Click here to close now.

Welcome!

Search Authors: Pat Romanski, Mike Kavis, Lori MacVittie, Vormetric Blog, Liz McMillan

News Feed Item

California Biomedical Companies Report Higher Product Approvals; Fewer Delays

BayBio, California Healthcare Institute and PwC Issue 2013 California Biomedical Industry Report

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.

(Logo: http://photos.prnewswire.com/prnh/20100917/NY66894LOGO )

"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.

Methodology
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.

About BayBio
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.

Learn more about PwC by following us online: @PwC_LLP, YouTube, LinkedIn, Facebook and Google +.

© 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.

SOURCE PwC

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

@ThingsExpo Stories
The world's leading Cloud event, Cloud Expo has launched Microservices Journal on the SYS-CON.com portal, featuring over 19,000 original articles, news stories, features, and blog entries. DevOps Journal is focused on this critical enterprise IT topic in the world of cloud computing. Microservices Journal offers top articles, news stories, and blog posts from the world's well-known experts and guarantees better exposure for its authors than any other publication. Follow new article posts on Twitter at @MicroservicesE
Wearable technology was dominant at this year’s International Consumer Electronics Show (CES) , and MWC was no exception to this trend. New versions of favorites, such as the Samsung Gear (three new products were released: the Gear 2, the Gear 2 Neo and the Gear Fit), shared the limelight with new wearables like Pebble Time Steel (the new premium version of the company’s previously released smartwatch) and the LG Watch Urbane. The most dramatic difference at MWC was an emphasis on presenting wearables as fashion accessories and moving away from the original clunky technology associated with t...
SYS-CON Events announced today the IoT Bootcamp – Jumpstart Your IoT Strategy, being held June 9–10, 2015, in conjunction with 16th Cloud Expo and Internet of @ThingsExpo at the Javits Center in New York City. This is your chance to jumpstart your IoT strategy. Combined with real-world scenarios and use cases, the IoT Bootcamp is not just based on presentations but includes hands-on demos and walkthroughs. We will introduce you to a variety of Do-It-Yourself IoT platforms including Arduino, Raspberry Pi, BeagleBone, Spark and Intel Edison. You will also get an overview of cloud technologies s...
SYS-CON Events announced today that SafeLogic has been named “Bag Sponsor” of SYS-CON's 16th International Cloud Expo® New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. SafeLogic provides security products for applications in mobile and server/appliance environments. SafeLogic’s flagship product CryptoComply is a FIPS 140-2 validated cryptographic engine designed to secure data on servers, workstations, appliances, mobile devices, and in the Cloud.
The WebRTC Summit 2014 New York, to be held June 9-11, 2015, at the Javits Center in New York, NY, announces that its Call for Papers is open. Topics include all aspects of improving IT delivery by eliminating waste through automated business models leveraging cloud technologies. WebRTC Summit is co-located with 16th International Cloud Expo, @ThingsExpo, Big Data Expo, and DevOps Summit.
Containers and microservices have become topics of intense interest throughout the cloud developer and enterprise IT communities. Accordingly, attendees at the upcoming 16th Cloud Expo at the Javits Center in New York June 9-11 will find fresh new content in a new track called PaaS | Containers & Microservices Containers are not being considered for the first time by the cloud community, but a current era of re-consideration has pushed them to the top of the cloud agenda. With the launch of Docker's initial release in March of 2013, interest was revved up several notches. Then late last...
SOA Software has changed its name to Akana. With roots in Web Services and SOA Governance, Akana has established itself as a leader in API Management and is expanding into cloud integration as an alternative to the traditional heavyweight enterprise service bus (ESB). The company recently announced that it achieved more than 90% year-over-year growth. As Akana, the company now addresses the evolution and diversification of SOA, unifying security, management, and DevOps across SOA, APIs, microservices, and more.
After making a doctor’s appointment via your mobile device, you receive a calendar invite. The day of your appointment, you get a reminder with the doctor’s location and contact information. As you enter the doctor’s exam room, the medical team is equipped with the latest tablet containing your medical history – he or she makes real time updates to your medical file. At the end of your visit, you receive an electronic prescription to your preferred pharmacy and can schedule your next appointment.
GENBAND has announced that SageNet is leveraging the Nuvia platform to deliver Unified Communications as a Service (UCaaS) to its large base of retail and enterprise customers. Nuvia’s cloud-based solution provides SageNet’s customers with a full suite of business communications and collaboration tools. Two large national SageNet retail customers have recently signed up to deploy the Nuvia platform and the company will continue to sell the service to new and existing customers. Nuvia’s capabilities include HD voice, video, multimedia messaging, mobility, conferencing, Web collaboration, deskt...
The Open Compute Project is a collective effort by Facebook and a number of players in the datacenter industry to bring lessons learned from the social media giant's giant IT deployment to the rest of the world. Datacenters account for 3% of global electricity consumption – about the same as all of Switzerland or the Czech Republic -- according to people I met at the recent Open Compute Summit in San Jose. With increasing mobility at the edge of the cloud and vast new dataflows being predicted with the growth of the Internet of Things (and The Coming Age of Many Zettabytes) in the near...
The list of ‘new paradigm’ technologies that now surrounds us appears to be at an all time high. From cloud computing and Big Data analytics to Bring Your Own Device (BYOD) and the Internet of Things (IoT), today we have to deal with what the industry likes to call ‘paradigm shifts’ at every level of IT. This is disruption; of course, we understand that – change is almost always disruptive.
SYS-CON Events announced today that Cisco, the worldwide leader in IT that transforms how people connect, communicate and collaborate, has been named “Gold Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Cisco makes amazing things happen by connecting the unconnected. Cisco has shaped the future of the Internet by becoming the worldwide leader in transforming how people connect, communicate and collaborate. Cisco and our partners are building the platform for the Internet of Everything by connecting the...
SYS-CON Media announced today that @WebRTCSummit Blog, the largest WebRTC resource in the world, has been launched. @WebRTCSummit Blog offers top articles, news stories, and blog posts from the world's well-known experts and guarantees better exposure for its authors than any other publication. @WebRTCSummit Blog can be bookmarked ▸ Here @WebRTCSummit conference site can be bookmarked ▸ Here
Temasys has announced senior management additions to its team. Joining are David Holloway as Vice President of Commercial and Nadine Yap as Vice President of Product. Over the past 12 months Temasys has doubled in size as it adds new customers and expands the development of its Skylink platform. Skylink leads the charge to move WebRTC, traditionally seen as a desktop, browser based technology, to become a ubiquitous web communications technology on web and mobile, as well as Internet of Things compatible devices.
SYS-CON Events announced today that robomq.io will exhibit at SYS-CON's @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. robomq.io is an interoperable and composable platform that connects any device to any application. It helps systems integrators and the solution providers build new and innovative products and service for industries requiring monitoring or intelligence from devices and sensors.
Docker is an excellent platform for organizations interested in running microservices. It offers portability and consistency between development and production environments, quick provisioning times, and a simple way to isolate services. In his session at DevOps Summit at 16th Cloud Expo, Shannon Williams, co-founder of Rancher Labs, will walk through these and other benefits of using Docker to run microservices, and provide an overview of RancherOS, a minimalist distribution of Linux designed expressly to run Docker. He will also discuss Rancher, an orchestration and service discovery platf...
Sonus Networks introduced the Sonus WebRTC Services Solution, a virtualized Web Real-Time Communications (WebRTC) offer, purpose-built for the Cloud. The WebRTC Services Solution provides signaling from WebRTC-to-WebRTC applications and interworking from WebRTC-to-Session Initiation Protocol (SIP), delivering advanced real-time communications capabilities on mobile applications and on websites, which are accessible via a browser.
SYS-CON Events announced today that Aria Systems, the leading innovator in recurring revenue, has been named “Bronze Sponsor” of SYS-CON's @ThingsExpo, which will take place on June 9–11, 2015, at the Javits Center in New York, NY. Proven by the world’s most demanding enterprises, including AAA NCNU, Constant Contact, Falck, Hootsuite, Pitney Bowes, Telekom Denmark, and VMware, Aria helps enterprises grow their recurring revenue businesses. With Aria’s end-to-end active monetization platform, global brands can get to market faster with a wider variety of products and services, while maximizin...
SYS-CON Events announced today that Vitria Technology, Inc. will exhibit at SYS-CON’s @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Vitria will showcase the company’s new IoT Analytics Platform through live demonstrations at booth #330. Vitria’s IoT Analytics Platform, fully integrated and powered by an operational intelligence engine, enables customers to rapidly build and operationalize advanced analytics to deliver timely business outcomes for use cases across the industrial, enterprise, and consumer segments.
SYS-CON Events announced today that Akana, formerly SOA Software, has been named “Bronze Sponsor” of SYS-CON's 16th International Cloud Expo® New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. Akana’s comprehensive suite of API Management, API Security, Integrated SOA Governance, and Cloud Integration solutions helps businesses accelerate digital transformation by securely extending their reach across multiple channels – mobile, cloud and Internet of Things. Akana enables enterprises to share data as APIs, connect and integrate applications, drive part...