Scott is our CEO and co-founder of Comanche Biopharma. Prior to Comanche, Scott was a co-founder of The Medicines Company where he served as director (1996-2009) until he joined the management team as Chief Medical Advisor (2009-2021). In that role, he was responsible for evaluating the company’s long-range global strategy and for the licensing or acquisition of innovative products, including inclisiran, for which the company was purchased by Novartis. Previously, Scott was a founding General Partner at JSB Partners, L.P., an investment bank with a focus on mergers and acquisitions, private financings and corporate alliances within the healthcare sector. From September 1991 to July 1999, Scott served as a founder and managing director of MPM Capital, LLC, a venture capital firm.

Scott holds a B.S. in chemistry (Phi Beta Kappa) and an M.D. (Alpha Omega Alpha) from the University of Alabama. His academic career included faculty positions at Harvard Medical School, the University of Colorado Medical School, and the University of South Alabama. He has been Board Certified in Internal Medicine, Pulmonary and Critical Care Medicine and Sleep Disorders Medicine. He currently is a Board member at Atalanta Therapeutics, a biopharmaceutical company focused on the application of RNA interference to diseases of neurodegeneration.

Mike is Co-Founder and President of Comanche Biopharma where he is responsible for leading operations and building the company. Previous to Comanche, Mike was Vice President of Commercial Planning and Healthcare Provider Strategy at The Medicines Company (MDCO) where he was responsible for the global pre-commercialization, go to market planning, lifecycle, and competitive intelligence strategy for Leqvio (Inclisiran) through to its acquisition by Novartis in 2020. Mike held various other positions of leadership in his more than 11 years at MDCO, including Chief Learning Officer and Head of Marketing for the post-operative business unit. Mike has played a leadership role in the development, approval and launch of new therapeutics in the areas of acute cardiovascular, surgery, infectious disease, and anesthetics. Previously, Mike worked for Massachusetts General Hospital (MGH) and the Center for Integration of Medicine and Innovative Technology (CIMIT). Mike grew up in northern New Mexico.

Allison is Chief Medical Officer at Comanche Biopharma. Allison is responsible for the strategy, direction and execution of the company’s clinical development plans. In addition to leading and supervising the Clinical Research Department, she has responsibility for Clinical Operations, Patient Advocacy, Medical Affairs and Pharmacovigilance.

Previous to Comanche, Allison was Vice President of Clinical Development, Infectious Diseases at Moderna and spent over five years in various roles with increasing responsibility for the development of mRNA-based vaccines and the first mRNA-encoded monoclonal antibody. Allison has led multidisciplinary teams on the successful execution of clinical programs from Phase 1 through Phase 3, including serving as the clinical lead for the Phase 3 pivotal efficacy trial for the COVID-19 mRNA vaccine.

During her tenure at Moderna, she was the clinical lead responsible for advancing several vaccines including RSV, hMPV-PIV, Zika and Chikungunya and led the Medical Affairs team for CMV and other latent virus vaccines. Prior to Moderna, Allison headed the global clinical team for the RSV maternal immunization vaccine program at Novavax. Prior to Novavax, Allison worked in translational medicine, early and exploratory clinical development, and Phase 1 through Phase 3 vaccine trials, including maternal immunization, for Novartis Vaccines and Diagnostics.

Before moving to the biopharma industry, Allison was an academic and private practice obstetrician-gynecologist. Her academic career included faculty positions at the Brown University Medical School and adjunctive faculty at the Harvard Medical School affiliated hospitals. Allison holds a B.A. in the History of Religion from Bryn Mawr College and an M.D. from the University of Chicago, Pritzker School of Medicine. She was Board Certified in Obstetrics and Gynecology after completing her residency training at Brown University.

Belen is Chief Operating Officer and founding employee of Comanche Biopharma, responsible for ensuring operational excellence across the organization. She drives priority projects in the development program, financial planning, supply chain operations and business development strategies. She has also played a key role executing Comanche’s CMC activities. Prior to Comanche, she led the valuation strategy of the R&D portfolio at AskBio, negotiated gene therapy development partnerships and contributed to the due diligence during the $4Bn acquisition by Bayer.

Belen combines a solid bioengineering background with extensive expertise in life sciences strategy, having executed numerous deals, corporate initiatives, competitive intelligence and market entry strategies during her tenure at McKinsey & Company and ISDIN. She has served as advisor in the creation of new drug and diagnostic ventures at Harvard Blavatnik Biomedical Accelerator, at Boston Children’s Hospital, and as Leader of MIT’s Healthcare Entrepreneurship Sector.

She holds a B.S. in Biotechnology from the University of Salamanca, and an MBA and a certificate in Entrepreneurship and Innovation from the Massachusetts Institute of Technology, where she focused on new business models for rare disease therapies.

Paul Antinori is General Counsel to Comanche Biopharma.

Previously, Mr. Antinori was Senior Vice President, General Counsel and Secretary of The Medicines Company, a publicly traded pharmaceutical company. During his tenure, the company grew from $15 million in revenue generated from one product in one country to over $700 million from multiple products sold globally.

Prior to The Medicines Company, Mr. Antinori was General Counsel at Physician Computer Network, Inc., a publicly traded healthcare information technology company. Prior to his in-house positions, Mr. Antinori was a partner at the Gibbons law firm in Newark, NJ and, before Gibbons, at other major law firms in New York and New Jersey.

Mr. Antinori received his J.D. from the University of Virginia School of Law and his B.A. from Boston College (Summa Cum Laude; Phi Beta Kappa).

Mack joined Comanche in December 2023 as Quality Management Systems Program Director, where he is responsible for implementing key Quality-owned business processes across the enterprise. He brings 16 years of life sciences experience within large pharma and startup environments. Prior to coming to work for Comanche, he held a Lifecycle Program Management position at Partner Therapeutics’ site manufacturing sargramostim, the active pharmaceutical ingredient in Leukine®. His work has focused on validation management of a new API manufacturing site and included implementation of novel programs. His technical experience includes focus on cGxP controls, risk management, regulatory submission preparation, and audit readiness. He believes in a commitment to consistent care, unmistakable quality, and upright curiosity to support a passion for patient care. Mack holds a BA from the University of Montana in Political Science and German Language. He obtained a post-graduate certificate from the University of Washington in Biotechnology Project Management. Mack grew up in western Montana.

Adel Rafai Far, PhD is Global Head of Chemical Development at Comanche Biopharma, where he is responsible for developing and executing CMC strategies for drug substance and drug product development. He has over 20 years of industry experience in drug discovery and development and broad expertise including medicinal, analytical, bioanalytical and process chemistry; early stage formulation and pharmaceutical development. Dr. Rafai Far was most recently Principal Fellow, chemical and analytical development at Novartis and prior to this Senior Director, drug substance development at The Medicines Company, where, in particular, he has contributed to the development, regulatory approval and commercialization of Orbactiv® , a long-acting lypoglycopeptide for the treatment of gram positive infections and Leqvio®, a small interfering RNA for the treatment of hypercholesterolemia. Adel holds a PhD from the University of Toronto in organic chemistry and has conducted postdoctoral research at the Scripps Research Institute. He has over 20 published articles in peer-reviewed journals and over 13 patents and patent applications. He is a member of the American Chemical Society and of the Ordre des Chimistes du Quebec.

Michael is Global Head of Design & IT, responsible for designing and maintaining the brand identity and overseeing the effectiveness of all communication platforms. Prior to working for Comanche Biopharma, Michael led his own design agency where he created numerous brands and helped to reenvision many others.

Michael has worked as a designer at startups and at a large consulting firm, using his designs and innovation to help companies secure multimillion-dollar contracts and connect with their audiences.

Michael also has a background in IT, marketing, and sales, all of which inform his designs and awareness of user interface and experience. He attended Art Center College of Design in Pasadena, California.

Mandy Gervasio joined Comanche in December 2021 bringing 20+ years of global Life Sciences industry experience. Mandy is an experienced Quality & Compliance leader with a demonstrated history of building, implementing and remediating Quality Systems. Mandy also shares a depth of expertise and practical experience in GxP cloud software technology & data analytics. Most recently, Mandy has led the charge for new start up ventures heading up the QA & QC organizational functions. Mandy has a passion for building, leading, and managing GxP programs that are fit for purpose and operationally effective. Mandy's experience spans a variety of technical niches including but not limited to sterile biologics, combination products and medical device software applications.

Mandy's fundamental belief is that a robust Quality Culture begins and ends with the People and an uncompromising focus on patient health. An effective Quality program must be founded upon a combination of applicable technical expertise, a passion for innovation & compassion for the patients in need. Mandy holds a MS Degree in Leadership from Northeastern University, a Bachelor's degree in Biology from UMASS and Post Grad professional certifications Six Sigma Lean, Risk Management & Data Analytics from Stanford University & MIT.

Vignesh (Viggy) is a molecular biologist with expertise in siRNA discovery and pre-clinical pharmacology from the Khvorova Lab at the University of Massachusetts Chan Medical School. The focus of his work is the exploration of chemical space of siRNA conjugates for the purpose of characterization and improvement of extra-hepatic delivery. His contributions include optimization of siRNA chemistry for several clinically relevant organs, modulation of siRNA potency through backbone chemical modifications and the discovery of clinical quality lead sequences for novel siRNA targets. Viggy received his PhD from the Saini Lab at the Indian Institute of Science where he discovered a novel mechanism by which the Tuberculosis bacterium responds to stress and nutrient availability. He currently works as a post-doctoral research associate at the RNA Therapeutics Institute and is the Director of Biology at Comanche Biopharma.

Laura Hitchings joins Comanche as the Clinical Project Director responsible for the clinical scope of work for all Comanche trials, focusing on site success and leading collaboration with CRO’s, CRA’s, Investigators and Coordinators. Originally from Dublin, Ireland, she studied midwifery at Trinity College and the Rotunda Hospital, an inner-city obstetric hospital supporting over 10,000 deliveries a year. Since moving to America in 2013 she has worked in bedside clinical research at UNC, DUKE, Childrens National Hospital (DC) and Inova Health System where her indications of experience include Maternal/fetal medicine, pediatrics, neurology and Neuro oncology. With over 10 years in research, she has experience leading NIH, PI initiated and large scale, multi-site research trials. In these roles Laura built successful research collaborations across institutions, supporting research naïve sites and creating and nurturing a fundamental research identity at those institutions. In her most recent role at Advarra she incorporated her clinical and tech experience to help sponsors create and implement online research platforms designed to support the site, sponsor and participant. She is passionate about site and patient centricity to streamline trials and ultimately be able to offer patients more treatment options.

Michael is the Director of Operations, Strategy, and Business Development at Comanche Biopharma. He oversees strategic operations as well as business development strategy and evaluation. Prior to joining Comanche, Michael was a Scientist and Team Leader at various diagnostic and therapeutic biotech companies, one of which was successfully acquired by Roche Diagnostics. His work has covered a range of projects, including small molecule chemistry, microfluidics, DNA sequencing, gene therapy, and AAV delivery. He holds a patent for his contributions on solid-state synthesis for a nanopore DNA sequencing platform.

Michael received his B.S. in Biochemistry from the University of Washington, MS in Life Science: Biotechnology from Harvard University, and MBA from Harvard Business School. At Harvard, he focused on investing and entrepreneurship within life sciences and healthcare.

Dr. Motheram is presently Global Head of Drug Product Development at Comanche Biopharma located in Concord, Massachusetts. He previously held research and management positions at Scynexis Inc., The Medicines Company, Bristol-Myers Squibb, DuPont Pharmaceuticals and Baxter International. He received his Ph.D. in Pharmaceutics from the University of Sciences, Philadelphia College of Pharmacy, Master of Science in Pharmaceutics, from the University of Mississippi; and Bachelor of Pharmacy from Kakatiya University, India.

Dr. Motheram has 27 years of diversified professional experience in pharmaceutical R&D in various aspects of pharmaceutical development ranging from development of early phase clinical products to commercial dosage forms, scale-up and technology transfer. Dr. Motheram has extensive CMC expertise in both small and large molecules leading to the development of several commercial products in a range of therapeutic areas including HIV, Oncology, Cardiovascular, Anti-infective and Critical Care medicine.

Dr. Motheram’s Ph.D. dissertation work involved characterizing the adsorption of proteins at solid/liquid interfaces and the structural changes of adsorbed proteins. His research interests include design, development, and optimization of oral and parenteral dosage formulations, and designing novel drug delivery systems for small molecules as well as biologics. Dr. Motheram is a co-inventor on patents concerning novel pharmaceutical compositions and co-authored manuscripts published in peer reviewed journals.

Kat Murphy is the Senior Vice President, Global Head of Clinical Operations at Comanche Biopharma, where she oversees the execution and management of all clinical studies within the company's development plan. With a career spanning over 25 years in the biotech and pharmaceutical industries, Kat brings a depth of experience from both CRO and small biotech perspectives, having led numerous clinical trials across various phases and indications to successful completion.

Prior to joining Comanche, Kat was instrumental at Arcturus Therapeutics, leading the pivotal trial in Vietnam that resulted in the world's first approval of a Self-Amplifying RNA (SA-RNA) COVID vaccine. This achievement underscores her skill in navigating the complexities of clinical trial management and her ability to drive groundbreaking advancements in medicine.

Before her time at Arcturus, Kat managed an international Phase 3 study on Lupus and was responsible for the recruitment and enrollment strategies of the PRESERVE-1 study, focusing on Preterm Preeclampsia subjects in the United States. Her efforts in these roles highlight her expertise in managing large-scale clinical trials and her commitment to advancing research in areas of significant unmet medical need.

Kat holds an M.Sc. in Regulatory Affairs from Northeastern University and a B.S. in Biology from Keene State College. Her educational background, combined with her extensive experience in leading complex clinical trials, particularly in challenging recruitment environments, positions her as a key leader within Comanche Biopharma.

John read Chemistry at St John’s College Oxford prior to completing a DPhil in Peptide Chemistry also at Oxford. Following his doctorate, John carried out post-doctoral research at the MRC Laboratory of Molecular Biology in Cambridge, working as a part of the team which developed the now almost universally utilised Fmoc-solid-phase synthesis methodology. Subsequent to further research as a staff scientist into neuro-transmitter peptides in the MRC Neurochemical Pharmacology Unit in Cambridge, John moved into industry, initially as a part of a start-up company formed by alumni of The Laboratory of Molecular Biology. Aside from his role at Comanche John is currently a Non Executive Director of Aptamer Group. Previously John was Senior Vice President at The Medicines Company, of which John had been a founding member in 1997 and led CMC drug development activities since the company’s inception.

Leah joined Comanche Biopharma in January 2023 as the Principal Quality Assurance Engineer. She brings 20+ years of Life Sciences industry experience, in both Plant and Process Engineering roles, as well as Quality and Compliance roles. She has demonstrated history of leading teams in support of both Clinical and Commercial products. Leah is passionate about building strong, effective and collaborative relationships with internal and external stakeholders. She has extensive experience in the start-up and qualification of new manufacturing facilities, equipment and utilities. She is equally experienced in supporting and executing all aspects of the Quality Management System. Leah holds a BS Degree in Chemical Engineering from Northeastern University.

David currently serves as the Global Head of Commercial Operations and Planning, chiefly responsible for the commercial go-to-market plan and launch execution of CBP4888. He brings to this role over 28 years of commercial and medical pharmaceutical and device development experience within the US market place, experience applied in both the healthcare provider and industry settings. Previous to Comanche, David was Chief Operating Officer at Vero Biotech where he was responsible for the development and launch of GENOSYL DS (Nitric Oxide for Inhalation-combination drug/device). David held Senior Commercial Operations and Medical Affairs positions at The Medicines Company and Bayer Pharma where was played instrumental roles in the development and launch of new therapies with the areas of Acute Cardiovascular, Surgery, Infectious Disease, Hematology, Oncology, and Rare Diseases. Previous to joining Industry, David held Clinical Pharmacy Leadership positions within Hospital, Specialty and Primary health care organizations in the Puget Sound area of Washington State.

Valerie is the Head of Patient Advocacy and Alliances at Comanche Biopharma where she is responsible for engaging advocacy groups and professional societies as well as cultivating strategic collaborations with key stakeholders. As a survivor of preeclampsia, Valerie is passionate about helping patients impacted by this condition and ensuring that the patient perspective is integrated into business decisions. With over 20 years of experience as a biopharmaceutical leader, Valerie has a breadth of experience in patient advocacy, alliance management, medical affairs, commercial operations, sales, and product launch excellence. She is recognized as a trusted collaborator with a record of cultivating strong relationships among key internal and external stakeholders across organizational levels to deliver solutions. Prior to joining Comanche Biopharma, Valerie held positions at Novartis, The Medicines Company, and Pfizer. Valerie holds a B.A. in Psychology from The College of Wooster and an M.A. in Higher Education Administration from Bowling Green State University.

As the Director of Knowledge Management, Gina oversees the company's resource library, ensuring the efficient review, retrieval, and distribution of essential medical, scientific, competitive, and regulatory information. Gina supports the Comanche Biopharma team by managing and curating the company’s knowledge assets. Her responsibilities include facilitating the dissemination of up-to-date information to support strategic decision-making, overseeing the organization and accessibility of key resources, and providing administrative support for grants and projects.

Prior to joining Comanche Biopharma, Gina served as Content Manager at The Medicines Company, where she managed medical information, Continuing Medical Education (CME) grants, and Medical Society grants, while also overseeing the company’s digital library and literature resources. In this role, she streamlined content management processes and contributed to the successful execution of numerous grants and educational initiatives. Gina’s experience also includes the position of Expanded Access Operations Manager, Medical Affairs, at GlaxoSmithKline, where she supported the compassionate use and global distribution of oncology drugs.

Craig is the Blais University Chair in Molecular Medicine at the University of Massachusetts Medical School (UMMS). He was also designated an Investigator of the Howard Hughes Medical Institute in 2000, the third HHMI researcher selected at UMMS. HHMI is a $13 billion medical research organization that employs more than 350 eminent researchers at 72 medical schools, universities and research institutes worldwide. Craig and his colleague Andrew Fire, Ph.D., formerly of the Carnegie Institution of Washington, received the 2006 Nobel Prize in Medicine for their discovery of RNA interference (RNAi). They demonstrated that a certain form of RNA had the unanticipated property of silencing — or interfering with — the expression of a gene, ultimately halting the progression of the invading viral infection. Atalanta’s science is founded on this award-winning RNAi mechanism. Craig holds his B.S. in biochemistry from Brown University and his Ph.D. in cellular and developmental biology from Harvard University. He was a postdoctoral fellow at the Fred Hutchinson Cancer Research Center before coming to UMMS in 1995. He is also a 1995 Pew Scholar in the biomedical sciences.

Moore is a biochemist and molecular biologist recognized for her work in eukaryotic RNA processing and metabolism. Moore was born and raised in New Market, Virginia. She graduated from the College of William and Mary in 1984 with a BS in Chemistry and Biology, and earned her PhD in Biological Chemistry from the Massachusetts Institute of Technology (MIT) in 1989. Following a Helen Hay Whitney Postdoctoral Fellowship at the MIT Center for Cancer Research, Moore joined the Brandeis University faculty in 1994, where she was named a Searle Scholar and Packard Fellow. In 2007, Moore moved to the University of Massachusetts Medical School (UMMS), where she served as a founding co-director of the RNA Therapeutics Institute and held the Eleanor Eustis Farrington Chair of Cancer Research. In 2011, Moore received the ASBMB William C. Rose Award for distinguished mentorship. Following a nineteen-year run as an HHMI Investigator (1997-2016), Moore resigned from HHMI to become the Chief Scientific Officer of the mRNA Research Platform at Moderna Therapeutics in Cambridge, MA. Moore maintains her academic affiliation with UMMS as a part-time faculty member.

Dr. Ananth Karumanchi, Medallion Chair in Vascular Biology, is Director of Renovascular Research in the Department of Medicine at Cedars-Sinai Medical Center, Los Angeles. He completed his medical degree from Kilpauk Medical College, University of Madras, India (1992). He then completed his residency in Internal Medicine at the Henry Ford Hospital, Detroit (1996) and fellowship in Nephrology at Beth Israel Deaconess Medical Center, Harvard Medical School Boston (1999). His laboratory is focused on discovering pathogenic pathways and bringing therapies to patients in the areas of hypertensive disorders of pregnancy and chronic kidney diseases. Dr. Karumanchi’s research activities are vertically integrated, ranging from molecular and cell biological studies to animal models to first-in-class human clinical trials. Dr. Karumanchi has published >300 papers (with several publications in NEJM, Circulation, Nature, Nature Medicine, and JCI with H index = 110). For his work on pregnancy hypertension, he has received prestigious awards such as the American Heart Association – Established Investigator Award (2008), the International Society for the Study of Hypertension in Pregnancy – Chesley Award (2010), Outstanding Investigator Award from the American Federation for Medical Research (2010), and the Gregory Pincus Memorial Medal from Worcester Foundation for Biomedical Research (2021). He was also elected to the American Society for Clinical Investigation (ASCI) in 2007 and to Association of American Physicians (AAP) in 2015. Dr. Karumanchi’s research has been funded by the NIH, AHA, Howard Hughes Medical Institute and the Gates Foundation.

Anastasia Khvorova, Ph.D., has more than 20 years of experience developing oligonucleotide technology and therapeutics. She is the Remondi Family Chair in Biomedical Sciences and professor in the RNA Therapeutics Institute and Program in Molecular Medicine at the University of Massachusetts (UMass) Chan Medical School. Her lab brings together hardcore organic and oligonucleotide chemists with RNA biologists and pharmacologists to develop novel approaches and solutions to understanding natural and therapeutic RNA trafficking and delivery. Dr. Khvorova founded the UMass Nucleic Acid Chemistry Center, the only nonprofit facility in North America capable of gram-scale synthesis of modified oligonucleotides.

Prior to UMass Chan Medical School, Dr. Khvorova spent 12 years in industry in different executive positions. She has co-founded several biotechnology companies.

Dr. Khvorova is named as inventor on more than 150 patents and 300 patent applications and has authored more than 100 peer-reviewed publications, including seminal articles in Cell, Nature, and Nature Biotechnology, defining the field of RNAi drug design and development. She has served as a director of the Oligonucleotide Therapeutics Society and currently is Director-at-Large and Scientific & Research Council Chair of the American Society of Gene and Cell Therapy.

Ravi I. Thadhani, M.D., MPH, is Chief Academic Officer at Mass General Brigham. He is a Professor of Medicine and Academic Dean at Harvard Medical School. Previously, he served as Vice Dean of Research and Graduate Research Education at Cedars-Sinai Medical Center in Los Angeles (2017-2019), Associate Director of Research at Mass General Brigham (2012-2017), and Chief of Nephrology at Massachusetts General Hospital (2013-2017).

In his role as Chief Academic Officer, Dr. Thadhani oversees a ~$1.8B research enterprise, graduate medical education, and continuing professional development for Mass General Brigham. Dr. Thadhani is a member of the Mass General Brigham executive leadership team under the direction of Anne Klibanski, M.D., President and Chief Executive Officer. Dr. Thadhani works with senior leadership across the Mass General Brigham system on a number of system strategic initiatives.

Dr. Thadhani also managed a successful research laboratory for approximately 25 years with continuous federal funding and employing data managers, operations directors, statisticians, nurses, research assistants, and laboratorians. He has published more than 300 manuscripts, including in the top Medical and Nephrology journals – New England Journal of Medicine, Journal of the American Medical Association, and Journal of the American Society of Nephrology. Dr. Thadhani has been inducted to several honor societies, including the American Society for Clinical Investigation, Association of American Physicians, American Epidemiological Society, and the American Clinical and Climatological Association. He has also received several distinguished national awards, including the Harold Amos Faculty Diversity Award from Harvard Medical School – the highest award for Fostering Diversity at Harvard Medical School; Alumni Award from the Harvard School of Public Health – a significant achievement, and the John P. Peters Award from the American Society of Nephrology – for Mentorship and Scientific Achievements.

Kalah Auchincloss has more than 15 years of food and drug legal, policy, and regulatory experience at the FDA, on Capitol Hill, and in the private sector. Kalah spent six years at the FDA, including as Deputy Chief of Staff for two FDA Commissioners, Dr. Robert Califf and Dr. Scott Gottlieb. As Deputy Chief of Staff, Kalah worked with senior FDA leadership to manage crises, develop policy decisions, implement communications strategies, and liaise with the Department of Health and Human Services, the White House, and other agencies. Kalah was also a primary point of contact in the immediate Office of the Commissioner for the six FDA Centers and other components of the Commissioner’s Office.

Prior to that role, Kalah spent time on Capitol Hill as the FDA detailee to the Senate Committee on Health, Education, Labor, and Pensions, working on the 21st Century Cures Act and other FDA-related legislation. She has also served in the FDA’s Center for Drug Evaluation and Research (CDER) as a regulatory counsel in the Office of Regulatory Policy, and as Director of CDER’s Office of Unapproved Drugs and Labeling Compliance in the Office of Compliance, leading a team of more than 50 staff working on pharmacy compounding, unapproved drugs, over-the-counter drugs, and other enforcement issues.

Before joining the FDA, Kalah was an associate at the law firm Foley Hoag LLP, in the firm’s health care practice group.

As an Executive Vice President at Greenleaf, Kalah is continuing her commitment to public health by providing strategic counsel to clients on compliance, enforcement, and policy matters. Kalah counsels clients across a range of product sectors and is knowledgeable about multiple areas of FDA regulation, including drugs, compounding, unapproved drugs, diagnostics, digital health, cosmetics, and cell and gene therapy.

Kalah holds a B.A. with honors from Williams College, a J.D. with honors from Georgetown University Law Center, and an M.P.H. from Harvard University.

Kara Boeldt is an internationally recognized patient advocate and peer educator, a certified trauma-informed professional, and the founder & director of EndPreeclampsia.org, a charitable maternal health organization with a global reach. After suffering a traumatic pregnancy in which she developed severe preeclampsia, HELLP syndrome, and a silent placental abruption at 31 weeks gestation, Kara began seeking out people with similar experiences. She realized that limited support was available where women could share their experiences and get evidence-based information. It was then that she began her 16-year journey of patient advocacy.

Utilizing the reach of the internet and social media to provide support and information, one of EndPreeclampsia’s programs, Preeclampsia, Eclampsia & HELLP Syndrome Survivors Global Support Network, has grown to over 37,000 members in 115 countries. This volunteer-run, evidence-based online community gains 1,000 new members per month seeking support and information about pregnancy health. Another program, Butterfly Brigade, is a group of women with lived maternal health complication experience who visit hospitalized antepartum mothers experiencing complications and extended hospital stays to deliver support and essential personal care supplies.

Kara is also a Patient Advisor for several organizations and research studies, including the Illinois Perinatal Quality Collaborative, the Iowa Maternal Quality Care Collaborative, and a member of several other state PQC’s. She runs an independent forum for patient advocates of PQCs to streamline communication, share ideas, and engage people in advocacy and advisory work. She is the Patient Advisor for the $10 Million HRSA Grant partnership between the University of Iowa Health Care and the Iowa Department of Public Health to improve maternal outcomes and a Stakeholder Advisory Board member of the Institute of Clinical and Translational Science at the University of Iowa.

Kara was the HOPE Award Recipient for Maternal Health Volunteer of the Year in 2009 and the Champions for Change Maternal Health Champion of the Year award recipient in 2019. She has led charitable giving initiatives raising hundreds of thousands of dollars for Maternal Health causes.

Jennifer Carney has a B.A. in English from Northwestern University, an M.A. in English from Penn State University, and more recently an M.P.H. in Community Health from UCLA. She has worked as an editor for a medical journal and administrator at UCLA for the past nine years. Prior to UCLA, she worked as an editor in educational publishing for McGraw-Hill and Wolters Kluwer. She has experience in writing, editing, indexing, and quality assurance for print and online educational materials and professional guides. She has volunteered with the March of Dimes, Preeclampsia Foundation, and currently serves as an Advisor for EndPreeclampsia, which provides an online support group to over 37,000 members from over 100 countries on Facebook. Ms. Carney experienced eclampsia, HELLP syndrome, sepsis, and ARDS with the birth of her second child in 2006.

Dr. Cindy Dinella is a founding partner and holds the position of President and Managing Partner of Advyzom. Advyzom is a leading boutique consulting company specializing in highly strategic regulatory and development advice and services for our partners in the pharmaceutical and healthcare industry. She is committed to providing experienced, scientific and proven successful leaders to advise and deliver on regulatory strategy, medical writing and regulatory intelligence. Cindy specializes in leading, guiding, and assisting biopharmaceutical companies with global and US drug development programs to meet and influence health authority requirements. She has strong leadership, strategic thinking, influence management and cross-functional teamwork skills, gained over many years of experience working across therapeutic areas, throughout phases of development including commercialization, with Senior Corporate Management and Boards, and with the Food & Drug Administration (FDA). She has led numerous FDA meetings across divisions, centers and with FDA senior management.

Monica Juarez is a compassionate advocate with a heart for both family and community. As a devoted wife to Jorge and loving mother to daughters Amelia and Lianna, Monica's journey through motherhood has been marked by resilience, empathy, and a commitment to making a difference.

Prior to becoming a parent, Monica served as a dedicated school librarian for 15 years. She holds a Bachelor's degree in English and a Master's degree in Library Science from Texas Woman's University, reflecting her passion for learning and literature. Today, Monica has embraced the role of stay-at-home mom, cherishing the moments spent nurturing her growing family.

Monica's introduction to motherhood was marked by adversity when she faced severe preeclampsia just 25 weeks into her first pregnancy. This traumatic experience resulted in the heartbreaking loss of her son, Roman, and a 110-day NICU journey for her daughter, Amelia.

As a member of the patient advisory board Monica channels her personal journey with preeclampsia and loss into advocacy, focusing on reshaping doctor/patient interactions following a preeclampsia diagnosis. By offering her insight and sharing the story of her own traumatic experience, she aims to contribute to the development of more empathetic and supportive healthcare practices.

Driven by her own experiences and belief in the power of information, Monica is deeply motivated to raise awareness of preeclampsia and empower expectant parents to advocate for their health. Additionally, she is committed to providing support for parents navigating the challenging journey of infant loss, offering understanding and comfort during what can often be a very isolating experience.

Monica dreams of a future where preeclampsia is preventable and where every parent can grow their families with confidence and hope.

Nicole Miles is a Chicago native, Smith College alumna ’12, and public health worker. From a very young age, she knew that helping mothers and babies was her calling. She helped out at her mother’s home daycare and nannied throughout college. As the eldest of three girls, she understood the importance of caring for the child and the family. Her family was the model for village-centered support and she grew up surrounded by extended family in addition to a host of family friends. Nicole was trained as a birth doula during her time at Smith by Warm Welcome Birth Services. As a full-spectrum doula, International Board Certified Lactation Consultant (IBCLC), and Newborn Care Specialist, Nicole is a dedicated birthworker who takes an integrative approach to birth and parenthood. After graduating from Smith, Nicole returned to the Windy City to work in community health at Advocate Trinity Hospital and to build community resources for families of color.

With over 10 years of childcare and birthwork experience, Nicole brings a wealth of knowledge and believes all families should have access to evidence-based information and resources about birth and parenthood. She is a valuable resource and is committed to collaborating with community members and practitioners to compile much-needed resources for families. Nicole wants families to feel excited and empowered about this life-changing event. Having a village is essential to positive maternal and infant mortality rates, and parents should have access to the providers, services, and support groups that will help them along their journey. Nicole is a member of Chicago Birthworks Collective, Breastfeed Chicago board member and Wisconsin Association of Lactation Consultants board member. She is currently the Birth Outcomes Made Better (BOMB) Doula Program Manager at the City of Milwaukee Health Department.

Moore is a biochemist and molecular biologist recognized for her work in eukaryotic RNA processing and metabolism. Moore was born and raised in New Market, Virginia. She graduated from the College of William and Mary in 1984 with a BS in Chemistry and Biology, and earned her PhD in Biological Chemistry from the Massachusetts Institute of Technology (MIT) in 1989. Following a Helen Hay Whitney Postdoctoral Fellowship at the MIT Center for Cancer Research, Moore joined the Brandeis University faculty in 1994, where she was named a Searle Scholar and Packard Fellow. In 2007, Moore moved to the University of Massachusetts Medical School (UMMS), where she served as a founding co-director of the RNA Therapeutics Institute and held the Eleanor Eustis Farrington Chair of Cancer Research. In 2011, Moore received the ASBMB William C. Rose Award for distinguished mentorship. Following a nineteen-year run as an HHMI Investigator (1997-2016), Moore resigned from HHMI to become the Chief Scientific Officer of the mRNA Research Platform at Moderna Therapeutics in Cambridge, MA. Moore maintains her academic affiliation with UMMS as a part-time faculty member.

Dr. Moore’s research at UMMS and HHMI encompassed a broad array of topics related to the role of RNA and RNA-protein (RNP) complexes in gene expression. She is particularly known for her mechanistic and structural analyses of spliceosomes and mRNPs, co-discovery of the exon junction complex (EJC), and studies of intracellular RNA transport and quality control pathways. She was also instrumental in developing multiple enabling technologies for the field, including methods for introducing site-specific modifications into long RNA molecules and single molecule methods for observing the dynamics of RNP complex assembly and disassembly. At Moderna Therapeutics, Moore directs research into novel delivery mechanisms for therapeutic mRNAs and how to increase their functional and longevity.

Originally, I am from the San Diego area until age 9 when my mother moved us to Northwest PA to a small town called Cambridge Springs. I attended Slippery Rock University of Pennsylvania where I received a BS in Geography/ Environmental Planning before moving to MA. I currently live and work in Worcester, MA. I have two children, Sabrina who is 19 and attending Lesley University in Cambridge, MA and Dante who is a Junior in high school. I am a Grant & Contract Specialist in the RNA Therapeutics Institutes at the University of Massachusetts Chan Medical School. I love watching college softball, NFL football on Sundays, reading, and playing sand/indoor volleyball on my free time. I am also President of the Central MA Alumni Chapter of Sigma Sigma Sigma.

I am a two-time survivor of HELLP/Preeclampsia. My daughter, Sabrina, was delivered via emergency c-section at 27 weeks due to HELLP Syndrome. Thankfully my second pregnancy lasted 34 weeks until symptoms were presented and my son, Dante, was delivered healthy.

Candice Privott is a distinguished African American maternal health advocate whose journey began with profound personal experiences. In 2019, she faced the devastating loss of her son Aiden, who was stillborn. This tragic event ignited her maternal health advocacy career, propelling her into action to prevent others from enduring similar pain and loss.

Driven by a deep sense of purpose, Candice has dedicated herself to improving the lives and outcomes of Black mothers and infants. Recognized as a tireless champion of maternal health, she confronts the systemic racial disparities that contribute to alarming rates of maternal mortality and morbidity within the Black community.

Profound challenges have marked Candice's journey through motherhood. As a survivor of postpartum depression, she intimately understands the mental health struggles that many mothers face. Additionally, Candice has overcome the life-threatening complications of preeclampsia and post-delivery hemorrhages, not once but twice. These harrowing experiences have fueled her advocacy work, driving her to advocate fiercely for comprehensive maternal healthcare that prioritizes the well-being of all mothers.

With an unwavering commitment to her cause, Candice has emerged as a highly respected leader in the field of maternal health. Her profound understanding of the multifaceted challenges facing Black mothers and families has fueled her advocacy efforts. Through her work, she strives to advance research and policy initiatives aimed at rectifying disparities and enhancing maternal health outcomes for Black women.

In addition to her advocacy endeavors, Candice is deeply invested in education and mentorship. She endeavors to empower the next generation of maternal health advocates and leaders, sharing her expertise and insights as a passionate educator and mentor. Candice is a sought-after speaker, leveraging her lived experiences to inspire and enlighten diverse audiences of health professionals, policymakers, and advocates.

Collaboration lies at the heart of Candice's approach to advocacy. She actively engages with a diverse array of stakeholders, including community-based organizations, healthcare providers, policymakers, and researchers. Together, they work to develop innovative solutions that address the root causes of maternal health disparities, fostering equity and justice for all mothers and families.

Candice stands as a beacon of leadership and inspiration in the field of maternal health advocacy. Her unwavering dedication and visionary leadership are driving forces behind her mission to create a brighter and more equitable future for all mothers and infants. In 2021, she welcomed her son, Grayson, further igniting her passion and commitment to ensuring that every mother receives the care and support they need to thrive. In her free time, Candice finds solace in traveling with Grayson, indulging in crafting activities, and cherishing moments with her family. These personal experiences enrich her advocacy work, providing her with a deep understanding of the joys and challenges of motherhood and fueling her determination to create positive change in the world.

Nasia is a determined and resourceful individual who thrives in connecting people and building strong relationships. As an accomplished operations manager with extensive experience, she has proven her ability to drive projects and ensure all elements are seamlessly integrated and moving forward.

Nasia is not only a successful professional but also a dedicated mother, raising a beautiful family of six alongside her fiancé. Together, they have four energetic boys and a playful soon-to-be one-year-old mini/ doodle dog, all of whom she adores deeply.

Having faced the challenges of preeclampsia during three pregnancies, Nasia knows firsthand the immense impact this condition can have on a family. She is now committed to sharing her heartfelt story with others, both to educate and to help individuals plan a life that fights against the odds of being diagnosed with
preeclampsia.

As a member of the patient advisory board, Nasia brings valuable insights from her personal experiences, as well as her exceptional skills in organization and communication. Her passion for connecting people and her determination to make a difference will undoubtedly contribute to Comanche’s mission of raising awareness and improving outcomes for those affected by preeclampsia.

Valerie is Comanche Biopharma’s Head of Patient Advocacy and Engagement, where she ensures that the patient voice is heard in corporate decision-making and strategy. She is a biopharmaceutical leader with over 20 years of experience in patient advocacy, strategic alliances, medical affairs, commercial operations, sales, and product launch excellence. Valerie is known as a reliable collaborator who has a track record of cultivating strong relationships with key internal and external stakeholders at all organizational levels to deliver solutions. Valerie is deeply committed to helping patients by developing therapies that save and improve lives.

Valerie lives in Indianapolis with her husband of 27 years, and they have twin daughters who are in their sophomore year at the University of Alabama. She began to show signs of preeclampsia at 28 weeks pregnant and was admitted to the hospital at 33 weeks when she developed HELLP syndrome. Madeline and Molly were born at 34 weeks and spent two weeks in the NICU, while Valerie spent one week in the hospital recovering. She is determined to create a future free of this disease.

Allyson Felix reigns as the most decorated American Track & Field Olympian of all time. She officially retired from her competitive running career in the summer of 2022, with a mind-blowing, thirty-one global medals at the Olympics and World Championships, and titles as both a World Record Holder and a Master’s World Record Holder.

In 2020, Felix broke records after winning her bronze and gold medal at the Tokyo Olympics - her fifth and final Olympic games. She continued to make history during the games, by sporting racing spikes created by her company – lifestyle and footwear brand, Saysh – becoming the first Track & Field athlete to do so. Publicly launched post Games in June 2021, Saysh not only aims to create an encouraging and supportive community for women, but it also designs and manufactures athletic-inspired footwear made for and by women, unlike most brands, whose shoes are created based off of men’s feet and footwear. Running in her own spikes on the largest stage in the world, Felix exemplified that she is about more than just medals – she was running for change, equity and acceptance for women and girls everywhere.  In keeping with its mission to empower and serve women, Saysh sought out women-led, women-funded partners for the brand’s recent Series A fundraising round, which brought in $8 million and included the Gap Inc.-owned Athleta brand. Current products include the Saysh One, the Saysh Two and the Scarf by Saysh.

Off the track, Felix is a fierce advocate for maternity rights for all women. In 2019, she wrote an opinion piece for The New York Times that called out Nike, her former sponsor, for not providing guaranteed protections for pregnant athletes and new moms. (Felix gave birth to her daughter Camryn in 2018.) The public reaction to the piece put pregnancy discrimination in athletics in the spotlight, and the practice was heavily criticized. More female athletes came to Felix’s side, offering up their stories. During the 2020 Olympics, Felix alongside her new sponsor Athleta, created the Power of She Fund: Child Care Grant – a fund to assist mom-athletes with childcare while competing at the games.

Dr Ann Taylor served as Chief Medical Officer at AstraZeneca from 2019-2021. In this role, she was responsible for AstraZeneca’s Patient Safety, Quality Assurance, and Regulatory Policy organizations, and the overall Benefit Risk assessment of our medicines. Prior to joining AstraZeneca in 2018, Ann was Vice President and Global Head of the Program Office for the Novartis Institutes for BioMedical Research (NIBR), responsible for portfolio management, strategy, and project management. She also previously served as Global Head, Translational Medicine at NIBR, after having positions of increasing responsibility in early clinical development at Pfizer Global Research and Development.

Ann received her M.D. from Harvard Medical School, after receiving her B.A. in Biology magna cum laude from the University of California, San Diego. She completed her internship and residency in Internal Medicine, and her fellowship in Endocrinology and Metabolism at Massachusetts General Hospital, before joining the faculty there.

She is passionate about bringing the patient voice to everything she does and has a particular interest in health equity and women’s health.

In addition to Comanche, she serves on the Boards of Terns Pharmaceuticals and UnLearn AI, as well as two non-profits, the New England Advisory Board of the Trust for Public Land and the Yleana Leadership foundation, which is improving the racial wealth gap by getting underserved kids into better colleges, with better financial aid packages, higher graduation rates, and better paying jobs. She also serves as Co-Chair of the National Academies of Science, Engineering and Medicine Forum on Drug Discovery, Development, and Translation.

Dr. Scott Gottlieb is a physician and served as the 23rd Commissioner of the U.S. Food and Drug Administration from 2017 to 2019. Currently, Dr. Gottlieb is a partner at the venture capital firm New Enterprise Associates and a Senior Fellow at the American Enterprise Institute. He also serves as a director of Pfizer Inc., Illumina, Aetion, TempusAI, and National Resilience. Prior to his service as FDA Commissioner, Dr. Gottlieb held several roles in both public and private sectors, serving as a venture partner at New Enterprise Associates from 2007 to 2017, and FDA’s Deputy Commissioner for Medical and Scientific Affairs from 2005 to 2007 and a senior advisor to the FDA Commissioner from 2003 to 2004. Additionally, he was a senior advisor to the Administrator of the Centers for Medicare and Medicaid Services in 2004. Dr. Gottlieb received a B.A. in economics from Wesleyan University and his M.D. from the Icahn School of Medicine at Mount Sinai, where he completed his residency in internal medicine and currently serves on the board of directors. He is an elected member of the National Academy of Medicine.

David is a partner at Atlas Venture focused on investments in novel therapeutics, often those that are near to first in human clinical testing.

Since joining Atlas in 2010, David has co-founded and served as CEO of numerous companies including Arteaus acquired by Eli Lilly in 2014, Annovation Biopharma acquired by The Medicines Company in 2015, and was a founding board member of both Delinia, acquired by Celgene in 2017, and Cadent acquired by Novartis in 2021. David is a co-founder and board member of Q32 Bio and Vima Therapeutics, and also sits on the boards of Affinia, Aerovate (NASDAQ: AVTE), and TRIANA Biomedicines.

David serves as an advisor to several organizations including Memorial Sloan Kettering Cancer Center’s (MSKCC) Technology Development Fund, as well as the American Heart Association’s One Brave Idea. He earned his B.A. from Stanford University, M.D. from Harvard Medical School, and completed his internship and residency training in internal medicine at Massachusetts General Hospital. He is also a founding board member of Acera: The Massachusetts School for Science, Creativity, and Leadership, a STEM focused K-8 school, which his wife Courtney founded in 2009.

Brendan Bulik-Sullivan is a general partner at GV, where he focuses on life sciences investments.

Before GV, Brendan’s career focused on applied statistics and machine learning research in genetics and biotechnology. He designed machine learning models for personalized immuno-oncology therapeutics at Gritstone Oncology and developed methods for statistical genetics research at the Broad Institute. Brendan’s work has been published in journals including Nature, Science, Nature Biotechnology, and Nature Genetics. In his free time, Brendan enjoys reviewing data and reading scientific journals. Brendan is interested in innovative therapeutic biotechnology and diagnostics across all stages and therapeutic areas.

Brendan has a B.A. in mathematics from the University of California, Berkeley, and a Ph.D. in statistical genetics from Vrije Universiteit Amsterdam.

Ketan Patel is a Partner with F-Prime Capital and has worked in the healthcare sector as an investor, consultant, and physician. Prior to joining F-Prime Capital in 2007, Dr. Patel advised biopharmaceutical and medical device companies on brand strategy, clinical development plans, and business development activities in the corporate consulting division of Leerink Swann & Company. Dr. Patel served as a physician at the VA Boston Healthcare System and at Weill Cornell Medical Center-New York Presbyterian Hospital and Memorial-Sloan Kettering Cancer Center where he completed his internal medicine training.

Dr. Patel focuses on investing in therapeutics and medical device companies and has served on the Board of Directors of ABK Biomedical, Aclaris Therapeutics (NASDAQ:ACRS), Avalyn Pharma, Caplin Steriles, Comanche Biopharma, Eywa Pharma, Ivenix (acquired by Fresenius Kabi), Laurus Labs (NSE:LAURUSLABS), Medwell Ventures, Menlo Therapeutics (NASDAQ:MNLO), NextWave Pharmaceuticals (acquired by Pfizer), NFlection Therapeutics, Pediatrix Therapeutics, Rallybio (NASDAQ:RLYB), and Vicept Therapeutics (acquired by Allergan).

Dr. Patel is a graduate of Tufts University School of Medicine, where he received both his MD and MBA as part of that institution’s Healthcare Management Program and was elected to the Alpha Omega Alpha Medical Honor Society. He completed his undergraduate studies in biology and economics with highest honors at Rutgers University.

Scott is our CEO and co-founder of Comanche Biopharma. Prior to Comanche, Scott was a co-founder of The Medicines Company where he served as director (1996-2009) until he joined the management team as Chief Medical Advisor (2009-2021). In that role, he was responsible for evaluating the company’s long-range global strategy and for the licensing or acquisition of innovative products, including inclisiran, for which the company was purchased by Novartis. Previously, Scott was a founding General Partner at JSB Partners, L.P., an investment bank with a focus on mergers and acquisitions, private financings and corporate alliances within the healthcare sector. From September 1991 to July 1999, Scott served as a founder and managing director of MPM Capital, LLC, a venture capital firm.

Scott holds a B.S. in chemistry (Phi Beta Kappa) and an M.D. (Alpha Omega Alpha) from the University of Alabama. His academic career included faculty positions at Harvard Medical School, the University of Colorado Medical School, and the University of South Alabama. He has been Board Certified in Internal Medicine, Pulmonary and Critical Care Medicine and Sleep Disorders Medicine. He currently is a Board member at Atalanta Therapeutics, a biopharmaceutical company focused on the application of RNA interference to diseases of neurodegeneration.

Muz Mansuri joined F-Prime Capital in January 2020 as a Venture Partner and is based in the Boston office. Muz has more than 35 years of experience in various R&D roles as a senior executive within the global biopharmaceutical industry. Prior to joining F-Prime, Muz was a member of the Executive Committee at Sanofi, as Executive Vice President, Strategy, Business Development, and Licensing. Among other responsibilities, Muz headed the Strategy, Business Development, Alliance Management and the Venture Group for Sanofi. Before this, he was at Gilead Sciences as Senior Vice President, Research and Development Strategy and Business Development. In that capacity he led the R&D Strategy, Business Development, and M&A activities for the company. Muz has served as Chief Executive Officer of several biotech companies and as a General Partner at Flagship Ventures (now Flagship Pioneering). He began his career in the pharmaceutical industry as a bench medicinal chemist with Bristol Myers. Muz received his B.Sc. and Ph.D. in Chemistry from the University College London. He conducted postdoctoral research at UCLA and Columbia University.