Since American Rami Levin took over as new CEO for Saniona in January, the company has had the clear ambition to build a full-fledged organisation in the United States. The establishment of the head office took a big step forward with the appointment of three central positions, at the same time as pivotal clinical studies in two rare eating disorders are approaching. BioStock contacted the CEO for a comment on how the new competencies strengthen the company’s goal of reaching the market with the primary drug candidate Tesomet.
At the beginning of 2020, Rami Levin was appointed as the new President and CEO of Saniona. It quickly became clear that Levin’s goal was to establish a new headquarters in the United States, the world’s largest biotech market and where most of the major healthcare investors are located.
An important secondary objective was to attract competent individuals to key positions at the new headquarters in Boston. On August 24th it was announced that the executive team will be expanded with three industry veterans.
Jason A. Amello takes on the role of Chief Financial Officer, Trista Morrison becomes Chief Communications Officer and Linea Aspesi is the new Chief Human Resources Officer. Amello and Morrison will start on 15 September 2020, while Aspesi will start on 1 October 2020.
»As we continue to advance Tesomet through late-stage clinical trials, I anticipate adding additional key roles and building out key functions to be able to achieve our goals« – Rami Levin, vd Saniona
Rami Levin gives his take
BioStock contacted CEO Rami Levin for a comment. Read more about the new recruits below.
Rami Levin, it has been your ambition from day one to build a full-fledged American organisation, while the company’s research expertise will continue to be based in Copenhagen. You have now put together a dynamic team with the addition of three industry veterans, is the plan to expand the management team with additional skills?
– Saniona will continue to add both expertise and scale as we advance our rare disease programs and create value for patients and for shareholders.
– My initial focus in building the executive team was to complement the existing position of Chief Scientific Officer, which is held by Jørgen Drejer, with a Chief Medical Officer. I hired Rudolf Baumgartner in April as Saniona’s Chief Medical Officer and Head of Clinical Development. My next priority was to ensure Saniona had adequate funding to complete its goals, which we achieved by raising USD65 million. The next step was to add expertise in finance, communications and human resources. These are essential functions as Saniona increases in size and becomes a more mature organization.
– As we continue to advance Tesomet through late-stage clinical trials, I anticipate adding additional key roles and building out key functions to be able to achieve our goals.
»We look forward to interacting with FDA regarding the HO program in Q4 of this year, with the goal of submitting INDs for approval in both HO and PWS before year end. We aim to initiate the HO trial in Q1 next year and the PWS trial before year end or early next year at the latest«
Through the three new recruitments, you ensure the advancement of the ongoing clinical studies with your primary drug candidate Tesomet for the treatment of two rare eating disorders, hypothalamic obesity (HO) and Prader-Willi syndrome (PWS). Can you outline the importance of possessing these three key competencies in order to achieve the clinical development goals?
– The functions of finance, communications and human resources are essential as Saniona increases in size and becomes a more mature organization.
– As Chief Financial Officer, Jason will be instrumental in our future financial ambitions for Saniona. He will also oversee financial planning and budgeting, accounting and reporting, taxation and treasury management. These functions are increasingly important following the completion of our recent USD65 million financing. Jason will also oversee several aspects of our operations, including procurement, facilities, and information technology.
– As Chief Communications Officer, Trista will be responsible for accurately and transparently conveying Saniona’s vision, goals and progress to our key constituents including potential patients, physicians, media, investors, potential partners, and potential employees. She will also be responsible for liasing with patient advocacy organizations to ensure that their needs inform our business strategies and decisions, which will be important as we conduct clinical trials.
– As Chief Human Resources Officer, Linea will be critical in assessing and meeting our talent needs as we grow. She will be key in building and hiring top talent to the organization. Additionally, she will work on initiatives that are central for a growing organization such as culture, employee engagement, total rewards, organizational design, learning and diversity and inclusion.
You recently completed a 65 MUSD financing round, which will take Tesomet all the way to registration for approval. How long do you expect it to take to reach the registration phase for the two indications?
– We anticipate the results from both the HO and PWS trials will be available during the second half of 2022 and the submission for approval for both inductions to take place between late 2022 and early 2023
What sub-targets do you hope that Saniona will achieve during the rest of the year?
– We look forward to interacting with FDA regarding the HO program in Q4 of this year, with the goal of submitting INDs for approval in both HO and PWS before year end. We aim to initiate the HO trial in Q1 next year and the PWS trial before year end or early next year at the latest. Additionally, we are making good progress in our preclinical advancement and will continue to build the team and hire top talent into the organization.
About the new recruits
Jason A. Amello has over 25 years of corporate finance experience in the biopharmaceutical industry, contributing to strategic business growth and financial and operational performance. Most recently he served as Senior Vice President, Chief Financial Officer and Treasurer of Akebia Therapeutics Inc., where, over a seven-year period, he helped lead Akebia’s financing efforts, including its initial public offering, and served as a key advisor for Akebia’s merger with Keryx Biopharmaceuticals. During his tenure at Akebia, Amello built out the entire finance organization and was responsible for treasury management, financial planning and budgeting, accounting and reporting, taxation, procurement, facilities, and information technology. Prior to joining Akebia, Amello served as Executive Vice President, Chief Financial Officer and Treasurer of Ziopharm Oncology, Inc., and prior to that he held multiple finance leadership positions at Genzyme Corporation, now Sanofi Genzyme, including Senior Vice President, Chief Accounting Officer. Earlier in his career, Mr. Amello spent 10 years in the business advisory and assurance practice of Deloitte. Amello holds a B.S. in Accounting from Boston College and is a Certified Public Accountant in the Commonwealth of Massachusetts. Amello currently serves on the Board of Directors of Acer Therapeutics, Inc. and the New England Baptist Hospital.
Linea Aspesi has 25 years of human resources leadership experience, with a focus on aligning talent strategies to the business vision, mission and strategy. She most recently served as Vice President, Head of Human Resources & Office Management for Sobi in North America, where she supported the company through 5x headcount growth and established and drove cultural transformation strategies in the areas of talent acquisition, integration, retention, development, engagement, total rewards, organizational design, learning and diversity and inclusion. Previously, Aspesi served as Head of Human Resources for the Industrial Affairs organization in the U.S. for Sanofi, where she designed and implemented talent strategies that transformed the organization of approximately 3000 employees, in the areas of manufacturing plant optimization, inclusive of plant closures and divestitures, business development and expansion. During Linea’s tenure at Sanofi, she held HR leadership positions, shaping talent strategies for the Boston Hub R&D organization, the Sanofi Genzyme Specialty Care business unit, of Rare Disease, Oncology, MS, Immunology and the Industrial IS organization. Prior to Sanofi, Aspesi held HR positions at multiple organizations including UMass Memorial Medical Center, Partners Healthcare System Inc., and HealthSouth. She previously served on the board of directors for Partnerships for a Skilled Workforce and for Seaglass Village.
Trista Morrison has nearly 20 years of experience in healthcare public affairs, including strategic communications and patient advocacy. Most recently she founded the consulting firm PR with Purpose, LLC. Prior to that she served as Vice President of Communications and Patient Advocacy for rare disease company Sobi in North America, where she built both departments and supported milestones including FDA approvals, product launches, acquisitions, significant data disclosures, and growth from 50 to 300 employees. Prior to joining Sobi, Morrison managed corporate, product and employee communications for Ironwood Pharmaceuticals Inc. She previously worked as a reporter for BioWorld Today and held various positions at multiple biotech public relations agencies. Morrison currently serves on the Board of Directors for the Network of Tyrosinemia Advocates (NOTA).