Aptuit Consulting Inc

649 views

Published on

Overview

0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
649
On SlideShare
0
From Embeds
0
Number of Embeds
9
Actions
Shares
0
Downloads
0
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Aptuit Consulting Inc

  1. 1. From Idea to IND: “The Emerging Role of Virtual Drug Development Teams" Bill Mackin PhD, RAC Principal Consultant Head Regulatory Affairs
  2. 2. Aptuit <ul><ul><li>Aptitude and Intuition </li></ul></ul><ul><ul><li>Reflects the combination of natural abilities required to successfully navigate the complex drug development process </li></ul></ul><ul><ul><ul><li>Intelligence and Insight </li></ul></ul></ul><ul><ul><li>www.aptuit.com/default.aspx </li></ul></ul>
  3. 3. Aptuit – The Mission <ul><ul><li>Aptuit is a pharmaceutical service company that conducts research, development and manufacturing on a contract basis for both large and small innovators. </li></ul></ul><ul><ul><li>Our mission is to &quot;engineer a better drug development process&quot; to serve these two very different clients equally well but in very different ways. </li></ul></ul>TIME COST QUALITY
  4. 4. Aptuit Consulting <ul><ul><li>April 16, 2006 Consulting Business Unit Established </li></ul></ul><ul><ul><ul><li>Coincident with acquisition of Pharma Consulting </li></ul></ul></ul><ul><ul><ul><li>Additional Sr. and Leading Pharma Industry Experts to Guide Innovators through Drug Development Process </li></ul></ul></ul>
  5. 5. Aptuit Consulting <ul><ul><li>Experienced and Talented Individuals </li></ul></ul><ul><ul><ul><li>Staff present in North America and Europe. Future growth planned in Asia </li></ul></ul></ul><ul><ul><ul><li>Focused expertise in small molecule, protein, peptide and cellular therapeutics </li></ul></ul></ul><ul><ul><ul><li>Deep preclinical expertise in Cardiovascular problem solving, including QT prolongation </li></ul></ul></ul><ul><ul><ul><li>Broad therapeutic area expertise and FDA interactions </li></ul></ul></ul><ul><ul><ul><ul><li>Skill sets to cover manufacturing through Phase 2 POC studies </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Currently managing Development for many emerging companies </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Staff come from Pharma with > 15 years experience covering all therapeutic areas </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Seasoned expertise and with success in over 100 INDs and many NDAs </li></ul></ul></ul></ul>
  6. 6. Aptuit Consulting <ul><li>Strategic/Tactical - Drug development strategy, management of process. </li></ul><ul><li>Can serve as virtual management Team. </li></ul><ul><ul><li>Work with emerging companies and investor groups </li></ul></ul><ul><ul><li>Solve problems along the path to IND and manage/support post-IND submission </li></ul></ul><ul><ul><li>Execute agreed development plans to agreed timelines </li></ul></ul><ul><ul><li>Manage FDA or EU interactions </li></ul></ul><ul><li>Preclinical - Safety assessment, and Discovery support </li></ul><ul><li>Clinical - Manage Phase 1/Phase 2 POC studies. Clinical Trial Supplies, process and logistics. </li></ul><ul><li>Regulatory - Regulatory strategy and operations. ePublishing and life cycle management of submissions </li></ul><ul><li>Legal/IP – Litigation and defense </li></ul>
  7. 7. Aptuit Consulting <ul><li>Managing outsourcing </li></ul><ul><ul><li>API Chemical Manufacturing </li></ul></ul><ul><ul><li>Analytical Chemistry </li></ul></ul><ul><ul><li>Pharmaceutics (formulation development) </li></ul></ul><ul><ul><li>Toxicology </li></ul></ul><ul><ul><li>DMPK/Bio-analysis, toxicokinetics </li></ul></ul><ul><ul><li>Safety Pharmacology </li></ul></ul><ul><ul><li>Phase I to 2a, Clinical Pharmacology </li></ul></ul>
  8. 8. Aptuit Consulting Expertise Formulations Experienced Team of International Drug Developers ePublishing CMC Pharm/Tox Medical Writing Clinical Development Regulatory DS/DP Mfg Biologics Mfg Due Diligence
  9. 9. Clients <ul><li>Product development – Funded, emerging Pharma and Biotech </li></ul><ul><ul><li>US and Canada </li></ul></ul><ul><ul><li>Europe </li></ul></ul><ul><ul><li>Israel </li></ul></ul><ul><ul><li>Asia </li></ul></ul><ul><li>Legal issues - generally mid size to large Pharma via Law Firms </li></ul><ul><li>Investment firms </li></ul>
  10. 10. APTUIT INDiGO TM “Getting it right the first time”
  11. 11. Aptuit INDiGO TM (A Program) <ul><li>Delivers “Best in Class” First in Human (FIH) programs </li></ul><ul><ul><li>Small Molecules, Peptides and Proteins, Devices, non-traditional therapies </li></ul></ul><ul><ul><li>All therapeutic areas (oncology, inflammation etc) </li></ul></ul><ul><ul><li>All routes of administration (oral, parenteral, inhalation etc) </li></ul></ul><ul><li>Accelerates development from API through Phase 2a by fast-tracking projects internally using Aptuit and/or externally dependent upon project requirements . </li></ul>
  12. 12. Aptuit INDiGO TM (B Program) <ul><li>Also provides highly customized approaches to providing solutions to difficult problems that may lead to “clinical hold” situations. </li></ul><ul><ul><li>Chemistry </li></ul></ul><ul><ul><li>Formulation </li></ul></ul><ul><ul><li>Metabolism </li></ul></ul><ul><ul><li>Pharmacokinetics </li></ul></ul><ul><ul><li>Toxicology </li></ul></ul><ul><ul><li>Regulatory </li></ul></ul>
  13. 13. Aptuit INDiGO TM (A Program) <ul><li>Delivers “Best in Class” First in Human (FIH) programs </li></ul><ul><ul><li>Small Molecules, Peptides and Proteins, Devices, non-traditional therapies </li></ul></ul><ul><ul><li>All therapeutic areas (oncology, inflammation etc) </li></ul></ul><ul><ul><li>All routes of administration (oral, parenteral, inhalation etc) </li></ul></ul><ul><li>Accelerates development from API through Phase 2a by fast-tracking projects internally using Aptuit and/or externally dependent upon project requirements . </li></ul>
  14. 14. Aptuit INDiGO TM <ul><li>How Does It Work? </li></ul>
  15. 15. Aptuit INDiGO TM The process EXECUTION of PLAN Draft Plan & Budget Executable plan for signature Consulting + Operations APTUIT INDiGO Team (DDE, PM, Ops) Secondary Review CDA, Initial mtg to determine Issues, Deliverables, Timelines, Indication Primary Review “ Is this an APTUIT INDiGO Program?” Proposal Go/No-Go Lead Generation  
  16. 16. Aptuit INDiGO TM The process Lead Received Primary Review “ Is this an APTUIT INDiGO Program?” Go/NoGo Secondary Review CDA, Determine Issues, Deliverables, Development Plan Draft Plan & Budget Executable plan for signature Consulting + Operations Establish Aptuit INDiGO Team (DDE, PM, Ops) Execute Plan
  17. 17. Drug Development Expertise <ul><li>Significant value to Client Company </li></ul><ul><ul><li>Significant DDE applied to program without hiring </li></ul></ul><ul><ul><ul><li>Gets it right the first time! </li></ul></ul></ul><ul><ul><li>Builds value in product at early level without significant cash input. </li></ul></ul><ul><ul><li>Expenses are associated with actual filing of IND or problem solving and resolution of Regulatory issues </li></ul></ul><ul><ul><ul><li>Eliminates many capital expenditures for project </li></ul></ul></ul>
  18. 18. Aptuit INDiGO ™ <ul><li>Questions </li></ul><ul><li>What is the value for the emerging BioPharma company to outsource management of development? </li></ul>
  19. 19. APTUIT INDiGO™ A Model for Emerging Companies (NuCo) <ul><li>Focused on DDE to deliver Phase 2a data </li></ul><ul><ul><li>Assuming new company ramp up over 4 years </li></ul></ul><ul><ul><li>Considering only cost incremental to 3 executives that would be required for in-sourced vs. out-sourced model </li></ul></ul><ul><ul><li>Add 7 key positions to in-sourced model over 3 years plus some external consultants </li></ul></ul><ul><ul><li>Assuming incremental office space and associated costs in in-sourced model </li></ul></ul>
  20. 20. Model Assumptions Small Office Both Building/Space (Lab/Office) No Yes Personnel (6 PhD, salaries and overhead) Yes Yes Sr Management (CEO, CFO, CSO) Out-Sourced In-Sourced Item
  21. 21. Aptuit INDiGO™ Applied to IND <ul><li>Customers </li></ul><ul><li>Cost </li></ul><ul><ul><li>~25K for Development Plan thru Phase 1 </li></ul></ul><ul><ul><li>3-5M for project </li></ul></ul><ul><li>Timeline </li></ul><ul><ul><li>6-12 months </li></ul></ul><ul><li>Deliverable </li></ul><ul><ul><li>Development Plan </li></ul></ul><ul><ul><li>Regulatory Approval </li></ul></ul><ul><ul><li>Phase 1 Data </li></ul></ul>
  22. 22. In-Source vs. Out-Source ($000) Comparable Costs to Deliver Phase 1 Data Getting it Done Well the First Time is a Value Proposition 2509 - - - - NPV Differential 3689 - - - - Cash Differential 818 - - - - NPV@12% 1000 - 200 400 400 Out-sourced Cost 3327 - - - - NPV@12% 4689 1563 1898 1175 50 In-sourced Cost Total Year 4 Year 3 Year 2 Year 1
  23. 23. Cost and Time Project Duration (months)
  24. 24. Company Y Overall Costs <ul><li>Vendor: $5,500,000 </li></ul><ul><li>Consulting: $800,000 </li></ul><ul><li>Minus $2,000,000 company savings for outsourced model </li></ul><ul><li>Total Cost Thru Phase 1 $4,000,000 </li></ul>
  25. 25. Aptuit INDiGO™ A Delivered <ul><li>Over past 6 months, 3 APTUIT INDiGO projects delivered </li></ul><ul><li>All are API thru FIH Studies </li></ul><ul><li>No significant issues from FDA </li></ul>“ Got it right the first time!!!
  26. 26. Success Breeds Success Aptuit Consulting Inc. and Taiwan Liposome Company (TLC) Collaborate to Complete all IND Enabling Work and IND Submission for Novel Anti-Cancer Treatment in 12 Months --First Anti-Cancer Drug from Taiwan, Lipotecan®, to Begin Phase 1 Trial under U.S. IND– Aptuit press release, June 25,20080
  27. 27. Aptuit Consulting <ul><li>Getting the Train Ready is Only the First Step </li></ul><ul><ul><li>Seed funding </li></ul></ul><ul><ul><li>NCE Identified </li></ul></ul><ul><ul><li>Additional funding </li></ul></ul><ul><ul><li>cGMP of NCE Complete </li></ul></ul><ul><ul><li>Pharm/Tox Completed </li></ul></ul><ul><ul><li>Clinical Protocol Completed </li></ul></ul><ul><ul><li>IND/CTD Filed </li></ul></ul>
  28. 28. Clinical Development Phase I End of Phase II Phase III Pivotal Studies
  29. 29. Aptuit Consulting Technical Expertise Stay on Track Prevent Disasters

×