Protecting Your Biotech IP and Market Strategy: Notes from Life Sciences Collaborative 2015 Meeting
Achievement Beyond Regulatory Approval – Design for Commercial Success
Stephen J. Williams, Ph.D.: Reporter
The Mid-Atlantic group Life Sciences Collaborative, a select group of industry veterans and executives from the pharmaceutical, biotechnology, and medical device sectors whose mission is to increase the success of emerging life sciences businesses in the Mid-Atlantic region through networking, education, training and mentorship, met Tuesday March 3, 2015 at the University of the Sciences in Philadelphia (USP) to discuss post-approval regulatory issues and concerns such as designing strong patent protection, developing strategies for insurance reimbursement, and securing financing for any stage of a business.
The meeting was divided into three panel discussions and keynote speech:
- Panel 1: Design for Market Protection– Intellectual Property Strategy Planning
- Panel 2: Design for Market Success– Commercial Strategy Planning
- Panel 3: Design for Investment– Financing Each Stage
- Keynote Speaker: Robert Radie, President & CEO Egalet Corporation
Below are Notes from each PANEL Discussion:
For more information about the Life Sciences Collaborative SEE
Website: http://www.lifesciencescollaborative.org/
Or On Facebook
Or On Twitter @LSCollaborative
Panel 1: Design for Market Protection; Intellectual Property Strategy Planning
Take-home Message: Developing a very strong Intellectual Property (IP) portfolio and strategy for a startup is CRITICALLY IMPORTANT for its long-term success. Potential investors, partners, and acquirers will focus on the strength of a startup’s IP so important to take advantage of the legal services available. Do your DUE DIGILENCE.
Panelists:
John F. Ritter, J.D.., MBA; Director Office Tech. Licensing Princeton University
Cozette McAvoy; Senior Attorney Novartis Oncology Pharma Patents
Ryan O’Donnell; Partner Volpe & Koenig
Panel Moderator: Dipanjan “DJ” Nag, PhD, MBA, CLP, RTTP; President CEO IP Shaktl, LLC
Notes:
Dr. Nag:
- Sometimes IP can be a double edged sword; e.g. Herbert Boyer with Paul Berg and Stanley Cohen credited with developing recombinant technology but they did not keep the IP strict and opened the door for a biotech revolution (see nice review from Chemical Heritage Foundation).
- Naked patent licenses are most profitable when try to sell IP
John Ritter: Mr. Ritter gave Princeton University’s perspective on developing and promoting a university-based IP portfolio.
- 30-40% of Princeton’s IP portfolio is related to life sciences
- Universities will prefer to seek provisional patent status as a quicker process and allows for publication
- Princeton will work closely with investigators to walk them through process – Very Important to have support system in place INCLUDING helping investigators and early startups establish a STRONG startup MANAGEMENT TEAM, and making important introductions to and DEVELOPING RELATIONSHIOPS with investors, angels
- Good to cast a wide net when looking at early development partners like pharma
- Good example of university which takes active role in developing startups is University of Pennsylvania’s Penn UPstart program.
- Last 2 years many universities filing patents for startups as a micro-entity
Comment from attendee: Universities are not using enough of their endowments for purpose of startups. Princeton only using $500,00 for accelerator program.
Cozette McAvoy: Mrs. McAvoy talked about monetizing your IP from an industry perspective
- Industry now is looking at “indirect monetization” of their and others IP portfolio. Indirect monetization refers to unlocking the “indirect value” of intellectual property; for example research tools, processes, which may or may not be related to a tangible product.
- Good to make a contractual bundle of IP – “days of the $million check is gone”
- Big companies like big pharma looks to PR (press relation) buzz surrounding new technology, products SO IMPORTANT FOR STARTUP TO FOCUS ON YOUR PR
Ryan O’Donnell: talked about how life science IP has changed especially due to America Invests Act
- Need to develop a GLOBAL IP strategy so whether drug or device can market in multiple countries
- Diagnostics and genes not patentable now – Major shift in patent strategy
- Companies like Unified Patents can protect you against the patent trolls – if patent threatened by patent troll (patent assertion entity) will file a petition with the USPTO (US Patent Office) requesting institution of inter partes review (IPR); this may cost $40,000 BUT WELL WORTH the money – BE PROACTIVE about your patents and IP
Panel 2: Design for Market Success; Commercial Strategy Planning
Take-home Message: Commercial strategy development is defined market facing data, reimbursement strategies and commercial planning that inform labeling requirements, clinical study designs, healthcare economic outcomes and pricing targets. Clarity from payers is extremely important to develop any market strategy. Develop this strategy early and seek advice from payers.
Panelists:
David Blaszczak; Founder, Precipio Health Strategies
Terri Bernacchi, PharmD, MBA; Founder & President Cambria Health Advisory Professionals
Paul Firuta; President US Commercial Operations, NPS Pharma
Panel Moderator: Matt Cabrey; Executive Director, Select Greater Philadelphia
Notes:
David Blaszczak:
- Commercial payers are bundling payment: most important to get clarity from these payers
- Payers are using clinical trials to alter marketing (labeling) so IMPORTANT to BUILD LABEL in early clinical trial phases (phase I or II)
- When in early phases of small company best now to team or partner with a Medicare or PBM (pharmacy benefit manager) and payers to help develop and spot tier1 and tier 2 companies in their area
Terri Bernacchi:
- Building relationship with the payer is very important but firms like hers will also look to patients and advocacy groups to see how they respond to a given therapy and decrease the price risk by bundling
- Value-based contracting with manufacturers can save patient and payer $$
- As most PBMs formularies are 80% generics goal is how to make money off of generics
- Patent extension would have greatest impact on price, value
Paul Firuta:
- NPS Pharma developing a pharmacy benefit program for orphan diseases
- How you pay depends on mix of Medicare, private payers now
- Most important change which could affect price is change in compliance regulations
Panel 3: Design for Investment; Financing Each Stage
Take-home Message: VC is a personal relationship so spend time making those relationships. Do your preparation on your value and your market. Look to non-VC avenues: they are out there.
Panelists:
Ting Pau Oei; Managing Director, Easton Capital (NYC)
Manya Deehr; CEO & Founder, Pediva Therapeutics
Sanjoy Dutta, PhD; Assistant VP, Translational Devel. & Intl. Res., Juvenile Diabetes Research Foundation
Panel Moderator: Shahram Hejazi, PhD; Venture Partner, BioAdvance
- In 2000 his experience finding 1st capital was what are your assets; now has changed to value
Notes:
Ting Pau Oei:
- Your very 1st capital is all about VALUE– so plan where you add value
- Venture Capital is a PERSONAL RELATIONSHIP
- 1) you need the management team, 2) be able to communicate effectively (Powerpoint, elevator pitch, business plan) and #1 and #2 will get you important 2nd Venture Capital meeting; VC’s don’t decide anything in 1st meeting
- VC’s don’t normally do a good job of premarket valuation or premarket due diligence but know post market valuation well
- Best advice: show some phase 2 milestones and VC will knock on your door
Manya Deehr:
- Investment is more niche oriented so find your niche investors
- Define your product first and then match the investors
- Biggest failure she has experienced: companies that go out too early looking for capital
Dr. Dutta: funding from a non-profit patient advocacy group perspective
- Your First Capital: find alliances which can help you get out of “valley of death”
- Develop a targeted product and patient treatment profile
- Non-profit groups ask three questions:
1) what is the value to patients (non-profits want to partner)
2) what is your timeline (we can wait longer than VC; for example Cystic Fibrosis Foundation waited long time but got great returns for their patients with Kalydeco™)
3) when can we see return
- Long-term market projections are the knowledge gaps that startups have (the landscape) and startups don’t have all the competitive intelligence
- Have a plan B every step of the way
Other posts on this site related to Philadelphia Biotech, Startup Funding, Payer Issues, and Intellectual Property Issues include:
PCCI’s 7th Annual Roundtable “Crowdfunding for Life Sciences: A Bridge Over Troubled Waters?” May 12 2014 Embassy Suites Hotel, Chesterbrook PA 6:00-9:30 PM
The Vibrant Philly Biotech Scene: Focus on KannaLife Sciences and the Discipline and Potential of Pharmacognosy
The Vibrant Philly Biotech Scene: Focus on Computer-Aided Drug Design and Gfree Bio, LLC
The Vibrant Philly Biotech Scene: Focus on Vaccines and Philimmune, LLC
The Bioscience Crowdfunding Environment: The Bigger Better VC?
Foundations as a Funding Source
Venture Capital Funding in the Life Sciences: Phase4 Ventures – A Case Study
10 heart-focused apps & devices are crowdfunding for American Heart Association’s open innovation challenge
Funding, Deals & Partnerships
Medicare Panel Punts on Best Tx for Carotid Plaque
9:15AM–2:00PM, January 27, 2015 – Regulatory & Reimbursement Frameworks for Molecular Testing, LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA
FDA Commissioner, Dr. Margaret A. Hamburg on HealthCare for 310Million Americans and the Role of Personalized Medicine
Biosimilars: Intellectual Property Creation and Protection by Pioneer and by Biosimilar Manufacturers
Litigation on the Way: Broad Institute Gets Patent on Revolutionary Gene-Editing Method
The Patents for CRISPR, the DNA editing technology as the Biggest Biotech Discovery of the Century