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Read stories from our Ambassadors and Entrepreneurs as well as all the latest news about Lyfebulb on our blog.
Have an idea for a post?MOUNT LAUREL, N.J., Nov. 20, 2024 /PRNewswire/ — The American Society of Transplant Surgeons (ASTS) and American Society of Transplantation (AST) announced today that the Transplant Therapeutics Consortium (TTC) received notification from FDA of acceptance of the Qualification Plan for the iBox Scoring System, a novel reasonably likely surrogate efficacy endpoint for kidney transplant clinical trials. This takes us one step closer to having new therapies that better the lives of transplant recipients and marks the successful completion of step two in the three-step process for FDA biomarker qualification. The iBox scoring system is the first transplant endpoint to reach this stage of qualification.
“With the iBox Scoring System on the pathway to FDA qualification, we are closer than ever to cutting-edge clinical tools that could extend the lives of transplant recipients. iBox is opening the door to using artificial intelligence and machine learning. This achievement signals a transformative shift in how we approach clinical trials for transplant patients and is a critical step forward in modernizing the field,” said AST President Jon Kobashigawa, MD.
Improving the long-term survival of transplanted kidneys is an important area of unmet need for transplantation recipients, and clinical trials testing new immunosuppressive agents are needed to improve kidney transplant outcomes. Although the current efficacy failure endpoint has typically shown the non-inferiority of immunosuppressive regimens, the iBox Scoring System is proposed to be used to demonstrate the superiority of a new agents compared to the standard of care (SOC) as a co-primary endpoint in pivotal drug therapeutic studies. As a reasonably likely surrogate endpoint, the iBox scoring system would be used in the Accelerated Approval Pathway at the FDA designed to allow for earlier approval of drugs that treat serious conditions and fill an unmet medical need.
“We are delighted that the iBox which received endorsement and qualification by the European Medicines Agency (EMA) in 2022 now also has received acceptance of the FDA Biomarker Qualification Plan as an efficacy endpoint for kidney transplant clinical trials. This acceptance will facilitate more rapid assessment of novel Immunotherapeutics for kidney transplant recipients and harmonization of multinational clinical trials. We are grateful to our many partners and collaborators in the Transplant Therapeutics Consortium for their steadfast support of this important initiative to facilitate innovation in transplantation,” said ASTS President Ginny Bumgardner.
“We desperately need new regulatory pathways which bring investment into transplantation. New therapies are essential to prolong the life of transplant recipients and take the best care of the gift of life provided by our donors” said Dr. Karin Hehenberger, President Lyfebulb, and a kidney and pancreas transplant recipient. “This step is critical to enable the dream of ‘One Kidney for Life’ to become a reality.”
The iBox scoring system is a composite endpoint used as a risk prediction tool that utilizes multiple clinically relevant features (estimated glomerular filtration rate (eGFR), proteinuria, anti-human leukocyte antigen donor-specific antibody, and kidney graft biopsy histopathology) at one-year post-transplant to predict 5-year graft survival. The iBox Qualification Plan is supported by strong mechanistic and epidemiologic data of the association with late kidney functional decline and failure and includes data from single center and randomized controlled trials representing over 2,500 de novo kidney transplant recipients.
The iBox scoring system (NCT03474003), has been developed and validated in a landmark publication released in the BMJ by a team of researcher led by Pr Alexandre Loupy in Paris French NIH (Inserm), APHP and Université Paris Cité, comprising 7557 patients from 10 academic centres from Europe and the US and 3 RCT’s. iBox leveraged high quality longitudinal data to build a robust predictive system for long-term kidney allograft loss. iBox has been extensively validated for use in the treatment of individual patients in the clinical care setting and common clinical scenarios including response to treatment in in T-cell mediated rejection, antibody-mediated rejection and immunosuppressive regimen minimization (BMJ 2019; 366:l4923).
The Transplant Therapeutics Consortium (TTC) is a public-private partnership founded in 2017 by the American Society of Transplantation (AST) and the American Society of Transplant Surgeons (ASTS). This collaboration unites the transplant community, industry leaders, and regulatory agencies to foster consensus-driven, data-focused research aimed at enhancing the development of innovative tools and methods for evaluating the safety and efficacy of solid organ transplants (SOT).
This regulatory qualification achievement was accomplished by employing the resources of the TTC members and engaging with FDA throughout the biomarker qualification process. TTC is supported through funding and input from the AST*, ASTS*, argenx*, Arkana Laboratories*, Bristol Myers Squibb*, CareDx*, Critical Path Institute, CSL, CTI Clinical Trial Services, Inc.*, Eledon*, European Society of Organ Transplantation, the U.S. Food and Drug Administration (FDA), Hansa Biopharma*, HUS Helsinki University Hospital, Immucor, KU Leunven, Memo Therapeutics AG*, Natera, National Institutes of Health, Novartis, Paris Transplant Group, Pirche, Sanofi*, Takeda*, Talaris Therapeutics, Thermo Fisher Scientific, The Transplantation Society, Transplant Genomics*, University of Manitoba, and Veloxis Pharmaceuticals*.
TTC is working on its next regulatory milestone, the submission of the Full Qualification Package for regulatory endorsement of the iBox Scoring System as a reasonably likely surrogate endpoint by the FDA.
As part of the 21st Century Cures Act, passed into law in December 2016, public-private partnerships consisting of government entities, including FDA, the biopharmaceutical industry, health care providers, academic researchers, and patient advocacy organizations, have been encouraged to work together to foster innovation in the development of new therapies by qualifying new drug development tools that can accelerate the process of making new therapies available to patients. For more information, click here. Any groups that would like to join in this effort or have information or data that may contribute to further advances, can contact JoAnn Gwynn at jgwynn@myast.org.
The Transplant Therapeutics Consortium (TTC) was launched in April 2017 and co-founded by the American Society of Transplantation (AST) and the American Society of Transplant Surgeons (ASTS). TTC brings together pharmaceutical companies, diagnostic companies, academic and nonprofit partners working toward a common goal of moving the field forward toward drug development solutions in transplantation.
American Society of Transplantation
Founded in 1982, the American Society of Transplantation (AST) is a non-profit, 501(c)3 organization dedicated to advancing the field of transplantation and improving patient care by promoting research, education, advocacy, organ donation, and service to the community through a lens of equity and inclusion. The society is the largest transplant organization in North America (consisting of nearly 5,000 professional members), representing a majority of the nation’s medical professionals engaged in the field of transplantation.
Learn more at myAST.org.
American Society of Transplant Surgeons
The American Society of Transplant Surgeons (ASTS) was founded in 1974 by 127 surgeons to unite the professionals who were advancing the fledgling field of organ transplantation.
From this small group of dedicated individuals, we have grown to represent over 2,000 transplant professionals who are dedicated to saving and improving lives through the transformative power of organ donation and transplant surgery. Learn more about ASTS by visiting our website at ASTS.org.
*Denotes Current TTC Members
MEDIA CONTACTS:
Shauna O’Brien – AST: sobrien@myAST.org
Anna Shults – ASTS: anna.shults@asts.org
SOURCE American Society of Transplantation
NEW YORK, May 17, 2024 — J.P. Morgan Life Sciences Private Capital, Blue Horizon Advisors and United Al Saqer Group announced today Rayees Rahman of Harmonic Discovery as the winner of the inaugural J.P. Morgan Asset Management: Life Sciences Innovation Summit. Harmonic Discovery is a precision pharmacology company applying its generative chemistry platform to advance next-generation kinase inhibitors.
In partnership with Department of Health – Abu Dhabi, the Summit took place on May 14-15, 2024 at Cleveland Clinic Abu Dhabi and showcased the 11 innovative finalists, as well as highlighted existing innovators and opportunities in the Emirate of Abu Dhabi. The event also featured keynote speeches from Dr. Laurie Glimcher of Dana-Farber Cancer Institute, Dr. Shahrukh Hashmi of Department of Health – Abu Dhabi, and Dr. David Ho of Columbia University Medical Center and provided attendees networking opportunities to gain valuable insights into the future of life sciences innovation.
“We are thrilled with the level of biotech passion and innovation that we observed at this year’s Summit in Abu Dhabi. The energy was truly palpable,” said Stephen Squinto, PhD, Chief Investment Officer, J.P. Morgan Life Sciences Private Capital. “We are thrilled to announce Rayees Rahman as the winner of our first Life Sciences Innovation Summit. Harmonic Discovery’s approach embodies the next generation of drug discovery and development. We appreciate the time and effort of all participants and cannot wait for our next event in the region.”
In addition, the jury designated Chun-Hao Huang of Algen Biotechnologies as honorable mention. Algen Biotechnologies is a platform therapeutics and drug discovery company using world-leading CRISPR and AI to find treatments for cancer, inflammation and metabolic diseases.
The winners were selected by an esteemed, international panel of judges, which included:
• Laurie Glimcher, MD, President and CEO at Dana-Farber Cancer Institute
• Jorge Guzman, MD, CEO at Cleveland Clinic Abu Dhabi
• Prof. Shahrukh Khurshid Hashmi, MD, Director of Research, Department of Health, Abu Dhabi
• Yasmine Hayek Kobeissi, PhD, CQF, BSc., Executive Director at Blue Horizon Advisors
• Anya Schiess, Managing Partner at J.P. Morgan Life Sciences Private Capital
• Walid Zaher, PhD, Co-Founder and CEO, Carexso
“Under the directives of the UAE’s wise leadership, and renowned for its world-leading medical infrastructure, Abu Dhabi stands at the forefront of healthcare excellence, offering an unparalleled opportunity for advancement in healthcare for global partners,” commented Dr. Asma Al Mannaei, Executive Director of Research and Innovation Centre at the Department of Health – Abu Dhabi. “It was our utmost pleasure hosting the J.P. Morgan Asset Management Life Sciences Innovation Summit 2024 on the sidelines of Abu Dhabi Global Healthcare Week and we commend the winners for their pioneering efforts in driving impactful advancements in healthcare; their dedication to innovation not only transforms the landscape of medicine, but also holds the promise of improving lives worldwide.”
Sponsors for the event included J.P. Morgan Life Sciences Private Capital, J.P. Morgan Commercial Bank, Blue Horizon Advisors, United Al Saqer Group, Thermo Fisher Scientific, and Salam Capital. The Summit organization, logistics and finalist recruitment were facilitated by Lyfebulb.
Of importance, at the Summit, Mr. Mohamed Al Breiki, Executive Director of Sustainable Development at Masdar City, announced that Masdar City Free Zone would award all 11 Finalists complimentary business licenses to further support their establishment in the region. Masdar City is one of the world’s most sustainable urban developments and innovation hubs with a growing focus on life science entrepreneurship in Abu Dhabi.
“As the main sponsor, we are committed to nurturing and fostering the growth of all 11 finalists in this vibrant biotech ecosystem,” concluded Nabil Kobeissi, Chief Executive Officer of Blue Horizon Advisors. “This Summit marks the beginning of a transformative journey, and we are confident that it will pave the way for a flourishing hub in the region. We are also pleased to announce that we will commit to invest in and partner with the winner, Harmonic Discovery, to support its future growth in the region.”
To learn more about the finalists and inaugural event, please click here to visit its dedicated website.
About J.P. Morgan Life Sciences Private Capital
J.P. Morgan Life Sciences Private Capital is a venture capital and growth equity investment team within J.P. Morgan Private Capital, Asset Management Alternatives, founded in late 2022. The group aims to leverage the experience of its Life Sciences Private Capital investment team and strategic advisors, and it’s relationships with pharmaceutical and life sciences companies to support innovative life sciences companies.
For more information: J.P. Morgan Life Sciences Private Capital press release.
About Blue Horizon Advisors
Blue Horizon Advisors is the independent private investment arm of a leading, multi-billion dollar single United Arab Emirates (UAE) family office. Blue Horizon Advisors comprises of leading investment professionals in Europe and the UAE and undertakes global strategic investments in public markets, private markets and real estate. Most recently, Blue Horizon Advisors established a Life Sciences vertical (“BHLS”), with a mission to becoming a prominent and influential force within the MENA region’s thriving life sciences sector.
BHLS is committed to enhancing health through research and development of innovative therapies and diagnostic tools to improve and prolong lives. BHLS is poised to execute its strategic vision through a multifaceted approach, encompassing strategic acquisitions, robust in-house development initiatives, dynamic joint ventures with global industry leaders / innovators to foster knowledge exchange, and pivotal collaborations with key stakeholders in our ecosystem, including esteemed hospitals, renowned universities, regulatory authorities as well as local and global investment houses.
J.P. Morgan Media Relations Contact
Shveta Vatsia
Phone: 516-524-5837
Email: shveta.vatsia@jpmchase.com
Lyfebulb Contact
Karin Hehenberger
Email: karin@lyfebulb.com
NEW YORK, April 4, 2024 /PRNewswire/ — J.P. Morgan Asset Management’s Life Sciences Private Capital, Blue Horizon Advisors and United AlSaqer Group are pleased to announce the 11 finalists of the inaugural J.P. Morgan Asset Management: Life Sciences Innovation Summit. The summit will take place on May 14-15, 2024 at Cleveland Clinic Abu Dhabi during Abu Dhabi Global Healthcare Week. The Department of Health – Abu Dhabi is sponsoring the event, aiming to bring together innovators, investors and industry leaders to explore the latest advancements and trends shaping the future of healthcare.
“We are very pleased to be partnering with the stellar leadership of the Department of Health – Abu Dhabi, Blue Horizon Advisors, United AlSaqer Group, Cleveland Clinic Abu Dhabi and other local leaders in launching our inaugural innovation summit,” said Stephen Squinto, Chief Investment Officer, J.P. Morgan Life Sciences Private Capital.
The finalists were selected from a pool of exceptional candidates across more than 20 countries and represent a diverse range of companies and research institutions developing innovative therapeutic solutions. Each finalist has demonstrated a commitment to advancing healthcare through creativity and groundbreaking research, with the ultimate goal of addressing unmet patient need for diseases of prevalence in the Middle East. Finalists selected to compete in the summit include:
The finalists will be judged by an esteemed panel, which includes:
“We are grateful to these preeminent scientists and business leaders for coming to Abu Dhabi to experience our growing innovation hub and meet these stellar finalists,” stated Nabil Kobeissi, Chief Executive Officer, Blue Horizon Advisors. “With over 150 highly qualified applications submitted from around the globe, clearly the medical research and innovation community is paying attention to this event.”
In addition to the pitch competition, where winners will ultimately be awarded, the summit will feature keynote speeches and networking opportunities to provide attendees with investment opportunities and valuable insights into the future of life sciences innovation. Learn more about the finalists and summit here.
About J.P. Morgan Life Sciences Private Capital
J.P. Morgan Life Sciences Private Capital is a venture capital and growth equity investment team within J.P. Morgan Global Alternatives, founded in late 2022. Life Sciences Private Capital launched its first early-stage biotechnology venture capital fund in early 2023, focused on building “move-the-needle” innovations that will ultimately improve quality of lives worldwide. The group aims to leverage J.P. Morgan’s market position in healthcare investment banking and business banking, robust relationships with the largest pharmaceutical and life sciences companies, and the tenure of the Life Sciences Private Capital investment team and strategic advisors to form, capitalize, and support leading innovative life sciences companies.
For more information: J.P. Morgan Life Sciences Private Capital press release.
About J.P. Morgan Asset Management
J.P. Morgan Asset Management, with assets under management of USD 3.1 trillion (as of 31 December 2023), is a global leader in investment management. J.P. Morgan Asset Management’s clients include institutions, retail investors and high net worth individuals in every major market throughout the world. J.P. Morgan Asset Management offers global investment management in equities, fixed income, real estate, hedge funds, private equity and liquidity. For more information: www.jpmorgan.com/am
J.P. Morgan Asset Management is the marketing name for the asset management business of JPMorgan Chase & Co. and its investment advisor affiliates worldwide.
About Blue Horizon Advisors
Blue Horizon Advisors is the independent private investment arm of a leading, multi-billion dollar single United Arab Emirates (UAE) family office. Blue Horizon Advisors comprises of leading investment professionals in Europe and the UAE and undertakes global strategic investments in public markets, private markets and real estate. Most recently, Blue Horizon Advisors established a Life Sciences vertical (“BHLS”), with a mission to becoming a prominent and influential force within the MENA region’s thriving life sciences sector.
BHLS is committed to enhancing health through research and development of innovative therapies and diagnostic tools to improve and prolong lives. BHLS is poised to execute its strategic vision through a multifaceted approach, encompassing strategic acquisitions, robust in-house development initiatives, dynamic joint ventures with global industry leaders / innovators to foster knowledge exchange, and pivotal collaborations with key stakeholders in our ecosystem, including esteemed hospitals, renowned universities, regulatory authorities as well as local and global investment houses.
SOURCE J.P. Morgan Asset Management
Combining Resources to Create the Premier, Patient-Focused Renal Solutions Provider
POMPANO BEACH, Fla. and NEW YORK, March 5, 2024 /PRNewswire/ — Patient Care America (“PCA”) announces that it recently completed the acquisition of Lyfebulb Holdings Inc., (“Lyfebulb”) an online digital platform that empowers people living with chronic illnesses to thrive through education, innovation, and connectivity.
“We are thrilled to welcome the Lyfebulb team into the Patient Care America family. Lyfebulb has established itself as a trusted resource for those living with serious health conditions, such as chronic kidney disease, diabetes and transplants,” stated Phil Keough, CEO of Patient Care America. “This partnership will help broaden our range of patient centered services to create leading comprehensive solutions that enhance the health and well-being of our patients.”
Patient Care America Acquires LyfebulbPost this
The Lyfebulb management team, led by co-founder and former CEO Karin Hehenberger, MD, PhD, will remain in place and lead Lyfebulb’s patient-engagement services. Dr. Hehenberger will operate as President of Lyfebulb, a Patient Care America company, and will also take on the role of Chief Medical Officer of PCA.
“Lyfebulb is excited to join forces with Patient Care America to continue to positively impact patients in the chronic illness space. We have spent over a decade identifying and validating the need for patient connectivity, education and innovation in diabetes and kidney disease, with a specific focus on the optimal management of kidney transplants,” added Dr. Hehenberger. “With the additional resources and capabilities offered by our new colleagues, we can accelerate the implementation of our accumulated knowledge through new digital tools, services and offerings.”
Lyfebulb will continue to operate its digital platforms, www.TransplantLyfe.com and www.CancerLyfe.com, as a Patient Care America company. Financial terms of the transaction are not disclosed.
About Patient Care America
Patient Care America, a leading national provider of nutritional therapies for malnourished dialysis patients, is a healthcare service organization comprised of dedicated professionals committed to delivering the highest quality patient care to achieve optimal therapeutic outcomes. Its dedicated, multidisciplinary team of pharmacists, nurses, dietitians, and other health care professionals provide NutriRite® Intradialytic Parenteral Nutrition (IDPN) and NutriRite Home™ Intraperitoneal Nutrition (IPN) formulas, helping enhance quality of life for all patients through innovative and patient-centered approaches.
Patient Care America Contact:
Phil Keough
CEO
Email: pkeough@pcacorp.com
Lyfebulb Contact:
Karin Hehenberger, MD, PhD
President, Lyfebulb, a PCA Company
Email: karin@lyfebulb.com
SOURCE Lyfebulb
Application Period Opens Today, November 16, 2023
NEW YORK, Nov. 16, 2023 /PRNewswire/ — J.P. Morgan Asset Management’s Life Sciences Private Capital and Blue Horizon Advisors announce the launch of the inaugural J.P. Morgan Asset Management: Life Sciences Innovation Summit, which seeks to attract top caliber, early stage entrepreneurs in life sciences to both compete for top prizes and seed the growth of the emerging scientific innovation hub in Abu Dhabi. The two-day Summit will take place in conjunction with the Abu Dhabi Global Healthcare Week on May 14th – 15th, 2024.
J.P. Morgan Life Sciences Private Capital and Blue Horizon Advisors are collaborating with Lyfebulb, an innovation accelerator that sources the most impactful solutions addressing true patient needs, to conduct the event. Entrepreneurs with therapies to better manage and care for diseases that are prevalent in the Emirati region are invited to submit applications. Examples of these diseases include, but are not limited to, diabetes, obesity, cardiometabolic disease, oncology, sickle cell anemia, cystic fibrosis, lysosomal storage disease, and rare monogenic disorders.
“We are thrilled to be collaborating with Blue Horizon to really shine the light on the opportunities for emerging growth biopharma companies in Abu Dhabi,” stated Dr. Stephen Squinto, Chief Investment Officer, J.P. Morgan Life Sciences Private Capital. “We see potential for Abu Dhabi to become another major hub of biotech innovation, and we look forward to showcasing the next generation of life science entrepreneurs and hearing from some of the world’s most renowned scientists and business leaders as summit speakers.”
The challenge is currently accepting applications here through January 22, 2024. After a 10-week application period and a thorough analysis by expert scientists and investors, 10 applicants will be shortlisted as finalists and will receive an invitation to listen to industry-esteemed speakers and pitch their business solutions over the course of a two-day summit, which will take place at the Cleveland Clinic Abu Dhabi.
The following expert panel of judges who will assess the innovators include:
Upon review and selection by the judges, winners will be announced. Importantly, all finalists will be afforded the opportunity to present a detailed business plan to the J.P. Morgan Life Sciences Private Capital team, Blue Horizon Advisors and other regional investment organizations for investment opportunities.
“We are excited to partner with J.P. Morgan Life Sciences Private Capital to conduct this innovation summit in Abu Dhabi,” said Nabil Kobeissi, Chief Executive Officer, Blue Horizon Advisors. “We fully believe in the potential of life sciences, in terms of talent and development, and we will continue to be a driving force to enable the region to achieve its full potential. Partnering on this inaugural event will be one of many initiatives that we are implementing to achieve our goal of seeding a thriving life sciences ecosystem in Abu Dhabi, the UAE and the broader region.”
Applicants may submit information now through January 22, 2024 at 11:59 p.m. EDT by visiting: https://lyfebulb.com/innovation-challenges/j-p-morgan-asset-management-life-sciences-innovation-summit-application/
The competition is free to enter from anywhere in the world. Applications must come from registered companies rather than individuals. Official eligibility criteria, and terms and conditions, can be found at https://lyfebulb.com/terms-amp-conditions-life-sciences-innovation-summit/
Finalists will be selected and notified in February, 2024.
About J.P. Morgan Life Sciences Private Capital
J.P. Morgan Life Sciences Private Capital is a venture capital and growth equity investment team within J.P. Morgan Asset Management Alternatives, founded in late 2022. Life Sciences Private Capital launched its first early-stage biotechnology venture capital fund in early 2023, focused on building “move-the-needle” innovations that will ultimately improve quality of lives worldwide. The group aims to leverage J.P. Morgan’s market position in healthcare investment banking and business banking, robust relationships with the largest pharmaceutical and life sciences companies, and the tenure of the Life Sciences Private Capital investment team and strategic advisors to form, capitalize, and support leading, innovative life sciences companies.
For more information: J.P. Morgan Life Sciences Private Capital press release.
About Blue Horizon Advisors
Blue Horizon Advisors is the independent private investment arm of a leading, multi-billion dollar single United Arab Emirates (UAE) family office. Blue Horizon Advisors comprises of leading investment professionals in Europe and the UAE and undertakes global strategic investments in public markets, private markets and real estate.
Most recently, Blue Horizon Advisors established a Life Sciences vertical (“BHLS”), with a mission to becoming a prominent and influential force within the MENA region’s thriving life sciences sector.
BHLS is committed to enhancing health through research and development of innovative therapies and diagnostic tools to improve and prolong lives. BHLS is poised to execute its strategic vision through a multifaceted approach, encompassing strategic acquisitions, robust in-house development initiatives, dynamic joint ventures with global industry leaders / innovators to foster knowledge exchange, and pivotal collaborations with key stakeholders in our ecosystem, including esteemed hospitals, renowned universities, regulatory authorities as well as local and global investment houses.
Material ID: 3ffce23f-8231-11ee-943d-5f978ab4f411
SOURCE J.P. Morgan Asset Management