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Take advantage of Early-Bird RegistrationSign up by September 17 and save … see page 14.
10 th ANNIVERSARY SYMPOSIUM
A Joint Symposium of BioNJ & Pennsylvania Bio
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SchEDuLE OF EvENtS at-a-gLaNcE (as of August 17, 2010)
Wednesday, October 27, 2010*
7:30 a.m. - 4:00 p.m. Registration7:30 a.m. - 8:30 a.m. Continental Breakfast8:30 a.m. - 11:30 a.m. Innovation Corridor Session I9:00 a.m. - 10:15 a.m. Tracks Session I (Growth Strategies for Bioscience Companies, Hot Topics in Business, and Medical Device, Diagnostics & Drug Delivery)
9:00 a.m. - 12:00 p.m. Company Presentations Session I9:00 a.m. - 12:00 p.m. Partnering Session I10:15 a.m. - 10:30 a.m. Refreshment Break10:30 a.m. - 11:45 a.m. Tracks Session II (Growth Strategies for Bioscience Companies, Hot Topics in Business, and Medical Device, Diagnostics & Drug Delivery)
12:00 p.m. - 1:30 p.m. Plenary Lunch 1:45 p.m. - 9:00 p.m. Exhibits1:45 p.m. - 3:00 p.m. Tracks Session III (Growth Strategies for Bioscience Companies, Hot Topics in Business, and Medical Device, Diagnostics & Drug Delivery)
1:45 p.m. - 4:45 p.m. Company Presentations Session II1:45 p.m. - 4:45 p.m. Partnering Session II3:00 p.m. - 3:15 p.m. Refreshment Break3:15 p.m. - 4:45 p.m. Plenary Session 4:45 p.m. - 6:30 p.m. Networking Reception in Exhibit Hall6:30 p.m. - 8:00 p.m. Dinner & Keynote Address8:00 p.m. - 9:00 p.m. Networking Dessert Reception in Exhibit Hall
thursday, October 28, 2010
7:30 a.m. - 4:00 p.m. Registration7:30 a.m. - 8:30 a.m. Continental Breakfast7:30 a.m. - 9:00 a.m. CEO Breakfast (By Invitation Only)8:30 a.m. - 11:30 a.m. Innovation Corridor Session II9:00 a.m. - 10:15 a.m. Tracks Session I (Communications & Public Affairs, Finance, and Hot Topics in Science)
9:00 a.m. - 12:00 p.m. Company Presentations Session III9:00 a.m. - 12:00 p.m. Partnering Session III10:15 a.m. - 10:30 a.m. Refreshment Break10:30 a.m. - 11:45 a.m. Tracks Session II (Communications & Public Affairs, Finance, and Hot Topics in Science)
12:00 p.m. - 1:30 p.m. Luncheon & Keynote Address 1:30 p.m. - 3:30 p.m. Company Presentations Session IV1:30 p.m. - 3:30 p.m. Partnering Session IV1:30 p.m. - 4:30 p.m. Innovation Corridor Session III1:45 p.m. - 3:00 p.m. Tracks Session III (Communications & Public Affairs, Finance, and Hot Topics in Science)
3:30 p.m. - 4:30 p.m. Closing Networking Reception
*times for sessions and programs are subject to change.For updates, please visit www.biotech2010.org.
A J o i n t S y m p o s i u m o f B i o N J & P e n n s y l v a n i a B i o
OCTOBER 27-28, 2010 | PEnnsylvania COnvEnTiOn CEnTER
w w w . b i o t e c h 2 0 1 0 . o r g
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WELcOmE LEttER
Join us for Biotech 2010, our 10th Anniversary Symposium, where bioscience leaders will come to imagine,
collaborate, and innovate.
In a little more than a decade, what started out as a modest meeting has grown to become the most
important gathering for bioscience professionals, investors, government offi cials, and academia who are
working to advance the biosciences in Delaware, New Jersey, and Pennsylvania.
This year on October 27 and 28, up to 1,000 attendees will fi ll the meeting rooms, Exhibit Hall, Plenary
Sessions, and hallways of the Pennsylvania Convention Center in Philadelphia.
We invite you to be among them.
Always mindful that this is your meeting, we have taken your input to identify and address both the
opportunities and challenges we all are facing, particularly during these times of continuing economic
uncertainty.
Thanks to the efforts of our generous sponsors and our dozens of volunteers, you will see enhancements
and refi nements to the symposium’s long-standing programs along with even more targeted opportunities
to network with old friends and meet new colleagues.
With each year, the words imagine, collaborate, and innovate take on a deeper and richer signifi cance.
We are proud of what this joint symposium between BioNJ and Pennsylvania Bio has accomplished, and
we encourage you to come join your colleagues as our community continues to lead and grow.
Best regards,
Jeffrey P. LibsonPepper Hamilton LLPSymposium Co-Chair
James J. MarinoDechert LLP
Symposium Co-Chair
Debbie HartPresident
BioNJ
Christopher P. MolineauxPresident
Pennsylvania Bio
Photos from Biotech 2009 by Anthony Sinagoga
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KEY SPONSORS (as of August 17, 2010)
A J o i n t S y m p o s i u m o f B i o N J & P e n n s y l v a n i a B i o
OCTOBER 27-28, 2010 | PEnnsylvania COnvEnTiOn CEnTER
w w w . b i o t e c h 2 0 1 0 . o r g
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5For more information on available sponsorship opportunities, please visit the Sponsorship section of www.biotech2010.org.
KEYNOtE DiNNER SPONSOR Celgene Corporation
KEYNOtE LuNchEON SPONSOR Pepper Hamilton LLP
WEDNESDaY LuNch PLENaRY SESSiON SPONSORCentocor Ortho Biotech Inc.
cEO BREaKFaSt SPONSORDechert LLP
WEDNESDaY aFtERNOON PLENaRY SESSiON SPONSORErnst & Young
WEDNESDaY NEtWORKiNg REcEPtiON SPONSORMerck & Co., Inc.
REgiStRatiON Bag SPONSORGlaxoSmithKline
cOmmuNicatiONS & PuBLic aFFaiRS tRacK SPONSORCephalon, Inc.
FiNaNcE tRacK SPONSORKPMG LLP
gROWth StRatEgiES FOR BiOSciENcE cOmPaNiES tRacK SPONSORMorgan, Lewis & Bockius, LLP
hOt tOPicS iN BuSiNESS tRacK SPONSOR PricewaterhouseCoopers
hOt tOPicS iN SciENcE tRacK SPONSORFisher Scientific
WatER BOttLE SPONSOREurand
iNNOvatiON cORRiDOR SPONSORAstraZeneca
vOLuNtEER aPPaREL SPONSOR Endo Pharmaceuticals
at a gLaNcE caRD SPONSORIMS Health
Bag tag SPONSOR United BioSource Corporation
LaNYaRD SPONSORDuane Morris LLP
PEN SPONSOREisnerAmper LLP
cLOSiNg NEtWORKiNg REcEPtiON SPONSORBiotechnology Industry Organization
cONtiNENtaL BREaKFaSt SPONSORSLilly USA, LLC sanofi pasteur
BREaK SPONSORSEndo Pharmaceuticals LifeCell Corporation Stradley Ronon Stevens & Young, LLP
cOmPaNY PRESENtatiONS SPONSORSonnenschein Venture Technology Group
PLatiNum SPONSOR Deloitte
gOLD SPONSORS Greater Philadelphia Life Sciences Congress University City Science Center
mEDia SPONSORS BioWorld Today Business Wire Medical Device Daily PharmaVOICE
mEDia SuPPORtERSBioCentury The Scientist
WWW.BIOTECH2010.ORG | PENNSYLVANIA CONVENTION CENTER | OCTOBER 27-28, 2010 | BIOTECH 2010
SPONSORS
Join the Biotech 2010 group on and follow us on @ Biotech_2010.
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WWW.BIOTECH2010.ORG | PENNSYLVANIA CONVENTION CENTER | OCTOBER 27-28, 2010 | BIOTECH 2010
KEYNOtE SPEaKER
Alex Gorsky is the worldwide chairman of Johnson & Johnson’s Medical Devices and Diagnostics Group and a
member of the Company’s Executive Committee. He assumed this role in September 2009.
Mr. Gorsky began his Johnson & Johnson career as a sales representative with Janssen Pharmaceutica in
1988. Over the next 15 years, he advanced through positions of increasing responsibility in sales, marketing,
and management and, in 2001, was appointed president of Janssen. In 2003, he was promoted to company
group chairman of Johnson & Johnson’s pharmaceutical business in Europe, the Middle East, and Africa.
He left Johnson & Johnson in 2004 to serve as the chief operating officer for Novartis Pharmaceuticals
Corporation. In 2005, he was named head of Pharma North America and CEO for Novartis.
Mr. Gorsky returned to Johnson & Johnson in 2008 as company group chairman and worldwide franchise
chairman for Ethicon. At that time, he also was appointed to the Surgical Care Group Operating Committee. In
early 2009, he was appointed worldwide chairman of the Surgical Care Group and also was appointed to the
Johnson & Johnson Executive Committee.
Mr. Gorsky holds a Bachelor of Science degree from the U.S. Military Academy at West Point, N.Y., and
spent six years in the U.S. Army, finishing his military career with the rank of Captain. He earned a Master of
Business Administration degree from The Wharton School of the University of Pennsylvania in 1996.
A longtime advocate of diversity and inclusion, Mr. Gorsky was named the 2009 Mentor of the Year by the
Healthcare Businesswomen’s Association, an organization he has been involved with for many years. During
his tenure with Novartis, he established the Novartis CEO Award for Diversity and Inclusion. Currently, he is the
executive sponsor of the Johnson & Johnson Women’s Leadership Initiative.
Mr. Gorsky serves on the board of directors of the Doylestown Hospital in Doylestown, PA. He and his wife, Pat,
have a son, Nicholas.
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alex gorsky Worldwide Chairman, Medical Devices and Diagnostics GroupJohnson & Johnson
Luncheon & Keynote AddressThursday, October 28, 201012:00 p.m. – 1:30 p.m.Sponsored by Pepper Hamilton LLP
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iNNOvatiON cORRiDOR
Sponsored by AstraZeneca
Abstract Submission Deadline - September 13th
Calling all students, faculty, principal investigators, early-stage companies, and entrepreneurs – submit a topic and abstract of your work for a poster presentation at the Biotech 2010 Innovation Corridor.
The Innovation Corridor offers you the opportunity to showcase your research, receive feedback on your poster from a panel of experts, and to receive a discounted rate of $100 to participate in the Innovation Corridor and other Biotech 2010 sessions on the day of your poster presentation.
For more information or to submit an abstract, visit the Innovation Corridor section of www.biotech2010.org.
PaRtNERiNg
Biotech 2010 features enhanced and improved Partnering, including a new complimentary online system for scheduling meetings as well as reserving Partnering Suites. As an attendee* of Biotech 2010, you will be sent an invitation to log on to biopartnering.com.
how will Partnering at Biotech 2010 Benefit You?
• Create your own personalized schedule, as well as company, product, and personal profiles
• Start your networking long before you arrive at Biotech 2010
• Unlimited meeting possibilities – there is no restriction to the number of meeting requests you can receive or submit
Want to reserve your own dedicated Partnering Suite? Just pay the full symposium registration, plus $350.
For more information, visit the Partnering section of www.biotech2010.org.
*The Partnering system is not available to Exhibit Hall-only attendees.
WWW.BIOTECH2010.ORG | PENNSYLVANIA CONVENTION CENTER | OCTOBER 27-28, 2010 | BIOTECH 2010
cOmPaNY PRESENtatiONS
Sponsored by Sonnenschein Venture Technology Group
Application Deadline - September 17th
Is your bioscience company interested in raising capital, partnering, or developing strategic alliances for your products or technologies? If so, submit an application to present your company at Biotech 2010.
Presenting companies will have the opportunity to make their pitch to an audience of business development executives, investors, CEOs, and other industry executives. The cost for presenting is the full symposium registration, plus $150 for BioNJ, DE Bio, or PA Bio members or $300 for non-members.
For more information or to submit an application to present, visit the Company Presentations section of www.biotech2010.org.
ExhiBit haLL
Wednesday, October 27, 2010 1:45 p.m. - 9:00 p.m.
With 1,000 leaders from across the mid Atlantic region expected to attend – the Biotech 2010 Exhibit Hall is your opportunity to reach key bioscience decision makers. Join the more than 60 bioscience companies and support organizations that will be on the floor at the Biotech 2010 Exhibit Hall.
Exhibit Fees On or before 9.17.2010 after 9.17.2010
BioNJ, DE Bio, or PA Bio Member $1,750 $2,000
Non-Member $2,300 $2,600
The exhibit fee includes one full registration. Exhibit Hall-only badges are available for exhibitors at $400 (includes access to Exhibit Hall and Keynote Dinner only).
For more information or to download the exhibitor application, visit the Exhibit Hall section of www.biotech2010.org.
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Wednesday, October 27, 2010
7:30 a.m. - 4:00 p.m. Registration
7:30 a.m. - 8:30 a.m. continental Breakfast Sponsored by sanofi pasteur
8:30 a.m. - 11:30 a.m. innovation corridor Session i Sponsored by AstraZeneca
9:00 a.m. - 10:15 a.m. tracks Session i
growth Strategies for Bioscience companies Session i Sponsored by Morgan, Lewis & Bockius, LLP
it’s all about the Exit: Strategies and tactics
Your company has made significant developmental progress. You have an excellent management team; but, the costs to develop the technology to the next milestone are daunting. You have less than one year’s worth of cash and your investors want an exit. What should you do?
Our panel of experts will discuss:
• Under what circumstances you should pursue a dual track (IPO and M&A simultaneously)?
• At what point should you officially engage a bank?
• What are the most important tactics for a successful IPO?
• Does pursuing an IPO really provide leverage for an M&A?
• What is the most effective way to pursue an M&A?
• Will investors be less interested if you are also pursuing an M&A?
Attendees will learn the nuances of a successful diligence and will gain an appreciation for the importance of the diligence team, the timing of its assembly, and the potential internal and external components.
hot topics in Business Session i Sponsored by PricewaterhouseCoopers
global collaboration: Opportunities in Emerging markets
Emerging markets, most notably the BRIC countries, are increasingly important to bioscience companies, covering a spectrum ranging from sources of low-cost R&D and manufacturing to high-growth markets for products. Pharmaceutical companies are shifting resources and investment to these markets and smaller firms will only be able to participate with pharma’s help. There are risks and unknowns that biotechs will need to work through and understand. The panel of pioneering companies will share their perspectives on:
• The current state of R&D in the BRIC countries
• The regulatory and legal environment in these countries
• The risks (IP, regulatory, legal) associated with emerging markets
• Tactics that help mitigate risks
• The opportunities (licensing/commercialization) that exist for small biotechs
• How small biotechs can team up and capitalize on inroads made by pharmaceutical companies
• What should be expected with the evolution of domestic firms within these markets?
medical Device, Diagnostics & Drug Delivery Session i
the coming 510(k) Overhaul: What’s in Store for Your company?
The vast majority of medical devices find their way to the U.S. marketplace via the 510(k) clearance process. This process has historically involved the demonstration of “substantial equivalence” to existing medical devices, and in most cases involves 90-120 days of regulatory review. The FDA’s Center for Devices and Radiological Health (CDRH) has announced a new set of strategic priorities for 2010 and beyond, and the changes include an overhaul of the 510(k) clearance process.
CDRH created an internal 510(k) Working Group, which issued its initial recommendations in August 2010. The Agency has also commissioned an Institute of Medicine review of the 510(k) process that is set to publish in June 2011. Industry representatives have expressed concern that the impending changes will ultimately blunt innovation through unnecessary regulations that would increase the development cost and timeline for new devices.
The panel will review the 510(k) changes that are likely to be implemented and outline how companies will likely need to adapt.
9:00 a.m. - 12:00 p.m. company Presentations Session i
9:00 a.m. - 12:00 p.m. Partnering Session i
10:15 a.m. - 10:30 a.m. Refreshment Break Sponsored by LifeCell Corporation
10:30 a.m. - 11:45 a.m. tracks Session ii
growth Strategies for Bioscience companies Session ii Sponsored by Morgan, Lewis & Bockius, LLP
Regulatory Strategies for growth
Recent proposed changes in the FDA approval processes have led to significant concerns on the part of bioscience companies. Some of the major issues that confound
SYmPOSium SchEDuLE OF EvENtS (Detailed)
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For more information on speakers and program updates, visit www.biotech2010.org.
WWW.BIOTECH2010.ORG | PENNSYLVANIA CONVENTION CENTER | OCTOBER 27-28, 2010 | BIOTECH 2010
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investors and corporate management alike include the length of time of new drug reviews, questions around clinical trials, uncertainty around regulatory reviews for devices, and the perception that regulatory processes are becoming unduly burdensome.
The panelists will discuss approaches that mitigate regulatory risks as an impediment to growth, including:
• Strategies that can reduce regulatory uncertainty with clinical trials
• Actions that should be taken to mitigate potential FDA concerns
• Planning for REMS or if the program began before implementation of REMS, the best way to plan for this in real time
• Approaches for dealing with foreign regulatory filings versus U.S. filings
• Approaches for managing regulatory interactions if you are not satisfied with the pace / outcome of feedback
hot topics in Business Session ii Sponsored by PricewaterhouseCoopers
commercialization Strategies for Development-Stage companies
Despite embracing new or emerging therapies and technologies, the evolving market is becoming ever more challenging for small bioscience companies. The cost to capitalize, commercialize, and compete in these industries present operational risks that are magnified in today’s changing environment. The strategy a company undertakes to bring its product to market is one of the more critical decisions an early-stage company will make.
This panel will provide insights based upon personal experiences of those who have been through this critical process, offering early-stage entrepreneurs and managers an opportunity to learn about key issues, potential hurdles, and rationales behind the decision-making process.
medical Device, Diagnostics & Drug Delivery Session ii
Reimbursement with a global Flair: What You Need to trek the medical Device Reimbursement Landscape
Design control… Check. Freedom to operate… Check. Channel analysis… Check. Reimbursement strategy…What?
Medical device reimbursement is sometimes overlooked and frequently misunderstood. A poorly-defined or missing reimbursement strategy could eliminate you from the market before you make your first sales call. Unfortunately, because a mastery of the subject is not typically built into
the organizational DNA, this is a lesson that many early-stage companies have learned the hard way.
In this session, the panel will walk the audience through a real-time “how to guide” focusing on the major components of reimbursement strategy for new medical device technologies.
Supported by actual case studies, the session will provide insight into:
• Where to start in developing specific CPT codes?
• The “ins” and “outs” of obtaining positive coverage policies
• Securing adequate payment rates for your medical device
• Identifying and working with key players
12:00 p.m. - 1:30 p.m. Plenary Lunch Sponsored by Centocor Ortho Biotech Inc.
Pennsylvania gubernatorial candidates Tom Corbett and Dan Onorato have been invited to address the audience on their plans for supporting the bioscience industry.
1:45 p.m. - 9:00 p.m. Exhibits
1:45 p.m. - 3:00 p.m. tracks Session iii
growth Strategies for Bioscience companies Session iii Sponsored by Morgan, Lewis & Bockius, LLP
alternative Business models
The bioscience industry is undergoing dramatic changes due to the economic downturn, the scarcity of capital, and contractions within various segments of the industry. These changes are forcing companies to re-examine their strategies for growth and to become much more creative and thoughtful about the way they nurture and grow their companies.
The necessity of finding innovative ways to finance and grow bioscience companies, including medical devices and diagnostics, has led to transformational business models. Our panel of experts will explore some of the insightful approaches companies are taking to launch, grow, and hopefully find a way to capitalize on their entrepreneurial business endeavors, including:
• Single project company versus a portfolio approach
• Strategic consolidation or roll up model
• Hibernation or survival model
• Put option model
• Virtual model
For more information on speakers and program updates, visit www.biotech2010.org.
WWW.BIOTECH2010.ORG | PENNSYLVANIA CONVENTION CENTER | OCTOBER 27-28, 2010 | BIOTECH 2010
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hot topics in Business Session iii Sponsored by PricewaterhouseCoopers
health care Reform: Bottom Line Perspectives
The Patient Protection and Affordable Care Act of 2010 will have significant effects on a company’s activities to develop, promote, obtain reimbursement, and report data regarding its products and services.
Our panel of experts will provide an overview, from a business perspective, of the most up-to-date information from this Act and how it will impact our industry now that we have moved from the legislative to implementation phase, including:
• Incentives to develop new treatments and devices
• FDA approval processes including any new requirements for demonstrating economic as well as medical benefits
• Reimbursement bases and calculations for sales to federal and state governments
• Criteria to receive Tier 1 or Tier 2 formulary placement with MCO plans
• Incentives for payors
• Promotion and advertising practices directed at publicly-funded individuals or groups
• Market exclusivity parameters arising from IP law, biosimilar designations, orphan drug status, and other issues
• Reporting requirements regarding medicine and device development, consultants, lobbyists, and promotion
medical Device, Diagnostics & Drug Delivery Session iii
Partnering among Pharma, BioPharma, Diagnostics, and medical Device companies – the New Deal?
An increasing trend is emerging in which pharmaceutical and biopharmaceutical companies are partnering with medical
device and diagnostic companies to formulate combination products. These collaborations not only forge new partnerships and develop new ways of doing business, but can ultimately result in highly-innovative life-saving technologies.
This track will present technological advances and improved medical benefits derived from these types of partnerships. Through the use of real world illustrations, the panelists will share their perspectives on:
• An optimal partnership model – financial and scientific
• Understanding and overcoming differences in business models
• Navigating the regulatory environment
• Strategies to ensure successful launch
• The future of partnering
1:45 p.m. - 4:45 p.m. company Presentations Session ii
1:45 p.m. - 4:45 p.m. Partnering Session ii
3:00 p.m. - 3:15 p.m. Refreshment Break Sponsored by Endo Pharmaceuticals
3:15 p.m. - 4:45 p.m. Plenary Session Sponsored by Ernst & Young
4:45 p.m. - 6:30 p.m. Networking Reception in Exhibit hall Sponsored by Merck & Co., Inc.
6:30 p.m. - 8:00 p.m. Dinner & Keynote address Sponsored by Celgene Corporation
8:00 p.m. - 9:00 p.m. Networking Dessert Reception in Exhibit hall
For more information on speakers and program updates, visit www.biotech2010.org.
WWW.BIOTECH2010.ORG | PENNSYLVANIA CONVENTION CENTER | OCTOBER 27-28, 2010 | BIOTECH 2010
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Thursday, October 28, 2010
7:30 a.m. - 4:00 p.m. Registration
7:30 a.m. - 8:30 a.m. continental Breakfast Sponsored by Lilly USA, LLC
7:30 a.m. - 9:00 a.m. cEO Breakfast (By invitation Only) Sponsored by Dechert LLP
8:30 a.m. - 11:30 a.m. innovation corridor Session ii Sponsored by AstraZeneca
9:00 a.m. - 10:15 a.m. tracks Session i
communications & Public affairs Session i Sponsored by Cephalon, Inc.
Walking the Razor’s Edge: Disclosure, transparency, and Reputation in the Era of Sunshine
Against the backdrop of health care reform, pricing scrutiny, and new legislation such as the Sunshine Act, bioscience companies are responding to calls for transparency. They are now revealing their ties to the medical community on a regular basis. Both BIO and PhRMA have responded with pathways for conduct and major health professional organizations have outlined policy recommendations.
Companies have responded to these calls for transparency by opening up their records and sharing annual payments to researchers and institutions starting at $50 per transaction, as well as expenses for third-party grants, consulting, and promotional efforts.
This session will focus on the need for increased industry transparency, the long-term implications of disclosure, and best practices for implementation. It will also examine the effect that this level of disclosure has on the reputation of stakeholders including companies, doctors, medical institutions, and others.
Finance Session i Sponsored by KPMG LLP
Deconstructing a term Sheet: Financing considerations for Earlier-Stage companies
What are the most critical elements of a term sheet and why are they relevant to early-stage companies? This session will provide attendees with an overview of financing considerations for development-stage companies including:
• The current market trends for equity financings
• The current “market” terms that will impact future financing events
• The pitfalls for management and/or existing shareholders
The panelists will discuss common terms and their recent experiences with equity financings of early-stage companies, with additional consideration given to management protections and typical VC or investor preferences and expectations.
The discussion will also cover different types of early-stage investors and the different expectations each type of shareholder brings to the table. They will also examine how to approach the various investors and how you graduate from one class of investor to another.
Finally, the panel will cover the types of investments that are available to development-stage companies and their experiences with different types of debt, equity, and convertible instruments.
hot topics in Science Session i Sponsored by Fisher Scientific
New approaches for cancer treatment: targeting the tumor microenvironment
For the last 30 years, scientists have worked to characterize the basic biology and molecular machinery of tumors. The creation of targeted therapies and molecular profiles is the most dramatic consequence of the human genome project and systems biology, but there is a large gap in our understanding of the systemic and local factors that lead to tumor progression and spread.
The microenvironment is a major new research focus and, among others, the questions this panel will address include:
• Do cells undergo some primary transformation that permits mutations to occur before it becomes malignant?
• Does the early transformed cell require supporting changes in the microenvironment to progress?
• Could inflammation or changes in the bone marrow or immune system have a distant effect on the tumor microenvironment?
• Do cancers arrive from stem cells or do transformed cells take on stem cell characteristics?
9:00 a.m. - 12:00 p.m. company Presentations Session iii
9:00 a.m. - 12:00 p.m. Partnering Session iii
10:15 a.m. - 10:30 a.m. Refreshment Break Sponsored by Stradley Ronon Stevens & Young, LLP
10:30 a.m. - 11:45 a.m. tracks Session ii
For more information on speakers and program updates, visit www.biotech2010.org.
WWW.BIOTECH2010.ORG | PENNSYLVANIA CONVENTION CENTER | OCTOBER 27-28, 2010 | BIOTECH 2010
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communications & Public affairs Session ii Sponsored by Cephalon, Inc.
compliant communication: Who’s Listening (and Who’s talking)? What You Say can be held against You
The era of controlled communications is over. Social media has opened up an increasing number of communication channels to any and all employees. Anyone within a company can now instantly transmit information about their companies, products, or pipelines. At the same time, regulatory agencies around the world, including the FDA, are increasing their scrutiny of off-label promotions and adverse event reporting.
This situation sets up an inherent clash between communications from companies and their employees and the regulatory bodies.
This panel will feature leading regulatory and legal experts from biotechnology, pharmaceutical, medical device, and diagnostic companies, who will discuss the challenges of meeting FDA and other regulatory rules in the era of instantaneous communications through social media.
Finance Session ii Sponsored by KPMG LLP
how Do the Buy-side and Sell-side Really Look at companies?
A group of leading health care research analysts/fund managers will discuss what compels them to provide research coverage, when and why they invest, and their view on what companies can do to achieve a premium valuation. During the panel, attendees will gain insight on smart money’s appetite for risk, valuation of innovation, and expectations for 2010 and beyond.
Topics will include:
• What criteria are used for investment decisions?
• What does the decision-making process include?
• What qualities do investors look for in a company?
• What qualities and/or background do investors look for in a management team?
• How and how much does the buy-side rely on the sell-side?
• When is a private company ready for an IPO?
• How early analysts like to see companies before an IPO?
• What are deal killers for IPOs and other investments?
• What will be the ultimate impact of health care reform on the capital markets?
hot topics in Science Session ii Sponsored by Fisher Scientific
Synthetic Life – how Far are We from Playing god?
On May 20, 2010, Dr. J. Craig Venter reported the design, synthesis, and assembly of the first bacterial cell controlled by a chemically-synthesized genome and a stormy discussion about the ethics has followed. While this breakthrough will affect numerous aspects of our lives, the discussion will focus on the positive and negative implications for medicine, including:
• Just what are the risk/benefits of such an advance?
• How might this help better mankind with future health endeavors, and the element of control, not just of the scientists, but of new microorganisms that may be produced and break through barriers?
• How will the advance differ in small companies versus academic institutions?
• Should the potential for terrorism be a main concern or should we have equally grave concerns about those with no ill intent?
• Will the synthetic cell mean we can grow new organs and body parts?
• What will be the impact on other scientific advances that are currently being developed?
12:00 p.m. - 1:30 p.m. Luncheon & Keynote address Sponsored by Pepper Hamilton LLP Alex Gorsky Worldwide Chairman, Medical Devices & Diagnostics Group Johnson & Johnson
1:30 p.m. - 3:30 p.m. company Presentations Session iv
1:30 p.m. - 3:30 p.m. Partnering Session iv
1:30 p.m. - 4:30 p.m. innovation corridor Session iii Sponsored by AstraZeneca
1:45 p.m. - 3:00 p.m. tracks Session iii
communications & Public affairs Session iii Sponsored by Cephalon, Inc.
New Bioscience Entrepreneurs: the Strategy Behind Positioning for investors and Partnering
Emerging companies usually have the difficult task of needing to focus simultaneously on advancing the science, building the business, and attracting funding. In this panel, startup CEOs, investors, and the financial media will discuss how communicating scientific achievements, business development milestones, and the strength of the team can be key to positioning a company to attract capital and
For more information on speakers and program updates, visit www.biotech2010.org.
WWW.BIOTECH2010.ORG | PENNSYLVANIA CONVENTION CENTER | OCTOBER 27-28, 2010 | BIOTECH 2010
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THURsDay
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THURsDay
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SYmPOSium SchEDuLE OF EvENtS (Detailed)
partnerships. The panel will focus on helping emerging and established bioscience firms explore how they can better leverage corporate communications to achieve strategic goals, including:
• Developing and refining your elevator pitch
• The three things every VC wants to see (and hear about)
• Fielding tough questions from VCs, shareholders, patients, and other stakeholders
• Who is listening, and via what media?
• The importance of communications: simplifying the message, timing, and consistency as the company grows
• Messaging to potential partners to attract non-dilutive investment and achieving industry validation
Finance Session iii Sponsored by KPMG LLP
collaborations: upfront Planning can Pay Dividends
In reaction to many of the same factors impacting the biotech industry, as well as the upcoming patent cliff for a number of blockbusters, the majority of large- and mid-sized pharmaceutical companies have made strong commitments to strategic collaborations. The strategies pursued by pharma have varied however, with a multitude of potential implications for biotechs. This session will address the varied strategic directions of historically key biotech licensing partners and assess the likely outlook for licensing activity in the near future and beyond.
Topics of discussion will include:
• What do recent strategic shifts in pharma and the response to health care reform mean for overall licensing activity?
• Do any of the pharma strategic initiatives signal a change in those firms’ commitment to biotech?
• Do the current trends favor any particular segments or stage of development of biotech?
• What is the importance of tax planning and implications related to potential transactions?
• What is the importance of merger and acquisition planning along with due diligence?
hot topics in Science Session iii Sponsored by Fisher Scientific
mimicking Nature: Who Will Win the Race – tissue Regeneration or artificial Organs?
The last decade has witnessed extraordinary research efforts in tissue engineering, stem cells and other disciplines of regenerative medicine. In parallel, scientists have also made significant strides toward the creation of functional artificial organs. Researchers involved in making these advances come from diverse settings – academicians from universities, researchers from not-for-profits, and VC-backed startups, as well as programs from established companies. No single approach has emerged as a clear winner, and an evaluation of their progress is still ongoing.
This session will discuss innovations for both tissue regeneration and artificial organs, and focus on two model organ systems including beta cell regeneration versus the artificial pancreas and retina stem cells versus the artificial retina.
3:30 p.m. - 4:30 p.m. closing Networking Reception Sponsored by the Biotechnology Industry Organization
For more information on speakers and program updates, visit www.biotech2010.org.
WWW.BIOTECH2010.ORG | PENNSYLVANIA CONVENTION CENTER | OCTOBER 27-28, 2010 | BIOTECH 2010
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REgiStRatiON
Register now at www.biotech2010.org. Early-bird rates end on September 17, 2010.
On or before 9.17.2010 After 9.17.2010
BioNJ, DE Bio, or PA Bio Member $775 $1,025
Non-Member $1,075 $1,350
Bioscience companies with 10 or fewer employees may register two employees for the price of one. E-mail [email protected] to request this type of registration.
Extend Your Conference Experience in Philadelphia
Did you know that the Healthcare Businesswomen’s Association (HBA) Annual Conference is also taking place in Philadelphia around the same time as Biotech 2010?
Biotech 2010 and HBA, the premier catalyst for the leadership development of women in healthcare worldwide, are collaborating to extend your conference experience. We are offering a discounted rate to all Biotech 2010 attendees to participate in the 2010 HBA Annual Conference at the conclusion of Biotech 2010. Attend the HBA Leadership Conference on Friday October 29th, from 7:00 a.m. – 4:00 p.m. for a discounted rate of $475 if you register before September 17th (the discounted rate is $650 after this time). You must be a registered attendee of Biotech 2010 to qualify for the HBA day pass discount.
For more information on the HBA Annual Conference, visit www.hbanet.org.
cONvENtiON cENtER
Pennsylvania Convention Center | 1101 Arch Street | Philadelphia, PA 19107
Located in the heart of Philadelphia, the Pennsylvania Convention Center is easy to reach by plane, train and car.
For more information on directions, parking, or access to the Pennsylvania Convention Center, visit the Symposium Overview section of www.biotech2010.org.
hOtEL iNFORmatiON
Biotech 2010 has reserved a hotel block at the Philadelphia Marriott Downtown that provides a group rate of $199 per room night. The deadline for reservations at this rate is October 12, 2010.
For more information, or to make reservations, visit the Symposium Overview section of www.biotech2010.org or call 800.266.9432.
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co-chairs
Jeffrey P. Libson, Esq.Pepper Hamilton LLP James J. Marino, Esq.Dechert LLP
BioNJ
Debbie HartPresident
Pennsylvania Bio
Christopher P. MolineauxPresident
Steering commit tee
marina atkinsonBioNJ
Jamie ayers Fisher Scientifi c
gil BasheMakovsky + Company
Rob BazemoreCentocor Ortho Biotech Inc.
mel Billingsley, Ph.D.Life Sciences Greenhouse of Central Pennsylvania
Fritz BittenbenderCephalon, Inc.
greg ByrnesPennsylvania Bio
christopher cashman JDP Therapeutics
Stephen costalasDechert LLP
manya DeehrEurand
Karen DeLonePennsylvania Bio
greg geissmanCelgene Corporation
Keith goldanNuPathe Inc.
charles grezlakMerck & Co., Inc.
Kristin hassanBioNJ
Jeffrey hendreyPricewaterhouseCoopers
Stephen Jannetta, Esq. Morgan, Lewis & Bockius LLP
thomas KoncsicsKPMG LLP
Brian LenzCorMedix Inc.
christopher miller, Esq.Pepper Hamilton LLP
David millerGlaxoSmithKline
cindy murrayPennsylvania Bio
William O’DonnellBioNJ
Kathleen OttoBioNJ
topper RayBlank Rome LLP
Judith SheftNew Jersey Institute of Technology
Bruce ShookNeuronetics, Inc.
Robert SilbergMerck & Co., Inc.
Randall Sunberg, Esq.Morgan, Lewis & Bockius LLP
Samir tari, m.D.PCAsso Diagnostics LLC
Donna tempel, Ph.D.Drais Pharmaceuticals, Inc.
greg thomasEndo Pharmaceuticals
tony torringtonErnst & Young
amber van NiekerkPennsylvania Bio
Raymond vennareThermalTherapeutic Systems
Lizanne WentzCorporate Communications
Karla WhitePennsylvania Bio
timothy WhittenTransave, Inc.
christopher YochimAstraZeneca
Pascal Yvon, PharmDBioSciences Expansion, LLC
A J o i n t S y m p o s i u m o f B i o N J & P e n n s y l v a n i a B i o
OCTOBER 27-28, 2010 | PEnnsylvania COnvEnTiOn CEnTER
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16 A J o i n t S y m p o s i u m o f B i o N J & P e n n s y l v a n i a B i o
OCTOBER 27-28, 2010 | PEnnsylvania COnvEnTiOn CEnTER
w w w . b i o t e c h 2 0 1 0 . o r g
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