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Regulatory Considerations
Leslie J Williams
ImmusanT, Inc • One Kendall Square, Suite B2004 • Cambridge, MA 02139Confide...
1. 2February 25, 2016 Confidential & Proprietary – Not For Distribution
Who Am I?
• Leslie J Williams: Founder, Director, ...
1. 3February 25, 2016 Confidential & Proprietary – Not For Distribution
Business Planning Considerations
Sector Device
(dr...
1. 4February 25, 2016 Confidential & Proprietary – Not For Distribution
Drug Development Process – Cost/Time
Preclinical C...
1. 5February 25, 2016 Confidential & Proprietary – Not For Distribution
Be Realistic About Development/Regulatory Path
1. 6February 25, 2016 Confidential & Proprietary – Not For Distribution
Regulatory
• Major Factor in Success and Funding
•...
1. 7February 25, 2016 Confidential & Proprietary – Not For Distribution
• Have you had a pre-IND meeting?
• Path forward?
...
1. 8February 25, 2016 Confidential & Proprietary – Not For Distribution
General Guidelines: Regulatory
1. Understand your ...
1. 9February 25, 2016 Confidential & Proprietary – Not For Distribution
Regulatory Considerations & Precedence
Monitor the...
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The Capital Network Deep Dives: Regulatory LSFT2016

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REGULATORY Considerations for early stage Life Science Startups
Leslie Williams - IMMUSANT
Jenny Freeman - Respiratory Motion

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The Capital Network Deep Dives: Regulatory LSFT2016

  1. 1. 1 Regulatory Considerations Leslie J Williams ImmusanT, Inc • One Kendall Square, Suite B2004 • Cambridge, MA 02139Confidential & Proprietary – Not For Distribution
  2. 2. 1. 2February 25, 2016 Confidential & Proprietary – Not For Distribution Who Am I? • Leslie J Williams: Founder, Director, President & CEO ImmusanT • 25+ years industry experience • Early Stage Start-Up Experience: Advisor and Co-Founder & CEO multiple companies • Ventaira Pharmaceuticals – President & CEO • INO Therapeutics (Ikaria) – Management • Big Pharma experience – Merck, GSK • Device/Equipment – Ohmeda • Venture Capital: Venture Partner – Battelle Ventures • Business Advisor and Mentor • Education: MBA, Washington University; BS, Biology/Nursing, University of Iowa
  3. 3. 1. 3February 25, 2016 Confidential & Proprietary – Not For Distribution Business Planning Considerations Sector Device (drug delivery, implanted, valves, monitoring; etc) Diagnostic Therapeutic (drugs, vaccines, biologics) Some drug delivery Healthcare IT / Services IP Yes - FTO YES Patent Life Important 10 years to develop Countries Know How Design / Method Regulatory PMA/510K Companion? 510K/PMA; CLIA IND, BLA (Fast track; Breakthrough) HIPAA Stark Law Prototype/ Demonstration √√√√ (seeing is believing) Depends on diagnostic No √√√ demonstration – talk to end user Animal Data YES YES MUST N/A Publication Important Important MUST N/A Scale Up Manufacturer ? GMP Manufacturer? GMP CMC – manufacturing GMP Must have or clear path Reimbursement Current or new CPT HCPCS Comparative Effectiveness YES Federal and State Distribution Think through – alone or partner; countries Important – Central Labs Think through - alone or partner; by Countries Must have Launch/Market trajectory US/EU/ROW Adoption - uptake US/EU/ROW Adoption - uptake
  4. 4. 1. 4February 25, 2016 Confidential & Proprietary – Not For Distribution Drug Development Process – Cost/Time Preclinical Clinical Approval Market Toxicology Investigational New Drug Application Phase I Phase II Phase III New Drug Application 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% Conditional probability of success 40% 75% 48% 64% 90% Sources: Dimasi, Hansen, and Grabowski (2003). Notes: The line marked “Overall probability of success” is the unconditional probability of reaching a given stage. For example, 30 percent of drugs make it to phase I testing. The line marked “Conditional probability of success” shows the probability of advancing to the next stage of the process conditional on reaching a given stage. For example, the probability of advancing to Phase III testing conditional on starting Phase II testing is 48 percent.
  5. 5. 1. 5February 25, 2016 Confidential & Proprietary – Not For Distribution Be Realistic About Development/Regulatory Path
  6. 6. 1. 6February 25, 2016 Confidential & Proprietary – Not For Distribution Regulatory • Major Factor in Success and Funding • Moving target • Planning and execution is critical • Obtain credible expertise • Avoid landmines • Know the challenges • Define risk mitigation strategy • Expect the unexpected • Identify Path: • Therapeutic, device, diagnostic, IT - IND, BLA, PMA, 510(k)
  7. 7. 1. 7February 25, 2016 Confidential & Proprietary – Not For Distribution • Have you had a pre-IND meeting? • Path forward? • Did the FDA identify any concerns or risks? • If the path is IND/BLA is there precedent? If diagnostic is this PMA, 510(k), what is the predicate? Traditional or Novel? • TPP; Indications for use? Aligns with business plan or reimbursement strategy? • Primary endpoints in the study? Will it support reimbursement? Early adoption? • Timeline for US approval? Global Strategy? • Names of Legal Counsel, Regulatory Experts Typical VC Questions 7
  8. 8. 1. 8February 25, 2016 Confidential & Proprietary – Not For Distribution General Guidelines: Regulatory 1. Understand your desired path to approval 2. Understand accelerated pathways and appropriateness for your product 3. Hire an expert (consultant) 4. Communicate with the FDA early and often if possible - look for guidance documents 5. Understand and research the division at the FDA that will be responsible for your product 6. Know as much about your product as possible (safety; mechanism) 7. Don’t short cut critical aspects of development– go slow to go fast 8. Budget appropriately (time & money) 9. MITIGATE RISK wherever possible Regulatory….without a strategy, you won’t get funded
  9. 9. 1. 9February 25, 2016 Confidential & Proprietary – Not For Distribution Regulatory Considerations & Precedence Monitor the development pathways and hurdles of similar products in pivotal trial and close to marketing •Circassia ToleroMune (synthetic peptide) cat allergy vaccine development –Successfully completed P-II study (Feb 2011) –Developed regulatory pathway with authorities/agencies* •Allergy Therapeutics Pollinex Quattro seasonal allergy vaccine – FDA clinical holds to be lifted with revised IND protocols – MAA submitted to Germany PEI and will pursue EU registration expansion using EU-MRP+

REGULATORY Considerations for early stage Life Science Startups Leslie Williams - IMMUSANT Jenny Freeman - Respiratory Motion

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