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May 16, 2023


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

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

Renée 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.

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

Ethel 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.

The conversation also touched on the current environment for biotech financing. The CEOs discussed the importance of preparedness in this dynamic and competitive landscape, including having a solid business plan, a clear value proposition, and a strong management team.

Non-dilutive funding, which includes grants, contracts, and other forms of funding that do not require giving up equity, was also discussed. The role of such funding as part of a comprehensive financing strategy was explored.

The roundtable participants also examined the role of corporate venture capital (VC) and pharma partners in biotech financing. They discussed the potential benefits and challenges of partnering with these entities, which can provide funding, strategic support, and resources.

The CEOs shared their perspectives on securing deals, current trends, and factors influencing the landscape. They also touched on the role of brokers/dealers, intermediaries in the securities market, in a biotech company’s financing strategy. The roundtable offered a comprehensive exploration of biotech financing strategies, with Dr. Rubin and other CEOs sharing their insights and experiences.

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

Reimbursement 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.

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Rockville's MaximBio Inks Contract with National Institutes of Health (RADx) Centered on a new Rapid Platform

ROCKVILLE, Md. , May 9, 2023 /PRNewswire/ -- MaximBio® is proud to announce it has signed a new agreement with the National Institutes of Health (NIH) through the Rapid Acceleration of Diagnostics (RADx® ) initiative, continuing a relationship fostered during the height of the COVID-19 pandemic. Building on their previous collaboration which resulted in the successful launch of the MaximBio ClearDetect® COVID-19 Antigen Home Test, the new partnership is centered around development of a COVID-19 and Influenza A/B combo test employing novel Lateral-Flow Technology. This technology, paired with the innovative FiarFly™ analyzer platform, and MaximBio's proprietary manufacturing techniques, results in class-leading assay performance.

The FiarFly™ platform is a flexible, low-cost solution designed to bring diagnostic testing closer to the patient, providing lab-comparable performance in the home at an affordable cost. The pocket-sized, battery powered reader, created for maximum accessibility and ease of use, can produce results at a higher performance (sensitivity) and at a cost comparable to visually read home-use tests. The platform allows for an expanded menu of tests on a single device and includes HIPAA-compliant connectivity for EMR results reporting.

In a recent interview, Jonathan Maa, MaximBio Inc. COO, pointed to the company's previous success and experience with RADx and expanded U.S. manufacturing capabilities as some of the primary factors leading to the new collaboration. "Our upgraded infrastructure allows us to produce in excess of 100 million tests annually, right here in the United States," he pointed out. He went on to say, "We are looking forward to working again with the NIH on this exciting new project and the opportunity to offer the market an innovative, yet affordable, diagnostic platform to transform the future of at-home testing solutions."

This project has been funded in part with Federal funds from the National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92023D00001. 

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USP to Host the 2023 BioHealth Capital Region Forum, Investment Conference, & Crab Trap Competition on September 19, 20 & 21

BioHealth Innovation, Inc. (BHI) is proud to announce that US Pharmacopeia (USP) will be hosting the 9th Annual BioHealth Capital Region Forum for the second year in a row on September 19th and 20th, 2023. In addition to this flagship event, USP will also host the 8th Annual BioHealth Capital Region Crab Trap Competition on September 20th and the 6th Annual BioHealth Capital Region Investment Conference on September 21st.

"We are looking forward to once again hosting the BioHealth Capital Region Forum. As an integral part of this dynamic region, USP is deeply committed to fostering innovation and collaboration across the BioHealth space. USP eagerly anticipates bringing together leading minds and stakeholders to advance our shared vision for the future." said Anthony Lakavage, J.D., SVP of Global External Affairs at USP.

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

Today (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.

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Women In Bio announces appointment of Gina Ford as Executive Director

Women 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.

“After an extensive search with hundreds of candidates, I am thrilled for Gina Ford to serve as the WIB Executive Director.” WIB President Azurii K. Collier, Ph.D. shared. “As a pharmacist by training, prior association Executive Director, and a formidable corporate executive, we believe Gina will identify and deliver on big audacious ideas. Gina is the right leader for WIB’s growth phase, and I look forward to all we will achieve together in a One WIB spirit.”

Gina Ford is a highly experienced professional with 20 years of expertise in life sciences, biotech, and pharmaceutical industries. Throughout her career, she has held leadership roles in Corporate Strategy, Commercial, Portfolio Management, Business Development and Patient Advocacy.

As the new Executive Director of Women In Bio, I am honored to lead an organization comprised of some of the most talented and accomplished women in the life science industry. Women In Bio has established itself as the premier organization dedicated to advancing women in our industry, and I am excited to work with our members and partners to continue this legacy. Together, we will drive progress toward greater gender diversity and equity and ensure that women have equal opportunities to thrive and succeed in the life sciences and beyond. - Gina Ford, WIB Executive Director 

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

Before the 2022 BIO International Conference begins in San Diego join AURP for an in-person conference focused 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. 

  • Wet Lab Incubator and Flex Space: What Every Community Wants
  • Diversifying Your Talent Pool Though University Real Estate Programs
  • The Future of Labs: Will Digital Bio Lesson Demand for Wet Labs?
  • Where is Lab Space Being Developed?
  • New Federal Funding Programs for Bio Research and Bio Clusters
  • Patents in Your Park: The Role of IP Protection

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

Scheduled 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 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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