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?
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. 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. 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
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
11. The sad facts of drug development
Global R&D Spending by World’s Top 500 Pharma & Biotech
Source: EvaluatePharma® (06 April 2009)
12. The sad facts of drug development
Probability of success to market for new active substances
13. The sad facts of drug development
Reasons for termination of Phase 2 trials in haematologic oncology
Source: TrialTrove (March 2008)
14. The sad facts of drug development
Probability of success for Phase 3 drugs
Source: Lehman Brothers’ PharmaPipelines database
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 Rubertis
Chakma, J. et al, Nat. Biotechnol. 27, 886-888 (2009) BioCentury, November 2009
“Growing the company means increasing value, not headcount”
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. The VAD solution
Virtual 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
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
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. Lasagna’s Law
Before After
Study Study
Number 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. Case Study 1:
Large, top 10, multinational pharmaceutical company
Effect of protocol feasibility and patient selection:
67% Reduction in Recruitment Time
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.co
COMPETITIVE 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.co
COMPETITIVE DRUG DEVELOPMENT INTERNATIONAL
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 times
Grahaem
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. 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 Pharmacia
Mike 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. 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 companies
Bernard 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. 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
