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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By 2020, pharma cold chain logistics spend is predicted to exceed $16 billion. Despite this huge investment, Pharmaceutical supply chains still face tremendous challenges. We sat down with keynote speaker Jack Shaw, Executive Director of the American Blockchain Council, Technology Futurist to discuss this. Below is a preview of the interview:
What will be the Blockchain’s direct impact on the Pharmaceutical supply chain?
Pharmaceutical supply chains face tremendous challenges. Ingredients get lost, chemicals become inactive due to insufficient temperature control, medicines are wrongly prescribed by malfunctioning computer systems, and counterfeit medications slip through cracks in security.
All of these problems are causing pharma companies to turn to emerging technologies to improve visibility and control across the supply chain. Many companies have begun to realise the specific utility of blockchain technology in this endeavor.
The immutability of records, easy and transparent sharing of data among authorized ecosystem participants, and the virtually hack-proof
capabilities of Blockchain (also known as Distributed Ledger Technology, or DLT) make it a
powerful and effective choice for better managing supply chains of all kinds.
How will Blockchain technology affect cold chain logistics now and in the near future?
Blockchain offers an efficient way for wholesalers and dispensaries to optimize their inventory management and control, anticipate supply shortages, and improve data integrity as well as the distribution of data that has not previously existed.
Download the full report to get more insights on:
-Blockchain's direct impact on the Pharma Supply Chain
-Blockchain technology's affect on cold chain logistics
-Cold chain pharmaceuticals' preparation for the future of technology
We sat down with David Merrit, Executive Vice President of Public Affairs and Strategy, America's Health Insurance Plans to discuss Healthcare Reform. Below is a preview of the interview:
How will healthcare reform affect the pharmaceutical supply chain?
"It seems you can’t talk health care today without talking about politics. How health reform will affect the supply chain depends on who’s in charge. The Trump Administration has put a very bright spotlight on rising prescription drug costs - from the very beginning of the process with manufacturers setting prices to the very end with what consumers pay at the pharmacy. Their focus has been on reducing regulation, increasing competition, and reducing what patients pay."
How does the national healthcare reform law affect the future of the pharma supply chain?
"Every American deserves access to affordable coverage and high-quality care. Policymakers and politicians will certainly debate how we balance affordability with access."
Download the Report to read the full conversation with David and hear what he has to say on:
- Healthcare Reform's affect on the pharma supply chain
- The national healthcare reform law affect on the future of the pharma supply Chain
- His advise on healthcare reform to the presidential campaigns
We sat down with one of our keynote speakers Bill Mahorney, Chief, Enforcement Division, FMCSA, Department of Transportation. As one of the key players responsible for enforcing the ELD Mandate, Bill will be addressing how this new law will affect the supply chain, logging books, hours of service regulations and cross-industry collaboration. To give you a sneak peek as to what you can expect to hear about onsite, we sat down with Bill to discuss what the ELD Mandate is and how it impacts the supply chain.
Below is a preview of the interview:
First and foremost, what is the ELD mandate?
"In a nutshell, the electronic logging device (ELD) rule [which was congressionally mandated as a part of MAP-21] is intended to help create a safer work environment for drivers as well as make it easier and faster to accurately track, manage, and share records of duty status (RODS) data. An ELD synchronizes with a vehicle engine to automatically record driving time, for easier, more accurate hours of service (HOS) recording. As a result of the ELD mandate, folks that used to use a logbook are now, as of December 2017, required to use an electronic logging device to ensure your hours of service are accurately recorded."
How does the ELD Mandate Affect the Cold Chain?
"We're talking about a device that is much more precise than an old fashioned logbook. Previously people could fudge here and there. Basically falsify and extend their day.
So, for example, if driver has to wait at a shipper location or got stuck because the shipper wasn't ready for them one way or the other, then they would not necessarily show that on their paper logbook. However, since an electronic logging device automatically records drive time and hours of service (HOS), in addition to being much more precise, it also cannot be manipulated by the driver or the carrier.
For the most part, the ELD will change things in a good way when it comes to the supply chain. The precision of the ELDs is gong to require shippers the carriers to work more closely together to make sure that time is not wasted and that the supply chain is efficient as it can be. ELDs will enable drivers to more efficiently move in and out of the shipper's location either on the front end or the back end and maximize their hours of service while keeping the goods moving properly."
Download the full interview with Bill Mahorney below
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 comprehensive, 75 page ebook contains a curated collection of past presentations, articles + whitepapers that explore that latest thinking when it comes to the packaging, labeling and serialization of life sciences products. Review and enjoy some of our top packaging related content from 2018 such as:
- 3 Areas Holding Back Optimized Packaging Processes
- Case Studies on Bulk Reusable Packaging and Real-Time Asset Tracking Technologies
- The Case for Fully Standardized Packaging Vendor Qualification Requirements
- Authentication in pharmaceuticals: a 5-step risk assessment strategy
- Update on DSCSA and Global Serialization Requirements: Risks and the Go Forward
Includes past presentations by:
- Jennifer Antonetti, Sr. Supervisor Global Distribution Packaging & Shipping Qualification, Biogen
- Craig Vermeyen, Senior Manager, Packaging Engineering, Kite Pharma
- Brian Files, Former Director of Regulatory Compliance & Policy, CVS Health
As medicine shifts from a “one-size-fits-all” approach to more customized care, patient engagement will become a critical component of supply chain management. In this ebook, we explore the growth of personalized medicine, what it means for life sciences supply chain leaders and how you can jumpstart your journey towards a patient-centric supply chain. Sections include:
- The rise of personalized medicines and their impact on the supply chain
- Timing is Everything: Reducing Prescription Abandonment Through Mobile Patient Engagement
- The Personalized Medicine Supply Chain: Challenges & Solutions
- Getting Patients Involved in the Cold Chain - 2018 presentation by Alan Kennedy, Founder and Executive Director, PHARMA TEAM-UP
Ahead of the 16th Global Forum taking place September 24-28, 2018 in Philadelphia, PA, we sat down with keynote speaker Tom Bonkenburg, Director, European Operations, St. Onge Company. Below is a preview of the interview:
How is Robotics impacting the supply chain sector?
"Since their beginning, robots have always lived in the ‘make’ side of the supply chain. Robots are very good at precisely repeating the same tasks hour after hour with high quality. This is a good fit for manufacturing where exacting precision is often an important requirement and robots are used to improve quality while reducing the cost of labor.
"The challenges typically found in the ‘deliver’ side, however, often require flexibility rather than exacting precision and the traditional manufacturing robots have not been a good fit. We now see new robotic concepts being developed that are about to enter the distribution arena allowing organizations to improve quality and reduce labor in the customer facing half of the supply chain. I find this an exciting development that will change the way we design our supply chains of the future."
What are the top two challenges companies face when it comes to adopting these new automated technologies?
"One of the main challenges that I see
companies facing is their outlook on capital
spending and ROI. Many corporations
require a payback of 3 years or less for new
projects and this often makes it difficult to
implement automated technologies. I see
this changing, however, as businesses are
having trouble finding quality labor and now
view automation as a longer term strategic
investment. In addition to this shift in
thinking, newer technologies coming onto
the market will be more flexible in their
finance models allowing operations to lease
rather than buy robots or move them from
site to site as needed to help keep capital
spending lower than it has been in the past.
A second challenge is that what works well in one industry does not always work in another. Every supply chain and every distribution center is different. Just because a technology works for Amazon does not mean it will work for you. Very often the CSuite does not understand this and tries to push in a technology direction that is not a good fit for them. Really understanding how the needs of your particular supply chain maps against available technology is key to making a good decision and getting buy in from the entire organization."
How do you see robotics transforming the pharma supply chain industry over the next 10-15 years?
I try to never predict what will happen by a specific date in time because we have been disappointed by technology projections in the past. In my opinion, however, the current trends will eventually lead to automation allowing smaller DCs to be productive throughout the day and night, faster service to customers, lower inventory levels, and an overall reduction in cost. Automation will continue to shape the supply chain and changes seem to come faster and faster every year.
Download the full Report to read the full discussion with Tom as he discusses:
- How robotics are impacting the the pharma supply chain sector specifically
- Common barriers to automation adoption and how to overcome them
- What life sciences supply chain leaders need to do today to prepare for a future of increased automation
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 email@example.com 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