AP NEWS | NEXT Life Sciences Appoints Dr. Darlene Walley as CEO of Plan A™

Peter Barton Hutt: Former FDA Chief Counsel joins the Advisory Board of NEXT Life Sciences

ORIGINALLY POSTED ON AP NEWS

LOS ANGELES, CA, UNITED STATES, October 24, 2024

NEXT Life Sciences, the maker of the male contraceptive product Plan A™, announced today the appointment of Dr. Darlene R. Walley as the Chief Executive Officer of Plan A™. Dr. Walley will spearhead Plan A™ and bring it to market and in addition, oversee the R&D efforts in other male birth control options NEXT is developing.

In addition, NEXT is announcing that Peter Barton Hutt, former Chief Counsel to the Food and Drug Administration (FDA) and former Board of Directors of Moderna Pharma is joining the NEXT advisory board. Hutt was pivotal in developing the FDA’s Medical Device Guidance and will be integral to helping Plan A™ rapidly enter the market and serve the millions of couples seeking better contraceptive options.

Both will work alongside NEXT’s CEO, L.R. Fox to lay a successful foundation for the next generation of transformative healthcare options that the company is developing. “We are thrilled to bring Dr. Darlene Walley on as the Chief Executive Officer of Plan A™ with her extensive background, expertise in biotech and pharma, and passion for bringing transformative products to market,” said L.R. Fox, CEO of NEXT Life Sciences. “Dr. Walley will be vital in leading our team to market and there is no doubt she will be a great asset to the NEXT Life Sciences family.”

Dr. Walley has over 30 years of life science business experience, having served as an Executive at Procter & Gamble, Gillette, and Arm & Hammer and CEO of multiple early-stage pharma and biotech companies.

To date, she has raised over $100M for these companies with over $1B in successful exits. In her extensive career, Dr. Walley has worked with startups, investment firms, and served on the Board of Directors of several companies, proving her skills through leading successful product launches, capital raises, and company performance improvements. Dr. Walley currently holds 12 patents, largely dealing with consumer health products, with 18 peer-reviewed publications.

“I am very excited and honored to be leading the incredible Plan A team to revolutionize contraception with a long-lasting, reversible, non-hormonal option for men,” stated Dr. Walley. “This opportunity allows me to use my over 30 years of experience in developing and launching first-in-class products worldwide. Plan A is another first-in-class product and everyone I mention it to is excited and onboard.”

Peter Barton Hutt, a distinguished attorney and expert in food and drug law, has made significant contributions to the regulatory landscape in the United States. Serving as the chief counsel for the U.S. Food and Drug Administration (FDA) in the 1970s, Hutt played a pivotal role in shaping policies that enhance food safety and regulate pharmaceuticals and biotechnology, including the development of the agency’s medical device guidance. Hutt has also shared his extensive knowledge through academia, teaching at several prestigious law schools, including Harvard Law School, and authoring numerous publications on regulatory matters. His influence continues to be felt across the industry as he advocates for effective legal frameworks that protect public health and safety.

"We've been waiting for this product for years. At last, Plan A has the technology that scientists have been looking for. I’m really excited about joining other distinguished leaders on the NEXT Life Sciences Advisory Board and look forward to supporting the team and contributing to the future development of the company,” said Peter Barton Hutt.

“I am pleased to welcome Peter to our advisory Board, his exceptionally accomplished legal and policy career will help us advance our mission of bringing a new generation of accessible contraception to the market,” said L.R. Fox, CEO of NEXT Life Sciences.

NEXT is developing Plan A™ to be a non-hormonal, long-acting, and reversible on-demand, contraceptive for men. The design of Plan A™ utilizes a hydrogel that acts as a flexible filter to block the flow of sperm within the male vas deferens, preventing pregnancy. The hydrogel used within Plan A™ is commonly known as Vasalgel®, a technology that earned significant attention during its 10 years of development with the non-profit Parsemus Foundation and shows a promising track record of success from pre-clinical data. The exclusive worldwide license for Vasalgel® was acquired by NEXT in 2022, with the goal to bring this technology through FDA authorization and rapidly to market.

About NEXT Life Sciences
NEXT Life Sciences, Inc. (NEXT) is revolutionizing modern reproductive healthcare and transforming lives through the development of its lead program, Plan A™, designed to provide a non-hormonal, long-lasting, and reversible contraceptive solution for men. NEXT’s executive management team and board members have a proven track record of leadership across early-stage research, product development, and global commercialization, having served in leadership roles at successful medical device and contraceptive companies that developed and launched products that achieved iconic status. For more information, visit
https://www.nextlifesciences.org/ and https://www.planaformen.com/.

Disclaimer
All forward-looking statements are not guarantees of future performance and undue reliance should not be placed on them. Statements within this document have not been evaluated by the Food and Drug Administration. Plan A™ is currently not approved by the FDA for commercial distribution.

NEXT Life Sciences
Plan A™ Male Birth Control
press@nextlifesciences.org

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