does your company have the big 3 - life science fast track
DESCRIPTION
Part of the Life Science Venture Fast Track: http://www.thecapitalnetwork.org/programs/life-science-venture-fast-track/TRANSCRIPT
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TCN Life Science Venture Fast Track
Does Your Company Have The Big Three: Intellectual Property, Regulatory,
and Reimbursement? January 21, 2014
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Panelists Therapeu(cs
Leslie Williams President and CEO ImmusanT
Emily Walsh Principal Tremont TherapeuPcs ConsulPng
Device
Nancy Briefs CEO InfoBionic
Nandini Murthy Regulatory Consultant ENEM ConsulPng
Moderator: KonstanPn Linnik Partner, Intellectual Property NuSer McClennen & Fish
Download slides: bit.ly/tcnLifeSci2014
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The Big Three
IP Market Exclusivity (Patent & Regulatory ExclusiviPes)
Regulatory Safety & Efficacy
Payors Value ProposiPon (Pricing, Reimbursement & Market Access)
Download slides: bit.ly/tcnLifeSci2014
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Patent Exclusivity
$
Loss of Exclusivity (LOE)
Generic entry Development��� 7-15 years
FDA Exclusivity
Download slides: bit.ly/tcnLifeSci2014
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IP -‐ Market Exclusivity
Regulatory -‐ Safety & Efficacy
Payors -‐ Value ProposiPon
Ave. Exclusivity ~12.5 yrs, ave. Exclusivity necessary for ROI is at least 12 yrs
50% of Phase III trials fail for lack of efficacy over placebo
3 out of 4 approved drugs are not profitable
$
Download slides: bit.ly/tcnLifeSci2014
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The Big Three: The EssenPals 1. To get reimbursed, the use must be on the label; can’t rely
on off-‐label use or off-‐label promoPon
2. There must be no generic subsPtute available; automaPc subsPtuPon is o_en required by law or by payors
3. To get adequate exclusivity, patent claims must cover the approved use
4. Clinical trials must be designed to support the label and the value proposiPon to payors
Download slides: bit.ly/tcnLifeSci2014
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Examples 1. Biogen’s BG-‐12 (MS or Psoriasis?)
2. Sepracor’s Lunesta (US) v Imovane (Europe)
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Panelists Therapeu(cs
Leslie Williams President and CEO ImmusanT
Emily Walsh Principal Tremont TherapeuPcs ConsulPng
Device
Nancy Briefs CEO InfoBionic
Nandini Murthy Regulatory Consultant ENEM ConsulPng
Moderator: KonstanPn Linnik Partner, Intellectual Property NuSer McClennen & Fish
Download slides: bit.ly/tcnLifeSci2014
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Nutter McClennen & Fish LLP • www.nutter.com 9
IP ProtecPon 1. File early…don’t wait 2. It’s all about the disclosure
3. Know the prior art
4. ArPculate your patent strategy
5. Reserve funds to perform a freedom to operate ASAP
6. Prepare for compePtors to use ambiguiPes in the patent system to their advantage
7. Don’t skimp on choosing a law firm
IP….without a strategy, you won’t get funded
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Nutter McClennen & Fish LLP • www.nutter.com 10
Reimbursement 1. Link with PaPent Groups – they can put pressure on Washington
2. ArPculate a sound comparaPve effecPveness argument 3. Know if you can use exisPng codes or need a new code 4. Hire a consultant if you need to 5. It will take 3+ peer reviewed publicaPons (with significant numbers) to convince payors to
grant coverage
6. You must show a reducPon in cost to the system 7. Determine if private pay, Medicare or Medicaid cover your paPent populaPon
8. Start dialogue with Payers including self-‐insured (large employers) early 9. Find a champion early
Reimbursement….without a strategy, you won’t get funded
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Nutter McClennen & Fish LLP • www.nutter.com 11
Regulatory 1. Understand your desired path to approval 2. Hire a consultant if you need one
3. Communicate with the FDA early and o_en if possible -‐ look for guidance documents
4. Understand and research the group at the FDA that will be responsible for the product
5. Know your device will work clinically before submiong to the US FDA
6. Don’t short cut criPcal aspects of development– go slow to go fast
7. Budget appropriately (Pme & money)
8. MITIGATE RISK wherever possible
Regulatory….without a strategy, you won’t get funded
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Regulatory Path Preclinical Clinical Approval Market
Toxicology InvesPgaPonal New Drug ApplicaPon
Phase I Phase II Phase III New Drug ApplicaPon
Phase IV / Postmarket surveillance
safety safety dosing efficacy
safety efficacy side effects
Expenses $15.2 million $23.4 million $86.5 million
Time 21.6 months 25.7 months 30.5 months
1 to 6 years 6 to 11 years 0.6 to 2 years 11 to 14 years
Overall probability of success
30% 14% 9% 8%
CondiPonal probability of success
40% 75% 48% 64% 90%
Sources: Dimasi, Hansen, and Grabowski (2003).
Notes: The line marked “Overall probability of success” is the uncondiPonal probability of reaching a given stage. For example, 30 percent of drugs make it to phase I tesPng. The line marked “CondiPonal probability of success” shows the probability of advancing to the next stage of the process condiPonal on reaching a given stage. For example, the probability of advancing to Phase III tesPng condiPonal on starPng Phase II tesPng is 48 percent.
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Overview
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MedTech Regulatory Overview
Nandini Murthy
Regulatory Consultant
Email: [email protected]
Phone # (781) 710-‐5378
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• Did you have a Pre-Sub Meeting with FDA? • Did the FDA identify any concerns or risks? • If the path is 510(k), what is the predicate? Traditional or
De Novo? • Indications for use? Aligns with business plan or
reimbursement strategy? • Does it need a clinical? If so, what is the study design?
RCT? Observational? OUS studies suffice? • Primary endpoints in the study? Will it support
reimbursement? Early adoption? • Timeline for US approval? After CE Mark? • Names of Legal Counsel, Regulatory Experts
Copyright ENEM Consulting LLC
Typical VC Questions
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• Majority of devices come to market via 510(k) • Primary premise is one of Substantial Equivalence to
predicate devices • Regulatory Strategy potentially counter to IP and
Reimbursement goals, where novelty of device may be emphasized.
• Claims of benefit or superiority are limited when pursuing a 510(k) clearance path
• The broader and more bold the claims, typically the longer and more complex the regulatory process
Copyright ENEM Consulting LLC
Regulatory versus reimbursement
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• Confusing the marketing need for regulatory requirement for a clinical study o Devices are designed with intent, sometimes bench or
animal studies are adequate for 510(k) • Starting the Clinical study prematurely, before regulatory
strategy has been identified o Is it an equivalence study? RCT? Single Arm? o Against a Gold standard? o What is the patient population (intended use)?
• Aligning Clinical study endpoints to marketing needs instead of regulatory validation
• Assuming that Clinical Studies conducted OUS to satisfy EU launch will suffice for FDA. They might, but need to plan accordingly.
Copyright ENEM Consulting LLC
Common missteps
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• Regulated environment • Moving target • Details matter • Planning and execution is critical • Many FDA Submission requirements typically not
subject to negotiation (e.g. cannot negotiate an exemption from biocompatibility tests for patient-contact devices because of timeline commitments to investors)
• There will be surprises during testing. Rely on experienced Regulatory and Project personnel
• Manage expectations throughout process
Copyright ENEM Consulting LLC
Regulatory Summary
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Develop a proprietary plaNorm for remote pa(ent monitoring
which leverages the cloud to reduce opera(ng costs
Data not Device Company
OUR VISION
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Disrupt the $3B arrhythmia detec(on market with a lower cost, high quality cloud-‐based SaaS
solu(on for cardiologists
OUR MISSION
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COMPANY FACTS • Founded March 2011 – M2D2 UMass Lowell, MA
• Team – Serial Successful Entrepreneurs
• Exis(ng $3B Global Arrhythmia Detec(on Market
• Innova(ve Proprietary Technology -‐ MoMe™
• Reimbursement – ExisPng Codes in place
• Regulatory – – CE Mark
– 510(k) filed
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MoMe™ Platform
Continuous Streaming ECG, Respiration, Motion
Cloud-‐Based solu(on
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Mul(-‐pass Algorithm Analysis
INTELLECTUAL PROPERTY US Patent 8,478,418 (July 2013)
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US Patent 8,620,418 B1 (Dec 2013)
• Systems and methods for processing and displaying pa(ent electrocardiograph data
ABSTRACT • A method is disclosed for displaying paPent ECG data.
The method includes receiving ECG data including an ECG waveform; receiving analyzed ECG data including arrhythmic events; generaPng an indicia of the detected arrhythmic event; and displaying the indicia of the detected arrhythmic event in relaPon to the ECG waveform at a posiPon associated with a Pme of the detected arrhythmic event. A system for displaying paPent ECG data is also disclosed.
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US REIMBURSEMENT Larchmont Strategic Advisors
• CPT Codes available and applicable
• Holter, Event & MCT
• Medicare reimburses all monitoring
• Private Payors reimburse for Holter, Event and ~85% reimburse for MCT
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Reimbursement for Arrhythmia Detection & Monitoring
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REGULATORY
OUS -‐ CE Mark – Successful NoPfied Body Audit – CerPficate December 2013
US -‐ 510(k) Submission • Pre-‐IDE MeePng August 2012 • No Human Clinical Required • Clinical TesPng against recognized Data Bases • Filed ‘Q4 2013