AP NEWS | Revolutionizing Birth Control: NEXT Life Sciences Announces Promotion of Dr. Darlene Walley to Chief Executive Officer

Dr. Robert Dudley joins NEXT Life Sciences as the Chief Development Officer

ORIGINALLY POSTED ON AP NEWS

LOS ANGELES, CA, UNITED STATES, December 17, 2024 /EINPresswire.com/ -- NEXT Life Sciences, the maker of the male contraceptive product Plan A™ and a leader in the development of other modern reproductive healthcare solutions announced today the promotion of Dr. Darlene R. Walley as the Chief Executive Officer of NEXT, succeeding L.R. Fox, who will remain as Founder and Executive Chairman. In his continued role, Fox will support the team, ensuring they have the right resources and setting the long term vision. In addition, NEXT is announcing that Dr Robert Dudley, founder and inventor of men’s health product AndroGel® will be joining NEXT as the Chief Development Officer.

“Dr. Walley has already had incredible success in securing a clear pathway for Plan A with the FDA and it made sense for her to lead the entire organization to get our portfolio of products to market,” said L.R. Fox, Founder and Executive Chairman of NEXT Life Sciences. “Plan A is one of many products in the pipeline as NEXT continues to revolutionize reproductive health. Dr. Walley is known for her tremendous success as an executive in both big Pharma and biotech startups where she has led companies specializing in drug development, manufacturing, and clinical research, and this rare combination puts her in an incredibly unique position to take all of our critical products to the world.”

“Since joining NEXT, I’ve had the profound opportunity to work with other people who are deeply passionate about creating solutions to some of the world’s most pressing issues. Working with Fox has been the high point of my career to witness his vision and brilliance at every level,” stated Dr. Walley. “The world needs and welcomes Plan A. Whether talking to men and women, researchers, regulators, investors and even my friends - everyone agrees the time is right for Plan A. I am excited to lead the talented team in bringing Plan A and our highly de-risked portfolio and pipeline of reproductive health products to the market which will have a wide reaching impact on society.”

Dr. Walley, who earlier this year joined NEXT as the CEO of Plan A™, 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, and 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 health products, with 18 peer-reviewed publications.

Founder and Executive Chairman of NEXT Life Sciences, L.R. Fox, will continue his focus on developing and pioneering world-leading technologies through his family office, NEXT Global. The focus of NEXT Global has always been to invest in and incubate technologies with the potential for transformational societal impact. NEXT Global carries out this vision through direct investments, startup incubations, and early-stage buy-outs, as well as nonprofit incubation through its support of the NEXT Foundation.

Dr. Robert E. Dudley is an experienced C-level pharmaceutical executive with over 20 years as President/CEO of small to private and public pharmaceutical companies. He has a strong record of capital raises with over $150M in equity raised to fund successful product development through regulatory approvals and commercialization in the U.S. and across major foreign markets. He is the primary Inventor of AndroGel®, one of the most successful men’s health products developed and commercialized worldwide with multiple-years of annual sales exceeding $1B. He also invented the first true oral testosterone replacement product approved by the FDA, known as JATENZO®, and oversaw its development through approval to market launch. He also holds numerous patents and has published many articles in top medical journals for his work in developing innovative reproductive health products.

"I am delighted to be part of an organization committed to innovative products in reproductive health -- particularly those aimed at men that benefit the couple," stated Dr. Dudley. "For over 30 years I have been involved in developing and commercializing products to improve men's health. Being part of the leadership team at NEXT Life Sciences is a perfect fit for my experience and will enable me to use my talents to help create cutting-edge products that help men and women live better, more satisfying lives."

“I am pleased to welcome Dr. Dudley to our team. He has been credited with proving the massive market potential of the men’s health space, most notably demonstrating the large opportunity with AndroGel®. He will help us advance our mission of bringing a new generation of accessible reproductive health products to the market,” said L.R. Fox, Founder and Executive Chairman of NEXT Life Sciences.

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

FORTUNE | The Companies Betting on Male Birth Control Step Closer to Approval - and into An Uncertain Political Chapter

FORTUNE | MOST POWERFUL WOMEN DAILY BY NINA AJEMIAN

– In control. For years, advocates of reproductive freedom have been waiting for the arrival of male birth control (besides condoms and vasectomies). New options are finally getting closer to market—just as the second Trump administration enters the White House. 

This is an issue on which the Trump White House could be a bit of a wildcard. On the one hand, the conservative roadmap Project 2025 threatens access to birth control for women, from allowing employers to opt out of covering it to limiting the contraceptive methods that can be covered under the Affordable Care Act. But male birth control has the luxury of being “removed from the whole debate” about abortion, says Darlene Walley, CEO of Next Life Sciences’ Plan A, a male contraceptive in development. Most women know that treatments for men and women are often viewed differently, like how insurers have covered birth control compared to Viagra. Trump’s Health and Human Services nominee Robert F. Kennedy Jr., meanwhile, is poised to overhaul the FDA and its drug approvals process just as new treatments seek the FDA’s signoff. 

“We’re in a time of transition, and the time is right for male contraception to really move out and get onto the market,” says Heather Vahdat, executive director of advocacy group the Male Contraceptive Initiative. There have been efforts made to get products on the market before, but no male contraceptive has cleared phase three trials. A lack of funding from pharmaceutical companies and severe side effects have gotten in the way. (Men have been more reluctant to tolerate side effects and treatments have been harder to get approved because pregnancy does not pose a physical risk to men.)

One of those birth control methods is Next Life Sciences’ Plan A, a non-hormonal, reversible contraceptive for men that lasts 10 years and is inserted in an outpatient procedure. Expected to enter clinical trials in the first quarter of 2025, Plan A uses a hydrogel that acts like a filter to stop sperm from moving through the vas deferens. The company plans for its FDA submission, approval, and commercialization to go through in 2027. “We’re hoping that by giving the other half of the population the ability to participate in birth control that we can have a profound effect on pregnancies,” Walley says.

READ MORE ON FORTUNE

FORTUNE | MOVERS AND SHAKERS: Dr. Darlene Walley

FORTUNE | MOST POWERFUL WOMEN DAILY | MOVERS AND SHAKERS

MPW Daily is your access to the world’s most powerful women. Every weekday, senior writer Emma Hinchliffe provides original reporting, key insights, and expert perspectives on the women leading the moment in business and beyond. 

NEXT Life Sciences, a male contraceptive developer, appointed Darlene Walley as CEO of Plan A. Most recently, she was chief business development officer at Pebble Life Science.

READ MORE ON FORTUNE

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

The Family Leads NEXT Life Sciences $2.5 Million Funding Round for Plan A Male Birth Control

ORIGINALLY POSTED ON Associated Press

JANUARY 2024

LOS ANGELES—NEXT Life Sciences, the maker of the male contraceptive product Plan A™, announced today that it has secured an oversubscribed $2.5M round of funding to help advance its mission of bringing Plan A™ to market. The Family, a high-impact startup accelerator led the round with participation from Transform VC and a combination of angel investors and early-stage Venture funds including entrepreneur Brock Pierce, Transform VC, StartupHealth, Pay It Forward Venture Capital, Particular Ventures, Keno Peer, Unpopular Ventures, and Joy Fund, bringing total seed funding to date to $4M.

The Family’s founder Ryan Breslow who is known for building the multi-billion-dollar company Bolt and his newest venture Love.com, will join NEXT Life Sciences as a strategic advisor and provide insights needed to bring Plan A™ to market.

“My mission for Family is to back top founders working on truly world-changing products and bring them to market more quickly,” said The Family Founder Ryan Breslow. “Plan A™ is unleashing bodily autonomy; it’s giving men the ability to share responsibility over long-term contraceptive decisions.  I’m all-in.”

“We couldn’t be more thrilled that the Family recognizes the potential impact for Plan A™ and we’re honored to welcome Ryan as a strategic advisor to help guide our team as we work to bring a revolutionary contraception to the market,” said NEXT Life Sciences, Inc. Founder and CEO L. R. Fox.  “With Plan A™, our goal is to change lives by giving men the ability to participate equally in family planning, so that couples have a more equitable relationship and the tools needed to be intentional  about their futures.”

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 finally to market. 

NEXT plans to start clinical trials for Plan A™ in 2024, followed by submission to the FDA.

About NEXT Life Sciences 

NEXT Life Sciences, Inc. (NEXT) is a medical device company striving to transform 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 FDA for commercial distribution.

READ THE ORIGINAL ARTICLE ON Associated Press

Bolt’s Ryan Breslow Is Backing This Male Birth Control Startup

ORIGINALLY POSTED ON Business Insider

JANUARY 2024

The market for male birth control is growing. One startup is touting a nonhormonal, long-lasting option — and thinks the tech could be ready for use in two years.

NEXT Life Sciences is taking a new approach with its male contraceptive called Plan A. The product uses Vasalgel, a hydrogel that blocks the flow of sperm through the vas deferens to prevent pregnancy.

This month, the startup landed fresh funding to power Plan A's first clinical trials, raising $2.5 million in seed funding led by Ryan Breslow's venture fund The Family, Business Insider has learned exclusively. Breslow, the founder of fintech startup Bolt, will now serve as a strategic advisor to NEXT.

NEXT's oversubscribed seed round included funding from entrepreneur Brock Pierce, Transform VC, StartupHealth, Pay It Forward Venture Capital, Particular Ventures, Keno Peer, Unpopular Ventures, and Joy Fund. The startup had raised $1.5 million in pre-seed funding in June. 

READ MORE ON Business Insider

World’s Leading Vasectomists and Male Contraceptive Experts Join in Support of Plan A: Male Birth Control

ORIGINALLY POSTED ON AP NEWS

LOS ANGELES, CALIFORNIA, UNITED STATES, August 4, 2023

NEXT Life Sciences, the team developing a long-lasting, reversible contraceptive for men known as Plan A™, announced new appointments to its Medical Advisory Board. This follows the recent appointments of Dr. Charles Carignan to lead Plan A™’s clinical trials as Chief Medical Officer and Cindy Domecus, R.A.C. as Chief Regulatory Advisor to guide the company as it navigates the FDA approval process.

The Medical Advisory Board will provide expertise, guidance, and medical insight to the NEXT Life Sciences leadership team as the company advances through their clinical trials. The latest appointees are each renowned clinicians and researchers within their fields, with their expertise spanning across all corners of the male reproductive health, vasectomy, and andrology spaces.

NEXT Life Sciences is proud introduce the following members to its Medical Advisory Board:

Dr. John Amory, who has published more than 130 peer-reviewed papers in the field of male reproduction and serves on the Advisory Board of the Male Contraception Initiative. He is currently Professor of Medicine and Section Head of General Internal Medicine at the University of Washington, where he works as an attending physician on the inpatient medicine wards and in the outpatient General Internal Medicine and Men’s Health Clinics.

Dr. Michael Eisenberg, who currently directs the Male Reproductive Medicine and Surgery Program at Stanford University. Dr. Eisenberg serves as an associate editor of Fertility and Sterility and Andrology and on the editorial boards of the Journal of Clinical Endocrinology and Metabolism and the Journal of Assisted Reproduction and Genetics. He is highly regarded both nationally and internationally and has delivered welcomed and celebrated lectures all over the globe.

Dr. Ron Weiss, who is referred to as the “Wayne Gretzky of vasectomies,” has performed nearly 60,000 vasectomies throughout his 30-year career, and is known as one of the most skilled practitioners of the no-scalpel vasectomy. In 2002 Dr. Weiss developed and refined the no-needle jet injector method of local anesthesia now used in Canada and around the world.

Dr. Doug Stein, who practiced adult general urology for over 17 years in Tampa, Florida, and now provides vasectomy services at up to 21 locations in Florida, many under the federal Title 10 program for low-income men without insurance. He is the Co-Founder of World Vasectomy Day, the largest annual male-oriented family planning event in history. He has performed over 50,000 vasectomies and 1900 vasectomy reversals.

L.R. Fox, CEO of NEXT Life Sciences, shared his enthusiasm around these new appointments and the expertise they bring to NEXT with their years of insight into the field of male contraception. “Truly, we are beyond excited to welcome these newest members of our Medical Advisory Board,” Fox said. “Bringing together the world’s most accomplished vasectomists and contraceptive leaders, that also share our vision of making long-lasting, reversible male contraception a tangible option in the market, is a dream come true for the team. With our previously appointed CMO, Dr. Carignan, and Chief Regulatory Advisor, Cindy Domecus, joining forces with this Medical Advisory Board we can hardly wait for what’s to come as we enter into clinical trials to bring Plan A™ one step closer to hitting the market.”

About NEXT Life Sciences

NEXT Life Sciences, Inc. (NEXT) is a medical device company striving to transform 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 FDA for commercial distribution.

General Contact:
info@planaformen.com

Media Contact:
press@planaformen.com

NEXT Life Sciences Announces Dr. Charles Carignan as Chief Medical Officer and Cindy Domecus as Chief Regulatory Advisor

ORIGINALLY POSTED ON FOX 2 NEWS

LOS ANGELES, CALIFORNIA, UNITED STATES, July 18, 2023

NEXT Life Sciences, the team developing Plan A™, a long-lasting, reversible contraceptive for men, announced today its appointment of Dr. Charles Carignan as its Chief Medical Officer and its new Chief Regulatory Advisor, Cindy Domecus, R.A.C.

“At NEXT we’re thrilled to be bringing on high-caliber leaders in the field of men’s contraception," said L.R. Fox, Chief Executive Officer of NEXT Life Sciences. “Dr. Carignan shares our vision of making the promise of a long-lasting male contraceptive finally a reality. With his addition, alongside our new Chief Regulatory Advisor, NEXT is gearing up for the next major phase of development for Plan A™.”

In his role as Chief Medical Officer, Dr. Carignan will lead Plan A™’s clinical trials and provide medical and clinical oversight to NEXT’s team of scientists and researchers.

Dr. Carignan brings with him extensive medical expertise, having served on committees of the U.S. Food and Drug Administration, Centers for Medicare & Medicaid Services, the World Health Organization, the United Nations, and the U.S. Agency for International Development. Additionally, he has led multiple successful corporations, serving as the founding president and CEO of NinePoint Medical, President and CEO of BionX Medical, and CEO of SoniVie Inc., and currently serves as the Executive Chairman of Cairdac and SamanTree Medical. He was also previously Executive Vice President and Chief Medical Officer of Novasys Medical, Chief Medical Officer of Endosurgery at Boston Scientific, and Vice President of Clinical Research and Medical Affairs at Conceptus, Inc. Training in general surgery at Columbia-Presbyterian Medical Center, Dr. Carignan continues to conduct physical training worldwide promoting the advancement of medical techniques and technology.

NEXT has also brought on Cindy Domecus, R.A.C. as Chief Regulatory Advisor to guide the company as it navigates the FDA approval process through clinical trials and ultimately to market. Domecus brings a strong background in both contraception and implantable medical devices, with over 35 years in the medical device industry, having served in both Regulatory Affairs and Clinical Research executive management positions since 1994. Domecus served in executive roles in Regulatory Affairs and Clinical Research for Conceptus, Inc. and Kyphon Inc., and in management roles in Regulatory Affairs for Systemix and Collagen Corporation. She was selected by the FDA to serve as the Industry Representative to the OB/GYN Devices panel, where she served a six-year term. Her experience and leadership have resulted in successful PMA, De Novo, 510(k), Breakthrough Device Designation, IDE, Pre-Submission and regulatory compliance efforts.

“This is an exciting time for Plan A™,” said NEXT CEO L.R. Fox. “With the demand for male contraceptives increasing, a priced equity funding round well underway, and the leading minds in male birth control options joining our team, we’re thrilled at the opportunity in front of us to finally move into clinical trials to make the promise of long-lasting, non-hormonal reversible male contraception a reality.”

About NEXT Life Sciences

NEXT Life Sciences, Inc. (NEXT) is a medical device company striving to transform 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 FDA for commercial distribution.

General Contact:
info@planaformen.com

Media Contact:
press@planaformen.com