|By PR Newswire||
|January 7, 2013 02:30 PM EST||
SAN FRANCISCO, Jan. 7, 2013 /PRNewswire/ -- Life sciences companies in California developed nine of the 32 novel medicines approved by the U.S. Food and Drug Administration (FDA) in 2012, according to the annual California Biomedical Industry Report, published today by BayBio, California Healthcare Institute (CHI) and PwC US. The pace of product approvals and pipeline productivity of California-based biomedical companies reinforces the state's position as the nation's leading source of biomedical innovation.
"California continues to deliver life-saving treatments and new technologies that offer hope for patients in need," said David L. Gollaher, Ph.D., president and CEO of CHI. "Last year alone, we saw the approval of novel medicines to treat rare forms of cancer, anemia associated with chronic kidney disease and cystic fibrosis, among others."
The California Biomedical Industry Report provides an annual snapshot of the biomedical industry in California, the largest biomedical cluster in the world and source of the greatest number of products in clinical development. The 2013 report found California to be:
- No. 1 in jobs: Biomedical industry employment in California has grown at an average annual rate of 0.5 percent over the past five years. There are currently 269,997 people employed in the total biomedical industry, and 152,806 employees in the core sectors of biopharmaceuticals, medical devices, instruments and diagnostics, and research and development/testing laboratories.
- No. 1 in new treatments to patients: Twenty-one percent of the nation's biomedical R&D pipeline is comprised of innovation from California laboratories.
- No. 1 in venture capital investments: California biomedical companies secured $1.98 billion in venture capital investment through the first three quarters of 2012, a greater amount than any other state and equal to the total combined amount that went to companies in the next eight states, ranked by VC investments.
- No. 1 in federal funding: $3.33 billion in funding from the National Institutes of Health (NIH) went to California institutions, more than any other state and 15.1 percent of total national NIH funding.
"As the center of biomedical innovation in the U.S, California's biomedical industry is a national treasure," said Gail Maderis, president and CEO of BayBio. "But the pace of R&D productivity and its global leadership position hang on the availability of capital to fund future innovation and a regulatory framework that is based on consistency and innovative technologies."
The 2013 California Biomedical Industry Report includes findings from a survey of 175 biomedical company CEOs, who report significant improvements in the FDA regulatory process over the past year and a notable reduction in project delays due to regulatory issues. Despite this progress, biomedical companies say that lack of adequate funding, government pricing intervention and the FDA regulatory environment represent the biggest risks to future success in biomedical innovation.
The 2013 Biomedical Industry Report found:
- Nearly 14 percent of respondents said that the FDA regulatory process had improved over the prior year.
- Sixteen percent of biomedical companies delayed a project because of regulation this past year, a 17 percent decline from the previous year.
- Fifty-nine percent of CEOs cited limited or lack of access to capital as the most threatening issue to the short-term health of biomedical innovation.
- More than 50 percent of CEOs report that health insurance coverage and reimbursement issues have become more difficult in the past year.
- Nearly 90 percent of CEOs believe the industry's relationship with FDA is extremely important to advancing biomedical innovation in California, but 57 percent feel that regulatory processes have not kept pace with advance of science and technology, and thus it poses a risk to innovation.
Growth and access to capital
Though California biomedical companies attract the greatest share of venture capital, overall access to capital has become an increasing challenge for the entire industry. The funding model is changing, and California companies and research institutions are at the forefront of national trends driving an increase in partnerships and alternative sources of funding.
More of California's biomedical companies are pursuing foundation funding, corporate partnering, corporate venture and angel investors than in years past. As the use of federal funds is debated, California institutions have demonstrated their value.
- $3.33 billion in funding from the National Institutes of Health (NIH) went to California institutions, more than any other state and 15.1 percent of total national NIH funding.
- California biomedical companies received $1.98 billion through the first three quarters of 2012, the most by any state and double the amount for the second largest state recipient.
- California's share of early and seed stage venture capital deals increased from 60 percent to 63 percent of total U.S. life sciences venture capital investment; however, overall biotech venture capital through the third quarter of 2012 declined to $2.98 billion from $4.91 billion in 2011.
- M&A activity among California companies declined by 36 percent from 2009, when M&A reached a 10-year high. The percentage of CEOs that indicated over the next 12 months their organization is more likely to participate in a merger or acquisition was down 11 points from the prior year.
"Biomedical innovation is being fueled by a new paradigm to advance R&D through a combination of diverse, alternative sources of funding, non-traditional partnerships and greater collaboration among the biotech, pharmaceutical, the investment community and regulatory bodies," said Tracy Lefteroff, Global Managing Partner, Venture Capital Practice and National Life Sciences Partner, PwC US. "Greater collaboration is driving investments in consortia that share information during the pre-competitive stage of research and development and in the post-marketing environment where opportunities exist to leverage consumer insights and patient safety information from multiple sources."
Short-term success over long-term progress
Nearly three-quarters of respondents said that coverage and reimbursement considerations are extremely important in the advance of biomedical research, innovation and investment in California. By comparison, only 39 percent of CEOs perceived reimbursement was a challenge in the prior year's biomedical industry report. The significant increase in reimbursement challenges is a potential reflection of higher expectations of value from consumers and payers, including federal and state government, employers and health plans.
"The long-term stability of life sciences is grounded in California companies' ability to innovate," Gollaher said. "From the start, our industry has adapted to formidable challenges -- gaining access to capital, overcoming regulatory and reimbursement obstacles. Based on a concentration of scientists and entrepreneurs unmatched anywhere else, our state is prepared to continue its biomedical leadership well into the 21st century."
The 2013 California Biomedical Industry Report is available at www.californiabiomedreport.com.
CHI and BayBio worked with PwC to collect and administer data for the 2013 CHI, BayBio, PwC California Biomedical Industry Survey. The survey was conducted in November 2012 and targeted approximately 175 companies that conduct business in California in the areas of pharmaceuticals, biotechnology, medical devices, diagnostics or medical equipment.
BayBio brings together the collective strength and experience of the world's most innovative and productive life science cluster, helping companies grow, connect and advocate to solve some of humanity's most pressing challenges. Online at www.baybio.org.
About the California Healthcare Institute
CHI represents more than 275 leading biotechnology, medical device, diagnostics, and pharmaceutical companies, and public and private academic biomedical research organizations. CHI's mission is to advance responsible public policies that foster medical innovation and promote scientific discovery. CHI's website is www.chi.org. Follow us on Twitter @calhealthcare, Facebook, LinkedIn and YouTube.
About PwC's Pharmaceutical and Life Sciences Industry Group
PwC's Pharmaceutical and Life Sciences Industry Group provides clients with audit, tax and advisory services. We deliver industry-tailored solutions on a wide range of strategic, financial and operational issues. Our Pharmaceutical and Life Sciences Industry Group is part of PwC's larger initiative for the health-related industries that brings together expertise and allows collaboration across all sectors in the health continuum. For more information, follow us at @PwCHealth or visit www.pwc.com/us/pharma and www.pwc.com/us/medtech.
About PwC US
PwC US helps organizations and individuals create the value they're looking for. We're a member of the PwC network of firms in 158 countries with more than 180,000 people. We're committed to delivering quality in assurance, tax and advisory services. Tell us what matters to you and find out more by visiting us at www.pwc.com/US.
© 2013 PricewaterhouseCoopers LLP, a Delaware limited liability partnership. All rights reserved. PwC refers to the US member firm, and may sometimes refer to the PwC network. Each member firm is a separate legal entity. Please see www.pwc.com/structure for further details.
Cloud computing delivers on-demand resources that provide businesses with flexibility and cost-savings. The challenge in moving workloads to the cloud has been the cost and complexity of ensuring the initial and ongoing security and regulatory (PCI, HIPAA, FFIEC) compliance across private and public clouds. Manual security compliance is slow, prone to human error, and represents over 50% of the cost of managing cloud applications. Determining how to automate cloud security compliance is critical to maintaining positive ROI. Raxak Protect is an automated security compliance SaaS platform and ma...
Nov. 30, 2015 12:00 AM EST Reads: 449
Today air travel is a minefield of delays, hassles and customer disappointment. Airlines struggle to revitalize the experience. GE and M2Mi will demonstrate practical examples of how IoT solutions are helping airlines bring back personalization, reduce trip time and improve reliability. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Dr. Sarah Cooper, M2Mi’s VP Business Development and Engineering, explored the IoT cloud-based platform technologies driving this change including privacy controls, data transparency and integration of real time context with p...
Nov. 29, 2015 06:00 PM EST Reads: 443
The Internet of Things (IoT) is growing rapidly by extending current technologies, products and networks. By 2020, Cisco estimates there will be 50 billion connected devices. Gartner has forecast revenues of over $300 billion, just to IoT suppliers. Now is the time to figure out how you’ll make money – not just create innovative products. With hundreds of new products and companies jumping into the IoT fray every month, there’s no shortage of innovation. Despite this, McKinsey/VisionMobile data shows "less than 10 percent of IoT developers are making enough to support a reasonably sized team....
Nov. 29, 2015 02:00 PM EST Reads: 485
Just over a week ago I received a long and loud sustained applause for a presentation I delivered at this year’s Cloud Expo in Santa Clara. I was extremely pleased with the turnout and had some very good conversations with many of the attendees. Over the next few days I had many more meaningful conversations and was not only happy with the results but also learned a few new things. Here is everything I learned in those three days distilled into three short points.
Nov. 29, 2015 01:00 PM EST Reads: 357
DevOps is about increasing efficiency, but nothing is more inefficient than building the same application twice. However, this is a routine occurrence with enterprise applications that need both a rich desktop web interface and strong mobile support. With recent technological advances from Isomorphic Software and others, rich desktop and tuned mobile experiences can now be created with a single codebase – without compromising functionality, performance or usability. In his session at DevOps Summit, Charles Kendrick, CTO and Chief Architect at Isomorphic Software, demonstrated examples of com...
Nov. 29, 2015 12:45 PM EST Reads: 421
As organizations realize the scope of the Internet of Things, gaining key insights from Big Data, through the use of advanced analytics, becomes crucial. However, IoT also creates the need for petabyte scale storage of data from millions of devices. A new type of Storage is required which seamlessly integrates robust data analytics with massive scale. These storage systems will act as “smart systems” provide in-place analytics that speed discovery and enable businesses to quickly derive meaningful and actionable insights. In his session at @ThingsExpo, Paul Turner, Chief Marketing Officer at...
Nov. 29, 2015 12:30 PM EST Reads: 427
In his keynote at @ThingsExpo, Chris Matthieu, Director of IoT Engineering at Citrix and co-founder and CTO of Octoblu, focused on building an IoT platform and company. He provided a behind-the-scenes look at Octoblu’s platform, business, and pivots along the way (including the Citrix acquisition of Octoblu).
Nov. 29, 2015 12:00 PM EST Reads: 528
In his General Session at 17th Cloud Expo, Bruce Swann, Senior Product Marketing Manager for Adobe Campaign, explored the key ingredients of cross-channel marketing in a digital world. Learn how the Adobe Marketing Cloud can help marketers embrace opportunities for personalized, relevant and real-time customer engagement across offline (direct mail, point of sale, call center) and digital (email, website, SMS, mobile apps, social networks, connected objects).
Nov. 29, 2015 11:45 AM EST Reads: 329
The Internet of Everything is re-shaping technology trends–moving away from “request/response” architecture to an “always-on” Streaming Web where data is in constant motion and secure, reliable communication is an absolute necessity. As more and more THINGS go online, the challenges that developers will need to address will only increase exponentially. In his session at @ThingsExpo, Todd Greene, Founder & CEO of PubNub, exploreed the current state of IoT connectivity and review key trends and technology requirements that will drive the Internet of Things from hype to reality.
Nov. 29, 2015 09:45 AM EST Reads: 454
Two weeks ago (November 3-5), I attended the Cloud Expo Silicon Valley as a speaker, where I presented on the security and privacy due diligence requirements for cloud solutions. Cloud security is a topical issue for every CIO, CISO, and technology buyer. Decision-makers are always looking for insights on how to mitigate the security risks of implementing and using cloud solutions. Based on the presentation topics covered at the conference, as well as the general discussions heard between sessions, I wanted to share some of my observations on emerging trends. As cyber security serves as a fou...
Nov. 29, 2015 09:15 AM EST Reads: 347
We all know that data growth is exploding and storage budgets are shrinking. Instead of showing you charts on about how much data there is, in his General Session at 17th Cloud Expo, Scott Cleland, Senior Director of Product Marketing at HGST, showed how to capture all of your data in one place. After you have your data under control, you can then analyze it in one place, saving time and resources.
Nov. 29, 2015 08:45 AM EST Reads: 232
With all the incredible momentum behind the Internet of Things (IoT) industry, it is easy to forget that not a single CEO wakes up and wonders if “my IoT is broken.” What they wonder is if they are making the right decisions to do all they can to increase revenue, decrease costs, and improve customer experience – effectively the same challenges they have always had in growing their business. The exciting thing about the IoT industry is now these decisions can be better, faster, and smarter. Now all corporate assets – people, objects, and spaces – can share information about themselves and thei...
Nov. 29, 2015 08:00 AM EST Reads: 282
The cloud. Like a comic book superhero, there seems to be no problem it can’t fix or cost it can’t slash. Yet making the transition is not always easy and production environments are still largely on premise. Taking some practical and sensible steps to reduce risk can also help provide a basis for a successful cloud transition. A plethora of surveys from the likes of IDG and Gartner show that more than 70 percent of enterprises have deployed at least one or more cloud application or workload. Yet a closer inspection at the data reveals less than half of these cloud projects involve production...
Nov. 29, 2015 07:00 AM EST Reads: 500
Continuous processes around the development and deployment of applications are both impacted by -- and a benefit to -- the Internet of Things trend. To help better understand the relationship between DevOps and a plethora of new end-devices and data please welcome Gary Gruver, consultant, author and a former IT executive who has led many large-scale IT transformation projects, and John Jeremiah, Technology Evangelist at Hewlett Packard Enterprise (HPE), on Twitter at @j_jeremiah. The discussion is moderated by me, Dana Gardner, Principal Analyst at Interarbor Solutions.
Nov. 29, 2015 06:45 AM EST Reads: 744
Discussions of cloud computing have evolved in recent years from a focus on specific types of cloud, to a world of hybrid cloud, and to a world dominated by the APIs that make today's multi-cloud environments and hybrid clouds possible. In this Power Panel at 17th Cloud Expo, moderated by Conference Chair Roger Strukhoff, panelists addressed the importance of customers being able to use the specific technologies they need, through environments and ecosystems that expose their APIs to make true change and transformation possible.
Nov. 29, 2015 06:00 AM EST Reads: 559
Too often with compelling new technologies market participants become overly enamored with that attractiveness of the technology and neglect underlying business drivers. This tendency, what some call the “newest shiny object syndrome” is understandable given that virtually all of us are heavily engaged in technology. But it is also mistaken. Without concrete business cases driving its deployment, IoT, like many other technologies before it, will fade into obscurity.
Nov. 29, 2015 06:00 AM EST Reads: 377
Microservices are a very exciting architectural approach that many organizations are looking to as a way to accelerate innovation. Microservices promise to allow teams to move away from monolithic "ball of mud" systems, but the reality is that, in the vast majority of organizations, different projects and technologies will continue to be developed at different speeds. How to handle the dependencies between these disparate systems with different iteration cycles? Consider the "canoncial problem" in this scenario: microservice A (releases daily) depends on a couple of additions to backend B (re...
Nov. 29, 2015 05:00 AM EST Reads: 462
The Internet of Things is clearly many things: data collection and analytics, wearables, Smart Grids and Smart Cities, the Industrial Internet, and more. Cool platforms like Arduino, Raspberry Pi, Intel's Galileo and Edison, and a diverse world of sensors are making the IoT a great toy box for developers in all these areas. In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists discussed what things are the most important, which will have the most profound effect on the world, and what should we expect to see over the next couple of years.
Nov. 29, 2015 04:30 AM EST Reads: 488
Container technology is shaping the future of DevOps and it’s also changing the way organizations think about application development. With the rise of mobile applications in the enterprise, businesses are abandoning year-long development cycles and embracing technologies that enable rapid development and continuous deployment of apps. In his session at DevOps Summit, Kurt Collins, Developer Evangelist at Built.io, examined how Docker has evolved into a highly effective tool for application delivery by allowing increasingly popular Mobile Backend-as-a-Service (mBaaS) platforms to quickly crea...
Nov. 29, 2015 04:00 AM EST Reads: 380
Growth hacking is common for startups to make unheard-of progress in building their business. Career Hacks can help Geek Girls and those who support them (yes, that's you too, Dad!) to excel in this typically male-dominated world. Get ready to learn the facts: Is there a bias against women in the tech / developer communities? Why are women 50% of the workforce, but hold only 24% of the STEM or IT positions? Some beginnings of what to do about it! In her Day 2 Keynote at 17th Cloud Expo, Sandy Carter, IBM General Manager Cloud Ecosystem and Developers, and a Social Business Evangelist, wil...
Nov. 29, 2015 03:00 AM EST Reads: 598