DRUG DEVELOPMENT   The cddi approach
Contents ABOUT CDDI  •   WHO is cddi?  •   WHAT is the scope of our services?  •   HOW can you use us?  •   WHY would you...
ABOUT CDDI
WHO is cddi? Seasoned executives experienced in biotechnology and  medium to large pharmaceutical companies Understandin...
WHO is cddi? Overview of Management   Grahaem                                                     Bernard    Internist   ...
WHO is cddi? Overview of People An international network of drug development professionals Highly qualified with extensi...
WHAT is the scope of our services?
HOW can you use us? Insourcing cddi  •   cddi people deployed as functional experts to fill gaps  •   cddi people perform...
WHY would you choose cddi?
THE CASE FORVIRTUAL ASSET DEVELOPMENT
The sad facts of drug developmentGlobal R&D Spending by World’s Top 500 Pharma & Biotech  Source: EvaluatePharma® (06 Apri...
The sad facts of drug developmentProbability of success to market for new active substances
The sad facts of drug developmentReasons for termination of Phase 2 trials in haematologic oncology     Source: TrialTrove...
The sad facts of drug development             Probability of success for Phase 3 drugsSource: Lehman Brothers’ PharmaPipel...
The burden of unnecessary fixed costs  “There’s inherent inefficiency                        “The unmet need in the indust...
The burden of unnecessary fixed costs          IMPACT ON EXIT STRATEGY                              IMPACT IF MILESTONE DE...
The VAD solutionVirtual Asset Development is the use of an external, professional,experienced and flexible team, integrati...
The VAD solution
VAD Advantages A dedicated senior project manager, embedded in the company, ensures  total commitment to the project and ...
CASE STUDYRapid Patient Recruitment
Why do studies overrun their timelines? In 2007 only 7% (USA) to 18% (Europe) of studies were  completed on schedule. The...
Lasagna’s Law                             Before                           After                             Study        ...
Case Study 1:Large, top 10, multinational pharmaceutical company     Effect of protocol feasibility and patient selection:...
Case Study 2:Rescue of single study in small biotech company
WHERE can we be reached?                                       UK                                          UK    GRAHAEM B...
Thank You
CDDI Managing Partners           Overview             • An accredited specialist in Internal Medicine with deep and broad...
CDDI Managing Partners               Overview                 • Extensive international drug development expertise with s...
CDDI Managing Partners                Overview                  • An executive level business manager with over 20y drug ...
Insourcing cddi functional experts Provide robust,                                    Provide expert “hands-  experience...
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Cddi Corporate Presentation

  1. 1. DRUG DEVELOPMENT The cddi approach
  2. 2. Contents ABOUT CDDI • WHO is cddi? • WHAT is the scope of our services? • HOW can you use us? • WHY would you choose cddi? THE CASE FOR VIRTUAL ASSET DEVELOPMENT • The sad facts of drug development • The burden of unnecessary fixed costs • The VAD solution CASE STUDY: • Rapid patient recruitment WHERE can we be reached?
  3. 3. ABOUT CDDI
  4. 4. WHO is cddi? Seasoned executives experienced in biotechnology and medium to large pharmaceutical companies Understanding of objectives and exit strategies of clients International backgrounds, lived and worked in US, Europe, Asia, South Africa, Australia (studies in >52 countries) Extensive track records in achieving development milestones for investors, biotech companies and large pharma Proven success in reducing time to critical end-points cost- effectively Expertise from strategic planning to detailed execution All phases of preclinical and clinical development, regulatory approval and market support
  5. 5. WHO is cddi? Overview of Management Grahaem Bernard  Internist  C-Level Executive  MB FRCP DTM&H FFPM  PhD  Clinical dev. strategy  Technical operations  Clinical operations  CMC specialist  Developed 19 marketed  Outsourced management products  Biologics approvals  Large Pharma senior roles Mike  Physician  MB MD FFPM  Clinical dev. strategy  Clinical operations  Developed >30 marketed products  Large Pharma senior roles
  6. 6. WHO is cddi? Overview of People An international network of drug development professionals Highly qualified with extensive career experience in pharma and biopharma companies Available as needed Spanning all strategic and operational functions of drug development Hands-on support of business processes / systems review, change management and due diligence Pulled together under cddi management to ensure focus on delivery
  7. 7. WHAT is the scope of our services?
  8. 8. HOW can you use us? Insourcing cddi • cddi people deployed as functional experts to fill gaps • cddi people perform as in-house team members • Specialists sourced by cddi as needed • Managing Partner assigned to support strategic direction and oversight Virtual asset development • Client infrastructure re-designed to facilitate VAD • cddi assemble virtual project team with dedicated project manager • Virtual project team accountable to cddi management • cddi management accountable to client’s executive management and Board
  9. 9. WHY would you choose cddi?
  10. 10. THE CASE FORVIRTUAL ASSET DEVELOPMENT
  11. 11. The sad facts of drug developmentGlobal R&D Spending by World’s Top 500 Pharma & Biotech Source: EvaluatePharma® (06 April 2009)
  12. 12. The sad facts of drug developmentProbability of success to market for new active substances
  13. 13. The sad facts of drug developmentReasons for termination of Phase 2 trials in haematologic oncology Source: TrialTrove (March 2008)
  14. 14. The sad facts of drug development Probability of success for Phase 3 drugsSource: Lehman Brothers’ PharmaPipelines database
  15. 15. The burden of unnecessary fixed costs “There’s inherent inefficiency “The unmet need in the industry built into the traditional drug is drugs, not companies.” ... “If development model. The you look at the biotech industry, about 90% of companies can be outsourced system allows you best described as being marginal. to do the same development Too many of them have had large with much smaller teams and sums invested in them before many more products delivering key data.” simultaneously.” David Collier at CMEA Capital Index Partner Francesco de RubertisChakma, J. et al, Nat. Biotechnol. 27, 886-888 (2009) BioCentury, November 2009 “Growing the company means increasing value, not headcount”
  16. 16. The burden of unnecessary fixed costs IMPACT ON EXIT STRATEGY IMPACT IF MILESTONE DELAYED “But if the company may be an “If you’re building for an acquisition target, then by acquisition, and your acquisition minimizing infrastructure, it makes doesn’t come around, then it’s it more attractive and easier for a “then what?” How do you potential acquirer to integrate manage in that type of what they want without worrying environment?”... about shedding infrastructure”... “The acquirers are trying to “Especially if you have a single spend less and less, which asset....the potential acquirer is represents a challenge to the largely interested in the asset, and model.” the infrastructure in support of that asset may not be as important in the acquisition.”James Niedel, MD at New Leaf Venture Partners David Berry, Partner at Flagship Ventures Chakma, J. et al, Nat. Biotechnol. 27, 886-888 (2009) Chakma, J. et al, Nat. Biotechnol. 27, 886-888 (2009)
  17. 17. The VAD solutionVirtual Asset Development is the use of an external, professional,experienced and flexible team, integrating the specific mixture of skills needed to achieve your specific objectives
  18. 18. The VAD solution
  19. 19. VAD Advantages A dedicated senior project manager, embedded in the company, ensures total commitment to the project and clear lines of responsibility and communication The team is instantly available, and can be tailored to the company needs on a constant basis Input from other experienced CDDI members, even if not directly employed on the project, gives added breadth and value Obviates the need to manage and coordinate several independent consultants, CROs and vendors Frees up management time and resource The core company can take care of running the business: managing its finances, legal affairs, business development and other operational fundamentals, some of which smaller companies might outsource
  20. 20. CASE STUDYRapid Patient Recruitment
  21. 21. Why do studies overrun their timelines? In 2007 only 7% (USA) to 18% (Europe) of studies were completed on schedule. The delay was greater than 1 month in 41% (Latin America) to 70% (USA) of studies (CenterWatch 2007). In the USA 57% of delays were due to slow patient recruitment and enrollment, and to protocol amendments (Thomson CenterWatch 2007). Typically 30% of investigators recruit no patients or just one patient. The number of patients predicted by investigators typically plummets by up to 90% at the start of a study (attributed to Dr Louis Lasagna).
  22. 22. Lasagna’s Law Before After Study StudyNumber of Patients Study Start During Study “The number of patients available to join a trial drops by 90% the day a trial begins. They re-appear as soon as the study is over.”
  23. 23. Case Study 1:Large, top 10, multinational pharmaceutical company Effect of protocol feasibility and patient selection: 67% Reduction in Recruitment Time
  24. 24. Case Study 2:Rescue of single study in small biotech company
  25. 25. WHERE can we be reached? UK UK GRAHAEM BROWN MB FRCP DTM&H FFPM BERNARD CHAN PhD MANAGING PARTNER MANAGING PARTNER +44 7768 733992 +44 7706 882782 grahaem.brown@cddi.co bernard.chan@cddi.coCOMPETITIVE DRUG DEVELOPMENT INTERNATIONAL COMPETITIVE DRUG DEVELOPMENT INTERNATIONAL USA MIKE TANSEY MD FFPM Email: solutions@cddi.co MANAGING PARTNER +1 908 720 7354 Web: www.cddi.co mike.tansey@cddi.coCOMPETITIVE DRUG DEVELOPMENT INTERNATIONAL
  26. 26. Thank You
  27. 27. CDDI Managing Partners  Overview • An accredited specialist in Internal Medicine with deep and broad experience of clinical strategy and operations and process improvement  Examples of Achievements • Significant role in development of 19 major products • Managed 5 major business improvement programs • Successfully merged organizations three timesGrahaem Brown  Previous Roles • SVP Development (UCB / Celltech) • Head Transition Management (Pfizer) • VP Clinical Research & Global Head Clinical Operations (Pharmacia) • Global Head Clinical Research (Novartis) • SVP R&D (Glaxo Canada) • Director Clinical Research (Glaxo Group Research)
  28. 28. CDDI Managing Partners  Overview • Extensive international drug development expertise with strategic & hands-on involvement in over 40 regulatory submissions  Examples of Achievements • Development, approval or commercialization of over 30 NCEs • Led worldwide change management in PharmaciaMike Tansey • Established multiple Far East drug development units  Previous Roles • EVP & CMO (La Jolla Pharmaceutical Company) • CMO & SVP Medical Development (Pharmacia) • CMO & SVP Clinical Development & Reg. Aff. (Pharmacia & Upjohn) • Corporate Medical Director (Rhône Poulenc Rorer) • Intl. Director Clinical Research (Glaxo R&D)
  29. 29. CDDI Managing Partners  Overview • An executive level business manager with over 20y drug development experience in biotech operations  Examples of Achievements • Led development & commercialization of UCB’s Cimzia® manufacture • Jointly led multiple re-engineering programs within 4 companiesBernard Chan • Led implementation of new business systems (EDMS & CRM)  Previous Roles • Chief Business Officer (CMC Biologics) • Chief Operating Officer (Xceleron) • Director of Biologicals Manufacturing (UCB) • Head of Biologicals Manufacturing Development (Celltech) • Product Development Manager (Medeva)
  30. 30. Insourcing cddi functional experts Provide robust,  Provide expert “hands- experienced leadership on” resources to project • Ensure programme has a • Ensure consistent drive fully resourced team towards business covering all the key functions milestones • As needed basis (e.g. if • Be the owner for the regulatory needed 4 days project, to assure time, per month rather than full quality and cost time) • Prevents issue of one team member wearing “too many hats” • Provide team consistency and stability by keeping the same experts involved throughout that stage of a project

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