BIOTECH - The development of a

new therapeutic for an acute inammatory disease

Students: Alberto Dal Santo & Emilia Klappe

BIOTECHS BACKGROUND
BIOTECH is a pharmaceutical which maily develops therapeutics. In 2006 they focused their attention on developing a new project named BIOTECH - 123. This project concerns the development of a new drug aimed to treat an acute respiratory disease that affects signicant proportions of US western population and which continues to increase in prevalence. Project BIOTECH-123 was a real big challenge for them because: the disease was new there were no other therapeutic in the market ready to tackle real interest on nance research for this therapeutic So this new drug had the potential to become a best-seller.

SOME LIMITS OF BIOTECH

BIOTECH was a new company that didnt have the possibility and the experience 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 large pharmaceutical rm which did later trials and commercialization process. BIOTECH had the experience ONLY in developing the therapeutic (early stage and pre-clinical development) but not in all the other phases like legal and regulatory approval, testing and commercialization. So they decided to nd a partner to complete all the other phases and aspects of the project in which they had a very little experience.

NEW DRUG DEVELOPMENT PROCESS

PRE-CLINICAL RESEARCH

CLINICAL TRIALS

LEGAL APPROVAL

COMMERCIAL IZATION

Synthesis and purication

Phase I

Phase II

Phase III
Animal testing

SHORT TERM
Human testing

LONG TERM

Therapeutic Developed

Ask an approval

Decision

Sponsor & review

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.

STALLION
For signing the partnership, Stallion imposed some requirements to BIOTECH 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 parties had to constantly communicate and share knowledge that was provided. 2) BIOTECH had to conduct and nish (on a lead role) some Phase I trials called B123-3, which were a repeat-dose study of B-123 on patients with a mild form of the disease. B123-3 were some clinical trials that BIOTECH was conducting at the moment they decided to externalize the project, searching for a partner.

KNOWLEDGE SHARING AND PROJECT MANAGEMENT

BIOTECH adopted a KM system called TARGET to share knowledge into the company and with Stallion. But they encountered some technological problems: putting into the same database information from different clinical research organizations involved in the process problem with incompatibility of databases different data format In particular, they had problems of communication during the weekly arranged meetings organized with the partner for sharing knowledge and informations about the progress of the project.

KNOWLEDGE SHARING AND PROJECT MANAGEMENT

After a while, BIOTECHs manager realized that those meetings werent as successful as they thought. The reasons of this inefciency were: people were not really contributing too many issues emerged from discussions that were not particularly relevant for the projects process not focusing on the real problems lack of interest and attention The business development manager of BIOTECH realized that problems during the meetings were caused by internal structure problems of the company itself.

BIOTECHS PROJECT MODEL

SCT FDA

DPT

Index:
S

Satellite Clinical Team Development Project Team US Regulatory Agency - PSC Partner Weekly Meetings

PTN

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 a more coordinated project structure which replaced the weekly meetings and improved the knowledge share.

Index:
S

NEW PROJECT MATRIX STRUCTURE

ST
R

Satellite Teams Development Project Team US Regolatory Agency - PSC Partner Reports R R

ST FDA
R

DPT
R

PTN ST

ST
R

NEW PROJECT MATRIX STRUCTURE

The consultant saw that inside the process there already were some communities of practice and he tried to organize them in some project teams, in order to make the structure more efcient. DPT has a central position and comprises representatives of all the satellite teams DPT receives reccomendations to be adressed from operational project satellite 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

NEW PROJECT MATRIX STRUCTURE

Before satellite teams, knowledge was shared only during weekly meetings. Reports help teams and management getting a better understanding on the whole BIOTECH-123s development process. Some rules of project management were introduced to save time and make process more efcient: satellite teams had to capture and share key learnings so that others could benet produce a template to highlight both positives and issues emerged during the process, together with recommendations utilize reports to re-use knowledge and past experiences learn from past mistakes

CONCLUSIONS
At the time the study ended, BIOTECH had still problems with trials B123-3 and they hadnt been able to fulll their goal. Stallion had decided they needed time to consider their position so partnership had been temporarily suspended.

KEY LEARNING POINTS

When managing knowledge into a rm, people have to consider that organization need to respond to dynamic, global and highly competitive environments It is important that rms identify for what purpose they aim to manage knowledge in order to establish what major knowledge processes need to be embedded across the rm Different institutional and sectoral contexts can inuence the management of knowledge work

REFERENCES
CASE STUDY 10.1 from Managing Knowledge Work and Innovation, a book written by Newell, Robertson, Scarbrough and Swan. Second Edition Palgrave MacMillan