Embed Size (px)
DESCRIPTION
IDSC provides drug discovery,preclinical development, clinical development, and outsourcing expertise to assist clients in delivering innovative medicines to the clinic & market faster, while minimizing attrition. We are an interdisciplinary group of 40 ex-pharma leaders averaging 25 years of big pharma experience. Our clients come to us for six main reasons: Drug discovery and development Interim leadership, consulting, fully integrated collaborations, due diligence, molecular modeling, and outsourcing management. Because we are a fully integrated drug discovery, preclinical development, and clinical development partner, we help our biotech, VC, academic, and pharma clients get from early discovery to IND filing and through phase I clinical trials in all major therapeutic areas and on to NDA in antibacterials, CNS, and oncology.
Citation preview
©2013 IDSC, LLC10/29/2013 WWW.IDSCBIOTECHNETWORK.COM 1
IDSC
Capabilities ● Expertise ● Services
Mark CreswellPresident and [email protected]: 734.433.9670Cell: 734.476.4097
©2013 IDSC, LLC
IDSC May Be A Fit For YOU…
10/29/2013 WWW.IDSCBIOTECHNETWORK.COM 2
FROM HIT TO THE CLINIC…
YOUR DRUG DISCOVERY AND DEVELOPMENT
PARTNER
• Biotech
• Pharma
• Academic
• VC
If you are a…
• Drug discovery…
• Preclinical development…
• Clinical development…
In need of…
…High Impact Consulting
©2013 IDSC, LLC10/29/2013 WWW.IDSCBIOTECHNETWORK.COM 3
Who is IDSC?
IDSC: Integrated Team of Specialists• Interdisciplinary group
• 40 Ex-Pharma Leaders
• 25 yrs Pharma Experience
• Sr. VPs, VPs, Exec. Directors
• Careers in:• Big Pharma
• Biotech
• Academia
• Consulting
©2013 IDSC, LLC
Stages of Drug Discovery & Development
Hit to LeadLead
Optimization
Preclinical Development to IND Filing
Clinical Development
DevelopmentDiscovery
IDSC’s Services Span:
10/29/2013 WWW.IDSCBIOTECHNETWORK.COM 4
Identify Clinical
Candidate
Draft & Submit
IND
Draft & Submit
NDA
FDAPre-IND Meeting
FDAPhase 2 Meeting
Evaluate HTS Hits or SBDD
Results
Select lead compounds
©2013 IDSC, LLC
Why Clients Come to IDSC
Interim Leadership
• Filling the gaps
• Most major therapeutic areas
• All line disciplines
• Small molecules, biologics, stem cells, diagnostics, devices, nutraceuticals
10/29/2013 WWW.IDSCBIOTECHNETWORK.COM 5
Due Diligence
• Investment opportunities
• Program reviews
• SWOT analyses
•Venture capitalists
• Pharma companies
•Academics
Molecular Modeling
• Structure based design
• Pharmocaphore modeling
•Homology models
•Docking, etc
• Small molecules or biologicals
Outsourcing Management
•Medchem, API/ biological, pharmacology, toxicology, ADME, etc.
• Identify CROs & CMOs
•Manage CROs & CMOs
Consulting
•Most major therapeutic areas
•All line disciplines
• Small molecules, biologics, stem cells, diagnostics, devices, nutraceuticals
Fully Integrated Collaborations
• IDSC supplies a full project team to our client.
•All discovery, preclinical development, or clinical development line discipline experts.
©2013 IDSC, LLC
Examples of What Our Leaders Do
Medicinal Chemists• Therapeutic area expert
• Evaluates SAR & decides what compounds to make
• Know ADME & design targets to improve ADME, potency, & efficacy
•Designs synthesis and manages outsourcing
10/29/2013 WWW.IDSCBIOTECHNETWORK.COM 6
API & CMC Managers•Manage CMOs
• Chemistry, biologicals, cell lines…
•Optimize chemistry process
• Troubleshoot biologicals
• Submit regulatory registrations
Clinicians• 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
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
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
ADME, Toxicologists, Pharmacologists
• Design in vitro and in vivo studies
• Identify vendors and manage outsourcing
• Evaluate study data and write INDsubmission study reports
• Make decisions based on study results
©2013 IDSC, LLC
Discovery Expertise
• Medicinal Chemistry
• Molecular Modeling
• Pharmacology
– in vitro
– in vivo
• ADME
WWW.IDSCBIOTECHNETWORK.COM10/29/2013 7
Line Discipline ExperienceTherapeutic Area Experience
• CNS
• Cardiovascular
• Dermatology
• Infectious Diseases
• Inflammation
• Immunology
• Metabolic Diseases
• Oncology
• Pain
©2013 IDSC, LLC
Development ExpertisePreclinical & Clinical
• 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
10/29/2013 WWW.IDSCBIOTECHNETWORK.COM 8
Small
Molecules
●
Biologics
●
Stem Cells
●
Devices
●
Nutraceuticals
©2013 IDSC, LLC
Fully Integrated Collaborations
Individuals
Small Teams
Team MembersContracted as:
10/29/2013 WWW.IDSCBIOTECHNETWORK.COM 9
DiscoveryPreclinical DevelopmentClinical DevelopmentTeams
Management:
Information & Data Sample logistics
Decision treeCRO management
IDSCDirectors
Client
IDSCTA Expert &
PM, POC
Management:
Information & Data Sample logistics
Decision treeCRO management
IDSC Toxicology
Director
IDSC Clinician
IDSCAPI & CMC
Director
IDSC Regulatory
Director
IDSC ADME
Director
IDSCClin-
Pharm
IDSCIn-vivo Pharm
Director
IDSCIn-vitro Pharm
Director
IDSC
In Vivo Pharmacology
CRO
API Scale UpCRO
ToxicologyCRO
ADMECRO
In Vitro Pharmacology
CRO
©2013 IDSC, LLC
Summary
10/29/2013 WWW.IDSCBIOTECHNETWORK.COM 10
IDSC’s clients come to us for Discovery, Preclinical Development, Clinical Development, and Project Management expertise
Expertise
IDSC offers the academic, biotech,
pharma, and VC community a fully
integrated drug discovery and
development partner
Discovery Development
Interim Leadership ● Consulting ● Fully Integrated Collaborations ● Outsourcing Management
Discovery
CommercialAssessment
ClinicalDevelopment
ProjectLeadership
RegulatoryCompliance
PreclinicalDevelopment
CROsClient
Small Molecules ● Biologics ● Stem Cells
Therapeutic Area Expertise• CNS• Cardiovascular• Dermatology• Infectious Diseases• Inflammation• Immunology• Metabolic diseases• Oncology• Pain
Discovery Expertise• Medicinal Chemistry• Molecular Modeling• Pharmacology• Outsourcing Management• ADME
Development Expertise• 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
Hit to LeadLead
Optimization
PreclinicalDevelopmentTo IND Filing
ClinicalDevelopment
Therapeutics . Stem Cells . Nutraceuticals . Devices . Diagnostics
IDSC
![Knowledge Management Strategy [وضع التوافق]...IDSC IDSC is one of the distinguishedIDSC is one of the distinguished think tanks in Egypt, which is primarily tasked with supporting](https://img.pdfslide.us/doc/110x75/5e412a8089b70f6dba078e5a/knowledge-management-strategy-idsc-idsc-is-one-of-the.jpg)
