Q&A Interview w/Pamela Levin, Communications Director for the Tisch MS Research Ctr

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Q&A Interview w/Pamela Levin, Communications Director for the Tisch MS Research Ctr

http://www.bioinformant.com/qa-with-pamela-levin-of-the-tisch-ms-research-center-of-new-york-preparations-begin-for-phase-ii-stem-cell-trial-for-ms/

Q&A with Pamela Levin of Tisch MS Research Center of New York – Preparations Begin for Phase II Stem Cell Trial for MS

February 8, 2016 By Cade Hildreth (CEO)

For patients with multiple sclerosis (MS), the Tisch MS Research Center of New York (MSRCNY) and its affiliated clinical practice, the International Multiple Sclerosis Management Practice, are important centers. They represent one of the few sites worldwide were clinical excellence is paired with cutting-edge research aimed at finding a cure for MS, a disease which affects 400,000 Americans and 2.5 million people worldwide.

In groundbreaking news released January 2016, the Tisch MS Research Center of New York (MSRCNY) announced that it is pursuing a Phase II clinical trial exploring the use spinal injections of neural progenitors derived from bone marrow mesenchymal stem cells (MSC-NPs) for the treatment of MS.

The announcement followed positive results from a FDA-approved Phase I stem cell trial. Importantly, that Phase I trial it was the first time in history that a treatment has demonstrated reversal of established disability in patients with MS.

The visionary behind Tisch MSRCNY is Dr. Saud Sadiq, who for 20 years has been involved with MS research and innovation. The Tisch MS Research Center of New York was formally launched in 2006, but it grew out of the MS center at the Neurological Institute of New York of the Columbia University Medical Center, which Dr. Sadiq joined in 1992. Since then, Dr. Sadiq has grown the Tisch MSRCNY into the largest independent MS center in the world. To learn more about Dr. Sadiq, read our recent Q&A interview with him.

To explore the Phase II clinical trial preparations now underway at the Tisch MS Research Center of New York (MSRCNY), a question and answer interview with Pamela Levin is included below.

In addition to speaking to the important of finding a cure for MS, Ms. Levin shares insights into Dr. Sadiq’s extraordinary commitment to finding a cure for MS, as well as his unwavering dedication to providing a world-class clinical experience for patients with MS. This interview also speaks to the substantial potential of stem cells for solving preciously incurable diseases, as the basis for Tisch MSRCNY’s Phase II clinical trial involves stem cell-derived neural progenitor cells. Enjoy!



Q&A Interview with Pamela Levin, Communications Director for the Tisch MS Research Center of New York

Cade Hildreth: What is your personal background and how did you become involved with the Tisch MS Research Center of New York (Tisch MSRCNY)?

Pamela Levin: I got to a point in life where I was not fulfilled by the work I was doing, so I went back to school for nursing. I wanted a noble profession, a feeling of “giving back.” When I graduated, I wanted to work in an area that I would have a personal connection with, so I looked into multiple sclerosis centers. My brother had been diagnosed with MS a few years prior.

Cade Hildreth: Approximately how many people worldwide are diagnosed with MS?

Pamela Levin: Approximately 2.5 million people worldwide, with several new cases diagnosed every day.

Cade Hildreth: How does MS affect the lives of patients who are diagnosed with it?

Pamela Levin: Just a diagnosis alone is scary. It can lead to depression or anxiety because with MS, you never know what the future holds. You can wake up one day with blurry vision, numbness and tingling and as time goes on lose physical function, bladder function and suffer from neuropathic pain among other issues.

MS can affect every person differently but for many people, their lives are changed – some may have to stop working or traveling, relationships are affected and for parents it can mean not being able to play catch, attend a soccer game or even just take your son or daughter to the bus stop.

Cade Hildreth: Who is Dr. Sadiq and how has his vision been central to the Tisch MS Research Center of New York?

Pamela Levin: Dr. Saud Sadiq has always said, “We must first discover the cause of MS in order to find the cure.” He created the Tisch MS Research Center of New York to do just that.

He set the Center up in a very unique way. It is attached to the affiliated clinical practice, the International Multiple Sclerosis Management Practice (IMSMP). This allows for translational, patient-based research meaning we have the ability to take blood or spinal fluid from a patient in an exam room and walk it just steps down the hall to a researcher in the lab. Dr. Sadiq and his research team examine many characteristics of the spinal fluid and that helps determine the best possible MS treatment a patient can be on.

So basically, all the research stems from the patient and translates back into the lives of the patients. Dr. Sadiq’s vision was to create a Center that was not tied to a university or be a place with a lot of ideological hindrances. He wanted to do research that is solely focused on discovering the cause of this disease and wanted 100% of donations to go directly to research.

It is like no other MS center in the world. Dr. Sadiq is Chief Research Scientist at Tisch MSRCNY and Director of the IMSMP. He is my brother’s neurologist and I have never met a more dedicated physician.

Cade Hildreth: Can you describe Dr. Sadiq’s commitment to the Tisch MS Research Center of New York, including a description of his daily activity or workweek?

Pamela Levin: He arrives at the Center around 5:00am and stays until 9:00pm – 10:00pm, always 6 days a week and often 7, and when designing the center, he had a bedroom built behind his office so he can sleep there. This helps when working in the lab late at night.

When he arrives in the morning, he will do phone consults with our international patients since that’s the best time for them to speak. He will review lab work, MRI’s and patient reports. He will then meet with a secretary to discuss follow-up calls or appointments patients need to have.

He conducts a clinical staff meeting reviewing every patient coming in that day and goes over their MS history without ever looking in a chart. He can tell you their spouse’s name, their children’s name, where they are traveling from and what insurance they have.

He sees patients from 9:00am – 6:00pm. He will then do evening phone consults with patients and then head to the lab to check the progress of what the researchers are working on. He wakes up at 3:45am and does it all over again. He makes house calls and gives EVERY patient his cell phone number.

If his day is marked “vacation” in the schedule book, you will most likely find him in the laboratory. That’s his happy place.

Cade Hildreth: How has the the Tisch MS Research Center of New York been funded to date?

Pamela Levin: The Tisch MS Research Center of New York has been solely funded through private donors and philanthropists as well as by obtaining grants through various orgaizations.

Cade Hildreth: What were the clinical outcomes from the recent Phase I stem cell study for MS by the Tisch MS Research Center of New York?

Pamela Levin: In Phase I, we saw patients gaining back function they thought had been totally lost. Patients were taking steps without the use of their cane, a patient who was wheelchair-bound for over one year is now able to use a walker!

Another patient, who would ambulate with assistance but fell frequently due to weakness and instability, has not fallen in over six months due to improved balance and is regaining normal strength in her lower limbs. In addition, many patients reported noticeable improvement in bladder function, vision and endurance.

Cade Hildreth: Practically speaking, how did these outcomes change patient lives?

Pamela Levin: Their quality of life dramatically improved both mentally and physically. They had more energy, felt stronger. Above all it has given hope to patients that their disability can be reversed.

Cade Hildreth: What are current approaches to MS treatment? How could your recent Phase I stem cell study for MS potentially alter this framework?

Pamela Levin: All FDA approved treatments for MS are currently designed to halt progression. There is nothing approved in terms of regenerative medicine. This would be the first of its kind. Our goal is to create a stem cell treatment that will repair the damage caused by MS.

Cade Hildreth: With such promising Phase I data, what is required to initiate the Phase II trial? (e.g. cost for facilities, staffing, patient recruitment, treatments, and associated expenses?)

Pamela Levin: Tisch MSRCNY is located on the west side of Manhattan. The Center occupies 2 floors however 12,000 square feet of our space is not yet built. We secured the space a few years ago to become our stem cell laboratory and culture facility and the projected cost is 10 million dollars for the build out.

The expected cost of Phase II of the stem cell study is another estimated 3 million dollars.

Cade Hildreth: Who are you seeking to partner with to progress this promising Phase I data into Phase II?

Pamela Levin: We’ll be partnering with the Judith Jaffe Multiple Sclerosis Center at New York-Presbyterian/Weill Cornell Medical Center to carry out Phase II. However, it is in our hands to raise the critical funding and we will also seek support in the form of grants from the National MS Society and NIH.

Our patients are the true partnership in this endeavor. It is their strength, courage, and faith that inspires us and moves us forward to this next phase.

Cade Hildreth: What financial and strategic benefits would an investor in your Phase II study receive?

Pamela Levin: This is difficult to define at this stage, however, if this becomes an FDA approved stem cell treatment for MS, financial and strategic benefits could have limitless potential. Our hope is that this treatment could someday be applied to cerebral palsy, ALS and spinal cord injury as well.

Cade Hildreth: If a philanthropic contributor would like to support the upcoming Phase II trial, how could he or she expect to forever alter the landscape of MS research? How would this contribution impact the world?

Pamela Levin: This stem cell trial is giving people their lives back. People with MS will now be able to travel, to continue to work, to fall in love and get married, to start a family and go to their kid’s soccer game or take their child to the bus stop in the morning. It’s giving hope that future generations won’t experience the suffering so many people are living with now. It’s securing a future in regenerative medicine and therapy to repair not just halt.

When a father who used a wheelchair or a motorized scooter, can hope to walk his daughter down the aisle at her wedding, I would say that’s a pretty big impact.

Cade Hildreth: How can people can in touch with you if they would like to get involved as an investor, donor, or patient?

Pamela Levin: For more information on how to get involved as a donor, please contact the Development Office at Tisch MSRCNY (646) 557-3900 or visit our website www.tischms.org.

For information on investor relations, please contact Amanda Oppenheimer at aoppenheimer@tischms.org or (646) 557-3872.

It is important to note, Tisch MSRCNY is a not-for-profit research facility and not a medical practice. However, if you wish to become a patient at our affiliated clinical practice, the International Multiple Sclerosis Management Practice (www.imsmp.org) please call (212) 265-8070.

Cade Hildreth: Thank you for the honor of doing this interview, as well as for your extraordinary commitment to improving the lives of patients with MS and finding a cure for the disease.
 
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