2015 CAS Schedule:
May 13th – Reimbursement – Fast Moving and Volatile – with Pat Trifunov
April 21th – Find Additional Sources of Capital for Your Business: Grants and Sellable Tax Credits – with Anne Fabry from MVM Associates/Garden State Incentives
Mar 17th – Interactions for Success with the FDA – with Kelliann Payne from Hogan Lovells.
Feb 24th – Engaging Partnerships – Looking at the World Around You a BioPharm Insight Case Study & Demo
2015 LaunchNJ-Lifescience subgroup meetup:
November 19th – How to Get the Most from Your CRO: A mixed panel of CROs and CRO startup users. (register to attend on the meetup site)
August 10th – Key components needed to raise funds: from Out-licensing to Venture Funding a panel of experts.
What are the key pieces you need to execute for successful connections from conceptualization of an idea on the benchtop to partnering with investors or funding sources.
– Obtaining the Asset – Out-licensing Challenges
– Funding Early Stage Initiatives – Early Initiatives: prototype development, pre-clinical and sometimes clinical research
– Initial Engagement with Equity Based Funders
Time: 11:00-1:00
Location: NJIT EDC (directions)
Moderator: Sam Kongsamut – Experienced Entrepeneurial Scientist with multiple roles from large pharma to entrepreneurial company
Panel:
Rick Colosimo: Rick’s diverse legal practice ranges from providing complex, “bet-the-company” transactional and corporate governance advice to independent directors and stakeholders in closely held businesses to structuring new businesses for startup founders positioning themselves to raise capital.
Haro Hartounian: From Chemical Engineering PhD and accademic roles Haro traslated science to successful founding role for a series of medical companies: Vyteris, Protagenic Therapeutics and Microislet. Haro is now the Entrepreneure in Residence at the NJIT EDC
Caroline Hoedemaker: The Founder of the tTAp: a Life Science Accelerator. Caroline’s career has branched from engineering to marketing to CEO – all focused on the execution delivering early innovation to the marketplace: both within early startups through Fortune 100 companies.
John Pennett: Eisner Amper’s Partner-in-Charge of the Life Sciences Group and Technology Group. He has 30 years of public accounting experience with a strong emphasis on public and private life science and technology companies
May 18th – CEO Engagement: A Panel of CEOs – What, When, Why, and HOW they joined science based founders and grew.
2015 CAS Detail:
May 13th – Reimbursement – Fast Moving and Volatile.
The daunting effort to predict the reimbursement future of your product in development
• Significant restructuring of the U.S. healthcare system
• Changes in private and public benefit designs in response to rising costs
• Movement towards pay per performance versus pay for service, led by the government
We’ll discuss how these reimbursement trends can be positively exploited in the development of your product value proposition.
Pat Trifunov of Velocity BioGroup shares her perspective. The Velocity BioGroup is a vaccine and biopharmaceutical consulting company dedicated to building commercialization priorities into all stages of clinical development. This means that payer, patient, health plan and regulatory benefits are translated alongside the medical efficacy and safety profile of each project we undertake. Our goal is to help your bio, pharma or medical device company stage your assets for market readiness by incorporating stakeholder values into the clinical strategy of your development. Why? You or your partner need deeply embedded commercial thinking built into your assets in order to sell them in today’s market!
Pat has a degree in pharmacy and has spent 25 years in the biopharmaceutical industry with several companies before starting her own business. She is the former Vice President of US Government Markets at GlaxoSmithKline. At GSK Pat led a team of contracting, account specialist and business strategists with a $3.5 billion book of business to the Medicare, Medicaid, Ryan White, VA, Department of Defense, and Indian Health to name a few.
In her position at GSK Pat was called upon to assess the potential market and community value of new products in development, based on their benefit risk profile. In addition to government, health plan and prescriber perspectives, Pat’s experience reflected her engagement in patient advocacy, tracking all the way back to the introduction of AZT into the HIV community.
April 21th – Find Additional Sources of Capital for Your Business – with Anne Fabry from MVM Associates/Garden State Incentives.
Grants and Sellable Tax Credits
• Additional Working Capital
• What Applies, and How to Qualify
• Realistic Expectations in Value or Incentive Savings
• Regional Commentary with a Focus on NJ and PA
Anne Fabrey Focuses on locating non- dilutive sources of capital such as grants and sellable tax credits for businesses. She specializes in securing resources for technology, biotech/life science and manufacturing related organizations as part of the MVM Associates and Garden State Incentives.
MVM Associates, Inc., is a leader in securing and managing a variety of grants and tax credits for companies throughout the United States. MVM is located in Fort Washington, PA with partner firm Garden State Incentive located in Camden NJ, specializes in sellable state tax credits. As a tax credit incentive leader in the industry, MVM has processed over $250 million dollars in transfer applications for hundreds of companies.
March 17th: Pre Submission Meetings with the FDA – with Kelliann Payne from Hogan Lovells
FDA Interaction
• When, Where, How
• Determining the lead center for your product
• The device de novo alternative
• Strategies for Success
Kelliann Payne: Kelliann Payne’s work focuses on issues related to medical devices. Her experience includes the development, regulation, advertising and litigation of medical devices. Specifically, Kelliann’s work at Hogan Lovells includes drafting premarket submissions for diagnostic and therapeutic medical devices, as well as evaluating applicable regulatory strategies for a range of medical devices. She also assists in preparing companies for meetings with the FDA to discuss applicable regulatory strategies for proposed medical devices or appeal prior FDA decisions. In addition, Kelliann reviews the scientific accuracy of claims made by a client or their competitor in promotional materials and formulates possible regulatory options.
Prior to joining Hogan Lovells, Kelliann was a senior consultant for a well-known scientific consulting firm. In this position, her activities included analysis of complex regulatory challenges and regulatory strategy for innovative products, preparation of medical device regulatory submissions, assistance with preclinical and clinical programs, preparation for FDA meetings and advisory panels, post-marketing product stewardship, due diligence for investments and acquisitions, and critical review of scientific data and regulatory literature.
In addition, Kelliann served as Assistant General Counsel at QVC, Inc. from 2013 to 2014. In her role at QVC, Kelliann counseled internal clients regarding the applicable FDA and FTC regulations that applied to beauty, health, and wellness products sold on-air and online
February 24th: Engaging Partnerships – Looking at the World Around You a BioPharm Insight Case Study & Demo
Assessments of the Environment and Where to Find Interest
• Complementary Fit
• Competitive Transactions
• Geographic Coverage
• Identification of Contacts
Dan Chupka: US Sales Director at BioPharm Insight will provide an overview of the possibilities BioPharm Insight provides followed by a case study demonstrating potential value for one of the potential portfolio companies.
BioPharm Insight is a comprehensive online system profiling global companies, key R&D and management contacts, drug pipelines, M&A and licensing deals, sales forecast and more. This real-time database is supported by proprietary forward-looking intelligence uncovered by a dedicated team of unbiased investigative journalists on a daily basis. BioPharm Insight provides comprehensive support for…
• Business development for CROs and service providers
• Market intelligence for biopharma analysts
• Competitive strategy assessments
• Industry trends, developments and forecasts
• Investment opportunities and evaluations
BioPharm Clinical is a centralized online hub providing convenient access and custom searches to enable you to improve global trial management quality and efficiency while shortening timelines – thus avoiding costly delays in foregone drug sales. Leading CROs, biopharmaceutical companies and EDC providers rely on BioPharm Clinical to…
• Improve patient recruitment
• Evaluate sites and investigators
• Benchmark clinical progress vs. competition
• Assess study feasibility
BioPharma Insight is part of Infinata, Inc. which provides data management, news and information solutions and easily-accessible marketing analytics to the life sciences, finance and wealth management industries. Infinata is part of the Mergermarket Group.
2015 LaunchNJ Detail:
May 18th via LaunchNJ meetup at the CCIT on route 1 6-9
Successful CEOs – What, When, Why, and HOW – They joined science based companies and made them grow.
Their initial engagement and tools they used to engage their teams
• Attracting Interest: CEO On-Boarding
• Identification of Fit: From initiation of core team through growth
• Initial Contract Variables to consider and use, and how they change in the process
• Leveraging of varied skill sets to improve traction
SPEAKERS BIO: Serial CEOs – with different approaches
Richard Russo: Richard Russo has had wide-ranging career in the medical device industry. Starting out in sales, he had held positions in sales management, product management and marketing. He has also been hands on and managed regulatory affairs, clinical trials, product development, strategic planning and acquisitions, all of which led eventually to general management. He has worked for such organizations as American Hospital Supply Corporation, CR Bard, Electro-Biology and Osteotech. He was also start up manager and investor in a startup, Meditron Corporation, which was successfully acquired by a public company.
Richard is currently the president & CEO of a startup medical device venture, Endomedix, Inc., located at the EDC incubator in Newark, New Jersey. Endomedix has developed a patented hydrogel technology for surgical hemostasis, tissue sealing and tissue engineering indications.
Theodore Rich: Mr. Rich is former founder, CEO, and Chairman of Fiberguide Industries Inc. Fiberguide is a world leader in the manufacture of specialty optical fibers and fiber optic assemblies with international sales.
Education: Master of Science in Applied Physics, Stevens Institute of Technology, Hoboken NJ, 1971; Bachelor of Science-Magna cum Laude in Physics with a minor in mathematics, Polytechnic Inst. of Brooklyn, Brooklyn, NY 1969.
History:
Chief Technical Officer Fiberguide Industries Inc. (part-time) 2005 – 2014.
CEO and Chairman Fiberguide Industries Inc. 1977-2005 (sold Company).
Member of Technical Staff at Bell Labs in Murray Hill, NJ 1965-1977.
Published several papers in leading technical journals, and holder of several patents in optical and fiber optic technologies
Michael Behr: Michael Behr is a seasoned business executive and marketing professional with proven record of achievement in developing business and the commercialization process. He has over 25 years of experience in the medical device industry. He founded CD Diagnostics, Inc. in 2008. He built the company from the concept of a novel process to diagnose infection in total joint replacements. He oversaw the initial raise of $1.5M in angel funding, assisted with marketing partnership that infused CD Diagnostics with $4M in funding and completed a series A funding of $2M. CD Diagnostics develops and manufactures immunoassays for joint fluid analysis. LS Enterprises named them “Start-up Company of the Year” in 2013.
Prior to founding CD Diagnostics he spent 20+ years in the orthopaedic industry with both Zimmer and J&J Orthopaedics. He has served on the Board of Directors for CD Diagnostics, the Philadelphia Boys Choir and the Whitpain Recreation Association.