Proof of Concept. Achieve your molecule s full potential

Transcription

1 Proof of Concept Achieve your molecule s full potential

2 Table of contents 01 Maximize the value of your molecule 02 Enhance your resources and 03 Increase your speed and efficiency 04 your product s market potential

3 Accelerating Maximize the candidate value of your molecule selection starts here Bridging PoC goals The 4 hurdles of drug development Maximize the value of your molecule Enhancing your chances for success Resources Resources Demonstrating your compound s proof-of-concept (PoC) is Expertise an across Specialized multiple disciplines important developmental milestone. We understand that you ve Limited in-house capabilities Many in-house capabilities been anticipating this moment for a long time. If you can show Venture capital funding Internal funding compelling, valid data supporting the safety, efficacy, quality, 3. and commercial potential of your molecule at this stage, you can: Covance bridges the gap with a complete view of PoC. Optimize the market value of your compound Enhance your ability to meet your drug development goals Meet the demands of regulators, providers and patients Pharma Goal Asset acquisition at lowest price Launch on their own Biotech A complete An asset strategy view that of considers PoC only clinical and technical issues is incomplete. Goal Sell or license at highest price1. Safety Launch on your own? 2. Efficacy Quality Extend your resources Access Accelerate the through your right 4. Maximize patient Create multidisciplinary studies populations, a complete molecule and efficiently value investigators, PoC reach story and and your ROI and personalized clinical study milestones sites service Commercial

4 Enhance your resources and Early clinical d therapeutic experience Market access considerations The biomarker connection In the early stages Covance of clinical Four has demonstrated types development, of biomarkers Covance therapeutic can play deliver experience an important the critical in role answers in accelerating you need to your PoC study. robust PoC data the following your Covance s target indications: population tell a and compelling the capabilities value story of our about Biomarker your asset: Center of Excellence Enhance your resources A complete view of PoC essential to identify the can drug help candidate you derive with actionable insight from each. the greatest chance Oncology of therapeutic success Number Cardiovascular and type of patients Extent of unmet need and and regulatory approval. Solid tumors Pharmacodynamic who Biomarkers may Congestive be affected can heart be used failure to demonstrate the compound binding to Hematologic its molecular malignancies target and the Dyslipidemia subsequent modulation Patient-reported of downstream pathways enabling outcomes Our early clinical development teams have early testing of your Direct compound s and Hypertension indirect mechanism costs of of action (PROs) and providing in existing a data-driven Supporting your PoC strategy with experience finding innovative approaches for Immune-mediated framework for decisions the disease on compound progression. class labels these logistically demanding studies, which both clinical and economic data inflammatory diseases Neuroscience often include requirements for overnight Rheumatoid Efficacy arthritis Biomarkers Prevalent/commonly are Neuropathic increasingly pain treated being incorporated Recommendation into clinical of trials in various stays, intensive pharmacokinetic sampling, Asthma therapeutic areas (often (retrospective) at Sleep Phase disorders I/IIa), rare/ sometimes relying validated on PROs advanced (or creation/ technologies or complex procedures. Your research skills and dedicated focus have enabled you to Psoriasisuch as genomic, untreated proteomic, Migraines (prospective) or imaging analyses. At validation this stage of PROs) of drug development, Multiple biomarkers sclerosis can provide critical data to indicate whether your compound is hitting the bring a promising compound through the early stages of target, correlates Current to clinical Infectious treatments, effect and how Early continued Clinical development Economic PoC is likely to be fruitful. development. Now, you need a partner with the scientific Metabolic safe and Hepatitis effective Cthey 35 years are, experience and market insights to help you cross the PoC goal line. Type II diabetes Safety Biomarkers and can how HIV be much key to they determining cost 250 employees the Operational safety of your executability compound, thereby Obesity expediting your decision-making process before Phase III Market and helping Access to predict the ultimate potential of your molecule or program. Covance consultants have across all aspects of drug 25 years experience 70 employees development and multiple therapeutic areas. We provide Patient stratification Biomarkers can be valuable indicators of which patients can be customized solutions and services to design and implement expected to respond to your investigational Biomarker drug based on its mechanism of action. Purpose-built facilities the optimal PoC strategy combining clinical, biomarker, Development/validation and economic data to demonstrate the value of your asset.

5 Increase your speed and efficiency Patient recruitment: optimizing your clinical trials Increase your speed and efficiency Accelerating your timelines and increasing your ROI Covance Scientific Network A complete view of PoC With nearly 200 sites around the globe for oncology, chronic ambulatory conditions such as Alzheimer s Disease and RA, and other special populations, the Network enables Covance to collaborate with our partners to generate significant patient volumes in a timely manner while modifying budget and contract negotiations to reduce burdensome paperwork for sites and shorten study startup. Covance received among the highest number of excellent ratings of any CRO (40% according to CenterWatch s 2013 Global Investigative Site Relationship Survey of more than 2,000 sites) for efficient contract and budget negotiation processes. You depend on high-quality, reproducible data to get We the have reduced study startup and streamlined budgeting and contracting for the study sites, freeing up their resources to focus on their core strengths and drive measurably answers you need quickly. At proof of concept you don t faster recruitment results. need the additional cost structure of a company who conducts You need a partner smaller studies with the same resources as an expensive We help you engage the who right can investigators: quickly get pivotal Phase III trial. experienced the necessary professionals data so who you will can deliver evaluate the work your in Our dedicated early clinical development team is nimble molecule s a way that full meets potential. your and focused on PoC, with greater flexibility to meet specific needs. aggressive timelines and give you confidence that you will translate clinical trial ROI to commercial ROI.

6 your product s market potential Why commercial PoC matters Integrated market access & GHEOR services your Oral product s market potential Injected Burden of illness: We can integrate our comprehensive, retrospective and prospective burden of illness study services Side effects to ensure skilled project management Side effects for your site selection and maintenance. Poor adherence High adherence A complete PoC solution Patient-reported outcomes (PROs): Our experience with well-regarded PRO instruments across many Medicare Part D Medicare Part B therapeutic areas enables you to capture the voice of the patient and minimize variability associated with the use of PRO Pharmacy instruments. acquisition Buy and bill Whether your specific goal is to sell or license your compound or bring a new drug to market yourself, it s Economic important By modeling to explore focusing and on pricing: Buy and We Bill, offer we development helped the sponsor of cost-effectiveness increase and budget impact models, analysis their new of secondary product s databases value from to $150M populate to these > $300M. models, and integration with patient studies and demonstrate both its clinical and market to potential understand as the early health outcomes that impact a disease state and related costs. in the process as possible to enhance your product s value proposition and make a strong case for continued Value message development & dossiers: We provide empirically based, Market readily access testable, is and the differentiating value messages, as well as dossiers (e.g., global value, development and investment. lens AMCP) through for global, which regional, country-specific, or market-specific purposes. potential buyers and investors think about The earlier you begin creating your complete Registration PoC story, studies: Our clinical, operational, and GHEOR experts provide fast results on clinical, economic, and patient-reported outcomes, ensuring that registries are payers, conducted providers, seamlessly from the greater your potential reward. As your partner, design through implementation and support. and patients. Covance will help you get it right the first time. At Covance, we re ready to help you succeed. Marketed Drug New Drug Market access strategy: Our market access and global health economics and outcomes research (GHEOR) teams provide comprehensive, targeted, and empirically guided strategies. A complete view of PoC For more information, contact your account executive or visit us online at Covance is an independent, publicly held company with headquarters in Princeton, New Jersey, USA. Covance is the marketing name for Covance Inc. and its subsidiaries around the world. THE AMERICAS COVANCE ( ) EUROPE/AFRICA ASIA PACIFIC Copyright 2013, Covance Inc. BROCVD