Skip to main content
All Posts By

admin

Aimee Smart

Aimee Smart

By Uncategorized

Vice President of Clinical Development and Regulatory Processes at Lung Biotechnology PBC and Lung Bioengineering Inc (subsidiaries of United Therapeutics Corporation)

Aimee Smart

Aimee Smart is an accomplished senior executive with more than 20 years of success in the pharmaceutical and biotechnology industries, Aimee enjoys leading deeply challenging projects where there is no clear path forward. She understands how to work with many people across various functions, operate under high pressure, and meet critical timelines to deliver results. And because everything she does in regulatory strategy, designing, and running clinical development programs is years in the making, her complex problem-solving ability includes considering the world of today while anticipating what might happen in the future.

In her current role of Vice President of Clinical Development and Regulatory Processes at LungBiotechnology PBC and Lung Bioengineering Inc (subsidiaries of United TherapeuticsCorporation), Aimee reports directly to the parent company CEO, driving clinical drug development and leading a multifunctional organization and a geographically dispersed team of ver 60 professionals, covering all aspects of development including; regulatory affairs, quality assurance, clinical development, product development, clinical supply, clinical operations, biostatistics and data management, and project management.

Aimee is part of the executive leadership team of United Therapeutics Corporation, representing her companies needs at the corporate level. She was responsible for Lung Biotechnology’sreorganization and setting its new strategic goals. And after leading the successful turnaround of the underperforming subsidiary to a respected, productive company, Aimee’s CEO asked he rto do it a second time and lead the Lung Bioengineering subsidiary.

During her more than 14-year tenure at Lung Biotechnology PBC, Aimee has served in increasingly senior clinical development, regulatory affairs and quality roles, including as Associate Vice President and Head of Office and Director, Global Regulatory Affairs. Her experience also includes regulatory affairs posts at VIRxSYS Corporation, Human GenomeSciences, Nabi Biopharmaceuticals, and Cato Research.

As much as she enjoys solving complex problems and driving results, Aimee is most passionate about ensuring that what she is doing is connected back to a meaningful mission that directly impacts people’s lives in a positive way.

Aimee earned her Bachelor of Science in Microbiology from North Carolina State University, where she was later honored with its Outstanding Young Alumni award. She completed her executive MBA from the University of Maryland in 2022 and was named one of the Best and brightest EMBA students by Poets & Quants magazine. In addition, Aimee holds certifications in Leadership Coaching for Organizational Performance from American University and in Regulatory Affairs for the U.S. and Europe from the Regulatory Affairs Professional Society.

She maintains professional memberships in the Drug Information Association, RegulatoryAffairs Professional Society, Women in Bio, and International Coach Federation. She also serves as a Member for the NCSU College of Sciences Foundations Board.

Immunimic Therapeutics Logo

Immunomic Therapeutics, Inc. Receives FDA Fast Track Designation for ITI-3000, a pDNA Vaccine, in Development for the Treatment of Merkel Cell Carcinoma

By News

Immunimic Therapeutics LogoNovember 08, 2022 08:30 AM Eastern Standard Time

ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc. (ITI), a privately-held clinical-stage biotechnology company pioneering the development of LAMP-mediated nucleic acid-based immunotherapy, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to the ITI-3000 program for the treatment of patients with Merkel cell carcinoma. The company is currently enrolling a phase 1 study evaluating ITI-3000, a plasmid DNA (pDNA) vaccine targeting patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer that is typically caused by the Merkel cell polyomavirus (MCPyV).

“The FDA’s decision to grant FTD underscores the potential for the ITI-3000 program to address a serious unmet need and serve as a meaningful therapeutic option for patients with Merkel cell carcinoma,” stated Dr. William Hearl, Chief Executive Officer of ITI. “We are committed to unlocking the full potential of ITI-3000 in patients with this aggressive form of skin cancer. We expect to report top-line data from our ongoing phase 1 trial of ITI-3000 in MCC patients next year and look forward to working closely with the FDA on a potential next phase clinical study design, while simultaneously continuing dialogue with possible partners.”

Read More
VogelsteinPetrocheilos 1

Catalio Capital Management’s new $85M fund is financing biomedical founders in ‘special situations’ – Technical.ly

By News

VogelsteinPetrocheilos 1Catalio Capital Management, an investment firm with offices in Baltimore and New York City, this week announced the close of a new fund that already counts a Johns Hopkins University-borne cancer detection company and patient-monitoring software system in its portfolio.

According to Catalio executives, the $85 million Catalio Credit Opportunities Fund I partners with what a statement called “39 world-renowned serial scientist-entrepreneurs at top-tier academic institutions in the US and Europe in order to vet opportunities to fund founders.” The fund, also described as a “special situations fund,” targets small and mid-sized private companies.

Image: (L to R) Catalio Capital Management cofounders R. Jacob Vogelstein and George Petrocheilos.

(Courtesy photo)

Read More
Linshom medical logo

Linshom Medical awarded $2.4M SBIR Fasttrack award from NIH (NHLBI) – World News Report – EIN Presswire

By News

Linshom medical logoBALTIMORE, MARYLAND, UNITED STATES, November 8, 2022 /EINPresswire.com/ — Linshom Medical was awarded a $2.4 Million Fasttrack SBIR grant from the National Institutes of Health (NIH), National Heart Lung and Blood Institute (NHLBI).

“This award further validates our technology for critical bedside respiratory monitoring and adds to the list of Linshom Medical’s achievements,” said Richard Hughen, CEO. “This award funds a clinical study to prove Linshom’s early detection capability of patient respiratory decline. It also funds the further miniaturization of our technology to reach more patients in more settings such as a nasal cannula and a wearable sensor for home monitoring.”

Read More
NCATS Director Joni L. Rutter, Ph.D.

NIH names Dr. Joni L. Rutter director of the National Center for Advancing Translational Sciences | National Institutes of Health (NIH)

By News

NCATS Director Joni L. Rutter, Ph.D.Lawrence A. Tabak, D.D.S., Ph.D., who is performing the duties of the National Institutes of Health director, has selected Joni L. Rutter, Ph.D., as director of NIH’s National Center for Advancing Translational Sciences (NCATS). Dr. Rutter has served as NCATS acting director since April 2021. She officially began her role as NCATS director on Nov. 6, 2022.

Image: NCATS Director Joni L. Rutter, Ph.D.

Read More
Us capitol building 2021 08 26 18 19 19 utc

Good News for Small Businesses Seeking Government Funding for Research and Development: SBIR/STTR Programs Extended Through 2025 | Wilson Sonsini

By News

Us capitol building 2021 08 26 18 19 19 utcUnder the SBIR and STTR Extension Act of 2022 (the Act), signed into law last month, the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs were extended through fiscal year 2025. These programs provide grants or contracts to small businesses to fund early-stage research and development. Over a dozen agencies participate in the SBIR or STTR programs, including the U.S. Department of Defense, the U.S. Department of Energy, and NASA. According to the Small Business Administration, more than 5,000 new awards, amounting to over $3 billion, are made each year under these programs. The complete list and link to each agency’s website (including current opportunities) can be found here.

 

Read More
Screen Shot 2022 11 01 at 2 51 27 PM

Innovation Lab Awarded Grant for ‘Move-D’ Elbow Brace | The Hearing Review

By News

Screen Shot 2022 11 01 at 2 51 27 PMAn Orange County-based startup, Innovation Lab, announced that it was awarded $30,000 in grant funding to help bring its “Move-D” mechanical elbow brace to market to help improve Activities of Daily Living (ADL) for pediatric ataxic cerebral palsy patients. The grant was awarded during the “Make Your Medical Device Pitch for Kids!” competition held during the 10th Annual Pediatric Device Innovation Symposium hosted by Children’s National Hospital on October 23, 2022.

 

Read More
914af581 565f 4304 9500 30abc9ed456e

MedTech Color Presents: The National Institutes of Health- Exploring SBIR/STTR Funding Opportunities

By News

914af581 565f 4304 9500 30abc9ed456eJoin this collaborative webinar between MedTech Color and the National Institutes of Health on November 8th 2022 at 2:30 PM ET. Attendees will learn about the NIH programs and initiatives relevant to diverse founders and entrepreneurs in the Medtech space including SBIR/STTR funding and related NIH programs for entrepreneurs. Hear from specific institutes and departments, such as the NIH Small business Education and Entrepreneurial Development (SEED), National Heart, Lung, and Blood Institute (NHLBI), and more, further describe their specific programs, have an open dialogue, and ask questions regarding best fit programs, resources and more!

MedTech Color aims to advance diversity, equity, inclusion, and belonging (DEIB) measures in the medical device industry for underrepresented ethnic minority groups. Their core objectives are: to increase the number of leaders of color who enter and stay in Medtech, add tangible value to the industry’s ecosystem via thought-leadership and actionable initiatives, and build a strong, diverse network of mentors and sponsors who champion thought leadership and innovative clinical advancement.

To register for the event, visit https://bit.ly/3Fgrvk0.

GCEC LasVegas 2022

Top university entrepreneurship centers, programs announced at annual Global Consortium of Entrepreneurship Centers Conference | Rice News | News and Media Relations | Rice University

By News

GCEC LasVegas 2022HOUSTON – (Nov. 2, 2022) – The largest crowd in the history of the Global Consortium of Entrepreneurship Centers (GCEC) Conference gathered last week in Las Vegas to celebrate creativity and innovation in university-based entrepreneurship education.

The GCEC is made up of more than 250 leading university entrepreneurship programs working together not only to share best practices and develop programs and initiatives, but also to collaborate and help each other advance, strengthen and celebrate the role universities fulfill in educating the entrepreneurs of tomorrow. The Rice Alliance for Technology and Entrepreneurship at Rice University’s Jones Graduate School of Business in Houston is the global headquarters for the GCEC.

 

Read More

Search

You have successfully subscribed to the newsletter

There was an error while trying to send your request. Please try again.

BioHealth Innovation will use the information you provide on this form to be in touch with you and to provide updates and marketing.