Le mindmapping au service des biotech

L’organisation et surtout l’organisation des idées est vitale, notamment pour les entreprises innovantes que sont les biotech.

Comprendre les associations, les interactions entre les concepts va bien au-delà des classiques « présentations », « plans », « listes » habituels.

Surtout dans des organisations innovantes, bouillonnantes et collectives comme les biotech, qui unissent chercheurs, manageurs, financiers, opérationnels.

Formalisée en 1971 par le psychologue Tony Buzan, ce mindmapping ou  « carte heuristique » (en français) permet :

-la prise de note

-des brain-storming efficaces

-la structuration d’un projet, la clarification des idées

-une visualisation ludique pour les tiers

Il s’agit en définitive d’un schéma, où le problème est inscrit au centre, et d’où rayonnent des branches et sous-branches.

Plus qu’un long discours, ou qu’un texte de 2 ou 3 pages, il offre bien un accès immédiat aux grandes problématiques des essais cliniques (réglementaire, éthique, organisationnel,..) !

Testez-vous, essayez la méthode :

-un simple paperboard ou une feuille A4 seront suffisants au début

-de nombreux logiciels gratuits (ex www.wisemapping.com)

-des consultants existent, capables d’assister votre entreprise à mettre ainsi en forme les fruits d’une réunion ou d’une présentation : Succès garanti !

Voir aussi sur Twitter

Looking for Biotech CFOs desperately

An explosion in the number of publicly listed biotech companies—in combination with these companies’ strong preference to hire almost exclusively from within the life sciences industry—has put intense pressure on the biotech CFO market. In short, the demand for CFOs with biotech companies’ ideal profile—high performers with a history of proven results and of sitting public CFO, IPO and biotech industry experience—simply outstrips supply. 

Read the entire Russel Reynolds analysis here.

Pass our “Clinical trials & insurance”test

Assess your practical understanding of clinical trials insurance 

Are you comfortable with?

If not, call your broker!

Results

Congratulation!   Either you already have a thorough experience of “clinical trials”, or you are ready to enter phase II ..

Hmm ..

 

Many important details (languages, wording, ..) are necessary to pass the regulatory barriers, with variations according to the countries.

 

We suggest you look for professional help. You will save time to focus on your candidates and your research process.

#1 Clinical trial insurance is a liability insurance

Insurance of clinical trials is typically a liability insurance that is to say it protects against claims (= with financial demands), from patients, former patients, practitioners, authorities, etc.

#2 Clinical trial insurance is compulsory

In some countries (United States, Brazil, China for example), insurance is not compulsory;

 

Other countries, such as the United Kingdom, New Zealand and Finland, require subscribing to a local policy but without mentioning limits;

 

Others, like France or Germany, require insurance for all tests, the limits being specified in the policy.

 

Even if not compulsory, insurance can be unavoidable if required by the local Ethics Committees.

#3 Limits of insurance can be freely chosen by the sponsor

#4 There are limits of insurance per patient & per protocol

Limits are set:

 

-by patient (ex 600 000 euros)

 

-by protocol (= per test) (ex 2 000 000 euros)

 

– possibly “per aggregate” (eg 3 000 000 euros) reflecting the maximum amount that the company agrees to have to pay (for example over a whole year)

#5 Some insurers refuse new molecules

New molecules, very innovative or invasive medical devices, very original research methods …:

 

The insurer has an aversion to unexpected cases, which prevents it from referring to actuarial tables to rate the risk (or simply accept / reject it)

#6 Certificate has to be set in the language of the country

Or more precisely in ALL the languages of the country (ex French / Dutch in Belgium).

 

May times the certificate is issued 1 in English 2 in the local language.

#7 Certificate must list the addresses of the centers

Some countries / some committees are satisfied with the mere mention of the number of centers, others demand the list of centers, others the addresses: Legal needs unfortunately vary a lot from country to country.

#8 In France, the Huriet law grants 10 years to introduce a claim

Victims can submit their claim for 10 years from the end of the search.

#9 In the USA, clinical trial insurance & liability insurance are equivalent

In the US, biotech companies fill a demand for classic Liability (a bit the equivalent of the Medical Liability Insurance they already benefit from).

#10 Protocol & Patient Information Letter are the sole documents needed by the insurer to quote

These 2 documents are the main pieces:

 

-The Protocol allows the insurer to examine the boldness of the research project and the quality of the methodology

 

-The Patient Information Letter (anyway mandatory) makes clear that the patient is correctly (and in simple words) warned. This is for the benefit of both the sponsor and the insurer.

 

– the insurer will also analyze the possible discrepancies between the 2 documents

 

 

 

In addition, the insurer obviously needs quantitative (number of patients screened) and qualitative data (countries chosen, number of centers, duration of study, quality of the CRO).

 

finish

An Overview Of Top Clinical CROs

In ClinicalLeader, an interesting review (even if dated 2015) of top CROs.

 

Three facts are being highlighted:

 

-the number of M/A, building global leaders

-the urgent need for small CROs to specialize

-the strategic alliances signed between CROs and data analysis service companies

 

A more recent study (2017 but in fact updating a 2015 research) can be found at Outsourcing-Pharma, study limited to the US market.