Welcome!

Cognitive Computing Authors: Pat Romanski, Jason Bloomberg, Rajesh Ramchandani, Liz McMillan, Mehdi Daoudi

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
SYS-CON Events announced today that MobiDev, a client-oriented software development company, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. MobiDev is a software company that develops and delivers turn-key mobile apps, websites, web services, and complex softw...
The cloud market growth today is largely in public clouds. While there is a lot of spend in IT departments in virtualization, these aren’t yet translating into a true “cloud” experience within the enterprise. What is stopping the growth of the “private cloud” market? In his general session at 18th Cloud Expo, Nara Rajagopalan, CEO of Accelerite, explored the challenges in deploying, managing, and getting adoption for a private cloud within an enterprise. What are the key differences between wh...
"Tintri was started in 2008 with the express purpose of building a storage appliance that is ideal for virtualized environments. We support a lot of different hypervisor platforms from VMware to OpenStack to Hyper-V," explained Dan Florea, Director of Product Management at Tintri, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
The security needs of IoT environments require a strong, proven approach to maintain security, trust and privacy in their ecosystem. Assurance and protection of device identity, secure data encryption and authentication are the key security challenges organizations are trying to address when integrating IoT devices. This holds true for IoT applications in a wide range of industries, for example, healthcare, consumer devices, and manufacturing. In his session at @ThingsExpo, Lancen LaChance, vic...
WebRTC has had a real tough three or four years, and so have those working with it. Only a few short years ago, the development world were excited about WebRTC and proclaiming how awesome it was. You might have played with the technology a couple of years ago, only to find the extra infrastructure requirements were painful to implement and poorly documented. This probably left a bitter taste in your mouth, especially when things went wrong.
Big Data, cloud, analytics, contextual information, wearable tech, sensors, mobility, and WebRTC: together, these advances have created a perfect storm of technologies that are disrupting and transforming classic communications models and ecosystems. In his session at @ThingsExpo, Erik Perotti, Senior Manager of New Ventures on Plantronics’ Innovation team, provided an overview of this technological shift, including associated business and consumer communications impacts, and opportunities it m...
You have great SaaS business app ideas. You want to turn your idea quickly into a functional and engaging proof of concept. You need to be able to modify it to meet customers' needs, and you need to deliver a complete and secure SaaS application. How could you achieve all the above and yet avoid unforeseen IT requirements that add unnecessary cost and complexity? You also want your app to be responsive in any device at any time. In his session at 19th Cloud Expo, Mark Allen, General Manager of...
WebRTC is bringing significant change to the communications landscape that will bridge the worlds of web and telephony, making the Internet the new standard for communications. Cloud9 took the road less traveled and used WebRTC to create a downloadable enterprise-grade communications platform that is changing the communication dynamic in the financial sector. In his session at @ThingsExpo, Leo Papadopoulos, CTO of Cloud9, discussed the importance of WebRTC and how it enables companies to focus o...
Big Data engines are powering a lot of service businesses right now. Data is collected from users from wearable technologies, web behaviors, purchase behavior as well as several arbitrary data points we’d never think of. The demand for faster and bigger engines to crunch and serve up the data to services is growing exponentially. You see a LOT of correlation between “Cloud” and “Big Data” but on Big Data and “Hybrid,” where hybrid hosting is the sanest approach to the Big Data Infrastructure pro...
In his General Session at 16th Cloud Expo, David Shacochis, host of The Hybrid IT Files podcast and Vice President at CenturyLink, investigated three key trends of the “gigabit economy" though the story of a Fortune 500 communications company in transformation. Narrating how multi-modal hybrid IT, service automation, and agile delivery all intersect, he will cover the role of storytelling and empathy in achieving strategic alignment between the enterprise and its information technology.
Buzzword alert: Microservices and IoT at a DevOps conference? What could possibly go wrong? In this Power Panel at DevOps Summit, moderated by Jason Bloomberg, the leading expert on architecting agility for the enterprise and president of Intellyx, panelists peeled away the buzz and discuss the important architectural principles behind implementing IoT solutions for the enterprise. As remote IoT devices and sensors become increasingly intelligent, they become part of our distributed cloud enviro...
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
"LinearHub provides smart video conferencing, which is the Roundee service, and we archive all the video conferences and we also provide the transcript," stated Sunghyuk Kim, CEO of LinearHub, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Things are changing so quickly in IoT that it would take a wizard to predict which ecosystem will gain the most traction. In order for IoT to reach its potential, smart devices must be able to work together. Today, there are a slew of interoperability standards being promoted by big names to make this happen: HomeKit, Brillo and Alljoyn. In his session at @ThingsExpo, Adam Justice, vice president and general manager of Grid Connect, will review what happens when smart devices don’t work togethe...
"There's a growing demand from users for things to be faster. When you think about all the transactions or interactions users will have with your product and everything that is between those transactions and interactions - what drives us at Catchpoint Systems is the idea to measure that and to analyze it," explained Leo Vasiliou, Director of Web Performance Engineering at Catchpoint Systems, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York Ci...
The 20th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held June 6-8, 2017, at the Javits Center in New York City, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Containers, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportunity. Submit your speaking proposal ...
Discover top technologies and tools all under one roof at April 24–28, 2017, at the Westin San Diego in San Diego, CA. Explore the Mobile Dev + Test and IoT Dev + Test Expo and enjoy all of these unique opportunities: The latest solutions, technologies, and tools in mobile or IoT software development and testing. Meet one-on-one with representatives from some of today's most innovative organizations
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
SYS-CON Events announced today that Super Micro Computer, Inc., a global leader in Embedded and IoT solutions, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 7-9, 2017, at the Javits Center in New York City, NY. Supermicro (NASDAQ: SMCI), the leading innovator in high-performance, high-efficiency server technology, is a premier provider of advanced server Building Block Solutions® for Data Center, Cloud Computing, Enterprise IT, Hadoop/Big Data, HPC and E...
SYS-CON Events announced today that Linux Academy, the foremost online Linux and cloud training platform and community, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Linux Academy was founded on the belief that providing high-quality, in-depth training should be available at an affordable price. Industry leaders in quality training, provided services, and student certification passes, its goal is to c...