Whitepapers & Reports
The personalized medicines market – which tailors drugs and treatments to the individual patient – is expected to reach revenues of $149 billion by 2020, according to Pharmaceutical Commerce.
And the rising use of biosimilars – a biologic medical product that is a near-identical copy of an original product by another company – is expected to result in the near doubling of the size of pharma cold chain logistics business over the next three years.
We sat down with Catherine Coppage, Supply Chain Planner, Personalized Medicines at Kiadis Pharma; Javier Gomez-Contreras, Supply Chain BGx LATAMOE Latina-Mid East Africa-India & Asia Pacific Lead at GlaxoSmithKline; and Jeremy Cress, Director Of Operations, Fibrocell Science to dive into the challenges and opportunities distributing personalized medicines present.
Below is a preview of the topics and questions covered:
How are cold chain processes adapted for personalized medicines and biologics?
Catherine Coppage: "When transporting personalized medicines it’s really important that no temperature excursions occur. It needs to be tightly managed and temperature monitoring is vital because there is no room for error. You cannot go back and take new patient samples because often patients are very sick. It’s a one chance opportunity.”
How do cold chain processes have to be adapted when transporting vaccines?
Javier Gomez-Contreras: “The supply chain has to be more established in new technology to deliver the products to patients. Some models in use currently do not have the technology to maintain the temperature correctly for long periods, especially in developing countries.
"In Brazil, for example, we have to travel far to deliver the products. In order to reduce the cost and [to transport by truck, not air], we have to identify technology resources – refrigerators, cameras and containers that may allow us to maintain the temperature for 72 hours.“
What are the main challenges that cell and gene products present for pharma supply chain professionals?
Jeremy Cress: “The stability of the products – the shelf life – presents challenges. How do we ensure that the product doesn’t expire before it is administered to the patient? A lot of cell and gene therapies have a very short shelf life so it’s important that the supply chain is able to support quick turnaround times.
“Ordering specialized raw materials is a challenge. You have to be on top of your game to ensure you have the proper raw materials in-house and at each of the sites. The coordination and timing of the ordering and the receipt of the raw materials presents a significant challenge as you scale up.
“Another challenge is patient scheduling. New cell and gene therapies in the rare disease space don’t have a huge patient population to treat and a lot of patients have debilitating diseases. Therefore, the logistics of moving them from their home to a specialized facility is a big challenge.”
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In meeting the growth ahead for clinical trials there must be a focus on efficiency as their supply already suffers from major issues with wastage levels. This is lack of control is problematic with the rising public scrutiny on spending by pharmaceutical companies.
Growth in Demand
The drive to address the diseases that strike the world’s aging population has increased Pharma’s R&D funding. This trend is set to remain, industry estimates state that after seeing lucrative growth in 2016 the clinical trial market size is set to balloon to $65.5 billion in the next eight years.
The supply of these trials is critical. Badly budgeted or scheduled clinical trials can jeopardize the progress made by a candidate.
Clinical trials are incorporating a larger amount of countries than ever before. Although this is positive for producing more representative data and developing products for emerging regions, this globalization does introduce logistical hurdles in terms of supply. Especially with country specific regulations constantly evolving.
Rapid growth seen in emerging markets incurs more supply challenges. Sponsors are expected to provide to trial sites in isolated regions that have limited infrastructure and stubborn climates.
Striking a Balance
Clinical trials require the production and distribution of investigational pharmaceuticals to thousands of participants over several years.
Sponsors and Clinical Research Organizations (CROs) need to ensure they don’t over supply sites. This excess leads to the wastage of expensive materials, as drugs reach expiry dates before they can be used.
When sites are under supplied, sponsors may have to halt enrolment or even freeze patient treatments. This could have a large influence on the outcomes of a trial. Due to a range of factors, study design, patient enrolment, quantity of sites, site location, that can suddenly change the level of supplies needed for a trial to run, supply managers reduce the risk of stock outs by supplying a surplus of medicine. This in many cases spills over to become overage – when the investigational medicines have to be wasted at the end of a trial or hit their expiry dates before consumption.
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Though life sciences companies see value across the full supply chain, it’s the last mile that matters the most to the customer. When customers can’t get what they want when they want it due to product loss, theft, spoilage, counterfeiting or other disruptions, it can be incredibly damaging to a company’s brand and bottom line.
Optimizing that last mile involves careful coordination between a complex network of partners, distributors, outsourcers, wholesalers, etc. to ensure the right product reaches the right consumer at the right time. A difficult task for any company but especially so for life sciences companies who’s supply chains are highly regulated and reach a customer base rivaled by few.
With this survey, we aim to demystify the last mile of the pharma supply chain (final packaging to customer delivery) by identifying potential areas of improvement, trending solutions and best practices. Our goal is to provide the industry with new set of benchmarks, data and expert analysis to help accelerate their supply chain optimization journey.
We surveyed 150+ pharma logistics leaders to learn more about the key challenges, solutions and trends impacting the last mile of the life sciences supply chain. Highlights include:
- Analysis of what causes the most last mile disruptions and how firms are addressing these issues
- An overview of our respondents top strategic priorities
- Facts & figures that outline where cold chain leaders are looking to invest on 2018 & 2019
This whitepapers covers the latest pharmaceutical logistics regulatory developments around the globe related to FMD, MHRA, ICH Q12, PACMP, GMP, DSCSA and more! Designed specifically to keep you up to date with key developments that we believe with shape the compliance agenda over the next year, key developments that you will need to tune in for! Highlights include:
- GMP inspections international collaboration efforts
- Supply Chain Security and Traceability – GPS
- EMA regulations
- Points to remember for your next GDP inspection
- The latest on Human Drug Compounding Outsourcing Facilities regulations
- An analysis of ICH Q12 concepts
- The cost of Brexit and the road forward
- An overview of EU's recently published report detailing the implementation of the Falsified Medicines Directive (FMD)
Plus! Commentary by 2018 Cold Chain Global Forum speakers:
- Rafik Bishara, Ph.D, former Director QKMTS, Eli Lilly and Company
- Ajay Pazhayattil, Former Associate Director, TOPV Apotex Inc.
Pharma is one of the most conservative industries –namely due to the fact that its products are high risk – very influential to the health, well-being and survival of their consumers. Regulations must be met to ensure that medicine quality and patient safety is protected. Therefore any changes, be it to product or process, need to be controlled to ensure that these vital elements are not in anyway jeopardized.
In the latest article by Pharma IQ,we uncover:
- How to identify and overcome common obstacles to change management in pharma
- Establishing standardized packaging vendor qualification requirements
- Why collaboration and intelligence sharing between drug manufacturers could drastically improve the landscape for the general market.
- And more!
Features insights by:
- Guy Hoskens, Clinical Supply Chain Logistics Expert, Janssen, Pharmaceutical
- Tonino Antonetti, Executive Director, Regulatory Affairs, Quality Management, Safety & Health, Roche Diagnostics
- Craig Vermeyen, Senior Manager, Packaging Engineer, Kite Pharma
To receive a copy of this article via email, write us at firstname.lastname@example.org with "16CCGF Content Request: Change & Collaboration in Pharma Logistics" in the subject line.
Experts have asserted that despite recent developments, pharmaceutical supply chains are still far from reaching their full technological potential. However, Blockchain holds significant promise to advance the digital strength of medicine supply. In this whitepaper, we explore:
- What is blockchain and how can it be applied to cold chain?
- Who in life sciences is currently using blockchain and for what?
- How will the emergence of blockchain impact the industry over the next decade?
Plus! We provide an overview of potential use cases for block chain such as:
- Leveraging R&D data for collaborative research
- Dynamic pricing managed for raw materials
- Compliance and quality tracking
- Pharmacovigilance reporting
- Temperature control
- Temperature monitoring and control