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The FDA & STEM CELLS: UNDERSTANDING 

STEM CELLS & THE CLINICAL TRIAL PROCESS

Concerns and Expectations of the FDA

CME WEBINAR SERIES

Registration & information page

* Please note: Registration is open to Medical Professionals and patients... and anyone seeking evidence-based reliable information.

WEDNESDAY, NOVEMBER 18, 2020 

We'd like to acknowledge

and express our gratitude to 

 

The Seim Family (Sponsor)

 

And, an Anonymous Contributor

and, also, funded in part by a grant from the San Diego County Board of Supervisors 

Thank you!

THE FDA & STEM CELLS:

UNDERSTANDING STEM CELLS & THE CLINICAL TRIAL PROCESS

Expectations and concerns of the FDA

Featured Guest Speaker: Peter Marks, M.D., Ph.D.

Wednesday, November 18, 2020     

5:00pm-7:00pm PST

Don't miss this unique opportunity to hear from the Director of the FDA’s Center for Biologics Evaluation and Research.

Registration Opens:  NOW OPEN

Cost: $35.00

MDs, PAs & RNs: This course offers 2 CME Credits.

These credits are Category 1 CME Credits.

Beth E. Roxland, J.D., M. Bioethics | Special Guest Moderator

Jeanne Loring, Ph.D.: | Distinguished Speaker: Stem Cells "101"

Peter Marks M.D., Ph.D. | Featured Guest Speaker 

  • The FDA’s Clinical Trial process for an evidence-based regenerative medicine therapy from creation to execution.

  • The FDA’s efforts to meet the needs of conditions with unmet medical needs. (e.g., Right to Try, Compassionate Use, RMAT designation)

  • Stem Cell Tourism - an Overview (Stem Cell Tourism is the focus for the next Summit CME Webinar on December 09, 2020.)

 

Q&A Panel Discussion follows

       Peter Marks, M.D., Ph.D           Jeanne Loring, Ph.D.

       Abigail Lawler, M.D.                   Rita Ceponiene, M.D., Ph.D. 

                   Beth Roxland, J.D., M. Bioethics

A LIVE webinar with moderated presentations from our guest speakers followed by a Q&A panel discussion

IN ORDER OF APPEARANCE:

Beth Roxland, J.D., M. Bioethics

Founder and Strategic Advisor, Roxland Consultants Ltd.

Special Guest Moderator

Beth E. Roxland is an Attorney and Bioethicist with unique experience across industry, law, government and academia. She is the Founder of Roxland Consultants Ltd., and serves as an independent advisor to law firms, academic medical centers, life-science and research entities, providing strategic support and guidance on complex regulatory, ethical, operational and communications challenges. Beth also serves on several oversight boards, and is a frequent author and public speaker.

Ms. Roxland was previously the Bioethics & Strategy Leader for Johnson & Johnson in its Chief Medical Office (Global).  In this industry-leading position, she launched an enterprise-wide Research Ethics Consultation Service to provide teams and individuals with real-time support on complex ethical R&D issues, and led the first-of-its-kind major colloquium partnering to foster public dialog and potential policy-making between industry, academia, non-profits and governmental entities on challenging ethical issues surrounding Early Access to experimental interventions. She also advised on commercialization of stem cell therapies, conducting clinical trials in war-torn regions, testing of a potential Ebola vaccine during a public health crisis, subject recruitment and withdrawal, and Expanded Access/ Compassionate Use and Right to Try, and research involving children and other “vulnerable populations.”

Prior to joining J&J, Ms. Roxland was the Executive Director of the New York State Task Force on Life and the Law (the State’s Bioethics Commission), where she led comprehensive reports – which were later adopted by the State into law, regulation and guidance – on the Allocation of Ventilators in a Pandemic Influenza, Determination of Brain Death, and Research with Adults Lacking Full Consent Capacity. While with the State, she concurrently served as the Special Advisor to the Commissioner of Health on Stem Cell Research Ethics, where she drove thoughtful policy for novel, sensitive types of stem cell research, including on SCNT, usage of embryos in research, and payment for gamete donation.

Beth began her career as an attorney, where she was a Senior Associate in the litigation department of Simpson Thacher and Bartlett LLP, and as a Federal Law Clerk in the Southern District of New York (S.D.N.Y.).

She graduated from Columbia University with a Bachelor’s degree in biology, and received a joint J.D.- Master’s in Bioethics mage cum laude from the University of Pennsylvania.

Jeanne Loring, Ph.D.,

Director & Chief Science Officer, Summit for Stem Cell Foundation

Professor Emeritus, Scripps Research Institute

Founder, Aspen Neuroscience

Distinguished Speaker

Jeanne F. Loring is the Professor Emeritus at the Scripps Research Institute where she was founding Director of the Center for Regenerative Medicine. She is also founder of two stem cell-based biotechnology companies, Arcos Bioscience (now part of Viacyte) and Aspen Neuroscience, a biotechnology company developing a neuron replacement therapy for Parkinson disease.  Dr. Loring has more than 30 years of experience in both biotechnology and academic research, focusing on stem cells, genomics, embryology and neurobiology. She holds five patents on stem cells and genomics, and has published more than 100 research articles in scientific journals that have been cited in scientific publications more than 14,000 times. She serves on both scientific advisory and bioethics boards, and advises governmental and private granting agencies in several countries. Through her laboratory courses, she has trained more than 400 scientists in stem cell technology.

In addition to her work on Parkinson disease, Dr. Loring investigates multiple sclerosis and autism, and works with the San Diego Zoo Institute for Conservation Research in an effort to rescue the Northern white rhinoceros from extinction using stem cell technology.  She is also involved in a project on the International Space Station to study neurogenerative disease.

Dr. Loring is an advocate for patients and an outspoken critic of stem cell clinics that operate outside of ethical or scientific oversight. She speaks out against unregulated stem cell therapies that have  caused severe injuries and even death, and the clinics who convince desperately ill patients to pay for treatments that are not effective.

Peter Marks, M.D., Ph.D.,

Director, Center for Biologics Evaluation and Research, FDA

Featured Speaker

 

Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development.  He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016.

Rita Ceponiene, M.D., Ph.D,

Director and Medical Advisor, Summit for Stem Cell Foundation

Panelist

 

Dr. Ceponiene is American Board of Psychiatry and Neurology certified member of the American Academy of Neurology and the Movement Disorders Society. Dr. Ceponiene is originally from Vilnius, Lithuania where she obtained Medical Doctor’s degree. She then completed a PhD program in Cognitive Neuroscience at the Helsinki University, Finland, followed by a post-doctoral research at the University of California, San Diego. In addition to her doctoral thesis, she has published over 40 peer – reviewed research articles during her academic career. She returned to clinical work after completing neurology residency and movement disorders fellowship at the University of California, San Diego. Dr Ceponiene’s goal of returning to clinical work was to be able to integrate her academic and clinical backgrounds for the direct benefit of the patients. She maintains active ties with the academic community via joint conferences and participation in educational events. She is passionate about educating patients and colleagues about the ongoing research into the nature and treatment of Parkinsonian disorders and about connecting patients with research study opportunities. One of them is the promise of the autologous dopamine neuron replacement therapy that is being developed via a rigorous, years of research community-vetted, data-backed scientific approach.

Abigail Lawler, M.D.

Director and Medical Advisor, Summit for Stem Cell Foundation

Panelist

Dr. Lawler is a board-certified member of the American Board of Psychiatry and Neurology and is a member of the American Academy of Neurology and the Movement Disorders Society. Dr. Lawler is originally from Ohio where she completed undergrad at Ohio University and also studied abroad through Duke University in Costa Rica where she completed a Spanish immersion program. She came back to Ohio for medical school at University of Toledo and then went on to complete her residency training in neurology at Medstar Georgetown University Hospital in Washington D.C., where she served as chief resident. Dr. Lawler stayed at Georgetown University to complete a fellowship in Movement and Memory Disorders at the highly acclaimed Translational Neurotherapeutics Program where she was extensively involved in clinical research, including the pivotal ongoing study using Nilotinib for treatment of Parkinson's Disease and Alzheimer's Disease, helped start the first ever Parkinsonism and Dementia clinic, and participated in baseline cognitive and neurologic assessments of retired NFL players for the NFL Players association. Dr. Lawler has published a variety of papers and posters on topics involving the use of Nilotinib in the treatment of Parkinson's Disease and Lewy Body Disease. Dr. Lawler is experienced in treating many different neurologic conditions but specializes in the diagnosis and treatment of Movement Disorders, offering a wide variety of treatment options beyond traditional medical management for Parkinson's Disease including programming and management of Deep Brain Stimulation and the Duopa LCIG infusion pump. Dr. Lawler also specializes in the diagnosis and treatment of a variety of Autonomic conditions, muscle dystonia and spasticity using Botulinum toxin injections, as well as all of the various types of Dementia. Dr. Lawler is very passionate about the care and treatment of patients with memory disorders and plans to start a new program and center of excellence with the goal of not only improving patient care and treatment options but starting a nationwide campaign of awareness.

FUTURE CME WEBINARS - Click on Image for INFORMATION & REGISTRATION

DECEMBER 9, 2020

3:00pm – 5:00pm PST

UNDERSTANDING STEM CELL THERAPIES:

SEPARATING HOPE & HYPE

Helping your patients navigate regenerative medicine.

There is a great interest in regenerative medicine as an alternative treatment for those with unmet medical needs. Renowned speakers will provide evidence-based information about: 

  • The capabilities of stem cells.

  • Pursuing regenerative medicine options:

  • FDA-approved & unapproved treatments

 

Featured Guest Speakers:

Zubin Master, Ph.D., Jane Lebkowski, Ph.D.,

Paul Knoepfler, Ph.D.

Special Guest Moderator:

Beth Roxland, J.D., M. Bioethics

Founder and Strategic Advisor, Roxland Consultants Ltd.

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INFORMATION

& REGISTRATION

CLICK IMAGE

OR Quick-link to Registration ONLY

JANUARY 27, 2021

3:00om - 5:00pm PST

INNOVATIVE RESERCH: THE QUEST FOR A PARKINSON'S CURE

Where are Researchers? AND...

Identifying the Cornerstones for Disease Modification

     Universal Approach / "Rescue Therapy"

      Individual Approach / "Cure"

Featured Guest Speaker: 

Alberto Espay, M.D., MSc, FAAN, FANA

INFORMATION

& REGISTRATION

CLICK IMAGE

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OR Quick-link to Registration ONLY