Title: Outsourcing Experience at BioDuro
1Outsourcing Experience at BioDuro
September 2009
2Research Trends - China
Key Challenge Creating a passion-filled
research environment that enables problem solving
and out-of-the-box thinking
3BioDuro was Set Up with a Different Vision
- Passionate, entrepreneurial, western research
culture that collaborates to perform
high-quality, integrated discovery services - By
- Attracting, retaining, and exciting the best
people - Creating entrepreneurial, research culture
- Maintaining high ratio of overseas PhDs
experienced staff - Institutionalizing learning as a key value
4BioDuro is an Example of the Next Wave of CROs
Goal Collaborative Research Organization
5What is Required to Overcome Challenges Create
Western Research?
- Entrepreneurial, research culture
- Innovation
- Problem-solving
- Initiative
- Exceeding expectations
- Nurturing/education of team
- Treatment of team member as valued part of team
- Team-building activities
- Training courses for both scientists and managers
- Number of scientists worked abroad at client site
6Integrated Programs Require Functional Excellence
Integrated Programs
7True Discovery Collaborations
Biology
Chemistry
- Have completed or are engaged in nearly 20
programs - Projects utilize BioDuro chemistry, biology,
pharmacology, DMPK, and safety - BioDuro has the ability to lead programs or
collaboratively serve as a strong 2 or
co-pilot
DMPK
Pharmacology
Safety
- Collaborative spirit - frequent, open
communication with clients - Intellectual input and decision making driven by
BioDuro
8Integrated ProgramsModels
- Functional Services Only
- Requires excellence in each area
- Management critical no drug discovery experience
needed - Client drives, BioDuro assists
- Junior drug discovery/project management leader
needed at BioDuro - BioDuro drives, client assists
- Senior leadership required at BioDuro
- Extensive drug discovery experience required
- BioDuro drives
- Strategic leadership needed at BioDuro
- BioDuro typically assumes limited risk-sharing
Increasing BioDuro Intellectual Input
9Program Selection
HTS/Hit ID
H2L
LO
PCD
Target Selection
IND
- Client selects the target(s) and files IND
- Starting point defined by program needs
- Hits from Client HTS screens
- Secondary scaffolds/historical data
- End point defined by program, client desires, and
the Joint Steering Committee
BioDuro
Client
10Experience with Integrated Programs
- Majority from Medium to Big Pharma
- Setting up validated, target to IND filing drug
discovery system at a CRO takes significant
effort and time - Most clients approach outsourcing in a step-wise
fashion to allow CROs time to develop core
strengths
11BioDuro Experience with Chemistry Metrics
- Negatively dependent on
- Scale
- Number of steps
- Difficulty of chemistry
- Team size changes
- Positively dependent on
- Stable goals
- Backlog of projects
- Precedented chemistry
12Metrics are not the Best Measure for Integrated
Programs
- Metrics are easy to collect and analyse
- However, they do not accurately measure the
effectiveness of integrated programs - They can also encourage the wrong behaviour
(i.e., CRO resistance to stop synthesis early due
to new data) - Customer satisfaction and project progression are
better measures
13Industry Best Practice Sharing Opportunities
- Share clearly defined project goals with CRO
- Motivational for CRO scientists
- CRO understands roles and needs of project better
- Project starts more quickly
- Take advantage of intellectual abilities of CROs
- Reduced burden on client
- Decisions can be taken at CRO
- Another set of minds contributing to the science
- Enhanced engagement reduces team churn
- Face-to-face team building meetings
- Builds strong project team across the globe
- Higher trust, better communication
14Industry Best Practice Sharing Opportunities
- Input into the project strategy establish
regular oversight meetings - Allows big picture understanding and input from
both teams - Able to spot and address structural issues
- Less formal reporting, more as needed reporting
- Conferences
- Reports
- Phone calls/e-mails
- Peer-to-peer communication
- Electronic notebook and tracking systems
- Reduce the amount of time needed to manage
projects - Less errors
15Intellectual Property Protection
- CROs are now being exposed to, and generating
sensitive data - Factors that lower the risk of data leaks
- No internal discovery programs
- Long-term commitment to outsourcing
- Understanding of importance of IP protection
- Low employee turnover
- Internal security very important
- Physical security
- Electronic security
- Frequent training and reminders are necessary
- Monitoring and enforcement systems are needed
16Client Liability
- Many clients recognise liability at a CRO if
lower standards are used - Following items are audited for compliance with
global client policy - Safety
- Waste handling
- Environmental protection
- Animal care
- Licensing, handling and storage of dangerous or
restricted chemicals
17Business Structures
- Attractive Pricing
- Most people outsource to Asia because of
financial advantages - Structures
- Integrated Service Offering (ISO)
- Flexible team of FTEs Ability to change mix/size
as program dictates, typically 13 PhD-non PhD
ratio - Some shared risk possible
- Full Time Equivalent (FTE)
- Project Based Fee for Service (FFS)
18Business Considerations Lessons Learned
- Leadership does client want?
- True leader to drive
- Or, strong 2 to input execute
- Experienced drug discovery leadership is
expensive, so ensure that maximum value is
recognised - Structures
- Risk sharing pros
- Helps align incentives clarify goals up-front
- Reduces cost
- Risk sharing cons
- Complications arise for pharmas to release IP to
which they have contributed - Unrelated business issues that stop programs must
be dealt with - Straight FTE may fit better for programs that are
likely to change
19Program Management
- Key features of good CRO management
- Detailed up-front planning with agreed upon
delivery timelines - Careful, realistic resource allocation
- Frequent communication with clients
- Tendency for CROs not to communicate openly when
there are issues
20Important that Client sees an Integrated Team at
the CRO, not just Separate Functions
Biology
Chemistry
DMPK/ Safety
Project Leader
Tendency for functions to interact directly
with client
Project leader roles at client and CRO critical
CLIENT
21Communication Issues
- Different time zones, languages and cultures
- Growing number of returnees help bridge these
gaps - Clients are also employing nationals of the CRO
country - Placing client project managers at CRO and CRO
managers at clients increasing in popularity
22Summary
- Asian CROs offer reduced costs
- Capabilities growing rapidly
- Resource allocation is very flexible
- Growing track record of successful integrated
collaborations in Asia - Determining the right team structure and business
model is key to success and building a long-term
relationship