Pharma directions Overview

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PharmaDirections is pharmaceutical consulting and project management company. Our focus is helping biotechs with their preclinical, CMC, formulation development and regulatory affairs activities.

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  • Bruce (click) What we have spent a great deal of time developing here at PharmaDirections is a tool called pathfinder. This is a tool to help find not just a path, (click) but the best path to your IND (click) and the best path to your NDA. (click) So it’s our tool for navigating this tangled maze of product development, and we hope (click) that it can also become the tool we use to get your product to proof of concept and to market as quickly and correctly as possible.
  • Bruce It would be nice to offer a one-size-fits-all solution to project planning, but the reality (click) is that no two projects are alike and no two plans should be. (click) And of course a plan is only as good as the planners (click) And there is no substitute for experience when it comes to putting a good plan together.
  • Bruce At the core of pathfinder is an organized list of tasks. (click) Starting with general areas of development like formulation, toxicology, manufacturing, regulatory, we (click) can focus in on one area, for example, formulation and analytical development, and under this we (click) have a list of different types of dosage forms: immediate and controlled release solids, sterile products, nonsterile liquids and semisolids, inhalation products. Looking (click) just at controlled release tablets and capsules as an example…. (click to next slide)
  • Bruce At the core of pathfinder is an organized list of tasks. (click) Starting with general areas of development like formulation, toxicology, manufacturing, regulatory, we (click) can focus in on one area, for example, formulation and analytical development, and under this we (click) have a list of different types of dosage forms: immediate and controlled release solids, sterile products, nonsterile liquids and semisolids, inhalation products. Looking (click) just at controlled release tablets and capsules as an example…. (click to next slide)
  • Bruce At the core of pathfinder is an organized list of tasks. (click) Starting with general areas of development like formulation, toxicology, manufacturing, regulatory, we (click) can focus in on one area, for example, formulation and analytical development, and under this we (click) have a list of different types of dosage forms: immediate and controlled release solids, sterile products, nonsterile liquids and semisolids, inhalation products. Looking (click) just at controlled release tablets and capsules as an example…. (click to next slide)
  • Bruce At the core of pathfinder is an organized list of tasks. (click) Starting with general areas of development like formulation, toxicology, manufacturing, regulatory, we (click) can focus in on one area, for example, formulation and analytical development, and under this we (click) have a list of different types of dosage forms: immediate and controlled release solids, sterile products, nonsterile liquids and semisolids, inhalation products. Looking (click) just at controlled release tablets and capsules as an example…. (click to next slide)
  • Bruce (click) We have the tasks broken down into four areas, analytical development, formulation, process, and testing. (click) If we look just at analytical development we see a list of tasks that typically need to be completed at this stage. (click) And for each of these tasks, we have associated costs, timing and dependencies on previous tasks. (click) We have over 1600 tasks listed in pathfinder to give you an idea of how complex it is. (click) Examples of successful planning are a little less memorable and less interesting than spectacular belly-flops since if everything is planned and executed perfectly there’s nothing to talk about other than “the product got to market on time.” But we do have one sort of interesting example of how a planned approach was used to overcome a pretty big technical hurdle, and I’ll go through that with you.
  • Bruce (click) We have the tasks broken down into four areas, analytical development, formulation, process, and testing. (click) If we look just at analytical development we see a list of tasks that typically need to be completed at this stage. (click) And for each of these tasks, we have associated costs, timing and dependencies on previous tasks. (click) We have over 1600 tasks listed in pathfinder to give you an idea of how complex it is. (click) Examples of successful planning are a little less memorable and less interesting than spectacular belly-flops since if everything is planned and executed perfectly there’s nothing to talk about other than “the product got to market on time.” But we do have one sort of interesting example of how a planned approach was used to overcome a pretty big technical hurdle, and I’ll go through that with you.
  • Bruce: So as you can see, there are a lot of advantages to generating and utilizing a detailed comprehensive plan. (click) It allows you to organize and integrate a full set of drug development activities. (click) It highlights program requirements. (click) It highlights program milestones, which will be especially important for your financial backers. (click) It defines costs. (click) And it identifies and addresses risks. And at this stage, I’ll turn the microphone back over to Tom to discuss how a well structured plan can help you in approaching potential backers.
  • Pharma directions Overview

    1. 1. 1
    2. 2. PharmaDirections Quick Facts• 9 years old• 150 Scientist Associates• 100 CROs/CMOs in our network• Focus on preclinical, CMC and PK• $30M of CRO/CMO contracts under management for client’s projects 2
    3. 3. PharmaDirections a product development solutionusing Best of Breed CROs and scientists 3
    4. 4. How are we different? 4
    5. 5. Our Place in the World of Drug Development• We are not a CRO• We are not just a consulting companyWe are:• A drug development management company• Specialized for managing work at CROs• Organized for Knowledge and Execution of product development programs 5
    6. 6. Relationship Options Needs-based contractual options: Ad Hoc Time and Fixed FeeConsulting Materials•Expertise •Manage •Full on an as- assigned planning needed program and basis sections execution with time of program and cost estimates 6
    7. 7. Knowledge and Execution Tools get development right get it right, smarter get it right, faster 7
    8. 8. Knowledge and Execution ToolsKnowledge Tools Execution Tools• In-silico Modeling • PathfINDAr™ with GastroPlus™ • Proprietary drug • Simulates absorption and development planning pharmacokinetics for tool orally dosed drugs • Instant GMP™• In-silico Modeling • Electronic Data Control with WinNonlin® and Quality System for cGMP Manufacturing • Descriptive and predictive modeling of PK • Master Control™ data • Part 11 compliant Document Management System 8
    9. 9. Knowledge and ExecutionIntellectual PropertyPolicy • Inventions are our highest value added activity • All intellectual property developed under contract is assigned to client • Our fees accommodate royalty free IP development 9
    10. 10. A Total Product Development Solution Combine industry experienced scientists with CROs and invested partners into an integrated multi-disciplinary project team 10
    11. 11. Thank You 11
    12. 12. Knowledge ToolsIn-silico Modelingwith GastroPlus™ : • Partnership with Simulations Plus • Simulates absorption and pharmacokinetics for orally dosed drugs • Used to design new formulations and products 12
    13. 13. Knowledge ToolsIn-silico Prediction of new pharmacokineticsModeling withWinNonlin® : • Descriptive and predictive modeling of PK data • PK/pharmaco- dynamic relationships • Prediction of in- vivo results • Used to help   Shorten your drug development period Economize your resources generate new IP  Improve the quality of your product 13
    14. 14. Execution ToolsMaster Control™:Part 11 compliantDocumentManagement System • Compliance with FDA document requirements • Internet-based routing with electronic signature • Used to hasten document reviews Regulated document control and approvals 14
    15. 15. Strategic Development Execution Tool:Finding the best path to your PathfINDAr TM Our tool for navigating the maze of drug product development 15
    16. 16. Developing a Plan No two projects are alike and no two plans should be alike. The better the planners, the better the plan. EXPERIENCED EXPERTS DEVELOP OUR PLANS 16
    17. 17. Execution Tools “Activity Breakdown Structure”PathfINDAr™: PathfINDArPrompts for 3700+ 1 Not Needed Strategic Planningdrug development 2 Not Needed Discoveryactivities 3 Not Needed Pharmacology and Toxicology • Complete 4 Not Needed Drug Substance (API) Development strategic 5 Not Needed Drug Substance (API) Manufacturing planning tool 6 Not Needed Formulation & Analytical Development • Accurate 7 Not Needed Drug Product Manufacturing assessment of 8 Not Needed Quality Assurance time and costs 9 Not Needed Regulatory Affairs • Used to define 10 Not Needed ClinPharm & PK programs and 11 Not Needed Clinical find gaps 12 Not Needed Barriers to Competition 13 Not Needed Validation 14 Not Needed Project Management 17
    18. 18. PathfINDAr1 Not Needed Strategic Planning2 Not Needed Discovery3 Not Needed Pharmacology and Toxicology4 Not Needed Drug Substance (API) Development5 Not Needed Drug Substance (API) Manufacturing6 Not Needed Formulation & Analytical Development7 Not Needed Drug Product Manufacturing8 Not Needed Quality Assurance9 Not Needed Regulatory Affairs10 Not Needed ClinPharm & PK11 Not Needed Clinical12 Not Needed Barriers to Competition13 Not Needed Validation 1814 Not Needed Project Management
    19. 19. PathfINDAr TM 3 Required Pharmacology and Toxicology 3.1 Not Needed Safety Pharmacology 3.2 Not Needed Genetic Toxicology 3.3 Not Needed Toxicology 3.4 Not Needed Reproductive Toxicology and Carcinogenicity 3.5 Not Needed Immunology 3.6 Not Needed ADME 3.7 Not Needed Drug Drug Interaction Studies 3.8 Not Needed Pharmacokinetics 3.9 Not Needed Tissue Distribution 3.1 Not Needed Bioanalytical 4 Not Needed Drug Substance (API) Development 5 Not Needed Drug Substance (API) Manufacturing 6 Not Needed Formulation & Analytical Development 7 Not Needed Drug Product Manufacturing 8 Not Needed Quality Assurance 9 Not Needed Regulatory Affairs 19
    20. 20. PathfINDAr TM 3 Required Pharmacology and Toxicology 3.1 Not Needed Safety Pharmacology 3.1.1 Not Needed hERG Testing 3.1.2 Required Cardiovascular (telemetry study) 3.1.3 Not Needed Pulmonary Assessment in Conscious Rats 3.1.4 Not Needed Neuropharmacological Profile in Rats 3.1.5 Not Needed Supplemental Studies 3.1.6 Not Needed Pharmacodynamic Drug Interactions 3.1.7 Not Needed Protein binding studies 3.2 Not Needed Genetic Toxicology 3.3 Not Needed Toxicology 3.4 Not Needed Reproductive Toxicology and Carcinogenicity 3.5 Not Needed Immunology 3.6 Not Needed ADME 3.7 Not Needed Drug Drug Interaction Studies 3.8 Not Needed Pharmacokinetics 3.9 Not Needed Tissue Distribution 3.1 Not Needed Bioanalytical 20
    21. 21. PathfINDAr TM 3 Required Pharmacology and Toxicology 3.1 Not Needed Safety Pharmacology 3.1.1 Not Needed hERG Testing 3.1.2 Required Cardiovascular (telemetry study) 3.1.2.1 Required Protocol development and approval 3.1.2.2 Required Telemetry study in dogs 3.1.2.3 Required Telemetry study in Non-Human Primates 3.1.2.4 Required Dosing Solution Method Dev/Val 3.1.2.5 Required Dosing Solution Analysis 3.1.2.6 Required Draft Unaudited Report 3.1.2.7 Required Final QA-audited Study Report 3.1.2.8 Required Bioanalytical (48 Samples) 3.1.2.9 Required Toxicokinetics 3.1.3 Not Needed Pulmonary Assessment in Conscious Rats 3.1.4 Not Needed Neuropharmacological Profile in Rats 3.1.5 Not Needed Supplemental Studies 3.1.6 Not Needed Pharmacodynamic Drug Interactions 3.1.7 Not Needed Protein binding studies 3.2 Not Needed Genetic Toxicology 3.3 Not Needed Toxicology 3.4 Not Needed Reproductive Toxicology and Carcinogenicity 3.5 Not Needed Immunology 3.6 Not Needed ADME 3.7 Not Needed Drug Drug Interaction Studies 3.8 Not Needed Pharmacokinetics 3.9 Not Needed Tissue Distribution 3.1 Not Needed Bioanalytical 21
    22. 22. PathfINDAr TM 3 Required Pharmacology and Toxicology 3.1 Not Needed Safety Pharmacology 3.1.1 Not Needed hERG Testing 3.1.2 Required Cardiovascular (telemetry study) 3.1.2.1 Required Protocol development and approval 3.1.2.2 Required Telemetry study in dogs 3.1.2.3 Required Telemetry study in Non-Human Primates 3.1.2.4 Required Dosing Solution Method Dev/Val 3.1.2.5 Required Dosing Solution Analysis 3.1.2.6 Required Draft Unaudited Report 3.1.2.7 Required Final QA-audited Study Report 3.1.2.8 Required Bioanalytical (48 Samples) 3.1.2.9 Required Toxicokinetics 3.1.3 Not Needed Pulmonary Assessment in Conscious Rats 3.1.4 Not Needed Neuropharmacological Profile in Rats 3.1.5 Not Needed Supplemental Studies 3.1.6 Not Needed Pharmacodynamic Drug Interactions 3.1.7 Not Needed Protein binding studies 3.2 Not Needed Genetic Toxicology 3.3 Not Needed Toxicology 3.4 Not Needed Reproductive Toxicology and Carcinogenicity 3.5 Not Needed Immunology 3.6 Not Needed ADME 3.7 Not Needed Drug Drug Interaction Studies 3.8 Not Needed Pharmacokinetics 3.9 Not Needed Tissue Distribution 3.1 Not Needed Bioanalytical 22
    23. 23. PathfINDAr TMEach task has estimated cost, timing,and resources associated with it.Over 3700 tasks are included inPathfINDAr. 23
    24. 24. Benefits of PathfINDAr™• Organizes and integrates a full set of drug development activities• Highlights program requirements• Highlights program milestones• Defines timing• Identifies costs and resources• Plots a strategic path to IND and NDA 24
    25. 25. Execution ToolsInstant GMP™:Electronic DataControl and QualitySystem for cGMPManufacturing • Visibility from anywhere in the world • Used at multiple vendors • Enables faster and higher quality GMP manufacturing Real-time batch record accessible via the web 25
    26. 26. Patents Developed for PDI Clients• Pharmaceutical compositions of calcitonin drug-oligomer conjugates US 6,770,625• Pharmaceutical Compositions of Insulin Drug-Oligomer Conjugates US 6,867,183• Methods of Synthesizing Insulin Polypeptide-Oligomer Conjugates US 6,913,903• Pharmaceutical compositions of drug-oligomer conjugates US 7,030,082• Insulin polypeptide-oligomer conjugates US 7,166,571• Pharmaceutical compositions of insulin drug-oligomer conjugates US 7,196,059• Proinsulin polypeptide-oligomer conjugates US 7,312,192• Methods of synthesizing proinsulin polypeptide-oligomer conjugates US 7,368,260 26
    27. 27. Patents Developed for PDI Clients• Proinsulin polypeptide-oligomer conjugates US 7,611,864• Micro-particle fatty acid salt solid dosage formulations US 7,635,675• Drug-oligomer conjugates and methods of treating diseases therewith US 20030069170• Methods of Reducing Hypoglycemic Episodes in the Treatment of Diabetes Mellitus” US 20040038867• Method for administering medicaments to subjects with swallowing difficulties and disorders” US 20070196495• Sustained Release Formulations of Zonisamide” US 20070148237• Compositions for affecting weight loss” US 20070117827• Sustained Release Formulations of Naltrexone” US 2007028102• Methods for Administering Weight Loss Medications” US 20080110792• Layered Pharmaceutical Formulations” US 20080113026 27
    28. 28. Other Inventions for PDI Clients• Novel pharmacokinetic profiles in treatments of: – Obesity – Platelet aggregation – Neurological diseases• Novel combination products to treat: – Rheumatoid Arthritis – Inflammatory Bowel Disease – Chronic Pain – Psoriasis• Novel salt forms of existing drugs to treat: – Rheumatoid Arthritis – Inflammatory Bowel Disease – Migraine – Emesis during chemotherapy 28
    29. 29. Our intellectual property is assigned to clients royalty free 29

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