1. IDSC From Hit to the Clinic…Your Drug Discovery & Development Partner
Mark Creswell
President and CEO
IDSC CONFIDENTIAL
Phone: Cell:
The Expertise & Value IDSC’s Biologics Ophthalmology Development Team Brings Our Clients
IDSC
From Hit to the Clinic…Your Drug Discovery & Development Partner
4/29/2019

2. Integrated Team of Specialists
Ophthalmology Team:
Who is IDSC?
Integrated Team of Specialists
1. Ophthalmic clinical development & regulatory, 10 1
2. Clinical development & operations leader,
Interdisciplinary group 9 2
3. ADME,
65 Ex-Pharma Leaders 8 3
4. Toxicology,
25 yrs Pharma Experience
5. Clinical pharmacology & PhI to PhII PK modeling
Sr. VPs, VPs, Exec. Directors
6. Formulation,
Careers in: 4
7. Analytical development & CMC, 7
Big Pharma
Biotech Companies
8. Regulatory, 6 5
9. Clinical operations team,
Academia
Post Career Consulting
10. Commercial assessment & valuation,
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3. IDSC Supports All Stages of Drug Discovery & Development
IDSC’s Services Span:
Discovery
Development
Hit to Lead
Lead Optimization
Preclinical Development to IND Filing
Clinical Development
Evaluate HTS Hits or SBDD Results
Select lead Series
Optimize Properties, Synthesis, SAR
Identify Clinical Candidate
FDA
Pre-IND Meeting
Draft & Submit IND
FDA
Phase 2 Meeting
Draft & Submit NDA
Clinical Operations & Medical Monitoring
Medicinal Chemistry
Pharmacology
Molecular Modeling
ADME
Early Safety
ADME & PK/PD Modeling
Drug Product Fill & Finish
Toxicology & Pathology
CMC Regulatory
Process Development
Regulatory Compliance
API Management
Clinical Study Design
Formulation
Clinical Operations
Analytical Development
Commercial Assessment & Valuation
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4. Why Clients Come to IDSC
Drug Discovery
Interim Leadership
Consulting
Filling the gaps
Most major therapeutic areas
All line disciplines
Small molecules., biologics, stem cells, diagnostics, devices, nutraceuticals
Most major therapeutic areas
All line disciplines
Small molecules., biologics, stem cells, diagnostics, devices, nutraceuticals
Preclinical Development
Clinical Development
Due Diligence
Fully Integrated Collaborations
Molecular Modeling
Commercial Assessment
Outsourcing Management
Investment opportunities
Program reviews
SWOT analyses
For venture capitalists
For pharma companies
For academics
Structure-based design
Ligand-based design
Structural Bioinformatics
Cheminformatics
Small molecules and biologicals
Commercial assessment & valuation
Market Research
Quant & Qual
KOsL, Payers, etc
Forecasting
Net Present Values
Medchem, API/ biological, pharmacology, toxicology, ADME, etc.
Parts of clinical that IDSC does not run ourselves
Identify CROs & CMOs
Manage CROs & CMOs
IDSC supplies a full or partial project team to our client.
All discovery, preclinical development, or clinical development line discipline experts.
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5. Help YOUR company? Can A Group With:
A Point of Clarity…
IDSC does not have laboratories and does not provide lab services... IDSC is a team of 65 consultants providing leadership to our clients. We do, however manage our clients’ outsourcing efforts.
A Rhetorical Question…
Can A Group With:
Over 1600 years of pharma experience;
Expertise across the major therapeutic areas;
Expertise in all the disciplines in the discovery & development continuum from…
Hit ID to launch in…
Small molecule & biologics therapeutics, stem cell therapies, disease diagnostics, medical devices, and nutraceuticals…
Help YOUR company?
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6. Examples of What Our Leaders Do
TA Experts and Project Leaders
ADME, Toxicologists, Pharmacologists
Head Ophthalmic Clinical Development & Strategy
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
Support ophthalmic preclinical development plan
Draft clinical plan & protocols for ophthalmic clinical trials
Participate in and/or lead clinical advisory boards & identify KOLs
Advise client, preclinical, and clinical project teams
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
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 IND submission study reports
Make decisions based on study results & program goals
Regulatory Experts
Clinical Development and Operations Leader
Clinicians
Clinical Operations
Clinical leadership & Project management
Biostatistics
Study management
Site monitoring
Data capture & management
Medical writing
Recruitment & Retention
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
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
Point of Accountability and POC
Develop corporate clinical strategy
Develop & manage clinical operations
Oversee clinical trials
Manage timeline & budget
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.
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7. Line Discipline Expertise
Drug Discovery
Preclinical & Clinical Development
Medical Markets
Medicinal Chemistry
Molecular Modeling
Pharmacology
in vitro
in vivo
ADME
Small Molecules ●
Biologics
Stem Cells
Devices
Diagnostics
Nutraceuticals
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
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8. Is Your Development Plan in Place?
Program Review
Gap 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 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 IND submission.
Provide a detailed written report and a teleconference call
Depending on # of directors and therapeutic area, it can take hours of consulting work (1-8 directors)
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 hours of consulting work (1-8 directors)
Development Plan
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©2013 IDSC, LLC

9. IDSC Team Members Contracted as:
KOLs
Client
Discovery Preclinical Development Clinical Development Team
Study Sites
FDA
Ophthalmology
Clinician
(MD)
Regulatory Ophthalmology
Team Members Contracted as:
Clinical Pharmacology
API, CMC, Analytical, Formulation
Individuals
TA Expert, PM, & POC
ADME PK/PD/TK Modeling
Toxicology
Small Teams
IDSC
Fully Integrated Collaborations
Clinical Operations
Directors
Management:
Information & Data
Sample logistics
Decision funnel
CRO management
Med-Chem & Pharmacology
The team grows and contracts as needed as the asset moves down the development continuum.
Abbreviations:
POC: point of contact
CMO: chief medical officer
CROs & CMOs: contract research organizations & contract manufacturing organizations
CROs & CMOs:
ADME
CROs
Ophthalmology
Pharmacology
CROs
Analytical labs, Clinics, &/or Clinical CROs
Toxicology
CROs
Chemistry & API Scale Up
CROs
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10. IDSC Clinical Development & Clinical Operations FDA Directors
Client
KOLs
Clinical Development
& Clinical Operations
Ophthalmology
Clinician
(MD)
Regulatory
& Document Submission Ophthalmology
Study Sites
FDA
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
Clinical Pharma-cologist
Biostats
Clinical Dev/Ops Leader & POC
Site Monitors
Medical Writers
IDSC
Keys To Success:
Team makes key decisions
Excellent project leadership
Excellent communication
Excellent project management
Directors
& Staff
Study Managers
E-Data Capture & Management
Significant operations expertise
Goal oriented team
Manage streamlined logistics process
API, Analytical, Formulation, CMC, Fill & Finish
CROs & CMOs:
Abbreviations:
POC: point of contact
KOL: Key Opinion Leader
CMO: chief medical officer
CROs & CMOs: contract research organizations & contract manufacturing organizations
Clinical PK Analysis
API, Final Dosage Form, Fill & Finish, Analytical
Clinical CROs (if needed)
IVRS, Electronic Data Capture Software
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11. Key Ophthalmology Project Team Members
Ophthalmic Regulatory Strategy & Clinical Development: 32 years biotech & consulting, small molecules, proteins, antibodies, VP clinical & regulatory at Dow Pharma Services, VP regulatory, clinical, and quality at Fibrogen, Inc., multiple ophthalmology IND submissions
Toxicology: 28 year big pharma, toxicology, dermatotoxicology, senior director dermatology drug safety R&D, dermatologics, multiple TAs including dermatology & Ophthalmology.
ADME: 28 year big pharma, nonclinical safety assessments, research fellow drug safety R&D, develop toxicology testing paradigm for dermatologics, dermatotoxicology
Clinical Development Leadership & Operations :  26 years big pharma & small biotech, clinical development & corporate strategy, program management, clinical operations, stem cell therapies, CV, CNS, oncology, women’s health, inflammation.
Clinical Pharmacology: 30 years big pharma, clinical pharmacology & PK/PD, multiple TAs including ophthalmology, study, data analysis, population PK & PK/PD, INDs, NDAs, JNDAs, MAAs, FDA, EMA, BfArM, Health Canada, MPA.
Manufacture Management: 16 years biotech, API management, small molecules, biologicals, cGMP, senior project and operations management, EHS officer, facility management, budget management, IMPD, IND, NDA, MAA.
Cell line and Protein Manufacture Management: 22 years biotech & consulting, API management, small molecules, biologicals, cGMP, manufacturing, supply chain, contract negotiation, audits, CMC regulatory, QA & QC, bioanalytical methods, CRO/CMO management.
Biologics Formulation: 30 years biotech; biologics; process development, formulation, analytical development, CMC, lyophilization, and stability.
Commercial Assessment & Valuation: 32 years big pharma and consulting; commercial strategy, market & product assessment, valuation, lifecycle planning, marketing, advisory boards.
Analytical Development, CRO/CMO management, Clinical operations, Fill & finish, CMC, etc.
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12. For More Information, Visit: www.idscbiotechnetwork.com
THANK YOU Mark Creswell President & CEO
310 N. Main St. Suite 204 Chelsea, MI USA Phone: Fax: Cell:
4/29/2019