Morning Plenary: "Opportunities and Challenges for Science and Innovation in 2021"
Michelle McMurry-Heath, MD
President & CEO, Biotechnology Innovation Organization (BIO)
Michelle McMurry-Heath assumed the leadership of the Biotechnology Innovation Organization (BIO) as President and CEO on June 1, 2020. A medical doctor and molecular immunologist by training, Dr. McMurry-Heath becomes just the third chief executive to steward the world’s largest biotechnology advocacy group since BIO’s founding in 1993.
BIO represents 1,000 life sciences companies and organizations from 30 countries. The organization’s mission is to support companies that discover and deploy scientific breakthroughs that improve human heath, environmental stewardship, and sustainable agriculture.
The common thread in McMurry-Heath’s work across academia, government and industry has been her focus on broadening access to scientific progress so more patients from diverse backgrounds can benefit from cutting-edge innovation. Driven by her own past family experiences navigating clinical trials and funding uncertainties within the rare disease community, McMurry-Heath calls “the distribution of scientific progress the social justice issue of our age.”
She comes to BIO from Johnson & Johnson where she served as Global Head of Evidence Generation for Medical Device Companies and then Vice President of Global External Innovation and Global Leader for Regulatory Sciences. She was also instrumental in bringing J&J’s incubator, JLabs, to Washington, DC. She led a global team of 900 with responsibilities in 150 countries around the globe.
Prior to her time at J&J, Dr. McMurry-Heath was also a key science policy leader in government. The Obama-Biden transition team tapped her to conduct a comprehensive analysis of the National Science Foundation’s policies, programs and personnel. President Obama then named her associate science director of the FDA’s Center for Devices and Radiological Health under Commissioner Peggy Hamburg. In that role, she championed clinical trial evolution, the use of real-world evidence in product evaluation, and an embrace of the patient’s voice in health research so new medical products deliver outcomes that matter to them.
McMurry-Heath was the founding director of the Aspen Institute’s Health, Biomedical Science, and Society Policy Program, where she promoted personalized medicine and bolstered international preparation for pandemic disease threats. She received her early training in science policy from the Robert Wood Johnson Foundation and later served as Senator Joe Lieberman’s top legislative aide for science and health. In that role, she drafted legislation to protect the country from biological attacks.
McMurry-Heath received her MD/PhD from Duke’s Medical Scientist Training Program, becoming the first African-American to graduate from the prestigious program. She spent 12 years working at the research bench before taking policy and leadership roles in government and industry.
McMurry-Heath lives in Washington, D.C. with her husband Sebastian Heath, a veterinarian, and their daughter, Isabella. To relax, she enjoys yoga, snorkeling and her daughter’s sporting events.
Maria Thacker-Goethe, MPH President & CEO, Georgia Bio; CEO, Center for Global Health Innovation
Maria Thacker-Goethe has more than 13 years of experience in non-profit management and development. She was appointed president and CEO for Georgia Bio and the Georgia BioEd Institute in February 2019. Maria has helped build the organization into one of the top state bioscience and medtech associations through her community outreach and engagement, member development, and leadership on various special projects and programs to increase community connections and resources. Additionally, she had been responsible for conceiving, developing and executing a comprehensive internal and external communications strategy.
In addition to her work with Georgia Bio, Maria is Executive Director of the Georgia Global Health Alliance which strives to advance global health equity by promoting and facilitating collaboration amongst business, academia, non-profits and government organizations within Georgia and linking them with partners in the US and other countries. Officially launched in late 2016, GGHA is working with the global health community in Georgia, local community business leaders, and national partners to develop strategy and organize the sector to embrace collaboration and speak with a collective voice. GGHA is a lead partner along with the Metro Atlanta Chamber and Deloitte for the Global Health ATL campaign. GGHA is housed within Georgia Bio.
Maria has a diverse background including environmental health, women’s health and health communications and marketing. Prior to joining Georgia Bio, Maria participated in a fellowship at Centers for Disease Control & Prevention/Agency for Toxic Substances and Disease Registry in environmental investigations, working closely with the National Center of Environmental Health in Chemical Demilitarization.
Maria serves as a board member of the CJD Foundation, the Southeast Life Sciences Association, the Council of State Bioscience Associations, the Coalition of State Bioscience Institutes, and the Kennesaw State University Research and Service Foundation. She is a 2019 recipient of the Atlanta Business Chronicle’s 40 Under 40 Award for career achievements and having demonstrated social responsibility; 2019 recipient of the Metro Atlanta Chamber Phoenix Award for her role as an ambassador for life sciences and global health in the state of Georgia; and 2009 recipient of the Power 30 Under 30 Award for professional and community excellence.
Maria received her Master in Public Health in health education/communication, and maternal and child health from Tulane School of Public Health and Tropical Medicine, and her Bachelor of Arts in Environmental Studies from Sweet Briar College. Additionally, Maria has volunteered for over 10 years with the Junior League of Atlanta/La Amistad Estrellitas program which works to empower Latina teens. When she is not busy working or volunteering, she spends her time with her daughter Cecilia and husband Patrick.
Afternoon Plenary: "Collaboration in the COVID Crisis: How Unprecedented Partnership are Accelerating Successful Vaccines & Therapeutics"
Paul Burton, BSc, MD, PhD, MRCS, FACC
Chief Global Medical Affairs Officer, Janssen Pharmaceuticals
Paul Burton is Chief Global Medical Affairs Officer for Janssen Pharmaceuticals. In this role Paul has overall responsibility for Janssen’s medical affairs strategy and operational execution, as well as leading global scientific data generation to support Janssen’s Global Medical Affairs organization across all therapeutic areas worldwide.
Previously, Paul was head of Cardiovascular and Metabolic Medical Affairs at Janssen Pharmaceuticals in New Jersey, USA, where he led a team dedicated to the medical affairs activities surrounding XARELTO /(rivaroxaban) and Invokana (canagliflozin) along with a group of established products in North America, which together generate approximately $10B in annual sales.
Paul has also led the JNJ collaboration with APPLE for the digital HEARTLINE™ study (www.heartline.com) of 150,000 over 65 year old Americans, and the digital, decentralized, CHIEF-HF study of INVOKANA in diabetic and non-diabetic HF patients. CHIEF-HF is the first decentralized, indication seeking study of its kind that is highly patient centric, returning study data to them, to allow patients to make informed treatment choices.
Previously, as Vice President of Clinical Operations Paul led a team of approximately 700 across Canada, USA, Brazil, Argentina and Mexico responsible for trial execution in oncology, CV/metabolism, neuroscience, immunology and infectious diseases, and as Vice President, Cardiovascular Franchise Medical Leader in R+D, Paul led 3 successful global submissions, and has extensive FDA/EMA/PMDA Complete Response strategy and label negotiation experience, as well as strategic leadership for numerous global health authority interactions.
Paul has a MD from the University of London, is board certified in surgery and a Member of the Royal College of Surgeons with specialist training in cardiothoracic surgery. He has a PhD in cardiovascular molecular and cellular biology from Imperial College in London and is a Fellow of the American College of Cardiology. He has published extensively in top tier peer reviewed journals.
Alejandro Cané, MD
VP, U.S. Medical and Scientific Affairs Lead, Pfizer
Dr. Alejandro D. Cané is specialist in Pediatrics and Pediatric infectious diseases graduated with honors from the University of Buenos Aires, Argentina. In addition, he has completed a Masters in Clinical and Pharmacological Research in Austral University in Argentina, and he also completed the Advance Course of Vaccinology of Merieux Foundation (France) and the University of Geneva (Switzerland).
In the academic area, he serves as Professor of Pediatrics, Infectious diseases, and Pharmacology, chairs in the pre and post degree from Austral University in Argentina and he has completed Pediatrics and Pediatrics Infectious Diseases residency in Children´s Hospital “Ricardo Gutiérrez” of Buenos Aires, among other positions head. His health care experience in Pediatrics and Pediatric Infectious Diseases area was developed in different hospitals such as the Children´s Hospital of Buenos Aires and Hospital Austral in Argentina.
It has made over 100 publications in the field of Pediatrics, Infectious Diseases and Vaccines and collaborated on several book publishing by addressing the same areas. Dr. Cané is a member of the National Committee of Pediatric Infectious Diseases of the Argentine Society of Pediatrics and the Commission of Vaccines of the Argentina Society of Infectology as well as member of Latin American Society of Pediatric Infectious Diseases.
He joined Wyeth in 2006 as Vaccines expert and during the last 15 years he has played different Vaccines Medical and Scientific Leadership roles in different regions all over the world, Latin America, Asia, China, Africa and Middle East. Since June 2019, he is Vaccines Scientific and Medical Affairs Lead in Canada and the US.
Partner, EY (moderator)
Danica is a Partner in Ernst & Young’s Assurance Services practice; with over 23 years combined public and private experience serving a variety of high growth-oriented companies at various stages of development. Her clients have included both public and private companies that have successfully navigated through acquisitions as well as both private and public offerings.
Her current responsibilities includes leading the firm’s quality initiatives in Latin America and Israel.
Danica is a certified public accountant in Georgia, New York and New Jersey.
Danica is the Executive Sponsor for the Latin Professional Network in Atlanta. She leads the firm’s initiatives surrounding inclusiveness effort in the Atlanta market, which include serving as a mentor throughout the organization.
As a wife and mother of three, Danica enjoys spending time with her family and volunteering in her local communities. A native from Panama, Danica is fluent in Spanish.
Clement Lewin, PhD, MBA
Associate Vice President Head BARDA Office & NV Stakeholder Engagement, Sanofi Pasteur
Clement Lewin is currently Associate Vice President Head BARDA Office and NV Stakeholder Engagement. He has been in the vaccines industry for over twenty years and joined Sanofi Pasteur in 2015. He is responsible for managing the company’s relationship with the US Department of Health and Human Services Biomedical Advanced Research and Development Authority BARDA focusing on pandemic preparedness as well as COVID-19 and supports engagement with external stakeholders.
He began his career at Merck Vaccines Division in a variety of domestic and international marketing positions. At Chiron Vaccines he served Vice President Strategic Planning & Business Intelligence and then Vice President Government Affairs & Immunization Policy for the US. He then joined Acambis and was responsible for Government Affairs, the Strategic Planning process and Marketing playing a key role in licensing ACAM2000, a cell culture-based smallpox vaccine, and securing a 10 year $450 million contract with the United States Government to supply the vaccine. Prior to his current role, Clem spent 7 years at Novartis Vaccines most recently as Vice President, Head of Medical Affairs & Immunization Policy for North America responsible for Medical Affairs activities and relationships with public sector stakeholders such as the CDC and National Vaccine Program Office and, in his role, helped launch several vaccines and manage the response to the 2009 pandemic. In addition to his experience in vaccines, Clem was at Bayer Pharmaceuticals as Director of Global Scientific Affairs for their anti-infective franchise.
Clem obtained his BSc and PhD from the University of London. After 5 years as a Research Fellow at the Universities of London and Edinburgh. During that period he published over 50 papers in peer reviewed journals on mechanisms of action and resistance to antibacterials. He left research to obtain an MBA with distinction from Cornell University and then joined the life sciences practice of Pittiglio Rabin Todd & McGrath specializing in product development issues.
Clem was the Biotechnology Industry Organization liaison to the Advisory Committee on Immunization Practices from 2004 to 2014. He served on the National Vaccine Advisory Committee from 2009-2012. He was on the advisory board of Bio Ventures for Global Health and a board member of the Alliance for Biosecurity. He currently serves on the Board of Trustees of Gaylord Hospital a long-term acute care facility in Connecticut.