Last night in Boston, the NVCA and Polaris Venture Partners kicked off the 2013 BIO conference by holding a panel discussion for investors, CEOs and journalists on the state of life sciences investing in the United States. Hosted by Mintz Levin, approximately 70 guests enjoyed some hearty New England clam chowder before sitting down to hear about “What Would Darwin Do? Adapting to an Evolving Life Sciences Sector.” Moderated by Bloomberg’s Shannon Pettypiece, the panel comprised six distinguished members of the life sciences ecosystem including:
Terry McGuire, Co-founder & General Partner, Polaris Venture Partners
Darren Carroll, Vice President, Corporate Business Development, Eli Lilly and Company
Patrick Verheyen, Vice President, New Ventures, Johnson & Johnson
Anna Protopapas, Executive VP, Global Business Development, Takeda Pharmaceuticals
Jesse Treu, Partner, Domain Associates
Jonathan Leff, Managing Director, Warburg Pincus
The discussion centered on the challenging environment for life sciences investment over the last several years and what it will take to ensure that the sector is able to emerge from the current down cycle effectively. There was general acknowledgement that the FDA approval process has been damaging to the investment environment but that there has been considerable progress in this area recently, including the FDA user fee bill poised to pass Congress in the coming days. The group also discussed the need to make a return for investors and the importance of fair and adequate reimbursement for new therapies and diagnostics. There was recognition that today innovators must not only produce better medicine but must also reduce healthcare costs. Most interesting was the overall agreement that the U.S. no longer has the guaranteed leadership position when it comes to life sciences innovation. Other countries are offering incentives to bring scientists and companies to their shores. It is imperative that U.S. policy makers avoid disincentives to investment and innovation or our country will surely fall behind others. One additional concern addressed by the panel was the potential for a gap in leadership at FDA if there is a change in the Administration.
While the challenges loomed large during the discussion, Terry McGuire was right to point out as the closing remark that the people innovating in the life sciences space (and their innovations) have never been better and there remains tremendous promise to bring new drugs and devices to market. We couldn’t agree more which is why we continue to advocate for public policies that allow investors to do just that.
|For the past two days, NVCA members have been in Washington, DC participating in the Department of Energy National Clean Energy Business Plan Competition. The competition is part of the White House's Startup America initiative to accelerate innovation and high-growth entrepreneurship. The six student-led teams had won regional competitions with the runners-up and finalists coming to Washington, DC to pitch venture capitalists on their business plan for $100,000 in prize money, as well as legal, technical and commercialization assistance.
NVCA Board Chairman Ray Rothrock gave an inspiring keynote address to the teams just before the winner was announced at the White House. As a veteran investor, Ray gave the students sage advice about risk taking and "doing big things" and that they shouldn't be daunted by failure as it is often a prelude to success. His words are sure to run through the minds of these students for years to come. NVCA Board Member Ray Leach of Jumpstart Also participated in a fireside chat with Robin Chase the co-founder of Zipcar and David Biello of the Scientific American.
Thirty new companies have been created around the country as a result of this competition. Several of these companies have won or applied for ARPA-E grants. The winner, NuMat Technologies from Northwestern University is commercializing a new nanomaterial that stores gases at lower pressure and has several promising applications.
Congratulations to all of the teams! Thank you to the many NVCA members that participated in the competition - ARCH Venture, Applied Ventures, Augment Ventures, Braemar Energy Ventures, Claremont Creek Ventures, EnerTech Capital, Jumpstart, Kleiner Perkins Caufield & Byers, Paladin Capital, Silicon Valley Bank and Venrock.
|As you have read here at NVCAccess, the Financial Accounting Foundation (FAF) recently approved the formation of a Private Company Council (PCC) which will be tasked with setting accounting standards for private companies. The PCC, which you can read about here, was formed in response to recommendations made by an FAF Blue Ribbon Panel upon which NVCA Board member Jason Mendelson participated. Subsequently, many NVCA members spoke up in support of the PCC formation.
The FAF is now seeking nominations for individuals to serve on the PCC. As they explain in their communications:
Members of the PCC will include users of private company financial statements, including bank lenders, equity investors, and/or sureties; preparers of private company financial statements from a variety of industries and companies of various sizes; and CPA practitioners from national, regional, and local firms.
The NVCA will be participating in the nomination process and encourage our members and all stakeholders of the start-up ecosystem to do the same. The nomination form can be found here. If you have questions, please contact me at Jstaylor@nvca.org. it is important that the venture capital and start-up communities are represented on this important process and standard setting body. We look forward to the work they will do an progress that will be made. The deadline for nominations is June 30, 2012.
|Yesterday, the Senate passed S. 3187, the FDA Safety and Innovation Act of 2012, by a vote of 96-1. Senator Sanders (D-VT) was the only no vote. The House is expected to vote on H.R. 5651, the FDA Reform Act of 201, next week. This bill is also expected to pass with few amendments. Both bills are similar and will raise $6.4 billion in user fees for the FDA over five years. House and Senate leaders have stated their goal is to finish and deliver a final package to the President before the July 4th Congress recess.
NVCA/MedIC believes that overall both bills are positive step forward in improving the FDA's regulatory process and include several of MedIC's priorities specifically:
- Expanding the accelerated approval process to new medical treatments;
- Providing a new pathway for breakthrough therapies;
- Providing incentives for antibiotic development;Improving the FDA's advisory committee conflict of interest rules;
- Clarifying the least burdensome standards for medical devices;
- Modifying the De Novo application process; and
- Accelerating the appeals process for medical devices.
NVCA/MedIC is also encouraged that S. 3187 includes a risk-benefit framework for the drug approval process that will provide a consistent and balanced approach to FDA's decision making regarding the benefit and risks of new drugs. However, we are continuing our efforts to include language in the bills that would define what variables should be considered within the structured framework and are asking for similar language for medical devices.
We will keep you apprised of all developments here at NVCAccess in the coming weeks.
Last Updated on Friday, 25 May 2012 10:52
Earlier today, the Financial Accounting Foundation voted to approve the establishment of a new body ―the Private Company Council (PCC)―to improve the standard-setting process for private companies.
Representatives from FAF and FASB have been reaching out and engaging with NVCA at a number of levels on this issue. Several NVCA board members were instrumental in our efforts to support the creation of the PCC. NVCA director Jason Mendelson of Foundry Group was invited and served on FAF's Blue Ribbon Panel which took a hard look at the state of private company accounting and determined that a different approach needed to be taken. Other board members active in the process include 2011-12 board chair Paul Maeder of Highland Capital Partners, Diana Frazier of FLAG Capital, Management, Mike Elliott of Noro-Moseley Partners, Trevor Loy of Flywheel Ventures, Stephen Holmes of InterWest Partners, and Anne Rockhold of Accel. More than a dozen members of the NVCA CFO Task Force were actively engaged in FAF and FASB efforts including James Stevenson of ABS Capital Partners, Mike Maher of USVP, and James Beck of Mayfield.
While there will be more complete information forthcoming next week, and the devil is often in the details, it appears that the venture capital and start-up communities have been heard and the changes we felt needed to be made to an already solid plan to establish the Council (issued for comment 10/2011) have been mostly made. These changes range from the "veto-proofness" and independence of the Council, to the importance of the PCC being chaired by someone other than FASB member.
We'll keep you apprised as the remaining details on the PCC come forward, and we have all had a chance to digest the plan in detail. For now, we are strongly encouraged by the formation of this entity and the promise it holds for private company accounting standards.
Last Updated on Wednesday, 23 May 2012 14:26