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©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC11/14/2014 WWW.IDSCBIOTECHNETWORK.COM 1
Mark CreswellPresident and CEOmarkcreswell@idscbiotechnetwork.com
Phone: 734.433.9670Cell: 734.476.4097
Capabilities ● Expertise ● Servicesand IDSC’s
Discovery & Development Teams
IDSCFrom Hit to the Clinic…Your Drug Discovery
& Development Partner
©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC
• Biotech• Pharma• Academic• VC
If you are a…
IDSC May Be A Fit For YOU…
11/14/2014 WWW.IDSCBIOTECHNETWORK.COM 2
FROM HIT TO THE CLINIC…
YOUR DRUG DISCOVERY AND DEVELOPMENT
PARTNER
• Drug discovery…
• Preclinical development…
• Clinical development…
In need of…
…High Impact Consulting
©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC11/14/2014 WWW.IDSCBIOTECHNETWORK.COM 3
Who is IDSC?Integrated Team of Specialists
→ Interdisciplinary group
→ 55 Ex-Pharma Leaders
→ 25 yrs Pharma Experience
→ Sr. VPs, VPs, Exec. Directors
→ Careers in:
→ Big Pharma
→ Biotech Companies
→ Academia
→ Post Career Consulting
©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC
IDSC Supports All Stages of Drug Discovery & Development
11/14/2014 WWW.IDSCBIOTECHNETWORK.COM 4
Hit to LeadLead
Optimization
Preclinical Development to IND Filing
Clinical Development
DevelopmentDiscovery
IDSC’s Services Span:
Identify Clinical
Candidate
Draft & Submit
IND
Draft & Submit
NDA
FDAPre-IND Meeting
FDAPhase 2 Meeting
Evaluate HTS Hits or SBDD
Results
Select lead Series
Optimize Properties, Synthesis,
SAR
Medicinal ChemistryPharmacology
Molecular ModelingADME
Early Safety
ADME & PK/PD ModelingToxicology & PathologyProcess Development
API ManagementFormulation
Analytical Development
Drug Product Fill & FinishCMC Regulatory
Regulatory ComplianceClinical Study DesignClinical Operations
Commercial Assessment & Valuation
©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC
Molecular Modeling
• Structure-based design
• Ligand-based design
• Structural Bioinformatics
• Cheminformatics
• Small molecules and biologicals
Interim Leadership• Filling the gaps
•Most major therapeutic areas
•All line disciplines
• Small molecules., biologics, stem cells, diagnostics, devices, nutraceuticals
Why Clients Come to IDSC
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Due Diligence
• Investment opportunities
• Program reviews
• SWOT analyses
• For venture capitalists
• For pharma companies
• For academics
Outsourcing Management
•Medchem, API/ biological, pharmacology, toxicology, ADME, etc.
• Parts of clinical that IDSC does not run ourselves
• 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 or partial project team to our client.
• All discovery, preclinical development, or clinical development line discipline experts.
Commercial Assessment
• Commercial assessment & valuation
•Market Research–Quant & Qual
– KOsL, Payers, etc
• Forecasting
•Net Present Values
©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC11/14/2014 WWW.IDSCBIOTECHNETWORK.COM 6
IDSC does not have laboratories and does not provide lab services... IDSC is a team of 55 consultants providing leadership to our
clients. We do, however manage our clients’ outsourcing efforts.
A Point of Clarity…
A Rhetorical Question…
©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC
Clinical Development and Operations Leader
• Point of Accountability and POC
• Develop corporate clinical strategy
• Develop & manage clinical operations
• Oversee clinical trials
• Manage timeline & budget
Examples of What Our Leaders Do
11/14/2014 WWW.IDSCBIOTECHNETWORK.COM 7
Clinical Operations• Clinical leadership & Project
management
• Biostatistics
• Study management
• Site monitoring
• Data capture & management
• Medical writing
• Recruitment & Retention
Regulatory Experts
• Guide client and IDSC team on and assure guidelines for the appropriate FDA division are met
• Assist client with preparation for and accompany client to regulatory agency meetings
• Assist client with preparation of and submission of regulatory documents
API & CMC Managers
• Identify CMOs and manage outsourcing
– Chemistry, biologicals, cell lines…
• Optimize chemistry process
• Troubleshoot biologicals
• Submit regulatory registrations
• API, CMC, cell lines, formulation, analytical, and, fill & finish, etc
IDSC is a team of 55 consultants providing leadership to ur clients… We do not have laboratories and do not provide lab services. We do, however manage our clients’ outsourcing efforts.
Clinicians• Support the indication preclinical
development plan
• Draft clinical protocols & plan
• Participate in and/or lead clinical advisory boards & identify KOLs
• Oversee clinical trials
• Advise client, preclinical, and clinical project teams
ADME, Toxicologists, Pharmacologists
• Design in vitro and in vivo studies
• Identify ADME & Toxicology CROs
• Identify in vitro & in vivo indication specific CROs & manage outsourcing
• Evaluate study data and write INDsubmission study reports
• Make decisions based on study results & program goals
Medicinal Chemists• Therapeutic area expert
• Evaluates SAR & decides what compounds to make
• Knows TA & ADME requirements & designs compounds to optimize ADME, potency, & efficacy
• Designs synthesis and manages outsourcing
TA Experts and Project Leaders
• Advise client on therapeutic area and disease indication
• Prepare program reviews
• Lead teams in preparation of gap analyses and development plans
• Serve as project leader for project teams
©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC
Therapeutic Area Expertise
11/14/2014 8WWW.IDSCBIOTECHNETWORK.COM
→ Inflammation
→ Infectious Diseaseas
→ Antivirals
→ Antifungals
→ Antibacterials
→ Immunology
→ Immuno-inflammatory diseases
→ Metabolic Diseases
→ Oncology
→ Blood disorders
→ Most tumor types
→ Pain
→ CNS
→ psychotherapeutics
→ Neuro-degenerative diseases
→ Dermatology
→ Including wound healing
→ Cardiovascular
→ Including cardio-devices
→ Ophthalmology
©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC
Line Discipline Expertise
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Drug Discovery
Preclinical & Clinical Development
• Medicinal Chemistry
• Molecular Modeling
• Pharmacology
– in vitro
– in vivo
• ADME
• ADME & PK/PD/TK modeling• Toxicology & pathology• Process chemistry/ API mgmt / CMC• Formulation, analytical, fill & finish• Clinical study design, MD, CMO• Regulatory support, including:
– Regulatory agency meetings– Document preparation & submission
• Clinical operations• Commercialization strategy• Product assessment & valuation• Market research
Small Molecules
●
Biologics
●
Stem Cells
●
Devices
●
Diagnostics
●
Nutraceuticals
©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC
Medical Devices
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Regulatory Compliance•Determine the correct regulatory strategy
• Ensure actives and goals are aligned with the regulatory strategy
•Write regulatory documentation
•Make regulatory submissions
• Prepare client for meeting with regulatory agencies
Strategic Planning•Guide company strategy
•We help our client:
–Establish a business plan
–Set company goals, timelines, budgets, and milestones
–Generate an exit strategy
• Identify and oversee external vendors
Clinical Development• Establish and run clinical advisory board
• Identify and utilize KOLs
•Determine clinical pathway
•Write clinical protocols
• Ensure nonclinical studies & other development activities align with clinical plan & regulatory requirements
• Clinical operations
Market Assessment•Asset valuation
•Determine market size and potential market penetration
• Competitive intelligence
• Position client to manage negotiations with investors and partners by receiving the highest value for their asset
• Performing product valuations are not just in the domain of “big-pharma”
Disease Diagnostics Nutraceuticals
©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC11/14/2014 WWW.IDSCBIOTECHNETWORK.COM 11
Directors
Management:
Information & Data Sample logisticsDecision funnel
CRO management
IDSC
Client
Toxicology
TA SpecificClinician
(MD)
API, CMC, Analytical,
Formulation
Regulatory
ADME PK/PD/TK Modeling
Clinical Pharmacology
Med-Chem & Pharmacology
Clinical Operations
Analytical labs, Clinics, &/or Clinical
CROs
Chemistry & API Scale Up
CROs
ToxicologyCROs
ADMECROs
PharmacologyCROs
TA Expert, PM, & POC
FDA
KOLs
CROs & CMOs:
Abbreviations:• POC: point of contact• CMO: chief medical officer• CROs & CMOs: contract research organizations
& contract manufacturing organizations
Team Members Contracted as:
Individuals
Small Teams
Fully Integrated Collaborations
Discovery Preclinical Development Clinical Development Team Study
Sites
The team grows and contracts as needed as the asset moves down the development continuum.
©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC
IDSCDirectors
& Staff
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Client
Medical Writers
Clinician (CMO)
Biostats
Regulatory & Document Submission
Site Monitors
Clinical Pharma-cologist
API, Analytical, Formulation, CMC, Fill &
Finish
Study Managers
API, Final Dosage Form, Fill & Finish, Analytical
IVRS, Electronic Data Capture
Software
Clinical CROs(if needed)
Clinical PKAnalysis
Clinical Dev/Ops Leader &
POC
Study Sites
E-Data Capture &
Management
CROs & CMOs:
FDA
KOLsClinical Development& Clinical Operations
IDSC Clinical Ops Team Will Provide:
Program leadership
Project management
Site assessment & selection
Patient recruitment & retention
Tool kits, Dear Dr. referral letters
Timeline & budget management
Site management
Site monitoring
Budget development
Contract & budget approval facilitation
Data management
Real time data monitoring & capture
Keys To Success:
→ Team makes key decisions
→ Excellent project leadership
→ Excellent communication
→ Excellent project management
→ Significant operations expertise
→ Goal oriented team
→ Manage streamlined logistics process
Abbreviations:• POC: point of contact• KOL: Key Opinion Leader• CMO: chief medical officer
• CROs & CMOs: contract research organizations & contract manufacturing organizations
©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC11/14/2014 WWW.IDSCBIOTECHNETWORK.COM 13
Program ReviewGap Analysis
Development Plan
Program Review•Often early in preclinical (Discovery)•Often performed by 1 director (consultant)•Review of client’s early data, issued patents, patent applications, &
relevant literature• Provide client with a SWOT (strengths, weaknesses, opportunities,
threats) analysis.• Provide brief scientific next steps needed, generally to move the
project to the next stage such as a funding spinout, out-licensing, VC funding, etc.• Provide a brief written report or teleconference or both•Often 10-20 hours of consulting work
Gap Analysis•Often performed late in preclinical development•Often performed by multiple directors (consultants)•Review client’s in vitro, in vivo efficacy, ADME, & tox data, issued
patents, patent applications, and relevant literature, clinical plan, & IND ready study reports• Provide client with key studies and protocols that are missing from the
technical package & and regulatory information needed to get to INDsubmission.• Provide a detailed written report and a teleconference call•Depending on # of directors and therapeutic area, it can take 25-115
hours of consulting work (1-8 directors)
Development Plan•Often performed when clinical candidate is identified• Performed by 1-8 directors (client’s budget dependent)•Review client’s in vitro, in vivo efficacy, & ADME data, issued patents,
patent applications, and relevant literature• Provide client with needed efficacy, ADME, & tox studies, protocols,
timeline, budget, regulatory needs, and cohesion with a PhI clinical plan to get to an IND submission • Provide a detailed written report and a teleconference call•Depending on # of directors and therapeutic area, can take 25-230
hours of consulting work (1-8 directors)
©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC11/14/2014 WWW.IDSCBIOTECHNETWORK.COM 14
IDSC is an Interdisciplinary Group of Over 55 Ex-Pharma Leaders Averaging 25-Years of Big-Pharma and Biotech Experience
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Small Molecule & Biologic Therapeutics ● Stem Cells Therapies ● Nutraceuticals ● Medical Devices ● Diagnostics
Hit to Lead Lead OptimizationPreclin Developto IND Filing
Clinical Development
DevelopmentDiscovery
Therapeutic Area Expertise•CNS (Most Indications)•Cardiovascular•Dermatology• Infectious Diseases (AB, AV, AF)• Inflammation• Immunology•Metabolic diseases•Oncology (Most tumors & Blood)•Ophthalmology•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•Clinical Operations•Commercial Assessment & Valuation
IDSC’s clients come to us for Discovery, Preclinical Development, Clinical Development, and Project Management Expertise
Interim Leadership ● Consulting ● Fully Integrated Collaborations ● Due Diligence ● Molecular Modeling ● Outsourcing Management
IDSC Brings the Academic, Biotech, Pharma, and VC Community a Fully
Integrated Discovery and Development Partner
©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC11/14/2014 WWW.IDSCBIOTECHNETWORK.COM 15
310 N. Main St. Suite 204Chelsea, MI 48118 USA
Phone: 734.433.9670Fax: 734.433.9671Cell: 734.476.4097
markcreswell@idscbiotechnetwork.com
THANK YOUMark Creswell
President & CEO
For More Information, Visit:www.idscbiotechnetwork.com
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