San Diego Life Sciences Company Tackles Debilitating Disorder
Imagine not being able to always control the movements of your body. Not being able to control your hand or foot movements. Imagine smacking your lips and blinking excessively or not being able to control your tongue. Would this impact your social interactions? Your work? Your relationships? Your self-confidence? These uncontrollable symptoms are experienced daily by approximately 500,000 Americans living with a movement disorder called Tardive Dyskinesia, or TD.
For people living with TD, the effects can be disruptive to normal every day function, socially isolating and potentially disabling. TD movements are often persistent and are usually irreversible. TD occurs in a portion of people treated with medications that block dopamine receptors in the brain, such as antipsychotics.
In people living with TD, these treatments are thought to have resulted in excessive dopamine signaling in the region of the brain that controls movement. Thus, TD most frequently occurs in people living with mental illnesses such as schizophrenia, bipolar disorder or major depressive disorder, and can add to the stigma of having a mental health condition. Some patients have admitted that TD makes them feel marginalized, like there is a barrier between them and the outside world. There are currently no FDA approved treatments indicated for TD.
Neurocrine Biosciences, a San Diego based company, has been focused on researching hard to treat neurologic, psychiatric and endocrine conditions that afflict highly underserved patient populations since its founding in 1992. Over the past 25 years, it has invested nearly $2.5 billion in drug research and development and has spent the last 10 years developing a drug specifically to treat TD. Neurocrine’s lead drug candidate, valbenazine, has received Breakthrough Therapy Designation and the product is currently under review by the FDA.
The company hopes that through its efforts, it can help bring conditions like TD to the forefront for discussion, advancement, and progress. Neurocrine hopes to encourage conversations about tardive dyskinesia and ensure that patients, their family, their caregivers and physicians are armed with the information and support they need.
CLSA Welcomes New Members and Explores Proposed Budget Cuts to NIH Funding
President & CEO
CLSA – California Life Sciences Association
March 23, 2017
Welcoming New Members
Please join me in welcoming the 18 new CLSA members who joined us in the last month: Aline, Ambryx Inc., GraphWear Technologies Inc., Henlix Inc., Inflammatix Inc., Innocart Inc., Innovation Properties Group Inc., Leerink Partners, Maverick Therapeutics Inc., MEI Pharma, Resilience Industries Inc., Sandhill Crane Diagnostics, Sharps Solutions, Skyline College, SYD Labs Inc., Tonix Pharmaceuticals, VitroLabs Inc., and X-Therma Inc. Our membership portfolio grows ever more robust with the addition of these organizations which add significantly to the expertise and resources available in the CLSA network.
Proposed Budget Cuts to NIH Funding Risk California Leadership in Life Sciences Research and Innovation
On March 16, the President released his budget blueprint for fiscal year (FY) 2018, which proposes deep cuts in funding for federal research at the NIH as well as an increase in FDA user fees. We have deep concerns with the President’s proposed $6 billion cut to the NIH budget, which would have a chilling effect on lifesaving R&D to improve patient care. CLSA and our broad membership will continue to work with our California congressional delegation to guard against these harmful cuts.
I also had the opportunity to speak out on the proposed cuts and what they would mean for California’s life sciences sector in the San Diego Union-Tribune and the San Diego Business Journal. Read our full statement on the cuts here and learn more about the budget blueprint here.
Join CLSA in the California Pavilion during BIO 2017
June 19-22in San Diego
Looking for a way to reach the thousands of leading biotech and pharma companies, CROs and CMOs, key academic institutions, major research labs, government agencies, consultants, and service companies who will be attending the BIO International Convention in San Diego this June? Space is still available in the California Pavilion, an important resource for convention attendees and your opportunity to make contacts and create relationships. Contact CLSA for more information.
CLSA Welcomes Two New Additions
Please join me in welcoming two fantastic new additions to the CLSA team:
Joe Pellegrino joins us from VWR as the new Director of Business Development, Northern California, where he has worked extensively with customers in biotech, pharma, med device, semiconductor, industrial, and education. Welcome to CLSA, Joe!
Julie Harness is CLSI’s new Associate Director, Innovation Services, where she will assist with the operation of CLSI’s growing FAST and CARB-X programs. Julie received her B.A. in Psychology, Biological Sciences from San Jose State University, and her Ph.D., Interdepartmental Neuroscience Program (INP) from UC Irvine. She joins CLSI from Precision for Medicine, and was founder and CEO of Cybelle Biosciences, where she created a drug discovery platform for Huntington’s Disease. Welcome to CLSA, Julie!
President & CEO
California Life Sciences Association
PS – Have newsworthy items to submit for consideration for our monthly CLSA Bulletin? Feel free to send those tips to Bianca Leveriza, CLSA’s Associate, Marketing & Events (BLeveriza@CALifeSciences.org).
President Proposes Concerning Cuts to NIH, FDA in FY18 Budget Blueprint
March 20, 2017
On March 16, President Donald Trump released his budget blueprint for fiscal year (FY) 2018. The budget blueprint is high-level and doesn’t include detailed line-by-line specifics, and only covers discretionary, not mandatory spending. Greater detail will be offered later this spring when the Administration publishes its full budget request, including mandatory spending (including programs like Medicare and Social Security) and tax proposals, likely in May.
Notably, the blueprint released last week proposes deep cuts in funding for federal research at the National Institutes of Health (NIH), a proposal that stands in contrast to the bipartisan sentiment expressed by Congress last fall with enactment of the 21st Century Cures Act which reaffirmed the importance of federally-supported basic, clinical and translational research, and established a mechanism for significant increases to the NIH budget over several years. CLSA is strongly opposed to this (and any) proposal to cut funding for NIH.
CLSA released a statement expressing strong concerns with the proposal to cut NIH funding, available here, and CLSA President and CEO Sara Radcliffe was quoted in articles in the San Diego Union-Tribune and San Diego Business Journal on this issue.
Further, the budget blueprint proposes to cut federal funding to the U.S. Food and Drug Administration (FDA), with an increase in user fees. The proposal is short on details, but on its face, appears inconsistent with the pending user fee agreements that were carefully and recently negotiated between industry and the agency (under the previous administration).
The FDA’s current authority to collect user fees expires at the end of this fiscal year, and needs to be reauthorized swiftly for FDA to continue to rely on user fees to support its critical product review activities. CLSA is aligned with our national association partners and supportive of preserving the commitments reflected in the carefully negotiated user fee agreements, and ensuring that these vital programs are reauthorized in a timely manner.
While the President’s budget blueprint serves as an important statement of the Administration’s priorities for the coming fiscal year, it’s important to remember that the budget request is a non-binding document and Congress has the final say on how much and to which programs and activities federal funding will be allocated. In fact, Speaker of the House of Representatives, Paul Ryan (R-Wisc.), said that the president’s spending blueprint is just the beginning of a “very long, multi-stage progress of budgeting.” Specifically, on the question of NIH funding, Speaker Ryan said, “We just passed the [21st Century] Cures Act, just this last December, to increase spending in the NIH, because we really think we’re kind of getting close to some breakthrough discoveries on cancer and other diseases… in Congress you’ll see probably some changes.”
Nonetheless, the budget request provides a framework for discussion of our nation’s funding priorities.
Below is a summary analysis of the president’s budget blueprint’s provisions of importance to the biomedical and life sciences sectors. Questions? Please contact Jenny Carey, CLSA’s Vice President of Federal Government Relations and Alliance Development (firstname.lastname@example.org).
President Trump’s FY 2018 “Budget Blueprint” Highlights
On March 16, 2017, President Donald Trump released his “Budget Blueprint” for fiscal year (FY) 2018. Several of the budget’s many provisions of importance to the biomedical and life sciences sectors are detailed below.
Department of Health & Human Services: The blueprint proposes a total of $69 billion for the Department of Health and Human Services in FY18, representing an overall $15.1 billion (17.9%) decrease from the FY17 enacted level.
- “Reforms key public health, emergency preparedness, and prevention programs. For example, the Budget restructures similar HHS preparedness grants to reduce overlap and administrative costs and directs resources to States with the greatest need.”
- “Reforms the Centers for Disease Control and Prevention through a new $500 million block grant to increase State flexibility and focus on the leading public health challenges specific to each State.”
- Increases opioid misuse prevention efforts by $500 million.
- Eliminates $403 million in health professions and nursing training program, noting that such programs “lack evidence that they significantly improve the Nation’s health workforce.”
NIH: Reduces overall funding from $32 billion in FY17 to $25.9 billion in FY18 (a $6.1 billion reduction).
- Proposes “a major reorganization of NIH’s Institutions and Centers to help focus resources on the highest priority research and training activities.” This includes eliminating the Fogarty International Center, which seeks to promote international medical research & collaboration.
- Consolidates the Agency for Healthcare Research and Quality (AHRQ) under NIH’s umbrella.
- Overall, the Budget “reduces administrative costs and rebalance[s] Federal contributions to research funding.”
FDA: The blueprint doesn’t specify a topline number for FDA.
- FDA medical product user fees will be increased “to over $2 billion in 2018, approximately $1 billion over the 2017 annualized CR level.”
- Without detailed budget tables, actual cuts/increases are difficult to ascertain. An analysis by CQ notes that FDA received approximately $1.96 billion in user fees in FY2016, $1.36 billion of which came from the non-tobacco drug and device divisions. A statement from the Alliance for a Stronger FDA notes that the budget proposal is “cutting more than a third of the agency’s appropriation and offsetting it with an enormous increase in medical product industry user fees.”
- The blueprint also states: “To complement the increase in medical product user fees, the Budget includes a package of administrative actions designed to achieve regulatory efficiency and speed the development of safe and effective medical products. In a constrained budget environment, industries that benefit from FDA’s approval can and should pay for their share.”
Read the full FY18 budget blueprint here.
Senator Hernandez Back with Legislation on Drug Price Reporting
March 18, 2017
Last August, State Senator Ed Hernandez (D-Asuza) pulled his drug price reporting legislation — Senate Bill (SB) 1010 — after the bill was amended in the Assembly Appropriations Committee. On March 15, he introduced SB 17, which is a somewhat modified version of last year’s bill.
At the press conference introducing SB 17, Hernandez, the chairman of the Senate Health Committee, was joined by Assemblyman David Chiu (D-San Francisco), billionaire activist Tom Steyer, and others, including representatives of Kaiser Permanente and the Pacific Business Group on Health. Comments at the press conference blamed the pharmaceutical industry for increases in health insurance costs and asserted more reporting from manufacturers would lead to lower drug prices.
The bill would require, among many other things, manufacturers of prescription drugs to submit a 90-day advance notice of a price increase to all California public agency purchasers, health insurers, and pharmacy benefit managers (PBMs) where that increase would mean the wholesale acquisition cost (WAC) has exceeded 25 percent over the previous three calendar years. For specialty drugs, the price increase threshold is only 10 percent.
This notice must also “include a statement of any changes or improvements to the clinical efficacy of the drug that explain the increase in [WAC].”
On the effective date of the increase, a host of information must be submitted to the state, including an explanation of “specific financial and nonfinancial factors used to the make the decision to increase [WAC],” the previous year’s marketing budget, any acquisition costs, the previous year’s sales volume, and any “documentation of increased clinical efficacy.”
For new specialty drugs, as defined under Medicare Part D, a manufacturer must notify the state three days before commercial availability regardless of FDA approval status. Within 30 days of this notice, the manufacturer must also submit a “description of the marketing and pricing plans” for the drug, the estimated number of patients to be prescribed the drug, the expected marketing budget, any acquisition costs related to the drug, and any documentation “showing increased efficacy of the drug compared to existing treatments.”
Finally, all the aforementioned information, for both new drugs and existing drugs with price increases, must be posted publicly on the internet by the state in a manner that allows identification of the information on an individual drug basis.
Unlike last year, Sen. Hernandez has not held any stakeholder workgroups or reached out to CLSA and others for input prior to introduction of the bill. We anticipate the bill being heard in the Senate Health Committee in mid-to-late April. Questions? Please contact Brett Johnson, CLSA’s Sr. Director, Policy & Regulatory Affairs (email@example.com).
Gottlieb Nominated for FDA Commissioner; Senate Confirms Verma to Lead CMS
March 19, 2017
Leadership of key federal departments and agencies with oversight of issues of importance to California’s life sciences sector continue to take shape under the new Trump Administration with the recent confirmation of Ms. Seema Verma as head of the Centers for Medicare and Medicaid Services (CMS), and with the nomination of Dr. Scott Gottlieb to lead the Food and Drug Administration (FDA).
Verma Confirmed as CMS Administrator
On March 13, by a vote of 55 to 43, the U.S. Senate confirmed Verma as Administrator of the Centers for Medicare and Medicaid Services. Administrator Verma, who previously served as founder and CEO of SVC, Inc., a health policy consulting firm, has extensive experience in the Medicaid space having worked closely with former Indiana Governor Mitch Daniels (R) and Vice President Mike Pence on the “Healthy Indiana” insurance coverage reforms and Medicaid expansion. In addition, Verma was involved in Iowa’s move to enact Medicaid managed care and helped craft Kentucky Governor Matt Bevin’s (R) Medicaid expansion waiver. Verma is the first CMS administrator to gain Senate confirmation since Marilyn Tavenner in May 2013. Tavenner served in the role for approximately two years and was replaced by Andy Slavitt, who held the position on an acting basis until the end of the Obama administration.
Gottlieb Nominated to lead FDA
On March 10, the President announced his intention to nominate Scott Gottlieb to be commissioner of the FDA.
Dr. Gottlieb was FDA’s deputy commissioner for medical and scientific affairs from 2005 to 2007, and chief policy adviser to the CMS administrator in 2004, during implementation of Medicare Part D. Earlier he was a senior adviser and director of medical policy development at FDA, where he worked on issues like orphan drugs, and combination products. Gottlieb has long been a resident fellow at the right-leaning American Enterprise Institute. He also serves on the Federal Health IT Policy Committee, which makes recommendations to HHS’s Office for Healthcare Information Technology, and practices medicine at New York University where he is also a clinical assistant professor. His confirmation hearing has not yet been scheduled.
Questions? Please contact Jenny Carey, CLSA’s Vice President of Federal Government Relations and Alliance Development (firstname.lastname@example.org).
Assemblymember Wood Moves Forward on Effort to Ban Copay Coupons
March 18, 2017
Asm. Jim Wood (D-Healdsburg), Chair of the Assembly Health Committee, is preparing Assembly Bill (AB) 265 to be heard in his committee at some time in the next month.
The bill would prohibit a drug manufacturer from offering in California “any discount, rebate, product voucher, or other reduction in an individual’s out-of-pocket expenses, including, but not limited to, a copayment or deductible” if a lower cost and therapeutically equivalent brand or generic drug is “available.”
CLSA has taken an oppose position on the bill due to its potential negative impact on patients for whom a prescriber has determined a certain brand medicine is necessary, among other reasons. We anticipate significant amendments to the bill prior to its hearing in Assembly Health Committee.
Northern California Continues Quest for Local Take-Back Ordinances
March 16, 2017
While the County of Los Angeles in Southern California deliberates over take-back legislation, the number of Counties in Northern California to pass take-back ordinances continues to grow.
Northern California Counties have led the way in pursuing take-back legislation in California. Seven Bay Area Counties (San Francisco, Alameda, San Mateo, Santa Clara, Santa Cruz, Marin, and Contra Costa) have all passed some form of take-back legislation. A potential eighth, Sonoma in the North Bay, is pushing hard to join them with plans to have a draft ordinance before their Board of Supervisors in early summer.
Sonoma’s County Board of Supervisors held a study session in late 2016 and directed staff to begin drafting drug take-back legislation while simultaneously conducting community research on the possible inclusion of sharps. Throughout 2017, County staff have pursued an ordinance methodically through conducting individual study sessions at each of the City Councils and other local government agencies within the County’s borders. These hearings serve to promote extended producer responsibility (EPR) throughout the County and to get localized feedback. Should the County pass an ordinance this summer it would cover the unincorporated areas of the County. County staff would then return to each of the Cities to push for localized ordinances that would cover their individual City jurisdictions and work collaboratively with the County’s language.
Much further north, rural Tehama County sits over two hours north of Sacramento with a population of only 63,000 residents. Tehama is the first County outside of the heavily populated areas along the Pacific Coast to study these issues publicly. County staff have held several study sessions in 2017 where they have been joined by Executive Director Heidi Sanborn of the pro-take-back California Product Stewardship Council. A local City Manager in the City of Corning in Tehama County serves as a member of their statewide Board of Directors and has been key to the rural push.
Sonoma and Tehama County will conduct further public meetings on their way to drafting legislation for their respective County Board of Supervisors in the coming months.
CLSA continues to be at the forefront of such local activities and speak on their impact of the industry. Questions? Please contact Reese Isbell, CLSA’s Director of Local Government and Community Relations at email@example.com.
Beyond Compliance: Device Firm Reaps Benefits from Project Leadership
When a global medical device manufacturer faced a tight turnaround for new FDA labeling compliance, it turned to professional project management to get them through. The thoughtful planning and communication not only helped the company beat the compliance deadline, but also broke down divisional barriers, created processes to meet upcoming compliance requirements, and evolved technology for future growth.
It began in 2012, when the FDA required all medical devices distributed in the U.S. to have a unique device identifier (UDI) code. This meant the company had to relabel four Class II pumps and 500 different accessories, such as tubing and IV sets, manufactured at three different global plants. The company also had to submit product information for each device to the FDA’s Global Unique Device Identification Database (GUDID).
Realizing the complexity of the project, the company hired Integrated Project Management Co. (IPM) to oversee the project and provide recommendations for future growth.
IPM developed a plan for how to approach the UDI transition, which required all products to comply simultaneously. Because this meant defining and coordinating efforts across multiple workstreams, a multi-site, team-based approach was required.
IPM visited three manufacturing plants and met with stakeholders at each location to help prepare the team for the work ahead. The plants also needed to replace a 20-year-old production line and packaging systems at 21 work stations with systems that could interface with the new SAP systems and databases required to drive label printing—a $20 million capital expense.
One plant had already developed a solution based on manufacturing products individually by serial number and barcodes. Borrowing and enhancing this concept would enable the two device manufacturing plants to meet UDI packaging and labeling requirements and eventually transition to a serial number-based method to meet future FDA requirements for product traceability. IPM and the company team decided to use this solution for pharma, pumps and accessories—an approach that reduced equipment costs in some cases by as much as 20 percent.
IPM also helped implement an adaptable system with the capability to print labels in real time via on-demand printing, which will help the company streamline its manufacturing processes.
The medical device manufacturer began printing the new labels in July 2016, and by July 31 was fully compliant with FDA requirements—two months ahead of deadline.
IPM had worked closely with the company’s management team on the transition and provided them with a guidebook for staying on track with future FDA and global requirements. After being embedded in the company’s team for more than three years, the lead IPM consultant was honored by his coworkers with a commemorative plaque recognizing his dedication to the team.
The project sponsor stated that the real benefit delivered by IPM was the ability to keep the company’s best interests front and center. Before the UDI project, few of the company’s projects came in on time. By project completion, techniques for project scoping, planning, communication, and execution were being used across the organization.
To read more about UDI compliance, visit http://www.ipmcinc.com/insights/beyond-compliance-device-firm-reaps-benefits-from-project-leadership
Chempetitive Group Rebrands as CG Life
Fast-growing Marketing and PR Firm Evolves Brand to Better Reflect Agency Culture, Focus on Converging Healthcare and Life Science Markets
CHICAGO & SAN DIEGO & BOSTON–(BUSINESS WIRE)–Chempetitive Group, an integrated marketing communications agency focused on life science and healthcare, has unveiled a new brand and name. The new name CG Life, and new tagline Do what matters, better communicate the energy that the agency brings to its work, relationships and the market. The change also more clearly reflects a broadening focus on guiding organizations to healthy growth at the intersection of the life sciences and healthcare markets.
CG Life has reimagined its logo – a visual identity that matches the bold, fun and curious culture of the agency and its people. The new design and campaign serve as a rallying cry for the agency’s team of highly experienced marketers and former scientists working in a deeply collaborative environment to advance science and healthcare as well as to create, learn, grow, play and improve their understanding of life.
OCTANe Announces Inaugural Report Detailing Impact On Orange County’s Tech Ecosystem
OCTANe, Orange County’s life sciences and technology accelerator organization, today announced the release of its inaugural OCTANe Impact Report, a comprehensive paper detailing the current state of Orange County’s tech and med-tech environment. The report includes OCTANe’s insights for spurring economic growth in the region while providing a comprehensive look at its progressive service portfolio.
“The tech and med-tech ecosystems in Southern California are growing at an astonishing rate – faster than most people realize,” said OCTANe CEO, Bill Carpou. “The future is bright for the region and OCTANe’s programs will continue to play a pivotal role in helping early-stage companies succeed.”
As part of the report, OCTANe’s announced its commitment to long-term job creation in Orange County and has pledged to help create a total of 22,000 jobs by 2025. To date, OCTANe’s LaunchPad Small Business Development Center (LaunchPad SBDC) has assisted nearly 1,500 companies by using the power of data, predictive analytics and human interaction to help attract capital. The program is the leading SBDC in the nation. Of the companies OCTANe has worked with, 321 graduated through the entire LaunchPad process and 236 received funding.