Canadian Chemistry R&D and Analytical Services - Expertise & Capabilities
www.pharmainventor.com
Team Members…
Confidential
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Laboratory Facilities-Overview Canadian Research and Innovation Service Provider (CRISP)
1668 Fosters Way, Delta, BC, Canada V3M 6S6 Phone: +1 604-338-3094/ +1 604-339-3244; E-mail: info@pharmainventor.com Confidential
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Company Management Dr. Anupama Patel, Chief Executive Officer
Prof. Thisbe Lindhorst
Worldwide Education & Research Work Experience • • • • • •
Pre-PhD training at the Indian Institute of Chemical Technology (India) Ph.D. in Organic Synthesis from Hamburg & Kiel Universities (Germany) Post Doctoral Fellow at the University of British Columbia (Canada) Senior Research Scientist positions at Albany Molecular Research Inc. Published several research articles in Peer-reviewed International journals Held Teaching and leadership roles prior to incorporating Pharma Inventor Inc. Confidential
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Company Management Dr. Kashinath Sadalapure, Chief Scientific Officer
Industrial Work Experience
Recognitions & Awards • • • • •
Sharabayya Gada Gold Medal Council of Scientific & Industrial Research (CSIR) Fellowships Wiley book Prize (Kiel, Germany) Best Researcher (CytoMed Inc. USA) Employee of the Year, 2005 (NAEJA Pharmaceuticals Inc. )
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IICT-Cytomed Inc. (USA & India) Xenon Pharmaceuticals Inc. (Canada) NAEJA Pharmaceuticals Inc. (Canada) Albany Molecular Research Inc. (USA) Phyton Biotech LLC. (Canada) Methylation Sciences Inc. (Canada) Multiple clinical development candidates
Leadership Positions from 2001-2021 @ Xenon Pharma, NAEJA, AMRI, Phyton Biotech, Methylation Sciences & Pharma Inventor Inc. Confidential
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Pharma Inventor Advantages ... • Vancouver based Business, Easy access & Quick Turn-around Times Vancouver is one of the most livable cities in the World • Family Owned Business, Founders Themselves are Skilled Scientists Vancouver is a magnet for global and regional scientific talents • Inventive, Cost-Effective, High Quality & Time Efficient Services Positioned to deliver high quality services with increased productivity at reduced cost • Absolute IP Protection Our clients own Intellectual Property (IP) and we work under strict confidentiality. • State-of-the-Art Scientific Infrastructure Opportunities for scaled growth • Strict Adherence to Health & Safety Standards WorkSafe BC and WHMIS Health & Safety Standards in Practice Confidential
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Comprehensive Services...
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Drug Discovery Capabilities ...
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In-house Chemistry Capabilities … •
Biological Target Selection and Database Review Literature review using Sci-Finder, Reaxys, POC data search in patents and research articles.
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Novel Structure Design and Synthesis of Compound Libraries Compound design & synthesis based on biological activity, selectivity, pharmacokinetic (i.e. ADME) and toxico-kinetic properties, as well as novelty search for patentability
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Hit to Lead Generation Lead hopping and screening using Biochemical assays.
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Lead Optimization Skilled medicinal chemists with proven track record of innovative patents and publications.
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Back-up Candidate Identification Synthesize diverse chemical scaffolds with optimized pharmacokinetic & toxicology properties.
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Process Development Green and environmentally friendly synthetic processes, technologies for manufacturing under cGMP conditions. Confidential
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In-house Chemistry Capabilities …
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Custom Peptide Synthesis… PHARMA INVENTOR INC. is very proud to offer high quality and cost-effective custom peptide synthesis service in a timely manner regardless of peptide complexity. Our extensive experience in peptide synthesis technologies has afforded us the capability to take on a wide range of sequences, purity levels, and modifications to meet our client's research/product needs.
PHARMA INVENTOR Advantages Consistent Results: >99% success rate Large number of modification High purities: from 90% to >99% Best Quality Control No limitation Rapid Turnaround Competitive pricing
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UPLC-CAD Analysis… PHARMA INVENTOR INC. is very pleased to offer charged aerosol detector (CAD) analysis, which is highly sensitive, consistent, high precision and wide dynamic range system to provide accurate results for any non-volatile and many semi-volatile analytes.
Applications of CAD Analysis: Lipids Proteins Peptides Carbohydrates Polymers Steroids Oligosaccharides Surfactants Polysorbate quantification and profiling
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UPLC-MS/MS integrated with CAD Detector
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SFC Purification Capabilities… PHARMA INVENTOR INC., offers chiral purification services using preparative Supercritical Fluid Chromatography (Prep-SFC) and Preparative High Performance Liquid Chromatography (PrepHPLC). Our expert scientists produce high quality compounds from milligrams to hundreds of grams in a fast turnaround time. Analytical SFC
Preparative SFC
PHARMA INVENTOR Advantages Purification of chiral compounds. Isolation of impurities in starting materials, intermediates, APIs and drug products. Purification of either single compounds or libraries. High-throughput purification for synthetic compounds. Chiral separation method development. Rapid Turnaround. Competitive pricing.
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Radiopharmaceuticals … PHARMA INVENTOR INC., is proud to announce radiolabeling capabilities for synthesis, method development and manufacturing of radiolabeled (C-14 and Tritium) small molecules of almost any complexity for use in pre-clinical and clinical studies.
PHARMA INVENTOR Advantages Radiosynthesis and synthetic routes development. Synthesis of radiolabeled (C-14 and Tritium) APIs to GMP. Full Certificate of Analysis and analytical profile. Chiral separation and salt formation. Storage and management of radiolabeled compounds. Safe and fast shipment to all destinations in North America. Rapid re-purification service. Competitive pricing.
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Diverse Synthesis Capabilities … Thio-CMI-977 5-LO Inhibitor Anti-asthmatic agent
O
O
S
H
H
NH2
N
F
H
OH
N
Co
O
N
Metal Catalyst (R,R)-Salen Co (III) OAc Stable, Brick Red Solid
H
O OAc
HO O OH O
OH
O
O HO
N
HO
OH
NH
OH
O N H
OH HO O
HO HO
O
HO
O N
O
O
HO O
N H
N H
OH N
O
O N H
O
HN O
HO O
NH
O N H
OH
Zaragozic acid analogs
O H3CO
OH O
OH
O
OH
O
O
OH
OH N
O OH
H HCl CH3 N CH3
(S)-Metoprolol β-Blocker Anti-hypertensive agent
O
O N H
O
O
oAc
BnO
OH O
OH
Salacinol α-Glucosidase inhibitor, Anti-diabetic agent
OH
N
HO
N HO HO
HO OH
O
O OH
O
O
OH O
HO
OH N
O
HO O O
O
N
OH
OSO3
S
HO
O
N
O
HN
NH
O
NH
OH
OH
OH
HO O
OH
NH
O
HO HO
O
O
OH
N
O
O
N
HO O
O
HO
N
HO O
O
O
N HO HO
HN
OH
OH
OH
HO
HO
HO O
O
O
N H
Setmelanotide
OH
HO O
O
O
HO O
O
O
OH
O
N
HO O
O OH
OH
HO
N
HO
HO
OH
O
O O
O
O
O
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O
O
O
O
O O
OCH3
OAc OBn
cardiolipin
Key Intermediates
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Analytical Services… PHARMA INVENTOR INC. provide broad range of analytical services including Method Development, Validation, Subject sample analysis, Quality Control Testing and Stability Studies.
Pharmaceutical Compounds
Natural Health Products
Herbal and Botanical Products/ Pesticides Analysis
Ultra Higher Performance Liquid Chromatography - Mass Spectrometer (Waters UPLC-MS/MS) UPLC-MS/MS integrated with Charged Aerosol Detector (CAD) Tripple Quadrupole Liquid Chromatography - Mass Spectrometer (TQD LC-MS/MS) High Performance Liquid Chromatography (Agilent 1100 HPLC) Preparative High Performance Liquid Chromatography (Agilent Prep 1200 HPLC) Karl Fischer Titration (KF Titration) Nuclear Magnetic Resonance (NMR) Spectrometer (1D, 2D, 13C, 31P, 15N, 19F on 400 MHz & 600 MHz) Trapped Ion Mobility Spectrometry coupled to High-Resolution Time-of-Fight Mass Spectrometry (Bruker TIMS TOF) Inductively Coupled Plasma Mass Spectrometry (ICP-MS) Multi Angle Light Scattering (MALS) Dynamic Light Scattering (DLS) Viscometer Fourier Transfer-Infrared Spectroscopy (FT-IR) with attenuated total reflectance (ATR) Gas Chromatograph (GC) with Flame Ionization Detector (FID) and Thermal Conductivity Detector (TCD), Gas Chromatograph Mass Spectrometry (GC-MS) o Fluorescence Spectrophotometer o Polarimeter, Stopped Flow Instrument o Lambda 25 UV/Vis Spectrophotometer
Cosmetics Products
Cannabinoid/Terpenoid Compounds (Under development)
o o o o o o o o o o o o o o
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Analytical Services… Chemistry Testing Services
Method development & validation
Analysis of Lipids and Carbohydrates
using Charged Aerosol Detector (CAD)
Residual solvent analysis
Physicochemical techniques such as:
characterization
UPLC-CAD, LC-MS/MS, NMR, HPLCUV, XRPD, TGA, DSC, CE-DAD, FT-IR, GC-MS-FID…
Biopharmaceutical Testing Services
Amino acid sequence analysis
Structural characterization and confirmation
Physio-chemical properties
Process and product related impurities
Biosimilar comparability studies
Immunochemistry / ELISA / PCR testing
Potency & QC release testing
Raw material testing for manufacturing
Toxicity analysis
Analytical support for clinical trial supplies Toxic heavy metals analysis (As, Hg, Cd, etc.) Comparative dissolution testing Stability studies Identify testing Absence testing Quick turnaround for all analytical testing
Stability Testing & Storage
Elemental impurities analysis
Solubility & Comparative testing
Drug product dissolution & release testing
Pharmacopeial / raw material analysis
In-Vitro & In-Vivo Samples Analysis
Investigative analysis of drug products
Karl Fischer Moisture Analysis
Bioanalysis in multiple biological (plasma, serum, blood, urine, saliva)
Validation of cleaning products
Non-GLP drug discovery analysis works
Pre-clinical toxicokinetic analysis
Bioavailability & bioequivalence studies
Preclinical and Phase 1&2 analytical support
Biomarker analysis Confidential
Bioanalysis Services
Controlled environment for sample storage Supervision of multiple stability programs Secure, Continuous monitoring & backup systems.
matrices
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Bioanalytical Services… PHARMA INVENTOR INC. provides method development, method validation and sample analysis for all relevant in-vitro and in-vivo matrices. Our expert bioanalytical team offers our clients a comprehensive range of state-of-the-art bioanalytical services including: Analysis in Chemistry • •
Isotope purity determination. Residual solvent determination in new chemical entities.
Analysis in DMPK • • •
Bioanalysis of in-vivo pharmacokinetic (PK) samples from different matrices, such as plasma and tissues. Bioanalysis with well-established procedures for all routine in-vitro ADME studies, such as plasma binding, permeability assays, metabolic stability and solubility. Bioanalysis of small, volatile or hydrophilic compounds using UPLC-MS/MS and GC-MS.
Analysis in Protein Science • •
Targeted protein quantification including therapeutic biologics and biomarkers. Protein characterization including protein MW determination. Confidential
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Discovery Biology Services… As a Chemistry R&D company mainly focusing on APIs development, PHARMA INVENTOR INC., has continuous investment into bench-side Discovery Biology capabilities and expertise tailored to small molecule therapeutic projects…
In-Vitro Biology Drug Metabolism and Pharmacokinetics (DMPK) Non-GLP Bioanalysis In-Vivo Pharmacology Studies Pharmaceutical Microbiology Testing Toxicology
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IP Consulting Services… In addition to Chemistry R&D and Analytical Services, PHARMA INVENTOR INC., is proud to provide Intellectual Property Consulting Services. We offer a comprehensive service that brings together all the skills required to create, protect, and defend your ideas.
IP Strategy Based on Experience GENERATION
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PORTFOLIO MANAGEMENT
EXPLOITATION & ENFORCEMENT
Patent Portfolio Management Responding to Examiner's Report/Office Actions Patent Landscaping Comprehensive & Customized IP solutions
End to End Patent Lifecycle Management
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Proven Discovery Track Record...
A Novel Synthesis of a Triazolesulfonyl Chloride as a Precursor for GlyT-1 Inhibitors
Kashinath Sadalapure etal., , Discovery R&D, AMRI, 26 Corporate Circle, Albany, NY. UK-Singapore Symposium on Contemporary Strategies and Practices in Medicinal Chemistry, 8 September 2011, Biopolis, Singapore DD-Hydantoin recreational water treatment
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Case Studies Case study #1: Seed-stage start-up company • Fast results & IP position
• Private Investor
Developed novel dug compounds through FTE services in < 1 year
• No science background
• Going to clinical studies Phase 1
• Short timelines
• Very successful fundraising
Case study #2: World-class Pharmaceutical company >7 years of successful business relationship with big pharma through FTE services to develop broad range of novel drug compounds
Our R&D Commitments
Quality
IP protection
Problem solving Confidential
Transparency
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FFS and FTE Services Each R&D project has different challenges and PHARMA INVENTOR INC. designs the project depending on the level of complexity utilizing either a fee for service (FFS) or a research-based full time equivalent (FTE) approach. Drug Target Search
Screening
Hit-to-Lead
Lead Optimization
Pre-Clinical
Clinical Phases 1, 2 and 3
Market
Fee For Service (FFS) FFS chemistry R&D services approach is chosen depending on the specific needs of each individual project. FFS approach is usually suitable when a project has strong precedent or literature background without the need for extensive development.
Full Time Equivalent (FTE) For technically more challenging and research-intensive chemistry R&D projects, FTE approach is highly recommended. FTE works very well for dedicated R&D projects and/or for the resolution of complexity/challenging chemistry problems. We can allocate specific team(s) of either one or more scientists with excellent expertise in your field to work on your project. Confidential
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SR&ED Benefits: FTE vs FFS Chemistry R&D Services 1. Scientific Research & Experimental Development (SR&ED) Canada Tax credit reimbursements (%)
Full-Time-Equivalent (FTE)
Fee-For-Service (FFS)
Materials Fee: ≤40% Fixed FTE Fee: ≥30%
Only Materials Fee: ≤40%
2. Access to Fully Dedicated Scientists & Chemistry Databases
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3. Flexibility in Targeting Specific R&D Objectives
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4. Bi-weekly Chemistry Progress Updates
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5. Creative Brainstorming for Novel Research Ideas
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6. Providing synthetic Route of Developed Compound 7. Providing Certificate of Analysis for the Final Product (i.e., NMR, LC-MS & HPLC, ICP-MS, GC-MS data) 8. Access to the in-house Analytical Instruments 9. Cost Estimates
Fixed FTE fee + materials expenses
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Variable fee (based on complexity of the project) & availability of Scientists
Recognition by Life Sciences Communities
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Contact Us PHARMA INVENTOR INC. 1668 Fosters Way, Delta, BC, Canada V3M 6S6 Phone: +1 604-338-3094/ +1 604-339-3244; E-mail: info@pharmainventor.com www.pharmainventor.com
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