We take a look at some of the people taking on top jobs in the biopharmaceutical industry this month.
We take a look at some of the people taking on top jobs in the biopharmaceutical industry this month.
Solid Biosciences Inc., a life sciences company advancing therapies for Duchenne muscular dystrophy (including its lead gene therapy candidate SGT-001), has appointed Dr. Iman Barilero as Chief Regulatory Officer.
Dr. Barilero brings with her three decades of experience as a strategic executive in the healthcare industry, working on regulatory approvals for new molecular entities in various areas of unmet medical needs across all phases of development in the US, EU, Switzerland, China, Japan and Brazil.
Dr. Barilero was most recently Senior Advisor to Innouvo providing strategic regulatory guidance to scientific ventures. Prior to her most recent position, she held senior positions in Regulatory Affairs and Pharmacovigilance at Agenus and Poxel in Boston. Previously, she was Vice President, Global Head Regulatory Science & Policy at Lundbeck A/S where she played a key role in influencing the external medical and regulatory policy environment that enabled the regulatory approval of Selincro, Trintellix and contributing to approval of Rexulti and Abilify Maintena in CNS disorders.
Earlier in her career, she held various leadership roles of increasing responsibility in Pharmacology, Clinical Science, Pharmacovigilance, Regulatory Affairs & Policy engagement at Johnson & Johnson, Roche, Wyeth and Bristol Myers Squibb. She started her career as a Researcher at Gustave Roussy in France, the European Cancer Center.
Dr. Barilero received her Doctorate of Pharmacy & Pharmaceutical Chemistry from the University of Damascus, Syria and her Master of Science and Doctor of Philosophy degrees in Molecular & Cellular Pharmacology, Oncology from the University of Paris VI.
Sensorion, a clincial-stage biotech working on novel therapies for hearing loss disorders, has appointed Nora Yang, Ph.D. as Chief Scientific Officer (CSO).
Dr. Yang has 20 years of executive and scientific leadership experience in pharmaceutical, biotech, venture capital industries, academia and government, building up a unique blend of expertise in biomedical research, drug development, regulatory sciences, finance, portfolio and pharmaceutical projects management.
Dr. Yang is a leader in gene and cell therapies for treating monogenic rare diseases, including expertise in developing three clinical stage gene therapies to treat monogenic rare disorders. She is an internationally recognized expert and leader in rare and ultra-rare disease translational research with deep domain knowledge and broad network in orphan drug development.
She joins Sensorion from Stratify Therapeutics, LLC, where she was Co-Founder and CSO, having previously held senior roles at the U.S. National Institutes of Health (NIH), Amgen Inc., and Eli Lilly & Co. In particular, she was instrumental in the development of clinical stage gene therapies to treat monogenic diseases.
In her new role, Nora Yang will be based in the US and will lead the preclinical organization at Sensorion Research Laboratories in Montpellier, France. She will also spearhead the development of collaborations between fundamental and clinical research, including working with Sensorion’s partner, Institut Pasteur.
Dr. Yang holds a Ph.D. in Chemistry, from the University of California, San Diego and the Gene Expression Laboratory at the Salk Institute for Biological Studies. Dr. Yang also holds a master's degree in Management from Stanford Graduate School of Business.
SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company developing a novel immunotherapy platform to produce specifically targeted, high potency, fully- human polyclonal antibodies, has appointed Carlos Carrillo, PhD, as senior vice president, regulatory affairs.
Dr. Carrillo brings over 25 years of experience managing regulatory strategy in the biopharmaceutical industry, along with CMC and process development expertise. He has held global leadership roles in regulatory affairs and project management at a number of biopharmaceutical and healthcare companies. Prior to joining SAB, he was director, regulatory affairs at Sagent Pharmaceuticals, where he was responsible for communicating with the FDA and providing guidance to the discovery, process development, quality and manufacturing teams.
Earlier, Dr. Carrillo worked as director, regulatory affairs/product portfolio at Johnson Matthey Pharma Ventures, where he managed regulatory assessments of CMC changes and executed regulatory planning and implementation. Before that, he was director, regulatory affairs/project management at Wockhardt and global project management at Fresenius Kabi.
Dr. Carrillo has additionally held roles at Hospira, Metrics, and Abbott Laboratories. He received his PhD in Regulatory Law and Policy of Drug Products, Medical Devices, Biologics and his MS in Drug Product Development, Patent and Intellectual Law, both from Northeastern University.
Following major growth, Genezen Laboratories Inc, a cell and gene therapy Contract Development and Manufacturing Organization (CDMO), has announced the appointment of three board members: Iain Baird, Diana Caldwell and Tedd Green.
The expansion of the team comes as Genezen works to meet the increasing demand of the cell and gene therapy sector and ramp up its service offering in the manufacturing of viral vectors, including early phase process development, vector production, and analytical testing services.
Iain Baird brings over 30 years of sector experience to Genezen, previously leading the CMC development of vaccines as well as designing and project managing biologic and CDMO facility builds in the cell and gene space. With extensive knowledge in quality and compliance, he has worked as an advisor to founders and CEOs at companies including Brammer Bio, OSO BioPharmaceuticals, and CANbridge Life Sciences.
Diana Caldwell is President, CEO and co-founder of Amplified Sciences, a start-up in-vitro diagnostics company that aims to detect and prevent disease. She brings 25 years of entrepreneurial and life science experience to Genezen. After a career in marketing at Eli Lilly, she founded and was CEO of Pearl Pathways in the regulatory and quality space and has supported a number of large and small biotech companies in driving growth while adding value for customers and patients.
Tedd Green has over 15 years’ experience in leadership, finance and operations, driving the success of CDMOs in the biopharmaceutical industry including roles as President of Cook Pharmica and Senior Vice President of Catalent Biologics. He co-founded and is currently COO at INCOG BioPharma Services.
Ocugen, Inc, a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases as well as developing a COVID-19 vaccine, has appointed Michael Shine as Senior Vice President, Commercial.
Michael Shine is a pharmaceutical and biotechnology executive with nearly 35 years of industry experience. Over the course of his career, Mr. Shine has held leadership positions within large pharmaceutical companies, including Novapharm Therapeutics, Colgate Oral Pharmaceutical, and Pfizer Vaccines (formerly Wyeth). He also served as Chief Marketing Officer with Thomas Reuters and spent more than eight years in the start-up pharmaceutical space.
Shine led the successful commercial launch of the global $6bn Prevnar vaccine franchise while with Pfizer Vaccines (formerly Wyeth). He was also responsible for the development of innovative strategies for Prevenar’s inclusion in national immunization programs in key markets, driving sales in excess of $2bn.
Shine holds a Master of Business Administration from Villanova University, and a Bachelor of Science in business administration from the University of Scranton.
Bristol, UK company eXmoor, a cell and gene therapy (CGT) services company, has added to its senior leadership team with Charlotte Nodwell as HR manager.
Charlotte joins eXmoor as it embarks on an ambitious growth journey, following its recent investment of £12m ($17m) from specialist healthcare investment firm MVM Partners. Nodwell with therefore manage all HR and recruitment processes whilst the company expands.
For the past four years, Nodwell held various positions at the Ministry of Defence (MoD) where she led HR projects including taking the role of transformation lead, policy manager and case work team leader.
Last year Charlotte was the HR project manager and resourcing lead for the creation of the COVID-19 facility NHS Nightingale hospital in Bristol on behalf of the MoD.
Before the NHS Nightingale project, Charlotte was transformation lead at the MoD, in its HR department. As transformation lead Charlotte managed HR initiatives which enabled the team to create a range of HR business services which looked at training and development of the MoD’s employees.
eXmoor has expanded rapidly over the last five years, developing a portfolio of clients across the UK and internationally, completing over 400 projects across 15 countries to date. In 2017, the company added process development laboratories to its consultancy base, with world leading expertise in viral vector process development. Today, eXmoor’s team of scientists, consultants and engineers delivers end-to-end CGT biomanufacturing projects, supporting businesses in commercialising research processes and developing fully licensed facilities.
