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Vertex sales reps
I did want to quote something my dr told me yesterday when I asked him about the new drugs that are coming out.He said he has a friend that was just hired by Vertex,and they are starting to hire more reps in the Atlanta area.He said they always do this right before a major NEW drug hits the market, that way Vertex can handle the overload.He said he is 99% sure they will be in market by June.He also said Vertex will target the big cities first.With the credentials that my dr has Im quite sure he has alot of connections and knows what hes talking about.Thought you all would like to know this!!!!! His friend told him that Vertex was gonna hire quite a few more before xmas.I guess this is good news?????
Yes frijole you are correct. I have seen job postings for HCV Sales and Marketing for Telaprevir also. A few examples that I think most on this forum can understand why Vertex needs these folks for their first product launch...
Associate Director, HCV Marketing
Reporting to the Director HCP Marketing, the Associate Director, HCV Marketing will focus on preparing for the launch of telaprevir and will work closely with other marketers to develop and execute integrated strategies to build awareness, increase diagnosis, and ensure appropriate treatment with telaprevir. The Associate Director will focus on promotional strategies and initiatives (both direct and indirect).
Key Responsibilities include:
- Liase with cross-functional partners within the company, including close collaboration with medical colleagues
- Development and execution of promotional programs
- Lead development and execution of branded creative campaign
- Act as marketing leader for review and approval process for key marketing initiatives
Regional Sales Manager
The Regional Manager will be instrumental in building a team dedicated to success within the HCV community. Initial responsibilities will include the analysis and design of the territory maps, as well as hiring Sales Representatives. In addition, the Regional Manager will be responsible for the successful execution of a new product launch and driving business initiatives through the design and implementation of regional business strategies.
Job Responsibilities:
· Promote safe and effective use of telaprevir within the labeled indication and in accordance with company training and policies
· Responsible for performance at the territory and regional level
· Understand the HCV environment; have in-depth knowledge of disease, local drivers, treatment and referral patterns, key account profiles, targets, influence patterns and barriers to optimal care
· Performance ownership responsibilities: assist in hiring, training, coaching and performance management of HCV Sales Representatives; ensure team members have in-depth level of knowledge of local HCV marketplace
· Work closely with the Area Director and other stakeholders to develop launch/post-launch strategies and business plans for the region
Therapeutic Specialist
Exciting opportunity to be a part of a first product launch effort for a hepatitis C product. The Therapeutic Specialist will be responsible for achieving and maximizing territory sales goals by developing a strategic business plan, communicating disease and product knowledge to healthcare professional customers, and utilizing effective and appropriate selling strategies.
Nygirl7: Off of the top of my head I believe the FDA fast track process has about a 6 month time frame to approve or deny fast track drugs.
From FDA website:
Fast Track
Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious diseases.
Determining whether a disease is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one. AIDS, Alzheimer’s, heart failure and cancer are obvious examples of serious diseases. However, diseases such as epilepsy, depression and diabetes are also considered to be serious diseases.
Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially superior to existing therapy.
Any drug being developed to treat or prevent a disease with no current therapy obviously is directed at an unmet need. If there are existing therapies, a fast track drug must show some advantage over available treatment, such as:
* Showing superior effectiveness
* Avoiding serious side effects of an available treatment
* Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome
* Decreasing a clinically significant toxicity of an accepted treatment
A drug that receives Fast Track designation is eligible for some or all of the following:
* More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
* More frequent written correspondence from FDA about such things as the design of the proposed clinical trials
* Eligibility for Accelerated Approval, i.e., approval on an effect on a surrogate, or substitute endpoint reasonably likely to predict clinical benefit
* Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA, and
* Dispute resolution if the drug company is not satisfied with an FDA decision not to grant Fast Track status.
In addition, most drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review. Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within
sixty days based on whether the drug fills an unmet medical need in a serious disease.
Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
----------------------------------------------------------------------------------------------------------------
Between 1993 and 2003 the median time required to review a priority review drug was reduced from 13.9 months to 6.7 months.
Pegasys, a combination product for the treatment of Hepatitis C was approved for marketing in 4 months.
Hectorsf
Associate Director, HCV Marketing
Reporting to the Director HCP Marketing, the Associate Director, HCV Marketing will focus on preparing for the launch of telaprevir and will work closely with other marketers to develop and execute integrated strategies to build awareness, increase diagnosis, and ensure appropriate treatment with telaprevir. The Associate Director will focus on promotional strategies and initiatives (both direct and indirect).
Key Responsibilities include:
- Liase with cross-functional partners within the company, including close collaboration with medical colleagues
- Development and execution of promotional programs
- Lead development and execution of branded creative campaign
- Act as marketing leader for review and approval process for key marketing initiatives
Regional Sales Manager
The Regional Manager will be instrumental in building a team dedicated to success within the HCV community. Initial responsibilities will include the analysis and design of the territory maps, as well as hiring Sales Representatives. In addition, the Regional Manager will be responsible for the successful execution of a new product launch and driving business initiatives through the design and implementation of regional business strategies.
Job Responsibilities:
· Promote safe and effective use of telaprevir within the labeled indication and in accordance with company training and policies
· Responsible for performance at the territory and regional level
· Understand the HCV environment; have in-depth knowledge of disease, local drivers, treatment and referral patterns, key account profiles, targets, influence patterns and barriers to optimal care
· Performance ownership responsibilities: assist in hiring, training, coaching and performance management of HCV Sales Representatives; ensure team members have in-depth level of knowledge of local HCV marketplace
· Work closely with the Area Director and other stakeholders to develop launch/post-launch strategies and business plans for the region
Therapeutic Specialist
Exciting opportunity to be a part of a first product launch effort for a hepatitis C product. The Therapeutic Specialist will be responsible for achieving and maximizing territory sales goals by developing a strategic business plan, communicating disease and product knowledge to healthcare professional customers, and utilizing effective and appropriate selling strategies.
Nygirl7: Off of the top of my head I believe the FDA fast track process has about a 6 month time frame to approve or deny fast track drugs.
From FDA website:
Fast Track
Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious diseases.
Determining whether a disease is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one. AIDS, Alzheimer’s, heart failure and cancer are obvious examples of serious diseases. However, diseases such as epilepsy, depression and diabetes are also considered to be serious diseases.
Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially superior to existing therapy.
Any drug being developed to treat or prevent a disease with no current therapy obviously is directed at an unmet need. If there are existing therapies, a fast track drug must show some advantage over available treatment, such as:
* Showing superior effectiveness
* Avoiding serious side effects of an available treatment
* Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome
* Decreasing a clinically significant toxicity of an accepted treatment
A drug that receives Fast Track designation is eligible for some or all of the following:
* More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
* More frequent written correspondence from FDA about such things as the design of the proposed clinical trials
* Eligibility for Accelerated Approval, i.e., approval on an effect on a surrogate, or substitute endpoint reasonably likely to predict clinical benefit
* Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA, and
* Dispute resolution if the drug company is not satisfied with an FDA decision not to grant Fast Track status.
In addition, most drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review. Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within
sixty days based on whether the drug fills an unmet medical need in a serious disease.
Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
----------------------------------------------------------------------------------------------------------------
Between 1993 and 2003 the median time required to review a priority review drug was reduced from 13.9 months to 6.7 months.
Pegasys, a combination product for the treatment of Hepatitis C was approved for marketing in 4 months.
Hectorsf
Interim results from the Phase IIb trial show viral breakthrough rate of 4.9% and relapse rate of 1.6%. I think maybe you mean viral breakthrough and not relapse? Anyway those figures are pretty much in line with other PIs I think.
I just checked Vertex's website and Cindy is right. There are a potload of jobs posted and available. Not for lower level sales, but Managed Care Liasons, Sales Managers, Marketing managers, etc, etc, etc. Many jobs in many markets. I wish my expertiese was in pharacology. I bet you could make some good money for awhile besides doing a good service.
I didn't see any jobs offered in manufacture, so that must be being farmed out.
It is nice to see this.
frijole
I didn't see any jobs offered in manufacture, so that must be being farmed out.
It is nice to see this.
frijole
re: TMC435, so far, I know two people who were RVR and the relapsed. I hope this is not the course for everyone.
nygirl: it takes so long to get to market to make sure there are no side effects. thalydimde (sp) in the 50's is responsible for that.
nygirl: it takes so long to get to market to make sure there are no side effects. thalydimde (sp) in the 50's is responsible for that.
Thanks! We do indeed feel very, very lucky.
They are doing the trial for relapsers and non-responders right now. There should be preliminary results in 3 or 4 months.
They are doing the trial for relapsers and non-responders right now. There should be preliminary results in 3 or 4 months.
TMC435 sounds like a good program. I hope they have success on the relapser and nonresponder area. Good luck to your hubby. sounds like he has achieved the golden ring
frijole
frijole
Forgot to add their interim results say 83% of the people who got the TMC435 achieved RVR. My husband was RVR but we won't know for another 6 months exactly how early he cleared.
Yes, I know anemia is associated with Boceprevir, that's why they're doing that study with Procrit vs. does reduction. The point I'm trying to make is that, unlike Boc, TMC435 does not seem to cause more anemia, nor is it thus far associated with a rash like Telaprevir. Possibly it will prove better than these two.
My husband was treatment-naive, so he couldn't compare his sx to SOC, but the only thing he had which seemed maybe not due to the peg & riba was some minor gastric upset. Overall he lucked out and had light to moderate sides. Fatigue was the worse, as for many. He finished 6 months ago and he's still clear. 24 weeks in tx. Sure beats 48 if you get the chance. I'm hoping they'll be doing a Phase III trial of TMC435 in the next year or so. If they do I urge anyone who can to jump on it. We'll see. It worked for us!
My husband was treatment-naive, so he couldn't compare his sx to SOC, but the only thing he had which seemed maybe not due to the peg & riba was some minor gastric upset. Overall he lucked out and had light to moderate sides. Fatigue was the worse, as for many. He finished 6 months ago and he's still clear. 24 weeks in tx. Sure beats 48 if you get the chance. I'm hoping they'll be doing a Phase III trial of TMC435 in the next year or so. If they do I urge anyone who can to jump on it. We'll see. It worked for us!
I have been going by what has been posted here - about additional anemia associated with BOC. Spectda concurs, it appears.
So how have the side effects been from the TMC435? I am not familiar with this one. Has he achieved UND yet?
frijole
So how have the side effects been from the TMC435? I am not familiar with this one. Has he achieved UND yet?
frijole
"Boceprevir is associated with about a 1 g/dL incremental decrease in hemoglobin. In the HCV SPRINT-1 study, anemia occurred in approximately half the subjects"
http://www.drugs.com/clinical_trials/final-results-boceprevir-phase-ii-hcv-sprint-1-study-showed-significantly-higher-svr-rates-compared-7079.html
http://www.drugs.com/clinical_trials/final-results-boceprevir-phase-ii-hcv-sprint-1-study-showed-significantly-higher-svr-rates-compared-7079.html
My husband did not take Boceprevir -- he was on a trial for TMC435, said to be a "second generation" PI. So far from their recently-reported interim results from the Phase IIb trial they are finding no significant additional side effects from the PI -- and that was also my husband's experience as far as we could tell. It's dosed in a much lower quantity than Tela or Boc, and you only need to take it once a day.
I could have misunderstood what he said about the FDA,he said someone was taking their time getting these drugs to market.I taped the office visit with him(so I didnt forget anything)Ill go back and listen to it again to make sure,but i do believe thats what he said.
I don't believe Vertex markets anything at this point. All they have been doing is research. They have decided to market Telaprevir themselves and have hired a firm to help them. However, this is a pretty unsusual move for an R & D company. I think this is a good sign.
And Cando is right. They have not presented anything to the FDA yet. No one is dragging their feet.
writeitdown -- I thought that Boceprevir did increase your chance of anemia -- which is fine as long as resuce drugs are available.
frijole
And Cando is right. They have not presented anything to the FDA yet. No one is dragging their feet.
writeitdown -- I thought that Boceprevir did increase your chance of anemia -- which is fine as long as resuce drugs are available.
frijole
Yeah you are right CanCan then how long is the FDA going to sit on it/them after they get to that phase of approval? Amazing the way things work, I mean look at WIDs husband - cured........others could be too. I get that they have to be careful but it's been Soooo long! that is why I was questioning why they'd be hiring so many people in December when the drugs not even to the FDA.
Does anybody know how long that approval usually can be?
Does anybody know how long that approval usually can be?
"I know what your saying.He said that it was a shame that the FDA was taking its time on this when people are dying waiting for these drugs"
Its not been turned over to the FDA, unless i missed something.
Its not been turned over to the FDA, unless i missed something.
Hi NYgirl -- guess what? The PI my husband did on his trial seems so far to be getting as good results as Telaprevir and Boceprevir with no rash and no increased chances of anemia. Even better drugs are being developed....
So many good people could have already been cured by now if they'd just stop dragging their feet. I truly don't understand at this point in time with so much information why it's still so slow going. Believe me if I could have done a PI rather than 72 weeks - I would have taken that choice gladly (especially since they seem to have gotten a handle on the rash a bit now.....not that I know how but boy in the beginning it was a problem and you don't really hear about it much any longer!)
Maybe they have to hire them so far ahead of time because they have quite a bit of training to do before they can go to a doctor's office. I imagine there are many other drugs that they will be selling too.
Just a thought.
Diane
Just a thought.
Diane
I know what your saying.He said that it was a shame that the FDA was taking its time on this when people are dying waiting for these drugs.I feel blessed not to have the damage that some of you all do and will be able to wait.He said Vertex wanted to have all their sales reps hired before x mas,not that the drug would be coming then...Lets keep out fingers and toes crossed especialy for the ones that really need this now.If I had 2 I would give up my chance so that someone else that needed it worse than me could treat!!!I know the waiting could seem like forever.
I hope that it's true but am not holding my breath. You have to understand we've been hearing this for YEARS (six years?) coming soon coming soon - not everyone is lucky enough to be stage 1 and they should temper their decisions in regard to the amount of liver damage wisely. I don't see it coming out by Christmas...........why would they hire sales reps so far in advance to being approved? Maybe it makes sense but what if it's not approved and they've spent all that money on sales guys and it's put on hold for another year?
Anybody know what else Vertex currently has in the pipeline that could be another reason I just find it somewhat strange to hire so many people so far out.......hoping it's true but from past experience just wondering.
Anybody know what else Vertex currently has in the pipeline that could be another reason I just find it somewhat strange to hire so many people so far out.......hoping it's true but from past experience just wondering.
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