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 UKs 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 patients 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 medicines move to the big time.
Read more:
Delivering the promise of regenerative medicine - PMLiVE
- Molecular discovery has potential to solve the billion-dollar global cost of poorly managed wound healing - Medical Xpress - March 29th, 2024
- Science Saturday: A year of new directions and advancements for ... - March 29th, 2024
- Diverse ways regenerative medicine is advancing health care - March 29th, 2024
- Exosomes and Stem Cells Are the Future of Anti-Aging - NewBeauty Magazine - March 29th, 2024
- Global Organoids and Spheroids Market Set for Remarkable Growth, Reaching USD 7.70 Billion by 2034 with a CAGR ... - GlobeNewswire - March 29th, 2024
- Growth Projections for the Regenerative Medicine Market - BioProcess Insider - March 10th, 2024
- Regenerative Medicine - Cell Therapies - BioProcess Insider - March 10th, 2024
- Transitioning from traditional surgical methods to the innovative use of stem cells - pharmaphorum - March 10th, 2024
- Stem cell-based regenerative medicine - PMC - National Center for ... - February 27th, 2024
- Unlocking the Mysteries of the Hippo Pathway: A Leap Towards Conquering Cancer and Regenerating Tissues - Medriva - February 27th, 2024
- PRISM MarketView Spotlights BioStem Technologies in the Expanding Wound Care Market - Yahoo Finance - February 27th, 2024
- Therapeutic Solutions International Files Patent on "Facilitating Effects" of JadiCells on Gene Therapy Mediated Cell ... - Yahoo Finance - February 27th, 2024
- RION Expands Manufacturing Operations with Cutting-Edge Facility in Rochester, Minnesota - Yahoo Finance - February 27th, 2024
- Hands-On Solutions: Applying Prosthetic Sensory Technology In Rehabilitation - Forbes - February 27th, 2024
- UC Irvine Embarks on a Transformative Journey in Stem Cell Research with a $4 Million Boost - BNN Breaking - February 27th, 2024
- Less Surgery, More Recovery: Here is How Regenerative Medicine is Shaping the Future for Neurosurgeons - News Channel Nebraska - February 27th, 2024
- SPONSORED: Regen Rx Offers Both Non-Invasive Regenerative Medicine Procedures and Ultrasound-Guided ... - exploreClarion.com - February 27th, 2024
- ROSM Celebrates 10 Years of Advancing Patient Care Through Regenerative Medicine - goskagit.com - February 27th, 2024
- Expanding the Horizons of Cell and Gene Therapy - RegMedNet - February 27th, 2024
- Regenerative medicine | NIST - February 10th, 2024
- Home - Kansas Regenerative Medicine - February 10th, 2024
- Translational Regenerative Medicine market is estimated to grow at a CAGR of 24.3% by 2034: Visiongain - Yahoo Finance - February 10th, 2024
- Cellular senescence is associated with osteonecrosis of the femoral head while mesenchymal stem cell conditioned ... - Nature.com - February 10th, 2024
- Top 3 grants in regenerative medicine: January 2024 - RegMedNet - February 10th, 2024
- Organogenesis Holdings Inc. to Report Fourth Quarter and Fiscal Year 2023 Financial Results on February 29, 2024 - Yahoo Finance - February 10th, 2024
- Unlocking the power of stem cell therapy - Drug Target Review - February 10th, 2024
- Innovative stem cell therapy could be "game changer" in epilepsy - The Pharma Letter - February 10th, 2024
- Neurona lands $120m to advance regenerative cell therapy pipeline - Longevity.Technology - February 10th, 2024
- Neurona Therapeutics Raises $120M to Advance Groundbreaking Pipeline of Regenerative Cell Therapy Candidates ... - GlobeNewswire - February 10th, 2024
- Treating Joint Problems in the Modern Age: How Regenerative Medicine Paves the Way - Health shots - February 10th, 2024
- Cancer-related mutations appear in stem cell derivatives used in regenerative medicine, shows study - Phys.org - January 17th, 2024
- Researchers genetically modify stem cells to evade immunological rejection - University of Arizona - January 17th, 2024
- The Impact and Implications of Regenerative Medicine in Urology - Cureus - January 17th, 2024
- LVHN announces opening of new stem cell transplant center. Here's what that means for the Lehigh Valley - The Morning Call - January 17th, 2024
- Clinical applications of stem cell-derived exosomes | Signal Transduction and Targeted Therapy - Nature.com - January 17th, 2024
- Therapeutic Solutions International Launches Adult Stem Cell Therapy Company Focused on Curing Epilepsy - Business Wire - January 17th, 2024
- Cell Therapy Technologies Market Projected to Reach Valuation of USD 47.3 Billion at 24.7% CAGR from 2024-2033 ... - GlobeNewswire - January 17th, 2024
- Cancer Mutations in 22% of Stem Cells: Concern for Regenerative Medicine - BNN Breaking - January 17th, 2024
- San Jose blood stem cell donor meets 15-year-old whose life he saved in Los Angeles - The Mercury News - May 17th, 2023
- Regenerative medicine: Current therapies and future directions - April 23rd, 2023
- What Is Regenerative Medicine? | Goals and Applications | ISCRM - April 23rd, 2023
- Important Patient and Consumer Information About Regenerative Medicine ... - April 23rd, 2023
- Regenerative medicine can be a boon for those with Drug-Resistant Tuberculosis - Hindustan Times - April 23rd, 2023
- About Regenerative Medicine - Center for Regenerative ... - Mayo Clinic - April 7th, 2023
- Regenerative Medicine | National Institutes of Health (NIH) - April 7th, 2023
- Porcine Vaccine Market is estimated to be US$ 4.41 billion by 2030 with a CAGR of 7.50%during the forecast - EIN News - April 7th, 2023
- Advancing Safe and Effective Regenerative Medicine Products - March 21st, 2023
- Active Wound Care Market Rising demand for Skin Substitutes to boost the industry (2023-2033) | CAGR of 5.5% - EIN News - March 21st, 2023
- Veterinary Orthopedic Implants Market is estimated to be 421.3 Million by 2029 with a CAGR of 5.3% - By PMI - EIN News - March 21st, 2023
- ASKA Pharmaceutical : February 7 2023 EME and ASKA Announce Collaboration Agreement on Creating Novel PharmaLogical VHH to address an unmet medical... - February 8th, 2023
- A Look At Some Of The Companies Innovating In the Cutting-Edge Regenerative Medicine Field - Yahoo Finance - October 15th, 2022
- The Switch to Regenerative Medicine - Dermatology Times - October 15th, 2022
- The Alliance for Regenerative Medicine Announces Election of 2023 Officers, Executive Committee, and Board of Directors - GlobeNewswire - October 15th, 2022
- Mathematical model could bring us closer to effective stem cell therapies - Michigan Medicine - October 15th, 2022
- 'We have to find a way': FDA seeks solutions to aid bespoke gene therapy - BioPharma Dive - October 15th, 2022
- American Academy of Stem Cell Physicians to Offer Licensed Physicians Board Examination in Regenerative Medicine - GlobeNewswire - October 15th, 2022
- Discover Medical Advances in Cellular Therapy Research Using Cord Blood for Cancer, HIV, Cerebral Palsy and Autism During World Cord Blood Day 2022 -... - October 15th, 2022
- The Risk-Reward Proposition for CGT Clinical Trials - Applied Clinical Trials Online - October 15th, 2022
- Cell therapy weekly: Ray Therapeutics and Forge Biologics expand partnership - RegMedNet - October 15th, 2022
- FDA Expands Oversight of Cell and Gene Therapies - Pharmaceutical Technology Magazine - October 15th, 2022
- Frequency Therapeutics Completes Enrollment of Phase 2b Study of FX-322 for the Treatment of Sensorineural Hearing Loss - Business Wire - October 15th, 2022
- The Health Benefits Of Sea Moss, According To Experts - Forbes - October 15th, 2022
- ProKidney Announces Multiple Abstracts Selected for Presentation at the American Society of ... - The Bakersfield Californian - October 15th, 2022
- Pain Management & Regenerative Medicine Specialists DFW - September 4th, 2022
- Tissue Engineering and Regenerative Medicine - National Institute of ... - September 4th, 2022
- First U.S. patient receives autologous stem cell therapy to treat dry AMD - National Institutes of Health (.gov) - September 4th, 2022
- International Stem Cell and Regenerative Medicine Research and Therapeutic Center in Egypt - Construction Review - September 4th, 2022
- Regenerative Medicine Market to Garner Bursting Revenues [+USD 27.29 Billion] with Top Growing Companies During 2022-2029 - eTurboNews | eTN - September 4th, 2022
- Immusoft Takes First-Ever Engineered B Cell Therapy into Clinic - BioSpace - September 4th, 2022
- Addressing Diversity Barriers to Regenerative Medicine Free Press of Jacksonville - Jacksonville Free Press - September 4th, 2022
- TikoMed's ILB mobilizes and modulates key growth factors that trigger a cascade of neuroprotective mechanisms able to target all... - September 4th, 2022
- Frequency Therapeutics to Participate in September Investor and Medical Conferences - Business Wire - September 4th, 2022
- Can the immortal jellyfish teach us how to reverse aging? - Earth.com - September 4th, 2022
- Applied StemCell Announces the Expansion of its cGMP Manufacturing Facility to Support Cell and Gene Therapy - Business Wire - September 4th, 2022
- Omega Therapeutics Announces Appointment of Rainer Boehm to its Board of Directors - PR Newswire - September 4th, 2022
- Rise In Number Of CROS In Various Regions Such As Europe Is Expected To Fuel The Growth Of Induced Pluripotent Stem Cell Market At An Impressive CAGR... - September 4th, 2022
- Regenerative Medicine Partnering 2015 to 2022: Terms and Agreements Entered Into by the Leading Companies Worldwide - ResearchAndMarkets.com -... - August 19th, 2022
- Pain Relief Treatments: The Benefits of Regenerative Medicine From Head to Toe - 30Seconds.com - August 19th, 2022
- FDA Issues Draft Guidance to Facilitate Development of Human Gene Therapy, CAR T Cell, and Regenerative Medicine Products - Wilson Sonsini Goodrich... - August 19th, 2022
- Marco Quarta to present at the 9th Aging Research & Drug Discovery Meeting 2022 - EurekAlert - August 19th, 2022