1. IDSC From Hit to the Clinic…Your Drug Discovery & Development Partner
Mark Creswell
President and CEO
Phone: Cell:
IDSC
From Hit to the Clinic…Your Drug Discovery & Development Partner
Capabilities ● Expertise ● Services and IDSC’s CNS Discovery & Development Team
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2. Integrated Team of Specialists
Who is IDSC?
Integrated Team of Specialists 10 1
Interdisciplinary group 9 2
55 Ex-Pharma Leaders 8 3
25 yrs Pharma Experience
Sr. VPs, VPs, Exec. Directors 7 4
Careers in: 6 5
Big Pharma
Biotech Companies
Post Career Consulting
CNS Team:
1. CNS expert & clinical strategy,
2. CNS clinician (MD),
3. ADME,
4. Analytical Development & CMC,
5. Commercial assessment & valuation,
6. Formulation,
7. Clinical development & clinical operations,
8. Toxicology,
10. CNS expert & pharmacology
9. Regulatory,
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3. 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
Medicinal Chemistry
ADME
Pharmacology
Early Safety
Molecular Modeling
ADME & PK/PD Modeling
Formulation
Regulatory Compliance
Analytical Development
Clinical Study Design
Toxicology & Pathology
Drug Product Fill & Finish
Clinical Operations
Process Development
Commercial Assessment & Valuation
API Management
CMC Regulatory
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4. Why Clients Come to IDSC
Drug Discovery
Interim Leadership
Filling the gaps
Most major TAs
All line disciplines
Small mols., biologics, stem cells, diagnostics, devices, nutraceuticals
Consulting
Most major TAs
All line disciplines
Small mols., biologics, stem cells, diagnostics, devices, nutraceuticals
Preclinical Development
Clinical Development
Due Diligence
Investment opportunities
Program reviews
SWOT analyses
For venture capitalists
For pharma companies
For academics
Fully Integrated Collaborations
IDSC supplies a full project team to our client.
All discovery, preclinical development, or clinical development line discipline experts.
Molecular Modeling
Structure-based design
Ligand-based design
Structural Bioinformatics
Cheminformatics
Small molecules and biologicals
Outsourcing Management
Medchem, API/ biological, pharmacology, toxicology, ADME, etc.
Parts of clinical that IDSC does not run ourselves
Identify CROs & CMOs
Manage CROs & CMOs
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
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5. Examples of What Our Leaders Do
TA Experts and Project Leaders
Advise client on CNS Diseases
Prepare program reviews
Lead teams in preparation of gap analyses and development plans
Serve as project leader for project teams
Medicinal Chemists
CNS experts
Evaluates SAR & decides what compounds to make
Knows CNS & ADME requirements & designs compounds to optimize ADME, potency, & efficacy
Designs synthesis and manages outsourcing
ADME, Toxicologists, Pharmacologists
Design in vitro and in vivo studies
Identify ADME & Toxicology CROs
Identify in vitro & in vivo CNS CROs & manage outsourcing
Evaluate study data and write IND submission study reports
Make decisions based on study results & program goals
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
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
Clinical Development and Operations Leader
Point of Accountability and POC
Develop corporate clinical strategy
Develop & manage clinical operations
Oversee clinical trials
Manage timeline & budget
Clinicians
Support CNS 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
Clinical Operations
Clinical leadership & Project management
Biostatistics
Study management
Site monitoring
Data capture & management
Medical writing
Recruitment & Retention
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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6. Line Discipline Expertise
Preclinical & Clinical Development
Drug Discovery
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
Regulatory Support, including:
Regulatory Agency Meetings
Document Preparation & Submission
Clinical Operations
Commercialization Strategy
Product Assessment & Valuation
Competitive Intelligence
Medicinal Chemistry
Molecular Modeling
Pharmacology
in vitro
in vivo
ADME
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7. IDSC Team Members Contracted as: Discovery Preclinical Development
Client
KOLs
Directors
Management:
Information & Data
Sample logistics
Decision funnel
CRO management
IDSC
Discovery
Preclinical Development
Clinical Development
Team
FDA
CNS
Clinician
(MD)
Regulatory
Study Sites
Clinical Pharmacology
API, CMC, Analytical, Formulation
CNS
Expert, PM, & POC
Team Members Contracted as:
ADME PK/PD/TK Modeling
Toxicology
Individuals
Clinical Operations
CNS Med-Chem & Pharmacology
Small Teams
Fully Integrated Collaborations
The team grows and contracts as needed as the asset moves down the development continuum.
ADME
CROs
CNS
Pharmacology
CROs
Analytical labs, Clinics, &/or Clinical CROs
Toxicology
CROs
Chemistry & API Scale Up
CROs
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8. IDSC Clinical Development & Clinical Operations
Client
KOLs
IDSC
Directors
& Staff
Clinical Development
&
Clinical Operations
Study Sites
FDA
Clinician (CMO)
Regulatory & Document Submission
Clinical Pharma-cologist
Biostats
Keys To Success:
Team can make key decisions
Excellent project leadership
Excellent communication
Excellent project management
Significant Operations expertise
Goal oriented team
Manage streamlined logistics process
Clinical Dev/Ops Leader & POC
Site Monitors
Medical Writers
Study Managers
E-Data Capture & Management
API, Analytical, Formulation, CMC, Fill & Finish
Abbreviations:
POC: point of contact
CMO: chief medical officer
CROs & CMOs: contract research organizations & contract manufacturing organizations
CROs & CMOs:
Clinical PK Analysis
API, Final Dosage Form, Fill & Finish, Analytical
Clinical CROs (if needed)
IVRS, Electronic Data Capture Software
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9. Key CNS Project Team Members:
Although a list of key CNS team members, this is only a partial list of IDSC’s CNS project team
Sharon Rosenzweig-Lipson, PhD: 21 years Big Pharma (Wyeth, Pfizer) & consulting, VP Research at Confluence, VP R&D at AgeneBio, Head of Translational Neuroscience at Pfizer/Wyeth, CNS expertise: AgeneBio, Pfizer/Wyeth, University of Pennsylvania.
Charlie Taylor, PhD: 27 years big pharma; research fellow, CNS; pharmacology; neurological disorders, psychiatric disorders, pain; gabapentin, pregabalin.
Bob Zimmerman, PhD: 25 years big-pharma, including advisory boards, COO & EVP, biotech; CNS pharmacology; preclinical models with large and small species.
Shelly Glase, PhD:  24 years big pharma & consulting, med-chem; outsourcing management, project management, CNS diseases, schizophrenia, inflammation, 5 clinical candidates. 
Richard Kavoussi, MD: 12 years big pharma at Pfizer, Wyeth, & GSK, 15 years academia, Led Phase III trials for Lyrica®, led worldwide medical affairs planning for Zoloft®, Zanax® XR, & Lyrica®, as VP Neuroscience at GSK and Sr Director Neuroscience Pfizer led CNS programs including AD
Zbigniew W. Wojcinski, DVM, DVSc, DACVP, DABT: 28 years big pharma, toxiocology, neurotoxicity, dermatotoxicology, senior director dermatology drug safety R&D, multiple TAs including CNS, CV, dermatology, & Ophthalmology.
Mark Ammann, PharmD: 21 years experience in regulatory strategy (Novartis, Pharmacia, Pfizer) involving numerous IND and NDA approvals, multiple TAs including psychiatry & neurology.
Mary Zimmerman, MS: 25 years biotech; SVP; regulatory affairs & strategy; IND, CTA, INPD, CTD submissions, CNS diseases, MS, oncology, antibacterials, asthma.
Lazo Radulovic, PhD: 20 years big pharma, 5 yrs consulting, ADME, small molecule & biologics, nonclinical safety assessments, FDA interactions, regulatory responses, preparation of NDA item 5 for marked drugs, head of CNS ADME.
API management, Formulation, Analytical Development, CRO/CMO management, Clinical operations, Fill & finish, CMC, etc.
In addition to years pharma experience, most of IDSC’s CNS team has had 3 to 7 years of consulting experience working on virtual teams for clients.
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10. For More Information, Visit: www.idscbiotechnetwork.com
4/5/2019
For More Information, Visit:
THANK YOU Mark Creswell President & CEO
310 N. Main St. Suite 204 Chelsea, MI USA Phone: Fax: Cell:
4/5/2019