Traditional approaches to drug development assume that all patients with a certain condition respond similarly to a given drug. But these one-size-fits-all treatments are effective in only 30 percent to 60 percent of patients due to differences in the way each individual responds to and metabolizes medicines, the UK’s National Health Service (NHS) reports.
Scientists believe personalized medicine, which delivers treatments customized to each patient’s unique biology, holds the key to improving effectiveness, helping not just patients but the societies in which they live as well.
How? By reducing the use of ineffective drugs, lowering the cost of chronic conditions and shortening hospital stays, according to a July 2018 report by two pharmaceutical trade associations, the European Biopharmaceutical Enterprises (EBE) and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
“In the Netherlands, personalized medicine has reduced chemotherapy usage and hospital stays,” the report states. “It is estimated that the mean hospital stay for targeted treatments is three to four days, whereas previously it was more than a week for chemotherapy regimens.”
Around the globe, innovative companies are using advanced technology to expand the application of personalized medicine to more health conditions, improving outcomes for patients while reducing the social impacts of illness.
PERSONAL EPILEPSY TREATMENT
Epilepsy patients, for example, face a brighter future thanks to technology being developed by BioSerenity, a team of experts headquartered in the Brain and Spine Institute of La Pitié-Salpêtrière, he largest teaching hospital in France.
Each patient wears a smart hat and vest embedded with biometric sensors and electrodes to sense abnormal activity, including seizures. The sensors relay data to medical professionals through a secure cloud platform, where machine-learning algorithms interpret its meaning to fine-tune diagnoses and analyze reactions to treatment.
“With our point-of-care diagnostics solution and companion apps, we monitor patients over a long period of time and in a real-world evidence setting,” BioSerenity CEO Pierre Frouin said. “Our telemedicine solutions use AI [artificial intelligence] to identify digital biomarkers in the signals recorded. Human experts then validate diagnosis.”
BioSerenity’s aim is to help the scientific community better understand conditions like epilepsy and improve long-term treatment.
“If we can detect early signs of deterioration, we can treat a patient before severe events take place, thus reducing hospitalization,” Frouin said. “We can also track the effect of therapy so we can optimize patient care and help them get the right treatment faster.”
It currently takes three to five years to stabilize an epileptic patient, but Frouin believes personalized medicine could cut that time significantly. “It could also lessen the burden on family members by reducing the likelihood of patients losing their job and their driving license,” he said.
ADVANCING ORTHOPEDIC SURGERY
Digital Orthopaedics develops 3D simulation systems to support decision-making in foot and ankle surgery.
“Our aim is to personalize surgery planning and execution and improve treatment,” said Eric Halioua, co-founder and CEO of the Belgium-based company. “We generate a digital 3D clone of the patient’s foot and ankle and simulate the surgery to assess the various options available to them.”
The technology benefits patients by establishing the root cause of their condition and identifying the best treatment. But it offers other advantages, too. “We can free up and make best use of physicians’ and surgeons’ time by delegating first steps or simple cases to less specialized resources” Halioua said. “For the healthcare payer, we can ensure the best medical benefit per dollar spent, and we can help to reduce the occurrence of complications and further operations, which can be extremely costly.”
Powerful computer simulations are central to Digital Orthopaedics’ vision. “There is a great deal going on to promote the usage of advanced simulation technology,” Halioua said. “Aside from helping humans, it will help to decrease the number of animal studies taking place, too. We now have the technology to mimic the human dynamic in silico – something which wasn’t possible one or two decades ago. The issue is transforming the way the industry is delivering and developing medicine and health care. We need to integrate these tools into our profession.”
Digital Orthopaedics plans to offer its solutions commercially in 2019.
ACCURATE DOSING
Medicines are only effective when the patient uses them properly. ExactCure, a personalized health care startup based in Nice, France, was founded to address the issue of patients who need a dosage different from what is considered standard.
“We are only just beginning to realize the potential of personalized medicine,” said Fabien Astic, who co-founded ExactCure with Frédéric Dayan and Sylvain Benito and who serves as the company’s chief business development officer. “We are entering a new era of true personalization. But part of the problem is that we’re all different, so we react to drugs differently.”
ExactCure’s technology resulted from three years of research in partnership with Inria, a public research body in France.
“We have developed an app [for smartphones] which takes patients’ individual metrics and runs them through an algorithm to simulate the impact of drugs on their body,” Astic said. “We can then tell how they’re going to respond to treatment, so we can personalize dosage.”
ExactCure’s vision is to make truly personalized medication a reality for everybody.
“By taking into account the individual characteristics of each person – such as weight, age and gender – we can accurately determine the best mode of treatment and improve outcomes,” Astic said. “There will be less need for emergency treatment, fewer visits to the hospital or doctor, fewer deaths – this is especially true for developed countries – and, ultimately, less pain.”
The company is conducting three pilots with a syndicate of pharmacists and doctors in France and Spain. The pilots were scheduled to begin in December 2018 and continue until February 2019. Because smartphones are used globally, however, Astic believes ExactCure could help patients in the world’s least developed countries as easily as in developed ones.
“There is no reason why personalized medicine can’t be a reality for everyone,” he said. “It’s possible because pretty much everyone now has a smartphone. As long as you have access to a smartphone and the internet, you can take advantage of our solution.”
REGULATORY CAUTION
While personalized medicine offers tremendous benefits, regulators must temper enthusiasm with caution, ensuring that these novel treatments are ready for public consumption. Therefore, global health providers are formulating policies and research programs that consider the social implications of this new approach.
“We must ensure that patients and the public are confident in the use of these technologies and that we can mitigate any potential concerns, particularly in the area of data security and confidentiality,” the UK’s NHS observed in its 2016report, “Improving Outcomes Through Personalised Medicine.”
In its 2017 workshop on personalized medicine, the European Medicines Agency emphasized the need to educate patients about the confidentiality implications of sharing their data, urging the industry to do more to educate patients so that they can give truly informed consent to personalized medicine approaches. Workshop participants, however, agreed that the benefits of personalized medicine could be far reaching.
“Improving the ability to better target treatment to patients who are likely to benefit from it and avoiding patients who may be at risk of being harmed would increase success rates of treatment, improve product development times and potentially reduce health care costs overall,” the EMA reported.
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