CASE STUDY 5 – FORESIGHT AND KNOWLEDGE ON IMPORTATION CERTIFICATES PREVENTS PHASE 3 PRODUCT DESTRUCTION

Pilatus was asked to source different oncology products for a Phase 3 trial. The client requested 3 products, each with multiple specific batches, to be sourced from the EU market. Our client was unaware that a China Inspection and Quarantine (CIQ) certificate was needed for their products to be cleared by customs.

 

CIQ is supervised by The General Administration of Quality Supervision, Inspection and Quarantine, one of the major quality management institutes of China. It is the CIQ certificate that permits your product to be imported into the country.

Particularly, there are 5 sets of documents you will need to provide in order to be granted a Q certificate:

  • A company profile accompanied with a product description and evidence to support why your goods can be declared.
  • A safety compliance declaration.
  • Quota Certificate(s)
  • Business Licence
  • Importing Licence

In addition to the Q Certificate…

Read this and our other case studies on our client area.

For smarter comparator sourcing solutions, contact Pilatus Clinical Services today on: UK: +44 (0)1923 204310

New Hire: Commercial and Operations Manager

Felicity Smith – Commercial & Operations Manager at Pilatus Clinical Services

Pilatus Clinical Services would like to welcome Felicity Smith to our team.

Felicity initially came on board to help oversee facility improvements at our headquarters in Watford, but has recently stepped up to become our Commercial and Operations Manager.

With a strong academic record, experience dealing with high value specialist products and a broad exposure to the pharmaceutical industry, Felicity will be focusing on ensuring operations are run efficiently to achieve excellence in client service at all times.

Bringing key organisational skills, she will in addition be working closely with the Quality Department to ensure the highest standards are maintained consistently.

Labiotech Refresh

Project 1_REFRESH General_Rev2-03 (1)

What an amazing time we had at the Refresh event hosted by Labiotech.eu! Julian, Philip and Rotimi networked with some amazing managers and owners of innovative biotechnology companies. The field is so vast and filled with a diverse network of talented and brilliant scientists, engineers, financial analysts it is no longer a matter of if, but more when commercial biotech will become a leading field in the medical and healthcare sector.

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Khaled El-Gendy Joins Pilatus Clinical Services Management Team

WATFORD, England, April 25, 2017 /PRNewswire/ —

Pilatus Clinical Services, one of the leading global biosimilar and comparator sourcing specialists, is delighted to welcome Mr Khaled El-Gendy to its management team. Bringing a wealth of experience to this space, Khaled will serve as our Vice President, Global Head of Business Development.

 

http://mma.prnewswire.com/media/492813/Pilatus_Clinical_El_Gendy.jpg

Khaled has over 20 years of pharmaceutical industry experience. Previously, Khaled was the Associate Director for Comparator Sourcing, Head of Commercial Operations for one of the market leaders for clinical trial supply. His responsibilities, amongst others, included the managing of multiple global commercial teams in the EU, USA and APAC regions for the sourcing of clinical trial products. He also drove market share expansion through the design and implementation of strategic partnerships with various biopharmaceutical companies and CROs. Prior, Khaled spent 14 years at Roche, both in Finland as well as in Roche’s HQ in Basel where he led the global sales of clinical trial supplies to third parties.

Khaled is a true believer in the “End2end” business model which describes the thorough completion of work managed within a specified timeframe. This approach utilises tailored strategies that prioritises the needs of customers whilst maintaining and developing excellent relationships with suppliers.

Kevin Wolfe, Company Director, comments, “We are very pleased to announce the addition of Khaled to our team. His experiences as both a supplier of clinical trial comparator products as well as a customer will no doubt give the Pilatus team insight into how we can bring even more value to our clients.”

Khaled is a citizen of Finland, with roots back in Egypt. With a well-rounded academic background, Khaled is now currently pursuing his doctorate to complement his post-graduate degree in Global Health from the University of Edinburgh.

Contact: Rotimi Dina, r.dina@pilatuscs.com , +44-01923-204310

SOURCE Pilatus Clinical Services

How Much are They Pumping Back In?

Following on from @Luca Dezzani’s post on the ‘Top 10 Pharmaceutical Companies 2017’ – https://tinyurl.com/mxollad, we at Pilatus were intrigued and wanted to find out the proportion of turnover reinvested into R&D, and the change it made in the rankings table when this criteria was incorporated.

 

 

Click here to expand the above image.

Firstly, AstraZeneca are punching above their weight! They’ve climbed 8 places with 26% of their total revenue being dedicated to R&D.

Likewise, Merck & Co have climbed up the ranking ladder. Merck spent no less than 25% of 2016’s revenue on research and development efforts.

Whatabout J&Jand Pfizer?

J&J and Pfizer, the two top ranking companies based on total revenue, appear not to be investing as great a proportion of their revenue into R&D based on the given data. However, it must be noted that the actual monetary value for both companies still ranks them in the top 6 (see spreadsheet below).

In summary, this data shows that last year, a total of just under $402 billion of revenue was generated. Whilst on average, the top ten pharma companies reinvested 18% of their turnover back into their labs.

Source: https://tinyurl.com/mxollad – Luca Dezzani, MD

2017 Trends & Transformations in the Pharma Supply Chain

An interesting read on the trends and transformations of pharma supply chain!

http://www.pharmpro.com/article/2016/12/2017-trends-transformations-pharma-supply-chain

THOUGHTS FROM PILATUS CLINICAL SERVICES

Trend #3: The rise of cold chain logistics
  • We have seen this reflected in our comparator sourcing requirements, with a growing demand for sourcing biosimilar comparators. In fact, 64% of comparators supplied by Pilatus in 2016 had to be controlled at 2° to 8°.

Things YOU should consider when selecting a vendor for cold chain comparator sourcing:

A) Does the vendor have the facilities, validated systems and processes in place to deal with your cold chain supply?

  • If working on a global clinical trial, what experience does your vendor have with global comparator supply customs clearance and cold chain shipping? Preparation is key in order to minimise transit time, ensuring on time supply and reducing the risk of temperature deviations. See a recent example of how Pilatus handled this issue in our 4th case study.

B) What are the vendor’s processes for managing temperature excursions?

  • Different manufacturers can vary in responsiveness and speed when it comes to dealing with temperature deviations. Strong relationships with innovators and manufacturers can speed this process.
  • Are intermediaries involved in the supply chain? The more steps there are in the supply chain can impact the speed and responsiveness in obtaining relevant product specific information.

 

  • Transformation #2: A shift toward global inventory management
  • This throws a big question mark over the increasingly popular local sourcing model for comparators. When local sourcing comparator products there are a number of challenges including working regionally with different vendors or different country supply managers.
  • If as the article suggests inventory management is moving towards global inventory management, working closely with the innovator and scheduling supply for your global supplies could be the way forward.
  • Could it be possible to schedule your local sourcing requirements centrally whilst maximising the benefits of reduced distribution costs and regulatory challenges?

 

 

NEW HIRES!

Pilatus Clinical Services would like to extend a very warm welcome to our newest hires!

Joshua Marsh has been an excellent addition to our Project Management department. In spite of being with us for 6 months, Josh has already taken charge of two major projects in our last financial year. Josh has a BSc degree in Biomedical Science from the University of Hull.

Maria Maciel our Quality Manager has enhanced our regulatory calibre, ensuring compliance with regulatory requirements and the continuous development of our Quality Management System. Maria will be leading global quality across the company, ensuring Pilatus remains a trusted name in the pharmaceutical space. Maria is a qualified pharmacist and brings a wealth of experience from her career within the industry.

Durotimi Dina is our new Business Development Associate, who will be supporting the company as we look to expand our presence in the global marketplace. Durotimi has a BSc from the University of Hull and an MSc in Biomaterials & Tissue Engineering from University College London.

For all comparator & biosimilar needs, contact our friendly team at http://www.pilatuspharma.com/