FDA posted a new Warning Letter on its website to ICON Clinical Research, the CRO responsible for many of the activities that led to the Johnson & Johnson sponsor Warning Letter last August (see previous posts). The heavily redacted document lists J & J only as “(B) (4)” but it is easy to compare the two and see that they are related. This is the first time in Years, someone correct me if I’m wrong, that FDA has gone after a CRO for their contracted responsibilities with a sponsor of clinical trials. It was ICON that performed the monitoring responsibilities that led to both Warning Letters.

Up until now it looked like FDA would only go after the sponsor when things went wrong at a clinical site. In the Sanofi Aventis Warning Letter of October 2007 the CRO was mentioned but no Warning Letter followed. In the J & J Warning Letter the CRO was redacted out and it has taken four months for FDA to write the CRO a Warning Letter. However, now that it is out, it is quite a doozy. Read for yourself:

According to information from the The Contract Research Organization Union China (CROU) under the China National Pharmaceutical Technology Market Association, it is developing the first industry standard for the Chinese CRO sector, Guidelines for Clinical Trial Services of Contract Research Organizations. Currently drafting of the document is already completed and it is likely to be introduced before the end of this year.

The Guideline was formulated with references to relevant WHO documents, ICH-GCP, the Drug Administration Law of China, Provisions for Approval of Drugs, and Guidelines for Quality Control of Clinical Trials (Chinese GCP), according to Gong Yanhua, Secretary General of CROU.

Members of the technical work group are mostly experts from leading clinical CRO such as Quintiles and Pharmanet, while those of the academic advisory group are mostly representatives of MNC and leading local pharma companies. As its next step, CROU hopes to establish a technical committee for standardization of clinical trial services of Chinese CROs soon

in preclinical research service, Chinese CROs possess better service capabilities than Indian CROs; whereas in clinical research service, it is just opposite. In process R&D and scale-up synthesis, both countries possess similar capabilities. However, Indian companies possess better skills and capabilities than Chinese companies in formulation, manufacturing and marketing of generic drugs

The pharma outsourcing industries in both countries have grown rapidly in the recent few years. They are currently valued at about $1.42 B in China and $1.77 B in India, respectively; each occupying only about 2% share in the global pharma outsourcing market. On the other hand, both markets are posed to still grow rapidly in the future as they are driven by a number of positive factors. However, China appears to have higher future growth potential than India as it has fewer growth resistors. It will very likely catch and even surpass India after 2010.

At present, India is better than China in small molecule drug R&D and manufacturing. But China is superior over India in biotechnologies including the R&D and manufacturing of macro compounds. India offers better product quality but China has more cost reduction advantage. In terms of investment opportunities, China seems to present more attractions than India as its industry infrastructure and biotechnologies are more advanced.

MNC pharma companies to control 8% of $20bn worth Indian medicines market by 2015. According to a FICCI study more than 60% of trials in India is conducted by Global Big Pharma companies.  Indian Clinical Research arena is often compared to the Indian outsourcing success and hte wave of BPO industry success in India.

Multi national companies that launched their own captive BPO centres India have now sold them to Indian vendors,  that trend has grown, the likes of , GE, Citi Bank, all have sold their captive centres to Indian vendors

In curent wave or Indian CRO success in clinical research is compared to such trends. There may be a possiblity that the likes of Novartis, Pfizer, Lilly, Sanofi, GSK can sell their captive centres that focus on clinical research to Indian CRO’s.

But for the time being such ambitions by Indian CRO will remain as pipe dream untill they will move  away from “I can do it cheaper and faster than in west”- sales pitch. And gains credibility and resources to offer value added service to Global Pharma

For example Indian CRO can offer backend integration with Indian Medicinal chemistry experts and companies to provide drug re-licencing /re-positioning services. They need to think about offering these value add services. Following are some of the areas Indian CRO’s can look

1. what happens to failed Clinical Trial and how can Indian CRO help Global Pharma to Drug repositioning/Re-profiling of drugs

2. How can Indian CRO provide Pharmacogenomics  services with clinical trial

3. How can Indian CRO help in personalized medicine initiatives

4. Even though it serves the vested interests of Global Pharma how can Indian CRO help in Extending patents of existing drugs with ANDA and NDDS

5. Pharmacovigilance and Post -Market Surveillance for Risk Assesement and Risk Mitigation

6. Data Warehousing and Data Mining by integrating clinical and non clinical data from multiple studies

7. Drug Life cycle management services

8. Generating Key opinion leaders and KOL platform by using data from multiple trials and resources

9. Premarketing Clinical Drug Safety and Risk Assessment

10. Designing Pharmacoepidemiology and Pharmacoecconomics stratgey and Aiding Evidence based pharmacotherapy

I enjoyed this article about the ascent of the Chief Risk Officer, The chief risk officers are coming, published in July 2009 by Lloyds. Specifically, the differences between the risk manager and the CRO are interesting as described by Peter den Dekker, president of FERMA, the association of European risk managers.

• The CRO is member of the board and part of the corporate decision-making body. He or she will be taking part in decisions about mergers and acquisitions, contracts, investments.
• The risk manager is a facilitator … his or her job is to embed the company’s risk management policy and programme in its business processes, so that the company has the right culture…
• Risk managers provide information that informs board decisions, but they do not make the decisions.

Click on the link above to read the complete article.

New technologies and services that lack a coherent marketing strategy can languish for years before they produce a decent revenue stream.   Take microdosing services for pharmaceutical development.   When this concept was launched commercially nearly 10 years ago it was positioned as a way to obtain an early insight into how new pharmaceutical compounds were processed in the human body (known as pharmacokinetics).  Testing could be done with a few volunteers using sub-therapeutic levels of drug (commonly 1/100^th of a therapeutic dose), in a sort of “pre-clinical-trial clinical trial”, supposedly cutting the time to obtain data that would reveal whether or not the new compound would be worth pursuing further.

Because it was ground breaking and required a process change in pharmaceutical drug development, the uptake was slow.  Many in the industry remain unconvinced that you can administer a microdose and confidently extrapolate that data to a normal therapeutic dose level, a consistent argument against adoption of this technology.   Still the proponents of the approach (Xceleron Ltd being the pioneers) carried on, trying to change minds within the regulatory authorities and the skeptical marketplace with some success.

More recently new applications of the microdosing approach have started to gain traction – namely in helping to understand why some compounds fail to achieve adequate levels in the blood stream or produce variable pharmacokinetic data.  These new methods get around the extrapolation argument and solve very real questions which animal studies and in vitro methods are unable to address.  It’s a shame that it took so long.

It seems to be a normal state of affairs that a biotechnology company develops an innovative approach to “streamline” the drug discovery/development process but it fails to effectively position the new product in the marketplace.  As a result it takes years for it to take off – the time it takes for the right people to understand the technology and make the mental leap to apply it to their particular issue.

How do you avoid wasting 10 years trying to convince pharma to adopt your new approach?

Start with a marketing strategy that:

• Defines who will adopt the technology
• Sets out the market positioning and points of differentiation – and tests them out on your chosen target customers
• Clearly states the product and service attributes that address under-served needs in the market
• Assesses the competition and external influences, threats and opportunities
• Identifies the most appropriate marketing channels
• Evaluates pricing options
• Includes effective communications and branding

Corporate Social Responsible News: Dow Corning’s Green Innovation Portfolio; CRO’s Summit Conference; Sulusso’s Sustainable Jewelry

Ask yourself how many client visits you or your business development team have taken where you’ve come away with a “bloody nose” or met a commercial “dead-end”.  Count up the cost of the flights, hotel rooms, wasted time and the delay in growing your business before you honed your message and got it right.  It took a few road-trips before you got that killer presentation, didn’t it.  Or are you still trying?

Before you go any further, why not consider hosting an Opinion Leader Forum?  Used widely in big pharma for gaining critical insight into prescribing practices and unmet medical need, it can be adapted for enabling technology companies and CROs to help them with their commercial strategy.

The practicalities of hosting a forum are simple:

1. Select a location and timing to coincide with a major relevant industry conference.
2. Invite a selection of large pharma/small biotech, existing clients and people you would like to do business with in the future, using the conference speaker lists or pre-attendee list if available.
3. Book a meeting room from 3-6pm at a respectable hotel and a private restaurant room suitable for around 12 people (8-10 guests + 2 company participants) from around 6:30pm onwards.
4. Offer a small honorarium or donation to a charity as an incentive.
5. If possible use a third party host to send out the invitations so that it doesn’t look like a selling opportunity (which it isn’t by the way).

Structure the forum around some key questions relating to your market, your proposition and ask open questions to gain advice and comment about potential new applications or services.   By all means have a couple of slides at the start to introduce your company and why you’re there, but DON’T be tempted to give a 20 minute presentation on your company and services as you currently define them.  This isn’t a sales pitch, it’s a LISTENING opportunity, where you get to understand what your customers actually want and need.  Make sure that there are at least a couple of people from your company there to take notes (but DON’T crowd out the room with all your people).  To make it more powerful, use a third party consultant who knows the industry to chair the forum.

You should get a better idea of the market need, ideas for new product development, a selection of the most appropriate key messages and positioning for your product/services and a strong steer for your commercial strategy.  And remember that people always like to be asked for their advice.  For your potential customers this might mean that they remember you the next time you knock on their door.  You’ll certainly stand out from the crowd because you actually listened and invited their opinion.  Not many of them to the pound as they say around here.

This week Zenith Press Released “Hope: A Collection of Obama Posters and Prints” Edited by Hal Wert with a foreword by Ray Noland. I haven’t actually seen it yet, but I have at least 2 pieces in the collection that I did during the 2008 Campaign. Included in the book are over 170 posters by more than 100 artists. There is some really great Ray Noland stuff along with David Choe, Bask, Billi Kid and tons more. If you’re interested in poster art it’s a must have.
You can get it @ Amazon Here

Or better yet, get up, leave the house and go buy it from your local independent bookseller before they go out of business.

Gli “afecionados“ della family conoscono bene le vicissitudini di Matteo riguardo le otiti, i timpanogrammi e gli incontri con l’otorino…

Negli ultimi due inverni Matteo ha sofferto di otiti anche se non in forma grave e per curarlo ci siamo rivolti oltre che al suo pediatra anche ad un otorino specializzato, che tra l’altro dirige il Centro (di) Rieducazione Ortofonica (CRO) di Firenze.

Secondo le sue indicazioni Matteo presentava una situazione del tutto normale, nel senso che le otiti sono un disturbo a cui vanno incontro moltissimi bambini e che dipende sostanzialmente dallo sviluppo dei canali uditivi e dal ”ristagno“ del catarro. Col crescere i canali si inclinano maggiormente favorendo il deflusso degli umori e le otiti con il tempo vanno via via scomparendo.

Ci sono bambini che fanno anche un’otite al mese e altri come Matteo solo 2/3 ma comunque la sostanzia non cambia; le otiti sono dolorose e molto debilitanti e possono avere conseguenze anche gravi se non adeguatamente trattate e seguite.

Per quanto riguarda Matteo il suo problema più grave è che da novembre dell’anno scorso e fino praticamente agli inizi di settembre ha avuto un timpanogramma piatto ad entrambe le orecchie. La sua capacità uditiva era calata ma non vistosamente e gli esami specifici fatti al CRO avevano evidenziato che pur sentendoci Matteo aveva bisogno che il timpano si “sbloccasse” pena il dover ricorrere al chirurgo per rimuovere le adenoidi.

Dovete sapere che oggi come oggi sono l’1/2% dei bambini viene sottoposto all’operazione di asportazione delle adenoidi, proprio perchè ormai esistono specifici trattamenti che danno nel tempo risultati abbastanza buoni tali da evitare il ricorso alla sala operatoria.

Quando siamo tornati dal mare avevamo il terrore di andare dall’otorino perchè temevamo che la situazione non fosse cambiata nè col caldo, nè con lo iodio, nè coi bagni nè con l’otovent. Invece fortunatamente la situazione è migliorata anche se non di molto. Il timpano sinistro è tornato quasi normale, mentre il destro si presenta ancora opaco e un pò sofferente ma comunque meglio che a luglio.

Ora tocca a noi non farlo raffreddare (ma come si fa visto questo tempo?!? Oggi ci sono 18 gradi, piove e sembra novembre!?!?) e continuare imperterriti con la ginnastica tubarica… se saremmo fortunati e bravi forse eviteremo definitavemente a Matteo un fastidioso intervento!

Consiglio quindi a tutti i genitori che hanno figli che soffrono di otiti di portarli il più possibile al mare, di farli giocare nell’acqua e di immergerli. perchè è proprio l’acqua salata nel naso che favorisce lo “stappamento“! E non dimenticate l’otovent….

Minha idéia inicial era de fazer esse blogue com o intuito de dar dicas ao público  leigo sobre os avanços e cuidados preventivos que devemos ter em Saúde Oral .

Mas sei que muitos colegas profissionais e estudantes da área de odontologia (medicina dentária) de todo mundo (blogosfera) tem acessado esse humilde blogue,  então esse artigo é direcionado ao “pessoal da odontologia” e nosso pacientes parceiros que poderão ajudar na fiscalização e na valorização do profissional odontólogo, pois o Cirurgião-Dentista é o segundo profissional mais confiável na opinião dos brasileiros, de acordo com pesquisa divulgada pela revista Seleções em setembro 2007.

Nesse post vou falar um pouco sobre o Código de Ética Odontológico (CEO) que deveríamos seguir para honrar o nosso grau de Cirurgião Dentista que nos foi outorgado. Não vou entrar no mérito se se concordo ou não com determinados artigos e nem no âmbito da fiscalização.

O CEO é muito complexo, apresentando muitos artigos detalhados, alguns óbvios, outros podem gerar ambiguidade jurídica, porém o enfoque que eu vou dar é no observância do CEU em relação a propaganda do seu consultório em veículos de massa como a internet.

0. Tenha em mente que fazer propaganda, divulgar seu serviço, vender seu peixe de forma correta NÃO é nem um pouco ANTI-ÉTICO.

1. Em sites, postagens, artigos e classificados online não esqueça de colocar o nome, cirurgião-dentista e número do CRO do responsável técnico. Coloque a expressão “CLÍNICO GERAL”  caso não seja especialista. Até na plaquinha de seu consultório ou se aparecer na televisão não esqueça de colocar o número de inscrição no Conselho.

2. Não critique seu colega ou  uma empresa no ramo da Odontologia. Cabe ao colega encaminhar sua reclamação em relação à colegas e empresas odontológicas – clínicas e planos de sáude – diretamente ao CRO.

3. Nada de colocar aquelas belas fotos de caso clínicos com a expressão “ANTES” E “DEPOIS”.

4. Não anuncie modadlidades de pagamento (cartão de crédito/ débito; cheque; boleto; carnê; financiamento bancário; dolar/euro/rupia/real; nota promissória) e parcelamento (10X sem juros 60X no crediário).

5. Não anuncie descontos ou favorecimentos em troca de tratamento (nada de convênios ou cartões de desconto, traga um amigo e ganhe R$10 de desconto na manutenção ortodôntica, recorte esse cupom e ganhe uma limpeza).

6. Não anuncie preços de tratamento.

7. Você poderá e deve dar entrevistas na mídia ou escrever artigos para esclarecimento em relação a importância da saúde bucal com intuito educativo e social. Nada de dar consultas, indicar tratamentos ou remédios para um caso clínico individual.

8. Não roubar publicações ou artigos sem citar ou pedir autorização do autor.

9. Slogan e logotipo faz parte de sua marca, você poderá utilizá-los sem receio. Se não tiver ainda crie-os.

10. Divulgar convênios ou credênciamentos registrados na ANS é livre, desde que não seja convênios por uma porcentagem de desconto.

“Preste atenção,
Não abra mão dos próprios sonhos…
Não tem perdão,
Não deixe de sonhar,
Não deixe de sorrir,
Pois não vai encontrar
Quem vá sorrir por ti ..”
(Chimarruts)

I heard a familiar story at a client. They had started up using pay per click campaigns to buy traffic on Google. The campaigns were apparently running well in that they had been able to far exceed their targets for unique visitors per day. They had two concerns with the PPC agency: that the cost of their clicks seemed way too high and that the ongoing management fee seemed similarly unreasonable now that the campaigns had been running for a few months. Apart from this they had started an RFQ to find a new agency to convert the traffic better on their product pages. They do not do any user testing and also found that A/B testing or multivariate testing seemed too complex. They were considering starting a new RFQ  process to find the best / cheapest agency to do this. Lastly, they had some concerns that they were missing out on organic traffic opportunies and felt sure that they needed the right experts to do this for them too.

Having two separate agencies for pay per click campaigns and for conversion rate optimisation seems a sure fire way of getting stuck as ‘piggy in the middle’. Both agencies will point to what the other does as the root cause of the clients high cost of conversion. The basis of improving conversions comes from finding the right traffic to send to correctly built pages. A page is correctly built when user say so by producing a higher conversion. The right traffic means finding the highest volume keywords that convert well. Similarly, optimising a site for organic conversions still comes down to finding the keywords that convert well.

Conversion needs to be the master of all internet marketing activities. It is ultimately an expression of a great user experience, showing that the company’s web presence has been listening and watching what users do online, knowing how they search and what experience they need when they find what they are looking for. Conversion is the measure of quality of organic and paid traffic. To buy traffic without knowing how it converts is to run the risk of buying junk for a high prices. To optimise a site for organic traffic without understanding for which keywords your optimising could mean again that you are setting your site up for a lots and lots of visitors who bounce on their first visit, or stay but never convert.  Similarly, user testing cannot be left aside. Whether it’s done formally in rooms with one-way mirrors, or down and dirty interviewing users in a coffeeshop, or fast and furious seeing which version of layout, imagery and content users prefer the best in an online multivariate test, there are so many low-threshold ways to get started hearing and seeing what users do and like.

There is a natural flow from a user searching for something in an engine to arriving at a landing page, possibly hitting a number of pages in between before ultimately converting and then continuing their business online. Companies must see this flow end-to-end and coherently because that’s how their customers see this flow. If companies don’t connect the dots, users won’t be able to either.

PT. Permata Indonesia
is Human Resources Consultant Firm. Our scope of services are professional recruitment and selection, labor contracting, training and development. Redeliver services for national and multinational company in Indonesia. Permata Indonesia is searching highly qualified and dedicated professionals to be positioned as follow :

Account Officer
(Jakarta Raya)

Candidate must possess at least a Bachelor’s Degree in any field.
GPA min 2,75 cumulative
Fresh graduates applicants are encouraged to apply.
Full-Time positions available.
target Oriented and have a strong motivation and good analytical skil.
Applicants should be Indonesian citizens or hold relevant residence status.

Field Collection
(Jakarta Raya)

Responsibilities:
Responsible to manage field collector’s and daily activities in order to achieve amount collected target and reduce credit cost and deliquency rate
Requirements:
Candidate must possess at least a SMU, Associate Degree or Bachelor’s Degree in any field.
Fresh graduates/Entry level applicants are encouraged to apply.
Full-Time positions available.
Applicants should be Indonesian citizens or hold relevant residence status.

Customer Relation Officer
(Jakarta Raya)

Requirements:
Bachelor Degree (S1) or Diploma Degree (D3) any majoring from reputable university
Male / Female
Fresh graduate are welcome
Innovative People with Initiatives to Learn
Good Interpersonal Skill and able to Work in Team
Good looking, Good Attitude, Communication Skills and Leadership
Target oriented, ambitious, and High motivation
Willing to travel

Customer Service
(Banten, Jakarta Raya, Jawa Barat, Jawa Tengah, Yogyakarta)

Requirements:
Min.D3 Degree Any Major GPA min 2.75 Scale 4.00
Female
Age max. 28 years old
Minimum Height 165 cm ( Propos ional weight )
Fresh graduated is welcome.
Has pleasant personality
Has Good Communication Skill
Fluent in English
Good Looking

Personal Banking Officer
(Jakarta Raya – Jakarta)

Requirements:
Bachelor Degree (S1) or Diploma Degree (D3) any majoring from reputable university
Male / Female
Fresh graduate are welcome
Innovative People with Initiatives to Learn
Good Interpersonal Skill and able to Work in Team
Good looking, Good Attitude, and Communication Skills
Target oriented, ambitious, and High motivation
Have own vehicle and driving license

Call Center
(Jakarta Raya)

Requirements:
• S-1 with min 2.75
• D3 with min 3.00• Fluently in English (both oral & written)
• Ready to work in shifting schedule
• excellent interpersonal & communications skills
• service oriented
• computer literate
• able to work under pressure

If you are qualifield and interested in the position, please email your complete CV and Photo (Below 200kb, Microsoft-word2003) to :

fahmi@permataindonesia.com
Or
petria@permataindonesia.com

—————- part-time job ——————

DREAM Association

Mirko “Cro Cop” Filipovic (Croatie)
Style : Kick-Boxing

VS

Tatsuya Mizuno (Japon)
Style : ???

Cliquez ici si problème avec vidéo