Site Payment Vendor Selection – Things to Consider


Hi everyone welcome to another episode
of ClinBiz where we love connecting with you on the business aspects of
clinical trials, so in today’s video we’re actually going to cover a topic
that we’ve been getting a lot of questions on here at Clinbiz which is a
topic of what are some things to consider when selecting a site payment
vendor? So we’re actually going to cover a few top tips today but we’ll have the
complete and full checklist later on this month to our newsletter subscribers
so if the topic interests you or you like to share with your teams make sure
you subscribe to our newsletter at CLINBIZ.COM. All right so stay tuned Well, welcome back so today we’re going
to talk about what are some things to consider when you’re selecting a site
payment vendor? So a site payments are usually payments that a clinical study
sponsor needs to pay an investigator site during the course of a clinical
trial for the work they perform in that clinical trial well it sounds simple enough right? But for some reason a lot of study sponsors
have had an issue and this is a pain point in our industry with actually
paying the sites on time, with the proper details accurately and all those kind of
things and this is where site payment vendors and services have come up in the
last few years which is great that we’re having some innovation in the industry
but that leaves us with some additional questions for when you’re selecting
those vendors what are some things to keep in mind and that’s what we want to
address in our video today. So what are some things some top the tips that you
need to make sure you have in place or you ask the proper questions when you’re
selecting a site payment vendor? So number one you should really first
establish what is the site payment model that you’re going to follow for your
organization and by that I mean are you going to fully outsource the payment
function meaning the people and the technology is going to be completely
done by your site paying vendor? Are you gonna be doing that? We’ll call that the
fully outsourced model. Or are you gonna be doing it in-house fully where you have
the people in-house and you have your own homegrown or good old Excel
spreadsheet that you’re using in-house and in that case you actually don’t need a site payment vendor. Or using a type of hybrid
approach? Again this is not a full, you know, checklist or anything like that but
for the purpose of this video we’ll stick with these three main types of
models and we’ll actually just address a fully outsourced and hybrid model for
the questions on this video. And the hybrid model would be when you have
in-house people to actually perform the site payment function but you’re looking
for a technology to better serve that function so you’re going out to a site
payment vendor to get that okay? So let’s jump onto some questions and some things
you need to have in mind when you’re selecting these vendors and let’s think
as if you’re going with a fully outsourced model or a hybrid
where you’re actually using the technology of this vendor. So one of the
very first things I would look for is what is the ease of working within
that system that site payment vendors system or using your services, how easy
is it to use it if you’re going to be using it in-house as a study sponsor
with your own people and their technology, or if you’re going to be
full outsourcing, how easy is it to work with them? How easy is it for sites to
work with them or perhaps even if there’s going to be a site facing portal
let’s say from that vendor with their technology how easy is it for sites to
actually get in and work there? And you know you’re gonna need to ask for some feedback in the industry of course and colleagues and
things like that, but also for you to be able to look at the system demo way and
things of that nature how easy is it to use? One key tip here I would say is
invite an end user, a person that’s gonna be going day in and day out of
performing site payments to actually take a look at the site payment vendor
systems and their processes and services because they are the key people that are
going to come up with very very good questions for you to ask your vendors
right from the beginning, so have your end user whoever’s gonna be doing site
payments actually test out the site payment vendors technologies or in the
very least see a demo and get information from them and they’re going
to actually be able to generate much much more questions for you. Also what is
the ease of the integration of their system with your own systems, right? How
easy is it to integrate their systems in connect their systems with other systems
that you may have, perhaps you want to connect them to your SAP system where a
CTMS system how quickly and also how easy is it to do that? How easy is the
integration? Does the site payment vendor provide that that technology as a
standalone or as a module or do you need to you know or get the other full suite of
systems or full suite of modules for that service how easy is it to integrate
with others? So very important the integration question and the
connection question for your site payment vendor. Something else you need to
look at is to confirm a couple of these things, again not a full
list here on this video. We’ll have that later on for you but how is that
site payment vendor going to accommodate things such as multiple payees, multiple
arms and sub-studies. We know that for let’s say multiple arms a lot of
oncology studies and some other studies are also very complex and they may have
multiple arms and that can become a nightmare for site payments believe it
or not if the proper configurations are not done in that payment vendor
technology or in your processes as well. so you need to think about it and ask them
and if possible ask to actually see how in their system it’s done – how multiple
arms are handled, sub studies and multiple payees. For example, outside of the
US it’s very normal to have multiple payees for an investigator site meaning
the study sponsor actually needs to pay that investigator site whatever payment
they’re going to make but they’re going to need to split it up among a
couple of different payees. So how is that site payment vendor going to be
handling or if in-house you’re going to be using their technology – how will your people be able to handle that in their system. So very
important questions to ask: multiple arms sub studies and multiple payees.
Something else you need to confirm is about budget amendments. Now
we know, if you’ve been in a clinical trial space for a while you know that
protocol amendments are inevitable sometimes in certain studies and these
protocol amendments if they have an impact on the budget they will need
to be updated, the budget amendments and actually have an impact on the site
payments as well. So when that happens you need to be asking upfront and seeing
in real time with your vendor how are they going to be addressing budget
amendments so when there is a budget amendment for a trial how are they going
to be doing that in their system and how long that’s going to be
taking. What’s the turnaround time? If your own people are going to be
using the system then I would suggest if at all possible to have your people go
into system and test it out or at least have the vendor demo out to you how
exactly a budget amendment would be done in real time. How much time – how quickly
you can get that done because that’s going to be one of
the determining factors for you to make that selection so it’s very
important to at least know and be prepared of how long that’s actually
going to take you in terms of budget amendments and their impact on site
payments. So ask those questions and ask to see how long that would take in their
system to have a budget updated which would impact new payments to your sites.
Something else you need to be thinking about is also what if there’s
an issue with the site or in a certain region and the site cannot or does not
want to use that technology site payment vendor’s technology for whatever
reason. They can’t log on to their portal or they do not want
to whatever is the reason – what are exception processes they already have
in place when those kind of things happen. Your site payment vendors should
be able to tell you or at least give you a couple of options of when situations
arise that do not follow the standard process what are some things that can be
available and then you can also see if those work for you and in-house
within your own organization as well because those situations do come up
especially if you’re going outside of the US so you need to be prepared to
deal with site payment vendor exceptions whenever you need to do that. Something else you need to be thinking about is also how will they be funded
and that’s a question you need to be asking the. Is it something that you’re
going to need to pre-fund a large amount to the site
payment vendor in order for them to make those payments? Is there going to be a
Just-In-time approach? Is there going to be a mixture of both or
something else? You need to be asking how they will be
funded and I would include also some folks from Finance at some point because
they’re going to be included at some point anyways in the
conversation so really find out how that
will be done for that site payment vendor to actually make the payments on
your behalf as a study sponsor. Ask those types of questions. The
last thing we’ll talk about here in this video, again full checklist coming up
later on this month for our subscribers, but in this video I’ll just say and it’s
something I recommend in many of our videos is to make sure that any
agreements, any promises in terms of turnaround times, in terms of
capabilities and the system – things that are available to you are really captured
in either a contract or a full guidance document of some sort
and referenced in the contract as well. this will be very important to keep all
parties accountable again not just a site payment vendor but also the study
sponsor on exactly what was agreed to, on exactly what were the conversations
in the beginning because obviously at the time everyone’s trying
to sell you a product,you know some promises can be made and so you want to
make sure that everyone is held accountable to what was agreed up front.
It’s not a problem if something is not possible in a system or things of that
nature but it’s very important that you understand from the beginning what is
possible versus not. So again, capture everything in a
document. So there you have it, just some top tips for you if you’re thinking of
selecting and implementing a site payment vendor in the future. Make sure
you have at least these tips down in your conversations and for your
implementation. Again we’ll have a full checklist on selection and
implementation of site payment vendors later on this month for our newsletter
subscribers so make sure you subscribe at www.clinbiz.com. I hope to see you at the
ClinBiz Summit 2020 coming up on March 24th through 26th at the Hyatt Regency
in Morristown New Jersey. It’s going to be an amazing conference you can attend in
person or online. If you’re planning to come in person, please do register soon
because we have limited space for that. Make sure you register quickly so
you’re not left out of this event. You can attend online as well and watch the
entire conference via our livestream registration option which is quite
unique and new. You don’t want to miss this conference if you’re at all
involved with the business aspects of clinical trials. You want to
be in that conference, you want to hear the conversations of things that
are coming, things that are happening. We have a ton of different things in the
agenda – check it out at www.clinbizsummit.com and I hope to see you soon – take
care – bye bye.

Good Manufacturing Practices for the Food Industry



think about this for a moment if you had a choice would you select the clean plate for your food or our dirty one would you choose food with a little dirt on it or food that is clean you probably would not want to be in a place where these types of choices are even an option most of us do not want to take the chance of getting sick because of something we eat food cleanliness safety and the health of our bodies are very important this is so important that the government has established a series of laws that regulate food production to ensure that safe products are made these laws protect our consumers and those that we love this law from the Food and Drug Administration or FDA is in the Code of Federal Register as CFR 21 – part 1 10 1 very critical issue addressed in this law is the issue of food contamination sources of contamination are everywhere they are present in your clothing on your skin and from machinery on a manufacturing line even improperly inspected raw materials can be a source of contamination for our product we control contamination by following a set of FDA manufacturing guidelines that will ensure that our product is safe these guidelines are called Good Manufacturing Practices or GMP s they address many potential contamination issues in the food processing industry including plant design the equipment we use production and process controls and the impact of the people who work directly in the making of our products GMP s are designed to provide consistent quality and prevent contamination in the food items we produce we have a very important job in producing food items people trust us to make a product that is safe to eat that's why we stress the rules we will tell you about in this GMP program pay close attention to the information presented in each lesson and follow these rules in our food manufacturing process all employees must be aware of and follow all GMP s and related procedures to ensure the highest quality of our products our customers and your family depend on you you

ICC Northwest featured on Manufacturer Marvels



hi this is John Criswell welcome to manufacturing marvels today we're in Canby Oregon with ICC Northwest newest addition to parent company ICC Group ICC group is an innovative engineering firm that delivers fit for purpose solutions to industrial clients based on four key areas of expertise including business insight delivery management process engineering and regulatory compliance ICC Northwest manufactures custom stainless steel tanks mixers and reactors for the food processing beverage pharmaceutical and cannabis industries in their fifty thousand square foot manufacturing facility in Canby Oregon they built vessels in the seven to 14 gauge stainless steel range and up to 1/2 inch thick the facility can also accommodate the construction of tanks up to 14 feet in diameter and 50 feet and overall height they manufacture their own flanged and dished heads up to 12 feet in diameter tanks can also be designed and manufactured to the American Society of Mechanical Engineers and ul specifications as well as any seismic requirements that exist their product range includes a wide variety of innovative vessels such as spark mix tanks with custom agitators vessels featuring computerized processing controls and processing systems including they're very popular craft brewing systems they also build extraction systems for the cannabis industry ICC Northwest holds two United States patents for the scent of oil an ultra sanitary impeller and the santa bearing the sanitary steady bearing with five regional offices the ICC Group offers a wide range of services from greenfield factory design to here-and-now production line adjustment come visit them at ICC dash n W net this is John Criswell for manufacturing marvels

Why Drug industry has to change



We take ever more pills. The pharmaceutical industry's
profit machine is running at full speed. Attempts to make medication cheaper
get deadlocked in the system. But health care premiums keep rising,
to the detriment of patients. What's wrong with the system?
How can it be improved? Four passionate pioneers fight,
each from their own expertise… …for new ways to keep medication
affordable for everyone. Many companies base their price
on cost plus a fair profit margin. In this case they go
for the maximum return. And with drugs that's very annoying
since everyone wants them. The system as it operates now
is very agreeable to them. They sell drugs that are ineffective
in 70-80% of patients. It's close to incredible. I think our governments,
including the Dutch government… …should show much more guts,
much more courage… …to intervene if companies won't make
important drugs available at a fair price. This is Backlight. Welcome
to the world of wealth and health. The Dutch use a lot of medication. It shocks me to see these huge
amounts that arrive in the morning… …and then to think:
that's what we ordered on just one day. Pharmacist Paul Lebbink
runs a pharmacy in The Hague. He acquired fame
by copying expensive drugs… …at only a fraction of the price,
to the chagrin of the industry. Why do we take so many pills? This is for blood pressure. I think medication is often prescribed
and given out automatically. Industry research focuses on proving… …that the use of ever more medication
has an added value. Less might be much better
for our health. Look at this package,
a big bag for one patient. This is for just three months. Each pharmacist wants to help patients
and the worst that can happen is… …that you can't provide a drug because
it's too expensive or unavailable. I see it as my primary task to ensure
that the patient can get the medication. Those are sachets with a powder
that has virtually no side effects. Lebbink is frequently faced
with new expensive drugs… …which he could produce himself
at much lower cost. The pharmaceutical industry is
now focusing on rare diseases… …developing medication for them
at a very high price. If something is so expensive that
patients can't afford it, it's no use. So that's a good reason to think:
if I were to make this myself… …would that lead to a price
the patient can afford? Until the early 20th century
pharmacists made their own drugs. Only in the 30s, 40s, 50s
did the industry emerge… …introducing processes
for larger-scale production… …of pills, capsules and powders… …so that pharmacists
produced less and less. I think 2-3% of the drugs
we provide to patients… …are prepared
by pharmacists themselves. We can't go much lower since the
industry can't provide customized drugs. That wouldn't be profitable for them. Plus there are compounds that a doctor
would like to try out before it's a drug. This is a product we make here:
morphine cream. A doctor had a patient
with many bedsores. And none of the drugs he prescribed
sufficiently eased the pain. He wanted me to make morphine cream
for application on the wounds. So there's no company
that produces this cream. No. There's not enough evidence
that it would be effective. Several of our patients report
that the cream decreases their pain. But that doesn't count
as scientific evidence. And you're allowed to prepare it?
– Yes, as a pharmacist I can do this. We can give this to patients who
use it as medication for themselves. In 2007 I was summoned in court
by Orphan Europe… …because I had prepared a compound
they had put on the market. They argued that I should have given
this patient their product. I disagreed. I found their price way too high:
150,000 euros a year per compound. Our price was 3000 euros.
The ingredients are not that expensive. This compound was initially bought
from the paint industry. We had produced it because
this boy lacked an enzyme. The judge cleared me on all counts. He said: A pharmacist can make a drug
for his own patients… …even if the patent on this drug
has not run out yet. The doctor should then
prescribe it generically. So you can't use the name
that was patented by the company. Under a generic name pharmacists can
make medication for their own patients. Did they put any pressure on you? They certainly did.
They visited me several times. But it was all done in a more
or less decent way, fortunately. To get a better understanding of the pill
industry we speak to Peter Gøtzsche. For ten years this Danish doctor
did marketing and research for Astra. He became a whistleblower… …and is now known for his thorough
critical studies on the pharma system. The unreliability of data led Gøtzsche
to set up the Cochrane collaboration… …a famous network for independent
research into the effects of drugs. The online database is now consulted
from all over the world. We have come to the conclusion that
pharma companies charge excessively. And the money paid to them
can't be spent otherwise. Access to health care, an internationally
recognized human right… …is therefore endangered,
since too much is spent on medication. Jan-Koen Sluijs is a solicitor. He was
shocked by the prices for new drugs. He often litigates on behalf of big
companies in competition cases. Now his team is looking for a way… …to legally force pharma companies
to decrease their prices. These Actavis hydrocortisone tablets,
I have no idea what the benefits are… …are very expensive,
120 times as much as before. What motivates you? It may sound pathetic,
but I fight against injustice. This is a kind of new revolution:
how to keep our society in balance. They often talk about innovation,
about development costs. It's time to put that behind us. Over the past two years
we've seen more and more research… …putting this in doubt and arguing… …that development and production
costs are far lower than they say. The problem is that we pay
and continue to pay through the nose… …without any need, for why
should they make such huge profits? This Gilead hepatitis C medication
is a prime example. They were the first on the market.
Development costs were moderate… …as they bought it
from a spin-off company. They made some minor changes, put it
on the market and made huge profits. Exactly. This is wrong.
I think everyone agrees about this: The budget for specialist health care
goes up by 1.5% a year, as agreed… …but virtually all the extra money
is spent on price rises for medication. I don't want to put it too dramatically,
but I think the result will be… …that your hospital bed is
a mattress in the corridor… …since the building…
– But with good medication. Yes, you'll get a lot of great drugs
but you'll never see a doctor. We pretend it's normal
to go for maximum profit. But most small companies in this
country base their price on the cost… …plus a fair profit margin. In this case
they go for the maximum return. And with drugs that's very annoying
since everyone wants them. You should honestly assess
whether this is a fair price. So market forces don't correct this?
– It's only a free market in the sense… …that the company sets its price,
and in the end… They use the system in order to…
Well, they abuse the system, basically. So either the market
should be opened up completely. No patents and so on, just tough
competition. That's one option. Or the government should say:
From now on we set the prices. But how can you argue
that the current system is illegal? Exploitation of clients is a type of abuse. We, our foundation,
want to go one step further: Can't you appeal to human rights… …and say that pharma companies,
through their excessive profit margins… …block access to health care? Is there a right to cheap medication?
– No, there isn't. But there is a right to accessible,
affordable and high-quality health care. And if need be,
we go to court to achieve this. I can't rule out that we will. The sector has not really proven
that it is open to change. A court case
against a pharma company. Total global turnover of the pharma
industry is almost 1000 billion euros. One trillion euros per year. The list is headed by Roche from
Switzerland and Pfizer from the US. My specialism is the treatment
of pancreatic cancer. On average Dutch patients live six
to nine months after being diagnosed. After five years
the survival rate is 5-6%. It's very aggressive, the second cause
of cancer deaths in the Netherlands. Currently more patients die
from pancreatic cancer… …than from breast cancer or cancer
of the large intestines: 8-10 per day. Casper van Eijck
is very independent-minded. The Feyenoord team doctor
is a respected researcher. He treated patients from around
the world, including Steve Jobs. Chemotherapy is effective
in only a limited number of patients… …while it generally has
many adverse effects… …very harmful adverse effects. My personal motivation is
to stop this aggressive form of cancer. We've worked on that for 25 years
and haven't made any real progress. That should change, especially
with this aggressive form of cancer. Pharma companies
are very risk averse. To Van Eijck's frustration
progress is too slow to save his patients. That's why he himself is eagerly
trying to find new drugs… …that do work
against pancreatic cancer. By now every scientist, be it in the
Netherlands or the US, is convinced… …that all forms of cancer
are curable in mice. For our patients that's not yet the case,
unfortunately. So at Erasmus Medical Centre
our emphasis is… …on so-called clinical research,
research in patients. That's expensive
but you need to facilitate it… …because it brings progress and you end
up with so much expertise in hospital… …that pharma companies can never claim
their development costs are very high… …as all the work will be done
in hospital. That's a way to keep
the price of medication low. It has always been my principle
to keep the industry at a distance… …to avoid the danger
of becoming dependent on them… …concerning the prescription of drugs
or whatever. I don't like that at all. Whenever pharma companies
approached me I said: I'd rather get funding for research
than expensive trips or dinners. Those are really a waste of money. A lot of people
have personal motivations. In most cases
they have lost relatives to cancer. My father died from it
at a very young age. That gives you a certain drive… …to try to achieve something
with your team. Two times sixty.
– That's right. Okay, fine. What kind of drugs are these?
– Cytostatics, for chemotherapy. Yes, 17 ml. That's right. These compounds are poisonous,
so if you work with them all day… …you need protection. This is one of our expensive drugs,
ipilimumab, a real tongue twister. One dose for one patient
costs around 17,000 euros. We often give an additional drug,
nivolumab… which also costs
several thousand euros… so the cost of this combination is
about 25,000 euros per "drip day". Patients get it once every three weeks
as long as they don't react badly to it. So it may continue for several months.
For some patients the results are good. But it's not a real cure. It only slows down the disease.
It doesn't make it disappear altogether. What's the value of this box?
– Its contents are worth a fortune. Why do we continue to pay
so much money… for cancer drugs that are ineffective
for so many patients? The system as it operates now
is very agreeable to them. They sell drugs that are ineffective
in 70-80% of patients. It's close to incredible. So for a very large group of patients
who get chemo therapy it's useless. Big pharma couldn't care less
that most patients don't benefit from it. And that should really be stopped. Why does chemo work for some
but not for others? That's what Casper van Eijck
wants to find out. But the industry won't fund
that kind of research. I can imagine that it's not
in the interest of pharma companies… …that doctors can predict
whether a drug is effective or not. It would mean that 60% of pancreatic
cancer patients won't take this drug… …decreasing their turnover
by 30 to 40 million euros a year. There are so many opportunities
for clinical research. And I think we should use
more of those opportunities. In my own patients I notice
that virtually all of them say: If it doesn't help me, I would still
contribute to other people's future. This social way of thinking is unique, I
think, for the Dutch patient population. Hello dear Casper, this video
is the last time you'll see me alive. The FOLFIRINOX therapy
that I opted for a few weeks ago… …as you will remember… …has sapped me to such an extent… …that one of these days
I will die from a complication. One of the things that are bugging
me is: I should tell Casper van Eijck… that I can no longer take part
in his wonderful research project. But please continue
on this promising path. I'm fine and I wish you all the best.
Bye. I say: Why don't we make it obligatory
for pharma companies… …to help fund research
aimed at predicting… …if someone will benefit from chemo
or not. I call it a chemo tax. I think it's important that pharma
companies think along with us… …but also help fund research… …aimed at avoiding a very tough therapy
if it's not effective. We also pay road tax
because we pollute the air. Chemo tax.
– I think it's quite a good idea. But how can we achieve that?
We ask patent attorney Ellen 't Hoen. For thirty years she's been advocating
a fairer system for drug pricing. I'm a solicitor and my area of expertise
is access to medication. Initially, I mainly worked in developing
countries, where the problem was huge. But my focus has shifted
to rich Western countries… …because drug prices
are going up everywhere. In the 90s 't Hoen was involved
in the successful fight… …to make aids medication
affordable and available in Africa. This helped save millions of lives. At the time aids medication
cost 15,000-20,000 dollar… per patient per year. Hardly anyone
in Africa had access to it. Each day 8000 people died,
and in those circumstances… …pharmaceutical companies
decided to sue Nelson Mandela. Everyone said:
Now they're really going too far. As soon as you try to get down
the price, they'll always say: Then we won't be able to develop new
drugs, since that's very expensive. It's true that it's expensive,
but we don't know how expensive. That's unclear. Companies should be
asked to provide information about it. This could be part
of government policies… …regarding national insurance coverage. Here Ellen 't Hoen gets her Ph.D.
for research that describes… …how governments can waive patent law
in the interest of public health. The Dutch government can't drive a
hard bargain with pharma companies… …because it's very difficult
to negotiate with a monopolist. But the government could say:
The price must go down… …or we'll ask someone
to produce it for a lower price. Then the power dynamics in these
negotiations would be totally different. The government should do that
much more often. We pay around 40,000 euros
for hepatitis C drugs… …that cost 60 euros to produce. That's patently unfair.
So the government should interfere. Could the government do that
in the current situation? Yes, according to Dutch patent law
the government can take up that role… …as I describe in my dissertation. At a European level
it would require some action. But if countries make better use
of their patent laws… …in the public interest… …the move to adjust these medication
regulations will follow automatically. Medication law is aimed
at making drugs available… …not at withholding them from patients,
which sometimes happens now. I think our governments
should show much more guts… …to intervene if companies won't make
important drugs available at a fair price. In his search for effective drugs
Van Eijck is pushing the boundaries. The government can make new drugs
available only after a long testing period. So Van Eijck approached
entrepreneur Ronald Brus. His startup helps doctors and patients… …in acquiring experimental drugs
from around the world without delay… …even if they have no official approval. This compound works very well,
especially in the beginning. I've seen the data
from the US mouse studies. We'd like to see exactly how
these studies were carried out… …and to assess whether this is feasible
for our patients. In the Netherlands immunotherapy
costs 70,000-80,000 euros on average. Since this drug has not been approved
it's not covered by any insurance. What's wrong with the system? The system has contributed
to the situation… …that all new drugs are very expensive… …and that it takes very long
for a drug to become available. Those two things have been revealed… …thanks to the internet and the expertise
of doctors and patients worldwide. People see that a drug shows great
results in one country and wonder: Why can't we get it here? And we've also started asking:
Why are drugs so expensive? Brus made his fortune
with the Crucell biotech company. Now he's a pioneer
in the new form of data-driven pharma. I'm a doctor. For thirty years I did
pharma research into drugs. And then, a number of years ago… …my father's illness made me look
for new medication for him. As the CEO of one of Europe's
biggest biotech companies… …I had friends in the pharmaceutical
industry who led big companies. One of them was developing a new drug
and offered it to me. Then I thought:
This is a great chance for my family. But why shouldn't others
also get that chance? Then I found out how hard it is,
even if we know a drug is effective… …to get it to Holland, so I founded
myTomorrows to facilitate that. We're currently active in 22 countries. Each month you lose is a lost month,
for you and for your patients. They'll never get it back. I still think this is the path
we should follow: We should make it clear
that it's very important to us… …to monitor the effect of a certain drug
in a limited group of patients. The government should also help us
regarding the availability of drugs. People will only make things available
if they get something in return. If a pharma company is forced
to hand something over… …without getting anything in return,
it won't work. I think the current system
will eventually break down. Doctors and patients around the world
want to have access to those data. The companies that make those data
available will be the most successful. It can't go on like this:
developing things in secret… …without sharing them with the patients
and doctors who helped you do that. With the current expertise, which can
be shared with billions of people… …that's no longer accepted. What do you say as a doctor?
How would a new system work? How would these drugs
be produced and priced? The ideal system is one
led by doctors and scientists… working in tandem with health
insurance and pharma companies. That would be my ideal. Then we
could make big strides very fast… …and it would all become much cheaper,
since we could assess in advance… …whether drugs are effective or not,
which is very important. Van Eijck is in a hurry:
each day patients die. In the Erasmus medical centre
he's taking a revolutionary step. Together with virologist Ron Fouchier
he's developing his own cancer drug. We had budgeted virus production
at 650,000 euros per badge. What's included in that?
– Everything. We are going over the business plan
for the virus production facility. We want to produce
these viruses ourselves. So you're making a new drug. We're developing a new drug
on the basis of viruses. We try to do that
without industry involvement… …with the help of science funds
and crowd-funding actions… …so that we are in control. What will it cost
to develop this virus therapy? I think if we add it all up
and we would… …we could use the very first badge
we make for a clinical study… …our total cost would be
10-15 million euros. How do you get funding? Mostly from the Support Casper
campaign… …a foundation set up
by next of kin of deceased patients. That way we're largely independent. The industry takes a great interest
in our research. They've already asked us
to show them how we're doing things… …since the industry will see us
as a competitor. So pharma companies are certainly
interested in what we're doing. In the first year, when we're renovating,
we won't need a 0.5 fte pharmacist. You need a technician to scale up
from 10 millilitres to 10 litres. What's the role of this quality official? I wouldn't know. That's actually
directly related to your IMPD. If this virus therapy proves effective,
will you apply for a patent? We already started the application
procedure for a number of viruses. We only do that to ensure… …that the price can't be driven up
if it should prove effective. After two years of toil
to get the project off the ground… …we now have an actual case. "Exciting" may not be the right word.
It's a memorable day, it really is. We can't uncork the champagne yet,
but this is what we've been waiting for. What's in today's paper? Foundation seeks fine for pharma
company over price increase. That's today's goal. We'll ask the ACM
to act against Leadiant… …the pharma company
that in ten years' time… …made its product
500 times as expensive… …as the original drug
that was already on the market. ACM?
– Authority for Consumers and Markets. They see to it that companies
don't abuse their position of power. We have established that Leadiant
had a trade permit for this drug. It bought the existing drug here
and scrapped its registrations… …so that others were not allowed to sell it. Then they increased the price, from
30 cents to 140 euros per capsule. That's 150,000 euros per year
per patient: a huge difference. Tie a ribbon around it. After a long career
this is something of which I think: As a solicitor I can make a difference
here. It has an activist element. I may not look like an activist,
but in this case… …I'm involved in activism. You always hear that it's all very bad… …but that these companies act
within the confines of the law. They endlessly repeat that. But I'm convinced that they don't act
within the confines of the law. Of course you're allowed
to take over a company. But you can't abuse your position.
They act improperly. They violate the due care principle. That's also part of the law. But you
need judges who pronounce that… …and solicitors who present this view
on behalf of a client. But this is step one,
and I think it's a fairly clear-cut case. Everyone who's not involved will agree… …that an increase from 30 cents
to 140 euros is unacceptable. But more is needed
to change this behaviour. That's our goal, to change the behaviour
of these pharma companies. Let's see. It's quiet. They're all having lunch now. There we go. Good afternoon.
– Our foundation, this is our chairman… …wants to ask ACM to act against
a pharmaceutical company, Leadiant.

EU Innovation Network – For SMEs with ideas on medicines



The European Innovation Network is a network of national competent authority innovation offices. And these are offices built specially to support and talk to innovators, academic innovators and industry innovators. We also have these informal discussions especially for academic groups or small SMEs, who don’t exactly know what is the plan, how to develop, so they bring their ideas and then we discuss that please take into consideration these guidelines. The regulatory network can support us in the development of medicines in many different positive ways. We’ve been very good users already of the scientific advice and parallel scientific advice processes. We found them incredibly helpful in order to align our thinking on our development plan with our regulators; we’re getting very helpful input. The parallel scientific advice with HTAs is been especially helpful as we think about evidence for health technology agencies across Europe. So this kind of event is crucial I think, because is about also removing some fear and some reluctance for smaller companies to come and discuss with the Agency. This is a great opportunity to do that; that you are here in a more relaxed environment and you can ask questions and you can see the face behind the names.