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Braeburn Pharmaceuticals - Executive of the Year

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Company: Braeburn Pharmaceuticals, Princeton, NJ
Entry Submitted By: Coltrin & Associates
Company Description: Braeburn Pharmaceuticals, an Apple Tree Partners company, is a commercial-stage pharmaceutical company delivering individualized medicine in neuroscience. Long-acting therapeutic treatment options can be essential to improving patient outcomes and facilitating recovery in neurological and psychiatric disorders, which are often complicated by stigma and present significant public health challenges.
Nomination Category: Management Categories
Nomination Sub Category: Executive of the Year - Pharmaceuticals

Nomination Title: Behshad Sheldon: Leading the Paradigm Shift in Opioid Addiction Treatment

Tell the story about what this nominated executive has achieved since January 1, 2016 (up to 650 words). Describe the impact he or she has had on your organization. Focus on specific accomplishments, and relate these accomplishments to past performance or industry norms.

Behshad Sheldon is well aware that 91 people die every day of an opioid overdose – the equivalent of a full 747-passenger jet crashing every five days. Many people are still unaware of the severity of the opioid addiction crisis, which the Centers for Disease Control (CDC) has deemed an epidemic.

Behshad, is a successful pharmaceutical executive (Otsuka, SmithKline Beecham) and CEO of Braeburn Pharmaceuticals — a private equity funded startup pharma company. Behshad is fundamentally changing the way opioid addiction and other neurological diseases are treated.

Shortly after Braeburn was founded, Behshad quickly met her first major obstacle in 2013 when the FDA rejected what was to be Braeburn’s first flagship product for opioid addiction called Probuphine®.

Behshad did not give up on Probuphine. On January 12, 2016, after conducting more studies, Behshad presented data to an FDA Advisory Committee in Washington D.C. At the conclusion of the hearing, the committee voted decisively in favor of recommending that the FDA approve Probuphine. While the vote was not a guarantee of FDA approval, it was a significantly positive milestone for Probuphine.

After an exhaustive effort by Behshad and her team over the next several months, Probuphine was approved in May of 2016.

Behshad’s determination to bring Probuphine to market is driven by the unique benefits it can offer opioid-addicted patients. It is different from all other treatments because it is a long-acting subdermal implant that delivers a steady dose of medication to patients for six months. An implant may not seem like a big deal, but when it comes to addiction, the benefits of a long-acting implant are potentially life changing. Here’s why:

• Adherence – doctors know the medicine/dose they prescribe is the exact medicine/dose a patient will receive
• Missing doses of oral medication increases a patient’s risk of relapse and overdose
• Oral medicines can be abused, with an implant risk is eliminated
• Unlike oral medication, patients never have to think about taking pills, helping to reduce pill-seeking or addictive behavior

Probuphine is not the only significant accomplishment Behshad has achieved in the past year. Behshad has guided Braeburn through several critical milestones for many products in their pipeline.

Braeburn completed a study for CAM2038, (which the FDA has granted Fast Track status for priority review) a long-acting injectable treatment for opioid addiction. Four non-fatal overdoses occurred during the study with patients who were taking traditional oral medicine, whereas there were no overdoses and significantly fewer cases of relapse in the CAM2038 study.

Braeburn also has a new study for CAM using it as long-acting treatment for pain. This could eventually eliminate the need for patients to take home bottles of addictive pills after operations or painful accidents. It’s Behshad’s vision for stopping addiction before it starts.

Here is an excerpt of what Nora Volkow, MD, Director of The National Institute on Drug Abuse (NIDA) has said:

“Behshad is at the very top of the list of outstanding senior executive women; her vision has engendered a proven record of achievements that have changed the healthcare industry for the better. I have followed her trailblazing career for many years and have always been impressed with her commitment to bring innovative treatment options to treat chronic diseases that are all too often made worse by the shadow of stigma... She has been a beacon of steady leadership and clear vision in an industry that can often be described as stormy and unforgiving, focused like a laser on serving patients suffering from health conditions for which, for too long, there has been little innovation.”

Ms. Sheldon deeply cares about the wellbeing of patients. This is why Behshad has dedicated her life to finding solutions that really work. Her treatments are created not merely to treat patients, but to bring normalcy back into their lives.

In bullet-list form, briefly summarize up to ten (10) of the chief accomplishments of this nominated executive since the beginning of 2016.

- Behshad has an overarching vision to create a continuum of care for opioid addicted patients and other undeserved, stigmatized patient populations
- Behshad is changing the approach to patient treatment by developing long-acting implantable and injectable treatments, eliminating the need for pills
- Behshad spearheaded the FDA approval of Probuphine, the first subdermal implant to treat opioid addiction
- Behshad oversaw the training and certification of approximately 2,500 physicians in the months following FDA approval of Probuphine
- Probuphine won Popular Science's 'Best of What's New' award as well as the Gold Stevie award for 'Best New Product' for Women in Business
- Behshad initiated and completed a number of studies on opioid addiction, chronic pain, and schizophrenia in 2016