Advancing safety in healthcare products

insights from industryJoanne Waldstreicher, M.D.Chief Medical Officer, Johnson & Johnson

An interview with Joanne Waldstreicher, M.D., Chief Medical Officer, Johnson & Johnson, conducted by April Cashin-Garbutt, MA (Cantab)

What is the vision behind Johnson & Johnson’s newest QuickFire Challenge to advance the safe use of healthcare products?

True benefit from healthcare products requires an unrelenting focus on patient- and consumer-centered safety, a principle that is at the heart of J&J’s Credo and is embodied in the mission of the Office of the Chief Medical Officer (OCMO).

Working to ensure that J&J is developing and making available the safest products possible is what the nearly 1000 employees of OCMO work towards each day.

Always looking for better ways to address safety on behalf of patients and consumers, we are embarking on the Advancing the Safe Use of Healthcare Products QuickFire Challenge to identify new and innovative ideas to increase the safe use of our products.

The challenge aims to improve safety in healthcare through improving the provision of balanced and factual information – and development of solutions – to ensure safety across the spectrum of medical devices, pharmaceutical and consumer products.

Therefore, J&J is encouraging entrepreneurs, academics, scientists, engineers or startup companies who are advancing potentially game-changing, early stage, innovative solutions to advance safety in healthcare products that help inform patients and consumers, simulate surgical procedures, and ensure proper storage and use of prescription, over-the-counter and cosmetic products.

What are the main challenges that need to be overcome to improve safety in healthcare?

Prescription medication errors cause at least one death every day and injure approximately 1.3 million people each year.

Moreover, with increased dissemination and sharing of health information via social media and online, there is a greater need than ever before for bioethical, transparent and evidence-based information sources that help patients and consumers make more informed healthcare decisions.

J&J believes in a patient- and consumer-centered, science- and data-driven approach guided by bioethics and values, and as such, we are always looking for ways to enhance the safe use of healthcare products for the patients, consumers and healthcare providers we serve every day.

These solutions will result in more informed healthcare decisions that translate into better health outcomes.

Who is the QuickFire Challenge open to and what will winners receive?

The QuickFire Challenge is open globally to novel solutions that advance safety by informing patients and consumers, simulating surgical procedures or ensuring proper storage and use of prescription, over-the-counter and cosmetic products.

Entries will be evaluated by a juried panel comprising senior scientific / medical research staff and medical safety experts within J&J who have expertise across pharmaceuticals, medical device and consumer sectors.

Winners will receive research grants totaling up to $200,000, entrance to a Johnson &Johnson Innovation – JLABS facility and / or mentoring from J&J Innovation.

The JLABS support will include infrastructure, services, educational programs and networks in global hotspots. Winning entries will be evaluated in each category and announced in fall of 2017."

What are the main innovation focus areas of the QuickFire Challenge?

The main focus areas for this QuickFire challenge include:

1. Empowering patients and consumers to make more informed healthcare decisions by providing better information and education about the safety of healthcare products (pharmaceuticals, medical devices and consumer products).
2. Improving training and development for surgeons by identifying new models that simulate the operating room environment.
3. Empowering patients and consumers to more safely administer and handle healthcare products.

Why is external collaboration important to Johnson & Johnson?

J&J is dedicated to scientific excellence, bioethics and values-based decision-making, and we have a history of collaborating externally to create innovative solutions for patients and consumers.

Through collaboration on this QuickFire Challenge, J&J Innovation hopes to identify scientifically sound, breakthrough ideas that will advance both the safe use and a greater understanding of the safety of healthcare products to positively impact outcomes.

This initiative represents the J&J Family of Companies' ongoing commitment to patient and consumer safety and independent safety assessments.

What is JLABS and what support can they provide?

J&J Innovation, JLABS, is a global network of open innovation ecosystems, enabling and empowering innovators to create and accelerate the delivery of life-saving, life-enhancing health and wellness solutions to patients around the world.

JLABS achieves this by providing the optimal environment for emerging companies to catalyze growth and optimize their research and development by opening them to vital industry connections, delivering entrepreneurial programs and providing a capital-efficient, flexible platform where they can transform the scientific discoveries of today into the breakthrough healthcare solutions of tomorrow.

At JLABS we value great ideas and are passionate about removing obstacles to success to help innovators unleash the potential of their early scientific discoveries.

JLABS is a no-strings-attached model, which means entrepreneurs are free to develop their science while holding on to their intellectual property.

JLABS is open to entrepreneurs across a broad healthcare spectrum including pharmaceutical, medical device, consumer and digital health sectors.

What do you think the future holds for safety in healthcare?

Patients, consumers and healthcare providers want to take advantage of educational tools and efforts to increase their knowledge even further, to become even more empowered to make informed decisions, and take responsible and effective measures to improve their safety.

Where can readers find more information?

Entries are due by May 24, 2017 and additional information can be found at jlabs.tv/safetyquickfirechallenge.

About Joanne Waldstreicher, M.D.

Joanne Waldstreicher, M.D., is Chief Medical Officer, Johnson & Johnson.  In this role, Dr. Waldstreicher has oversight across pharmaceuticals, devices and consumer products for safety, epidemiology, clinical and regulatory operations, and development of the corporate ethical science, technology and R&D policies, including those related to clinical trial transparency and compassionate access.

She also chairs the Pharmaceuticals (Janssen) R&D Development Committee and supports the Device and Consumer Development Committees, which review late stage development programs in the pipeline.  Dr. Waldstreicher also holds an appointment as a Faculty Affiliate of the Division of Medical Ethics, Department of Population Health, New York University School of Medicine.

Among her prior roles in Janssen, the pharmaceutical sector of Johnson & Johnson, Dr. Waldstreicher was responsible for late-stage development spanning the areas of neuroscience, cardiovascular and metabolism including Invokana®, Xarelto®, Invega Sustenna®, and Invega Trinza®.

Before joining Johnson & Johnson in 2002, Dr. Waldstreicher was head of the Endocrinology and Metabolism clinical research group at Merck Research Laboratories, and responsible for overseeing clinical development of Mevacor®, Zocor®, Proscar® and Propecia®, and for clinical development programs in atherosclerosis, obesity, diabetes, urology and dermatology. During that time, she received numerous awards and distinctions, including the Merck Research Laboratory Key Innovator Award.

Dr. Waldstreicher received both the Jonas Salk and Belle Zeller scholarships from the City University of New York and graduated Summa Cum Laude from Brooklyn College.  Dr. Waldstreicher graduated Cum Laude from Harvard Medical School in 1987, and completed her internship and residency at Beth Israel Hospital, and her endocrinology fellowship at Massachusetts General Hospital.  She has won numerous awards and scholarships, and has authored numerous papers and abstracts.  Dr. Waldstreicher combines broad experience in science and medicine along with a passion for advancing transparency and ethics.

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