My name is Tetyana Obukhanych. I hold a PhD in Immunology.
So it was with a mixture of curiosity laced with healthy doses of pessimism that I attended the Personalized Medicine: The Conference was orchestrated by Dr. I must say I was pleasantly surprised by the august assemblage of stake holders from academia, large and incipient producers pharma, bio-tech, diagnostics, medical deviceshealthcare providers physicians and hospitalspayers, as well as regulators.
What is Personalized Medicine? Why is this significant for Patients and Healthcare? This implies delivering treatment to patients that is proactive, predictive, personalized and participatory unlike the status quo today.
If the treatment does not work and presents significant side effects or adverse events, the doctor most likely would alter dosage or prescribe an alternative medicine.
This iterative cycle is repeated, until the diagnosis and treatment that actually presents the desired clinical outcome in the patient is reached. The paradigm has reached a point of diminishing returns as evidenced by the fact that most drugs prescribed in the U.
Herceptin, a monoclonal antibody delivered by Genentech often recognized as the pioneer of the bio-tech industryhas been found to be particularly efficacious as a first line treatment with chemotherapy, in treating aggressive forms of breast cancer in women whose tumors have an overabundance of HER 2, a protein that promotes cell growth.
This is also compelling from a cost-benefit perspective. A very similar business case 4 also presents itself for patients with high cholesterol who are prescribed high statins for treatment — these tend to be ineffective or not completely ineffective in a significant number of these patients!
As well, health Insurance needs to be dramatically improved to assure affordable health insurance for every American. These include facilitating collaboration among researchers, clinicians and the Healthcare Value Chain at large, accessing, processing and integrating clinical, genetic and genomic data from multiple, often heterogenous and disconnected sources, and having the robust IT platforms software and hardware built on common industry standards to do so.
Regulations — How soon can a new innovation be delivered while assuring safety, quality and efficacy? Educating the thousands of physicians in North-America and across the globe trained in the current paradigm presents a daunting challenge with enormous cost and change management implications.
While the conference attempted to address each of the six issues identified above, potential solutions in three areas reimbursement, business models, IT infrastructure were deemed the most important, tactically addressable and are summarized below: Policy amendments to effect these fundamental changes to healthcare reimbursement is currently being contemplated.
How do Regulations need to change to make this happen? The sequencing of the human genome has helped scientists link an ever increasing number of diseases to specific genes. As well, scientists have been making great strides in mapping the molecular pathways by which a change or mutation in a gene actually manifests itself in a disease.
This culminates in the ability to manage many fatal cancers as chronic conditions by attacking them early, resulting in more lives saved 2. The economics of delivering a large number of molecules targeted at smaller patient populations will demand a radical transformation from the current model predicated on the discovery, development and commercialization of a very small number of molecules targeted at large patient segments.
The biggest challenge, according to the Pharma companies, is the science of drug discovery — how to identify and validate a genetic association with a disorder and then develop a molecule to address this. Pharmacogenomics and related technologies have driven significant advances in this arena, but there is still a long way to go.
Pharma companies like Pfizer and Lilly are increasingly seeking approval for companion diagnostics e. Eli Lilly also presented compelling quantitative data demonstrating a business case for developing targeted therapeutics.
From a regulations perspective, these Pharma and Bio-Tech producers expressed the imperative for granting additional periods of exclusivity for innovations targeted at smaller targeted populations, similar to the 7 year exclusivity for Orphan Drugs and pediatric drugs.
Without these additional periods of exclusivity, the current economics of drug development simply does not lend itself to rendering targeted therapeutics viable — they would go out of business.
As well, the imperative for shorter development cycles and costs demanding a fundamental re-thinking of FDA regulations is warranted.
It is astounding that in the 21st century, archaic, paper based medical records, the resulting inaccuracies and inability to access this information in life and death situations results in over 80, deaths annually in the US alone.
Who will make it Win-Win for patients to adopt? Nadine Cohen from Johnson and Johnson — what is missing today are effective tools to analyze the data and deliver meaningful analysis that will help them commercialize drugs faster.
Use of drug disease modeling and scenario simulation is an idea whose time has come, to drive decision making re: As well, lack of collaboration across functions and trading partners and little to no visibility into downstream demand and patient insights is costing the Life Sciences industry especially Big Pharma, billions of dollars in value leakage by way of excess inventory, stock outs with life and death implications.
Also exacerbating this is little to late visibility into adverse events and complaints resulting in huge penalties that can be significantly alleviated with tools for analysis of post-marketing data to understand and proactively impact patients who show adverse reactions to new drugs.
Empowering customers with the information and decision support they need, to result in the best possible outcomes at the lowest cost, is the key. Who will make it Win-Win for Patients to adopt?From Producer Innovation to User and Open Collaborative Innovation Modeling a Paradigm Shift: From Producer Innovation to Open User and Collaborative Innovation 1.
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