TAKE Solutions Limited Delivering Domain-intensive Services In Life Sciences And Supply Chain Management
At A Glance 17 7 Offices Countries Europe HQ: Frankfurt, Germany Major trial operations center in Germany and sites through Europe USA HQ: Princeton, NJ 15,872 1,500+ Specialists in UK, Clinical, Regulatory & Sweden, Germany, Safety consulting and Poland, Denmark, Russia technology centers. FTE Revenue FY18 and other locations Trial operations through (INR Mn) strategic partnerships >91% Revenue from Life Sciences (Q4 FY18) APAC HQ: Chennai, India Clinical Operations (Incl. Generics) in Bangalore, Chennai, Mangalore and Manipal Regulatory & Moving Towards Safety operations hub in LATAM Delivery Centre: 100% Chennai Bogota, Columbia Regulatory & Safety support across 9+ from Life Sciences countries in region 2 www.takesolutions.com
TAKE is a preferred partner for Life Sciences Companies , Improving Efficiency And Driving Better Outcomes Across The Drug Development Value Chain
Life Sciences Drug Development Landscape US $1 – 1.5 Billion per Drug! Bringing a drug to the market is a complex process involving many time consuming and Drug Discovery Post-approval Pre-clinical Trials Regulatory Approval Clinical Trials (Phase I to III) expensive stages ~ 1 Year ~ 1.5 Years ~ 5 Years ~ 7 Years On Going Basic Research (R&D) Human Trials Molecule formulation (compound) Phase I: 10s Volunteers As long as the drug is Roughly for every Animal Trials is identified to combat a disease Phase II: 100s Patients in the market, the 10,000 compounds Phase III: 1000s Patients regulators require Clinical Trials identified only 1 is that its safety is approved for sale The molecule is tested for it’s monitored and by the regulator safety and efficacy reported regularly Regulatory Submissions The findings are submitted to the regulator for approval at each stage Safety Monitoring The molecule is monitored and adverse events are reported at each stage Manufacturing Approved drugs are mass produced and sold to the public 4 www.takesolutions.com
Where Do We Come In? US $1 – 1.5 Billion per Drug! Drug Discovery Post-approval Pre-clinical Trials Regulatory Approval Clinical Trials (Phase I to III) ~ 1 Year ~ 1.5 Years ~ 5 Years ~ 7 Years On Going Basic Research (R&D) Molecule formulation (compound) is identified to combat a disease Clinical Trials The molecule is tested for it’s safety and efficacy Regulatory Submissions The findings are submitted to the regulator for approval at each stage Safety Monitoring The molecule is monitored and adverse events are reported at each stage Manufacturing Approved drugs are mass produced and sold to the public 5 www.takesolutions.com
As a strategic partner, TAKE Solutions delivers full-service Clinical, Regulatory and Safety services and solutions to the Life Sciences Industry LIFE SCIENCES
Need for Outsourcing in Life Sciences A paradigm shift is taking place in Life Sciences R&D R&D Marketing & Clinical Marketing & Clinical Branding Research Branding Research Sponsor Sponsor Company Company Regulatory Regulatory Manufacturing Manufacturing Affairs Affairs Outsourced Inhouse Safety (PV) Safety (PV) Increased Management Reduced Cost of Reduced Time Outsourcing has three Bandwidth Drug Development to Market distinct advantages Focus on core activities Remain competitive in Quicker Turn-around (R&D and Marketing) the market time 7 www.takesolutions.com
Life Sciences Outsourcing An Attractive Growth Opportunity Life Sciences The USD 32 Bn Life Sciences Outsourcing Outsourcing Industry will USD 32 Bn (2017) reach USD 39 Bn by 2020 Life Sciences Outsourcing USD 39.1 Bn Clinical 6% (2020) $27.6 Bn (2017) to $32.9 Bn (2020) CAGR 11.5% Regulatory CAGR $2.6 Bn (2017) to $3.7 Bn (2020) 10.5% Safety $1.8 Bn (2017) to $2.5 Bn (2020) CAGR 8 www.takesolutions.com
Types of Sponsors Who is Outsourcing? Although Large Innovators account for the majority, Mid / Small Innovators are an equally attractive segment in this space! Generics accounts for 10% Large Innovators (Turnover >US$ 5Bn) The Mid/Small Innovators are responsible for half of the (Turnover US$ 1-5 Bn) account outsourcing market for 25% of the market Innovators are bio-pharma Generics are bio-pharma companies that Others include medical devices Companies that discover new drugs produce existing drugs after patent expires companies, academia, & CROs 9 www.takesolutions.com
Why Do Sponsors Choose Us? = Technology Platform Based Services + Our Unique Formula Knowledge Partner Clinical Regulatory Capabilities Services across Nets Markets Full Operational Capabilities Industry Forums Consulting Technology Experts Across The Globe Safety Innovative Platforms Offering both end-to-end services and bespoke functional services 10 www.takesolutions.com
We Deliver Results Consistently Recognized as a Leader in Life Sciences 120+ 2017 – Leader in IDC MarketScape: Worldwide Life Science Drug Network Safety Services Members 4000+ 330+ 100000+ Sites 2013 – Leader in IDC MarketScape on Drug Safety Services Clinical Regulatory Worldwide Life Science Drug Safety Services Trials 1000+ Submissions BABE & Lab 2011 – Leader in IDC MarketScape: Worldwide Life Sciences R&D Studies 80000+ IT Outsourcing Patients & 300+ Volunteers Safety Majority of Consulting our associates Engagements are PhDs, Doctors, 20% Statisticians, of associates The only company to host Scientists and with over 10 MBAs 7 unique proprietary Multicultural years of Talent from Industry Life Sciences industry network forums! over 25 Experience Countries 11 www.takesolutions.com
Our Life Sciences Journey We have built our Clinical , Regulatory and Safety offerings organically … Regulatory Regulatory Clinical Regulatory Capabilities Capabilities Capabilities across across Services Services Services across Markets Markets Nets Nets Markets Consulting Consulting Technology Technology Safety Safety Safety Technology 2007 2011 2016 … and have strategically added to our competencies through acquisitions Ecron Acunova, WCI Consulting, India UK Today TAKE is a Single Global Life Sciences Brand with capabilities across Clinical, Regulatory and Safety 12 www.takesolutions.com
100+ Innovator and Generics Sponsors We deliver High-quality, global trials 330+ enabled by our proprietary eClinical Clinal Trials platform 1000+ BA/BE & Lab Studies USPTO Patent for “ Method for Conducted Clinical Trials for the Conducted 1 st Stem Cell Product in the 7% of All Biosimilars Trials in Optimizing Clinical Data Indian Market India in 2017 Standardization ” www.takesolutions.com
Key Clinical Offerings For Heads of Clinical Operations, focused on sharing best practice to define Medical Bioavailability & excellence in delivery of clinical trials Imaging Bioequivalence Services Studies Biologics & OneClinical Biosimilars Full Service Our Optimized eClinical and Analytics Studies Clinical Clinical Trials Management Platform Trials Offers Comprehensive Trial Oversight and Non- Enables Faster Decisions Services Technology Interventional Solutions Studies Clinical Ops ICH E6 GCP Clinical Data Transformation Assessment Services Strategic Clinical Consulting 14 www.takesolutions.com
How Do We Help Our Clients? Full-service phase II stem cell therapy study Business Need Results Sponsor required a full- service phase II stem cell 1st stem cell-based study in a rare patient pool biological product with high screen fail rate approved by DCGI “ We Greatly Appreciate the valued contribution of Navitas Life Sciences towards our ” success in our endeavour to bring ‘Stem cell Product’ to the world market. - Sponsor 15 www.takesolutions.com
Submissions Across 130+ Countries 10,000+ Paper Submissions We help life sciences 46,000+ eCTD companies Stay Compliant 100,000+ 15,000+ Global Regulatory Submissions* Nees 5+ Submitted USA, APAC & Unique Technology Propositions 8% of Total Regulatory LATAM Regulatory Hubs Submissions to USFDA 2012-2017 *including life cycle management of approved products www.takesolutions.com
Key Regulatory Offerings For Labeling Professionals; focused on the full lifecycle of labeling For Regulatory Information Management (RIM) professionals to develop best practices Regulatory and leading edge solutions for RIM Information Management Submissions & Report with over 150 clients, is a Publishing fully integrated web-based eDMS and eCTD Submissions traceREADY is a next generation mobility License platform that enables easy implementation of SOPs and audit readiness with accurate Maintenance Technology Labeling & Services data at all times Solutions Artworks Regulatory Regulatory Data and RA Systems Labeling Information Management Intelligence E2E Labelling Assessment Regulatory Strategy and Consulting Express Artwork Product Lifecycle Management Strategic Regulatory CMC Management Submission Management & Consulting Regulatory Operations Strategy 17 www.takesolutions.com
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