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An Introduction to inVentiv Health November 2013 Who We Are 13,000 employees in 40 countries, rapidly transforming promising ideas into commercial reality inVentiv Health, Inc. is a leading global provider of best-in-class professional services supporting clients in the biopharmaceutical, medical device, and diagnostic markets looking to accelerate performance. 2 Why We Are Here To respond to the evolving dynamics in the global healthcare market Market Opportunities Market Challenges Demand for healthcare solutions is growing (population, economic growth) Innovation continues to drive change (technology) Increasing complexity/regulation requires greater expertise Price pressure from payers Cost increases (R&D efficiency, regulation) Requirements for differentiated/ measureable outcomes Patent cliff Large “siloed” organizations 3 …The Implications Increasing demand for outsourced solutions Relentless drive for efficiency/effectiveness Increased demand for simplified engagement models—“one-stop shop” Global, global, global Gradual shift toward “outcomes-based” services What We Bring CLINICAL World class talent and capabilities all in ONE company COMMERCIAL World’s largest provider of healthcare sales, marketing, and communications solutions The leading management consulting group specializing in pharmaceuticals and biotechnology Top 5 CRO Outsourced sales teams and sales Launch planning and support Broad portfolio of services support Marketing communications Advertising and public relations Digital communications/social media Corporate and business development Public affairs and advocacy Market research and analytics Medical education Organizational design and improvement Patient access solutions Pricing & market access A leading clinical research organization, 2012 CRO of the Year Deep therapeutic expertise Late stage/outcomes depth Unique capabilities in patient recruitment Patient outcomes, REMS, and Rx access Sample management and compliance 4 CONSULTING Corporate, product and portfolio strategies Education and training What We Do Supporting Outcomes-Based Solutions Across the Product Lifecycle 5 Help our clients to accelerate performance, improve outcomes and make lives better worldwide Where We Work AFRICA AUSTRALIA Cairo, Egypt Capetown, South Africa Johannesburg, South Africa Auckland, New Zealand Brisbane, Australia Melbourne, Australia Sydney, Australia Wellington, New Zealand ASIA Bangkok, Thailand Beijing, China Gurgaon, India Hong Kong, China Hyderabad, India Islamabad, Pakistan Karachi, Pakistan Kuala Lumpur, Malaysia Lahore, Pakistan Mumbai, India Manila, Philippines New Delhi, India Pune, India Osaka, Japan Seoul, Korea Shanghai, China Singapore Taipei, Taiwan Tokyo, Japan 6 EUROPE Antwerp, Belgium Athens, Greece Barcelona, Spain Berlin, Germany Bratislava, Slovakia Bucharest, Romania Budapest, Hungary Cologne, Germany Dublin, Ireland Eltville-Martinsthal,Germany Frankfurt, Germany Freiburg, Germany Istanbul, Turkey Kyiv, Ukraine Leusden, Netherlands Lisbon, Portugal London, UK Madrid, Spain Maidenhead, UK Milan, Italy Moscow, Russia Novosibirsk, Russia On the ground anytime, anywhere around the world Paris, France Prague, Czech Republic Ramsgate, UK Rome, Italy St. Petersburg, Russia Stockholm, Sweden The Hague, Netherlands Vienna, Austria Warsaw, Poland Zug, Switzerland Zurich, Switzerland MIDDLE EAST Dubai City, Dubai Jeddah, Saudi Arabia Ramat Gan, Israel Riyadh, Saudi Arabia NORTH AMERICA Ann Arbor, MI Augusta, GA Blue Bell, PA Boston, MA Bloomington, MN Burlington, Canada Burlington, MA Cary, NC Charlotte, NC Columbus, OH Conshohocken, PA Deerfield, IL Irvine, CA Irving, TX Lake Mary, FL Lexington, KY Mexico City, Mexico Montreal, Canada New York, NY Newark, DE Newtown, PA Overland Park, KS Parsippany, NJ Pointe-Claire, Canada Princeton, NJ Quebec City, Quebec Raleigh, NC Redmond, WA San Diego, CA San Francisco, CA San Juan, Puerto Rico Santa Monica, CA Saratoga Springs, NY Somerset, NJ Southport, CT Tampa, FL The Woodlands, TX Thousand Oaks, CA Toronto, Canada Washington, DC West Chester, OH Westerville, OH SOUTH AMERICA Buenos Aires, Argentina Lima, Peru San Isidro, Peru Santiago de Chile, Chile São Paulo, Brazil How We Deliver Strategic collaboration, shared accountability, delivering extraordinary outcomes Clinical All of inVentiv’s services are customizable. Commercial We have the ability to combine our best-in-class services and vast resources Consulting in numerous possible ways to meet clients’ specific needs. With this flexibility, we help our customers solve complex challenges, deliver extraordinary outcomes, enhance value and improve lives. 7 Why inVentiv One strategic partner focused on making a difference • Best-in-Class Capabilities • Global Scale • World-Class Talent • Customized Solutions • Operational Excellence • Unique Insights & Analytics Our Results Top-five clinical research organization #2 healthcare communications firm Largest provider of outsourced healthcare sales forces in the US (second largest in Japan) Largest recruiter of clinical and pharma sales people in world Assisted over 2 million patients with gaining access to medication Launched the first Facebook page for a branded drug; launched the first branded pharma campaign on Twitter Has over 120 million patient prescription records (Think Analytics!) Worked on naming for more than one third of the approved drugs since 2008 Generated over $1 billion of incremental revenue (for clients) in last three years through increased compliance 8 Clinical Development Services inVentiv Health Clinical Overview • Industry leader › Top 5 global CRO › Significant global footprint - more than 6,000 employees, offices in 32 countries, operating in over 70 countries • Diversified services across the product development continuum › Complete product development capabilities in Phase I-Late Stage Services › Customized to the way you outsource: Staff Augmentation, Staffed Groups, Functional Service Provider, Full Service Programs, and/or Strategic Relationships › inVentiv Commercial and Consulting expand service offering from clinical to commercialization strategies, product branding, marketing, and sales • Depth of therapeutic, medical, clinical, regulatory and scientific expertise › 168 MD and 160 PhD staff members across the organization › Therapeutically-aligned teams › International regulatory expertise 10 7,000 Employees operating in over 70 Countries Dedicated to Clinical Research inVentiv Health Clinical Network NORTH AMERICA EUROPE ASIA PACIFIC Ann Arbor, MI Basking Ridge, NJ Blue Bell, PA Burlington, ON Cary, NC Chicago, IL Deerfield, IL Lake Mary, FL Montreal, QC New York, NY Princeton, NJ Quebec City, QC San Diego, CA Somerset, NJ Tampa, FL West Valley City, UT Barcelona, ES Berlin, DE Bratislava, SK Bucharest, RO Eltville-Martinsthal, DE Frankfurt, DE Gravenhage, NL Kusnacht, CH Kyiv, UA Leusden, NL Madrid, ES Maidenhead, UK Milan, IT Moscow, RU Nanterre, FR Neu-Isenburg, DE Novosibirsk, RU Prague, CZ Ramsgate, UK Rome, IT St. Petersburg, RU Stockholm, SE Warsaw, PL Auckland, NZ Bangkok, TH Beijing, CN Gurgaon, IN Hong Kong, CN Hyderabad, IN Kuala Lumpur, MY Makati City, PH Mumbai, IN Pune, IN Seoul, KR Shanghai, CN Singapore, SG Sydney, AU Taipei, TW Tokyo, JP LATIN AMERICA Buenos Aires, AR Lima, PE Mexico City, MX Santiago, CL Sao Paulo, BR 11 FIELD-BASED Brisbane, AU Brussels, BE Providencia Santiago, CL Paris, FR Ramat Gan, IE Tokyo, JP Wellington, NZ San Isidro, PE Johannesburg, ZA Belgrade, Serbia Bangkok, TH Zagreb, HR Sofia, BG Budapest, HU Copenhagen, DK San Jose, CR Clinical Organization Raymond Hill President, inVentiv Clinical Cynthia Osborne Executive Assistant 12 Riaz Bandali President, Early Stage Dawn Anderson President, Phase II-IV Gregg Dearhammer President, Strategic Resourcing Marty Birkhofer Chief Medical Officer Gregory Skalicky Exec. VP, Business Development Rick Shimota Chief Financial Officer MJ Carino Sr. VP Human Resources Joe Fortunato Sr. VP, Quality Assurance Ramita Tandon Sr. VP & GM Patient Outcomes Joseph Tetzlaff Chief Information Officer David Peters VP, Communications & Corporate Development Eric Sherbert General Counsel Early Stage Development Riaz Bandali President, Early Stage Susanne Gosselin Executive Assistant George Scott VP, Bioanalytical Services 13 Zohar Bassevitch Sr. Director, PM & CP Catherine Derasp VP, Clinical Operations Mario Tanquay VP, Clinical Pharmacology Phase II-IV Development Dawn Anderson President, Phase II-IV Gregory Hockel Exec. VP, Regulatory Affairs Jeanne Ashton Sr. VP, Global Data Services Alison O’Neill Sue Stansfield Exec. VP, Clinical Operations, Phase II-IV Sr. VP, Global Therapeutic & Clinical Operations, NA Jeffrey Trotter Exec. VP, Late Stage 14 Kriszta Varga-Cox Supervisor, Admin. Services Strategic Resourcing Gregg Dearhammer President, Strategic Resourcing Linda Kemnitz Executive Assistant 15 Maria Smith Sr. Director, Grants & Contracts Malinda Irelan Executive Assistant Curt Esper Facilities Specialist Ann Pongracz Director, Medical Writing Barbara Goranson Director, Strategic Resourcing Prashant Kirkire Sr. Director, Operations Diana Cucos VP, Strategic Resourcing Mark Cooper VP, Strategic Resourcing Marty Anderson VP, Strategic Resourcing Tracy Mayer VP, Strategic Resourcing Amy Meszaros VP, Strategic Resourcing Brenda Hoeper Sr. VP, Strategic Resourcing Jeff Noll Manager, Recruiting Mishka Symonette Exec. Director, Recruiting Sara Gordon VP, Communications & Corporate Development Brian Nelson Director, Global Recruitment Center Business Development Gregory Skalicky Exec. VP, Business Development Diana Petrone Executive Assistant Daniel Smith Sr. VP, Business Development Jason Casarella VP, Business Development Fernando Martinez Angela Russian Exec. Director, Business Development VP, Business Development, EMEA & APAC 16 Michael Ryan VP, Business Development, Phase II-IV Andy Malavsky Exec. Director, Marketing Farah Ahmad VP, Business Development Brian McAllister Sr. Director, Business Development Human Resources MJ Carino Sr. VP, Human Resources Jeanne Fisher HR Associate Rosemary McGuire VP, Human Resources 17 Michelle Johnson Exec. Director, Human Resources Donna Elbert VP, Human Resources Patient Outcomes Ramita Tandon Sr. VP & GM Patient Outcomes Jill Guary 18 Erica Rascov Sr. Feasibility Associate Brent Peterson Sr. Feasibility Associate Halina Filipowicz Sr. Feasibility Associate Communication & Corporate Development David Peters Sr. VP, Communication & Corporate Development Michael McDevitt Sr. Director, Clinical Data Programming Ruth Boone Sr. Financial Analyst Gary Leach Financial Analyst Alison Leaver Sr. Data Services Trial Leader Nicholas Jackson Dr. Metrics & Process Optimization 19 General Counsel Eric Sherbert General Counsel Susan Lipsitz Assoc. General Counsel Jesse Moore Assoc. General Counsel Valarie Palumbo Sr. VP, Corporate Quality Assurance Charles Jewell Assoc. General Counsel Lisa Hieb Assoc. General Counsel 20 Learning Development Open Position Learning & Development Nancy Connell VP, Learning & Development 21 Clinical Introduction Phase I/Bioequivalence Bioanalytical Services Phase II-III All Phases Phase I Studies • • First in Human • Special Populations • Thorough QTc • Drug Interactions • • Generics • Bioavailability • Bioequivalence • High-end Generics • Clinical Laboratory • • • Sample Handling Method Development and Validation Sample Analysis Discovery Support Small Molecule: LC/MS/MS GC/MS/MS Biomarkers Large Molecule: ELISA and RIA, Ligand Binding Cell-based Assays Immunogenicity Assays Biomarkers Capabilities • Pharmacokinetic Analysis • 1000+ validated assays • Scientific Affairs and Reporting • ~900,000 samples analyzed per year Capabilities • 2 labs with over 44,000 sq ft • 1 clinic with over 22,000 sq ft • 22 4 clinical wards with 200 beds Full Service Phase IV Strategic Resourcing • Biostatistics • Staff Augmentation • Product Selection • Clinical Development Planning • Staffed Groups • • Data Management • Functional Service Provider Risk Management and Development • Medical Monitoring and Oversight • Strategic Alliances • Pharmacoeconomics • Clinical Monitoring • • Medical Writing • Medical Writing Product Launch Support Programs • Patient Recruitment • Pharmacovigilance • Pharmacovigilance • Project Management • Project Management • Drug-Utilization Strategies • Site Management • Clinical Staffing • Patient Outcome Studies • Study Monitoring • Disease Management • International Regulatory Consultation/Operations • Brand Expansion • Strategies for Competitiveness • Medical/Scientific Consultation Technology • Project Management Information System • Expertise with all major clinical trial databases • Study Supply Management • Investigator Database • Randomization • Electronic Trial Master File • Electronic Data Capture • Electronic Regulatory Submissions • PKS • Perceptive Informatics ‘ Initiator Phase I and Bioequivalence Services Accelerating Drug Development Diverse study and therapeutic experience Expedited Phase I studies Mitigate risk with a professional and skilled team Mitigate risk with a professional and skilled team 23 • 15 years of Phase I drug development in a wide variety of therapeutic areas and dosage forms • Conducted hundreds of studies; file more than 200 CTAs/year • Full suite of services ranging from protocol design to study report preparation • Outstanding project management skills comprised of with medical and scientific experts to ensure volunteer safety • Regulatory expertise, medical writing, biostatistics, pharmacokinetics experts • Extensive experience working with FDA, EMA, Heath Canada, and Europeanbased agencies • Rapid recruitment • Streamlined study execution • State of the art data management technologies ensure fast, accurate reporting for real time decision making • 22,000 square foot clinical facility with 200 beds divided into 4 units • Clinical lab, on-site pharmacy • Partnerships with local hospitals Bioanalytical Services: Market-leading Small, Large Molecule Scientific Expertise This is how inVentiv Health Clinical transforms promising ideas into commercial reality: Scientific Expertise Rapid Analysis and Large Capacity of Small Molecule Expertise in Large Molecules Risk Management through quality and compliance 24 • 18+ years of experience in method development, validation and analysis • Over 1000 assays and biomarkers methods available • Two GLP facilities with state-of-the art instrumentation • One of the largest capacities of any bioanalytical lab • Largest suite of mass specs in the industry • Rapid turnaround times • Scientific expertise in a wide variety of large molecule projects • Scientific leadership to address more complex projects including novel compounds • High capacity • Project Management • Robust Sample management process • Outstanding quality and compliance and regulatory expertise Integrated, Full-Service Phase II-III Product Development Expertise Comprehensive Development Services Mitigate Risk with a Professional and Skilled Team Specialization in Therapeutic Areas Rapid Patient Recruitment • Biostatistics, Data Management and Statistical Programming • Clinical Monitoring, Project Management and Strategic Oversight • Patient and investigator recruitment • Clinical development planning and expert project management • International regulatory consulting • Medical/scientific • Therapeutically aligned leadership with strong product development experience and background • Integrated teams deliver technical, operational and therapeutic expertise for lifecycle management • Trial feasibility and site selection, site approvals • Patient recruiting strategy • Access to claims data of 90 million patients in the US 25 Specialization in Core Therapeutic Areas • Therapeutically aligned leadership with strong product development experience and background • Fully integrated teams to deliver technical, operational and therapeutic expertise • Therapeutically aligned site selection and patient recruitment expertise • Other specialty areas: › Pediatrics >80 Studies › Phase IV >195 Studies 26 Therapeutic Area of Focus Trials Hematology and Oncology >370 Neuroscience >430 General Medicine >300 Infectious Disease >260 Cardiology, Endocrinology, Metabolic disease >230 Pain and Inflammatory Disease >150 Phase IV Services: Bridging the Gap Between Development and Commercialization Comprehensive Phase IV Services Real world experience, real value 27 • • • • Observational/non-interventional • Post-approval safety surveillance Retrospective research • Epidemiology Label extension trials • Patient-reported outcomes Expanded access studies • Pragmatic, scientifically sound, trial design and operational cost-efficiency Proactive Recruitment • inVentiv Physician Network provides access to investigators dedicated to observational and non-interventional research and patients Part of the Expert inVentiv network • Part of expert inVentiv network dedicated to safe and effective commercialization, including ParagonRx (REMS) and Campbell Alliance (consulting, CER) Custom Resourcing Solutions Flexible/Scalable Resourcing • More than 3,000 people working in 30 countries • Combines strength of FSP with industry leading staffing capabilities • Worked with over 160 companies-suite of services ranging from staff augmentation to strategic partnerships • Experienced FSP Partner 46 active FSPs, 25 clients including Top 5 and 10 Pharma • Dedicated teams in all functions/phases can achieve up to 30% savings • Staff lift outs/asset transfer can yield huge savings for clients • • Worldwide Staffing Resources • • • 28 12 managed staffing relationships, 9 unique clients 40+ years combined experience in US, EU, Asia and Latin America Contract or permanent staffing, internal teams, FSPs Database of ~200,000 candidates worldwide with broad therapeutic and functional expertise Industry-leading retention rates Therapeutically-aligned Expertise Developed over 12 years Dedicated staff for each division Physicians within TA Senior leaders (20+ years) Project managers (10+ years) CRA alignment All geographic regions Hematology & Oncology Neuroscience Pain Cardiovascular Inflammation Metabolic 29 Vaccines/ ID & Respiratory Resources become experts within a core therapeutic area General Medicine Operational efficiency Scientific quality Site, KOLs, and regulatory relationships Engaged and informed management Therapeutically-aligned Expertise Oncology Unique inVentiv advantages › The Navicor Group, an InVentiv Company › Dedicated Phase 1 team › Substantial specialization in breast cancer Oncology Trials › 381 last 5 years (all services) › 251 Clinical › > 8,900 sites › > 61,000 patients Solid tumors 30 Hematologic › 156 last 5 years› › 8,700 sites › 66,000 patients › › 95 last 5 years 4,065 sites 30,750 patients › Expertise in rare hematologic malignancies › 11 recent NDA/sNDA approvals Therapeutically-aligned Expertise Neuroscience Unique inVentiv advantages › Partnership for Phase 1 disease state › Integrated Rater Training services › Scale licensing and translation Neuroscience Trials › 345 last 5 years (all services) › 146 Clinical › > 5,900 sites › > 44,300 patients 31 › Staff have served as PI, site coordinators (especially AD) › Psychologists on team (including neuropsychologists) › 8 recent NDA/sNDA approvals Therapeutically-aligned Expertise Pain and Inflammation Unique inVentiv advantages › More than 50 RA/OA trials › Post-surgical experience › Drug - Device combinations Pain and Inflammation › Manage scheduled substances Trials › 153 trials last 5 years (all services) › 106 clinical › > 6,800 Sites › > 39,400 Patients 32 Therapeutically-aligned Expertise Cardiovascular and Metabolism Unique inVentiv advantages › Imaging including IVUS › Hospital based-studies › Endpoint management Cardiovascular and Metabolism › Pediatric and adolescent CV/Metabolism Trials › 247 last 5 years (all services) › 123 Clinical › > 7,300 Sites › > 67,300 Patients 33 Therapeutically-aligned Expertise Vaccines and Infectious Disease Unique inVentiv advantages › Cold chain process › Bio-terrorism research › Government funded (DoD, HHS, BARDA) ID/Vaccine and Respiratory › Vaccine network › Site capacity building/TB › Strategic partnership experience ID/ Vaccine Trials › 186 last 5 years (all services) › 87 Clinical › > 3,200 Sites › > 60,300 Patients 34 Therapeutically-aligned Expertise General Medicine General Medicine Dermatology Gastroenterology Nephrology/Urology Ophthalmology Rare Diseases Transplant Women’s Health Unique inVentiv advantages Trials › 260 last 5 years (all services) › 140 Clinical › Dialysis site networks › Home health network › > 6,000 Sites › Hospital-based study experience › > 62,500 Patients › Stem cell research › Significant orphan drug/rare disease experience 35 Therapeutically-aligned Expertise Pediatrics Cardiovascular Dermatology Endocrinology & Metabolism Gastroenterology Hematology & Oncology Infectious Disease/Vaccines Neuroscience Rare Diseases Respiratory Pediatrics Unique inVentiv advantages Trials › 110 last 5 years (all services) › 72 Clinical › Consulting of the European Pediatric legislation and the US FDA PREA and BPCA Acts › > 2,400 Sites › Pediatric Investigational Plans (PIPs) › > 34,200 Patients › Experience with pediatric investigators › Pediatric Informed Consent › Consulting on age appropriate formulations and toxicity testing 36 Feasibility and Patient Recruitment/Retention World class, comprehensive services Investigator and Patient Strategies • inVentiv Clinical’s protocol feasibility, site selection and patient recruitment strategies are driven by data and analytics • Ensures an effective and efficient approach to securing and retaining both investigators and patients 38 Investigator and Patient Strategies • Our extensive experience managing and conducting global assessments includes: › Greater than 1,100 total patient recruitment and retention projects spanning 170+ indications › >90 countries globally, >200 feasibility and site identification programs annually › Aggregated wealth of historical performance data and investigatorreported information to build a data asset that can better prioritize investigator sites › Run algorithms against the data to identify the right number of the most effective investigators › Increases the number of high-performing sites to meet trial timelines • Best practices approach involves thorough analysis of the study design as well as ideal patient and investigator profiles 39 Data Driven Analysis and Planning • We maintain exclusive access to United Health Group integrated claims database reports › Captures140 million covered lives inclusive of Commercial, Medicare and Medicaid populations › Longitudinal dataset is mined using ICD-9, CPT, NDC codes and FDA BMIS records • Specific to indication and protocol criteria, information related to physician treatment patterns, research experience, and patient health care are assessed › Key applications • Identifies ideal physician profiles (location, name, practice, etc) who is treating, to what degree they treat, research experience, specialty • Gives broader community and referring physician pool • Data findings are then applied/extrapolated globally 40 Data Driven Analysis and Planning • Adheris, an inVentiv Health company, database contains rich and real- time prescription data for more than 120 million patients › Largest, direct-to-patient (DTP) database for HIPAA compliant, clinical trial patient recruitment › Provides proprietary access to patient and prescription level, plus disease and physician profile data including the following: • Patient demographics • Product daily dose, formulation and strength • Six years of treatment history • Physician demographics, practice characteristics › Identify prospective clinical trial candidates in a faster, more effective DTP manner for efficient outreach 41 Our Step-by-Step Approach to Designing the Plan OUR APPROACH All our programs are based on a detailed assessment of the challenges to deliver only the most-effective, evidence-based solutions. 42 1. Understand the recruitment and environmental challenges 2. Identify and understand our stakeholders and their drivers for participation 3. Understand how, when and where to engage/integrate with patients, HCPs and other stakeholders 4. Create a powerful visual identity that resonates across all stakeholders 5. Target the right messages to the right stakeholders at the right time; measure and analyze One strategic partner supporting clients through every phase of the product life cycle Why inVentiv Health? • Best-in-Class Capabilities • – Innovative solutions based upon industrywide experience • Global Scale – Seamless ability to scale up or down as needed • – Operations in more than 40 countries • World-Class Talent – 13,000 employees across three business segments • Operational Excellence – Ability to make decisions and deploy resources rapidly 43 Customized Solutions Rigorous Analytics – Proven methodologies applied across the lifecycle • Unique Insights – Strategic lens applied to tactical know-how