SAJE Consulting LLC

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SAJE Consulting LLC

• www.SAJEConsultingLLC.com

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SAJE Consulting

• Founders
• Helen S. Pentikis, Ph.D.
• Carol Braun Trapnell, M.D.
• Business objectives
• Provide state-of-the-art, innovative drug
  development consulting services to pharmaceutical
  and biopharmaceutical companies
• SAJE will fully integrate with your project team
  to allow us to completely understand and
  implement your scientific and corporate goals and
  objectives

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SAJE Founders

• Helen S. Pentikis, Ph.D.
• Over 15 years of experience both in private
  industry and the FDA
• Expertise in regulatory and strategic drug
  development with a focus on pharmacokinetics
  (PK), pharmacodynamics (PD), and biopharmaceutics
  involving numerous therapeutic areas
• Carol Braun Trapnell, M.D.
• Over 20 years of experience in drug development
  in both private industry and the FDA
• Expertise in clinical pharmacology, strategic
  drug development, regulatory science
• Experience in many therapeutic areas

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Services Provided

• SAJE Consulting specializes in strategic drug
  development, management, and analysis of programs
  in support of all phases of nonclinical and
  clinical research
• Our goal is to streamline and expedite product
  development using state-of-the-art scientific and
  regulatory approaches
• We strive to avoid scientific and regulatory
  pitfalls in every phase of development
• Our approach considers all aspects of the drug
  development program including
• Project goals
• Program goals
• Business goals

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SAJE Strategic Partnerships
Clin Pharm
POC
CMC
Bioanalytical
Pharm/Tox
PM
Trial Mgmt
Reg Strategy
PK/PD
Biostats/DM
Sponsor Project Team
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Faster, Smarter, Efficient Development
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Product Development Planning

• Product development strategic planning
• Provide regulatory and scientific strategies for
  product development worldwide --- in all of our
  projects
• Develop plans to streamline and expedite the
  approval process
• Design preclinical and clinical strategies in
  concert with products development plan
• Perform scientific and regulatory due diligence

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Regulatory Capabilities

• Experience working with FDA regulations as
  related to product development
• Examples
• Integration of PK/PD in product development
  programs
• 505(b)2 development programs
• Orphan drug development
• Life cycle management
• FDA Interactions assist in document/presentation
  preparation for meetings and attend meetings on
  behalf of our clients
• Examples
• Pre-IND meetings
• End of Phase 1 meetings, End of Phase 2 meetings,
  etc.
• FDA Advisory Committee meetings
• Mock FDA Advisory Committee meetings
• Write, edit, and/or review timely and quality
  documents for an entire submission or for
  individual sections of submissions

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Translational Science

• Expertise in bridging pre-clinical and clinical
  development
• Use of all data to aid in the identification of
• Patients, dosing regimen, diseases to be tested
• Biomarker identification
• PK/PD modeling

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Clinical Pharmacology

• Develop biopharm/PK strategy as part of the drug
  development plan
• Design clinical pharmacology studies and
  substudies
• Perform PK analyses
• NCAs and population PK/PD analyses
• Prepare regulatory-ready reports and FDA
  submissions

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Clinical Research

• Design studies to achieve multiple objectives
  all phases
• In collaboration with investigators and thought
  leaders
• In context of overall development plan and
  regulatory strategy
• Knowledge and experience for the unique needs of
  any given clinical program

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Therapeutic Areas

• Expertise in numerous therapeutic areas
  including

• Hematology/Oncology
• Infectious Diseases
• CNS
• Therapeutic biologics
• Cardiovascular
• GI
• Dermatology
• Metabolic/Endocrine

• Womens health
• Stem cell therapy
• Pain
• Pediatrics
• Respiratory
• Urology
• Immunology
• Special populations

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Drug Delivery Experience

• Oral solid dosage form
• Immediate release
• Sustained/modified release
• Liquid dosage form
• Immediate release
• Sustained/modified release
• Intravenous
• Intramuscular

• Subcutaneous
• Sublingual
• Transdermal
• Topical
• Intranasal
• Inhalation
• Rectal
• Ocular
• Intravaginal

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Preclinical and Bioanalytical Services

• Strategy and management of the following
• Toxicology studies
• Pharmacology
• Metabolism
• Assay development
• Services offerings include
• Protocol design
• Site selection
• Monitoring
• Report review and TK analysis
• Regulatory assistance

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Biostatistics and Programming

• Statistical assistance and analysis throughout
  all phases of drug development
• Planning, analysis, interpretation, report
  writing
• Outstanding programming support for statistics,
  PK, reports (tables/listings/figures) in SAS

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Case Study slide 1 of 2

• In 18 months
• 10 Nonclinical studies completed including
• 90 day rat, monkey
• Seg III DRF, high dose study, lower dose study
• DRF for MTD rat, mouse
• 13 week rat, mouse
• TK study mouse
• CAC submission rat
• 4 Phase I/Clin Pharm studies completed, including
• SAD
• MAD
• Mass balance
• Food effect/relative oral bioavailability

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Case Study slide 2 of 2

• In 18 months
• Phase 2a Proof of Concept study in patients,
  including a six month, treatment extension,
  rollover study
• Investigator meeting
• Thought leader meetings
• 25 sites
• Enrollment at 50 completion
• SAJE Consulting guiding principles of innovation,
  strategic management, process identification and
  implementation were integral in this success!

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SAJE Consulting Success Factors

• We employ a value-added approach
• Innovative scientific and regulatory strategic
  management
• Improving quality, reliability, and productivity
• Big Picture approach to expedite and achieve
  your goals
• We have the edge in science
• Innovative tools and approaches
• A proven track record of success
• Focus on core competencies via strategic
  alliances
• Active collaboration with regulatory authorities
• Enhanced use of technology
• We provide personal attention to the needs of
  your project