BIOPHARMA SOLUTIONS TM Expedite Your Drug Development Program

Transcription

1 BIOPHARMA SOLUTIONS TM Expedite Your Drug Program

2 Maximize the Value of Your Asset The journey of drug development can be complex stressful. But it doesn t have to be that way. Join more than 600 biopharmaceutical companies each year that partner with Covance to help manage their novel drugs through the development continuum. You get deep expertise applied to your program by working with a team that has managed more than 1,800 unique molecules, 300 enabling programs 125 First-in-Human (FIH) trials in the past five years. w, you can confidently enjoy development efficiency that spans preclinical, clinical commercial phases. Gain insights through solutions specifically designed to meet the needs of biopharma companies that can save you time money while maintaining study quality data integrity. A unique solution that gives you: A dedicated team, with broad therapeutic expertise, that delivers continuity through study concept execution, regulatory submissions clinical trials. A drug development approach that minimizes risk maximizes opportunities. Flexible processes simplified financial options that help you meet the goals milestones of your investors. Get an unprecedented continuity of science, regulatory process strategies throughout your program a CRO partnership experience unlike any other. DISCOVERY DEVELOPMENT COMMERCIALIZATION RESEARCH PRECLINICAL PHASE I PHASE II PHASE III PHASE IV Individual Milestone Solutions Lead Optimization Safety & Efficacy Early Phase Solutions Lead Optimization through PoC Lead Optimization through Enabling Enabling Full Solutions through FIH through PoC FIH PoC Phase III-IV Covance MarketPlace Market Access Regulatory Lead Optimization through Phase IV

3 Optimize Your Probability of Success Put the experience of the world s largest drug development database to work on your program. You have access to a global infrastructure industry-leading nonclinical, regulatory clinical expertise to ensure a tightly aligned, continuous solution to bridge your journey across key development milestones. That s why pharmaceutical biotech companies have named Covance as their preferred partner every stage of development. 1 COVANCE MARKETPLACE matter what phase you are in, you can ge the right connection with potential partners, while safeguarding your asset through a unique networking solution called Covance MarketPlace. LEAD OPTIMIZATION Minimize delays during the nonclinical clinical stages of your drug development program by identifying the right molecule, revealing the one that best minimizes risk. EARLY PHASE DEVELOPMENT SOLUTIONS Get one consistent dedicated drug development team with a single point of contact to advance your program seamlessly from nonclinical through FIH proof-of-concept (PoC ) phases. LATE-STAGE CLINICAL DEVELOPMENT Collaborate with a dedicated management team to efficiently navigate the complexities of drug development, such as simplifying trial protocols, optimizing the selection of trial site location, quickly recruiting the right patient populations, improving trial technology accessing insight from global regulatory experts. CMC SOLUTIONS From analytical testing to life-cycle management, build a strong strategy overcome analytical challenges through Chemistry, Manufacturing Controls support both biologics small molecule programs. CENTRAL LABORATORY SERVICES Tap into the power of the world s leading network of central specialty laboratories to access a wide range of comprehensive solutions. From stard testing to customized assays, you ll receive globally consistent actionable data to meet your study s financial timeline milestones. REGULATORY AFFAIRS Enjoy smooth regulatory approvals with a strategy that addresses audit, submission, publishing post-licensing support. More than 150 regulatory affairs professionals in more than 14 countries are at your service. MARKET ACCESS AND COMMERCIALIZATION Gain a clear understing of your asset s clinical economic value in terms that resonate with payers, providers, patients, investors potential pharma partners. By combining perspectives in safety, efficacy, quality commercial potential, you can quickly reach decision points increase your ROI. 1 Source: Robert W. Baird & Co. survey data.

4 Expedite Your Drug Journey Click on a development phase to view it in greater detail. NON General Tox Target Protocol Dev. Stability Safety / Immuno- Study toxicology IND/ CTA Prep FIH Study Phase I First in Phase IIa Proof of Principle Human (FIH) (PoP)/Proof of Concept (PoC) *Exploratory Trials Recruit- ment Phase IIb PoP/PoC First-in-Human Study Single Ascending Multiple Ascending Proof of Principle (PoP)/ Drug Phase III *Phase IIIb Peri- Phase III Registrational Approval *t all programs will require peri-approval studies., Phase IV /or Peri-approval Registrational Peri-approval Post Markett In Vitro In Vivo Exploratory Tissue Cross Reactivity FIH Study TOX (Chronic Tox ) TOX (DART O al & Reproductive Tox) Biomarker /PD Study ADA Final ADA Validation ADA ADA NAb NAb Dev. Dev. /PD of Samples Immunogenicity (ADA & NAb) Assessment Pharmacokinetic Data Dev. Dev. / Sample / Sample Chemistry, Manufacturing & Controls m Analytics Write Reports Assay Robustness Assessment () Assay Robustness Assessment Pre-Validation Activities/ Perm Support Assay Validation Activities Reports BLA Support/Reports Download Poster Download Brochure Reference Dev. Stard CMC Prep. & n- Batch Record Refinement Prep Formulation Pre-Formulation with Accelerated Stability Prepare Report Meeting Pre-IND SUBMITTED Release ICH Stability Key Intermediates, Drug Product Optimization Final Image Validation Testing Key Intermediates, Meeting PII of End Launch Market BLA/NDA/MAA REPORT PREPARATION Define Commercial Develop Commercial Evidence Develop Commercial Evidence Develop Commercial Evidence QUARTER QUARTER Q2 Q3 YEAR Q4 Q2 / 1 Q1 / / Q3 / Q4 / BLA/NDA/MAA REPORT FINALIZATION Communicate Commercial Value

5 NON Target Reports Assay Robustness Assessment () Write Reference Dev. Stard CMC Prep. & Stability / Study In In Exploratory Vitro Vivo Tissue Cross Reactivity Biomarker /PD Study ADA ADA Validation Final Dev. Dev. Formulation Safety FIH Study Single Ascending n- Phase I First in Human (FIH) *Exploratory General Tox Trials IND/ Protocol Dev. CTA Prep First-in-Human Study FIH Study / Sample Batch Record Refinement Prep Prepare Report Pre-Formulation with Accelerated Stability ADA ADA NAb NAb Dev. Dev. Pre-IND Meeting SUBMITTED Multiple Ascending PoP/PoC TOX (Chronic Tox ) Phase IIa Proof of Principle (PoP)/Proof of Concept (PoC) Proof of Principle (PoP)/ Drug Assay Robustness Assessment Phase IIb TOX (DART O al & Reproductive Tox) /PD of Samples Immunogenicity (ADA & NAb) Assessment Pharmacokinetic Data Chemistry, Manufacturing & Controls m Analytics / Sample Drug Product Optimization Final Image Pre-Validation Activities/ Perm Support *Phase IIIb Peri- Post Phase III Registrational Approval Market *t all programs will require peri-approval studies., Phase IV Peri-approval /or Phase III Registrational Assay Validation Activities Reports BLA Support/Reports Validation Testing Key Intermediates, Peri-approval BLA/NDA/MAA REPORT PREPARATION BLA/NDA/MAA REPORT FINALIZATION Communicate Define Commercial Develop Commercial Evidence Develop Commercial Evidence Develop Commercial Evidence Commercial Value Q3 Q2 / YEAR Q4 1 Q1 / Q2 / Q3 / Q4 / Release ICH Stability Key Intermediates, NON Phase I First in Human (FIH) Click here to return to the full map view. Target / In Vitro In Vivo Stability Study (Dose Tolerance) Exploratory Tissue General Tox Protocol Safety (Can Be Run as Part of ) (Can Be Run as Part of ) FIH Study FIH Study ( Specialists generate as part of IND submission package.) *Exploratory Trials (*Requires Exploratory IND) First-In-Human Study (Average study length approx. 8-9 months.) Single Ascending Multiple Ascending (May include cohort(s) of patients seen in a research clinic a hybrid design. ) TOX (Chronic Tox ) Biomarker /PD Study Final ADA ADA Validation ADA NAb ADA NAb /PD of Samples Immunogenicity (ADA & NAb) Assessment Pharmacokinetic Data / Sample / Sample () Write Reports Assay Robustness Assessment () CMC Reference Stard Release ICH Stability Key Intermediates, n- Refinement Batch Record (1) Formulation Pre-Formulation with Accelerated Stability Prepare Report Drug Product Optimization & Final Image Drug Product Optimization Final Image Meeting Pre-IND SUBMITTED Q3 Q2 / YEAR Q4 1 Q1 / Q2 / Q3 / Q4 / Define Commercial

6 Target / Dev. Study Dev. CMC NON Final Dev. Stability In In Exploratory Vitro Vivo Tissue Cross Reactivity Formulation Safety FIH Study Single Ascending Multiple Ascending n- Refinement Pre-Formulation with Accelerated Stability General Tox Protocol Dev. FIH Study / Sample Prepare Report IND/ CTA Biomarker /PD Study ADA ADA Validation Reference Stard Prep. & ADA ADA NAb NAb Dev. Dev. Write Reports Assay Robustness Assessment () Batch Record Prep Pre-IND Meeting Q3 Q2 / YEAR Q4 1 Q1 / Q2 / Q3 / Q4 / Prep First-in-Human Study SUBMITTED Phase I First in Human (FIH) *Exploratory Trials PoP/PoC TOX (Chronic Tox ) Phase IIa Proof of Principle (PoP)/Proof of Concept (PoC) Proof of Principle (PoP)/ Drug Assay Robustness Assessment Drug Product Optimization Final Image Phase IIb TOX (DART O al & Reproductive Tox) /PD of Samples Immunogenicity (ADA & NAb) Assessment Pharmacokinetic Data Chemistry, Manufacturing & Controls m Analytics Pre-Validation Activities/ Perm Support / Sample Release ICH Stability Key Intermediates, *Phase IIIb Peri- Post Phase III Registrational Approval Market *t all programs will require peri-approval studies., Phase IV Peri-approval /or Phase III Assay Validation Activities Reports Registrational BLA Support/Reports Validation Testing Key Intermediates, Peri-approval BLA/NDA/MAA REPORT PREPARATION BLA/NDA/MAA REPORT FINALIZATION Define Commercial Develop Commercial Evidence Develop Commercial Evidence Develop Commercial Evidence Communicate Commercial Value Phase IIa Proof of Principle (PoP)/ Proof of Concept (PoC) PoP/PoC Proof of Principle (PoP) / (Average study length approx. 12 months.) Phase IIb (Average study length approx months.) Click here to return to the full map view. Drug *Metabolism DDI studies can be done anytime in Phase I, II, or IIb as long as they are completed bee Phase III. TOX (DART al & Reproductive Tox) /PD of Samples Immunogenicity (ADA & NAb) Assessment Pharmacokinetic Data / Sample Assay Robustness Assessment Pre-Validation Activities/Perm Support Release ICH Stability Key Intermediates, Develop Commercial Evidence Develop Commercial Evidence

7 Target / Dev. Study Dev. CMC NON Stability In In Exploratory Vitro Vivo Tissue Cross Reactivity Final Dev. Formulation Safety FIH Study Single Ascending Multiple Ascending n- Refinement Pre-Formulation with Accelerated Stability General Tox Protocol Dev. FIH Study / Sample Prepare Report IND/ CTA Biomarker /PD Study ADA ADA Validation Reference Stard Prep. & ADA ADA NAb NAb Dev. Dev. Write Reports Assay Robustness Assessment () Batch Record Prep Pre-IND Meeting Q3 Q2 / YEAR Q4 1 Q1 / Q2 / Q3 / Q4 / Prep First-in-Human Study SUBMITTED Phase I First in Human (FIH) *Exploratory Trials PoP/PoC TOX (Chronic Tox ) Phase IIa Proof of Principle (PoP)/Proof of Concept (PoC) Proof of Principle (PoP)/ Drug Assay Robustness Assessment Phase IIb TOX (DART O al & Reproductive Tox) /PD of Samples Immunogenicity (ADA & NAb) Assessment Pharmacokinetic Data Chemistry, Manufacturing & Controls m Analytics Drug Product Optimization Final Image Pre-Validation Activities/ Perm Support / Sample Release ICH Stability Key Intermediates, *Phase IIIb Peri- Post Phase III Registrational Approval Market *t all programs will require peri-approval studies., Phase IV Peri-approval /or Phase III Assay Validation Activities Reports Registrational BLA Support/Reports Validation Testing Key Intermediates, Peri-approval BLA/NDA/MAA REPORT PREPARATION BLA/NDA/MAA REPORT FINALIZATION Define Commercial Develop Commercial Evidence Develop Commercial Evidence Develop Commercial Evidence Communicate Commercial Value Phase III Registrational *Phase IIIb Peri-Approval Post Market Phase III, Phase IV /or Peri-approval *t all programs will require peri-approval studies. Click here to return to the full map view. Registrational (Usually requires two. Average study length approx months.) Peri-approval (Timing is highly variable. Health authority sponsor will negotiate scope, size timing of any needed Phase IIIb studies. Sponsor-initiated health economics studies to support commercialization.) TOX (DART al & Reproductive Tox) /PD of Samples Immunogenicity (ADA & NAb) Assessment Pharmacokinetic Data / Sample Assay Validation Activities Reports BLA Support/Reports Release ICH Stability Key Intermediates, Validation Testing Key Intermediates, Drug Product Optimization Final Image sbla/nda/maa Submis ion Develop Commercial Evidence BLA/NDA/MAA REPORT PREPARATION BLA/NDA/MAA REPORT FINALIZATION Communicate Commercial Value

8 Expedite Your Drug Journey Join more than 600 biopharmaceutical companies that partner with Covance each year to help manage their novel drugs through the development continuum. NON Phase I First in Human (FIH) Phase IIa Proof of Principle (PoP)/ Proof of Concept (PoC) Phase III Registrational *Phase IIIb Peri-Approval Post Market Target / In Vitro In Vivo Study (Dose Tolerance) Exploratory Tissue Stability Protocol General Tox Safety (Can Be Run as Part of ) (Can Be Run as Part of ) FIH Study FIH Study ( Specialists generate as part of IND submission package.) *Exploratory Trials (*Requires Exploratory IND) First-in-Human Study (Average study length approx. 8-9 months.) Single Ascending Multiple Ascending (May include cohort(s) of patients seen in a research clinic a hybrid design. ) PoP/PoC TOX (Chronic Tox ) Proof of Principle (PoP) / (Average study length approx. 12 months.) Drug Phase IIb (Average study length approx months.) *Metabolism DDI studies can be done anytime in Phase I, II or IIb as long as they are completed bee Phase III. Phase III Registrational (Usually requires two. Average study length approx months.), Phase IV /or Peri-approval *t all programs will require peri-approval studies. Peri-approval (Timing is highly variable. Health authority sponsor will negotiate scope, size timing of any needed Phase IIIb studies. Sponsor-initiated health economics studies to support commercialization.) TOX (DART al & Reproductive Tox) TOX (DART al & Reproductive Tox) Biomarker /PD Study Final ADA ADA Validation ADA NAb ADA NAb /PD of Samples /PD of Samples /PD of Samples Immunogenicity (ADA & NAb) Assessment Immunogenicity (ADA & NAb) Assessment Immunogenicity (ADA & NAb) Assessment Pharmacokinetic Data Pharmacokinetic Data Pharmacokinetic Data / Sample / Sample / Sample / Sample () Write Reports Assay Robustness Assessment () Assay Robustness Assessment Pre-Validation Activities/Perm Support Assay Validation Activities Reports BLA Support/Reports CMC Reference Stard Release ICH Stability Key Intermediates, Release ICH Stability Key Intermediates, Release ICH Stability Key Intermediates, n- Refinement Batch Record (1) Validation Testing Key Intermediates, Formulation Pre-Formulation with Accelerated Stability Prepare Report Drug Product Optimization & Final Image Drug Product Optimization Final Image Drug Product Optimization Final Image Drug Product Optimization Final Image Drug Product Optimization Final Image Pre-IND Meeting SUBMITTED tend of PII Mee ing BLA/NDA/MAA REPORT PREPARATION BLA/NDA/MAA REPORT FINALIZATION Define Commercial Develop Commercial Evidence Develop Commercial Evidence Develop Commercial Evidence Communicate Commercial Value Q3 Q2 / YEAR Q41 Q1 / Q2 / Q3 / Q4 / Download Poster Learn more at covance.com/thebioexperience Covance Inc., headquartered in Princeton, NJ, USA, is the drug development business of Laboratory Corporation of America Holdings (LabCorp). COVANCE is a registered trademark the marketing name Covance Inc. its subsidiaries around the world. The Americas COVANCE ( ) Europe / Africa Asia Pacific Copyright 2017 Covance Inc. BROBPH

9 Let s begin the conversation that can jump-start your drug development program. Contact your Covance Business Director to learn more about solutions designed specifically biopharmaceutical companies, or visit Covance Inc., headquartered in Princeton, NJ, USA, is the drug development business of Laboratory Corporation of America Holdings (LabCorp). COVANCE is a registered trademark the marketing name Covance Inc. its subsidiaries around the world. The Americas COVANCE ( ) Europe / Africa Asia Pacific Copyright 2017 Covance Inc. BROBPH