IDSC From Hit to the Clinic…Your Drug Discovery & Development Partner Mark Creswell President and CEO markcreswell@idscbiotechnetwork.com IDSC CONFIDENTIAL Phone: 734.433.9670 Cell: 734.476.4097 The Expertise and Value IDSC’s Dermatology Development Team Brings Our Clients …Preclinical & Clinical Development IDSC From Hit to the Clinic…Your Drug Discovery & Development Partner 11/6/2018 WWW.IDSCBIOTECHNETWORK.COM

Integrated Team of Specialists 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 1 9 2 8 3 7 4 6 5 8. Clinical development & clinical operations program leader, 7. Regulatory, 5. Formulation, 6. Analytical development & CMC, 4. Toxicology, 9. Commercial assessment & valuation & marketing, 10. Clinical ops team (no photo) Dermatology Team: 1. Dermatology clinician (MD), 2. Clinical & regulatory strategy, 3. ADME 11/6/2018 WWW.IDSCBIOTECHNETWORK.COM

Stages of Drug Discovery & Development IDSC’s Services Span: Development Discovery Hit to Lead Lead Optimization Preclinical Development to IND Filing Clinical Development Identify Clinical Candidate Draft & Submit IND Draft & Submit NDA FDA Pre-IND Meeting Phase 2 Meeting Evaluate HTS Hits or SBDD Results Select lead compounds Optimize Properties, Synthesis, SAR Medicinal Chemistry Pharmacology Molecular Modeling ADME Early Safety Outsourcing Management ADME & PK/PD Modeling CMC Regulatory Toxicology & Pathology Regulatory Compliance API Process Development Clinical Study Design API Management Clinical Operations Formulation Commercial Assessment & Valuation Analytical Development Drug Product Fill & Finish 11/6/2018 WWW.IDSCBIOTECHNETWORK.COM

Why Clients Come to IDSC Interim Leadership Fully Integrated Collaborations Consulting Filling the gaps Most major TAs Strong dermatology team All line disciplines Small molecules, biologics, stem cell therapies, devices, diagnostics, nutraceuticals Most major TAs Strong dermatology team All line disciplines Small molecules, biologics, stem cell therapies, devices, diagnostics, nutraceuticals IDSC supplies a full or partial project team to our client. All discovery, preclinical development, or clinical development line discipline experts. Due Diligence Outsourcing Management Investment opportunities Program reviews Development plans SWOT analyses Venture capitalists Pharma companies Academics Medchem, API/ biological, pharmacology, toxicology, ADME, etc. Any part of clinical not run internally by IDSC Identify CROs & CMOs Manage CROs & CMOs 11/6/2018 WWW.IDSCBIOTECHNETWORK.COM

Examples of What IDSC’s Leaders Do: Clinical Operations Clinicians Head Clinical Development and Clinical Operations Clinical leadership & Project management Biostatistics Study management Site monitoring Data capture & management Medical writing Recruitment & Retention Support preclinical dermatology development plan Draft clinical protocols for dermatology products Participate in and/or lead clinical dermatology advisory boards Oversee clinical trials Advise client, preclinical, and clinical project teams Point of Accountability Develop corporate clinical strategy Develop & manage clinical operations Oversee clinical trials Manage timeline & budget ADME, Toxicologists, Pharmacologists Regulatory Experts API & CMC Managers Guide client and IDSC team on and assure regulatory guidelines are met: For the FDA It’s DDDP* Assist client with preparation for and accompany client to regulatory agency meetings Assist client with preparation of and submission of regulatory documents CMC regulatory guidance 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 Design in vitro and in vivo studies Dermatoxicology studies Identify vendors and manage outsourcing Evaluate study data and write IND submission study reports Make decisions based on study results *DDDP- Division of Dermatology and Dental Products 11/6/2018 WWW.IDSCBIOTECHNETWORK.COM

Development Expertise Preclinical & Clinical: 11/6/2018 Development Expertise Preclinical & Clinical: ADME & PK/PD/TK modeling Toxicology, dermatoxicology, & pathology Process chemistry, API mgmt., & CMC Formulation, analytical, fill & finish Clinical study design Clinical operations Regulatory compliance Regulatory agency meetings Reg document preparation & submission Commercialization strategy Product assessment & valuation Competitive intelligence Small molecule therapeutics ● Biologic therapeutics Stem cells Devices Diagnostics Nutraceuticals 11/6/2018 WWW.IDSCBIOTECHNETWORK.COM

IDSC IDSC Team Members Contracted as: Discovery Preclinical Development Clinical Development Team Client Derm. Clinician (MD) Regulatory Clinical Pharmacology API, CMC, Analytical, Formulation Derm. Expert, PM, & POC Individuals Small Teams Fully Integrated Collaborations Team Members Contracted as: Derm. ADME Derm. Toxicology IDSC Directors IDSC Clinical Operations Med-Chem & Pharmacology Directors Management: Information & Data Sample logistics Decision funnel CRO management Management: Information & Data Sample logistics Decision tree CRO management *The team grows or contracts as needed as the asset moves down the development continuum. ADME CROs Derm. Pharmacology CROs Analytical labs, Clinics, &/or Clinical CROs Toxicology CROs Chemistry & API Scale Up CROs 11/6/2018 WWW.IDSCBIOTECHNETWORK.COM

IDSC Clinical Development & Clinical Operations Directors FDA Management: Information & Data Sample logistics Decision tree CRO management IDSC Directors 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 PK Analysis Clinical Dev/Ops Leader & POC Study Sites & Staff E-Data Capture & Management CROs & CMOs: FDA KOLs 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 Abbreviations: POC: point of contact CMO: chief medical officer CROs & CMOs: contract research organizations & contract manufacturing organizations 11/6/2018 WWW.IDSCBIOTECHNETWORK.COM

Clinical Development & Operations Leader 11/6/2018 Clinical Development & Operations Leader Project Leader / Manager of Clinical Cross-functional Team Responsible for clinical programs and regulatory filings Develop and optimize clinical development strategy Oversee development & management of clinical programs Oversee clinical operations Track progress & enable on time delivery or mitigate delay Effective communication between stake holders Develop & manage budget Where possible, identify cost saving in existing budgets Ensure most effective use of resources 11/6/2018 WWW.IDSCBIOTECHNETWORK.COM

Clinical Operations Team 11/6/2018 Clinical Operations Team Study managers Implement clinical study protocols Evaluate protocol feasibility, develop and manage clinical site payments, prepare and facilitate investigator meetings, manage drug supply, and manage data flow and data quality. Site monitors Our ops team creates a detailed monitoring plan that specified all aspects of remote and on site data monitoring. Data management Tools, Integrity, real time data monitoring, electronic data capture Medical writing Ensure well-structured documents that present information clearly and concisely Biostatistics Ensure the study is powered for a successful decision Evaluate study result Recruitment: A detailed recruitment and retention program is defined prior to the start of each clinical study.  A "tool kit" specifically designed for each study is developed which includes potential recruitment materials for site use (e.g. Dear Dr. referral letters, IRB approved advertisements), relevant lab manuals, PK/PD instructions, trial master files etc.  The recruitment retention document outlines enrollment and milestones along with actions to be taken in the case that milestones are not met. 11/6/2018 WWW.IDSCBIOTECHNETWORK.COM

IDSC’s Key Dermatology Development Team Bios: Howard Welgus, MD: 30 years academia & pharma, global head of dermatology & inflammation (Pfizer), clinician, CMO, medical affairs. Former Professor of Dermatology in Medicine. Dermatology research expertise in acne, psoriasis, atopic dermatitis, hair growth, wound healing and pigmentation Barry Calvarese BS: 30 plus years career in biopharmaceutical & medical devices, VP, Regulatory & Clinical Affairs, dermatology, 23 new INDs submitted including for acne, basal cell carcinoma, atopic dermatitis, psoriasis. Drafted, submitted NDAs for major dermatology products: Atralin, Ziana, Metrogel, Clobex Spray, Desonate, Acanya, onychomycosis. Francie Kivel, MS:  26 years big pharma & small biotech, clinical development & corporate strategy, program management, clinical operations, stem cell therapies, CV, CNS, oncology, women’s health, inflammation. Mark Ammann, PharmD: 21 years experience in regulatory (Novartis, Pharmacia, Pfizer) involving numerous IND and NDA approvals. Global head, inflammation and dermatology therapeutic areas and regulatory site head for Pfizer, Ann Arbor . Zbigniew W. Wojcinski, DVM, DVSc, DACVP, DABT: 28 year big pharma, toxiocology, dermatotoxicology, senior director dermatology drug safety R&D, dermatologics. Louis L. Radulovic, PhD, MPH: 28 year big pharma, nonclinical safety assessments, research fellow drug safety R&D, develop toxicology testing paradigm for dermatologics, dermatotoxicology API management, Formulation, Analytical Development, CRO/CMO management, and CMC. Clinical Operations: multiple personnel including study managers, site monitors, data capture and management, medical writers, and biostatisticians. Jeff Simpson, BS: 28 years big pharma and consulting; commercial strategy, product assessment, valuation, lifecycle planning, marketing, advisory boards. Inc Dermatology 11/6/2018 WWW.IDSCBIOTECHNETWORK.COM

Thank You For More Information, Visit: www.idscbiotechnetwork.com Or… Watch this 4 ½ minute video: Mark Creswell President & CEO 310 N. Main St. Suite 204 Chelsea, MI 48118 USA Phone: 734.433.9670 Fax: 734.433.9671 Cell: 734.476.4097 markcreswell@idscbiotechnetwork.com 11/6/2018 WWW.IDSCBIOTECHNETWORK.COM