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Autumn 2007

2007 Annual Conference to focus on devices
and diagnostics

Ohio’s growing bioscience community will converge on Dublin, Ohio, Nov. 12-13, for the 2007 BioOhio Annual Conference. This year’s event will focus on medical devices and diagnostics, two bioscience industry sectors experiencing dramatic growth in Ohio.

According to AdvaMed (the Advanced Medical Technology Association), the medical device market in the U.S. was approximately $86 billion in 2006, with a 10% annual growth rate expected for 2007. The global market approaches $220 billion. BioEnterprise, a BioOhio regional affiliate, reported that Midwest device startups raised $356 million in 2006, which accounted for 45 percent of total Midwest healthcare venture funding.

In a recently released AdvaMed report on the overall medical technology industry, including devices and diagnostics, Ohio ranked tenth in employment with 12,820 jobs.

BioOhio spokesperson Matt Schutte said a combination of factors and assets explains Ohio’s prominence in medical devices and diagnostics. “First, the market for these products is growing along with the aging of baby boomers,” he said. “This burgeoning patient demand spurs innovation among Ohio’s world-class medical research institutions. The market opportunity has captured the attention of Ohio’s engineering and manufacturing sectors, which has led to company and job growth.”

An opening reception with a bioscience student poster session, exhibitor booths, Ohio-centric door prizes, and a device and diagnostics product showcase will occur on Nov. 12. The Nov. 13 agenda will feature several Ohio-based medical technology industry experts as well as four out-of-state featured speakers.

Dr. Ron Yustein, Clinical Deputy Director of the FDA’s Office of Device Evaluation in Rockville, Maryland, will provide updates on FDA initiatives and regulatory changes that impact medical devices and diagnostics. From Washington, D.C., AdvaMed Senior Executive Vice President Amy Jensen Cunniffe will discuss issues impacting advanced medical technology industry growth, convergence with other bioscience sectors, and the industry’s “value chain,” from research through outsourcing to manufacturing. New York-based Jeff Krauss of Psilos Group will head up a panel session on venture capital trends. And Gary Miller, co-founder of Exactech, a publicly-traded medical device company in Florida, will participate in a panel of device and diagnostic company leaders.

Lt. Governor Lee Fisher also plans to visit briefly and share his thoughts on Ohio's future investment in bioscience innovation. For a complete agenda and registration information, visit www.bioohio.com/programs/bioohio.asp.

While this year’s Annual Conference boasts a stellar agenda of industry experts, it is—at its core—a networking event for all bioscience disciplines, from devices and diagnostics to pharmaceuticals and translational research. When 300-plus bioscience professionals from throughout the state converge, connections are a natural byproduct.

The 2007 BioOhio Annual Conference will double as a celebration of the organization’s 20th anniversary. BioOhio was founded as Edison Biotechnology Center in 1987. It remains one of seven non-profit, state-funded Edison Technology Centers located throughout Ohio.

The 2007 BioOhio Annual Conference is made possible, in part, with support from valuable sponsors, including the Ohio Department of Development, Calfee, Halter & Griswold, LLP, and AccuNet, among others.

BioOhio gets community colleges to think collaboration

As part of its ongoing effort to develop comprehensive workforce support solutions for Ohio’s bioscience industry, BioOhio convened a meeting of key Ohio community colleges and educators in Columbus on August 16 to discuss collaboration and resource networking.

The event drew leaders from Cincinnati State, Clark State, Columbus State, Cuyahoga Community College, Greater Cincinnati Tech Prep, Hocking College, Lakeland Community College, North Central State, Raymond Walters College, Cuyahoga Community College, Sinclair Community College, and Stark State. Representatives from Battelle, the Ohio Department of Development, and the Ohio Board of Regents also participated. 

Bill Tacon, BioOhio’s senior director of workforce and education, chaired the meeting and provided context for the participants by describing Ohio’s expanding industrial bioscience base, especially in biomedical and biopharmaceutical manufacturing. “These sectors often look to community colleges to provide both two-year degreed entry level staff and incumbent workforce training solutions,” Tacon explained. 

Outdoor brainstorming: (l to r) Larry Mayer, Columbus State CC; Phyllis Williams, Sinclair CC; Jim Kalna, Columbus State CC; and Getachew Boru, Hocking College.

Ohio Board of Regents Workforce Development Administrator Cathy Hill told the group that “this was the perfect time” to devise and develop an innovative proposal or alliance.

The community college educators shared information about their respective bioscience-related programs, some of which are in their initial phases. Ample discussion centered upon pursuing grants by working with university partners and linking non-credit workforce training to curriculum offerings. Recommendations included updating curricula to better reflect industry needs revealed in a recent BioOhio employers survey. There was a consensus among participants to establish a formal workforce-focused network among the community college bioscience faculty and technical programs.

Since the meeting, BioOhio has submitted a proposal to the Ohio Board of Regents describing the establishment of a formal two-year college bioscience campus network, as a first step to providing workforce solutions to Ohio’s growing bioscience industry.

Tacon indicated that follow-on meetings will solicit participation from the complete higher education spectrum, as well as employers and public officials.

Midwest mingles with Middle East
Ohio and Israel making bioscience connections

In Tel Aviv this past June, BioOhio, the Ohio Department of Development, Israel Economic Mission, and SGI Global Business Advisors joined forces to promote Ohio’s bioscience business, healthcare, and research excellence at BioMed Israel, a major international conference and exhibition for the life sciences industry.

A number of companies have explored Ohio as a result of this trip and at least one is negotiating a manufacturing site.

The conference featured a special panel session entitled “An Overview of Ohio’s Global Center of Excellence for Healthcare Delivery, Research, and Medical Education." Ohio was the only state given the opportunity to make such a presentation. The panel featured leaders from Cleveland Clinic, Akron General Medical Center, Ohio State University Medical Center, NEOUCOM, and Ohio Health Corporation. The ensuing discussion as well as conversations at the BioOhio exhibit booth revealed a multitude of connections between Ohio and Israel.

With strong Jewish communities throughout the state, Ohio has been the destination of many Israeli companies over the past decade. In the Northeast Ohio city of Beachwood alone, 40 Israel-based companies have established operations.

The Ohio Department of Development's International Trade Division has operated an Eastern Mediterranean Regional Office in Tel Aviv for 12 years. It's currently managed by Richard Schottenstein. BioEnterprise, a BioOhio affiliate in Cleveland, also has an office in Israel under the guidance of Avshalom Horam, who is recruiting Israeli bioscience companies to develop their U.S. presence in Cleveland.

Bridge Investment Fund is a venture capital fund focused on investing in international technology companies, primarily from Israel, that will establish their U.S. operations in Ohio. With offices in Cleveland and Tel Aviv, Bridge is particularly interested in international life science companies that have synergies with the leading health care industries and institutions in Northeast Ohio.

In January 2006 via the Greater Akron Investment Partners (GAIP), Akron invested $1.5 million in Targetech, a Netanya-based incubator. "This is the first U.S. city to put together a public-private partnership that invested directly into a foreign incubator," said BioOhio Vice President John F. Lewis, Jr.

In June 2007, the Targatech link to Northeast Ohio was expanded. Companies at Targetech now can participate in Case Western Reserve University's Weatherhead Action Learning Program, where students participate in classes to solve real-life company problems with the latest techniques and business tools available.

The BIRD Foundation (BIRD is an acronym for Israel-U.S. Bi-national Industrial Research and Development) is designed to stimulate, promote and support industrial R&D of mutual benefit to the U.S. and Israel. Howard Gudell, of the Ohio-Israel Chamber of Commerce, is one of BIRD's 11 U.S. representatives. The Cleveland Clinic, AlphaMicron and Cincinnati Machine have all received BIRD grants.

Next April, the Ohio-Israel connection grows even more when Columbus Mayor Michael Coleman and TechColumbus will lead a group of local technology and university leaders to Israel on a mini-trade mission that will include a business plan competition.

BioOhio Government Affairs Update
written and monitored by Colby & Company

The explosive growth that is occurring in Ohio’s bioscience industry is being repeated elsewhere in the country. This rapid growth is drawing the attention of federal and state administrations and legislatures. BioOhio, as the bioscience association for the state, not only monitors emerging administrative positions and legislative actions, but also is active in ensuring state and federal policymakers make good, informed decisions about policies impacting the growth of the Ohio bioscience industry.

Gov. Ted Strickland, Lt. Gov. Lee Fisher and the Ohio Legislature have been supportive of BioOhio efforts to create, attract and expand bioscience and health care companies. The biennial budget is tight, but economic growth and development has been a top priority of the new administration and legislature.

In recent months, BioOhio has been active on several state and federal advocacy fronts, including the following.

Biomedical Research and Tech Transfer Program (BRRT)  
Securitization of state tobacco funds in the recently-passed state budget bill will sunset the Biomedical Research and Tech Transfer program in two years. Ohio's medical research community, along with BioOhio, expressed great concern about ending the program, which has provided tens of millions in research and commercialization funding to institutions such as Case Western, Cleveland Clinic, the Ohio State University, Cincinnati Children's and University of Cincinnati, among others. To communicate these concerns, BioOhio convened a conference call with Lt. Gov. Fisher and many key BioOhio member universities and institutions to advocate for retention of the BRRT and a long-term, stable source of funding. Lt. Gov. Fisher made a commitment to conference call attendees to seek alternative sources of funding for the next budget. The LG reinforced this commitment to BioOhio staff and select members in August. The Ohio Legislature included a provision in the budget expressing the Legislature's intent that the BRRT continue.

Patent Reform
In early September, Congress passed HR 1908, The Patent Reform Act of 2007, introduced by Reps. Howard Berman (D-CA) and Lamar Smith (R-TX), by a narrow margin. The U.S. Senate voted their own patent reform bill, S1145, sponsored by Sens. Patrick Leahy (D-VT) and Orrin Hatch (R-UT), out of Senate Judiciary Committee on July 18. The bill, which BioOio opposes in its current form, creates uncertainty and weakens enforceability of validly issued patents. Some of the proposed reform provisions, such as an expanded apportionment of damages and an indefinite post-grant opposition process, pose serious negative consequences for continued innovation and American technological leadership in a competitive global economy. The bill also omits important provisions that are truly justified, such as changes that will discourage the improper use of the inequitable conduct defense. BioOhio has sent letters to Ohio Sens. Sherrod Brown and George Voinovich.

NIH Funding
In June, the Senate Appropriations Committee approved $29.9 billion for NIH, an increase of $1 billion (3.5 percent) over the FY2007 level, and $250 million more than the House. However, the Senate bill mirrors the House transfer from NIH to the Global HIV/AIDS fund from $99 million in FY2007 to $300 million for FY2008. As a result, the actual NIH increase over FY2007 is only $799 million (2.8 percent), compared to $549 million (1.9 percent) in the House bill. In July BioOhio joined our national affiliate BIO in urging the House to support $30.8 billion in NIH funding in FY2008. Passage of the bill is expected this week.

Follow-on Biologics
BioOhio weighed in against federal legislation aimed at making it easier for the FDA to approve generic biologics, more commonly referred to as "follow-on" biologics. In letters to our Congressional delegation, BioOhio wrote that any new approval pathway should contain the following: Clear Guidance, providing scientific standards for follow-on biologics approval through a clear, public guidance process; Clinical Trials and Safety, ensuring that no follow-on protein is approved before its safety and efficacy have been tested in humans; Interchange-ability, prohibiting substitution or interchangeability with an original biologic since, unlike generic drugs, follow-on biologics are not the same as the innovator’s product; and Innovation, protecting continued biotechnology innovation by providing substantial (14 years) data exclusivity before another manufacturer can rely on the expensive safety and efficacy testing conducted by the innovator for its own approval. The federal legislation is on hold for the remainder of this year.

Eurand expanding in Ohio
Company also launched IPO in spring

In 1985, specialty pharmaceutical company Eurand, based in Milan, Italy, opened its U.S. operations in Vandalia, near Dayton. On September 27, 2007, the company broke ground on a 13,000 square feet expansion to its 90,000-square-foot research and manufacturing facility. The $5.5 million investment also will include renovations in portions of the existing building.

Eurand, a BioOhio member, develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies. Eurand has had four products approved by the FDA since 2001 and has a pipeline of product candidates in development for itself and its collaboration partners.

Governor Ted Strickland (r) at groundbreaking with Eurand North American President John Fraher (l) and BioOhio President & CEO Tony Dennis.

In May, Eurand successfully launched an initial public offering of 7 million ordinary shares priced at $16 a share. The stock trades on NASDAQ under the symbol EURX.

John Fraher, Eurand's North American president, was quoted in the Dayton Daily News as saying the expansion will focus on research and development, which is the key to the company's growth. Fraher also said the company plans a second $2.5 million phase of expansion in about a year, and the company's staff of 140 may grow by about 20 by the end of 2009.

Ohio Gov. Ted Strickland attended the September 27 groundbreaking ceremony. BioOhio President & CEO Tony Dennis also was on hand to celebrate this Ohio bioscience growth event.

“Ohio is committed to investing in the research, facilities and workforce that will make our state a leader in the bioscience industry,” Strickland said. “We’re proud to partner with Eurand in the company’s continued investment in Montgomery County.”

BioOhio News Briefs

2nd Annual Ohio Bioscience Career Fair set
Last October, BioOhio held the inaugural Ohio Bioscience Career Fair. It exceeded our expectations in every way, from the 250+ job candidates to the quality and commitment of our employer exhibitors. So deciding on a repeat performance in 2007 was a no-brainer.

The 2nd Annual Ohio Bioscience Career Fair will be held Nov. 27 from 2pm-7pm, at the Holiday Inn Worthington, on the north side of Columbus' 270 outerbelt. More information for exhibitors and job-seekers can be found at: www.bioohio.com/careerfair2007.asp.

A new addition to the BioOhio team
BioOhio is pleased to announced the addition of Jennifer Goldsberry as our membership and events coordinator. An Ohio native and graduate of Bowling Green State University, Jen brings a wealth of non-profit organization experience with her. Until recently, she managed Florida State University Foundation's stewardship outreach programs. But don't worry, she's a Buckeye through and through.

Jen Goldsberry

If you're a BioOhio member—or if you haven't yet seen the light—you'll likely see or hear from Jen soon.

Committed to our members
BioOhio is Ohio's only statewide bioscience membership and development organization. To learn more about membership, visit www.bioohio.com/membership/benefits.asp or call Membership & Events Coordinator Jennifer Goldsberry at 614/675-3686, x1004.

BioOhio welcomes the following members who have come on board since June:

• AxioMed Spine Corporation
• Ulmer Berne, LLP
• BCC Group LLC
• Vertebration
• Hylant Group
• BioStorage Technologies
• McNeal Enterprises, Inc.
• TeamNEO
• Pressure Biosciences, Inc.
• Akron General Medical Center
• Syncro Medical Innovations, Inc.
• BioLOGIC Corp., LLC.
• Enlyton, Ltd.
• Integrated DNA Technologies
• Remedy Compensation Consulting
• Plastic Moldings Company, LLC
• CincyTechUSA
• Compliance Associates
• Rosa S. Raskin
• Laboda, Henry
• Woods, Brent

View full member list here.

"Career Connection" Speakers Bureau
During the 2006 BioOhio Annual Conference, a topic seemingly kept coming up. College students and faculty said they valued interaction with “industry” and they wished there were more opportunities for this interaction. Likewise, a few company representatives mentioned how much they enjoyed interacting with Ohio bioscience students. In response, this summer BioOhio launched the “Career Connection” Speakers Bureau, a collection of bioscience industry experts (exclusively from BioOhio member companies) willing to share a little time and knowledge with undergraduate and graduate students of schools and universities that are BioOhio members. As the name of the speakers bureau implies, the primary focus will be bioscience career and business topics. For more information on serving as a speaker or securing a speaker for your school, contact Matt Schutte at 614/675-3686, x6.

Bioscience events in Ohio

2007 BioOhio Annual Conference
Nov. 12-13 | Embassy Suites Dublin-Columbus
For a full run-down on this stellar event, check out the lead story, or visit: www.bioohio.com/programs/bioohio.asp

Ohio: The Global Pioneer in Biomedical Imaging
Oct. 19, 2007 | Ohio State University Medical Center, Columbus
Discussions will range from reviews of current imaging modalities, technical innovation, directions for new research, industry and business ideas, funding sources, Ohio’s Third Frontier investments in imaging, and more. For registration or to see a complete agenda: www.radiology.osu.edu/global_pioneer.html

Building on the Basics: Equipping Research Professionals for Success
Nov. 9 | Doubletree Hotel Cleveland South, Independence, OH
2nd Annual GCP Conference hosted by BioOhio members M3 Clinical Research and Case Western Reserve University. For more information, contact Dawne Bowman at 330/460-5030 or dbowman@m3clinical.com.

For more details on these and other Ohio bioscience events: www/bioohio.com/programs/events.asp.