1. IDSC From Hit to the Clinic… Your Drug Discovery & Development Partner
Mark Creswell
President and CEO
Phone: Cell:
IDSC CONFIDENTIAL
IDSC
From Hit to the Clinic…
Your Drug Discovery & Development Partner
Capabilities ● Expertise ● Services & IDSC’s Oncology Discovery & Development Team
9/18/2018

2. Integrated Team of Specialists
Oncology Team (small subset):
Preclinical & oncology expert & project leadership
Preclinical & oncology expert & pharmacology
Oncology clinicians (MD)
ADME
Analytical development & CMC
Commercial assessment & valuation
Formulation
Regulatory
Toxicology
Preclinical & oncology expert & medicinal chemist
Who is IDSC?
Integrated Team of Specialists 1
Interdisciplinary group 10 2 9
55 Ex-pharma leaders
25 Years pharma experience 3 8
Sr. VPs, VPs, Executive Directors 4
Careers in: 7
Big pharma 5 6
Biotech companies
Post career consulting
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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
Very strong & deep in oncology
All line disciplines
Biologics, small mols., stem cells, diagnostics, devices, nutraceuticals
Consulting
Most major TAs
All line disciplines
Very strong & deep in oncology
Biologics, small mols., stem cells, diagnostics, devices, nutraceuticals
Preclinical Development
Clinical Development
Due Diligence
Investment opportunities
Program reviews
SWOT analyses
For venture capitalists
For pharma & biotech companies
For academics
Fully Integrated Collaborations
IDSC supplies a full or partial 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
Biologics and small molecules
Outsourcing Management
Medchem, API/ biological, pharmacology, toxicology, ADME, etc.
Parts of clinical that IDSC does not run ourselves
Identify CROs & CMOs
Manage CROs & CMOs
Commercial Assessment
Commercial assessment & valuation
Market Research
Quantitative & Qualitative
KOLs, Payers, etc
Forecasting
Net Present Values
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 oncology, indication, & tumor type.
Prepare program reviews
Lead teams in preparation of gap analyses and development plans
Serve as project leader for project teams
Medicinal Chemists
Antibacterial expert
Evaluates SAR & decides what compounds to make
Knows oncology and blood disorder requirements & ADME & designs compounds to optimize ADME, potency, efficacy, & market profile
Designs synthesis and manages outsourcing
ADME, Toxicologists, Pharmacologists
Design in vitro and in vivo studies
Identify ADME & Toxicology CROs
Identify in vitro & in vivo oncology 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 (oncology appropriate if needed) 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 indication / tumor type preclinical development plan
Draft clinical protocols & plan for specific indication / tumor type
Participate in and/or lead clinical advisory boards & identify KOLs
Oversee aspects of 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 our 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
Biologics ●
Small Molecules
Stem Cells
Devices
Diagnostics
Nutraceuticals
ADME & PK/PD/TK modeling
Toxicology & pathology
Process development/ API Mgmt / CMC
Formulation, analytical, fill & finish
Clinical Study Design (MD clinicians)
Regulatory Support, including:
Regulatory Agency Meetings
Document Preparation & Submission
Clinical Operations
Commercialization Strategy
Product Assessment & Valuation
Market Research
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
Oncology
Clinicians
(MD)
Regulatory
(oncology)
Study Sites
Clinical Pharmacology
API, CMC, Analytical, Formulation
Oncology
Expert, PM, & POC
Team Members Contracted as:
ADME PK/PD/TK Modeling
Toxicology
Individuals
Clinical Operations
Med-Chem or Biologics, & Pharmacology
Small Teams
Fully Integrated Collaborations
The team grows and contracts as needed as the asset moves down the development continuum.
ADME
CROs
Imaging & Pharmacology
CROs
Analytical labs, Clinics, &/or Clinical CROs
Toxicology
CROs
API prep, Cell lines, etc.
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 Oncology Project Team Members:
Alex Bridges, PhD:  28 years big pharma, 6 years Academics, 5 yrs biotech, oncology, metabolic disease, medicinal chemistry, Executive Director at Pfizer, Dacomitinib (phase III), Palbociclib (Phase III).
Bob Zimmerman, PhD: 25 years big-pharma, biotech, biologics, antibacterials, oncology, pharmacology, large and small species, recombinant proteins, monoclonal antibodies, vaccines, and engineered proteins.
Anne Norment, MD, PhD: 20 years biotech, immunology, oncology, pharmacology, translational research, project leadership.
Lori Dostal, PhD, DABT: 26 years big pharma & consulting, reproductive & developmental toxicology, general toxicology, juvenile toxicology, neurotoxicity, fertility studies, pre-IND to NDA.
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.
Mark Ammann, PharmD: 21 years experience in regulatory strategy (Novartis, Pharmacia, Pfizer) involving numerous IND and NDA approvals.
Mary Zimmerman, MS: 25 years biotech, SVP, regulatory affairs & strategy, IND, CTA, INPD, CTD submissions, Alzheimers disease, MS, oncology, antibacterials, asthma.
Rick Stead, MD: 24 years experience, clinical and regulatory strategy for development of biotechnology products, including oncology and hematology products, academic experience in hematology & coagulation.
Karen Steffen, BS: 16 years biotech, API management, small mols, biologicals, cGMP, senior project and operations management, EHS officer, facility management, budget management, IMPD, IND, NDA, MAA.
API management, Formulation, Analytical Development, CRO/CMO management, Clinical operations, Fill & finish, CMC, etc.
In addition to years pharma experience, the IDSC oncology team members have 3-7 years of consulting experience working on virtual teams for clients.
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10. Why Partner with IDSC: Summary
IDSC’s clients come to us for both ad hoc consulting & project based consulting and individual directors, multiple directors, and/or entire project teams.
IDSC’s directors have contributed collectively to multiple oncology drugs in the clinic or on the market: Proleukin®, Epogen®, Neupogen®, Femara®, Sandostatin® LAR, Gleevec®, Zometa®, Dacomitinib (phase III), Palbociclib (Phase III) for example.
IDSC brings its clients a pool of 31+ oncology team experts to utilize as needed:
Oncology experts: 2 medicinal chemists, 1 in vitro pharmacologist, 2 in vivo pharmacologists, 1 in vivo pharmacologist / project leader, 3 clinicians, 1 biostatistician, 2 regulatory experts, multiple clinical development & operations leaders, clinical operations personnel
Supporting personnel : 1 PK/PD modeler, 1 ADME expert, 1 clinical pharmacologist & PK/PD modeler, 3 toxicologists, 1 biostatistician, 3 API managers, 2 formulations experts, 1 analytical development expert, 1 fill & finish expert, 2 CMC/regulatory experts, clinical operations personnel
IDSC’s 55 directors average 25 years of experience in big pharma, biotech, and academia plus consulting experience and have been Sr. VPs, VPs, & Exec. Directors.
IDSC’s Regulatory Experts: Large pharma, FDA, small biotech, multiple drug approvals
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11. For More Information, Visit: www.idscbiotechnetwork.com
9/18/2018
For More Information, Visit:
THANK YOU Mark Creswell President & CEO
310 N. Main St. Suite 204 Chelsea, MI USA Phone: Fax: Cell:
9/18/2018