AccessHope CRO Origin Story

“It would be the height of folly – and self defeating – to think that things never before done can be accomplished without means never before tried.”

Sir Francis Bacon

Sir Francis Bacon was a man of unusual insight. As usual he cuts directly to the truth of something that, upon reflection, seems so obviously true, even four hundred years later. Though a seeming impossibility in todays’ hyper-partisan politics, the Right to Try law was ACTUALLY a bi-partisan bill, passing the U.S. Senate by unanimous consent. No Republican or Democrat or Independent in the Senate voted against it. Period. Prior to the passage of the federal law, 41 states had passed their own versions of the law, almost all with unanimous or near unanimous votes, from otherwise deeply-divided and partisan State legislatures. Such is the power of an obvious truth. Prior to Right to Try, patients with life-threatening diseases did not have meaningful access to investigational drugs under the FDA’s then regimen of randomized clinical trials with only compassionate-use exceptions.

Though I am (as my friends are wont to say, and in the spirit of full disclosure) a typical knee-jerk liberal, born and raised in Washington DC, I consider it a privilege to have worked with the Goldwater Institute, and other conservative institutions, to help draft and advocate for the law’s passage, both in the state-by-state wins and finally in Congress. To its credit, the coalition agreed to many changes in order to ensure passage of a Bill that would dramatically increase access to investigational medicines for patients with life-threatening diseases in a safe and ethical manner, with the potential to help drug developers dramatically cut their development time and budgets.

I have no interest in rehashing the arguments used by various Right to Try opponents, who claimed that Right to Try was somehow “anti-FDA” and anti-patient. It is now the law of the land. Nor do I approach Right to Try from an “anti FDA” perspective. Beacon of Hope CRO was founded in order to implement the Right to Try mandate to expand access to investigational drugs dramatically, and not to just one patient at a time, but at scale. As we begin operations, I believe it is important for all of our stakeholders, patients and drug developers alike, to understand the perspective that we do come from.

As a biotech CEO for 17 years, developing therapies for life-threatening and/or intractable diseases and indications, I can tell you that the FDA is a dramatically underfunded and overworked agency. This contributes in no small part to the ever-increasing time and money needed to get new drugs approved and out to the public. This trend is not going to change. If you are interested in the daily battles the agency must fight merely to keep pace with its own mandates, check out the first rate work being done at:

https://strengthenfda.org

This constant squeeze on resources makes it imperative that we find a way for companies to obtain ethically-sourced, meaningful data in a much quicker and less expensive manner, as an effective way to lower development costs of drugs for life-threatening diseases. Right to Try can do this. At the same time, we can increase, at scale, access to these drugs in development for patients who, literally, do not have the time to wait for the approval process to play out over the decade that is now the average timespan for a drug approval. I come to Right to Try as an industry insider who knows that the drug development system simply costs too much and takes too long.

I worked hard to convince others that Right to Try could only work if it RELIED upon the FDA’s gold standard reputation for safety in drug development. The law could not act, nor be perceived as, adversarial towards the FDA process. Otherwise, companies would not avail themselves of the incentives to participate and expand access. The enacted law clearly reflects this balance.

I also come to Right to Try as a parent of a child who has dealt with multiple brain tumors and related issues for his entire life. We have been blessed beyond hope and prayer, twice he has been the beneficiary of experimental therapies that were outside of the traditional clinical trial process. These have had long-lasting beneficial effects. When it comes to potential treatments for life-threatening diseases, Access Hope CRO understands, and is infused with, “the urgency of now” experienced by all potential Right to Try Patients and their families.

Finally, I come to Right to Try having had the privilege of interacting with the patient, care-giver and treatment communities for many diseases, which are now eligible indications for Right To Try. I understand the frustrations with clinical trial protocols that exclude all but a few. I have witnessed the innate tensions between the treatment community and those they would help. I believe that Right to Try can provide a way for drug developers to bridge that gap.

We know that no single law can “fix” all the things that are broken in our industry. And the data tell us that many investigational drugs end up failing in the trial process. Right to Try makes no false promises. It is founded on the principles of truly informed consent and transparency. Yet it is also founded on the principle of hope, on the belief that patients, in concert with their doctors and a drug’s developer, can best balance the risks against the potential benefits of trying an investigational drug. The new law has created powerful incentives for companies to participate, and heretofore unknown freedom and speed for treatment programs to begin. Right to Try was created to provide the framework to facilitate that process. Access Hope CRO was created to implement it. We believe it is indeed time to try something never done before, to accomplish something never accomplished before.