pharma directions overview
DESCRIPTION
PharmaDirections is pharmaceutical consulting and project management company. Our focus is helping biotechs with their preclinical, CMC, formulation development and regulatory affairs activities.TRANSCRIPT
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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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PharmaDirections
a product development solutionusing Best of Breed CROs and
scientists
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How are we different?
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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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Relationship Options
•Expertise on an as-needed basis
•Manage assigned program sections with time and cost estimates
•Full planning and execution of program
Ad HocConsulting
Time and Materials
Fixed Fee
Needs-based contractual options:Needs-based contractual options:Needs-based contractual options:Needs-based contractual options:
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Knowledge and Execution Tools
get development right
get it right, smarter get it right, faster
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Knowledge and Execution Tools
Knowledge Tools• In-silico Modeling
with GastroPlus™• Simulates absorption
and pharmacokinetics for orally dosed drugs
• In-silico Modeling with WinNonlin®• Descriptive and
predictive modeling of PK data
Execution Tools• PathfINDAr™
• Proprietary drug development planning tool
• Instant GMP™• Electronic Data Control
and Quality System for cGMP Manufacturing
• Master Control™• Part 11 compliant
Document Management System
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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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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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Thank You
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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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Knowledge Tools
In-silico Modeling with WinNonlin® :
• Descriptive and predictive modeling of PK data
• PK/pharmaco-dynamic relationships
• Prediction of in-vivo results
• Used to help generate new IP
Prediction of new pharmacokinetics
Shorten your drug development period Economize your resources Improve the quality of your product
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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 and approvals
Regulated document control
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PathfINDArTM
Strategic Development Execution Tool:
Our tool for navigating the maze of drug product development
Finding the best path to your
PathfINDArTMPathfINDArTM
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Developing a Plan
No two projects are alike and no two plans should be alike.
The better the planners, the better the plan.
EXPERIENCEDEXPERTS DEVELOP
OUR PLANS
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Execution Tools
PathfINDAr™: Prompts for 3700+ drug development activities
• Complete strategic planning tool
• Accurate assessment of time and costs
• Used to define programs and find gaps
“Activity Breakdown Structure”
PathfINDAr1 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
14 Not Needed Project Management
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PathfINDAr1 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
14 Not Needed Project Management
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3 Required Pharmacology and Toxicology
3.1 Not Needed Safety Pharmacology3.2 Not Needed Genetic Toxicology3.3 Not Needed Toxicology3.4 Not Needed Reproductive Toxicology and Carcinogenicity3.5 Not Needed Immunology3.6 Not Needed ADME3.7 Not Needed Drug Drug Interaction Studies3.8 Not Needed Pharmacokinetics3.9 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
PathfINDArTM
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3 Required Pharmacology and Toxicology
3.1 Not Needed Safety Pharmacology3.1.1 Not Needed hERG Testing3.1.2 Required Cardiovascular (telemetry study)3.1.3 Not Needed Pulmonary Assessment in Conscious Rats3.1.4 Not Needed Neuropharmacological Profile in Rats3.1.5 Not Needed Supplemental Studies3.1.6 Not Needed Pharmacodynamic Drug Interactions3.1.7 Not Needed Protein binding studies
3.2 Not Needed Genetic Toxicology3.3 Not Needed Toxicology3.4 Not Needed Reproductive Toxicology and Carcinogenicity3.5 Not Needed Immunology3.6 Not Needed ADME3.7 Not Needed Drug Drug Interaction Studies3.8 Not Needed Pharmacokinetics3.9 Not Needed Tissue Distribution 3.1 Not Needed Bioanalytical
PathfINDArTM
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3 Required Pharmacology and Toxicology
3.1 Not Needed Safety Pharmacology3.1.1 Not Needed hERG Testing3.1.2 Required Cardiovascular (telemetry study)
3.1.2.1 Required Protocol development and approval3.1.2.2 Required Telemetry study in dogs3.1.2.3 Required Telemetry study in Non-Human Primates3.1.2.4 Required Dosing Solution Method Dev/Val3.1.2.5 Required Dosing Solution Analysis3.1.2.6 Required Draft Unaudited Report3.1.2.7 Required Final QA-audited Study Report3.1.2.8 Required Bioanalytical (48 Samples)3.1.2.9 Required Toxicokinetics
3.1.3 Not Needed Pulmonary Assessment in Conscious Rats3.1.4 Not Needed Neuropharmacological Profile in Rats3.1.5 Not Needed Supplemental Studies3.1.6 Not Needed Pharmacodynamic Drug Interactions3.1.7 Not Needed Protein binding studies
3.2 Not Needed Genetic Toxicology3.3 Not Needed Toxicology3.4 Not Needed Reproductive Toxicology and Carcinogenicity3.5 Not Needed Immunology3.6 Not Needed ADME3.7 Not Needed Drug Drug Interaction Studies3.8 Not Needed Pharmacokinetics3.9 Not Needed Tissue Distribution 3.1 Not Needed Bioanalytical
PathfINDArTM
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3 Required Pharmacology and Toxicology
3.1 Not Needed Safety Pharmacology3.1.1 Not Needed hERG Testing3.1.2 Required Cardiovascular (telemetry study)
3.1.2.1 Required Protocol development and approval3.1.2.2 Required Telemetry study in dogs3.1.2.3 Required Telemetry study in Non-Human Primates3.1.2.4 Required Dosing Solution Method Dev/Val3.1.2.5 Required Dosing Solution Analysis3.1.2.6 Required Draft Unaudited Report3.1.2.7 Required Final QA-audited Study Report3.1.2.8 Required Bioanalytical (48 Samples)3.1.2.9 Required Toxicokinetics
3.1.3 Not Needed Pulmonary Assessment in Conscious Rats3.1.4 Not Needed Neuropharmacological Profile in Rats3.1.5 Not Needed Supplemental Studies3.1.6 Not Needed Pharmacodynamic Drug Interactions3.1.7 Not Needed Protein binding studies
3.2 Not Needed Genetic Toxicology3.3 Not Needed Toxicology3.4 Not Needed Reproductive Toxicology and Carcinogenicity3.5 Not Needed Immunology3.6 Not Needed ADME3.7 Not Needed Drug Drug Interaction Studies3.8 Not Needed Pharmacokinetics3.9 Not Needed Tissue Distribution 3.1 Not Needed Bioanalytical
PathfINDArTM
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PathfINDArTM
Each task has estimated cost, timing, and resources associated with it.
Over 3700 tasks are included in PathfINDAr.
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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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Execution Tools
Instant GMP™: Electronic Data Electronic Data Control and Control and Quality System Quality System for cGMP for cGMP ManufacturingManufacturing
• 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
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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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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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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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Our intellectual property is assigned to clients royalty free