CHI CEO Provides Testimony on Capitol Hill

On June 2, CHI President and Chief Executive Officer David L. Gollaher, Ph.D., provided testimony to the House Oversight & Government Reform Subcommittee on Health Care's "Pathway to FDA Medical Device Approval: Is there a Better Way?" His statement and comments during aquestion-and-answer sessionwere based on the findings from CHI's recent report, produced with The Boston Consulting Group (BCG)"Competitiveness and Regulation: The FDA and the Future of America's Biomedical Industry."

"The FDA and its regulatory policies profoundly influence the current state and future strength of the medtech industry," said Gollaher. "But its regulatory processes have become unpredictable and slow, which, when combined with the impact of the Great Recession, the capital markets crisis, and more efficient regulatory processes in Europe, are having enormous and far-reaching effects on the American competitiveness."

The committee also heard from Rep. Erik Paulsen (R-Minn.); FDA Center for Devices and Radiological Health Director Dr. Jeffrey Shuren; Dr. Rita Redberg, professor of medicine and director of women's cardiovascular services in the division of cardiology at the University of California, San Francisco; and Jack Lasersohn, a general partner at The Vertical Group. Speakers discussed the importance of the medical device industry to the United States, focusing on improvements to patient care, job creation, and economic competitiveness. Gollaher highlighted challenges and opportunities faced by the medical technology sector, including uncertainty in regulatory pathways.

Click here to read the CHI press release.

Click here to read the CHI testimony.

Click here to listen to The Burrill Report podcast.

REGISTER NOW: Take This Pill and Tweet Me in the Morning, Aug. 4

Registration is now open for the Aug. 4 event "Take This Pill and Tweet me in the Morning: How Advances in Social Media and Mobile Health are Creating Consumer-Centric Healthcare." The event, which will take place at The Salk Institute in La Jolla, will bring together hundreds of leaders from California's biotechnology industry, academic research community, entrepreneurs, investors, healthcare providers, policy experts and patient advocates. New speakers have been added to the lineup, including: Matthew Holt, co-founder of Health 2.0; Douglas Trauner, CEO of TheCarrot.com; Ryan Sysko, CEO of WellDoc; Eric Olson, senior director of commercial regulatory affairs at Genentech; Derek Newell, former CEO of Health Hero Network, a unit of Bosch and maker of Health Buddy; Jon Linkous, CEO of American Telemedicine Assoc.; Eve Kurtin, senior advisor for Vantage Point Capital Partners; and Deven McGraw, director of the Health Privacy Project at the Center for Democracy and Technology.

Advances in social media and mobile health technologies are giving consumers more influence than ever over their health and healthcare. The pharmaceutical and life sciences industries have officially taken note, working to understand how consumer-centric healthcare will affect their markets, and considering how they can use social media and offer "mHealth" tools and services. But there are significant policy and economic questions associated with the transition to consumer-centric healthcare. These include:

• Regulatory oversight (How should mHealth tools and social media be regulated and who should regulate them)?
• Financial models (How can providers be reimbursed for use of mHealth tools?)
• Patient privacy and data security (Who owns the data generated by mHealth tools and how can privacy and security be ensured?)

For sponsorship opportunities, please contact Molly Ingraham, vice president of business development (Ingraham@chi.org or 858-456-8884).

Click here to register for the early-bird rate of $149 for CHI members. To reserve a hotel at the negotiated rate of $219 a night at the Estancia La Jolla Hotel & Spa, contact the hotel directly at (877) 437-8262 by Tuesday, July 5, and provide the CHI group name.

CHI is encouraging Twitter users to retweet our event information, with the bonus of receiving $25 off the event registration. Click here for details. We encourage you to use the CHI event hashtag #takethispill.

CHI and Hogan Lovells Host 'The FDA Drug Lag: Challenges and Opportunities' in San Mateo

CHI and Hogan Lovells convened a half-day program on the U.S. Food and Drug Administration (FDA) drug lag and the challenges and opportunities in working with the agency on new drug applications. Our guests heard from speakers including CHI's CEO David Gollaher, Ph.D.; Rick Winningham, chief executive officer of Theravance Inc.; Marcea Lloyd, senior vice president, government and corporate affairs and general counsel at Amylin Pharmaceuticals; Dr.  Beth Seidenberg, partner with Kleiner Perkins Caufield & Byers; Joseph T. Kennedy, vice president, general counsel and secretary for Transcept Pharmaceuticals, Dr.  Shelley Chu, Ph.D., principal of Frazier Healthdcare; and Hogan Lovells partners Robert Church, Kevin Clayton, David Fox and Lynn Mehler.

Click here to read the wrap-up on the CHI Blog.

CHI Participates in OCTANe's VC in the OC

On May 24, CHI traveled to Irvine, Calif. for OCTANe's Annual VC in the OC event. OCTANe is a networkingorganization for Orange County's biomedical and information technology industries, and CHI was an event partner. The event featured highlights of the OC Innovation Report, perspectives on healthcare investing and partnership strategies. Mark Stevens, partner with Sequoia Capital, described his vision for creating the USC Stevens Institute for Innovation during a keynote address.

Click here to read the wrap-up on the CHI Blog.

CHI Hosts Musculoskeletal Health Briefing on Capitol Hill
On May 24, CHI hosted an insightful briefing in Washington, D.C. highlighting the importance of therapeutic advancements and innovations in musculoskeletal disease and injuries. The program was held on Capitol Hill, and was attended by congressional staff, patient advocates, industry representatives and members of the press, among others. The assembled panel of experts addressed a variety of issues in the area of musculoskeletal conditions, providing an excellent awareness-raising overview and highlighting some of the successful research, technologies, and treatments being offered by CHI members.Panelists included: Dr. Said A. Ibrahim, MPH, professor of medicine and vice chair of the Department of Medicine at University of Pennsylvania School of Medicine; Dr. Deborah Kado, MS, associate professor in the Departments of Orthopedic Surgery and Medicine at Geffin School of Medicine at UCLA; Laetitia Cousin, vice president of regulatory and clinical affairs and quality assurance at NuVasive; and Scott Simonet, Ph.D., vice president of research at Amgen.

CHI would like to thank the speakers who made the trip to Washington, D.C., and for making the briefing a successful event. For more information on CHI's advocacy efforts in D.C., contact Caitlin Doyle (Doyle@chi.org or 202-974-6323).

Click here to read the wrap-up CHI Blog post authored by CHI fellow Brent Davidson.

CHI Blog Features Frank Ahmann, LoneStar Heart President and COO

In this week's edition of the CHI Blog, we speak with the president and chief operating officer of LoneStar Heart, a California and Texas-based medical device company that istesting new approaches to treating congestive heart failure. Frank Ahmann, a veteran of the biotech and medical device industries, says it will take a multi-pronged approach to getting heart cells to regenerate. LoneStar heart uses an implantable hydrogel, which acts to mechanically improve the heart, with small molecules or biologics licensed from the University of Texas.

Click here to read the CHI Blog.

CHI Welcomes Optivia Biotechnology

Located in the San Francisco Bay Area, Optivia Biotechnology is a private company that aspires to deliver the full potential of transporter biology in drug discovery and development. By leveraging its cutting-edge transporter biology platform, Optivia assists its clients and partners in developing safer and more efficacious small molecule drugs, and engages in discovery of new therapeutics for oncology and CNS diseases.

Yong Huang, Ph.D.

Founder, President and CEO

Huang, a life sciences entrepreneur and innovator, has nearly a decade of experience in moving novel ideas to the marketplace. Besides Optivia, he founded or contributed to four life sciences companies. Huang is the principal investigator for nearly $6 million in NIH grants and is the co-inventor and co-author of more than 30 patents and scientific articles. Huang received his bachelor's degree from Tsinghua University, China and his doctorate in bioengineering from University of California, Berkeley.

SPONSORSHIPS AVAILABLE: California Healthcare Policy Forum in San Francisco, Nov. 3

Sponsorships are now available for CHI's annual healthcare policy forum, "Shifting Sands: Forces Reshaping the Biomedical Innovation Business Model." The event, to be held in San Francisco at the Julia Morgan Ballroom at the Merchants Exchange, will bring together more than 200 of the leading executives from biotechnology, medical device and pharmaceutical companies as well as leaders from the state's academic research community with policy makers to discuss critical issues and opportunities facing the biomedical community. For sponsorship opportunities, please contact Molly Ingraham, vice president of business development (Ingraham@chi.org or 858-456-8884).

Innovation in Action

CHI has rounded up the latest news from our members. If your organization has news you want featured on our website and in our publications, contact our editor, Heather Chambers ( Chambers@chi.org or 858-456-8885).

A new iPhone application developed by CHI member ResMed could help users determine whether they suffer from sleep apnea, a condition affecting about 18 million Americans.
The Sleep Assess app allows users to record their nighttime breathing to pick up snoring, and pairs their responses to questions such as "Has anyone observed you stop breathing during your sleep?" with actual data on sleep apnea.

Scientists with CHI member Roche may have discovered a way aroundthe elusive blood-brain barrier by attaching engineered antibodies to receptors that typically transport iron to the brain. The early-stage approach could potentially open new pathways for attacking Alzheimer's disease,schizophrenia, Parkinson's and even autism.

CHI member Sanofi unveiled a new round of late-stage data this week demonstrating success in treating Type 2 diabetes patients using its experimental drug lixisenatide paired with basal insulin. Analysts hailed the study's results showing that the drug significantly lowered blood sugar levels and also led to weight loss in patients with Type 2 diabetes.

CHI EVENTS

Hill Briefing: CHI to Host Alzheimer's Disease Briefing on Capitol Hill, July 14

CHI and the Healthcare Institute of New Jersey will host an informational briefing on the importance of therapeutic advancements and innovations in Alzheimer's disease. The briefing will take place from 9:30 to 11 a.m. at the Capitol Visitor's Center, Congressional Meeting Room South. Congresswoman Linda Sanchez (D-Lakewood) will provide welcome remarks. According to a 2011 report released by the Alzheimer's Association, an estimated 5.4 million people are living with Alzheimer's disease, and someone develops the disease every 69 seconds. The United States, like many other countries, has an aging population with nearly one in five residents reaching the age of 65 or older by 2030. Additionally, in 2010, 14.9 million family members and friends provided 17 billion hours of unpaid care to those living with Alzheimer's and other dementias — care valued at approximately $202 billion. With the steady increase in dementia caused by Alzheimer's disease and other conditions — and without a cure — the development of new innovations and treatments remains all the more critical improving the quality of live for those affected. This program will include an overview of advances stemming from California and New Jersey's life science sectors, with a panel discussing current research and drug development, as well as future discoveries. Information on additional speakers will be provided at a later date. For more information on CHI's advocacy efforts, contact Caitlin Doyle (Doyle@chi.org or 202-974-6323).

SAVE THE DATE: CHI's Annual End-of-Year Reception, Dec. 8

Join CHI-California Healthcare Institute, legislators, staff and biomedical industry leaders for the Annual End of Year Reception at Sonoma Restaurant in Washington D.C. on Thursday, December 8. Sonoma Restaurant will be the venue for cocktails and conversation between public policy makers and California's biomedical opinion leaders. Come help us kick off the holiday season and celebrate 2011! For more information on CHI's Annual End of Year Reception, contact Caitlin Doyle ( doyle@chi.org or 202-974-6323) or Molly Ingraham (ingraham@chi.org or 858-456-8884). Sponsorship opportunitiesare available. For more information, contact Molly Ingraham, CHI vice president of business development (Ingraham@chi.org or 858-456-8884).

INDUSTRY EVENTS:

BARDA Industry Day: Contracting for Countermeasures, June 7-9

Join the Biomedical Advanced Research and Development Authority (BARDA) for its Industry Day: Contracting for Countermeasures. The event takes place June 7-9 at the San Diego Convention Center, 111 W. Harbor Drive, San Diego, Calif., 92101. BARDA, within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. BARDA manages Project BioShield, which includes the procurement and advanced development of medical countermeasures for chemical, biological, radiological, and nuclear agents, as well as the advanced development and procurement of medical countermeasures for pandemic influenza and other emerging infectious diseases that fall outside the auspices of Project BioShield. In addition, BARDA manages the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE). Click here to RSVP for the event.

17th MDMA Annual Meeting: Protecting the Future of Innovation, June 8

The 17th MDMA Annual Meeting, planned for June 8 in Washington D.C., will provide the definitive opportunity to learn how the United States can remain the global leader in med-tech innovation, and how we can all play a role in shaping the regulatory and legislative agendas. Attendees will hear from a diverse group of expert panelists on issues including the impact of healthcare reform, changes at the FDA, comparative effectiveness and more. Also get first-hand updates on the latest news and trends from leading med-tech CEOs, venture capitalists and government officials. For more information, including registration, click here.

Wilson Sonsini Goodrich & Rosati Medical Device Conference 2011, June 14

Come and see CHI's President and CEO, David Gollaher, Ph.D. speak on the panel "Are FDA Policies Affecting U.S. Competitiveness?" Tuesday, June 14, at the Wilson Sonsini Goodrich & Rosati Medical Device Conference 2011. This year's conference will focus on understanding the challenges facing Medtech start-up today, and the strategies that are emerging to respond to these challenges. In a series of topical panels presented over the course of a day, participants will hear from industry CEOs, venture capitalists, industry strategists, investment bankers and market analysts.

Click here for more information and to register.

SAVE THE DATE: AdvaMed 2011 - The Med Tech Conference, Sept. 26-28

AdvaMed 2011 brings together policymakers, experts and insiders for critical dialogues on subjects ranging from regulatory affairs and reimbursement to IP and business development. The event takes place Sept. 26 to 28 at the Walter E. Washington Convention Center, 801 Mount Vernon Place NW, in Washington, D.C. For more information, call 202-434-7213 or visit www.advamed2011.com.

SAVE THE DATE: 2011 Innovation Night at La Jolla Playhouse, Dec. 7

Innovation meets here. Now in its fourth, record-breaking year, Innovation Night at La Jolla Playhouse brings together leaders in the fields of life sciences, technology and communication and their associated service industries for the premier networking event of its kind. As a participant, your organization will have the opportunity to connect with over 400 key decision makers in these pioneering industries.

Click here for more information.

To submit your company's news or story ideas, please contact Heather Chambers at  Chambers@chi.org .

CHI represents more than 250 leading academic research, biotechnology, medical device and pharmaceutical organizations in California. CHI's mission is to advance responsible public policies that foster medical innovation and promote scientific discovery. Become a fan of CHI on  Facebook , join our  LinkedIn group, follow us on  Twitter and become a follower of CHI's  Blog .