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Delivering the promise of regenerative medicine

By Rich Quelch

regenerative medicine

Regenerative medicine is an exciting sector that’s still largely unknown to the public. 

As defined by the Medical Research Council, ‘regenerative medicine is an interdisciplinary field that seeks to develop the science and tools that can help repair or replace damaged or diseased human cells or tissues to restore normal function’.

The liver is the only organ in the human body capable of regenerating itself spontaneously – even after serious injury – but in the future, any part of the human body will be capable of doing so.

Our own cells will also be able to treat and cure diseases and conditions of the blood and immune system, as well as restore the blood system after treatments for specific cancers.

Advances in science and greater investment are pushing the boundaries of regenerative medicine. Once only imaginable in science fiction, the latest applications include engineered skin tissue to treat burns victims, custom-grown bones for implants and joint replacements, personalised dietary treatments using gut bacteria and just recently, the world’s first 3D vascularised engineered heart was created using a patient’s own cells and biological materials.

However, the use of living cells as therapies presents real and difficult-to-solve supply chain challenges which need to be overcome before regenerative medicine can truly deliver on its curative promises.

Understanding the potential of regenerative medicine

Regenerative medicine is one of, if not the most, exciting advancements in modern science which has far-reaching benefits for big pharma, healthcare systems and patient outcomes.

Regenerative medicine is a ‘growth’ industry in more than one sense of the word; as a sector, it’s growing from strength to strength. In fact, last year the global regenerative medicine market was worth $28bn and it’s expected to grow to $81bn by 2023.

As a more efficient and less invasive alternative to transplanting cells or organs to replace damaged or lost tissue, established pharma companies alongside small biotech start-ups are racing to discover and bring to market medicine-based approaches which stimulate the body’s natural ability to repair itself.

The cutting-edge innovations of regenerative medicine generally fall into three distinct categories:

  1. Replenish
  2. Replace
  3. Rejuvenate.

Stem cells can generate vital growth factors to naturally reduce inflammation, increase muscle mass, repair joints, grow hair and boost the immune system, replenishing the body.

Organ regeneration and 3D printing are replacing the reliance on the failing donor system and overcoming the issue of organ rejection. The root causes of ageing are being better understood and delayed by using stem cells to rejuvenate the body.

Marking a new era in healthcare and one which has the promise of addressing the needs of an ageing population challenged by escalating chronic diseases, regenerative medicine is certainly a game changer.

Beyond more effective medical treatments that can be applied routinely despite age, co-morbidities or disease severity, it also has the potential to cure many of today’s ‘ncurable’ diseases and support healthcare systems to move towards a preventative model.

Delivering regenerative medicine from lab to clinic

Today, regenerative medicine is largely confined to a research environment. In fact, according to a recent report, there were 1,028 clinical trials for regenerative therapies taking place globally at the end of 2018.

Regenerative medicine is poised to transform healthcare as we know it, offering potential cures for deadly diseases which before would require long-term treatment to manage.

However, while billions are being spent on regenerative medicine research and clinical studies, little resource has, so far, been allocated to the management and delivery of innovative medical therapies at scale.

Currently, the race appears to be on between smaller medtech companies and big pharma to see who wins first-mover advantage in the regenerative medicine market.

Today, many international pharmaceutical companies prefer to partner with medtech start-ups to in-license products in early clinical development stages as opposed to conducting early development on their own. This is a risk-reduction tactic, but it could mean big pharma misses the boat.

The question remains unanswered as to whether a peer-to-peer collaborative model will prosper where medtech companies – that are in some instances one step ahead of big pharma in terms of drug development – are happy to be a third- party provider to big pharma that have the budgets and networks to truly deliver the regenerative medicine revolution.

In a recent document published by the UK government in response to the Regenerative Medicine Inquiry by the House of Commons Science and Technology Committee, policymakers stressed the importance of commercialising new therapies to meet the changing needs of the health sector.

In the UK, the Regenerative Medicine Expert Group (RMEG) has been tasked with developing an NHS regenerative medicine strategy to ensure the NHS is fully prepared to deliver innovative treatment and that regulations support and not hinder its delivery.

The Cell and Gene Therapy Catapult is also continuing to work to bridge the gap between ‘translational’ research and commercialisation.

However, for the UK to be well-positioned to offer safe and effective regenerative therapies, a strategy is needed that covers the whole value chain from academic research, commercial development and clinical application.

The effect of Brexit on the UK’s regenerative medicine sector remains unclear, but the UK has the opportunity to develop an independent framework outside the EU regulatory system to accelerate the development of new therapies and its economic potential while upholding the highest patient safety standards.

In any case, EU and UK regulators need to prioritise the standardisation of regulations governing manufacturing, quality control and the supply chain to keep up with advancements made by the FDA in the US.

Establishing an efficient supply chain for regenerative medicine

The promise of regenerative medicine requires an innovative look at the complete product life cycle, including the development of an efficient distribution network.

Once these novel drugs become mainstream, the entire healthcare ecosystem will have to adapt. Regulatory approval for any drug relies on it safely and successfully fulfilling its medical intent.

As such, information about supply chain management needs to be submitted to the regulator after the completion of phase 3 clinical trials, including packaging, labelling, storage and distribution.

The clinical supply chains required to deliver these therapies are arguably the most complex the industry has seen so far. Regenerative medicine is either personalised or matched to the donor-recipient. They are also highly sensitive to exogenous factors like time and temperature.

Advanced IT solutions and monitoring systems are being developed and employed to ensure end-to-end traceability. These are giving clinicians access to view the progress of therapies and their distribution in real-time and allow users to automatically schedule or amend material collections in line with manufacturing capacity, helping to keep the supply chain as agile as possible.

The live tissues and cells which form the basis of regenerative medicine products are highly sensitive and some have a shelf life of no more than a few hours.

Therefore, materials need to be transported from the site of harvest to manufacturing facilities, and from manufacturing facilities to medical institutions under strictly controlled conditions, within certain times and temperatures, according to cell and tissue requirements.

Temperature-controlled logistics solutions are vital to ensure a safe, effective and financially viable supply chain network for these high-value shipments. Cryopreservation is one technique increasingly being used to deliver medicines at optimum temperature using vapour phase nitrogen; however, many clinical settings remain ill-equipped to handle such equipment.

On-site production is an alternative manufacturing arrangement, particularly for autologous products which are derived from a patient’s own cells.

However, this throws up a number of compliance and infrastructure challenges, as the hospital would need to comply with a host of regulations including installing a Good Manufacturing Practice (GMP)-licensed clean room.

As a first-generation technology, stakeholders will have a greater tolerance for higher pricing... but only for a limited time period. By streamlining the currently very expensive manufacturing process and improving supply chain management, yields will automatically get larger and costs will slowly come down.

While there are many challenges in the road ahead, 2019 certainly appears to be the start of regenerative medicine’s move to the big time.

Rich Quelch is Global Head of Marketing,

30th October 2019

Rich Quelch is Global Head of Marketing,

30th October 2019


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