presentation biotech

8/4/2019 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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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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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

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