The Apple Heart Study: Transforming clinical trial conduct.

Ken Mahaffey, MD

October 8, 2019
6-9PM, Wilson Sonsini Goodrich & Rosati

The Apple Heart Study was a pragmatic, virtual study of over 400,000 participants to evaluate the Apple Watch ability to detect irregular heart rhythms. The innovative design and operational success will be discussed and the results presented.

Dr. Mahaffey is the Vice-Chair of Clinical Research in the Department of Medicine at Stanford University and the Director of the Stanford Center for Clinical Research (SCCR). SCCR is an academic research organization to support researchers to design and conduct clinical research studies and to enroll Stanford patients in clinical trials. SCCR has expertise in mobile and digital technology investigation. Dr. Mahaffey’s own research focuses on the design and conduct of multicenter clinical trials and analyses of important clinical cardiac issues using large patient databases. His research efforts have resulted in the approval of new therapies for the treatment of patients with acute coronary syndromes, diabetes, and atrial fibrillation.

Dr. Mahaffey also studies the methodology of clinical trials including the standardization of the definition of MI used in clinical trials, the adjudication of clinical endpoints, and the evaluation of evidence-based operations. He works with the FDA and chaired the MI and Death Definitions Working Group in the Standardized Data Collection for Cardiovascular Trials Initiative. Dr. Mahaffey is a member of the Stanford University Institutional Review Board.

Event Speaker Bio:

Dr. Mahaffey is the Vice Chair of Clinical Research in the Department of Medicine at Stanford University and the Director of the Stanford Center for Clinical Research (SCCR). SCCR is an academic research organization to support researchers to design and conduct clinical research studies and to enroll Stanford patients in clinical trials. SCCR has expertise in mobile and digital technology investigation. Dr. Mahaffey’s own research focuses on the design and conduct of multicenter clinical trials and analyses of important clinical cardiac issues using large patient databases. His research efforts have resulted in the approval of new therapies for the treatment of patients with acute coronary syndromes, diabetes, and atrial fibrillation. Dr. Mahaffey also studies the methodology of clinical trials including the standardization of the definition of MI used in clinical trials, the adjudication of clinical endpoints, and the evaluation of evidenced-based operations. He works with the FDA and chaired the MI and Death Definitions Working Group in the Standardized Data Collection for Cardiovascular Trials Initiative. Dr. Mahaffey is a member of the Stanford University Institutional Review Board.

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Identifying pathogens 100x faster using Dynamic Bio-Affinity Patterning Technology

Kevin Hacker, Co-Founder & CEO

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The Odyssey of an Orphan Device – Eclipse Regenesis’ Short Bowel Syndrome Solution
Andre Bessette

Date(s) – 09/10/19
6:00 pm – 9:00 pm

Event Description:
Eclipse Regenesis, Inc. is developing the first restorative therapy to address pediatric and adult Short Bowel Syndrome (SBS), a malabsorption disorder caused by a lack of functional small intestine. Current chronic therapies for SBS include expensive medication and intestinal surgery, which come at a staggering average 5-year cost of $1.6M per patient. Via distraction enterogenesis, the Eclipse XL1 System is able to harness the body’s own tissue regenerative capabilities to produce new, fully functional intestine in vivo. The Eclipse XL1 is the first device based solution for SBS, which is a rare orphan disease market that has been dominated by biotech. From it’s birth in a lab at UCLA to incubation at Stanford and now final emergence as a Bay Area start up, Eclipse’s odyssey touches on many of the current medtech industry challenges of getting a surgeon’s brilliant idea translated into clinical reality to address a syndrome that has no solution today.

Event Speaker Bio:

Andre Bessette, CEO, Eclipse Regenesis, Inc.

Andre Bessette has over 20 years of medical device industry experience with a broad range of applications including orthopedics, sports medicine, oncology, general surgery, plastic surgery, cardiology, pain management, and ENT. He has held various leadership positions in engineering, operations, finance, clinical, sales and marketing throughout his career. Currently, he is Co-Founder and Chief Executive Officer of Eclipse Regenesis, Inc. based in Menlo Park, CA. Prior to Eclipse, he was the Chief Commercial Officer and Executive Vice President for Vantage Surgical Systems. Vantage was an early stage development company focused on a novel minimally invasive robotic surgical systems. Before that, he was Vice President of Marketing for SentreHEART, Inc. which is focused on the development of the first catheter based solution for left atrial appendage closure. From 2006 to 2011, he was the Vice President of Marketing, Clinical Affairs, and International Business at PEAK Surgical, Inc. PEAK was focused on the development and commercialization of an advanced energy surgical platform for multiple surgical specialties. He was part of the original management team that took PEAK from inception (2006) all the way to acquisition by Medtronic, Inc. in 2011. Prior to PEAK, he worked at ArthroCare Corporation (now SNN) in various marketing and international management roles.

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To Fold or Not to Fold?  Protein Quality Control Gone Awry – Lessons from Cancer, Diabetes, Aging, and Chronic Disease

Jeyanthi Ramasubbu

Date(s) – 08/27/19
8:30 am – 10:30 am

Event Description:
Aberrant protein processing is an underlying mechanism of neurodegenerative diseases such as ALS, Alzheimer’s, Parkinson’s, Dementia and many more. Protein quality control, which includes proper expression, folding, transport and clearance is critical for cellular function and organismal health. When cell defense fails and proteostasis malfunctions, is it doom time for healthy cells? Protein misfolding has long been associated with neurodegenerative diseases, but interestingly, it’s also a common feature in some chronic metabolic and oncogenic diseases such as type II diabetes, cystic fibrosis, sickle cell anemia and certain cancers. Aging and longevity are invariably tied to changes in protein management systems such as chaperones and clearance networks. How are these diverse chronic diseases as well as aging and health correlated? Are alterations in protein quality control a cause or consequence of disease and aging? Can protein homeostasis machinery rescue dysfunctional cells in chronic diseases and restore good health? What are the possible therapeutic strategies to maintain proteostasis?

Event Speaker Bio:

Jeyanthi Ramasubbu has more than 20 years of scientific and leadership experience in drug discovery, development and drug delivery. Jeyanthi joined the founding team at ALS Therapy Development Institute, a nonprofit biotech based in Boston and helped grow the organization as the world’s largest biotech focused on ALS research. As Associate Director, Pharmacology, she was a key player in establishing the Discovery Research Program and leading >40 scientific collaborations with academia and industry, both in the US and globally. She was selected as a Finalist for the ‘Academic Scientist of the Year Award” by Informa Sciences for outstanding contribution to pharmaceutical research. Prior to pivoting to drug discovery, she served as Senior Scientist in multiple biotech firms developing biodegradable drug delivery systems. She holds patents on novel, programmable microsphere delivery systems using poly(lactide/glycolide) polymers for modulating drug release over variable durations from few days to several months. Jeyanthi has a PhD in Biochemistry and obtained post-doctoral training with Prof. Patrick DeLuca, College of Pharmacy, University of Kentucky. Her interests include understanding the role of proteome and proteostasis in health and disease and developing patient-centric solutions to slow, prevent or stop chronic diseases.

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The Future of Clinical Trials
Tom Rico Pamukcu

The clinical research methods of yesterday won’t work for the science of tomorrow, yet the field as a whole is slow to adapt. With the end of blockbuster drugs and the rise of personalized medicine, companies and researchers will need to evolve to avoid being left behind. Not only is adapting to change critical for survival, but those that can adapt the fastest will have a tremendous opportunity in the years ahead.

This talk will identify the good, the bad, and the ugly in the current state of clinical trials, and cross-reference it against advancements in adjacent fields. Expect to learn actionable steps to take today to prepare for the clinical research of tomorrow. Building on your existing understanding of clinical research, you’ll receive new insights for how to personally leverage advances and new trends in technology, policy, and funding to better help your patients and your biotech initiatives thrive.

Speaker Bio

Tom Rico Pamukcu is a clinical research expert who has spent the past decade leveraging technology to improve clinical research across academia, industry, and start-ups. He is the founder of a new technology consultancy dedicated to helping researchers modernize clinical trials. Previously, Tom managed global operations for Genentech’s late-stage pediatric oncology pipeline. Before joining Genentech, Tom worked at multiple levels of clinical research at Stanford University. He served as Research Manager for Stanford’s Division of Pain Medicine, and prior to that, managed research at the Sleep Center.

Tom specializes in integrating technology into research, and pioneered some of the first implementations of tools such as EDC, e-Consent, and artificial intelligence into clinical trials across his various institutions. He is currently on the board of the Northern California Chapter of the Association of Clinical Research Professionals. Tom received his BS in Cellular and D

 

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Legal Issues of Artificial Intelligence and Smart Medical Devices in Healthcare
Stephen Wu, JD
Silicon Valley Law Group

Artificial intelligence and robotics will cause sweeping changes to society, including in the area of healthcare and medical devices.  AI and smart medical devices have the potential to enhance health and care outcomes, improve patient experiences, lower healthcare costs, and improve health professionals’ experiences.  Yet, with new technologies, legal issues will crop up.  Examples include HIPAA compliance, security breaches, product liability, and malpractice.  This program will cover the impact of AI and robotics on healthcare, key legal issues that arise, and how providers and technology companies can manage legal risks.

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Wearable Heart Rate Variability Sensor
Denise Gutierrez, Peter Lazari, Meghna Negi

San Jose State University Biomed Engineering Student Presentation
May 21, 2019

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ResusciMate –  A CPR Feedback Device
Jessica Lourdes Felix, Joshua Julian Sale, Wanisha Sirpakdi

 

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Hospice Care – What You Need to Know

Ed Wendler, Hospice of the Valley Ambassador

For the last ten years, Ed has volunteered his time as an ambassador for Hospice of the Valley. He has found his most satisfying experiences have happened when he has been assigned to visit with military veterans during their final days. Listening to their stories and helping them relive favorite memories is a part of the way hospice caregivers provide support during difficult times. Ed will discuss: What is hospice care? Who is eligible? Who pays for it? How does hospice care work?

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