Pilatus Comparator Solutions are looking forward to meeting old and new friends at Clinical Trial Supply West Coast next Week

Pilatus Comparator Solutions will be Exhibiting at the Clinical Trial Supply West Coast Conference next week in Burlingame CA.

Both Julian Wolfe and Elisa Purvis are looking forward to catching up with old friends and making some new acquaintances there, so please do come and visit us on Exhibitor Stand one.

http://www.arena-international.com/ctswest/

Pilatus Welcomes Elisa Purvis as our International Business Development Manager

Elisa joins Pilatus as International Business Development Manager, where she will be responsible for managing, maintaining and growing Pilatus’ key strategic customers, as well as building awareness and educating the market about Pilatus as a global expert in the delivery of Comparator Sourcing  Solutions for clinical trials.

Her most recent role was Pharmaco Business Manager at Celesio, where she worked closely with a number of its key strategic pharmaceutical manufacturer clients, negotiating wholesale contracts and implementing a variety of distribution and service models.

Prior to that, Elisa spent eight years in the pharmaceutical industry working in a number of roles within Pfizer’s Established Brands business unit, delivering commercial growth of post-patent medicines, leading cross-functional teams to develop, implementing innovative patient services, and new business development across multiple channels.

Sales & Marketing Director Ian Hoban says “We are delighted that Elisa is joining us and her track record of delivering high value business solutions to business clients speaks for itself and I am really looking forward to seeing Elisa strengthen our Client relationships further”

Pilatus in the Media

Industry Viewpoints: The Keys to Effective Comparator Sourcing

Supply Chain

09:03, March 13 2018

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Ian Hoban, Kevin Wolfe & Julian Wolfe, Pilatus Clinical Services, speak to CTA Editor Henry Kerali about the challenges of comparator sourcing

For clinical trial sponsors across the world, sourcing comparators can present a number of logistical and regulatory issues. How to source, transport and deliver comparators for a clinical study are all part of a complex process involving a myriad of stakeholders.

In this Industry Viewpoint, CTA Editor Henry Kerali speaks to Ian Hoban, Julian Wolfe and Kevin Wolfe of Pilatus Clinical Services, as they explain the keys to effective comparator sourcing.

Henry Kerali: What are some the key considerations sponsors need to factor in when sourcing comparators for a clinical trial?

Ian Hoban: With respect to comparator sourcing, sponsors need to understand what they’re trying to achieve and where they’re trying to achieve it. From there, it’s important to assess how that relates to the availability of the comparator by asking of themselves the following questions:

  • What quality documentation is required and is it freely available?
  • What markets are comparators being sourced from – are they large enough to sustain the required demand, and should I consider having back-up alternatives planned in?
  • What countries and markets are the trial site contained within?
  • What customs documentation/tariffs are required for both the previous two points and what back-up plans are required for unforeseen circumstances, such as customs hold-ups, to ensure product integrity is maintained?
  • Do I want to share trial details with the comparator manufacturer, and if not, am I fully aware of and happy with the limitations this may result in?
  • What commercial market intelligence do I have, and is it current and detailed enough to avoid potential supply disruptions?
  • Have I selected the right comparator sourcing partner and do they challenge my thought process sufficiently to keep me one step ahead of the game?

HK: What length of time is required when planning to source a comparator?

Ian Hoban: The starting point should be determining the worst case scenario, namely, a severe delay to the trial start date. That delay will subsequently have a knock-on effect on the study end date, and can ultimately affect the sponsor obtaining a timely marketing authorization. This could well have an impact the market analyst’s value of a sponsor organization, which can be catastrophic. So, in effect, planning for the worst case scenario can set you on the right course when sourcing a comparator.

Julian Wolfe: Quite often, comparators are thought of a little too late. Therefore, it’s essential sponsors set out a plan for sourcing comparators by a certain date and by a certain time, and working back from there. Furthermore, establishing a plan that’s robust with a Plan B and a Plan C allows the sponsor to act in unforeseen circumstances. Ultimately, it’s difficult to place a set timeframe on a comparator, which is why it’s important to understand the market dynamics and the usage of that comparator as each product is different.

HK: What information are sponsors expected to supply before and when purchasing their comparator product?

Ian Hoban: In clinical trials, there needs to be a hard endpoint when the stock is required. Sponsors therefore need to consider when to have a conversation about comparator sourcing – a few months beforehand simply isn’t sufficient enough lead time. Questions surrounding what a reasonable batch size is and how many batches you want are important factors to consider. By sourcing larger quantities, sponsors can carry out packaging and labelling for study purposes as a one-off cost, rather than in multiples. However, this is where expiry date availability becomes a factor. Typically, products have their own profile on what’s available in the market and what’s available from the manufacturer’s likely lead times. This can guide sponsors on the correct course of action to take.

Kevin Wolfe: Furthermore, it’s key to consider what presentation do sponsors need to do the trial again. If you’re trying to source a vial, and the comparator is only available as a pen, how can you get around that? Is the dosage in the right format in the volumes required? We’ve had studies in Asia-Pacific where a sponsor used one strength by virtue of the patient population and the disease, whereas in Europe and the U.S. a different strength was used. And yet, they were trying to source a product from the bigger markets in a presentation that isn’t freely available because they’ve put the wrong dosage form in their submitted protocols. Therefore, it’s essential to plan ahead, and this is where Pilatus can offer guidance and advice.

Julian Wolfe: Another consideration that many sponsors fall foul of and where comparator experts come into play is what the destination points for that product are. Sponsors must know what product documentation is needed, what the tax and customs regulations are, and the lead times needed when applying for certification. This is key in enabling freer movement from market to market.

Kevin Wolfe: What’s more, providing a forecast schedule for the lifetime of the product will greatly help when working with the manufacturer. Here at Pilatus, we engage with manufacturers on a regular basis to ensure the volume requirements for the study are met further down the line. We see a lot of requests come through for a specific amount at a specific point in time. While that may be achievable, when scaling up that might not be feasible. So, it’s important to engage with the manufacturer earlier in the process to guard against hiccups in the future.

HK: From a comparator purchasing point of view, what do sponsors need to consider when submitting protocols for a global study?

Ian Hoban: It’s important to have a number of sourcing options built into the protocol. If Plan A fails, Plan B can be enacted, meaning the sponsor won’t have to reapprove the trial by inserting things that could have been done upfront. Many sponsors don’t engage with their comparator partners early enough to ensure a contingency plan is put in place. We believe it’s an important function of a comparator sourcing specialist like Pilatus to challenge our clients and make them plan for the worst case scenario.

HK: What are your views on Brexit in relation to comparator sourcing?

Ian Hoban: There are three factors to bear in mind when it comes to the impact of Brexit: the regulatory impact on the pharmaceutical industry, the movement of goods, and the differentials in currency exchange rates.

If you think about the regulatory impact, at the start of March for the first time, we got real clarity from the U.K. government when Theresa May proposed an affiliate membership of the European Medicines Agency. The remaining issues thereafter would surround the extent to which the U.K. will pay to be an affiliated member, as well as what rights and privileges they have in proposing new regulations.

As for the movement of goods, Brexit has engendered a fair amount of concern. The reality is if there’s a very soft Brexit, not a whole lot will change. If there’s a hard Brexit, in the worst case scenario there will be tariffs to move goods around. That said, working with a comparator sourcing specialist, such as Pilatus, is beneficial as they will constantly monitor the regulations, customs requirements, lead times, and all the speed barriers hampering the movement of goods around the EU.

Lastly, with currency fluctuations, it’s important to have a foot in both camps – a presence in the U.K. and the EU. Sponsors must switch their strategy accordingly and minimize the risk incurred when currencies change. Overall, I think there’s a little bit of clarity emerging with regards to Brexit.

But what Brexit does emphasize is the fact that change is ongoing. However, there are always a few key drivers generating the demand for comparator sourcing in clinical trials. It’s incumbent upon everyone operating in this space to evolve ahead of the game – look at what’s happening in the future, and plan for it, rather than react to it, and that differentiates those who succeed from those who fail.

Pilatus Clinical Services Exhibiting at CTS Europe 14 -15 March

We are delighted to be in Milan at CST Europe 2018.
If you are here, please come and see Matt Labron & Ian Hoban at the Pilatus Comparator Solutions stand – we’ve got lots of exciting developments to update you with and great advice to assist you in developing world-class Comparator Sourcing Solutions for your clinical trials.

Should you like to call to arrange a convenient time to meet with us, please call Ian on +44 (0) 7591 204031

CTS Europe

Pilatus Clinical Services – German Subsidiary PCS GMBH Awarded WDL & GDP Certificate

LONDON, March 14, 2018 /PRNewswire/ —
As part of Pilatus Clinical Services ongoing plans to strengthen its position in Europe and as part of establishing a Global footprint, the company has announced that following a recent inspection by the German regulatory authorities, its German facilities in Brandenburg have been granted a WDL/GDP Certificate.
Managing Director, Philipp Hofmann says, “We have now been established and trading since April 4th 2017, but it was imperative that we are geared up to be in a position to operate under this WDL/GDP Certificate. I am proud of the dedication put in by the team to ensure that we received the go ahead from the regulatory authorities in record time.”
This will greatly strengthen Pilatus Clinical Services’ position in Europe and enhance its access to manufacturers and suppliers in Europe, to transform the service offered to clients.
With Brexit looming, this move will also mitigate any risk of exposure to Pilatus Clinical services and our Clients.
Management of end to end supply chain, so you don’t have to worry about it. To find more out about Pilatus Clinical Services, please take a look at our website http://www.pilatusclinicalservices.com/
Contact details for PCS GMBH:
+49-3328-428-9909
p.hofmann@pilatuscs.com
http://www.pcs-deutschland.com
PCS GmbH, Mahlowerstr. 249, 14513 Teltow,
Amtsgericht Potsdam| HRB 30039 P | USt-IdNr. DE312595524

Pilatus to Exhibit at Clinical Trial Supply Europe 14th – 15th March

Please keep a look out for Pilatus Clinical Services, a specialist in providing Comparator Solutions in clinical trials, who will be exhibiting at Clinical Trial Supply Europe 14th – 15th March 2018 Milan, Italy.

We are looking forward to catching up with colleagues and meeting new potential clients at next week’s Clinical Trials Supply Europe Conference.

Pilatus Clinical Services has gone through tremendous growth over the last 12 months and are excited at the prospect of sharing with delegates this wealth of news and how we have significantly strengthened our capabilities during this time.

Pilatus Clinical Services Colleagues attending are:

Ian Hoban:         Sales & Marketing Director:

Mob:                   +44 (0) 7591 204031

Email:                 i.hoban@pilatuscs.com

 

Matt Labron:     Account Manager

Mob:                   +44 (0) 7702 033478

Email:                  m.labron@pilatussc.com

 

If you would like to find out more about we can enhance your trial success, please feel free to contact either of us before or during the conference.

Website:             http://www.pilatusclinicalservices.com/

Phone number:+44 (0) 1923204310

Announcement: Jennifer Batanga joins Pilatus clinical Services as Quality Manager.

 

We are delighted to announce that Jennifer Batanga, who was previously Quality Assurance Supervisor at Baxter has joined Pilatus Clinical Services as our Quality Manager.

Jennifer has been working in the Pharmaceutical Industry for over 10 years in wide variety of roles within the Quality field. She has a proven track record in supporting aseptic filling, aseptic compounding, API and final product manufacturing and distribution.

She has an extensive knowledge of quality systems, quality management and process improvement. In her previous role, she had responsibility over the QMS whilst ensuring services improved via the efficient and effective QMS implementation throughout the unit.

Jennifer says: “I am a quality focused person who is always looking for ways to facilitate quality improvement and performance through the implementation of appropriate actions to capture and address issues in pursuit of improved customer satisfaction.”

In addition to fulfilling her quality role, Jennifer is looking forward to working closely with Clients to further enhance their customer experience with Pilatus Clinical Services.

New Sales & Marketing Director Ian Hoban

Pilatus Clinical Services are delighted to announce another addition to our management team. Mr Ian Hoban, previously Commercial Manager at Eli Lilly, will now fulfil the role of Sales & Marketing Director. Ian has close to 30 years of experience in the pharmaceutical industry, acting in a variety of roles including those of senior leadership at both Pfizer and Eli Lilly.

Pliatus New Sales and Marketing Director

In his most recent position, Ian was responsible for managing the commercial development of numerous therapeutic brands, from development through to product launch and ultimately to loss-of-exclusivity. Ian is well-versed in the pharmaceutical supply chain and understands how getting the optimal solution in place is fundamental to the delivery of successful project outcomes.

Ian is no stranger to the clinical trials supply arena. Before his function as a Business Development Director, he held a consultative role at a major pharmaceutical company; helping deliver added value to their customers and partners following the acquisition of a number of diversified businesses.

‘Our commercial footprint is growing. With the incorporation of our sister company; PCS GmbH in Germany and future expansions in the pipeline, we are confident in achieving our goal of providing smarter comparator sourcing solutions to the clinical trial community. Myself, and the remaining board members are excited at the prospect of working with Ian to capitalise on these expansions and maximising Pilatus’ brand in the comparator sourcing space,’ said Julian Wolfe, Commercial Director at Pilatus Clinical Services.

Ian has a passion for collaboration and has seen how business partnerships can deliver strategic insight. At Pfizer UK, in the Established Products Business Unit, Ian oversaw the implementation of numerous techniques and witnessed how they transformed business outcomes in a highly competitive space.

This is another great advancement for the Pilatus group, improving our status as a leading service provider in comparator sourcing for clinical trials.

German Subsidiary Incorporation and the Arrival of our New Managing Director

Pilatus Clinical Services (PCS), a world leader in comparator sourcing in clinical trials, would like to announce the incorporation of their German subsidiary PCS GmbH. PCS GmbH is a service provider to the pharmaceutical industry, and will work closely with laboratories, manufacturers and clinical trial sites, to provide end-to-end solutions for product procurement, distribution and intelligence. With a warehouse/distribution centre situated in Velten and an office hub in Teltow, Germany, the two facilities will act as an extension to Pilatus’ clinical trial service offerings.

Germany is a dominant market for clinical trial supplies and has one of the greatest numbers of authorised distributors to the top 20 pharmaceutical and biotech companies in Europe. The Company’s investment is a response to this and capitalises on their strong and trusted relationships formed with German-based manufacturers and authorised distributors of biologics, biosimilars, generics and small molecule IMPs.

The two new facilities will complement the tailored approach Pilatus takes with each of their clients. With sharper market insight and a dedicated procurement team, all clients are assigned a project manager. Pilatus is a well-recognised brand in the clinical trials space. This has stemmed from their smarter solutions approach, encompassing not only the initial purchase of the comparator, but utilising techniques to maintain consistent pricing and supply of the product for the duration of your trial.Conforming to regulation, PCS GmbH works under GDP /GMP guidelines and provides full transparency of your product from the beginning to the end of the procurement journey.

The directors of Pilatus Clinical Services have named Mr. Philipp Hofmann, as the Managing Director of PCS GmbH.

‘Philipp is a wonderful addition to our team. With decades of experience in this industry; many of which in key shareholder and management positions. Philipp will ensure that our procurement services reach a greater number of clinical trial sponsors’ Julian Wolfe, Commercial Director of Pilatus Clinical Services.

Prior to leading PCS GmbH Philipp, acting as a key stakeholder, managed several pharmaceutical wholesaling businesses in Germany and the Netherlands; some of which saw him establishing and running the procurement departments. Philipp’s career to date has focused on supply chain management and stock distribution, through which he has been able to establish close relationships with manufacturers and authorised distributors in Europe.

Philipp is a German national and studied Philosophy, Politics and Economics at Denison University in Ohio and the Vienna School of Economics in Austria.

About Pilatus Clinical Services

Pilatus Clinical Services is a leading global comparator sourcing specialist. With a strong supply chain network and a dedicated sourcing team, Pilatus is committed to delivering smarter solutions in the complex and demanding arena of clinical trial procurement.