Reproduced with permission from Life Sciences Law & Industry Report, 6 LSLR 1024 (Oct. 5, 2012). Copyright 2012 by The Bureau of National Affairs, Inc. (800-372-1033)

Personalized Medicine, Rare Diseases, Regenerative Medicine, Food Safety & Security To Be Discussed

Bethesda, Maryland (September 14, 2012) – Science is moving at a break-neck speed.  People are living longer, healthier lives thanks to new biomedical and agricultural breakthroughs, and there’s more to come!  Attendees at the Mid-Atlantic Bio Conference, taking place September 27 and 28 in Bethesda, MD, will have a unique opportunity to listen to the experts debate the next hot topics in biotechnology, including developing and commercializing treatments for orphan diseases, new technologies to improve our food safety and security, novel funding sources for early-stage companies, and recent revisions to U.S. patent law.

“As biomedical research has advanced, much of what was considered science fiction a decade ago is becoming reality today,” said Sara Nayeem, M.D., a Principal at the venture capital firm New Enterprise Associates and a member of the Conference Steering Committee.  “We are finally beginning to see real advances in areas such as regenerative medicine, immunotherapy, gene therapy and personalized medicine, spurred in part by advances in next-generation sequencing and other technologies.  New products and therapies emerging from these efforts have the potential to address a host of diseases in a more targeted manner, with new and potentially safer mechanisms of action.”

“The Mid-Atlantic Bio Conference is excited to be able to provide our attendees with such a content-rich 2-day program and also direct access to experts in research and development, regulatory issues, intellectual property, and pharmaceutical commercialization,” added Jeffrey M. Gallagher, Virginia Bio Interim Executive Director.

Three of these sessions, led by industry thought-leaders, include: 

Succeeding in Rare Diseases: A Collaborative Approach

Orphan products can often deliver life-saving therapies where no other option previously existed.  Panelists will discuss recent regulatory changes, combined with the ever-increasing environment in which reimbursement will be limited to the most innovative products, create both traps and opportunities.  Our experts will also examine successful orphan products, which require expertise, new relationships and novel strategies allowing the potential to generate significant financial returns.

 Panelists:

Tim Cote, CMO, NORD, and former Director OOPD
Ros Cheetham, M.D., Vice president, Medicine Development Leader, Rare Diseases, GSK
Anne Pariser, M.D., Associate Director for Rare Diseases, Rare Disease Program, Office of New Drugs, Center for Drug Evaluation and Research, FDA

Regenerative Medicine:  Breakthroughs in Business Models and Technology

Building on years of scientific advances, the business of bringing the promise of regenerative medical science to the clinic and marketplace is making strides and reaching milestones.  Leaders in the business and science of stem cells and regenerative medicine identify breakthrough companies, technologies and products, discuss what is working and what is up ahead.

Moderator:  Brian A. Pollok, Ph.D. Principal, Rapidan BioAdvisors

Panelists:

Curt I. Civin, M.D., Associate Dean for Research, University of Maryland School of Medicine, Director, Center for Stem Cell Biology & Regenerative Medicine
Mahendra S. Rao, Director, NIH Intramural Center for Regenerative Medicine.
Thomas Fellner, Ph.D., Director, Innovation, Pluripotent Stem Cell Technologies, Lonza
Michael Werner, Executive Director, Alliance for Regenerative Medicine

Personalized Medicine in Oncology and Beyond: Advances in Defining and Treating Patient Sub-populations

Developing targeted therapeutics is a key goal in oncology today, as genomic advances have accelerated our ability to pinpoint the driving mutations in individual tumors.  In some cases, biomarkers have also allowed us to monitor responses of cancer patients to therapy. Experts from pharma, diagnostics/biomarkers, and academia will explore the challenges and opportunities inherent in defining and developing targeted therapies for genetically-defined sub-populations.

 Moderator: Judy Britz, Ph.D., Executive Director, Maryland Biotechnology Center

Panelists:

Sonia Pearson-White, Ph.D., Scientific Program Manager for Oncology, Inflammation and Immunity, The Biomarkers Consortium, Foundation for the National Institutes of Health
Eric Hedrick, M.D.,  Chief Medical Officer, Epizyme
Antony Newton, Chief Commercial Officer, Personal Genome Diagnostics Personalized Medicine
Isaac Bright, M.D., VP, Corporate Development, bioTheranostics

Transformative Technologies to Ensure Food Safety and Security

Join a panel of experts to hear the latest science and related issues in food safety and how these issues might be addressed; current topics in food safety policy and regulation, in particular any barriers that exist and potential solutions or work arounds; type of research that is occurring and the role that research plays in enhancing food safety; and the local versus global perspective.

Moderator: Kara Cooper, Ph.D. Senior Scientist, Global Health and Security, MRI Global

Panelists:
Thomas S Hammack, Acting Director, Division of Microbiology, FDA
Douglas White, CEO, Opgen, Inc.
Janie Dubois, Ph.D.,  Manager, International Food Safety Training Laboratory at University of Maryland
Ted Olsen, President and CEO, PathSensors, Inc.

About Mid-Atlantic Bio
Mid-Atlantic Bio – taking place September 27-28 in Bethesda, Md. – is one of the country’s premier biotech conferences for senior-level executives, policymakers, academia, financiers, media and service providers. Its proximity to the US government, federal labs, commercial research and development, academic centers of excellence and a growing investment community, make it a uniquely valuable venue for those in the life sciences community. First launched as an industry gathering at the Academies of Science, the conference is a joint initiative of the founding host organizations: the Mid-Atlantic Venture Association, the Virginia Biotechnology Association, and the Tech Council of Maryland. The Conference is also pleased to welcome the North Carolina Biotechnology Centeras a strategic partner for 2012. For more information, please visit midatlanticbio.org.

For the latest news and updates: follow us on Twitter @MidAtlanticBio or join our LinkedIn and Facebook groups.

CONTACT:
Audrey Chang
(202) 295-8779
media@midatlanticbio.org

Panelists to Address Range of Financing Opportunities, from SBIR and Angel Investors to Venture Capital and Partner Licensing Agreements

 Bethesda, Maryland (September 12, 2012) – Locating much-needed financing tops the list of nearly every biotech company, whether they need to move forward with additional research and development or need funding to bring a new product to market.  The 2012 Mid-Atlantic Bio Conference will give entrepreneurs and business leaders the opportunity to hear from, and network with, leaders at a variety of capital sources, including venture capital, angel and corporate investors; industry professionals and business leaders; peer scientists; grant and patient advocate program managers; and potential strategic partners.

By bringing in top-of-the-line speakers, attendees at the conference will get an insider’s look at translational research and commercialization; novel sources of capital; trends in development costs and funding opportunities through the Small Business Innovation Research (SBIR) program.

“We have heard from attendees that they want sessions that reflect the current marketplace for partnering, collaborating and connecting in what many view as an elusive financing environment. This year’s panels contain the best minds in biotech and finance and will give insight into how to create valuable business partnerships, as well as explore additional traditional as well as non-traditional funding sources to bring innovative products to market,” said Julia Spicer, Executive Director of Mid-Atlantic Venture Association.

In addition to attending panel sessions, attendees will have the opportunity to use BioMatch, a mobile app program (iPhone or Android) that helps facilitate interaction and networking.  This new business networking tool offers a robust online and mobile platform for sharing company and product information and set up and track one-on-one meetings at the conference.

This year’s conference takes place September 27-28 in Bethesda, MD.

Innovative Partnering Models for Moving Bioscience Discoveries to the Marketplace  
Join members of the university, corporate, investor and NIH communities to look at several innovative models in translational research and commercialization, to assess what is working and what opportunities are available.

Moderator: Mark Crowell, Executive Director, UVa Innovation and Associate Vice President for Research, University of Virginia

Panelists:

Anthony Coyle, PhD, VP/CSO, Centers for Therapeutic Innovation, Pfizer Inc.
Todd Chappell, BioHealth Innovation, Entrepreneur in Residence, NIH
Christopher P. Austin, M.D., Director, NCATS Division of Pre-Clinical Innovation, National Center to Accelerate Translational Science

Novel Capital Sources for Bioscience Companies
With venture funding dollars decreasing overall, companies must continue to look for novel ways to fund their research. This discussion brings a mix of funding programs created to capture larger audiences.  To ensure you have the right information to fund your programs, our panel members will discuss these options and more.

Moderator: Peter Ginsberg, Vice President for Business and Technology Development, The North Carolina Biotechnology Center

Panelists
Margaret Anderson, Executive Director, FasterCures
John Hollway, President, Pragmatos Consulting
Freeman White, CEO Launcht and Participating Member, Crowd funding Intermediary Regulatory Advocates
David Sandak, Vice President for Research and Business Development, Accelerate Brain Cancer Cure (ABC2)

New Developments in Traditional and Corporate Venture Capital
Join the panelists as they discuss shifts at the FDA, implications of the PDUFA V legislation, and trends in overall development costs (“virtual models” to reduce burn, companion diagnostics, and development in / partnerships for ex-U.S. markets).  Panelists will also examine exits appetite for mid- to late-stage healthcare companies among public investors, big pharma/big device company interest in mid-stage products, and implications of recent liquidity trends for the venture capital industry.

 Moderator: Nina Kjellson, General Partner, InterWest Partners

Panelists

Art Pappas, Managing Partner, Pappas Ventures
Brian Gallagher, Ph.D., Partner, SR One
Robert Weisskoff, Ph.D., Partner, Fidelity Biosciences
David Berry, M.D., Ph.D., Partner, Flagship Ventures

SBIR/STTR: Strategies, Program Changes and Current Opportunities
In the first of this special two-hour session, experts will describe the changes in rules proposed to implement recent reauthorization, and will also discuss the strategic role of SBIR/STTR and non-dilutive funding in the financial strategy of a startup.  In the second hour, program representatives from leading NIH Institutes will describe current open funding opportunities, and will be available for one-on-one breakout discussions with attendees.

 Panelists
Matt Portnoy, NIH SBIR/STTR Program Coordinator, Director, Division of Special Programs, OEP, OER, NIH, DHHS
Christy Shaffer, PhD, Venture Partner and Managing Director, Hatteras Venture Partners
Kurt Marek, Program Director SBIR coordinator, National Heart Lung Blood Institute (NHLBI)
Stephanie Fertig, Research project manager SBIR Program, National Institute of Neurological Disorders and Stroke (NINDS)
Jennifer Shieh, AAAS Science & Technology Policy Fellow, SBIR Development Center, National Cancer Institute (NCI)

About Mid-Atlantic Bio
Mid-Atlantic Bio – taking place September 27-28 in Bethesda, Md. – is one of the country’s premier biotech conferences for senior-level executives, policymakers, academia, financiers, media and service providers. Its proximity to the US government, federal labs, commercial research and development, academic centers of excellence and a growing investment community, make it a uniquely valuable venue for those in the life sciences community. First launched as an industry gathering at the Academies of Science, the conference is a joint initiative of the founding host organizations: the Mid-Atlantic Venture Association, the Virginia Biotechnology Association, and the Tech Council of Maryland. The Conference is also pleased to welcome the North Carolina Biotechnology Center as a strategic partner for 2012. For more information, please visit midatlanticbio.org.
For the latest news and updates: follow us on Twitter @MidAtlanticBio or join our LinkedIn and Facebook groups.

CONTACT:
Audrey Chang
(202) 295-8779
media@midatlanticbio.org

High-Level Policy Overviews and Discussions, in the Government’s Own Back Yard

2012 Mid-Atlantic Bio

BETHESDA, Md.–(BUSINESS WIRE)–From healthcare reform and PDUFA to changes in intellectual property protections and Small Business Innovation Research regulations, it can be difficult to keep up with policy changes. Through a wide-ranging program, the 2012 Mid-Atlantic Bio Conference will help attendees understand the latest developments on Capitol Hill and at the FDA.

“With an FDA workshop, sessions focused on the changes to the America Invents Act as well as the future of health policy, the latest SBIR changes and developing medicines for orphan diseases, we have a comprehensive public policy program that can’t be beat”

“With an FDA workshop, sessions focused on the changes to the America Invents Act as well as the future of health policy, the latest SBIR changes and developing medicines for orphan diseases, we have a comprehensive public policy program that can’t be beat,” said Art Jacoby, Chief Executive officer, Tech Council of Maryland. “Our attendees will be able to learn about these policies and how they affect their companies straight from the experts here in Washington, DC.”

“One of the greatest draws for our constituents,” Steve Casey, Vice President of Statewide Operations for NCBiotech, added, “is the fact that Washington, DC is the epicenter for health care policy in our country. This conference offers participants a unique opportunity to engage with government officials who directly influence policy and funding decisions, as well as sessions that allow researchers, business executives and government officials to collaborate on ways to improve access to life-changing therapies and foster a competitive research and development environment.”

This year’s conference takes place September 27-28 in Bethesda, MD.

Plenary Panel: Seeing a Bright Future: What’s ahead for an ever-changing Life Sciences Industry
Thought leaders from industry, investment and public policy share observations and insights on developments, trends and opportunities.

Panelists
N. James Barrett, Ph.D., General Partner, New Enterprise Associates (NEA)
Vicki Seyfert-Margolis, Senior Advisor to Chief Scientist, FDA
Ron Cohen, M.D. President and CEO Acorda Therapeutics, Inc.

Reassessing intellectual property strategies in response to the America Invents Act
Over the coming year several significant changes to IP will be phased into law: a modified first-to-file system for awarding patents; a post grant review procedure on petition by a third party; an expanded definition of prior art; an expanded prior use defense against infringement; and a new administrative derivative proceeding, among others. Intellectual property experts from corporate, university, and private practice who are daily studying and responding to these changes in the law will offer insights.

Panelists
Bruce Artim, Director, Federal Affairs, Eli Lilly and Company
Wes Blakeslee, Executive Director, Johns Hopkins Tech Transfer

Best Practices for Working with the FDA, Parts I & II
During this two-part workshop, panelists drawn from the FDA, regulatory consultants, and other companies will discuss opportunities, challenges and the best practices in key areas for early stage companies as well as the recent reauthorization of PDUFA. The presenters will also discuss – in detail – the elements of a good FDA submission.

Moderator: Peter A. Patriarca, Senior Clinical Consultant, Biologics Consulting Group
Panelists
Joelle P. Blakaitis, MS, RAC, Director, Global Regulatory Affairs, MedImmune
Shannon Williams, Chief Scientific Officer, ADial Pharmaceuticals
Lynn Whipkey Mehler, Partner, Hogan Lovells
FDA staff

SBIR/STTR Workshop: Current Opportunities and understanding program changes
The SBIR (Small Business Innovation Research) and STTR (Small Business Technology Transfer) Grants provide one of the largest sources of early stage technology funding (over $2 billion per year). In the first of this special two-hour session, experts will describe the changes in rules proposed to implement recent reauthorization, and a discussion of strategic role of SBIR/STTR and non-dilutive funding in the financial strategy of a startup. In the second hour, program representatives from leading NIH Institutes will describe current open funding opportunities and will be available for one-on-one breakout discussions with attendees.

Panelists
Matt Portnoy, NIH SBIR/STTR Program Coordinator, Director, Division of Special Programs, OEP, OER, NIH, DHHS
Christy Shaffer, PhD Venture Partner and Managing Director Hatteras Venture Partners
Kurt Marek, Program Director SBIR coordinator, National Heart Lung Blood Institute (NHLBI)
Stephanie Fertig, Research project manager SBIR Program, National Institute of Neurological Disorders and Stroke (NINDS)
Jennifer Shieh, AAAS Science & Technology Policy Fellow, SBIR Development Center, National Cancer Institute (NCI)

Succeeding in Rare Diseases: A Collaborative Approach
Orphan products can often deliver life-saving therapies where no other option previously existed. Panelists will discuss recent regulatory changes, combined with the ever-increasing environment in which reimbursement will be limited to the most innovative products, creating both traps and opportunities. Our experts will also examine successful orphan products, which require expertise, new relationships and novel strategies allowing the potential to generate significant financial returns.

Panelists:
Tim Cote, CMO, NORD, and former Director OOPD
Ros Cheetham, MD, Vice president, Medicine Development Leader, Rare Diseases, GSK
Anne Pariser, M.D. Associate Director for Rare Diseases, Rare Disease Program, Office of New Drugs, Center for Drug Evaluation and Research, FDA

About Mid-Atlantic Bio

Mid-Atlantic Bio – taking place September 27-28 in Bethesda, Md. – is one of the country’s premier biotech conferences for senior-level executives, policymakers, academia, financiers, media and service providers. Its proximity to the US government, federal labs, commercial research and development, academic centers of excellence and a growing investment community, make it a uniquely valuable venue for those in the life sciences community. First launched as an industry gathering at the Academies of Science, the conference is a joint initiative of the founding host organizations: the Mid-Atlantic Venture Association, the Virginia Biotechnology Association and the Tech Council of Maryland. The Conference is also pleased to welcome the North Carolina Biotechnology Center as a strategic partner for 2012. For more information, please visit midatlanticbio.org.

For the latest news and updates: follow us on Twitter @MidAtlanticBio or join our LinkedIn and Facebook groups.

Contacts

Mid-Atlantic Bio
Audrey Chang, 202-295-8779
media@midatlanticbio.org

New Online Platform Connects Companies With Potential Partners On Site

BETHESDA, Md.–(BUSINESS WIRE)–The Mid-Atlantic Bio Conference today opened BioMatch to all registered conference attendees. BioMatch is the business networking tool for the conference and offers a robust online and mobile platform for attendees to share information and set up one-on-one meetings at the conference. Mobile apps for BioMatch are available for iPhone or Android devices.

“With attendees from more than 30 states and 10 countries, Mid-Atlantic Bio has always been a terrific networking event. Developing new partnerships is at the heart of what we do. BioMatch simply enhances the opportunities through the latest online and mobile technologies.”

“BioMatch is one of the signature offerings at Mid-Atlantic Bio, and we are thrilled to open access to this improved platform that will help people connect at the conference,” said Robin Deacle at North Carolina Biotechnology Center. “With attendees from more than 30 states and 10 countries, Mid-Atlantic Bio has always been a terrific networking event. Developing new partnerships is at the heart of what we do. BioMatch simply enhances the opportunities through the latest online and mobile technologies.”

Using BioMatch, attendees can create profiles and upload specific licensing and product information which they can share with other conference registrants. They will also be able to see who is attending the Mid-Atlantic Bio Conference, learn about them in advance of the conference and schedule and track one-on-one appointments. BioMatch uses a new system that organizers implemented in response to feedback from attendees at prior conferences.

The platform provides a way for attendees to manage their own schedules and activities. The recently announced SBIR sessions – which offer the opportunity for one-on-one meetings with National Institutes of Health program managers – utilize the BioMatch platform.

“By offering an easy-to-use and easy-to-access tool for registered conference attendees to make on-site connections and build existing relationships, we are hoping to catalyze more business connections and opportunities, which we know are a priority for conference attendees,” said Jeffrey M. Gallagher at Virginia Bio.

Mid-Atlantic Bio takes place on September 27-28, 2012. Hundreds of biotech companies from across the industry will be coming together during this regional event.

The 2012 Mid-Atlantic Bio Conference is presented by the Mid-Atlantic Venture Association, the Virginia Biotechnology Association, the Tech Council of Maryland, along with their new, strategic partner, the North Carolina Biotechnology Center.

About Mid-Atlantic Bio

Mid-Atlantic Bio – taking place September 27-28 in Bethesda, Md. – is one of the country’s premier biotech conferences for senior-level executives, policymakers, academia, financiers, media and service providers. Its proximity to the US government, federal labs, commercial research and development, academic centers of excellence and a growing investment community, make it a uniquely valuable venue for those in the life sciences community. First launched as an industry gathering at the Academies of Science, the conference is a joint initiative of the founding host organizations: the Mid-Atlantic Venture Association, the Virginia Biotechnology Association, and the Tech Council of Maryland. The Conference is also pleased to welcome the North Carolina Biotechnology Center as a strategic partner for 2012. For more information, please visit midatlanticbio.org.

Contacts

Mid-Atlantic Bio
Audrey Chang, 202-295-8779
media@midatlanticbio.org

Research Managers from Several NIH Institutes to Participate in Sessions and One-on-One Consultations with Life Sciences Companies

BETHESDA, Md.–(BUSINESS WIRE)–As a special offering presented during the upcoming annual Mid-Atlantic Bio conference, co-hosts announced a comprehensive line-up of programming focused on the Small Business Innovation Research (SBIR) program to help interested companies learn more about specific opportunities at the National Institutes of Health (NIH). Sessions will include an update on the recent rule changes and new requirements, advice on how to apply for the competitive program and the opportunity for individual meetings with program managers from a variety of Institutes of the NIH.

“During this period of economic uncertainty, emerging companies face a particular challenge in securing funding for innovative approaches”

“The SBIR program continues to be an important source of funding and support for emerging companies seeking to commercialize innovative research and develop market applications,” Jeffrey M. Gallagher, Virginia Bio Interim Executive Director and co-host of Mid-Atlantic Bio said. “We are particularly grateful that our geographical proximity to NIH’s world class program managers allows us to provide conference attendees individual interactions and one-on-one meetings during our upcoming event.”

The SBIR sessions will run throughout the day on Friday, September 28, starting with a series of one-on-one consultations that will be pre-scheduled online through the Mid-Atlantic Bio registration site and available to conference participants. Participating SBIR program managers will create online profiles with specific guidelines and program information, which will be available to interested companies, who can then set up appointments online. The participating companies will then meet individually with the NIH program managers to discuss specifics of the SBIR opportunities and ask questions about the process.

The afternoon sessions consist of two panels. The first will focus on an overview of the SBIR program and the recent changes to the program. Panelists will discuss the new guidelines and how they impact the ability of companies to participate in the program, as well as considerations on whether and how to pursue funding. In addition, representatives of the venture capital community will discuss the strategic role of SBIR funding in the lifecycle of life sciences companies.

“While the SBIR program is a critical funding stream for emerging life sciences companies, it is important that executives understand how SBIR funding can complement other sources, such as angel investment or venture capital, and are familiar with the specific rules that come into play when seeking funding from a mix of sources which includes SBIR,” said Julia Spicer, Executive Director of Mid-Atlantic Venture Association, a co-host of the conference.

A second afternoon panel will cover specific opportunities at the National Heart Lung Blood Institute (NHLBI), National Institute of Neurological Disorders and Stroke (NINDS), and National Cancer Institute (NCI), among other Institutes. Participating companies also will receive information on funding opportunities currently available as well as advice and guidelines on submitting their applications. Additional one-on-one consultations with the presenting program managers will be available at the close of the SBIR sessions.

The SBIR sessions are a highlight of the two-day Mid-Atlantic Bio conference, one of the biggest and most important regional conferences for the life sciences sector – typically attracting attendees from 30 states and 10 countries. Registration for the conference will be available until September 24. However, early registration ends Monday, August 27.

“During this period of economic uncertainty, emerging companies face a particular challenge in securing funding for innovative approaches,” said Norris Tolson, President and CEO of the North Carolina Biotechnology Center, a new strategic partner participating in Mid-Atlantic Bio for the first time. “We know that conversations during the SBIR sessions with NIH program managers will greatly benefit our small companies.”

The 2012 Mid-Atlantic Bio Conference is presented by the Mid-Atlantic Venture Association, the Virginia Biotechnology Association, the Tech Council of Maryland, along with their new, strategic partner, the North Carolina Biotechnology Center.

About Mid-Atlantic Bio

Mid-Atlantic Bio is one of the country’s premier biotech conferences for senior-level executives, policymakers, academia, financiers, media and service providers. Its proximity to the US government, federal labs, commercial research and development, academic centers of excellence and a growing investment community, make it a uniquely valuable venue for those in the life sciences community. First launched as an industry gathering at the Academies of Science, the conference is a joint initiative of the founding host organizations: the Mid-Atlantic Venture Association, the Virginia Biotechnology Association, and the Tech Council of Maryland. The Conference is also pleased to welcome the North Carolina Biotechnology Center as a strategic partner for 2012. For more information, please visit midatlanticbio.org.

Contacts

Mid-Atlantic Bio
Audrey Chang, 202-295-8779
media@midatlanticbio.org