Category: People

  • Biden Taps Former FDA Chief Califf to Again Lead Agency

    Biden Taps Former FDA Chief Califf to Again Lead Agency

    Former U.S. Food and Drug Administration Commissioner Robert Califf is expected to return to the regulatory agency after President Joe Biden nominated the cardiologist for the position. According to the Washington Post, if confirmed by the Senate, Califf would take over an agency poised to make key decisions on the vaping industry, as well as coronavirus vaccines and treatments while facing criticism of recent controversial drug approvals and widespread burnout due to the ongoing pandemic.

    Robert Califf/ Credit: Duke University

    Califf previously served as commissioner for nearly a year in Obama’s second administration after an overwhelming vote in his favor. The White House has not finalized its decision, and the people with knowledge cautioned the situation could still change. But nine months into its search for a permanent FDA chief, Califf is now viewed as the leading candidate for the job.

    Despite the agency’s prominent role in the nation’s coronavirus response, it has been without a permanent leader since Biden took office in January. Califf would replace acting Commissioner Janet Woodcock, the agency’s longtime drug chief, who has helmed the agency for nine months. Califf returned to cardiology after his tenure at FDA and currently works for the Duke Clinical Research Institute, but also took a position leading health policy at Google’s parent company Alphabet in 2019.

    While he garnered support from many senators in his 2016 confirmation process, Sen. Bernie Sanders (I-Vt.) voiced concerns about his industry ties and said he could oppose the vote. Califf at the time had written papers with pharmaceutical industry executives and consulted for drug and device makers.

  • Kim Hesse to Lead Enthalpy’s Business Development

    Kim Hesse to Lead Enthalpy’s Business Development

    Photo: kunakorn

    Enthalpy Analytical has hired Kim Hesse as director of business development with a focus on the testing of nicotine containing products.

    Hesse’s strong business development experience will help expand Enthalpy’s market leadership in tobacco and vape testing. “I am excited to join Enthalpy Analytical,” said Hesse. “This opportunity will give me exposure to new markets, customers and geographies with expanded capabilities, including toxicology services. I look forward to continuing to contribute value to the tobacco industry and supporting clients with the best solutions.”

    Hesse holds advanced degrees from Kent State University and attended Arizona State University’s School of International Business Management. 

    Her laboratory testing career began January 2008 in Hamburg, Germany, where she trained in laboratory instrumentation and its application in the analysis of crop protection agents. Over the years, Hesse has expanded her expertise and now works closely with both the pharmaceutical and tobacco laboratory industries.

    Hesse is a recognized expert in laboratory testing and the regulatory requirements of the tobacco testing trade. Due to her extensive knowledge, Hesse is a sought-after orator and has spoken at numerous industry events around the world.

  • New Managing Director at German E-Cig Association

    New Managing Director at German E-Cig Association

    Michal Dobrajc (left) and Oliver Pohland (Photo: VdeH)

    Oliver Pohland has been named managing director of the German e-cigarette association Verband des e-Zigarettenhandels (VdeH). He succeeds Michal Dobrajc, who has served in the position since Dec. 21, 2018.

    Pohland has years of experience in the private sector and political association management. He also has an extensive network at the state, federal and EU levels. Most recently, Pohland served as the federal manager of the THW Federal Association.

    Pohland, who successfully quit smoking through vaping, plans to advocate for reasonable regulation of vapor products at all levels. In his view, the beleaguered vaping sector should be given an opportunity to grow and assist smokers in switching to less harmful nicotine products.

    Earlier this year, the VdeH campaigned vigorously against government plans to significantly raise taxes of vapor products.

    “I am really looking forward to my new job,” said Pohland in a statement. “As managing director, I will use all my expertise and experience to create a legal framework that benefits all member companies. My goal is to give the members of VdeH a strong voice at all levels of politics.”

    Dobrajc, who will continue chairing the VdeH for the time being, said he looked forward to working with Pohland.

    “In Oliver we have gained an experienced expert on the German and European political landscape,” he said. “I am confident that the VdeH will benefit from his pragmatic and honest way of working.”

  • Former Juul Labs CEO Takes Lead at Digital Pharmacy

    Former Juul Labs CEO Takes Lead at Digital Pharmacy

    Kevin Burns, who resigned in 2019 as chief executive officer of Juul Labs Inc. amid growing controversy over the marketing of e-cigarettes, was named CEO of online service Alto Pharmacy, according to Bloomberg.

    Burns, who joined Alto a year ago as chief operating officer, replaces co-founder Matt Gamache-Asselin as CEO, according to a memo sent to employees Thursday. Gamache-Asselin plans to remain involved, leading the product and technology organization.

    Burns joined Juul in 2017, when the e-cigarette maker enjoyed a heady valuation and was seen as one of the leading companies in the burgeoning industry. But growing use of vaping devices by teens and young non-smokers drew an outcry from public health officials, and the company announced the day Burns departed that it would stop advertising and lobbying.

    Alto, part of a crop of hot startups in the online pharmacy space, was founded in 2015. The company has explored the idea of going public via a blank-check firm, Bloomberg reported in May, and was projected then to have revenue of about $700 million this year. Burns worked at yogurt maker Chobani and at private equity firm TPG Capital before joining Juul.

  • Arcus Compliance Appoints CBD Guru Robert Sidebottom

    Arcus Compliance Appoints CBD Guru Robert Sidebottom

    Photo: tadamichi

    Arcus Compliance appointed a new nonexecutive director, Robert Sidebottom.

    Sidebottom has broad commercial, management and board-level experience across the vape and CBD sectors. He is the group managing director for the Eco Vape Group of companies and was formerly the managing director for the vape compliance company Adact Medical.

    Sidebottom is a leading advocate of vaping, which he views as one of the essential tools in assisting smokers to quit traditional cigarettes. His commercial and compliance experience is underpinned by his qualifications and experience in project management, personnel management and finance.

    “I am thrilled to be joining the Arcus Compliance leadership team, and I look forward to contributing to their strategic direction and continuing the exponential growth as the prime compliance agency in the sector,” said Sidebottom in a UKVIA press note. “The Arcus board have set the correct tone of professionalism and customer service, and I am very happy to have the opportunity to work with them.”

    “We are thrilled to have Robert on board,” said Lee Bryan, managing director of Arcus Compliance. “He will be working closely with our other directors and in particular our other [nonexecutive director,] John Dunne. Prior to his appointment and for the last 12 months, Robert and I have discussed how we can improve vaping compliance, with the aim of making products as safe as possible for the vaping community and switching smokers to the 95 percent safer alternative of vaping.”

    Arcus Compliance has enjoyed rapid growth over the last 18 months and has significantly increased its market share within the SaaS space in the electronic nicotine-delivery systems (ENDS) and vape product sector. Arcus Compliance is currently regarded as the leading regulatory consultancy in Europe for ENDS products and boasts a client base of many of the world’s leading brands.

  • Former Juul Executive Joins Poda Lifestyle and Wellness

    Former Juul Executive Joins Poda Lifestyle and Wellness

    Photo: Poda Lifestyle and Wellness

    Former head of corporate affairs for Juul Labs Nicholas Kadysh has joined Poda Lifestyle and Wellness as a member of the global advisory board.

    With over a decade of experience as a public affairs and regulatory expert, Kadysh has led government relations and regulatory departments for a number of large corporations, including acting as head of corporate affairs for Juul Labs, as government affairs and public policy leader for General Electric Canada and as director of public affairs for Red Bull Canada. Kadysh is currently the founder and CEO of PharmAla Biotech.

    Prior to his work in the corporate sector, Kadysh gained a deep understanding of government as a campaign and legislative staff member in multiple levels of government, most recently directing the outreach department of the Office of the Leader of the Opposition at Queen’s Park in Toronto. He has also worked at the Canadian Parliament as a policy advisor.

    Kadysh is trilingual (English, French and Russian) and is a graduate of Queen’s University. He is active in nonprofit and community initiatives in Toronto, including fundraising for Toronto East General Hospital and as a member of the board for Yonge-Dundas Square.

    “I believe that Poda is well poised to gain significant market share in the rapidly growing heat-not-burn market,” said Kadysh in a statement. “With my vast experience in public affairs and as a regulatory expert, I look forward to helping guide Poda as they continue their global expansion. Entering highly regulated markets requires careful planning and skillful execution, and there are many potential pitfalls to be avoided.”

    “Having worked closely with Nick at Juul Labs Canada, I can personally attest to the skill and expertise that Nick brings to the table,” said Michael Nederhoff, previous president of Juul Labs Canada, who joined Poda’s global advisory board in early July. “Nick has a wealth of regulatory experience across various categories and in multiple countries, which will be invaluable as we scale the business.”

  • Pyxus Announces Retirement of Chief Financial Officer

    Pyxus Announces Retirement of Chief Financial Officer

    Photo: bortnikau

    Joel L. Thomas will be retiring from his position as executive vice president and chief financial officer at Pyxus International upon the appointment of his successor. Thereafter, Thomas will continue to serve as a strategic advisor to facilitate the transition of his responsibilities until he retires from that position on or before June 30, 2022. The company has initiated an executive search for Thomas’ successor.

    “On behalf of Pyxus and the board of directors, I would like to thank Joel for his dedication and contributions to the company,” said Pieter Sikkel, president and CEO of Pyxus International, in a statement.

    “Throughout his time with the company, Joel has provided financial leadership and implemented innovative financing structures to meet our evolving global requirements. His leadership and dedication were critical over the past year as we navigated the impact of the Covid-19 pandemic and implemented significant restructuring efforts that have positioned our business for long-term success. Joel’s passion for the business, our shareholders, our employees and our customers is evident to anyone who interacts with him, and I wish him all the best in the next chapter of his journey.”

    Thomas has spent the past 16 years of his career with the Pyxus International, including serving the last seven years as CFO. 

    “It has been a privilege to work and serve alongside our talented global team,” said Thomas. “I’m proud of the steps we have taken to create a solid foundation for the company that will enable it to achieve long-term success.” 

  • Helius Appoints Perry to the Cannabis Company’s  Board

    Helius Appoints Perry to the Cannabis Company’s Board

    New Zealand’s largest licensed medicinal cannabis company, Helius Therapeutics, has appointed Joanna Perry to its Board of Directors. The appointment comes as the New Zealand-based company prepares to enter both the domestic and international markets. Perry will serve as chairperson on the board’s Audit Finance Committee.

    Joanna Perry, Credit: Helius

    “Joanna’s significant governance experience, combined with her well-known inquisitive probing, will be a real asset. Her nature to challenge and always seek continuous improvement strongly aligns with Helius’ internal cultural value of staying curious,” says Carmen Doran, CEO of Helius Therapeutics.

    Having raised $48m in capital since 2018, Helius has invested significantly in both its facility and talent, according to a press release. Perry’s arrival to the board of Helius is timely, with its state-of-the-art, integrated medicines manufacturing facility in Auckland’s East Tamaki set to begin production.

    “Our world-class executive leadership team is complete, and our board is equally excited to bring high quality, highly efficacious medicinal cannabis products to market with an exciting R&D pipeline to follow,” says Doran.

    Perry says it is a once-in-a-lifetime opportunity to be involved with such an innovative biotechnology company, leading the infancy of New Zealand’s medicinal cannabis sector. “I’m delighted to add my governance and financial experience to the vast pharmaceutical and cannabinoid medicine experience of the Helius team. It’s an incredible journey not only for Helius, but for the country,” says Perry.

  • Celebrity Website Profiles RLX Founder Kate Wang

    Celebrity Website Profiles RLX Founder Kate Wang

    Photo: RLX Technology

    The Celebrity Net Worth website recently published a profile of RLX Technology Founder Kate Wang, who the publication describes as one of the richest self-made women in the world.

    Wang graduated from Jiatong University with a degree in finance in 2005 and took a management trainee job at Proctor & Gamble in Guangzhou. In 2011, she moved to New York City to get her Master of Business Administration degree at Columbia.

    After grad school, Wang spent a year at the Beijing office of Bain & Co. She then moved to Uber China, followed by the Chinese ride-sharing service Didi Chuxing, which merged with Uber China in 2016.

    In 2017, Wang tried e-cigarettes to help her quit smoking, but she found the Chinese offerings available at the time to be terrible. She saw an opportunity and decided to focus on older smokers who were trying to quit, like her father, who was suffering the health consequences from his two-packs-per-day habit.

    Through crowdfunding on JD.com, Wang raised $6 million in seed capital in June 2018, positioning the RLX Technology as a tech startup.

    After a little more than a year of operation, RLX had garnered almost half of the largely unregulated domestic vaping market in China.

    In January, RLX went public on the New York Stock Exchange and raised $1.4 billion.

    However, when Chinese regulators in October 2019 banned internet sales of e-cigarettes to discourage underage vaping, 20 percent of the company’s business evaporated overnight.

    Undeterred, RLX started building a physical store presence. In January 2020, RLX opened a flagship store in Shanghai. Today, RLX has more than 5,000 stores in 250 cities in China. The company requires ID and put facial recognition in place to prevent minors from shopping for e-cigarettes in RLX stores. RLX still has more than 60 percent of China’s growing e-cigarette market.

    Despite the challenges, RLX’s sales grew 147 percent to $585 million in 2020, up from $19 million in 2018.

    In March, however, Chinese regulators revealed a draft of rules that would reclassify e-cigarettes as tobacco products and bring them under the control of the State Tobacco Monopoly Administration (STMA). Such a move would greatly diminish vapor companies’ potential earnings. All tobacco products in China are sold through government-owned stores. In response to the news, the share price of RLX dropped 54 percent—erasing $16 billion from the company’s market cap.

    Meanwhile, the U.S. Securities and Exchange Commission announced it would begin enforcing a law that Chinese companies listed on the New York Stock Exchange would have to provide audits or be de-listed.

    In the worst-case scenario, Wang would be forced to sell at a price set by China Tobacco (which would likely jeopardize most, if not all, of her profit) and be forced to de-list in the U.S.

  • Paul Hardman Joins Broughton as Head of Scientific Affairs

    Paul Hardman Joins Broughton as Head of Scientific Affairs

    Broughton Nicotine Services has appointed Paul Hardman as head of scientific affairs, the latest in a series of senior level appointments, as it continues to expand its services.

    The business, which has helps electronic nicotine device companies bring noncombustible products to market, is currently expanding its full-service regulatory consultancy into modern oral nicotine products, heated tobacco products and Cannabidiol products.

    A scientist with extensive experience in inhaled product development across pharmaceutical and consumer products, Hardman will have the task of growing the scientific affairs team to enable the business to grow and offer a premium consultancy experience for clients in the industry.

    “We’re delighted to have welcomed someone of his caliber into this new role,” said Nveed Chaudhary, chief regulatory officer of Broughton Nicotine Services. “His addition to the Broughton team will strengthen the business further as we look to expand our full-service regulatory consultancy. Paul will take responsibility for delivering product development and optimization activities, drawing on his years of industry leadership and experience.”

    Prior to joining Broughton, Hardman was scientific lead with Imperial Brands, where he was responsible for designing the testing strategy for the chemistry of inhaled and oral next-generation nicotine products, from assessing a variety of prototypes at the early stages of development through to characterization of products for submission through the U.S. Premarket Tobacco Product Application process.

    He began his career working at a specialist pharmaceutical company where he gained experience of dry powder and metered dose inhaler development, including for the treatment of local lung conditions and systemic absorption. Hardman also has experience leading the quality control department in a multinational pharmaceutical company involved in the production of generic nicotine lozenges.

    Paul’s addition to the Broughton team will strengthen the business further as we look to expand our full-service regulatory consultancy.

    He began his career working at a specialist pharmaceutical company where he gained experience of dry powder and metered dose inhaler development, including for the treatment of local lung conditions and systemic absorption. Hardman also has experience leading the quality control department in a multinational pharmaceutical company involved in the production of generic nicotine lozenges.

    “I am passionate about the opportunity to work with multiple clients and really get to the heart of their products so that Broughton Nicotine Services can best serve these businesses by championing those points in their regulatory submissions,” said Hardman.  

    “My role will involve growing the team to enable us to deliver a highly effective offering as Broughton moves into new areas, and I am eager to build on the success the business has already achieved.”