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ANNUAL

OUTSOURCING
SURVEY
W ELCOME TO OUR 6th Annual CONTRACT PHARMA
Outsourcing Survey! More than 350 sponsor-side respon-
dents offered up their opinions on outsourcing trends for this
Signs of Improvement?
Last year, a whopping 62% of total respondents believed that
they’d spend the same or less on outsourcing spending in
year’s poll. the coming year; this year, that dipped to 55%. Happily, the 10%+
On the following pages, we’ve provided a sample of the find- less spending than previous year” respondents dropped from
ings, focusing mainly on the major outsourcing projections of our to 13%; from 23% last year, while no change increased from to
respondents, broken out by their business categories. Here’s a 29% of all correspondents, from 25% last year.
breakdown of the respondents: Along those lines, 35% of respondents said that they had
cancelled outsourcing projects in the previous year due to
Company Type Job Function
the economy; the same percentage as in our 2009 survey. We
Top 20 Pharma . . . . . . .23.4%
Small/Mid-Tier Pharma .18.0%
R&D . . . . . . . . . . . . . . . .21.5%
Corp. Mgmt. . . . . . . . . .13.0%
added “to reduce company size” to our responses for “Why The Science Of Research
does your company outsource?”; 7% of respondents chose
Generic Pharma . . . . . .10.1% QA/QC/Validation . . . .12.3%
that answer, led by Top 20 Pharma, with 41% of those responses. At DiTEBA, we are committed to your success by providing
Virtual Pharma . . . . . . . .9.8% Project Manager . . . . . . .9.5%
Emerging Biopharma . . . .8.2% Contract Manager . . . . . .6.6% analytical and bioanalytical chemistry services that accelerate
—GYR
Specialty Pharma . . . . . . .7.0% Purchasing/Sourcing . . . .5.7%
Top 10 Biopharma . . . . . .6.3% Production/Mfg./Pkg. . . . .5.7% Photo courtesy of Fisher Clinical Services R&D intensive projects.
Consumer/ . . . . . . . . . . .3.5% Business Development . .5.7%
OTC Healthcare Marketing/Sales . . . . . . . .5.4% As a pharmaceutical contract research organization, we strive
Other . . . . . . . . . . . . . . .13.6% Clinical Research . . . . . . .4.1%
Supply Chain Manager . . .3.5%
to be an innovative and cost-effective partner that delivers
Regulatory Affairs . . . . . .2.5% consistent, quality services with unmatched integrity.
Engineering . . . . . . . . . . .1.3%
Other . . . . . . . . . . . . . . . .3.2% Through the science of research, let DiTEBA expedite
the process of bringing your product to market.

Research
Turning Research Into Reality
Reality
1620 Tech Avenue, Unit 3
 Analytical Testing  Formulation Development Mississauga, ON Canada
 Bioanalytical Testing Support Testing L4W 5P4
 In Vitro Release Rate Testing Toll Free: 1•800•671•9053
 Stability Storage and Testing
 Physical Testing Phone: 905•625•7995
 Cleaning Verification and Fax: 905•625•3767
Validation Testing www.diteba.com
info@diteba.com
2010 OUTSOURCING SURVEY 2010 OUTSOURCING SURVEY

Past Imperfect
Respondents who report that their outsourcing spending Respondents who report that their outsourcing spending
GREW in the previous year: 43.9% SHRANK in the previous year: 33.9%
WHAT DO THEY DO? WHAT DO THEY DO?
R&D ................................................................................18.5% R&D ................................................................................25.0%
Corporate Management ..................................................15.3% QA/QC/validation ............................................................14.6%
QA/QC/Validation ............................................................10.5% Corporate Management ..................................................14.6%
Project Manager..............................................................10.5% Project Manager................................................................9.4%

WHERE DO THEY WORK? WHERE DO THEY WORK?


Top 20 Pharma ...............................................................28.2% Small/Mid-Tier Pharma ...................................................19.8%
Small/Mid-Tier Pharma ...................................................16.1% Top 20 Pharma ...............................................................16.7%
Virtual Pharma................................................................14.5% Generic Pharma..............................................................12.5%
Generic Pharma ...............................................................8.9% Top 10 Biopharma.............................................................9.4%

WHAT TYPES OF OUTSOURCING DO THEY MANAGE?* WHAT TYPES OF OUTSOURCING DO THEY MANAGE?*
Analytical & Testing Services..........................................50.0% Analytical & Testing Services ..........................................47.9%
Manufacturing: Fill/Finish .................................................37.1% Manufacturing: API..........................................................30.2%
Methods Development / Validation ..................................37.1% QA/QC ............................................................................30.2%
Process Development / Scale-Up....................................37.1% Formulation Development...............................................29.2%
Stability Studies ..............................................................36.3% CMC................................................................................25.0%
Manufacturing: Solid Dosage..........................................34.7% Methods Development / Validation .................................25.0%
Formulation Development...............................................33.1% Stability Studies ..............................................................25.0%

* Respondents can select multiple answers for this category)

2 2010 CONTRACT PHARMA OUTSOURCING SURVEY www.contractpharma.com 2010 CONTRACT PHARMA OUTSOURCING SURVEY • Sponsored by Diteba Research Laboratories 3
2010 OUTSOURCING SURVEY 2010 OUTSOURCING SURVEY

Future Shock
Respondents who project that their outsourcing spending Respondents who project that their outsourcing spending
will GROW in the next year: 44.9% will SHRINK in the next year: 26.1%
WHAT DO THEY DO? WHAT DO THEY DO?
R&D ................................................................................20.3% R&D ................................................................................20.3%
Corporate Management...................................................11.7% QA/QC/validation ............................................................14.9%
QA/QC Validation.............................................................11.7% Corporate Management ..................................................13.5%
Project Manager..............................................................10.2% Project Manager..............................................................10.8%

WHERE DO THEY WORK? WHERE DO THEY WORK?


Top 20 Pharma ...............................................................29.7% Top 20 Pharma ...............................................................20.3%
Small/Mid-Tier Pharma ...................................................16.4% Small/Mid-Tier Pharma ...................................................18.9%
Virtual Pharma................................................................12.5% Generic Pharma..............................................................12.2%
Generic Pharma..............................................................10.9% Emerging Biopharma ......................................................10.8%

WHAT TYPES OF OUTSOURCING DO THEY MANAGE?* WHAT TYPES OF OUTSOURCING DO THEY MANAGE?*
Analytical & Testing Services..........................................49.2% Analytical & Testing Services ..........................................41.9%
Manufacturing: Fill/Finish ................................................32.0% Formulation Development...............................................28.4%
Methods Development / Validation .................................32.0% Manufacturing: API ..........................................................27.0%
Stability Studies...............................................................31.3% Process Development / Scale-Up....................................27.0%
Manufacturing: Clinical Trials Materials...........................28.9% Clinical Trials (Phase I-IV)...............................................25.7%
CMC................................................................................28.1% Manufacturing: Fill/Finish ................................................25.7%
Process Development / Scale-Up ...................................28.1% Manufacturing: Solid Dosage..........................................25.7%

* Respondents can select multiple answers for this category)

4 2010 CONTRACT PHARMA OUTSOURCING SURVEY www.contractpharma.com 2010 CONTRACT PHARMA OUTSOURCING SURVEY • Sponsored by Diteba Research Laboratories 5
2010 OUTSOURCING SURVEY 2010 OUTSOURCING SURVEY

Commercial Interruption
Of the respondents who say that their companies outsource at least 50% of their commercial manufacturing . . .

59.4% report that more than half of their outsourcing dollars go to preferred providers

78.1% report that their company have never received a warning letter due to an inspection at a CMO

51.6% either probably or definitely will not outsource a project to Asia in the next year

81.3% are would use the word “partnership” to describe their relations with a provider

31.7% report that they have canceled or delayed outsourcing projects in the past year, due to the economy

are most likely to work at a Virtual Pharma (32.8% of respondents), and also predominantly
outsource more than half of clinical materials (85.2% of respondents) and APIs (88.9% of respondents)

6 2010 CONTRACT PHARMA OUTSOURCING SURVEY www.contractpharma.com 2010 CONTRACT PHARMA OUTSOURCING SURVEY • Sponsored by Diteba Research Laboratories 7
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Ups and Downs


50% of all respondents said that they describe their outsourcing model as
Strategic (entire classes of functions performed out-of-house), down from 55% last year.

The other 50% said they would describe their outsourcing model as
Tactical (case-by-case, based on availability).

Virtual Pharma companies were most likely to call their relationship Strategic (70%),
while Small/Mid-Tier Pharma was most likely to call their relationship Tactical (63%).

The largest group to say it will do 10+% more outsourcing next year
describe their companies as Top 20 Pharma, at 28%.

That was also the demographic that said it will do 10+% less outsourcing in the next year,
with 19% of the responses to that question.

8% of respondents said that their companies had


received a regulatory warning letter because of an inspection at a CMO;
72% said they had not and 20% were not certain.

8 2010 CONTRACT PHARMA OUTSOURCING SURVEY www.contractpharma.com 2010 CONTRACT PHARMA OUTSOURCING SURVEY • Sponsored by Diteba Research Laboratories 9
2010 OUTSOURCING SURVEY 2010 OUTSOURCING SURVEY

CONTRACTING &
OUTSOURCING 2010
CONFERENCE & TABLETOP EXHIBITION
SEPTEMBER 23-24, 2010 • HYATT REGENCY NEW BRUNSWICK

Don’t miss the industry’s leading


Networking Conference & Tabletop Exhibition
for Pharmaceutical and Biopharmaceutical
decision-makers! Register today!
Two-day Conference: Sept. 23-24
Speakers represent FDA, large, specialty and
virtual Pharma and Biopharma, and more!
One-day Tabletop Exhibition: Sept. 23
Exhibitors include top CMOs, packagers,
distributors, CROs and suppliers!

Sign up today! • www.contractpharma.com/2010conference or www.regonline.com/cpa10

10 2010 CONTRACT PHARMA OUTSOURCING SURVEY www.contractpharma.com 2010 CONTRACT PHARMA OUTSOURCING SURVEY • Sponsored by Diteba Research Laboratories 11
2010 OUTSOURCING SURVEY 2010 OUTSOURCING SURVEY

12 2010 CONTRACT PHARMA OUTSOURCING SURVEY www.contractpharma.com 2010 CONTRACT PHARMA OUTSOURCING SURVEY • Sponsored by Diteba Research Laboratories 13
2010 OUTSOURCING SURVEY

THE GLOBAL SOURCE FOR PHARMACEUTICAL AND BIOPHARMACEUTICAL


CONTRACT SERVICES AND OUTSOURCING

ONLINE
WWW.CONTRACTPHARMA.COM
IN PRINT

WEEKLY E-NEWSLETTER
CPDIRECT

CONTRACT PHARMA is the premier global news source dedicated to


Pharmaceutical and Biopharmaceutical outsourcing.
With 10 yearly print issues, the CPDirect weekly e-newsletter, and contractpharma.com,
CONTRACT PHARMA covers all the bases with the latest breaking news and editorial features!
For advertising information, please contact
Gary Durr – gdurr@rodpub.com / 201-880-2229 or
14 2010 CONTRACT PHARMA OUTSOURCING SURVEY www.contractpharma.com Damaris Kope – dkope@rodpub.com / 201-880-2252
2010 OUTSOURCING SURVEY 2010 OUTSOURCING SURVEY

Outsourcing Decisions
How much did your outsourcing spending WHAT TYPES OF OUTSOURCING DECISIONS ARE YOU INVOLVED IN?*

change in the past year? Analytical & Testing Services..........................................46.5%


Formulation Development...............................................28.8%
Packaging: Clinical ..........................................................19.6%
Manufacturing: Biologics, Bulk ........................................19.3%

(by outsourcing decision) Stability Studies ..............................................................28.2%


Manufacturing: Fill/Finish .................................................27.8%
Regulatory Filing .............................................................18.7%
Manufacturing: Parenterals .............................................18.7%
Total Process Development / Scale-Up....................................27.8% Packaging: Commercial ..................................................18.4%
Methods Development / Validation ..................................27.8% Validation Services ..........................................................17.7%
Manufacturing: API ..........................................................27.5% Labeling ...........................................................................17.1%
CMC................................................................................26.6% Supply Chain Management ............................................16.1%
Manufacturing: Solid Dosage..........................................25.9% Preclinical / Toxicology ....................................................14.6%
Clinical Trials (Phase I-IV)...............................................25.9% Microbiology....................................................................13.6%
R&D Services .................................................................25.3% Sterility Testing................................................................12.3%
QA/QC ............................................................................25.3% Manufacturing: Oral Liquid Dosage ................................12.0%
Manufacturing: Clinical Trials Materials...........................24.7% Logistics...........................................................................11.4%
Chemistry ........................................................................21.2% Manufacturing: High Potency ...........................................11.4%
Manufacturing: Injectable Dosage ...................................21.2% Clinical Logistics ...............................................................9.2%
Manufacturing: Biologics, Finished Dosage....................20.3% Sales .................................................................................8.9%
Drug Delivery Systems ...................................................19.9% IT ....................................................................................5.4%

* Respondents can select multiple answers for this category

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Reduce, Reuse, Recycle


This year, we added “To reduce company size” to our list of responses to the question, “Why do you outsource?”
Only 7.2% of that question’s respondents chose that answer, so the sample set isn’t much to go on.
Still, here’s a little info about that group.
WHAT DO THEY DO? HOW MUCH DID THEIR OUTSOURCING SPENDING
Marketing/Sales ..............................................................29.4% CHANGE FROM THE PREVIOUS YEAR?
Project Manager..............................................................23.5%
R&D .................................................................................11.8% 10%+ less than previous year .........................................17.6%
Business Development ....................................................11.8% 6-10% less than previous year .........................................5.9%
Did not change ...............................................................29.4%
WHERE DO THEY WORK? 1-5% more than previous year .........................................11.8%
Top 20 Pharma................................................................41.2%
6-10% more than previous year........................................5.9%
Top 10 Biopharma ...........................................................17.6%
Small/Mid-Tier Pharma ....................................................11.8% 10%+ more than previous year.......................................29.4%
Specialty Pharma ............................................................11.8%
HOW MUCH DO THEY EXPECT THEIR OUTSOURCING
WHAT TYPES OF OUTSOURCING DO THEY MANAGE?* SPENDING TO CHANGE IN THE NEXT YEAR?
Analytical & Testing Services..........................................29.4%
Clinical Trials (Phase I-IV)...............................................29.4% 10%+ less than last year .................................................17.6%
Sales ...............................................................................29.4% 1-5% less than last year....................................................5.9%
CMC................................................................................23.5% 1-5% more than last year ................................................47.1%
Manufacturing: Biologics, Finished Dosage....................23.5% 10%+ more than last year...............................................29.4%
Packaging: Clinical..........................................................23.5%
Stability Studies ..............................................................23.5% * Respondents can select multiple answers for this category

24 2010 CONTRACT PHARMA OUTSOURCING SURVEY www.contractpharma.com 2010 CONTRACT PHARMA OUTSOURCING SURVEY • Sponsored by Diteba Research Laboratories 25
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I Would Prefer To
46.5% of respondents said that more than half of their outsourcing dollars go to preferred providers.

WHAT DO THEY DO? HOW MUCH DID THEIR OUTSOURCING SPENDING


R&D ................................................................................23.5% CHANGE FROM THE PREVIOUS YEAR?
QA/QC Validation............................................................15.1%
Project Manager...............................................................11.8% 10%+ less than previous year.........................................16.8%
Corporate Management ..................................................10.1% 6-10% less than previous year .........................................4.2%
1-5% less than previous year............................................5.9%
WHERE DO THEY WORK? Did not change ................................................................21.8%
Top 20 Pharma ...............................................................24.4%
1-5% more than previous year ........................................14.3%
Small/Mid-Tier Pharma....................................................17.6%
Virtual Pharma................................................................13.4% 6-10% more than previous year ......................................14.3%
Specialty Pharma .............................................................9.2% 10%+ more than previous year.......................................22.7%
HOW MUCH DO THEY EXPECT THEIR OUTSOURCING
WHAT TYPES OF OUTSOURCING DO THEY MANAGE?* SPENDING TO CHANGE IN THE NEXT YEAR?
Analytical & Testing Services..........................................59.7%
Stability Studies...............................................................37.0% 10%+ less than last year ..................................................8.4%
Methods Development / Validation .................................36.1% 6-10% less than last year .................................................5.9%
QA/QC ............................................................................33.6%
1-5% less than last year....................................................5.0%
Process Development / Scale-Up ...................................32.8%
Manufacturing: Fill/Finish.................................................31.9% Will not change................................................................31.9%
R&D Services..................................................................31.9% 1-5% more than last year.................................................17.6%
5-10% more than last year..............................................12.6%
* Respondents can select multiple answers for this category 10%+ more than last year...............................................18.5%

26 2010 CONTRACT PHARMA OUTSOURCING SURVEY www.contractpharma.com 2010 CONTRACT PHARMA OUTSOURCING SURVEY • Sponsored by Diteba Research Laboratories 27
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Why Not Outsource?


More than a third of our respondents said that they’d cancelled outsourcing projects in past year,
due to the economic climate. We asked them to describe the projects they delayed.

• Specific class of APIs • Late stage product • Delayed start of API and CTM manufac-
• Tech transfer to CMO • Delayed non-priority projects turing until toxicology or clinical results
• Analytical services • Clinical manufacturing and packaging became available. Canceled API/CTM
• Synthesis • Nutritional manufacturing if toxicology or trial
• Alternate clinical dosage forms • API Manufacturing results were not as expected.
• Analytical testing • Timelines shifted • Any project that went down in the list on
• Re-packaging and pre-clinical services • Validation support time to market or future values
• BE Studies • Clinical development programs • Tech transfers from one CMO to another
• Phase I API manufacturing • CMC to consolidate our outsourced base
• Early phase • Development • Discovery programs
• CMC devleopment • Clinical trials • Basic chemistry was normally out-
• Contract synthesis delayed • Small chemistry and pathology services sourced, but a low level of projects led to
• Phase III trial and CMO production • Preclinical and CMC doing the work in house
• Phase II clinical trials • Analytics, clinical trials • Preclinical
• Capital intensive • Tox studies • Bulk biologics manufacturing optimiza-
• Clinical and IND-enabling studies • Scale-up tion
• New product types or innovations • Lower priority candidates • Difficult synthetic projects
• Intermediate and API synthesis • Manufacture of CTM • Specialty formulation development
• Clinical trials • Clinical Trials • Phase I & II

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What sort of project would you be


comfortable with outsourcing to Asia?
Note: Some respondents who said they were likely to outsource projects to Asia declined to provide an example.
“API” or some variety thereof was the most common response.

• API • IT • Commercial manufacturing


• Eary stage raw material only - • Formulation development • Lower risk projects where the cost
Pre-Starting material • Manufacturing for market access in Asia savings are big enough to justify the risk
• Chemistry services (<1 kg) or advanced • Intermediates development • Low IP, commodity product
intermediate (>5 kg, non-cGMP) • Very competitive generic • Medicinal chemistry
• Clinical trials manufacturing requirements • Clinical trials & CMC
• Bulk drug intermediates and APIs • API raw material synthesis • Small Molecules
• API • stability • Criteria has not been defined as yet
• Solid dosage chemical • Formulations from India • Follow-on biologic
• Pilot clinical study and possibly • Pharmacovigilance • Toxicology
API sourcing • Established product • Fill/Finish
• Bioanalytical method transfer & • API and API intermediates to Asia – • Project without proprietary know-how
validation as a feasibility exercise no drug product! • Exploratory work
• All projects • Second line • Low IP risks
• Manufacturing • Formulation and analytical development • Non-GxP, discovery support
• Molding parts • Biologic manufacture • Development projects a few steps away
• Preclinical PK studies • Phase I from the API
• Non-GLP • Analytical chemistry • Only as a test
• CMO and release testing • Ones where cost is a driver • Clinical trial management and discovery
• Currently we are already outsourcing • Basic stability and formulation work work
API and manufacturing • CNS • Clinical supply or testing for local market
• Custom raw materials and intermediates • Simple, early stage only • Less quality critical projects

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0.00% 0.25% 0.50% 0.75% 1.00%

0.00% 0.25% 0.50% 0.75% 1.00%


0 25 50 75 100
32 2010 CONTRACT PHARMA OUTSOURCING SURVEY www.contractpharma.com 2010 CONTRACT PHARMA OUTSOURCING SURVEY • Sponsored by Diteba Research Laboratories 33
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Cancellation Policy
35% of respondents said that they 65% of respondents said that they
HAVE cancelled an outsourcing project HAVE NOT cancelled an outsourcing project
in the past year due to the economy in the past year due to the economy
WHAT DO THEY DO? WHAT DO THEY DO?
R&D .................................................................................27.8% R&D ................................................................................19.0%
Corporate Management..................................................20.3% QA/QC/validation ............................................................16.3%
Purchasing/Sourcing ........................................................11.4% Project Manager..............................................................12.9%
QA/QC Validation ..............................................................7.6% Corporate Management ..................................................12.2%

WHERE DO THEY WORK? WHERE DO THEY WORK?


Small/Mid-Tier Pharma ...................................................22.8% Top 20 Pharma ...............................................................23.1%
Top 20 Pharma ...............................................................19.0% Small/Mid-Tier Pharma ...................................................16.3%
Specialty Pharma ............................................................11.4% Virtual Pharma................................................................12.9%
Generic Pharma..............................................................10.1% Generic Pharma..............................................................10.2%

WHAT TYPES OF OUTSOURCING DO THEY MANAGE?* WHAT TYPES OF OUTSOURCING DO THEY MANAGE?*
Analytical & Testing Services..........................................54.4% Analytical & Testing Services ..........................................51.0%
CMC................................................................................39.2% Manufacturing: Fill/Finish ................................................32.0%
Process Development / Scale-Up ...................................38.0% Methods Development / Validation .................................32.0%
R&D Services .................................................................36.7% Manufacturing: API..........................................................30.6%
Methods Development / Validation .................................35.4% Stability Studies ..............................................................30.6%
Stability Studies ..............................................................35.4% Formulation Development...............................................29.9%
Packaging: Clinical..........................................................34.2% Process Development / Scale-Up....................................27.9%

* Respondents can select multiple answers for this category)

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More on Cancellations
About those 35% who said they have cancelled outsourcing projects in the past year:

HOW MUCH DID THEIR OUTSOURCING SPENDING HOW MUCH DO THEY EXPECT THEIR OUTSOURCING
CHANGE FROM THE PREVIOUS YEAR? SPENDING TO CHANGE IN THE NEXT YEAR?

10%+ less than previous year .........................................31.6% 10%+ less than last year.................................................15.2%
6-10% less than previous year .........................................8.9% 6-10% less than last year .................................................6.3%
1-5% less than previous year............................................6.3% 1-5% less than last year....................................................3.8%
Did not change................................................................13.9% Will not change ...............................................................20.3%
1-5% more than previous year ..........................................8.9% 1-5% more than last year................................................20.3%
6-10% more than previous year........................................8.9% 6-10% more than last year..............................................10.1%
10%+ more than previous year .......................................21.5% 10%+ more than last year...............................................24.1%

48.1% of them said that they outsource to focus on core competencies.

Only 8.9% said that they outsource to reduce company size.

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0 1 2 3 4 5 0 1 2 3 4 5

0 1 2 3 4 5 0 1 2 3 4 5

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0 1 2 3 4 5 0 1 2 3 4 5 0 1 2 3 4 5 0 1 2 3 4 5

0 1 2 3 4 5 0 1 2 3 4 5 0 1 2 3 4 5 0 1 2 3 4 5

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What is your biggest complaint about


Contract Service Providers you’ve worked with in the past?
Here’s an edited selection of what our respondents had to say.
“Timeliness / On-Time delivery” was the #1 complaint, with “Quality issues” running a close second.

• Misrepresentation of capabilities • Poor contingency planning


• Asian CSPs not adhering to timelines • Lack of open-book pricing
• Timeline commitments and GMP complaince on shop floor, • Time to release results
both with manufacturing and QA/QC • Increasing costs of services
• Audit scheduling • Start-up is always great but close-down is always
• Don't stick to timelines agreed upon up front a tough time
• Unreliable supply • Poor communication
• Late with reports • Internal vs. external focus
• Missed protocol activities • Contamination issues
• Keeping projects on schedule • Ability to turn work over quickly
• Reliability • Unresponsive or minimal response to suggestions
• Failure to deliver in a timely manner • Lack of experience in a key area that was originally stated
• Timeliness to be a competency The Science Of Research
• Staff turnover • Changes in project scope
• Prompt communication of problems • Not service oriented At DiTEBA, we are committed to your success by providing
• Over-promising • Expectations not consistent with actual results
• For some CSPs, GMP concepts and practices not "current" • Not being able to talk to the person doing the work analytical and bioanalytical chemistry services that accelerate
with industry and regulatory trends • Insufficent technical resources
• Faster communication and feedback. • Lack of ownership of the project R&D intensive projects.
• Lack of stability of employees at a CRO • Their inability to view the alliance as a partnership
• Cost • Communication gaps As a pharmaceutical contract research organization, we strive
• The cost and time at time of bid is markedly different from • Increasing study budgets; CRO was not willing to take
the final outcome responsibility for its own feasibilities. to be an innovative and cost-effective partner that delivers
• Lack of responsiveness • Delay of the API delivery
consistent, quality services with unmatched integrity.
• Ease of doing business • Billed for work not in the protocol
• Attrition and retraining • Incremental charges
• Poor quality • Schedules Through the science of research, let DiTEBA expedite
• Do not take ownership of projects • Quality
• Product quality • On-time delivery the process of bringing your product to market.
• Communication issues • Inability to understand customer needs fully
• Lack of effective communication about a project’s progress • We don’t have too many complaints, but with those providers
• Poor project management that we decided not to use again, there was
• On-time delivery an inability to meet timelines, a lack of understanding
• Not reliable of what it takes to get a NCE into Phase III, and weak
• Needs too much hand-holding and management analytical know-how
• Quality and yield • Failure to be transparent about issues
• Overcommitment • Inability to translate provided study designs into appropriate
• The committment time and cost proposals
• Cost increases • Under-resourced
• Big gaps between claims and actual capabilities • Lack of awareness of cGMP
during initial discussions • Lack of established and reproducibile business systems
• Conformance to tech transfer schedules and late deliveries • Contract / agreement negotiations too long Research
Turning Research Into Reality


Over budget and longer than promised timelines
Priorities driven by the almighty $ rather than relationship


Lack of communication
Incomplete quotes Reality
• Poor quality and CGMP adherence • Rarely take an owner's perspective
• Mis-communication. • Making changes without providing notification 1620 Tech Avenue, Unit 3
• Data transfer • Too hard to set up and work with each one individually
 Analytical Testing  Formulation Development Mississauga, ON Canada
• Not meeting timelines • Inability to say NO
• Flexibility • Slow response to inquiries (poor communication).  Bioanalytical Testing Support Testing L4W 5P4
• Lack of commitment to the sponsor's needs • Maintaining attention to small customer. 
 Stability Storage and Testing In Vitro Release Rate Testing Toll Free: 1•800•671•9053
• Not dedicating seasoned personnel to our project • Higher cost / lower quality than the hype for outsourcing in
• Lack of information sharing. India/China  Physical Testing Phone: 905•625•7995
 Cleaning Verification and
• Understanding flexibility needed for clinical work Fax: 905•625•3767
Validation Testing www.diteba.com
42 2010 CONTRACT PHARMA OUTSOURCING SURVEY www.contractpharma.com
info@diteba.com

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