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Andy

DrugDisco

Role of global public sector research in discovering new drugs and vaccines

By News Archive

DrugDiscoAnalysis of international public-sector contributions to Food and Drug Administration (FDA)-approved drugs and vaccines allows for a more thorough examination of the global biomedical innovation ecosystem by institution of origin. Using new and existing methods, we have identified 364 FDA-approved drugs and vaccines approved from 1973 to 2016 discovered in whole or in part by Public Sector Research Institutions (PSRIs) worldwide. We identified product-specific intellectual property contributions to FDA-approved small molecule and biologic drugs and vaccines from the FDA Orange Book, our peer network, published studies, and three new sources: reports of medical product manufacturers’ payments to physicians and teaching hospitals under The Sunshine Act of 2010, a paper by Kneller and 64 royalty monetization transactions by academic institutions and/or their faculty that one of us (AS) maintains. We include a total of 293 drugs discovered either wholly by a US PSRI or jointly by a U.S. and a non-U.S. PSRI. 119 FDA-approved drugs and vaccines were discovered by PSRIs outside the U.S. Of these, 71 were solely discovered outside the US, while 48 also involved intellectual property contributions by US PSRIs. In the context of the global public sector landscape, the US dominates drug discovery, accounting for two-thirds of these drugs and many of the important, innovative vaccines introduced over the past 30 years. Contributions by Canada, UK, Germany, Belgium, Japan, and others each amount to 5.4% or less of the total.

Click here to read more from The Journal of Technology Transfer

Dr. Monica Bertagnolli

President Biden Announces Intent to Nominate Dr. Monica Bertagnolli as Director of the National Institutes of Health

By News Archive

Dr. Monica BertagnolliToday (May 15, 2023), President Biden announced his intent to nominate Dr. Monica Bertagnolli as Director of the National Institutes of Health (NIH), the world’s preeminent biomedical research organization. Dr. Bertagnolli is a world-renowned surgical oncologist, cancer researcher, educator, and physician-leader who has the vision and leadership needed to deliver on NIH’s mission to seek fundamental knowledge and promote human health.  

Statement from President Biden: “Dr. Bertagnolli has spent her career pioneering scientific discovery and pushing the boundaries of what is possible to improve cancer prevention and treatment for patients, and ensuring that patients in every community have access to quality care.

As Director of the National Cancer Institute, Dr. Bertagnolli has advanced my Cancer Moonshot to end cancer as we know it. She has brought together partners and resources from different sectors to launch groundbreaking efforts in cancer prevention and early detection, a national navigation program for childhood cancers, and additional programs to bring clinical trials to more Americans.

Dr. Bertagnolli is a world-class physician-scientist whose vision and leadership will ensure NIH continues to be an engine of innovation to improve the health of the American people.”

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Panel2

BHI/NIH EIR Anna Zornosa Moderates Panel of Experts: Unlocking Reimbursement for Innovators in Maternal Health Solutions

By News Archive

Panel2Reimbursement is key to the success of innovators who have products, therapies, and new modes of service for expectant and new mothers. Not only is it key to have the codes and contracts that are critical to billing, the payors themselves (both commercial and Medicaid) open the door to meeting the moms and babies for whom the products are intended.

Anna Zornosa (seated on the right), EIR with both BHI and the NIH, moderated a panel featuring three OB GYNS who represent key sectors of the reimbursement ecosystem: Dr. John Keats (first on the left), a maternal health expert with Cigna, represented the commercial insurer viewpoint; Dr. Barbara Levy, vice-chair of the  AMA’s CPT panel, represented the view of how codes are established; and Dr. Miguel Fernandez (third from the left), spoke of his experience with Medicaid programs as Chief Medical Officer of Aetna Better Health of Florida. The three concurred that innovators need to lead with data showing the impact of their innovations on patients’ outcomes as the basis of initial conversations. The lively panel brought to life examples of successful innovator-reimbursement partnerships and responded to dozens of audience questions.

RubinAllain2

BHI’s EIR Ethel Rubin, Ph.D., Joins JLABS @ NYC Roundtable

By News Archive

RubinAllain2Ethel Rubin, Ph.D., an Entrepreneur-in-Residence at BioHealth Innovation, Inc. (BHI), recently participated in a “CEO Roundtable” for JLABS @ NYC. The discussion revolved around various financing strategies for biotech companies. In addition to Dr. Rubin, the roundtable also featured Sally Allain, MBA, M.S., Head of JLABS @ Washington, DC, and Board Member of BHI. Her participation added further depth to the discussion, bringing in her unique insights and experiences in the biotech sector.

The roundtable brought together CEOs from the biotech sector to discuss various topics. These included the different types of investors in the biotech space and strategies for identifying and engaging with them. The participants also delved into the concept of an investment thesis, a guiding principle that dictates the kind of opportunities investors seek.

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ReneeConf

BHI EIR Renée JG Arnold Shares Expertise at the 28th Annual International ISPOR Meeting

By News Archive

ReneeConfRenée JG Arnold, PharmD, RPh, who serves as an Entrepreneur-in-Residence at BHI NHLBI EIR, recently moderated and participated in a panel discussion at the 28th Annual International meeting of ISPOR, which was held on May 8, 2023 in Boston. The panel, titled “Blazing the Trail for Digital Health Innovation: Resources and an Example Based on a Digital Health Application for Dementia Family Caregivers,” was attended by 75 delegates and focused on various aspects of digital health application development. Topics included the challenges and opportunities associated with the development of digital health applications, available NIH grants and product development resources, real-world experience in developing digital health solutions, and emerging regulations in the US for digital health.

After the panel discussion, Arnold and the other panelists continued the conversation with 15 attendees in a separate venue, where they further explored various aspects of digital health applications. Other panelists included Kathleen Rousche, PhD, Director of the Innovation & Commercialization Office at NHLBI; Eric Jutkowitz, PhD, an Associate Professor at Brown University; and Anindita (Annie) Saha, the Assistant Director of the Digital Health Center of Excellence at the US Food and Drug Administration.

GinaFord250

Women In Bio announces appointment of Gina Ford as Executive Director

By News Archive

GinaFord250Women In Bio is proud to announce that Gina Ford has joined our team as Executive Director. Gina brings a wealth of experience, having worked in the life science and non-profit industries for years. She is a champion of women in the sciences, and we are thrilled to have her guide WIB into the future. 

As WIB nears the conclusion of its latest 3-year Strategic Plan and looks ahead to the future, we are thrilled to have Gina at the helm. Her leadership will continue to drive positive changes that will elevate our operational excellence, enrich our existing programming, and reinforce WIB’s position as a premier organization for women impacting the life sciences and beyond.

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AURPCaucus

Join AURP in Boston for a Deep Dive into Building Communities of “Biotech Innovation”!

By News Archive

AURPCaucusJoin AURP in Boston for a Deep Dive into Building Communities of Biotech Innovation!

Before the 2023 BIO International Conference begins in Boston, the AURP Bio Health Caucus will focus on building research space supporting communities of bio innovations. 
Developers, A/E firms, researchers, economic development reps, VC firms, and bio innovation district managers will want to attend.

https://www.aurp.net/bio-health-caucus

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Harsha and Rich 250

Navigating the Challenges of Rare Disease Research with Dr. Harsha Rajasimha on BioTalk

By News Archive

 Harsha and Rich 250
Join us for an enlightening episode of BioTalk with Rich Bendis as we explore the pivotal role of patient registries in rare disease research and treatment. Our guest, Harsha Rajasimha, MS, Ph.D., CEO of Jeeva Informatics Solutions and Founder and Executive Chairman of IndoUSrare, shares his extensive experience in clinical genomics data science and precision medicine.

In this episode, Dr. Rajasimha introduces Jeeva Informatics Solutions and IndoUSrare, his non-profit organization. He discusses the importance of patient registries in accelerating rare disease research, the current obstacles in the field, and the potential solutions.

We discuss the role of governments in rare disease research and treatment and the potential for collaboration with non-profits in clinical trials. Finally, Dr. Rajasimha shares the goals of the upcoming Indo-US Rare Summit at the GMU Campus in Arlington, VA.

Tune in for valuable insights from a leader in rare disease research and patient advocacy.

Listen now via your favorite podcast platform

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Harsha and Rich 250

Navigating the Challenges of Rare Disease Research with Dr. Harsha Rajasimha on BioTalk

By BioTalk with Rich Bendis Podcast

 Harsha and Rich 250Join us for an enlightening episode of BioTalk with Rich Bendis as we explore the pivotal role of patient registries in rare disease research and treatment. Our guest, Harsha Rajasimha, MS, Ph.D., CEO of Jeeva Informatics Solutions and Founder and Executive Chairman of IndoUSrare, shares his extensive experience in clinical genomics data science and precision medicine.

In this episode, Dr. Rajasimha introduces Jeeva Informatics Solutions and IndoUSrare, his non-profit organization. He discusses the importance of patient registries in accelerating rare disease research, the current obstacles in the field, and the potential solutions.

We discuss the role of governments in rare disease research and treatment and the potential for collaboration with non-profits in clinical trials. Finally, Dr. Rajasimha shares the goals of the upcoming Indo-US Rare Summit at the GMU Campus in Arlington, VA.

Tune in for valuable insights from a leader in rare disease research and patient advocacy.

Listen now via your favorite podcast platform

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IndoUS

Raising Awareness: Indo US Bridging RARE Summit 2023 to Shine a Spotlight on Rare Diseases

By News Archive

IndoUSScheduled for October 29-30, 2023, at the George Mason University Campus in Arlington, VA, the Indo US Bridging RARE Summit 2023 aims to unite the global rare disease community and raise awareness about these conditions. While rare diseases are increasingly understood in the United States and Europe, there remains a lack of awareness in other parts of the world, including India. By addressing this gap, the summit aims to make a positive impact on the lives of 1.5 billion people in India and the global population of 8 billion.

Bringing together leaders representing diverse stakeholders in rare diseases, the summit serves as a platform for knowledge-sharing, exchanging experiences, and fostering collaborations to address the challenges faced by rare disease patients and their families. The event covers crucial themes such as cross-border patient engagement, care pathways encompassing screening, diagnosis, and treatment options, digitization of rare diseases including registries and emerging markets, diversity, equity, and inclusion in the globalization of orphan drugs, orphan drug clinical trials, and regulatory pathways.

IndoUSrare, the organizing body behind the summit, is committed to connecting rare disease patients worldwide and prioritizing education, research, and engagement to enhance their quality of life.

For sponsorship opportunities and event information, interested individuals can contact summit@indousrare.or and visit https://www.indousrare.org/summit/. The Indo US Bridging RARE Summit 2023 is an important platform for collaboration and knowledge exchange to make a positive impact on the rare disease community worldwide.

The summit planning committee includes prominent individuals representing various organizations and institutions involved in rare disease research and advocacy. Some of the committee

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