruz, the... Read more »

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