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Project Management in the Pharmaceutical Industry

Project Management in the Pharmaceutical Industry. 16:30 h Project Management and the development of a new medicine Anton Van Kolfschoten 17:15 h Management of the registration of influenza vaccines Dorine Leyssius & Reny ten Haaf 18:45 h FDA Advisory committee Meeting

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Project Management in the Pharmaceutical Industry

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  1. Project Managementin the Pharmaceutical Industry 16:30 h Project Management and the development of a new medicine Anton Van Kolfschoten 17:15 h Management of the registration of influenza vaccines Dorine Leyssius & Reny ten Haaf 18:45 h FDA Advisory committee Meeting The management of an acceptance test for a new medicine by external stakeholders Jan Jansen

  2. Project Management in the Development of New Medicines Anton VanKolfschoten PhD, RegTox, PMP February 22nd 2011

  3. Anton Van Kolfschoten • Master in Bio-medical Sciences • University of Utrecht; PhD 5 years • Research in Pharmacology & Toxicology • Solvay Pharmaceuticals/Abbott 29 years • Non-clinical safety testing 17 years • Project management 12 years • PMP since 2010

  4. What Is Drug Development The science of developing a pharmaceutical drug candidate through development, approval, launch, and Life Cycle Management. During Development a drug candidate is tested for safety and efficacy, approved by regulatory authorities and launched. During Development a manufacturing process is established, validated and transferred to a commercial manufacturing facility. Once a drug is launched Development continues to monitor safety and develop new indications and/or improved drug delivery.

  5. The Drug Development Process Long, Complex, Costly Only 1 in 10,000 Compounds in Drug Discovery Receive Regulatory Approval PhRMA Profile 2009

  6. Advancing and Sustaining the Pipeline – Guiding Principles • In Discovery, a high number of compoundsis generated to createthe optimal pharmacological profile. • During Development, the number of compounds is decreasing due to attrition • While a compound progresses in Development, the risk of attrition decreases while the costs of development increase Marketed Drug One Portfolio One Team Phase 3 Cost per Compound Decreasing Risk Phase 2 Phase 1 Advanced Preclinical Number of Compounds Source: Abbott

  7. Pharmaceutical Industry ChallengesAverage R&D Spend Per NME Has Been Rising Average R&D spend per FDA Approval (small molecules and biologics)* * Average R&D spend per NME defined as 5 year lagging average R&D spend divided by sum of present period NME and BLA approvals Note: Biologics included only from 1986 onward, biologics approvals assumed negligible in prior periods Source: McKinsey analysis, NME data from multiple publications and statistical sourcebooks Industry R&D spend data from the Pharmaceutical Research and Manufacturers of America, PhRMA Annual Membership Survey, 2006.

  8. Challenges for Pharmaceutical IndustryRate of FDA approvals has been decreasing…

  9. Development of New DrugsProject Initiation - Strategic Considerations Unmet Medical Need/Profitability Approvability Feasibility/ Expertise Source: Abbott

  10. Scope - example from AbbottRole of DOP and TPP in Pipeline Optimization DOP Set objectives Discovery/ early development Full development File, launch, LCM Pre-R+D Disc. P-C P1 P2a P2b Ph. 3 Reg. Mkt. TPP DOP 1. 2. 3. Requirements or priorities to achieve commercial success Framework for assessing attractiveness of emerging asset attributes Integrated, consistent commercial input for early-stage R&D compounds Disease Opportunity Profile and Target Product Profiles Guide Discovery and Development Decision-Making Scope for New Medicine Source: Abbott

  11. Target Product Profile – Scope of Development Requirements for • Indication (disease to be treated) • Patient population • Efficacy in disease • Safety for patients • Presentation form (tablet, capsule, drops, suppository, injection) • Interaction potential with other drugs • Costs of goods • Reimbursement possibilities • Launch conditions

  12. High Level Drug Development Timeline Pre-clinical Development Pre-clinical Development Discovery Discovery Clinical Development Clinical Development Application for First Market Application Review for First Market Global Launches Global Launches Marketing Support 3–5 Years 3-5 Years < 1 Year < 1 Year ~7–10 Years ~1 Year ~1 Year ~5-10 Years ~5–10 Years Time to develop a drug = 10 to 15 years Source: Abbott

  13. Drug Development Is Comprised of Many Stages R&D Key Milestones First Regulatory Enabling Toxicity Dose Active Substance Code Assigned First Human Dose First Submission Discovery Pre-clinical Development Clinical Development Application for First Market International Launch Program First Launch First Patient Dose Not to scale First Pivotal Dose

  14. Probability of Success for various Phases

  15. Preclinical Activities Include in vitro (test tubes) and in vivo (animal) Studies • Effectiveness in preliminary screens • Potential dosage • Metabolites • Toxicology and safety • Extensive animal studies are conducted to determine if a drug is likely to be safe in humans • Toxicology studies are performed for differing purposes • Studies performed using Good Laboratory Practices (GLP) and meeting regulatory requirements for duration and power are suitable to submit to regulatory authorities • Additional studies are also conducted to gain preliminary data and scientific knowledge

  16. What Is Drug-Product Development? From idea… …to drug substance… …to medicine for the patient Drug development turns a laboratory concept into a consistent and well-characterized medical product that can be mass produced. It is the process whereby a compound is discovered, tested for safety and efficacy, approved by regulatory authorities and marketed. It involves physical design and specifications of the product, as well as manufacturing and quality control approaches 90% of new medicines are discovered & developed by industry Source: Abbott

  17. Nonclinical Activities Include Developing Manufacturing Process • Manufacture of active Pharmaceutical ingredient (API) • Process design and development • Scale up • Validation • Manufacture of Drug Product (DP) • Formulation for first-in-human (FIH) • Formulation design to meet product needs • Manufacturing process development • Validation • Bioavailability • The Drug Product must meet bioavailabity requirements to deliver the drug

  18. Developing a Dosage Formulation The Process of Taking the Drug and Inactive Ingredients to Produce StableDosage Forms that DeliverSafeand TherapeuticallyEffectiveLevels of Medicine Upon Administration Source: Abbott

  19. Phase 1 Clinical Testing • First time in humans(FIH) • Healthy volunteers (not patients) • Small number of subjects (~20–80) • Examples of questions that researcher must answer satisfactorily include: • Is the drug safe? • Within what dose range? • What is the maximum tolerated dose? • How quickly is the drug absorbed? • Where in the body is the drug distributed? • How quickly is the drug eliminated? • How difficult is the drug to manufacture? Source: Abbott

  20. Phase 2 Clinical Studies Approximately 100 to 300 patients with the targeted disease are tested to determine the drug’s effectiveness to treat disease and short-term side effects Source: Abbott

  21. Phase 2 Clinical Studies (cont.) • First time in patientswho have disease or condition • Proof of concept (POC) to see if drug actually works as experimental data suggested • Is the drug safe in patients? • Is the drug effective within the safe dose range? • What is the minimum effective and the optimal dose? • Is the drug effective in mild, moderate and severe cases of the disease or condition? • Statistical difference from placebo • More patients than Phase 1 (n~100s) • Phase 2 studies are generally not statistically powered to support registration Source: Abbott

  22. Phase 3 Clinical Studies Thousands of patients are tested in clinics or hospitals to determine the drug’s effectiveness and side effects. Phase 3 studies are conducted in many sites around the world and cost tens to a hundred million dollars. Source: Abbott

  23. Phase 3 Clinical Studies (cont.) Phase 3 studies involve large numbers of patients (n~1000s) and are conducted at multiple sites in multiple countries. Studies last from months to several years and answer questions such as: • Is the drug safe in large populations? • Do the benefits of therapy out weigh the safety risks? • Does the drug interact with other drugs? • Is the drug more or less effective than other competing drugs? • Is the drug effective under unusual circumstances? • Do patients build up a tolerance to the drug? • Is there an explanation for the times when the drug is not effective? Source: Abbott

  24. Regulatory Submission and Approval Regulatory submissions seek approval to sell a new drug • All data are compiled and submitted for review by the regulatory authorities • If regulatory authorities concur that the data prove safety and effectiveness, it will approve the drug, along with official labeling, and guidelines for its administration • Submission documents • United States (FDA) • New Drug Application (NDA): Small Molecules • Biologics License Application (BLA): Biologics • European Union (EMA) • Marketing Application (MA): Small Molecule or Biologic Source: Abbott

  25. After Regulatory Approval Regulatory approval is the starting point for many post approval activities and life cycle management improvements to the products such as new indications • Product launch • Product marketing and education to physicians, patients, and payors • Post-market surveillance • Follow up on adverse reactions • Respond to physicians’ needs Source: Abbott

  26. Pharmacovigilance/ Safety Team Clinical Pharmacology Team Health Economy Team Marketing Team Regulatory Team Liaison (US/EU) Reg CMC (US/EU) Tech Support (US/EU) Japan, EELA/AMAC Research Team Clinical Team Project ManagementCompound Project-Team Structure Situation in (former) Solvay Project Management Team Project Director (P-team) leader Cross-functional Project Team (P-team) GPRM Team Leader ClinPharm Team Leader GHE Team Leader GPS Team Leader PDS Team Leader Chemical & Pharmaceutical Development Team Research Team Leader Regulatory Team Leader Clinical Team Leader

  27. Global Project Team(GPT) “The fundamental project working unit for drug development” • Sets the strategic direction for the project, makes recommendations to governance bodies and executes the project plan • Develops and delivers • Target Product Profile (TPP), • Product Development Plan (PDP) • Product Labeling • Risk Management Plan (RMP) • Project Communication Purpose and Key Deliverables Source: Abbott

  28. EmpowermentAccountability SeniorStrategic Leadership R&D + Commercial Team Members Leadership Team Empowers Project Teams and Line Functions Project Strategy,Planning and Execution Project Team HeadcountBudgetScience Line Functions

  29. Thank you! QUESTIONS ?

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