Presentation Biotech
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Transcript of Presentation Biotech
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SOME LIMITS OF BIOTECH
BIOTECH was a new company that didnt have the possibility and theexperience to face the whole process by itself.
In fact, its most signicant revenues came from:
royalties the company received from the developement of a new drug
other royalties it received when the drug was licensed to a largepharmaceutical rm which did later trials and commercialization process.
BIOTECH had the experience ONLY in developing the therapeutic (earlystage and pre-clinical development) but not in all the other phases like legaland regulatory approval, testing and commercialization.
So they decided to nd a partner to complete all the other phases andaspects of the project in which they had a very little experience.
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NEW DRUG DEVELOPMENT PROCESS
PRE-CLINICALRESEARCH
CLINICAL
TRIALS
LEGAL
APPROVAL
COMMERCIAL
IZATION
Phase I
Phase II
Phase III
Synthesis andpurication
Animal testing
SHORT TERMHuman testing
LONG TERM
Therapeutic Developed Ask an approval Decision Sponsor & review
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PARTNERSHIP
BIOTECH found 4 possible partners for BIOTECH-123 project.
During their research for the perfect partner, they faced some problems:
conicts of ideas
different points of view to how conducting the trials
lack of communication
limited knowledge of the partners about the projects process
trials plans based on assumptions
legal and regulatory problems
At the end they chose Stallion as the perfect partner.
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STALLION
For signing the partnership, Stallion imposed some requirements toBIOTECH which had to be respected.
In particular, BIOTECH had to respect two conditions:
1) Stallion had to be involved in the whole projects process and the partieshad to constantly communicate and share knowledge that was provided.
2) BIOTECH had to conduct and nish (on a lead role) some Phase I trialscalled B123-3, which were a repeat-dose study of B-123 on patients witha mild form of the disease.
B123-3 were some clinical trials that BIOTECH was conducting at themoment they decided to externalize the project, searching for a partner.
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KNOWLEDGE SHARING ANDPROJECT MANAGEMENT
BIOTECH adopted a KM system called TARGET to share knowledge intothe company and with Stallion.
But they encountered some technological problems:
putting into the same database information from different clinical researchorganizations involved in the process
problem with incompatibility of databases
different data format
In particular, they had problems of communication during the weeklyarranged meetings organized with the partner for sharing knowledge andinformations about the progress of the project.
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KNOWLEDGE SHARING ANDPROJECT MANAGEMENT
After a while, BIOTECHs manager realized that those meetings werent assuccessful as they thought.
The reasons of this inefciency were:
people were not really contributing
too many issues emerged from discussions that were not particularlyrelevant for the projects process
not focusing on the real problems
lack of interest and attention
The business development manager of BIOTECH realized that problemsduring the meetings were caused by internal structure problems of thecompany itself.
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BIOTECHS PROJECT MODEL
DPT
SCT FDA
PTN
S
D
F
P
Index:
Satellite Clinical Team
Development Project Team
US Regulatory Agency - PSC
Partner
Weekly Meetings
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BIOTECHS PROJECT MODEL
Problems of this model:
managers (DPT) had too much responsabilities in the process
inefcient delegation of tasks
boring and not useful meetings
Biotech decided to call an external consultant who introduced amore coordinated project structure which replaced the weekly meetings andimproved the knowledge share.
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NEW PROJECT MATRIXSTRUCTURE
DPT
ST
ST
ST
ST
R
R
RR
R
R
R
R
FDA
PTN
Index:
S
D
F
P
R
Satellite Teams
Development Project Team
Partner
US Regolatory Agency - PSC
Reports
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NEW PROJECT MATRIXSTRUCTURE
The consultant saw that inside the process there already were somecommunities of practice and he tried to organize them in some projectteams, in order to make the structure more efcient.
DPT has a central position and comprises representatives of all thesatellite teams
DPT receives reccomendations to be adressed from operational projectsatellite teams to clinical, pre-clinical, manufacturing and business dev.
All the actors of the process communicate with reports
DPT keeps the partner constantly informed
At the end, DPT reports to FDA and PSC to have the nal approval
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NEW PROJECT MATRIXSTRUCTURE
Before satellite teams, knowledge was shared only during weekly meetings.
Reports help teams and management getting a better understanding on thewhole BIOTECH-123s development process.
Some rules of project management were introduced to save time and makeprocess more efcient:
satellite teams had to capture and share key learnings so that otherscould benet
produce a template to highlight both positives and issues emerged duringthe process, together with recommendations
utilize reports to re-use knowledge and past experiences
learn from past mistakes
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CONCLUSIONS At the time the study ended, BIOTECH had still problems with trials B123-3and they hadnt been able to fulll their goal.
Stallion had decided they needed time to consider their position sopartnership had been temporarily suspended.
KEY LEARNING POINTS
When managing knowledge into a rm, people have to consider thatorganization need to respond to dynamic, global and highly competitiveenvironments
It is important that rms identify for what purpose they aim to manageknowledge in order to establish what major knowledge processes need tobe embedded across the rm
Different institutional and sectoral contexts can inuence the managementof knowledge work
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REFERENCES
CASE STUDY 10.1 from Managing Knowledge Work and Innovation, a bookwritten by Newell, Robertson, Scarbrough and Swan.Second EditionPalgrave MacMillan