PharmaDirections is pharmaceutical consulting and project management company. Our focus is helping biotechs with their preclinical, CMC, formulation development and regulatory affairs activities.
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
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3. PharmaDirections
a product development solution
using Best of Breed CROs and scientists
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5. Our Place in the World of Drug Development
• We are not a CRO
• We are not just a consulting company
We are:
• A drug development management company
• Specialized for managing work at CROs
• Organized for Knowledge and Execution of
product development programs
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6. Relationship Options
Needs-based contractual options:
Ad Hoc Time and Fixed Fee
Consulting Materials
•Expertise •Manage •Full
on an as- assigned planning
needed program and
basis sections execution
with time of program
and cost
estimates
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7. Knowledge and Execution Tools
get development right
get it right, smarter
get it right, faster
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8. Knowledge and Execution Tools
Knowledge 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
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9. Knowledge and Execution
Intellectual Property
Policy
• Inventions are our
highest value added
activity
• All intellectual
property developed
under contract is
assigned to client
• Our fees
accommodate
royalty free IP
development
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10. A Total Product Development Solution
Combine industry experienced scientists
with CROs and invested partners
into an integrated multi-disciplinary
project team
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12. Knowledge Tools
In-silico Modeling
with GastroPlus™ :
• Partnership with
Simulations Plus
• Simulates absorption
and
pharmacokinetics for
orally dosed drugs
• Used to design new
formulations and
products
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13. Knowledge Tools
In-silico
Prediction of new pharmacokinetics
Modeling with
WinNonlin® :
• 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
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14. Execution Tools
Master Control™:
Part 11 compliant
Document
Management System
• Compliance with
FDA document
requirements
• Internet-based
routing with
electronic
signature
• Used to hasten
document reviews Regulated document control
and approvals
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15. Strategic Development Execution Tool:
Finding the best path to your
PathfINDAr
TM
Our tool for navigating the maze of drug product
development
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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. Execution Tools
“Activity Breakdown Structure”
PathfINDAr™: PathfINDAr
Prompts for 3700+ 1 Not Needed Strategic Planning
drug development 2 Not Needed Discovery
activities 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
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18. PathfINDAr
1 Not Needed Strategic Planning
2 Not Needed Discovery
3 Not Needed Pharmacology and Toxicology
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
10 Not Needed ClinPharm & PK
11 Not Needed Clinical
12 Not Needed Barriers to Competition
13 Not Needed Validation
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14 Not Needed Project Management
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
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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
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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
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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
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23. PathfINDAr TM
Each task has estimated cost, timing,
and resources associated with it.
Over 3700 tasks are included in
PathfINDAr.
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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
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25. Execution Tools
Instant GMP™:
Electronic Data
Control and Quality
System for cGMP
Manufacturing
• 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. 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
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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
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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
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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.