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2
There’s inherent inefficiency built into the
traditional drug development model. The
outsourced system allows you to do the same
development with much smaller teams and
many more products simultaneously
David Collier at CMEA Capital
Chakma, J. et al, Nat. Biotechnol. 27, 886-888 (2009)
deliveringintelligent drug development 2
Why Even Consider
Virtual Pharmaceutical Development?
deliveringintelligent drug development
A Definition of
Virtual Pharmaceutical Development
3
The use of external professional,
experienced and flexible teams,
with the mix of skills relevant to
meeting the desired objective (POC, specific phase of development, acquisition, partnership, IPO etc.)
as an alternative to building infrastructure.
deliveringintelligent drug development
Situations Amenable to
Virtual Development
4
• Single asset (any stage)
• Uncertainty about viability of compound
• Low-priority asset for which no in-house resources
• Drug repositioning
• Pre-clinical phase
• Intent to build a team if milestone (eg POC) reached
(low-cost initially, with no residual cost if fails)
• For start-ups and VCs geared to M&A
deliveringintelligent drug development
The Pros of Virtual Development 1
5
• No, or low, office overheads and expenses
• Fewer staff overheads
• No recruitment costs
• No salary to pay if no work (use as needed)
• Reduced risk of over-run costs (greater efficiency)
• Avoid severance*
• Little legacy infrastructure*
Better capital efficiency and lower burn rate
*Especially if acquired, or if fail to be acquired
deliveringintelligent drug development
The Pros of Virtual Development 2
6
More effective staff management
• Immediate availability
• Relevant expertise
• Better qualified
• Lower turnover
deliveringintelligent drug development
The Pros of Virtual Development 3
7
• Simpler governance
• Faster decision-making; less bureaucracy
• Start to build permanent organisation when more certain
of outcome
• More time to recruit best staff
• Time to train new staff
Greater flexibility
Greater speed to objective
Greater productivity
8
If you’re building for an acquisition, and your acquisition doesn’t
come around, then it’s “then what?”
How do you manage in that type of environment?
The acquirers are trying to spend less and less, which
represents a challenge to the model.
David Berry, Partner at Flagship Ventures
Chakma, J. et al, Nat. Biotechnol. 27, 886-888 (2009)
deliveringintelligent drug development 8
Acquisition: To Be or Not To Be?
9
“The unmet need in the industry is drugs, not
companies.”… “If you look at the biotech industry,
about 90% of companies can be best described as
being marginal. Too many of them have had large
sums invested in them before delivering key data.”
Index Partner Francesco de Rubertis,
BioCentury, Nov 2009
deliveringintelligent drug development 9
Cost Savings and M&A Strategy
10
But if the company may be an acquisition target, then by minimizing
infrastructure, it makes it more attractive and easier for a potential
acquirer to integrate what they want without worrying about shedding
infrastructure…
Especially if you have a single asset….the potential acquirer is largely
interested in the asset, and the infrastructure in support of that asset
may not be as important in the acquisition.
James Niedel, Managing Director at New Leaf Venture Partners
Chakma, J. et al, Nat. Biotechnol. 27, 886-888 (2009)
deliveringintelligent drug development 10
Infrastructure and Exit Strategy
deliveringintelligent drug development
Achieving Proof of Concept: a ComparisonFlexion
11
22 People
10 New Medical Entities
6 Therapeutic Areas
deliveringintelligent drug development
The Cons of Virtual Development
(and how to manage them)
12
• No direct control Primarily a management issue
Establish clear objectives and processes
Physical presence whenever possible
Communication
• Low level of commitment and urgency (not accountable) An issue when using any kind of contractor
Structure contract to pay by objectives
• Lack of creativity and efficiency due to physical separation Create effective communication plan
Ensure physical presence at relevant meetings (meetings do not necessary result in efficiency or creativity)
• Geographical and temporal delays An issue for any multinational project
Tried and tested ways exist to address these aspects
Virtual team should be international (when relevant)
Communication
The Traditional Development Model
13
CROs
Site Management
IVRS
CTMS
Central Labs
Supplies
External VendorsThe Company
The CEO
CFO
Legal
HR
IT
CMC
Supply
QA
Preclinical
Analytical
Business Dev
CMO
Stats
Data Management
Safety
Medical
Clinical Pharm
Clinical Ops
Regulatory
Proj Management
Writers
Consultants
Therapeutic Experts, Advisory Boards, DMBs etc.
deliveringintelligent drug development 13
Intermediate or Semi-Virtual Models
14
CROs
Site Management
IVRS
CTMS
Central Labs
Supplies
External Vendors The Company
The CEO
CFOBusiness Development
PreclinicalProject Manager
Admin
Legal
HR
IT
CMC
Supply
QA
Analytical
CMO
Stats
Data Management
Safety
Medical
Clinical Pharm
Clinical Ops
Regulatory
Proj Management
Writers
Therapeutic Experts
Advisory Boards
DMBs
Consultants
deliveringintelligent drug development 14
CROs
Site Management
IVRS
CTMS
Central Labs
Supplies
The Virtual Development Organisation
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Contract Operations
Finance, Legal, BD, IT, HR etc.
Consultants
Therapeutic Experts, Advisory Boards, DMBs etc.
External Vendors*Integrated Virtual
Development TeamThe Core Company
Dedicated Senior
Project Leader
CEO
Inventor
Board
VCs
Stats
& DMRegulatory
* Contracts with the Core Company
CMC &
Supply
Ops
Manager
Safety
Project
M/gement
QA
ClinPharm
Others
deliveringintelligent drug development 15
deliveringintelligent drug development
Essential Management Qualities for
Managing Virtual Development
16
• Previous experience
• Ability to delegate
• Comfortable working without immediate infrastructure
• Excellent communicator
• Strong team and culture builder
• Good project manager
“A great molecule can be screwed up by a
mediocre management team”
Jeff Stein, CEO of Trius Therapeutics and Partner at Soffinova Ventures
Chakma, J. et al, Nat. Biotechnol. 27, 886-888 (2009)
• A global biotechnology and pharmaceutical consulting
company, with partners in US, Asia and Europe
• A full range of services, from IND to NDA and throughout
the product life-cycle
• Flexibility to meet your needs - whole programmes or
specific components.
• Founded and managed by senior executives with
extensive experience, both in Biotech and majorpharma
companies such as Glaxo, Pfizer, Novartis, Pharmacia
and Hoechst
competitive drug development international
deliveringintelligent drug development 17
About us
• cddi is led by seasoned Industry professionals who have
been personally accountable in some way for developing
more than 30 products globally from discovery to market.
• Our global network of partners have the functional and
therapeutic area skills needed for programs, from
strategic development to hands-on operational project
tasks
• We have a proven track record in reducing time lines
cost effectively
• We don’t just “consult”, but accept responsibility for
achieving your objectives……. reliably, quickly, and cost-
effectively
Why Is cddi Different?
deliveringintelligent drug development 18
• Highly experienced biopharmaceutical specialists
• Project evaluation / due diligence by experts
• Project management, with dedicated teams to take
projects effectively to the next inflexion point
• Optimisation of organisations, reduction in infrastructure
costs and operational excellence
• Ability to “rescue” projects with problems such as slow
patient recruitment
• Global reach with a worldwide network of partners
What we Provide
“You cannot create experience. You must
undergo it”
Albert Camus
deliveringintelligent drug development 19