A panel of health reform experts at NCBIO’s Annual Meeting told members that pending federal legislation will likely raise the competitive bar for life science companies and require companies to focus on products that reduce cost and add value to patients and providers. The panel was a centerpiece of the Organization’s annual gathering of members September 29th at the North Carolina Biotechnology Center.
 Sponsors Representatives:
Michael Constantino, Ken Eheman, Alan Jones & David Chapin
Dr. Kevin Schulman, Director of Health Sector Management and Center for Study of Health Management at the Duke University Fuqua School of Business said, “With Medicare and other plans pushing for the use of generics, real innovation or something at the orphan drug or genomic level will be the areas of focus rather than finding a drug that would be s substitute for something already on the market.” Schulman also said that current reform legislation is likely to fall short in holding down future health care costs.
 Speakers: Chris Badgley, Gary Salamido & Dr. Kevin Schulman
Another panelist, Chris Badgley, Senior Vice President of Government and Public Affairs for PhRMA, told the audience that the focus of the ongoing national debate is shifting from reform of the nation’s health care system to reform of health insurance. Badgley predicted some form of the legislation proposed by US Senator Max Baucus (D-Montana) would pass Congress this year. He also said that reform legislation would likely include language establishing a new approval pathway for biosimilars with a twelve-year data exclusivity period for innovator biologics.
Badgley and Schulman were part of the NCBIO panel on “Health Care Reform: Potential Implications for the Life Science Industry.” Garry O’Grady, Senior Vice President and General Manager of the Pharmaceutical Institute moderated the panel and gave an overview of the proposal pending before the US House and the US Senate.
The panel’s third member, Gary Salamido Executive Manager of State Government Affairs for GlaxoSmithKline, pointed out that health reform changes – especially changes to Medicaid – will likely hold significant implications for state governments, including significant increases in overall cost. He noted that any such increases would be particularly challenging given the current budget deficits that facing many states.
Participants and sponsors of the event found the session informative. "Health Care Reform will touch all of us in different ways, but we are encouraged that it appears the various proposals should not significantly negatively impact the opportunity for innovative biotech and life science companies focused on serving unmet medical needs,” said Ken Eheman of Wyrick Robbins Yates and Ponton LLP.
"From our work at Forma Life Science Marketing, we know the potential impact that health care reform will have on many sectors of the life science industry,” said David Chapin of Forma, another sponsor of the meeting. “Through hard work on Capitol Hill and here in North Carolina, NCBIO is once again helping to shape the near and long term future of the life sciences in our state,” Chapin continued.
More than 120 people participated in the forum and the Annual Meeting. "North Carolina's life science industry continues to grow as evidenced by the turnout for the NCBIO event," stated Alan Jones of CRB. "Our company sees indications every day of the interest in North Carolina as a location for companies. Involvement in issues like health care reform are extremely important for the future direction of the industry."
“The Annual Meeting is just one of the activities NCBIO has hosted this year to provide information and services for our members,” NCBIO President Sam Taylor told participants in his report to the membership. Taylor reviewed advocacy efforts at the state and national level this year and discussed preliminary policy proposals for the 2010 General Assembly.
NCBIO thanks Gold Level sponsors for the event CRB, Forma Life Science Marketing and Wyrick Robbins Yates and Ponton, LLC; and Bronze Level sponsor Ernst & Young.
Dr. Robert Schotzinger, President and CEO of Viamet Pharmaceuticals, is the new Chairman of the NCBIO Board of Directors. Dr. Schotzinger was elected at a Board meeting following the NCBIO Annual Meeting held on September 29th.
"I look forward to working with the NCBIO Board, members and staff to help continue North Carolina’s leadership in the life science industry,” stated Dr. Schotzinger. “Having already served on NCBIO’s Executive Committee, I am well acquainted with the broad efforts that NCBIO has undertaken to improve the climate for our industry, and I want to ensure those efforts continue."
Schotzinger replaces Eric Ward of CropSolution, who has served as Chairman for the past two years. Sam Taylor, who will continue to serve as President of NCBIO, thanked Mr. Ward for his leadership. “Eric has provided strong guidance on a number of issues, particularly related to agricultural biotechnology and capital formation issues, and we appreciate his service.” Ken Lee of Hatteras Venture Partners was re-elected Vice-Chairman of the Organization, and Tim Gupton of Hughes Pittman & Gupton LLP was re-elected Treasurer.
Other members elected to the Executive Committee are Esther Alegria (Biogen Idec), Peyton Anderson (Affinergy), Chris Capel (Smith Anderson), Ed Field (Aldagen), Susan Thomason (Quintiles Transnational Corporation) and Eric Ward (CropSolution).
Fourteen individuals were elected to the NCBIO Board of Directors at the Annual Meeting September 29th. “The Board members represent a diverse group of life science companies and service sectors that work within the industry,” stated Sam Taylor, NCBIO President.
Those selected include; Karen Albritton (CapStrat), Esther Alegria (Biogen Idec), Peyton Anderson (Affinergy), Lou Arp (Eisai), Dennis Burns (TCG), Chris Capel (Smith Anderson), Terry Costello (Yonkers Industries), Ed Field (Aldagen), Mike Luther (David H. Murdock Research Institute), Adam Monroe (Novozymes), Alan Musso (Targacept), Crawford Pounds (PricewaterhouseCoopers), Tom Staab (Inspire Pharmaceuticals), and Eric Ward (CropSolution).
Other current members of the Board are; Jonathan Bryant (BASF Plant Science), Jeff Collins (Pappas Ventures), Charles Goldstein (BD Technologies), Tim Gupton (Hugh Pittman & Gupton LLP), Matt Jennings, Ken Lee (Hatteras Venture Partners), David Miller (GlaxoSmithKline), Russ Read (National Center Biotechnology Workforce - Forsyth Tech Community College), John Russell (K&L Gates), Robert Schotzinger (Viamet Pharmaceuticals), Susan Thomason (Quintiles Transnational Corporation), Norris Tolson (NC Biotechnology Center), Jan Turek (Biolex Therapeutics), and Mark Weedon (BWA Consulting).
 The North Carolina Board of Science and Technology is considering proposed amendments to the guidelines for the One North Carolina Small Business Fund’s Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Phase I Incentive and Matching Fund Programs. The proposed changes are due to the reduction in state funding for the programs.
The Programs currently funds applications on a first-come, first-served basis. The Board is considering changes that will apply a stochastic (i.e., statistical probability) process for selecting a pre-defined number of awardees from the pool of applicants. The process would give all applicants during a single solicitation period an equal chance of receiving a Program award. According to John Hardin, Executive Director of the Board, the new method is commonly used to in situations where scarce resources must be allocated and there are no undisputable grounds for giving preference to a particular individual or group.
Click here to see proposed changes to the Program. The Board will accept oral and written comments on the proposed amendments until October 22. Interested persons should contact John Hardin via e-mail or phone at 919-715-0516.
To continue the State life science industry’s record-setting growth rate, the North Carolina Biotechnology Center, with the help of statewide partners, is building an addition to its Research Triangle Park headquarters.
Construction on the $10.4 million addition, planned for several years, was kick-started with a $1 million gift from the Biogen Idec Foundation’s Transformational Grants in Science Education initiative. The Biogen Idec Foundation grant will support the expansion of the Center’s educational training facility for K-12 science teachers.
“We are delighted to make this major grant to the North Carolina Biotechnology Center, which has played such a leading role in educating the workforce in North Carolina,” stated Craig Schneier, Ph.D., Chair of the Foundation and Biogen Idec’s Executive Vice President of Human Resources, Public Affairs and Communications.
Norris Tolson, President and CEO of the NC Biotechnology Center, commented, “The Biogen Idec Foundation has shown the strategic thinking and bold action that define leaders. Their generous contribution will help extend our support for the life-science community, creating new opportunities and paying dividends well into the future. We are delighted to partner with the Biogen Idec Foundation and honored to receive its help in developing biotechnology as an engine for job creation and wealth generation.”
The Center has also received leadership gifts from the Duke Energy Foundation, PPD and the Triangle University Center for Advanced Studies.
“For twenty-five years, the state has invested in biotechnology research, education and business development through Biotechnology Center funding programs and collaborations,” said Robert A. Ingram, Vice Chairman, Pharmaceuticals, GlaxoSmithKline and chairman of the Center’s Building Committee. “Leadership by the Center created a thriving industry with broader needs, and we are pleased to move forward with building the infrastructure to allow the Center to extend that leadership.”
From 2001 to 2006, the State’s biotechnology-based industry grew 18.6 % – three times the national rate and five times the rate of the state’s private sector.
“This industry contributes $45.8 billion to the State’s economy each year, a testament to the investment this Center leverages with state dollars,” said Arthur M. Pappas, chairman of the Biotechnology Center’s board of directors and managing partner of the venture-capital firm Pappas Ventures. “Investing in expansion now is essential for the State to benefit from the projected high growth in life science research, development and job creation over the next ten years.”
Since the Biotechnology Center opened in 1984, the industry has grown from a handful of companies to more than 520 companies and almost 60,000 jobs with an average salary of more than $69,000.
“We have the potential to create an additional 65,000 to 70,000 jobs by 2020 as we develop new applications of biotechnology right here in North Carolina,” said Norris Tolson, president and chief executive officer of the Center.
The North Carolina Biotechnology Center invites you to join other industry leaders at BIO 2010 through sponsorship of the North Carolina Pavilion. BIO 2010 will be held in Chicago May 3-6. Reach over 15,000 decision makers and take advantage of the numerous networking and business partnering opportunities. The Center is offering cost-effective exhibiting solutions to fit every budget – learn more at the website.
Please have your organization’s media/marketing coordinator send news about your company to Brenda Summers - bsummers@ncbioscience.org
Biogen Idec Foundation $1 million Transformational Grant in Science Education to the North Carolina Biotechnology Center is the second recent transformational grant in science education the Foundation has made in North Carolina. It awarded $60,000 to the Contemporary Science Center in Durham, NC for the creation of a community learning laboratory for hands-on education of high-school science students. In addition to the transformational grant program, the Foundation has undertaken a micro-grants program in support of science education projects that might otherwise go unfunded, such as field trips and laboratory supplies. More than $50,000 in micro-grants will be awarded this year through the Cambridge (MA) Community Foundation, the Triangle (NC) Community Foundation and the San Diego (CA) Foundation.
“The Biogen Idec Foundation’s primary mission is to encourage innovative approaches to the teaching of science at the middle and high-school levels,” said Craig Schneier, Ph.D., Chair of the Foundation and Biogen Idec’s Executive Vice President of Human Resources, Public Affairs and Communications. “Since its incorporation in 2003, the Foundation has awarded almost $10 million in grants for science education and community service. Last year, we initiated a Transformational Grants program to encourage organizations to undertake major new transformational initiatives that would reinvigorate the way science is taught in the United States.”
Biolex Therapeutics, Inc. has entered into an agreement with Cook Pharmica LLC under which Cook will manufacture drug substances for use in Biolex's planned Phase 3 clinical trials of Locteron. Locteron, controlled-release interferon alpha 2b, is designed to improve patient care by providing a more convenient once-every-two week dosing schedule and by reducing the side effects, including flu-like symptoms, associated with pegylated interferons, the current standard of care. Biolex completed enrollment of the SELECT-2 Phase 2b trial of Locteron for the treatment of chronic hepatitis C in June 2009, and first results are expected in the fourth quarter of 2009.
Eli Lilly is offering to screen compounds for free through its Phenotypic Drug Discovery Initiative, PD2 (pronounced PD-squared). Participation is limited to investigators working for Institutions which are research universities, institutes, and small biotechnology companies. International laws regulate Lilly's business relationships, including engagement of government officials or other persons who may be able to influence Lilly's business interests. Therefore, although participation is open globally, Lilly reserves the right to delay or deny affiliation of the interested Institution in cases where the type of Institution or regional differences in shipping or other regulations might compromise the spirit and, or integrity of the PD2 program until these issues have been resolved to Lilly's satisfaction.
Inspire Pharmaceuticals, Inc. has received the North Carolina Health & Life Sciences Award in the category of "Breakthrough Research" for its denufosol tetrasodium program for cystic fibrosis (CF). This award recognizes innovative research that has the potential to solve problems of great importance to science or society. Inspire received the award at the annual Dinner of Champions, which celebrates leaders in the health and life sciences fields, hosted by the Eastern North Carolina chapter of the National Multiple Sclerosis Society. "We are honored to receive this award for Inspire's dedicated research and development of denufosol, a novel compound designed specifically for the treatment of CF lung disease. We believe denufosol has the potential to make an important difference in the lives of CF patients as an early intervention treatment that targets the underlying CF defect,” stated Christy L. Shaffer, Ph.D., President and CEO of Inspire.
Adam Monroe is the new President of Novozymes’ North American region. Monroe replaces Lars Hansen, who has returned to Denmark to head the company’s European region.
Monroe joined Novozymes in 1991 in the Process Engineering group. Since then, he has served as Production Manger for Granulation, Regional Director of Supply Chain Operations and Director of Supply Chain Operations, Americas.
Talecris Biotherapeutics Holdings Corp. has raised approximately $950 million in an initial public offering of common stock. Talecris is a global biotherapeutic and biotechnology company that discovers, develops and produces critical care treatments for people with life-threatening disorders in a variety of therapeutic areas including immunology, neurology, pulmonology and hemostasis.
Executives of TCG will be attending the AdvaMed conference and partnering meetings in Washington, DC, on October 12-14. The conference has a partnering program for its 300+ company participants that is specifically designed to help companies, meet prospective commercial partners. Companies that are interested in partnerships but don't plan on attending this meeting, can contact Dr. Robert Keefer at 919-354-4204 to make arrangements for TCG to set up one-to-one meetings to represent your company in any way using a short non-confidential summary your company (or TCG) would prepare.
Targacept, Inc. will present data from its completed Phase 2b clinical trial of TC-5214 as an augmentation treatment for major depressive disorder at the Nicotinic Acetylcholine Receptors as Therapeutic Targets Symposium (nAChR2009) in Lincolnshire, Illinois on October 15, 2009. Additionally, Targacept announced that data regarding AZD3480 (TC-1734) and TC-5619 are also scheduled to be presented at nAChR2009. nAChR2009 is a satellite meeting of the 39th annual meeting of the Society for Neuroscience.
 BioSimilars and Health Care Reform
BIO President Jim Greenwood has praised the Senate Committee on Health Education Labor and Pensions and the House Committee on Energy and Commerce for adopting biosimilars legislation that “strikes the necessary balance among expanding access and competition, ensuring patient safety and promoting continued biomedical innovation that will lead to new and improved medicines and treatments.”
“We urge the Congress to include this biosimilars language as they continue efforts to reform our nation’s health care system,” Greenwood continued. “We look forward to continuing our participation in the process of health care reform with the goal of increasing access and reducing costs while promoting the continued development of new therapies and cures.”
Greenwood said “BIO shares President Obama's goal of ensuring that all Americans have access to affordable, sustainable, high quality health care. Biotechnology plays an essential role in achieving this goal. Biotechnology expands the boundaries of science by discovering, developing, and delivering innovative and needed medical products to patients. Further, market-based reforms provide the best opportunity to achieve the goal of universal access while providing high quality care and incentives for the discovery and development of innovative improvements throughout the health care delivery system.”
October 12-14, 2009.
AdvaMed 2009, Washington, D.C. A conference designed by industry for industry, AdvaMed 2009 is the premier MedTech Conference for CEOs, business executives, policy-makers, media, financiers, and other MedTech leaders from around the world. In only its second year, AdvaMed 2008 attracted 1,400 industry leaders – including more than 500 CEOs, presidents and C-level executives. For more information click here.
October 12-16, 2009.
IBC's BioProcess International Conference & Exhibition (BPI) is coming to the Raleigh Convention Center on October 12-16, 2009. BPI has become the largest, most well respected forum focusing on technical, regulatory and strategic planning challenges in the manufacturing of biotherapeutics. BPI allows you to interact with industry experts and colleagues across various disciplines of biopharmaceutical manufacturing to develop valuable partnerships and gain a competitive advantage for continuous improvement. For more information click here.
October 29, 2009.
NCBIO Medical Device Forum Meeting. 10:00am at the NCBIO offices 100 Capitola Drive, Suite 106 (CED Classroom). An update on the launch of the North Carolina Advanced Medical Technologies Center of Innovation will be given. To RSVP please contact Jennifer at 919-281-9060 or jfong@ncbioscience.org.
October 30, 2009.
NCSU College of Management BioSci Forum.
The Fifth Annual BioSciences Forum provides an opportunity for those engaged in any sector of the biosciences industry - from agriculture to technology - to come together for a frank discussion of the unique management issues that affect each of them. This forum is presented annually as an outreach of the BioSciences Management Initiative of the North Carolina State University College of Management. For more information click here.
December 3-4.
SEBIO Investor Forum, Charleston, SC. The annual conference, designed to stimulate venture investment in the region, offers an “early-stage” event focused on preparing newly emerging companies for raising venture capital and a “presenting companies” event, which showcases a second group of young companies that have already completed one “round” of institutional financing.
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NCBIO This Month
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