Contenu connexe Similaire à IDSC Expertise Capabilities Services Video 2013 (20) IDSC Expertise Capabilities Services Video 20131. Mark Creswell
President and CEO
markcreswell@idscbiotechnetwork.com
Phone: 734.433.9670
Cell: 734.476.4097
Capabilities ● Expertise ● Services
IDSC
10/29/2013
WWW.IDSCBIOTECHNETWORK.COM
©2013 IDSC, LLC
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2. IDSC May Be A Fit For YOU…
If you are a…
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FROM HIT TO THE CLINIC…
Biotech
YOUR DRUG DISCOVERY AND DEVELOPMENT
Pharma
PARTNER
Academic
VC
In need of…
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Drug discovery…
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Preclinical development…
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Clinical development…
…High Impact Consulting
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WWW.IDSCBIOTECHNETWORK.COM
©2013 IDSC, LLC
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3. Who is IDSC?
IDSC: Integrated Team of
Specialists
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Interdisciplinary group
40 Ex-Pharma Leaders
25 yrs Pharma Experience
Sr. VPs, VPs, Exec. Directors
Careers in:
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Big Pharma
Biotech
Academia
Consulting
©2013 IDSC, LLC
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4. Stages of Drug Discovery & Development
IDSC’s Services Span:
Discovery
Lead
Optimization
Hit to Lead
Evaluate HTS
Hits or SBDD
Results
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Development
Select lead
compounds
Identify
Clinical
Candidate
Preclinical
Development
to IND Filing
FDA
Pre-IND
Meeting
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Clinical
Development
Draft &
Submit
IND
FDA
Phase 2
Meeting
Draft &
Submit
NDA
©2013 IDSC, LLC
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5. Why Clients Come to IDSC
Interim Leadership
Fully Integrated
Collaborations
• Filling the gaps
• Most major therapeutic
areas
• All line disciplines
• Small molecules, biologics,
stem cells, diagnostics,
devices, nutraceuticals
• IDSC supplies a full project
team to our client.
• All discovery, preclinical
development, or clinical
development line
discipline experts.
Due Diligence
Molecular Modeling
• Investment opportunities
• Program reviews
• SWOT analyses
• Venture capitalists
• Pharma companies
• Academics
• Structure based design
• Pharmocaphore modeling
• Homology models
• Docking, etc
• Small molecules or
biologicals
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Consulting
• Most major therapeutic
areas
• All line disciplines
• Small molecules,
biologics, stem cells,
diagnostics, devices,
nutraceuticals
Outsourcing
Management
• Medchem, API/ biological,
pharmacology, toxicology,
ADME, etc.
• Identify CROs & CMOs
• Manage CROs & CMOs
©2013 IDSC, LLC
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6. Examples of What Our Leaders Do
Medicinal Chemists
ADME, Toxicologists,
Pharmacologists
• Therapeutic area expert
• Evaluates SAR & decides what
compounds to make
• Know ADME & design targets
to improve ADME, potency, &
efficacy
• Designs synthesis and manages
outsourcing
• Design in vitro and in vivo studies
• Identify vendors and manage
outsourcing
• Evaluate study data and write IND
submission study reports
• Make decisions based on study
results
API & CMC Managers
Clinicians
• Manage CMOs
• Chemistry, biologicals, cell
lines…
• Optimize chemistry process
• Troubleshoot biologicals
• Submit regulatory registrations
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• Support preclinical
development plan
• Draft clinical protocols
• Participate in and/or lead
clinical advisory boards
• Oversee clinical trials
• Advise client, preclinical, and
clinical project teams
WWW.IDSCBIOTECHNETWORK.COM
Regulatory Experts
• Guide client and IDSC team on
and assure regulatory guidelines
are met
• Assist client with preparation for
and accompany client to FDA
meetings
• Assist client with preparation of
and submission of regulatory
documents
TA Experts and Project
Leaders
• Advise client on therapeutic area
• Prepare program reviews
• Lead teams in preparation of gap
analyses and development plans
• Serve as project leader for project
teams
©2013 IDSC, LLC
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7. Discovery Expertise
Line Discipline Experience
Therapeutic Area Experience
• Medicinal Chemistry
• Molecular Modeling
• Pharmacology
– in vitro
– in vivo
• ADME
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CNS
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Cardiovascular •
Dermatology
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Infectious
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Diseases
• Inflammation
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Immunology
Metabolic
Diseases
Oncology
Pain
©2013 IDSC, LLC
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8. Development Expertise
Preclinical & Clinical
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ADME / Toxicology / Pathology
PK/PD/TK Modeling
Process Chemistry/ API Mgmt / CMC
Formulation/ Fill/ Finish…IV/ Solid
Regulatory Compliance
Clinical Study Design
FDA Meetings
IND/NDA Preparation & Submission
Commercialization Strategy
Product Assessment & Valuation
Competitive Intelligence
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Small
Molecules
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Biologics
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Stem Cells
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Devices
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Nutraceuticals
©2013 IDSC, LLC
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9. Discovery
Preclinical Development
Clinical Development
Teams
Client
IDSC
ClinPharm
Team Members
Contracted as:
IDSC
ADME
Director
Fully Integrated Collaborations
Individuals
Small Teams
ADME
CRO
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IDSC
Regulatory
Director
IDSC
Clinician
IDSC
In-vitro
Pharm
Director
In Vitro
Pharmacology
CRO
WWW.IDSCBIOTECHNETWORK.COM
IDSC
API & CMC
Director
IDSC
TA Expert &
PM, POC
IDSC
IDSC
Directors
Management:
Information & Data
Management:
Sample logistics
Information tree
Decision & Data
Sample logistics
CRO management
Decision tree
CRO management
In Vivo
Pharmacology
CRO
IDSC
Toxicology
Director
IDSC
In-vivo
Pharm
Director
Toxicology
CRO
©2013 IDSC, LLC
API Scale Up
CRO
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10. Summary
Expertise
Discovery
Clinical
Development
Preclinical
Development
Project
Leadership
Regulatory
Compliance
Commercial
Assessment
IDSC
Client
CROs
Therapeutic Area Expertise
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CNS
Cardiovascular
Dermatology
Infectious Diseases
Inflammation
Immunology
Metabolic diseases
Oncology
Pain
Discovery Expertise
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Development Expertise
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Medicinal Chemistry
Molecular Modeling
Pharmacology
Outsourcing Management
ADME
Small Molecules ● Biologics ● Stem Cells
IDSC offers the academic, biotech,
pharma, and VC community a fully
integrated drug discovery and
development partner
Discovery
Hit to Lead
ADME & PK/PD/TK Modeling
Toxicology & Pathology
API management & CMC
Formulation, Fill & Finish
Regulatory Compliance
FDA meetings, IND/NDA prep &
submission
• Clinical Study Design
• Commercial Assessment &
Valuation
Development
Lead
Optimization
Preclinical
Development
To IND Filing
Clinical
Development
Interim Leadership ● Consulting ● Fully Integrated Collaborations ● Outsourcing Management
Therapeutics . Stem Cells . Nutraceuticals . Devices . Diagnostics
IDSC’s clients come to us for Discovery, Preclinical Development, Clinical
Development, and Project Management expertise
10/29/2013
WWW.IDSCBIOTECHNETWORK.COM
©2013 IDSC, LLC
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