Preventing Supply Chain Disruption During Times of Uncertainty

Preventing Supply Chain Disruption During Times of Uncertainty

Business continuity of healthcare companies is being significantly challenged and there are serious risks of supply chain disruption due to the global Covid-19 emergency. It is critical that companies assess, manage and control these risks to ensure continuity of supply.

 

Supply Chain and Regulatory

COVID-19, which is caused by the coronavirus, has had a major global impact since its outbreak in China in December 2019. Immediate concerns are for the well-being of employees globally and a focus on business continuity planning.

The European Medicines Agency (EMA) have issued guidelines surrounding ensuring continuity of supply of medicines in light of ongoing shortages during the current pandemic (1). Whilst respecting regulatory requirements, flexible and pragmatic measures have been implemented by global regulators to prevent any supply disruption. These areas include inspections of GMP manufacturing facilities, pharmacovigilance corrective and preventative action plans, audits and the validity of GMP certificates. Although regulatory authorities globally are working to keep approval of drugs moving, the impact of COVID-19 is clearly demonstrated by the change in commercial launch plans due to the pandemic. Many big pharma companies in the US have postponed launch plans and expect further delays to the approval of their drugs in the future.

Regulatory agencies across the globe have aligned themselves on the design of phase 3 trials for the development of COVID-19 vaccines (2). Phase 3 testing for COVID-19 vaccines will primarily involve demonstrating efficacy and safety of the vaccine. There was agreement across the board that clinical trials should be designed with stringent success criteria in order to demonstrate the efficacy of the vaccines. In Europe Johnson & Johnson released a statement announcing they would be starting Phase 1/2a trials for their COVID-19 vaccine in the second half of July. In addition, EMA has put in place a program to monitor efficacy and safety of COVID-19 vaccines used on a day to day basis in clinical settings. The goal is to be readily prepared to monitor vaccines once they are authorized for use.

The EMA has finalised 17 scientific advice procedures to give guidance for drug developers for COVID-19 related medicines. It is reported that there are 38 potential vaccines in development with an additional 154 treatments in development also for COVID-19 (3). These treatments range from immunomodulators to antivirals. For vaccine development, it is estimated that we may see approval of the first vaccine for COVID-19 by Q1 of 2021, however it is difficult to predict this precisely. There will be additional challenges following approval in order to ensure continuity of supply, including scale up and commercial manufacturing volumes. The EMA has finalised 17 scientific advice procedures to give guidance for drug developers for COVID-19 related medicines. It is reported that there are 38 potential vaccines in development with an additional 154 treatments in development also for COVID-19 (3). These treatments range from immunomodulators to antivirals. For vaccine development, it is estimated that we may see approval of the first vaccine for COVID-19 by Q1 of 2021, however it is difficult to predict this precisely. There will be additional challenges following approval in order to ensure continuity of supply, including scale up and commercial manufacturing volumes. For current COVID-19 critical medicines, the EU Executive Steering Group on Shortages of Medicines Caused Major Events are now focused on preparations for a potential second wave of coronavirus infections. The aim is to ensure an adequate supply of COVID-19 critical medicines are available if a second wave of the virus hits later on this year (4). Accelerated procedures for COVID-19 treatment developments have been put in place to expedite every step of the regulatory pathway whilst ensuring sufficient data is obtained on safety and efficacy of treatments in development.

Meanwhile in the USA, the FDA is actively preparing for the resumption of some domestic regulatory inspections. The FDA put on-site inspections on pause back in March 2020 but did continue to carry out several remote inspections. The FDA has developed a risk assessment tool to determine where is safest to conduct domestic inspections (5). The resumption of pre-approval inspections (PAI) will be welcomed by many companies. Ensuring PAIs are carried out without further delay where possible will prevent any further disruption to supply of product to the market. In addition, the FDA continues to place an emphasis on providing diagnostic testing tools for COVID-19. Over the last few weeks the FDA has issued Emergency Use Authorizations for several diagnostic test bringing the total issued to 208 testing tools. These include antigen tests, antibody tests and molecular tests (6).

The latest information received from international transportation companies shows that global air cargo capacity is 28% lower in comparison to this time in 2019. Transatlantic flight capacities are down 52% in comparison to previous years whilst Latin America route volumes are down by 66% currently.  With spikes in coronavirus cases occurring over the last few weeks air cargo capacity has declined.  As rates remain high, it is critical to ensure your company has assessed your supply chain, forecasted your inventory supply and demand, and booked air capacity at least two weeks in advance of shipping. HiTech Health can work with you to identify, assess and mitigate the risks posed by the current global health crisis to your shipping lanes. Ultimately, our goal is to ensure that patients who rely on medicinal products continue to be supplied in an efficient and steady way.

 

Complexity of Supply Chain – Autologous Cell Therapies

The COVID-19 pandemic continues to throw up challenges when it comes to supply chains of healthcare products, but none more so than that of Cell and Gene Therapies (6). A major challenge that has arose throughout the COVID-19 crisis is the collection and delivery of cells and product in clinical trials that are still ongoing. Most clinical trials take place in a hospital for these kinds of therapies. Often it is the case that the therapy is delivered by hand to the patient. However, restrictions in place throughout hospitals all over the world has made this quite difficult, especially as manufacture and patient treatment using cell and gene therapies can be extremely time sensitive. Another issue we have seen over the last year is the need for standardisation across these complex supply chains as the product progresses through clinical trials. In many cases the overall supply chain can consist of up to five shipments of materials across multiple temperature ranges. Therefore, it is important to standardize as many processes within the supply chain as possible. For cell collection and preparation, specific kits are required. These kits can be standardized if there are multiple collections and preparations. The value of this standardisation becomes much more important as the therapy continues to progress to the trail process. It may be the case that over 20 trial sites will be used and therefore standardisation reduces the process variation as much as possible. This facilitates results that focus on the efficacy of the therapy more so than variability within the supply chain. This point also highlights the importance using qualified systems and solutions when shipping your product. It is critical to invest in consistent, validated packaging and shipping qualification solutions.

 

Clinical Trials

The EMA released additional guidelines on 01st July 2020, stating they intend to support the clinical trials that are providing robust and reliable results in an effort to treat patients across the globe affected by COVID-19. In their guidelines the EMA describe key characteristics of clinical trials most likely to result in the most concise evidence required for companies to received accelerated approval. In addition, clear instructions on how data should be collected, analysed and reported out have been given in order to streamline this process (7).

Guidance documents for remote Good Clinical Practice (GCP) are in development in the EU and the EMA have collaborated with other regulators to minimum disruption. Greater flexibility regarding submission deadlines, briefing information and dossiers and review times on applications have been reduced from up to 70 days down to 20 days. In addition, rolling reviews of data have been implemented for COVID-19 treatments in development. Marketing Authorisation (MA) applications for COVID-19 have also been granted expedited review.

 

Key Considerations for your company

Companies that source, manufacture or supply medicinal products that are currently not deemed essential COVID-19 treatment should consider the following:

  • Have you assessed your supply chain for the short, medium and long-term future? Is it time for you to move from a single source supply chain to dual sourcing model?
  • If using contract organisations for the manufacture of your product, have you secured capacity for the next 2-3 years?
  • Are all the materials for the manufacture of your product available for the remainder of 2020 and through to 2021?
  • Expect potential cancellation or delays of shipments. How will you ensure your product remains safe and within the required storage conditions?
  • Ensure sufficient inventory levels to avoid disruption to on-going clinical trials or commercial supply to patients in need. How will COVID-19 affect your forecasting and production scheduling for the rest of 2020 and years to come?
  • The financial impact of increasing costs of manufacturing and supply costs in addition to the stock market decline. Has your organisation developed financial risk mitigation plans?
  • Assess the impact that employees and partners working remotely will have. How will this affect your IT infrastructure, HR requirements and support for manufacturing and supplying products in a timely manner?
  • Assessed short, medium and long-term operational restrictions for the movement of products?
  • Redesigning shipment sizes due to availability of capacity in your shipping lanes?
  • Assessed the impact of lockdown regions on shipping qualification/validation studies?

This list above is not exhaustive, however, it provides examples of some key considerations to be reflected upon to avoid serious disruption. What is critical is that Companies plan and manage through such times of uncertainty in order to provide the best possible outcomes for their business.

Contact us to learn more about HiTech Health.

 

References:

  1. https://www.ema.europa.eu/en/news/global-regulators-work-towards-alignment-policy-approaches-regulatory-flexibility-during-covid-19-2
  2. https://www.ema.europa.eu/en/news/international-regulators-align-positions-phase-3-covid-19-vaccine-trials
  3. https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines-covid-19
  4. https://www.ema.europa.eu/en/news/eu-actions-support-availability-medicines-during-covid-19-pandemic-update-7
  5. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-prepares-resumption-domestic-inspections-new-risk-assessment-system
  6. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-august-10-2020
  7. https://bioprocessintl.com/manufacturing/cell-therapies/the-cell-therapy-supply-chain-logistical-considerations-for-autologous-immunotherapies/
  8. https://www.ema.europa.eu/en/news/international-regulators-provide-guiding-principles-covid-19-clinical-trials

 

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Read the Business Post article “HiTech Health is on a different level after refining elevator pitch” with HiTech Health’s Managing Director Brian Harrison by clicking on the link below:

Read the full article here: https://www.businesspost.ie/smes/hitech-health-is-on-a-different-level-after-refining-elevator-pitch-03f7b65f

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Navigating supply chains and product portfolios during a pandemic

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HiTech Health can now import and release batches of medicines in the EU

HiTech Health can now import and release batches of medicines in the EU

In early January 2020, HiTech Health officially obtained both a Manufacturer’s / Importer’s Authorisation (MIA) licence for Medicinal Products for Human Use (commercial) and an MIA licence for Investigational Medicinal Products for human use (IMPs / clinical trials). This marks the successful application to the HPRA and audit conducted on-site at HiTech Health’s Dublin office. The newly received MIA licences for commercial products and IMPs is an opportunity for our clients to partner with us to provide them with EU Qualified Person (QP) and importation and certification services of medicinal products in the EU.

Commercial MIA
For all companies wishing to import and/or release batches of medicines in the EU , it is a legal requirement to hold a commercial MIA licence granted by a European country’s national regulatory authority. A commercial MIA licence is also required for repackaging or relabelling of medicinal products as well as any analytical retesting of imported finished product. HiTech Health are now in an excellent position to offer clients the opportunity to avail of our commercial MIA licence to certify medicinal products for release to the EU market. This offers the benefit of companies not having to substantially invest in the costly and thorough process of obtaining their own MIA licence which involves implementing a full quality management system (QMS). By partnering with HiTech Health, companies could potentially benefit from the three main advantages below:

  1. Experienced cross-functional team to support clients every step of the way. HiTech Health employees have over 100 years of combined industry experience in Quality, Operations and Supply Chain and have a proven track record of delivering results for clients.
  2. Financial savings: Instead of setting up an office and hiring a team of full-time employees in the EU, it is financially more cost effective to contract HiTech Health to provide the required quality services with no obligations for long-term commitments.
  3. Timeline reduction: Developing a QMS and starting the MIA application process could take up to 12 months. Collaborating with HiTech Health can accelerate this lead-time to 3-4 months and help patients in a quicker time frame. After Brexit, Ireland is the only English-speaking country in the European Union.

Clinical Trials MIA (IMPs)
In addition to commercial drug batches, HiTech Health is now authorised to import and certify Investigational Medicinal Products (IMPs) for use in clinical trials within the EU. We can support the release and supply of IMPs to clinical trial sponsor sites throughout the EU in a cost effective and timely manner. After confirming a product has been manufactured and tested in accordance with EU GMP requirements, the HiTech Health MIA licence enables us to import and certify IMPs on behalf of clients allowing them to focus on their other core business activities. Our experienced in-house team have extensive knowledge of clinical trial sponsors and centres across Europe and can assist with supporting products to commercialisation.

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Continuous Manufacturing: Industry reacts to new FDA guidelines

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In February of this year the US Food and Drug Administration (FDA) released a 27-page draft guidance, ‘Quality Considerations for Continuous Manufacturing’. The FDA is seeking to encourage the adoption of continuous manufacturing as the agency believes it can improve consistency and potentially reduce the risk of drug shortages.

In this draft guidance, the agency provides insights on its current stance on critical quality issues in NDAs, abbreviated NDAs (ANDAs), supplemental NDAs, and ANDAs for small molecule, solid oral drug products produced using continuous manufacturing methods. However, while some of the recommendations made in the guidance may apply to other types of pharmaceuticals, the FDA states that it does not provide recommendations for biological products.

For several decades, manufacturing industries, from petroleum to food processing, have employed continuous manufacturing processes. In stark contrast, pharmaceutical companies have been much more conservative to adopt new continuous manufacturing approaches and the majority have opted to remain with traditional production methods, moving materials through each step of the manufacturing process in single large batches. Continuous manufacturing processes produce drug ingredients or finished drug products continuously, without having to wait for each batch to finish before commencing a new batch.

The Office of Pharmaceutical Quality (OPQ), which is located within the Centre for Drug Evaluation and Research (CDER), has used its Emerging Technology Program to encourage and support companies in implementing continuous manufacturing. Drugmakers may communicate with the FDA to understand and navigate through scientific and policy issues that might arise with emerging continuous manufacturing technologies. The guidance document released by the FDA provides quality system considerations for companies seeking to adopt continuous manufacturing.

Within the guidance document, the agency advises each manufacturing site to evaluate their quality system design to determine if modifications are required to support continuous manufacturing. Such considerations include equipment qualification and maintenance, in-process material diversion strategy including criteria for rejecting batches, handling of unplanned process disruptions which occur, raw and in-process material investigations, and more.

Dr Janet Woodcock, Director of FDA’s CDER, commented, “Right now, manufacturing experts from the 1950s would easily recognize the pharmaceutical manufacturing processes of today. It is predicted that manufacturing will change in the next 25 years as current manufacturing practices are abandoned in favor of cleaner, flexible, more efficient continuous manufacturing.” The FDA stated that potential benefits of continuous manufacturing may include:

Integrated processing with fewer steps

  • Reduced manual handling, increased safety
  • Shorter processing times
  • Increased efficiency

Smaller equipment and facilities

  • More flexible operations
  • Reduced inventory
  • Lower capital costs, less work-in-progress materials
  • Smaller ecological footprint

On-line monitoring and control for increased product quality assurance in real-time

  • Amenable to Real Time Release Testing approaches
  • Consistent quality

‘Quality Considerations for Continuous Manufacturing’ draft guidance document examines three stages of process validation: process design, process qualification, and continued process verification. Given that continuous manufacturing systems involve many variables, the three stages outlined by the FDA are imperative to focus on if companies are seeking to improve operational and quality efficiency. Adopting continuous manufacturing is highly technical and incurs great costs. However, taking into account the possible benefits and long-term savings of continuous manufacturing, this transition may be worthwhile for many companies due to fewer interventions and the expectation of increased quality. The draft guidance document can be viewed here.

To discuss this further or any HiTech Health services you can contact us today.

References

  1. FDA, Office of Pharmaceutical Quality 2018 Annual Report, available at https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM632265.pdf; see also Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on FDA’s modern approach to advanced pharmaceutical manufacturing, Feb. 26, 2019, available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm632043.htm.
  2. FDA, Office of Pharmaceutical Quality 2018 Annual Report, available at https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM632265.pdf.
  3. FDA, Quality Considerations for Continuous Manufacturing, Draft Guidance, February 2019, available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM632033.pdf.

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Key Serialisation Considerations for Orphan Drugs

Adapting company strategies to serialisation

Falsified medicines are counterfeit drugs that reach the market illegally. They have not been approved and may contain ingredients which are of poor quality and/or at the incorrect dose. Notably, falsified medicines pose significant health risks to patients, as well as jeopardise the legitimacy of pharmaceutical companies, tarnishing consumers’ trust and prospective generated revenue. In this article, HiTech Health takes a look into the serialisation requirements and key considerations for orphan drugs used to treat rare diseases.

As of 9th February 2019, the European Union Falsified Medicines Directive (FMD) came into effect. Marketing Authorisation (MA) holders of approved medicines are now required to place two new safety features on the packaging of their products; a unique 2-dimensional barcode which allows for identification of the medication and an anti-tampering device on the packaging of the product. Similarly, in the United States, the Drug Supply Chain Security Act (DSCSA) was brought into effect by the FDA in November 2018 to ensure serialisation of all medications. The introduction of FMD and DSCSA requires each party involved in the supply chain process to verify the authenticity of the product, preventing the entry of falsified medicines into the marketplace.

Overall, companies have started adopting a strategic business view for serialisation, identifying benefits beyond regulatory compliance, such as an approach to safeguarding brand reputation, ensuring patient safety and actively contributing to an effective management of the supply chain.

 

5 key parameters to serialise, verify and store your product

Orphan drugs must comply with current serialisation regulations in the same manner that any other authorised pharmaceutical product is required to. However, orphan drugs face several unique challenges when it comes to serialisation compliance. They are typically of very high value and they are often distributed in small quantities directly to hospitals, speciality practices or patients’ homes. All drugs must now be serialised at the package level using a 2D DataMatrix barcode that provides accurate and contemporaneous information on the drug product identifier, lot number and expiration date. Generally, hospitals, pharmacies and distribution centres will scan the 2D DataMatrix barcode when the drugs arrive at their facility or at the point of dispensing. The quantity of orphan drugs that enter legal supply chains may be much less than other medicines and, generally, the supply chain is patient-centric focused, with a more direct access to the final consumer.  As orphan drugs are often shipped in small quantities direct to patients or their primary care physicians, there may be challenges in ensuring the required serialisation hardware and software are available to verify if the medicine is legitimate or could potentially have been falsified.

Being involved in the development, manufacturing and distribution of orphan drugs, one must be aware of how and where patients will receive the medication. In order to comply with FMD and DSCSA, orphan drug serialisation must follow a process that aligns with the key parameters of serialisation, verification and storage:

  1. Secondary packaging serialisation uses a 2D DataMatrix barcode. If required, serialisation is completed at the sealed case level, using a 2D DataMatrix or linear barcode. Data must be machine and human readable that include orphan drug product identifier, lot number and expiration date.
  2. Cold-chain distribution needs to be successfully controlled and managed with anti-tampering devices.
  3. The orphan drug product received by the patient, doctor, pharmacy or speciality distribution centre will have the 2D DataMatrix barcode scanned at arrival or at the point of dispensing.
  4. The serialisation software will verify the orphan drug product identifier and ensure that the drug is not falsified. The software should respond to requests for verification from authorised users to verify the product identifier, including the serial number, within 24 hours at most.
  5. Serialisation data on all orphan drugs must be stored in an active, readily available location for a minimum of five years past the date of manufacture.

 

Many orphan drugs, like immunotherapies, are fragile in their composition and have specific packaging requirements as well as temperature-controlled shipping and storage needs. When selecting a packaging partner for orphan drug products, it is critical to conduct due diligence processes to ensure your selected partner can comply with serialisation regulations and the challenges of handling small quantities of sensitive products.

 

Identify the most appropriate solution for your unique needs

For orphan drugs, where product flexibility is paramount, effective packaging solutions are key in the EU multi-lingual market. Traditional packaging and labelling might result in product waste. Limited shipments of material to several countries could be facilitated using multi-lingual packaging. Further, if you are manufacturing a drug for a small patient population, it is imperative to have controls on your inventory and effective management of the supply chain. During distribution, will the serialisation hardware and software be usable in every destination that the orphan drug is distributed to? By targeting orphan drug providers, counterfeiters can possibly take advantage of newly introduced serialisation systems and create new revenue streams from high value orphan drugs. The validation and qualification of your chosen serialisation software and hardware units is a paramount step in ensuring you have a robust supply of orphan drugs to patients.

 

It is apparent that applying a unique identifier at the level of the individual product unit is now a core requirement for all medicines with no distinctions. Overall, the primary drivers for serialisation include the ability to control and monitor a highly complex distribution network from manufacturer to consumer, in which products possibly change hands several times. Authentication of orphan drugs at various levels in the supply chain becomes very difficult without data sharing across the supply chain. From our experience, process flexibility is key in the supply chain of orphan drugs and, therefore, there is the need of an integrated cross-functional process and systems at every stage of the supply chain to allow for clear and effective delivery of high quality orphan drugs to patients.

At HiTech Health we focus on strategies that can optimise the process, continuing to promote product quality. Get in touch if you wish to discuss your orphan drug development processes and supply chain models with one of our experts.

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