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PQE250

PQE Group US Earns 2023 Great Place To Work Certification™

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PQE250PQE Group receives certification in the U.S. as a work environment where “you trust the people you work for, take pride in what you do, and have fun with the people you work with.”

May 18, 2023, Washington DC — PQE Group US is proud to be Certified™ by Great Place To Work® for the second year in a row. This esteemed recognition is solely based on the feedback of our present employees regarding their work experience at PQE Group. This year, a remarkable 91% of our employees expressed their satisfaction with their workplace, which is 34 points higher than the average U.S. Company.
Great Place To Work® is the global authority on workplace culture, employee experience, and the leadership behaviors proven to deliver market-leading revenue, employee retention and increased innovation. “Great Place to Work Certification is a highly coveted achievement that requires consistent and intentional dedication to the overall employee experience,” says Sarah Lewis-Kulin, the Vice President of Global Recognition at Great Place To Work. She emphasizes that Certification is the sole official recognition earned by the real-time feedback of employees regarding their company culture. “By successfully earning this recognition, it is evident that PQE Group stands out as one of the top companies to work for, providing a great workplace environment for its employees.”

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Flavo250

Baltimore’s Flavocure Biotech Announces FDA Clearance of IND Application for Caflanone (FBL-03G), for Clinical Trials in Pancreatic Cancer Patients.

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Flavo250Baltimore, Maryland–(Newsfile Corp. – May 17, 2023) – Flavocure Biotech, Inc. (“Flavocure”), today announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase I, first-in-human clinical study of Caflanone (FBL-03G) for the treatment of pancreatic cancer. Pancreatic Ductal Adenocarcinoma (PDAC) accounts for about 2% of all cancers and is associated with 5% of cancer‐related deaths. Caflanone treatment is combined with radiotherapy (RT) for enhanced efficacy against cancer cells.

“We are thrilled to obtain clearance to advance Caflanone (FBL-03G) into clinical trials and are excited about the prospects of what this new class of therapeutic agent may mean for cancer patients,” said Dr. David G. Brooks, MD, Ph.D., Interim Chief Medical Officer of Flavocure Biotech, Inc. “This is an important milestone for our company, representing our first program to receive FDA clearance to proceed into a clinical trial. This new approach combining radiotherapy with our lead drug candidate, caflanone, leverages our groundbreaking science and has broad potential applicability in many therapeutic areas,” said Dr. Ngeh J. Toyang, Ph.D., Chief Executive Officer and co-Founder of Flavocure Biotech, Inc.

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regenxbio250

REGENXBIO Announces NAV® Technology Platform Will Support Bespoke Gene Therapy Consortium’s First Rare Disease Clinical Portfolio

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regenxbio250ROCKVILLE, Md., May 16, 2023 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) today announced that preclinical research in Mucopolysaccharidosis type IVA (MPS IVA), also known as Morquio syndrome, was selected for inclusion in the Foundation for the National Institutes of Health Accelerating Medicines Partnership® Bespoke Gene Therapy Consortium (AMP® BGTC), clinical trial portfolio. The Consortium brings together partners such as NIH and FDA, as well as partners from private and non-profit sectors.

Sponsored by Nemours Children’s Hospital, MPS IVA is one of eight programs selected as part of AMP® BGTC’s first clinical portfolio to help accelerate the development of bespoke gene therapies, with the goal of streamlining the regulatory approval process. MPS IVA is a metabolic condition that primarily affects the skeleton, and is estimated to impact 1 in 200,000 to 300,000 individuals.

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DrugDisco

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

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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

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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

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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

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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

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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

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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”!

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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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