Last reply 2 years ago
@Billybonza : An Open Letter

It is with some sadness that I have felt compelled to publish this open message to you, @billybonza. I have tried the subtle approach, but I don’t believe that you have subtlety in your repertoire.

We, at Shift.MS, provide an environment to support anyone with MS. It is an informal and friendly place, to share experiences and generally support one another.

We acknowledge that we are all different and that we all have different journeys with this unpredictable condition. There may be cases where there are differing of opinions and that is to be accepted. Reasoned arguments do allow important and salient facts to be aired.

But, we are all different and we can have alternative opinions. We just have to accept that fact, once reasoned argument has been exhausted.

What we do not do is try and hit someone with our verbal stick and beat them into submission to accept our view.

There are a couple of House Rules that I want to bring to your attention :

Keep it friendly. You’re bound to come into contact with people with different opinions to you. If you disagree with someone, please do so in a calm and respectful manner. We will remove any member who we feel is being harassing, defamatory, abusive, threatening or aggressive. That’s not what we’re about. There’s no place for it here; and

No two the same. We expect people to talk about medical experience and drug choices, however we will not tolerate promotion of one drug or therapy over another. Feel free to provide information, but please let people come to their own conclusions. Please don’t tell people that they have chosen the wrong treatment, or that yours is best.

In your house, @Billybonza, you can make the rules, but this isn’t your house. So, we ask that you abide by our rules.

The forum exists for the greater good of the membership and it will survive to continue that role. However, your place in our House may not survive.

So, please accept this as a formal warning that your dictatorial behaviour will not be tolerated. As with any house, we have a door. It is your choice if you use it voluntarily or not. But, it will be our choosing if we ask a member to use it.

So, please display some tolerance to alternative views.

Thanks for reading.


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3 years ago

I accept. That was written with the full knowledge that this would be the response or worse.

I accept the house rules of the forum and I will abide by them moving forward.

I will however not be ganged up on and I will not have any subtle ‘bulling’ like attempts to isolate me in any circumstances. So next time, which there won’t be, but in the freak occurrence that there is, that I feel like this is what’s going on I’ll refer it to you trusting that you will deal with the other party equally as appropriately.

Thank you.

3 years ago

PS I’m not promoting anything

3 years ago

Sad but true, not everyone can feel “Your” passion. However thanks to you i have decided to really live while i can and AM going to do a 400ft bungee jump. Paying for it, well, I’ll get there.
Cheers for a breath of fresh air, but i see that the rules are there to protect those who are freshly arrived on these shores and are a bit fragile, we can all understand that! Billy – you scare the normal folk mate!
Peace out.

3 years ago

@druid , you’ll have to post some details, beneficiary, weblink etc.

Then we can see if we can get you some extra sponsorship.

But, don’t blame me, I’m not pushng you….. 😉

3 years ago

Its not a charity jump, although they do set them up. This is off my own back and its £149 a jump.

3 years ago

Never heard so much one sided hoohah over calling someone an appendage head in all my life. Get a grip

3 years ago

3 years ago

Only trouble I have with much of what Stubler has had to say is it in no way relates to what I did. I called a grown man and woman a name who were acting like children trying to gang up and tease or ‘bully’ subtly with code language and as it actually is, tried to continuously force his opinion on me. So where’s open letter 2 to them addressing that. Think about it.

3 years ago

Not newbies, not innocent, quite capable of taking care of themselves

3 years ago

It is with great sadness I present the truth, not just my half-arsed opinion. All the open letters in the world will never change the truth

In this white paper, Thomson Reuters provides a snapshot
of the importance of patient-based drug sales forecasting in
the current market conditions. This analysis looks at the role
of forecasting and the factors to consider in developing a
patient-based forecast.
Creating a patientbased
Image Copyright: REUTERS/Eliseo Fernande
For more information on Thomson Reuters Forecast™ and
Thomson Reuters Pharma™ visit: or email
[email protected]
Thomson Reuters Forecast ing White Paper
Thomson Reuters Forecast ing White Paper
PART I – The Role of Forecast ing
As the financial meltdown struck, a typically safe haven of
the economy during a recession felt a panic. One of the more
severe implications of this downward-spiraling economy was
the loss of the traditional money-raising avenues of debt and
equity issuance. Given the capital-intensive nature and highrisk
component of drug development, biotechnology companies
rely on new capital more than any other industry. With very
tight credit markets, companies were unable to borrow or raise
money, and prospective investors applied increased scrutiny to
the potential value of companies’ assets, making the ability to
construct a reliable forecast more important than ever.
The value of an asset is determined by analyzing the net
present value (NPV) of its future cash flow. For drugs, this
analysis begins with determining which patients will benefit, to
arrive at the drug’s future sales potential. Understanding the
current and potential market, the impact and timing of future
events, and inherent risks are fundamental when developing
product forecasts. Whether the purpose is to license a drug,
raise capital, or purchase stock on the open market, developing
a dynamic and reliable forecast is the analyst’s tool for
determining the value drivers of a particular company.
The Import ance of Forecast ing:
Three Perspectives
1. Big Pharma
The success of blockbuster drugs has lead to impressive cash
flow and high returns for pharmaceutical companies. However,
with size also comes constant pressure to continue to innovate
and grow. This is particularly acute now, as the industry faces a
veritable cliff of impending patent expirations. There is a vital
need for companies to fill their pipelines with new therapies to
replace lost revenue. At the same time, developing and gaining
approval for new drugs has become more difficult. These
factors mean big pharma needs to employ new strategies to
maintain and grow business. This is done through a better
assessment of the risk/return profile of drugs in their pipelines
and outsourcing risk by partnering with biotechnology
companies in need of their financial, technical, and marketing
resources. Forecasting plays an essential role in determining
which drugs will lead to the best returns and which drugs
should be dropped before they consume too many resources.
“Biotechnology companies are highly
dependent on well functioning capital
markets to finance their development
projects since many will not see revenue
for perhaps a decade. It generally takes
approximately $1 billion, including the
cost of failures, to get a new therapy to
market. This financing generally comes in
the form of equity investment. When credit
markets seize up, as we’ve seen in the past
13 months, there is less capital available for
investors to put at risk, and the capital that
is put at risk is dedicated to shorter term,
lower risk options. So while some areas
of the economy have seen a slowdown,
biotech has seen a near-freeze.“
Jim Greenwood President and CEO
Biotechnology Industry Organization1
“The cost of developing compounds has
become so high and become so risky
that we are looking to share the risks and
opportunities and find more and more
partnerships,” says William Weldon, Chief
Executive Johnson & Johnson. “You’ll see
more and more sharing of risks because the
upside can be spectacular.“2
Financial Times, “J&J wants deals with
rivals to share risk,” 25 October 2009
Thomson Reuters Forecast ing White Paper
OUTPUT 1998-2008
2. SME Innovators and Biote chs
Smaller companies focused on innovating new therapies
usually require outside financing to continue operations
while they prove the value of their concept. Often they will
seek to partner with a larger company that can offer greater
development resources and market access. Whether their
strategy is to secure financing, form a partnership, or both, it
is necessary for smaller companies to develop forecasts that
gauge the value of their pipeline and account for overall market
conditions so they can properly negotiate agreements.
3. The Financial Co mmunity
For the investor, being able to accurately forecast the revenue
of a product candidate, and hence the potential future value
of a company is key to understanding investment risk and
possible return.
Because most smaller companies have few drugs in their
pipeline, each drug represents a great deal of exposure to
the overall risk of the investment. Combine this with the
unpredictable nature of drug development, and there is a high
degree of volatility around important development events.
The value of the particular drug to an organization will
determine the amount of volatility around the event. Depending
on the type of company, an investor may look to capitalize off of
the volatility or to avoid these risks altogether.
R&D expenditure Development times NME output
* e devel pment t me da a po nt or 2 0 nc u e data from
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008*
* The development time data point for 2008 includes data
from 2007 and 2008 only
SOURCE: CMR International 2009 Pharmaceutical
R&D Factbook
Thomson Reuters Forecast ing White Paper
PART II – Developing a Patient-based
Dru g Forecast
Patient-based forecasting is a reliable approach to use when
analyzing a marketplace and the potential sales a therapy may
have within it. “We don’t do patient-based forecasts because
it’s fashionable,” says Thierry Boutin, head of forecasting for
sanofi-aventis. “We need patient-based forecasts because
a well-defined segmentation is needed to match the
requirements of the payers.”3
Understanding the primary drivers behind a forecast enables
the analyst to create a dynamic therapeutic model, project the
impact of future events, and quickly adjust the forecast as these
events occur. We will now look at each of these drivers in turn.
The Prevalence AND Incidence
of the Disease
The first step in patient based modeling is to identify the
incidence and prevalence of disease within a select category.
Typically, reliable data are available from government sources,
prominent organizations and foundations. Examples are the
Centers for Disease Control, American Cancer Society, World
Health Organization, and the National Multiple Sclerosis
Society. Beyond data from specific organizations, it is also
important to review other sources to formulate the best estimate
of a patient population. These may include estimates from:
• The respective disease foundations
• M edical literature
• Proprietary market research
• C ompanies developing drugs for the indication
Population estimates for different geographic locations such
as the United States and Japan are available and can be used
to adjust the rate of disease to the respective location. For
example, the rate of obesity in Japan is much lower than in the
United States, but the rate of osteoporosis in Japanese women
is much higher than in Caucasian women.
There are then several ways to model future increases in the
affected population. The estimated population growth of a
specific demographic, past changes in rates, and estimates in
the changing demographics of a country are all factors that will
impact future disease rates. Perhaps the best example of this is
the aging of the Baby Boomer generation in the United States
and the upcoming increases in disease rates expected due to an
older population.
Thomson Reuters Forecast ing White Paper
The Number of Patients Being Treated
or Diagnosed
Once the overall affected population is determined, the next
step is to eliminate those patients who will not be treated
pharmacologically. At this stage, it is important to understand
current and future trends in diagnoses and treatments so
as not to eliminate patients who may benefit from future
advancements in treatments.
Many times the sources used to measure prevalence/incidence
can also be leveraged to determine the extent of diagnoses and
treatment. Of course, not all diagnosed patients will go on to
receive treatment. After determining the number of patients
diagnosed, the percentage of patients treated is estimated from
guidelines on current disease management.
The Number of Patients Eligible
for Treatment by the Specific
Dru g Candidate
The forecast must identify the specific patient populations
individual drugs will target. Once the number of addressable
patients is determined, an analyst can narrow down eligible
patients based on proposed therapy indication or clinical
benefits. Typically, this is the patient population for which the
drug is indicated, or for which it has shown clinical benefit.
Many times this will be determined through the mechanism of
action, an in-depth knowledge of the clinical trial populations,
and the drug’s clinical profile. Increasingly, it may involve
determining the proportion of patients who carry a specific
biomarker. For example, an increasing number of biomarkerguided
therapies are being developed such as HER-2
(Herceptin for breast cancer), K-Ras (Erbitux for colorectal
cancer), and Apolipoprotein E4 (Bapineuzumab for Alzheimer’s
disease). Only the proportion of the patient population that
carries the relevant biomarker will be eligible for treatment.
In this segment of a model, it is also important to take into account
potential indications beyond the primary indication that could
expand the base market as the life cycle of the therapy progresses.
Thomson Reuters Forecast ing White Paper
Average Price per Patient
For drugs still in development, the price of similar approved
drugs can be used to determine if the drug should be priced
at an equivalent value, at a premium, or at a discount. It is
also important to take into account what the market will bear,
especially when no drugs have been approved for an indication.
By combining the price of the therapy and the proposed dosing
regimen, one can develop pricing and revenue scenarios on a
per-patient basis.
The Candidate’s Market Share
Estimating the peak market share a drug can achieve and the
uptake of the drug into the marketplace involves numerous
objective and subjective inputs. First, evaluators must quantify
the use of drugs that are currently marketed. In addition,
primary market research is essential. Explore the number and
location of treatment centers, key thought leader discussions,
and manufacturing capacity since, all play an important role in
determining the potential market share available to new drugs.
Analyzing Market Share Assumptions
With the known inputs of patient population, drug price, and
drug sales, an estimate for the number of patients treated
can be obtained. Since analysts have identified the eligible
patient population, the current market share of these drugs
is determined by dividing the patients treated by the patients
eligible. There are several ways to compare market share across
drugs. The underlying estimate to use for this is the number
of patients treated which can then be divided using different
denominations of patient groups within:
1) total treated population;
2) eligible population;
3) drug class;
4) marketed products.
Dividing by the total patient population allows one to analyze
the penetration of a drug or group of drugs relative to the total
addressable market. This determines the current state of the
market and the opportunity that exists for newer drugs to either
grow the market or take share from current treatments.
Thomson Reuters Forecast ing White Paper
Chart of penetration of disease -modifying
multiple sclerosis (MS) treat ments 2008-2012:
Co mparing Co mpetitive Profi les
The primary driver for the use of a drug is the clinical data
that has led to the drug’s label. It is fairly easy to compare
major efficacy and safety findings between two drugs. In
cases where the efficacy and safety are comparable, the route
of administration, dose frequency, price, and ability of the
corporate sales force also become important competitive
factors. Often, the therapeutic areas are large enough to
support multiple successes and adding new drugs to a market
may not be a ‘zero-sum’ game.
Approva l and Laun ch Timing
An estimate for when a drug will reach the market can be made
using development catalysts such as trial data and regulatory
events. Review periods vary depending on the nature of the
application and the timing of each specific regulatory body.
Peak Market Share and Sales Ramp
Drug sales ramp up over time as doctors and patients become
more informed and familiar with a product, sales organizations
are built out, and additional clinical data are released. One can
determine the appropriate growth curve for drugs by examining
historical sales trajectories for similar drugs, although each drug
needs to be evaluated individually in context with its competitors.
YEAR 2009 2010 2011 2012 2013
MS Appro ved
Dru gs
200,759 202,546 202,606 197,726 211,059 # of patients treated with
approved drugs
Dru gs in
1,533 8,908 26,286 51,998 84,015 # of patients treated with
drugs in development
BMT* Dru g
Covera ge RRMS
200,759 208,236 223,364 243,833 264,551 # of RRMS and SPMS
patients treated with
approved and development
BMT* Dru g
Covera ge PPMS
1,533 3,218 5,528 5,891 7,343 # of PPMS patients treated
BMT* Dru g
Covera ge To tal
202,292 211,454 228,892 249,724 295,075 # of RRMS, SPMS and
PPMS patients treated
To tal Trea ted/
378,398 383,128 387,917 392,766 515,320 # of total patients
diagnosed that may seek
Penetra tion % 53.5% 55.2% 59.0% 63.6% 57.3% % penetration of DMD into
diagnosed and may seek
treatment population
* BMT = BioMedTracker, data is available in Thomson Reuters Forecast
Thomson Reuters Forecast ing White Paper
Type II Diabetes Market
The chart below illustrates Peak Market Share Forecasts for DPPIV
inhibitors, oral formulations, non-insulin type.
Pea k Shares-Achieving Pea k
Appro val
Da te
Januvia/Janumet 15.00% 2013 15 Oct 2006
Alogliptin 1.25% 2019 1 Apr 2012
Onglyza 2.50% 2016 31 Jul 2009
Ondero 5.00% 2018 1 Oct 2011
Dutogliptin 1.25% 2020 1 Apr 2014
AMG 222 1.00% 2020 1 July 2013
total DPP IV* 26.00%
* Repesents 26% of the total Type II Diabetes market in the US
Understan ding Current and Potentia l Co mpetition
Share assumptions will also be determined by looking at potential
competitive therapies in development. Visibility to the pipeline
for drugs within an indication and within a drug class or franchise
helps determine the risk that more competition will emerge for
a drug. Pipeline databases such as Thomson Reuters Pharma™
can provide a list of drugs in a therapy area and/or drug class,
along with details on each. The clinical development timelines
of possible competitors can also impact launch scheduling and
ramp time.
Disco very
Phase 1 Clinica l
Phase 2 Clinica l
Phase 3 Clinica l
Pre-registra tion
Insulin Sensitizer 26 4 16 6 2 1
DPP IV inhibitor ant 12 2 5 7 2 1
Dipeptidyl peptidase 12 2 5 6 1 1
Gluca gon-like peptid 10 11 5 3 1
Insulin release stim 10 5 2 2 1
Lipid metabolism mod 7 1 3 1 1
PPAR gamma agonist 7 2 2 5
G-pro tein cou pled re 6 2 2
Hyperglycem ic agent 6
Unspecified dru g tar 5 6 1
Data is taken from Thomson Reuters Pharma.
Thomson Reuters Forecast ing White Paper
Sensitivities and Scenarios
Given the wide variety of inputs one must consider on even the
most basic forecast, running different scenarios and looking at
the sensitivities of different inputs becomes vitally important.
For each input explored, an analyst can take a low, moderate,
and high assumption to create a range of estimates for patients
treated and drug sales. By estimating the future drivers behind
each input, such as future clinical data results, one can quickly
adjust the base case as events unfold and not be surprised by
the outcomes if they fall within one of the scenarios projected.
Applying Therapeuti c Models to Other Drugs
Having well defined, transparent inputs within a therapeutic
model allows an analyst to apply a comparable drug’s model to
assumptions for a new drug, even those in early development
that do not have a forecast.
Since a dynamic model of the therapeutic area has been
created, the analyst can plug in assumptions for the different
inputs for any drug and quickly obtain a new forecast.
Determining assumptions for early stage drugs can be
difficult as much less data have been released and the eligible
populations and competitive profile are based more on future
expectations for data rather than on a known clinical profile.
For example, an early stage GLP-1 drug may show up in a
company’s pipeline. Even though the dosing schedule may
not be known for the new drug, an analyst can use different
assumptions to create scenarios for dosing and efficacy. This
will allow the estimation of peak share as compared to the
current treatments and allow analysts to arrive at a range of
future sales estimates.
Revenue and Profit Share Splits
Many times drug revenues will be shared via royalties or profit
shares. For existing deals, one can use information provided
by the companies involved, such as SEC documents or original
press announcements, to evaluate the partnerships and the
approximate split of revenue for each drug. Databases that
contain pipeline and deals data, such as Thomson Reuters
Pharma, contain deal terms linked to drugs.
If the information is not readily available, analysts can calculate
the split by looking at comparable deals.
Patent Life
When a drug goes off patent, typically many different versions of
the drug flood the market at a much lower price point, causing
revenue to plummet. This often results in it becoming unprofitable
for a company to continue marketing the drug. A company can try
to compete by lowering the price of the branded drug, or rely on
the superiority of the brand name to retain what revenue it can.
A forecast must take into consideration when the primary patent
will eventually expire, if there is a possibility for extensions, and
the effect the presence of a cheaper version of a drug will have on
other drugs in the indication.
Thomson Reuters Forecast ing White Paper
Likelihood of Approval (LOA )
The risk of a drug in Phase II development never reaching the
market is much greater than for of a Phase lll drug. It is possible
to handicap a drug by the likelihood of the drug’s approval (LOA).
Calculation of LOA starts with an objective Average Approval
which represents the average probability of FDA approval for
marketing in the United States for the specified indication,
based on the historical performance of drugs in the same
development phase. These are averages generally accepted
by the pharmaceutical industry and research community. The
Average Approval is a starting point for analyzing specific data
about the drug to arrive at the LOA.
The average approval numbers are as follows:
The probability of approval of a given drug for a particular indication
is then subjectively moved up or down based on an analysis of each
of the events relevant to the particular drug including:
• An examination of the clinical development program such as
trial designs.
• The historical performance of similar drugs.
Events which may lead to an LOA adjustment include clinical trial
data, regulatory events, partnership announcements, preclinical
data, as well as events for competitive and related drugs.
Corporate Forecast
If analysts are able to combine individual drug forecasts into a
forecast for the corporation’s entire marketed and development
portfolio, they can gain an in-depth understanding of the
business drivers for a corporation. They can use the likelihood
that a drug will come to market to weight the individual
components of a revenue stream to reach a probabilityadjusted
revenue stream.
The analyst can then adjust the LOA-based future catalysts and
predict how much a specific event will impact a company, either
positively or negatively.
0 20 40 60 80 100
Thomson Reuters Forecast ing White Paper
Understan ding Timing and Impa ct of Future Events
There are several types of catalysts that can impact a forecast.
As discussed above, clinical data determines how a drug will
be used and in which patient population. Also, analysts must
determine development timelines and regulatory events, which
can take several months to years to resolve. They must build
forecasts based on the different assumptions for the outcome
of each of these events. Using a handicapping system such as
LOA helps provide insight into the probability that one scenario
will occur over another.
Benchmarking Versus Ot her Est imates
Once analysts obtain a future sales estimate, it is important
to crosscheck the outcome with other estimates. Research
analysts working for investment banks publish reports in
which they provide sales estimates for individual drugs. While
just having the final sales number is useful, it is important to
realize that in cases where sales estimates combine multiple
indications, each therapeutic area needs to be included to
reach comparable estimates.
A primary drawback to using consensus estimates is the lack of
transparency into the many inputs involved. With patient-based
forecasts analysts can use the sensitivity and scenario charts
developed to gauge where the consensus estimates fall within
their proprietary forecast.
Clearly, the business of forecasting a drug’s viability in the
marketplace and as a financial investment is a complicated and
multi-faceted process. It is an exercise made even more important
by financial pressures impacting businesses of all kinds worldwide
and making the need for sound financial decisions more important
than ever.
In addition to the information provided in this discourse,
readers will find resources to help in the development of more
accurate and useful forecasts for pharmaceuticals by consulting
Thomson Reuters Forecast. Information about this resource can be
found at:
Thomson Reuters Forecast ing White Paper
1 Greenwood, Jim. “The Financial Crisis and Biotechnology,” 3 October 2008,
2 Financial Times, “J&J wants deals with rivals to share risk,” 25 October 2009
3 Roner, Lisa. “Leaving copy and paste forecasting in the past,” Eye for Pharma, 15 September 2009,

Image Copyright: iSTOCK PHOTO
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consensus analyst forecasts and transparent patient-based forecasts
along with drug summaries from Thomson Pharma’s trusted pipeline
database. Review and adjust with your own assumptions to quickly
generate your own forecasts.
For more information visit
Thomson Reuters Forecast™ gives you the most accurate available method of assessing
the sales potential of new drugs by integrating and summarizing multiple perspectives
on drugs that will compete with yours.
For each therapeutic franchise, Thomson Reuters Forecast enables you to compare
the most significant candidates in the development pipeline and the key drugs that
have reached the market. It provides a consensus of analyst forecasts for pipeline and
marketed drugs, and downloadable, patient-based revenue models for drugs in more
than 100 indications, providing transparent assumptions on incidence and prevalence,
eligible numbers of patients, estimated timing of approval, pricing, and market share
within the indication.
In addition to proprietary revenue forecasts, catalysts and likelihood of approvals are
provided through a partnership with BioMedTracker.
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2 years ago

@Billybonza, I just want to say …when I first joined Shift.MS I really needed someone to talk to, someone that that empathised; you listenned, you understood, you made me feel I wasnt alone in my understanding of things and I wasnt crazy, you gave me strength aswell as put smile on my face.. Thank you.

Hope you’re well. Take care.

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