What attracts venture capitalists to fund certain start-ups and not others? Many of today's leading medical device and biotech companies began as start-ups funded by VCs who took a risk. This seminar will provide a forum for discussion of how lower-risk strategies combined with successful commercial marketing plans can be achieved to help entrepreneurs attract the capital vital to a start-up's success. Members of the business community who have played critical roles in bringing start-ups to fruition will provide key expertise on this subject.

Highlights that will be discussed by this panel include:

The real-life experiences of CEOs in growing an early-stage company
What criteria do investors use to evaluate a biotech or device start-up?
At what stage should VCs be approached?
What concerns VCs when considering their next investment?
How important is it for the start-up to have other products in the pipeline?
What role does patent protection play in the consideration of funding?
How to differentiate your start-up to make it attractive for funding

Looking at the Future: What do Medical Device Companies Need to Consider to be Ready for a Merger or Acquisition?

Katayun I. Jaffari, Esq.: Saul Ewing, LLP
Maria Maccecchini, Ph.D.: Robin Hood Ventures
Jeffrey J. Totten, MBA: Dean & Company

Entrepreneurial firms and well established corporations play an important role in the development of medical devices. Often,these firm's business plans include merging or being acquired as an exit strategy or to add value to their existing portfolio. We hope to provide a forum for interactive discussion to explore the important factors that will lead to a successful merger or acquisition. This panel discussion and examination of case studies will feature members of the business and legal communities who have played integral roles, providing key expertise during past mergers and acquisitions.

Highlights discussed by this panel included:

How is value created during a merger or acquisition?
What are the important issues to consider from the point of view of company being acquired or merged?
What are the important issues to consider from the point of view of a larger company?
Who should be included as part the team during a merger or acquisition?
What contractual and legal issues are important in the M&A process?
What regulatory/compliance issues are important?

Do I Really Have To Worry About Reimbursement In Addition To Getting My Device Through The FDA?

John Reiss, Ph.D., J.D.: Saul Ewing, LLP
Marta L. Villarraga, Ph.D.: Exponent, Inc.

In today’s fast-paced environment to get devices to the market you need to make sure that as you are planning your regulatory strategy to get your device cleared or approved by the FDA, you are also considering how it will be reimbursed.

This case study presentation will identify and analyze critical reimbursement considerations for developers trying to bring innovative devices to market.

Highlights of this panel discussion will include:

Providing an example where a device was cleared but the reimbursement strategy took much longer and why
Making your organization more attractive to potential investors by not only thinking about the regulatory pathway but also the coverage for the device
Case studies of examples of adequate and inadequate coverage strategy
Case studies of examples of success stories in both the regulatory and reimbursement landscape

IP Protection On The Road To Commercialization: Proper Due Diligence for Prosecution and for Avoiding Infringement Claims

Lynn Malinosky, Esq.: Woodcock Washburn, LLC
Joseph Lucci, Esq.: Woodcock Washburn, LLC
Maurice Valla, Esq.: Woodcock Washburn, LLC
Robert McGrath, Ph.D.: Associate Vice Provost for Entrepreneurship and Technology Commercialization; Drexel University

In today’s research environment with so many discoveries being made that could lead to commercialization of medical devices, awareness of intellectual property protection needs to be a priority. Steps taken at the initial stages of development to protect the intellectual property can lead developers down an easier road to success.

This panel discussion will provide an overview and analysis of critical awareness that inventors need to maintain in order to protect their inventions, increase the value of the commercialization, and avoid future infringement claims.

Highlights of this panel discussion will include:

Protecting your intellectual property: What, When, Who
Making your organization more attractive to potential investors with adequate IP protection
How to balance the protection of IP with the desire to publish
Case studies of examples of adequate and inadequate IP protection
Case studies of examples of IP situations that led to infringement challenges

What Risks Could Sink Your Company
- And Insuring You to Stay Afloat

Michael J. Bronzino, CPCU, ARM: Underwriting Manager; Chubb Group of Insurance Companies
Michael B. Yeager, CPCU, ARM: Sr. Life Sciences Underwriting Specialist; Chubb Group of Insurance Companies

Given today’s highly competitive business environment and the pressure to bring a new product or idea to the marketplace, would you or your organization be able to withstand any type of delay, interruption, or shut down in operations?

This seminar and discussion will provide an overview and analysis of critical risk management techniques that you can use to address those exposures that could potentially interrupt, delay or shut down your early stage medical device or biotechnology company.

Highlights of this presentation will include:

Protecting your investment and intellectual property
Making your organization more attractive to potential investors
Establishing a review process to successfully identify and analyze potentially catastrophic loss exposures
Development of a disaster recovery and/or contingency plan
Use of various risk control and risk financing techniques to effectively manage critical exposures - including the utilization of commercial insurance as a means to minimize and transfer specific loss exposures
Emerging legal trends in product liability
Importance of choosing appropriate business partners
Case studies will highlight various situations

Getting Your Arms Around Your Business Early: Choosing Business Experts Who Can Help You

Tony Dimun: Chairman, Nascent Enterprises, LLC
Rob Pritchard: President, Pritchard, Bieler, Gruver & Willison, P.C.
Michael Bronzino: Regional Manager, Chubb Group of Insurance Companies

This seminar and panel discussion will feature members of the business community who have played roles in providing key expertise for emerging medical device and biotechnology companies as they transition from idea to commercialization. Beyond having a great idea and identifying a market niche for a new medical technology, emerging companies will stand a better chance of success if they identify proper business expertise as they develop their enterprise. If you are in the field of biotechnology or medical devices as an entrepreneur or an investor, or someone providing services to such industry, this panel will provide an overview of resources available for these emerging businesses.

Highlights that will be discussed in this panel presentation include:

Choosing an appropriate management team
Understanding the organizational structure of a company
Setting up an advisory board that will enhance the success of your technology
Identifying adequate sources of capital investment and managing the investment properly
Understanding what investors are looking for
Selecting the proper entity based upon key foundational elements
Understanding what early accounting controls you need and how to change them as you grow
Positioning the company within the business plan to maximize the exit strategy
Considering insurance and liability coverage to protect your investment
Planning for a successful marketing strategy

Beyond Basics: What Entrepreneurs Need to Know About Angel Funding to Obtain an Early Stage Investment

Gail Crane
Managing Director, Southern Cross Management, Inc.

Michael P. Herr
President & CEO, IntuiTouch, LLC

Maria Maccecchini
Member, Robin Hood Ventures

Chris Starr
Executive Director, Mid-Atlantic Angel Group

What is Angel Funding? How should an entrepreneur approach early stage investors? What should the entrepreneur bring to the table? Four members of the entrepreneurial and early stage funding community will present a brief seminar and engage in a panel discussion with the audience to provide insight about these and other questions. We hope to provide a forum for interactive discussion to explore the important factors that will lead to a successful early stage investment. If you are in the field of biotechnology or medical devices as an entrepreneur, a member of a large corporation in that field, an investor, or someone providing services to such industry, this panel will provide a great perspective on the various tangible and intangible aspects affecting early stage funding.

Highlights that will be discussed in this panel presentation include:

The role of Angel investments in the funding stages of a company
The requirements of these different funding stages: How do Angel requirements differ from VC requirements?
The significance of an entrepreneur’s ability to establish credibility among the funding community
The intangible factors viewed as important in the decision making process for Angel investment groups
The value of relationships and referrals in increasing exposure to more opportunities
The trend of investing in progressively later stages and requesting a progressively faster exit: What does that mean for the entrepreneur?
The importance of managing expectations in early stage funding
The perspective of biotechnology and medical device funding as seen by the Angel community

Role of Non-Profit Trade Organizations in the Development and Commercialization of New Medical Technology in the Northeast

Joseph Bronzino
President, Biomedical Engineering Alliance and Consortium (BEACON), Hartford, CT

Richard A. Miller
Vice President, Marketing and Communications, Innovation Philadelphia, Philadelphia, PA

This seminar and panel discussion will feature speakers from two major non-profit trade organizations that have a role in the development and commercialization of new medical technology in the northeast United States. If you are in the field of biotechnology or medical devices as an entrepreneur, a member of a large corporation in that field, or someone providing services to such industry, this panel will provide a great overview of resources available and the outlook of this industry.

Highlights that will be discussed in this panel presentation include:

Major advances in medical technologies that have enabled the United States to be a major exporter of medical technology.
Academic, medical, and corporate entities that are members of the collaborative effort that forms BEACON, which is dedicated to the development of new medical technology.
Goals, objectives and operation of BEACON and the benefits it provides to its members.
Overview of Innovation Philadelphia and its role in the development and commercialization of medical technologies in the greater Philadelphia area.
Overview of Innovation Philadelphia, its resources for early-stage life science organizations, and its role in the development and commercialization of medical technologies in the greater Philadelphia area.
Strategy that is positioning Innovation Philadelphia as a leader in technology-based economic development.

Should People in Poor Nations Be Used to Evaluate Medical Devices and Drugs: An Ethical Dilemma

Arthur L. Caplan, Ph.D.
The Emanuel and Robert Hart Professor of Bioethics & Director, Center for Bioethics, University of Pennsylvania

This one-hour seminar will discuss the trend of evaluating medical device performance in international subjects. Many medical device and drug companies (large and small) use foreign patient populations to evaluate the success of new medical devices and drugs. This has typically played an important role in the path toward regulatory approval and setting up IDE studies in the United States. Topics to be discussed include:

Why International Subjects? Why are companies turning to international subjects to evaluate their new medical devices and drugs? How are these kinds of studies regulated in foreign countries? How do those practices compare to those in the United States? Who is responsible for obtaining informed consent?
Is it an Ethical Dilemma? What ethical implications are at issue in this kind of practice? How much are these international subjects benefiting from the access to these new technologies? How much are the companies benefiting from these practices? What obligations are there to those enrolled in these studies when the studies end?

Protecting and Enforcing Intellectual Property: Trends and Practices in Biotech & Medical Devices

Lynn A. Malinoski, Esq.
Partner, Woodcock Washburn LLP

Paul F. Prestia, Esq.
Shareholder, RatnerPrestia, P.C.

This one-hour seminar will discuss strategies for protecting, enforcing and litigating intellectual property in the biotechnology and medical device industries. This discussion will provide an interactive forum from both the prosecution and litigation perspectives to provide insight on key issues that come up during the development and management of intellectual property. Recent trends and practices will be discussed in the context of case studies. Topics to be discussed include:

Limit of Claims: When are broad claims more appropriate than narrow claims? What are the advantages and drawbacks of each perspective? How can claim construction have an effect on future infringement litigation?
Timing of Filing: When is it appropriate to file? When is early or deferred filing more strategically appropriate? How can funding affect this decision? When is a provisional application appropriate? How much should be included? How can a provisional application affect future litigation?
Inequitable Conduct: Is a full disclosure more appropriate than a restrictive one? Should all the test results or examples be included in the application? How can the timing of disclosures affect the management of the IP? What should be disclosed about pending litigation or pending patent applications?
Due Diligence: How much should be disclosed to potential investors? How will this affect the prosecution and potential future litigation?

Strategies for Obtaining Seed Capital: Where to Look, How to Get it, and Lessons from the Trenches

Brian K. Halak, Ph.D.
Principal, Domain Associates, L.L.C.

Geoffrey R. Erickson, Ph.D.
Senior Associate, Fund Management, A.M. Pappas & Associates

Alastair Clemow, Ph.D.
CEO, Gelifex

This one-hour seminar will discuss strategies for obtaining seed capital for medical device companies and lessons learned from specific case studies. This seminar will provide an interactive forum from both the entrepreneur and VC perspective to understand how to approach funding sources, decide how much capital to raise, and assess current trends in funding strategies.

Where to Look: Finding the right funding source is imperative to getting an early-stage medical device off the ground. Understanding what VCs and other investors are looking for is essential for securing funding. Locating alternative sources of capital, including government grants, is also critical.

How to Get It: Different funding strategies have shown varying degrees of success. Deciding how much capital to raise, from whom, and when to approach VCs and other funding sources, as well as understanding the requirements necessary to raise capital, play significant roles in successful funding. It’s not just about the money – a catchy pitch, a demonstrable need in a sizable market, an experienced corporate team, a realistic plan for becoming cash-flow positive, technical acuity, and a sound financial plan are also important.

Lessons Learned: The funding market has changed dramatically over the last few years. The resulting movement towards greater adversity to risk has seriously affected the disbursement of funds by VCs for early-stage companies. Is the most likely exit still a sale, or is it preferable to move towards becoming a publicly traded company? Are reimbursement strategies beginning to take a bigger role?

Three Litigation Developments Impacting the Biotechnology & Medical Device Community Fraud-On-The-FDA Claims, Right-to-Treatment-With-Dignity Claims, and Punitive Damages

William M. Janssen, J.D.
Partner, Chair of Life Sciences Practice, Saul Ewing LLP (Philadelphia)

This one-hour seminar will discuss three important developments in the litigation of plaintiff injury cases against the biotechnology and medical device industries. Effective risk management is essential for success in these industries, whether one is long established or a new entrant. Keeping current on major litigation developments -such as these- helps the risk manager stay well informed. Each of the three topics will be introduced, followed by a brief summary of how the Nation's courts are applying these principles:

Fraud-On-The-FDA: Three years ago, the U.S. Supreme Court ruled that the federal Food, Drug, and Cosmetic Act impliedly pre-empted claims alleging that the FDA had been defrauded. How has this case been applied in the years since the decision was released?

Breach-of-Dignity Claims: In 2001, Maryland's highest court ruled that participants conducting clinical trials might be liable for violating a subject's "right to be treated with dignity". What type of new liability might this type of claim create?

Punitive Damages Limitations: Last April, the U.S. Supreme Court ruled that the Constitution imposes limits on the sizes of punitive damage awards. Because products liability claims represent a significant volume of all punitive damage awards, how might this ruling apply in our industries?

Getting the Most out of your Pre-clinical Testing and Modeling Data for your FDA Submission

Janice M. Hogan, J.D.
Partner, Food, Drug, Medical Device and Agriculture Practice, Hogan & Hartson, LLP

Marta L. Villarraga, Ph.D.
Managing Engineer, Biomechanics Practice, Exponent, Inc.

This one-hour seminar will discuss how to get the most out of your pre-clinical testing data and computational data (where applicable) in preparation for your FDA submission. Major decisions and investments are typically made by the biotechnology and medical device industry when designing pre-clinical studies to collect data for regulatory approval. It is important to ensure that the best set of data is provided to facilitate a successful application and expeditious approval. Hypothetical case studies will be utilized to describe different scenarios.

This is your opportunity to learn about:

The role that guidance documents and industry standards play in the design of pre-clinical studies for regulatory submissions
Pathways to follow when such documents do not exist or do not provide enough detailed information specific to your application
How to incorporate computational data (if applicable) in your submission

Bringing Your Medical Device to Market ...And Getting Paid

John B. Reiss, Ph.D., J.D.
Partner, Saul Ewing LLP

This one and a half hour seminar will introduce manufacturers of biotechnology and medical device products to the coverage and payment decisions made by various health care third-party payors, and to suggest strategies that they should develop during the early stages of product development and any FDA application to minimize potential later problems with coverage and payment.

Coverage involves those sets of decisions that third-party payors make about whether to cover a product or service in the first place. For example, many policies have exclusions for experimental products and services. If a brand new product is being developed, to the extent it can avoid being characterized as experimental, it will facilitate the coverage and eventual payment decision. If the product is so new that it has to fall into the experimental class, then what strategies can be used to minimize the impact? For example, if a device is investigational but not experimental, Medicare will pay for it. If it is experimental and investigational, Medicare will not.

Once third-party payors have decided to cover a product, they still have to decide how much to pay for it. If the product falls into an existing CPT code classification (CPT codes are developed by the American Medical Association to describe certain products and services) then there will already be a market price for the product. The product needs to be designed and manufactured so that the manufacturer can make a profit given the price already set by third-party payors. If that price is insufficient, then the device has to be differentiated sufficiently (without necessarily causing, for example, a PMA to be required rather than a 510(k)) so that it will need a new CPT code that can be paid a higher price.

These are some of the strategic issues about which thought should be given early in the product development process so that the manufacturer is not later caught by surprise at either too low, or no, payment.

Topics to be Discussed:

What are coverage determinations?
How are coverage determinations made by third-party payors?
When are coverage determinations made by payors?
What are existing payment methodologies used by third-party payors, and how do devices and biologics fit into those?
The CPT coding system and how you can get a new code.
Understanding the coverage and payment issues in the context of product development and the FDA approval process to see what strategic issues a manufacturer should consider.
FDA labeling provisions and the relationship to coverage and reimbursement issues.