Agenda

Gary Disbrow, PhD

Director Deputy Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, U.S. Department of Health and Human Services Dr. Gary Disbrow is the Director of the Biomedical Advanced Research and Development Authority (BARDA), a component of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services. BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. BARDA has established hundreds of public-private sector partnerships and as of July 2021 BARDA now has a portfolio of 61 products that have earned FDA regulatory approvals, licensures or clearances. Dr. Disbrow joined BARDA in January of 2007 and has held a variety of positions related to the advanced development and procurement of medical countermeasures against an array of threats to national security and public health. Prior to becoming the BARDA Director, Dr. Disbrow served as acting BARDA Director, Deputy Assistant Secretary of ASPR and Medical Countermeasures Program Director. In October 2013, Dr. Disbrow was named Acting Director of the Chemical, Biological, Radiological and Nuclear (CBRN) Division and was subsequently named the Director of the Division in December of 2014. During that time, the CBRN Division built a robust pipeline of candidate products under advanced research and development. In 2014 and 2015, Dr. Disbrow was identified as the Ebola Incident Coordinator for BARDA and worked closely with the BARDA Director on funding needs, development of candidate products, and was the primary liaison for BARDA across the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE).  These efforts led to the first licensed Ebola vaccine, ERBEVO licensed in December 2019 and the first licensed Ebola therapeutics, Inmazeb licensed in October 2020 and Ebanga licensed in December 2020. Upon joining BARDA in January 2007 Dr. Disbrow began working on the smallpox vaccine program. Dr. Disbrow played a key role in awarding the first contract under Project BioShield using the authorities for advanced payment and milestone payments provided under the Pandemic and All-Hazards Preparedness Act (2006).  JYNNEOS was licensed in September 2019. Prior to joining BARDA, Dr. Disbrow was a Research Assistant Professor of Oncology and Pathology at Georgetown Medical Center where he worked on human papillomavirus (HPV) vaccines and therapeutics. Dr. Disbrow has previously worked at W.R. Grace, Kodak, and Genencor. Dr. Disbrow attended the University of Rochester and Georgetown University for his undergraduate and Ph.D. respectively.

Murat Kalayoglu, MD, PhD

President, Cartesian Therapeutics Dr. Kalayoglu is co-founder and CEO of Cartesian Therapeutics, a fully-integrated, clinical stage biopharmaceutical company developing novel cell and gene therapies to treat cancer, autoimmune diseases and respiratory diseases. Prior to Cartesian, he was co-founder and CEO of Topokine, which he led from concept to late-stage clinical trials, followed by a successful sale to Allergan (now Abbvie; NYSE:ABBV). Prior to Topokine, he was co-founder and COO of HealthHonors Corporation, which he led from concept to commercialization, followed by a successful sale to Healthways (now Tivity Health; NASDAQ:TVTY) Dr. Kalayoglu is a board-certified ophthalmologist who completed his residency and research fellowship at Harvard, MD/PhD in immunology at the University of Wisconsin-Madison, and MBA from the MIT Sloan School of Management.

Jon Rowley

Chief Product Officer, RoosterBio Jon A. Rowley, PhD, is the Founder and Chief Product Officer of RoosterBio Inc. Jon started RoosterBio in 2013 as part of his personal quest of having the biggest impact possible on the commercial translation of technologies that incorporate living cells, including cellular therapies, engineered tissues, and tomorrow’s medical devices. With a Ph.D. from the University of Michigan in Biomedical Engineering, Jon has authored over 35 peer-reviewed manuscripts and has 20 issued or pending patents related to biomaterials development, tissue engineering, and cellular therapy. He started his industry career at BD as a scientist and R&D manager in a Cell & Tissue Technologies group focused on applying high throughput screening technologies to cell therapy media development and tissue engineering. Jon then contributed to the clinical development of Aastrom Biosciences’ Tissue Repair Cell product, where he was Sr Manager of Process Development responsible for manufacturing process improvements and cell delivery to the patient. Jon also spent 5 years as Director of Innovation and Process Development in Lonza’s Cell Therapy CMO business. He currently resides in Walkersville, MD with his wonderful wife and their 3 awesome children.

Martin Rosendale

Chief Executive Officer, Maryland Life Sciences

Martin is the Chief Executive Officer of the Maryland Life Sciences, a division of the Maryland Tech Council, a partner with Newport LLC, and a partner at WMCS Investments. An engineer turned microbiologist and industry leader, Martin is passionate about the human and business value of technology, life sciences, and biotechnology. A five-time CEO and twice company founder, his experience spans public, private and not-for-profit businesses. He has launched, branded, acquired or commercialized more than 10 products and companies. Over 30 years of experience, and a strong drive to achieve and help, enable Martin to work through complexity toward insight and solutions to grow businesses.

Martin has raised equity capital for public and private companies and non-dilutive capital through strategic partnerships. He led a biotherapeutics company through a period of hyper growth taking the company from first sale to $200 million in annual revenue in three years. He worked with the Centers for Medicare and Medicaid Services to establish Medicare reimbursement for a complex product category. He also facilitated the merger of the two largest technology industry organizations in Maryland, forming the Maryland Tech Council and strengthening its industry presence.

Sally Allain

Head, Johnson & Johnson Innovation - JLABS @ Washington, DC | BLUE KNIGHT™ As Regional Head of JLABS @ Washington, DC, Sally sets the strategic direction and oversees all operational activities for JLABS in the greater Washington metro region, including Maryland and Virginia. In this role, Sally is responsible for the process of evaluating and selecting a strong portfolio of innovators for JLABS @ Washington, DC, and building strategic partnerships with corporate, academic, government and industry organizations that aim to strengthen the region’s life sciences innovation network. Sally joined JLABS after serving as Senior Director, Strategy & Operations on the Global External Innovation team at Johnson & Johnson, where she supported portfolio management and reporting and strategic business development efforts across the organization. Prior, Sally was with Janssen R&D, Immunology, where she managed a team in research operations and alliance management for the early discovery to early development portfolio. Sally understands well the needs of healthcare entrepreneurs, having launched her research career at a San-Diego based biotech startup and then working internationally for a UK-based governmental economic development agency creating early-stage biotech and academic collaborative programs aimed at accelerating the development of products to address the needs of patients and consumers. Sally received her MBA from the University of California Berkeley, Haas School of Business, where she was recognized by ‘Poets and Quants’ as one of the ‘Top 50’ EMBA students across US & International Programs in 2016; a Master of Science Degree in Microbiology / Immunology from Virginia Tech; and a Bachelor of Science Degree in Biology from Virginia Tech.

Bill Enright

Chief Executive Officer, Vaccitech

William “Bill” Enright is a seasoned biotech executive with more than thirty years of experience in building and financing both privately held and publicly held companies. Bill spent more than ten years at Altimmune (NASDAQ: ALT) as a Director, President & CEO, moving multiple programs into clinical testing, completing several acquisitions and eventually taking the company public. Prior to joining Altimmune, Bill spent six years with GenVec, Inc. (acquired by Intrexon) with increasing responsibilities, which included a role as Head of Business Development. He currently serves on the Board of Directors of Gravitas Therapeutics, Inc.

Dr. Lisa Dunkle

Vice President, Clinical Development Global Medical Lead, Novavax A graduate of Wellesley College and Johns Hopkins School of Medicine, my career includes a former position of Professor of Pediatrics and Microbiology at St. Louis University School of Medicine, where my research interests were focused on clinical research on antiviral agents, prior to my 30+ year career in clinical drug development in the pharmaceutical industry. As Executive Director of Antiviral Clinical Research, Bristol-Myers Squibb, I built the division and headed the teams that developed Videx® and Zerit® for treatment of HIV and Baraclude®, for the treatment of Hepatitis B. As Sr. Vice President, Drug Development, Achillion Pharmaceuticals, I built the Drug Development team and headed development of the company’s first antiviral agent for HIV and HBV, elvucitabine. As Senior and Executive Director of Antiviral Clinical Research, Schering-Plough, I headed the team that developed a novel CCR5 antagonist, vicriviroc, for the treatment of HIV. Also served as subject-matter expert on Licensing teams for vaccine development, including cell-culture-derived influenza vaccine. In 2011, I joined Protein Sciences Corporation as Chief Medical Officer, where I headed the clinical development of the first purified recombinant protein influenza vaccine. Following retirement from Protein Sciences, in the midst of the global coronavirus pandemic, I was recruited to my current role as Vice President of Clinical Development at Novavax to head the registrational development of our recombinant protein vaccine for SARS CoV-2 in collaboration with NIH and Operation Warp Speed. Honors include Fellow, Infectious Diseases Society of America, Who’s Who in America and Distinguished Alumna of Johns Hopkins University (2011). Current research interests include clinical development strategies, especially for novel recombinant protein vaccines for emerging vaccine-preventable infectious diseases.

Stephen Thomas

Professor, Health Policy & Management, Director, Maryland Center for Health Equity, University of Maryland College Park

Dr. Stephen B. Thomas is Professor of Health Services Administration, in the School of Public Health and Director of the Maryland Center for Health Equity at the University of Maryland in College Park. He has developed a significant network of relationships across multiple health disparity influencing sectors including: academic researchers; healthcare providers and service organizations; community leaders; and local, state, and federal policymakers. He has served as PI (joint with Dr. Quinn) for our Center of Excellence in Race, Ethnicity and Health Disparities Research (P20 MD006737, NIMHD). He has specific expertise in the development, implementation and evaluation of minority health and health disparity interventions. He has certificates in Bioethics and a proven record of success with recruitment and retention of racial and ethnic minority populations in biomedical and public health research. He also has extensive experience in overcoming barriers associated with the legacy of the Syphilis Study Done at Tuskegee (1932 - 1972) and conducting scientifically sound and culturally tailored community based interventions designed to eliminate racial and ethnic disparities to achieve health equity. This experience informed the basis for recruiting study participants through trusted venues, and providing culturally tailored training for all community based providers and academic researchers who may interact with the study participants.

Jim Jackson

Vice President, Manufacturing, Kite, a Gilead Company Jim comes to Kite from the MD Anderson Cancer Center, where he was Site Head and Head, Cell Therapies Manufacturing dedicated to manufacturing of a variety of clinical and experimental cell therapy modalities, including CAR-T. Prior to MD Anderson Jim was Executive Director, Drug Product Manufacturing at Regeneron Pharmaceuticals. Jim has additional manufacturing experience from GSK, Novartis and Merck. In his spare time Jim enjoys powerlifting, golf, fishing and traveling. His favorite cuisine is Thai, but Texas BBQ comes in a close second. Jim, his wife and his three daughters are in the process of relocating from Texas to the Frederick area. Please join me in welcoming Jim to Kite.

Nicholas Ostrout, PhD

Global Head of Commercial Development, Lonza

Dr. Nicholas Ostrout leads the commercial development team for the Personalized Medicine Business Unit at Lonza. Dr. Ostrout earned his PhD in Immunology from Case Western Reserve University and has been working in sales, marketing, and business development for most of his career. Nicholas most recently came from Miltenyi Biosciences. Dr. Ostrout is primarily focused on launching the Cocoon Platform into the market and scaling out manufacturing capabilities for cell and gene therapies with the Cocoon both internally within Lonza and with external partners. Nick’s primary goal, as part of Lonza’s PerMed team, is to make these lifesaving cell therapies at a lower cost, and on a higher scale, in order to be able to treat as many patients as possible.

Sarah Meeks

Senior Vice President, Global Business Development, MaxCyte

Sarah has over 20 years of senior-level management experience in business development in biotech sector. She is currently Senior Vice President of Global Business Development at MaxCyte, Inc. and has been with the Rockville, Maryland biotechnology company since 2019.  In her current role, she is responsible for establishment of Strategic Partnerships with cell therapy companies world-wide in addition to directing the company’s Value for Patients Initiative. Previously, she was the Vice President of Business Development for Synpromics Ltd. from 2016 until its acquisition by AskBIO in 2019.  From 2013 to 2018, she served as Adjuvant Partner’s Chief Scientific Officer, leading business development and corporate strategy for a number of clients, including large cap pharmaceutical companies, biotechnology companies, technology providers, and major medical centers with a focus on cell and gene therapy. She is on the founding team of Cardiogen Sciences, Inc. (acquired in 2015 by Audentes Therapeutics) and was the Senior Director, Technology Sections at the Alliance for Regenerative Medicine including launching and managing the Gene Therapy Section and the Genome Editing Task Force. Prior to Adjuvant Partners, Sarah held the position of Vice President, Business Development for Orasi Medical, Circle Biologics and BioE. Sarah holds a Doctorate in molecular biology and bioethics from the University of Minnesota and a Bachelor of Science degree in biochemistry from the University of Wisconsin. From 1995-2004, she completed a post-doctoral fellowship with James M. Wilson, MD, PhD in the University of Pennsylvania’s Human Gene Therapy Program focused on in vivo muscle directed gene therapy as well as served as a licensing manager for the UPENN Center for Technology Transfer and continued her education taking classes in the MBA program at the University of Pennsylvania’s Wharton School. She is an active director on the board of the Shakespearean Youth Theatre (2021-present) and formally the Director of Advancement on the Minneapolis United Youth Soccer (2017-2020) Board.

Dr. David Agus

Chief Executive Officer, Ellison Institute, physician, author, CBS Medical Contributor

David B. Agus is one of the world's leading doctors and pioneering biomedical researchers.

He is a professor of medicine and engineering at the University of Southern California’s Keck School of Medicine and Viterbi School of Engineering. He is the founding director and CEO of the Lawrence J. Ellison Institute for Transformative Medicine of USC.

A medical oncologist, Dr. Agus leads a multidisciplinary team of researchers dedicated to the development and use of technologies to guide doctors in making health-care decisions tailored to individual needs.

An international leader in new technologies and approaches for personalized healthcare, Dr. Agus serves in leadership roles at the World Economic Forum and other prestigious organizations. He is also a CBS News contributor.

Dr. Agus’ three books “The End of Illness”, “A Short Guide to a Long Life” and “The Lucky Years: How to Thrive in the Brave New World of Health” are all New York Times and international bestsellers. He is a 2017 recipient of the Ellis Island Medal of Honor.

Dr. Tahseen Mozaffar

Professor, Neurology and Laboratory Medicine, University of California, Irvine

Dr. Tahseen Mozaffar is a Professor of Neurology and Pathology and Laboratory Medicine and the Vice Chair for Research in the Department of Neurology at University of California, Irvine. He is the Director of the UC Irvine-MDA ALS and Neuromuscular Center and the Director of the UC Irvine Neuromuscular Program. Dr. Mozaffar serves as chair of one of the biomedical committees and the institutional liaison for Trials Innovation Hub for the Center for Translational Sciences Award (CTSA) at University of California, Irvine. He is the Principal Investigator for UCI-NEXT, the NeuroNEXT award to the University of California, Irvine, one of 25 such NeuroNEXT sites funded by the NINDS/NIH. He is also the Lead Investigator for a multicenter NIH/NIAMS funded Natural History Study in sIBM (INSPIRE-IBM), scheduled to start July 2021.

He graduated medical school at the Aga Khan University in Karachi, Pakistan in 1989. After a rotating internship in Internal Medicine and General Surgery at the Aga Khan University Hospital, he came to the US for neurology residency training. He completed neurology residency training at Barnes Hospital in St. Louis, Missouri in 1995 and then completed a two clinical and research fellowship in Neuromuscular Disorders at Washington University in 1997. After a three-year faculty appointment at the Aga Khan University in Karachi, Pakistan, Dr. Mozaffar returned to the US and was appointed as Assistant Professor of Neurology and Director, UC Irvine Neuromuscular Program University of California, Irvine in 2000, where he has built an internationally recognized clinical and research program in Neuromuscular Disorders.

He is actively involved in clinical and translational research in Neuromuscular Disorders, including currently serving as Principal Site Investigator on over a dozen clinical trials in myasthenia gravis, rare and ultra-rare myopathies and in immune myopathies. He has co-authored over 175 peer-reviewed publications and has authored or co-authored over a dozen book chapters and invited reviews. As an expert in these rare and ultra-rare myopathies, he is actively sought as an advisor by pharmaceutical companies for trial design and identifying disease targets. He serves on a global advisory board for Pompe at Amicus and for Spark Therapeutics. He serves on the Data Safety Monitoring Board for Acceleron, Sarepta and NIH. He is a standing study section member for the ETTN study section at the NIH.

He is a member of the Medical Advisory Board for the Myositis Association and serves as the MAB Liaison to the Board at TMA. He till recently was on the executive committee of the Muscle Study Group. He served on the conference planning committee for the MDA Clinic Directors Conference, 2nd Global conference on myositis (GCOM), the 3rd Global Myositis Conference, the Muscle Study Group, and the International Congress on Neuromuscular Disorders. He is the Director of the nationally recognized Annual UC Irvine Neuromuscular Colloquia, now in its 10th year of existence and Director of the Annual Neuromuscular Pathology Colloquium, now in its 5th year.

Dr. Mozaffar’s immunological research interests include characterization of the myopathology in various forms of immune myopathies, including the first description of myopathology in Jo-1 antibody associated myositis. Based on his seminal work, this form of immune myopathy has now been given a separate classification of anti-synthetase syndrome. His most recent work has been in various subtypes of dermatomyositis, immune mediated necrotizing myopathy and in collaboration with Professor S. Armando Villalta, a deep phenotyping of the immune infiltrates in sporadic inclusion body myositis. His other area of interest is myasthenia gravis, an autoimmune disease of the muscle. He is the site PI for the first CAR-T cell therapy trial in MG in collaboration with Cartesian Inc.

Peter Olagunju

Chief Technology Officer, TCR2 Therapeutics Mr. Olagunju joined TCR² in 2021 as Chief Technical Officer. He brings over 20 years of experience in cell and gene therapy, clinical development, program management, manufacturing and technical operations. Prior to joining the Company, he was Senior Vice President of Technical Operations at FerGene Inc., where he led the technical operations function for the commercialization of a gene therapy for bladder cancer. Before that, Mr. Olagunju was Vice President of Global Patient Operations at bluebird bio, Inc., where he held several roles of increasing responsibility and was the program lead and functional head of manufacturing supporting the European approval for ZYNTEGLO®, a transformational gene therapy for Transfusion dependent Thalassemia. Earlier in his career, he held senior positions in Commercial Technical Operations and served as the Head of Quality at Dendreon Corp. and ZymoGenetics, Inc. Mr. Olagunju holds an M.B.A. from the University of Washington and a B.S. in Biology from the University of Illinois at Urbana-Champaign.

Michael Singer M.D., Ph.D.

Chief Scientific Officer, Cartesian Therapeutics Dr. Singer is Chief Scientific Officer at Cartesian Therapeutics. Prior to Cartesian, he was co-founder and CSO at Topokine Therapeutics and Health Honors. He led clinical development for several monoclonal antibodies at Novartis. His research spans over 20 years in the basic and clinical sciences, with award of competitive grants and publications in journals such as Nature and PNAS. Dr. Singer is a board-certified ophthalmologist and admitted to practice patent law. He has served as a Surgeon in the Veterans Health Administration and teaches at Yale. Dr. Singer completed residency at Harvard and holds a BS, MD, and PhD from Yale University.

Doug Doerfler

President and Chief Executive Officer, MaxCyte

Mr. Doerfler has 35+ years of vast experience in biotechnology product and company development, commercialization, and international financing. He was a founder of MaxCyte in July 1998. Previously, he was President, CEO and a Director of Immunicon Corporation. He also held various executive positions with Life Technologies, Inc. (now Thermo Fisher).

Mr. Doerfler is an active Life Sciences industry advocate, serving as Chair Emeritus of the Maryland Tech Council and on the executive committee of the Biotechnology Innovation Organization. He received his BS in finance from the University of Baltimore School of Business and holds an Industrial Relations certificate.

Craig Malzahn

Senior Vice President, Technical Operations, REGENXBIO Craig Malzahn is Senior Vice President of Technical Operations, overseeing process development, external and internal manufacturing, manufacturing sciences, engineering, and the supply chain. Craig has over 25 years of experience in biopharmaceuticals including manufacturing of vaccines, antibodies, and gene therapies. He joined RegenxBio in 2019 from GlaxoSmithKline, where he was VP and Site Head for GSK’s biopharm large-scale commercial manufacturing site. As Site Head, he oversaw successful new product introductions, license applications, regulatory inspections, contract manufacturing, a large-scale capacity expansion, and commercial supply of multiple blockbuster commercial products. Prior to GSK, Craig led the transformation of the supply chain from clinical to a commercial supply and was program lead for an anthrax anti-toxin collaboration with the U.S. Government at Human Genome Sciences. He held increasing levels of responsibility in vaccine manufacturing at Baxter and North American Vaccine. Craig has a MS in Biotechnology from Johns Hopkins University and a BS in Biology from Virginia Tech.

Nicole Palya Wood

Senior Regional Director, State Advocacy, PhRMA

Nicole Palya Wood serves as the Senior Director of State Advocacy for the Mid-Atlantic Region. She is responsible for developing and implementing comprehensive state legislative and engagement strategies in support of PhRMA’s priorities in Delaware, Maryland, Pennsylvania and Virginia.

A native of Virginia, Nicole graduated from James Madison University and caught the bug for legislative affairs while working as a legislative aide for Senator Frank Ruff in the Virginia State Legislature.  She would later represent the National Rifle Association as the State Lobbyist in the Mid-Atlantic and Southern Region as well as serving as Manager of Government Affairs for TAP Pharmaceuticals.

On the National stage Nicole served as the Director of Legislative Affairs for the Federal Home Loan Bank of Atlanta lobbying the United States House Financial Services and Senate Banking Committees. She continued with her work on rural housing and community banking issues as the Senior Lobbyist for America’s Community Bankers, where she also served as a resource on farm credit issues. At the National Grange, Nicole served as the Legislative Director, leading the National legislative agenda and partnered with PhRMA to advocate for rural healthcare and tele-health issues before Congress.

Nicole was appointed to the Virginia State Chamber Commerce and the Virginia Center for Health Innovation Board of Directors in 2015. Nicole and her husband live in Richmond, Virginia with their two children. Of all of the roles she has served in, Nicole is proudest of being able to say she was an advocate first in all of them.

Brad L. Stewart

Chair, Maryland Tech Council

Senior Vice President, Montgomery County Economic Development Corporation (MCEDC)

Brad is a serial biotech entrepreneur now working to grow Montgomery County’s economy, which approaches $100 billion per year and is the leading economic driver of Maryland. He leads strategy and innovation, and also a team of economic development specialists focused on growing a diverse cross-section of businesses – including life sciences, technology, cybersecurity, defense, and hospitality. Brad is also a dedicated advocate for the life sciences industry.  He chaired Maryland Life Sciences for a decade, the State affiliate of BIO, and is Chair of the Maryland Tech Council.  Brad is a fearless leader who’s invested his career in building, and turning around, life sciences companies to maximize shareholder value.  He thrives on complex strategic opportunities and has successfully executed against challenges repeatedly while commercializing companies on a global scale. Brad has served in multiple Chief Executive, Board and Board Advisory roles across a diverse range of specialty-areas of the life sciences industry including: immunology, oncology, transplant, orphan drugs, diagnostics, development and management of joint ventures, plus extensive management consulting and corporate strategy assignments.  He also has extensive management consulting experience from leading the life sciences corporate strategy practices for two major international consulting firms. Previously Brad served as Chief Executive Officer of Immunology Partners and Chief Executive Officer of Cylex, Inc., where he executed a turnaround for an early stage, venture capital backed company (Roche, Siemens, Canaan Partners).

Kelly Schulz

Chief Executive Officer, Maryland Life Sciences, a Division of Maryland Tech Council Kelly Schulz is a mother, wife, successful small business owner, and served seven years in Governor Hogan’s administration as the Secretary of Labor and Secretary of Commerce. In her most recent role as Secretary of Commerce, Kelly oversaw the state’s primary economic development agency, responsible for attracting new businesses, job growth, and workforce development. Under Kelly’s leadership, the department also served as the largest resource to provide financial assistance to struggling Maryland companies adversely impacted by COVID-19. Prior to entering her career in public service, Kelly was always focused on her community. While raising her boys, Kelly put herself through college and worked as a server and bartender in the evenings and on weekends, yet always made time to serve on the school PTA and to volunteer with Brandon and Bradley’s sports teams. Kelly went on to work as a program manager for a defense contractor and then became a partner in opening a small business – a cybersecurity firm. Wanting to continue to serve her community, Kelly was successfully elected to the Maryland House of Delegates, representing Frederick County. As a Delegate, Kelly took her knowledge and experience as a small businesswoman and served on the Economic Matters Committee where she focused on legislation relating to banks and other financial institutions, business occupations and professions, economic development, labor and employment, unemployment insurance, and workers’ compensation. Recognized by newly-elected Governor Hogan for her knowledge and expertise on economic matters, she was appointed as Secretary of the Maryland Department of Labor, Licensing and Regulation (DLLR) in 2015. At DLLR Kelly managed nearly 2,000 employees and oversaw an annual budget of $375 million. Under her leadership, Maryland’s apprenticeship program grew to its highest level since 2008, with more than 10,000 apprentices statewide and received national recognition as one of the top programs in America. Additionally, Kelly worked tirelessly to work with businesses regulated within the department to have a clear voice on how to work successfully within the state as a partner as opposed to the preexisting adversarial relationship. In 2018, after Governor Hogan’s reelection, Kelly assumed her role in the Department of Commerce where she continued her positive approach to building relationships with a variety of industries to improve their opportunities within the state. Kelly likes to promote Prosperity with a Purpose – bringing more opportunities to the state has an effect on those that would not otherwise have opportunities. Kelly currently lives in Frederick County, Maryland with her husband John Nowell.

Robert van den Berg, PhD, MBA

Head of the Data, Sciences & Computational, Vaccinology Group GSK

Chris leads the Global Manufacturing Leadership Team (GMLT), which includes the Site Operational Leaders and cross-functional partners from Quality, MSAT, IT, HR and Finance. Chris is responsible for viral vector, clinical and commercial cell therapy operations, developing manufacturing strategy, executing site operations, ensuring cGMP compliance, establishing new capabilities, advancing process and analytical technologies, building teams and developing people. Additionally, Chris is responsible for culture development at our sites driving an inclusive culture of safety, quality and production excellence. Chris is a global business leader with over 30 years of biotech and pharmaceutical operations experience across various functions within Technical Operations. Chris joined Kite in 2018 as Site Head of Cell Therapy Operations in Fredrick, MD. Prior to that Chris was with Astra Zeneca, where he was VP & Site Head of Operations for their monoclonal antibody site. Previously Chris spent 10 years at Novartis in positions of increased responsibility, including VP & Site Head of Vaccines Operations, and VP & Global Head of Technical Operations Strategy. In this role Chris was responsible for product life cycle management, long range production planning and manufacturing network strategy for a network operating in eight countries. Prior to his time at Novartis, Chris held various manufacturing and engineering leadership roles at Amgen. Chris holds a bachelor’s degree in Computer Science from Eastern Michigan University and master’s degree in business from the Fuqua School of Business at Duke University. He is also a frequent guest lecturer at Duke and North Carolina State Universities for operational excellence in biomanufacturing and biotechnology processing.

Matthew Hepburn, MD

Director, COVID Vaccine Development, HHS-DoD Countermeasures Acceleration Group Dr. Hepburn is currently the Vaccine Development Lead for the Countermeasures Acceleration Group (CAG), formerly known as Operation Warp Speed, a partnership between the Departments of Health and Human Services (HHS) and Defense (DoD) founded in May 2020 to help accelerate the development of COVID-19 vaccines. Prior to this position, Dr. Hepburn served as the Joint Project Lead of Enabling Biotechnologies for the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense. In this role, he was responsible for establishing a start-to-finish capability to develop vaccines and therapeutic solutions against current future biological threats. Due to the creation of this foundational capability, Dr. Hepburn and the Enabling Biotechnology team implemented the DoD Vaccine Acceleration Project, which provides key investments to advance vaccines and antibody therapeutic efforts, with special emphasis on acceleration of manufacturing these products and clinical trials. These investments also provided critical initial actions to enable Operation Warp Speed. Dr. Hepburn served 23 years in the United States Army as an infectious diseases physician, retiring as a Colonel. His final assignment was as a Program Manager at DARPA (Defense Advanced Research Projects Agency), the research and development agency of DoD responsible for the development of emerging technologies for use by the military. Dr. Hepburn served there for nearly six years (2013-2019) and implemented numerous breakthrough investment programs to prepare for the current pandemic. These investments led to improved infectious diseases forecasting, better diagnostics and medical care in resource-limited settings, and development of vaccine and therapeutic products. A significant investment in rapid antibody discovery and scaling was the Pandemic Prevention Platform aimed at discovery of antibodies and product into clinical trials in 60 days. These investments were applied during the current pandemic, leading to many of the current therapeutic antibody portfolio of investment by Operation Warp Speed and the Department of Defense. Concurrent with the first two years at DARPA, Dr. Hepburn also served on the research and development team at the newly Research, Development and Acquisitions Directorate at the Defense Health Agency. From 2010-2013, he served as Director of Medical Preparedness on the White House National Security Staff. In this role, he was responsible for leading interagency policy process to address the lessons learned from the H1N1 influenza pandemic. Accomplishments included completion of the National Strategy for Biosurveillance, which created the policy framework to support advances in public health surveillance applied for the current pandemic. Additional assignments have included Chief Medical Officer, Level 2 Treatment facility in Iraq (2009-2010), for which he earned a Bronze Star. Prior to deployment, Dr. Hepburn was Clinical Research Director at the U.S. Army Medical Research Institute for Infectious Diseases (2007-2009), leading domestic and international clinical research efforts on biodefense products. This role entailed extensive service with the Cooperative Threat Reduction program in the republics of the former Soviet Union. Col. Hepburn was also an exchange officer to the United Kingdom (2005-2007) and internal medicine chief of residents at Brooke Army Medical Center (2000-2001) at Fort Sam Houston, Texas. Dr. Hepburn completed his infectious disease fellowship and internal medicine residency training at Brooke Army Medical Center in San Antonio, Texas. He received his medical degree and undergraduate degree in biomedical engineering from Duke University.

Mike Klichinsky

Co-Founder and Senior Vice President, Research, Carisma Therapeutics

Mike is a co-inventor of the CAR Macrophage technology and a scientific co-founder of Carisma Therapeutics Inc. In his role as VP of Discovery Research, he oversees the research & discovery efforts of the company.

Mike developed CAR Macrophages during his doctoral thesis under the co-mentorship of Saar Gill and Carl June at the University of Pennsylvania. Michael’s scientific expertise is in the intersection of immunology, synthetic biology, cancer immunotherapy, and translational pharmacology.

Mike previously earned a Doctor of Pharmacy degree from the University of Sciences in Philadelphia, and a PhD in Pharmacology from the University of Pennsylvania.

Jeffrey Hung

General Manager, Vigene Biosciences

Jeffrey has over 20 years of experience in the biotechnology industry. He joined Vigene in 2016 and orchestrated the acquisition of Omnia Biologics. He has also overseen Vigene’s expansion into GMP manufacturing and new product areas such as biosensors. An experienced entrepreneur, Jeffrey was instrumental in successfully growing GenScript and SABiosciences, two previous companies, to IPO and acquisition stage, respectively. He also previously held the position of Chief Marketing Officer at ATCC. Jeffrey is the author of multiple patents, publications, and book chapters. He holds a Ph.D. in genetics from Cornell University, an MBA from UC Berkeley, and a B.S. in biology from Peking University.

Dr. Bruce Levy

Chief of Pulmonary and Critical Care Division, Brigham and Women's Hospital, Harvard Medical School

Dr. Bruce Levy is the Parker B. Francis Professor of Medicine at Harvard Medical School and Chief of the Pulmonary and Critical Care Medicine Division at Brigham and Women’s Hospital. Dr. Levy’s Airway Inflammation and Resolution “AIR” laboratory aims to identify new pathways to resolve pulmonary inflammation, infection or injury by understanding the roles of naturally-derived, specialized pro-resolving mediators in health, and then translating these findings to the pathobiology of important lung diseases, including ARDS. His work has helped lead to more than 200 peer-reviewed publications, over 10 patents awarded or pending, and continuous funding from the National Institutes of Health since 1993. He is an active participant in NIH grant review study sections. He is an elected member of the ASCI, AAP and Interurban Clinical Club. He is active in the American Thoracic Society and has served in several leadership roles for the ATS, including as Chair of the Publication Policy Committee and a member of the Board of Directors.

Ben Skowronski

Senior Director, Maryland Office Lead, Associate, CRB Ben is currently the Maryland Office Leader for CRB’s Rockville office. CRB is a globally integrated company providing architecture, engineering, construction, and consulting services for some of the most sophisticated spaces in the world. Our biopharma regulatory consultants are focused on achieving successes for CRB life sciences’ clients. Ben has worked in the AEC industry for over 17 years, solely focused on the life science industry the last eleven years. He is the Chapter President and an active member of the Chesapeake Bay Area Chapter of ISPE (International Society of Pharmaceutical Engineers). He is very active in the Biohealth Capital Region, is a past member of the Bioprocessing Advisory Board at Frederick Community College, past board member of Biobuzz, and currently serves on Zaching Against Cancers board

Thomas VanCott, PhD

Vice President, Global Head of Product Development, Cell and Gene Therapy, Catalent Biologics Dr. VanCott joined Catalent through its acquisition of Paragon Gene Therapy in 2019. Prior to Paragon he spent 14 years as the President and CEO of Advanced Bioscience Laboratories Inc. (ABL), and previously held several positions at the Henry M. Jackson Foundation for the Advancement of Military Medicine. Dr. VanCott received a doctorate in physical chemistry from the University of Virginia, and a bachelor’s degree in chemistry from Dickinson College, Carlisle, Pennsylvania.

David Anderson

Senior Director, Quality Site Head, Kite, a Gilead Company David Anderson leads the Quality team at Kite’s newest cell therapy manufacturing facility in Frederick, Maryland. He has a combined18 years of biopharmaceutical experience with experience in GMP/GCP, development of small molecules, mAbs, ADCs, vaccines, plasmids, combination products and cell therapies. Throughout his career he has had direct experience with 25 products spanning the lifecycle from discovery to post commercial retirement. David has held roles from hands-on manufacturing, process and analytical development, qualification/validation, project management, and Quality Systems design. Prior to joining Kite, he worked at MedImmune and Wyeth.

Brian Stamper

Senior Director of Manufacturing, Kite, a Gilead Company Brian is the Senior Director of Manufacturing of the Kite Pharma cell therapy commercial manufacturing facility in Frederick, MD. He has over 20 years in the industry, including roles at Eli Lilly, AstraZeneca, and Lonza where he worked in Process Development, Manufacturing Sciences and Technology, and in Manufacturing. He has a BS in Biochemistry from Indiana University, an MS in Biological Engineering from Purdue, and an MBA from Johns Hopkins. He lives in Frederick County Maryland with his wife and three daughters, where he enjoys watching them dance and play sports.

KaShauna Rohlehr, MBA, PMP

Associate Director - Alliance, Program and Project Management, GSK KaShauna G. Rohlehr is a highly motivated, results-driven technical and project management professional with 16+ years of experience in the pharmaceutical industry. Over her career, she has held positions within production, quality, technical, and supply chain organizations supporting vaccines and biopharmaceuticals manufacturing. She has been employed with GlaxoSmithKline (GSK) for 11 years, where she is currently Associate Director of Alliance, Program and Project Management. Prior to joining GSK, she worked for Merck & Co., Inc. in West Point, PA. KaShauna holds a B.S. in Chemical Engineering from the University of Virginia, a Master in Business Administration (MBA) from Drexel University and the Project Management Professional (PMP) certification. She is actively involved in her community as a member of the National Society of Black Engineers (NSBE), Delta Sigma Theta Sorority, Inc., and Jack & Jill of America, Inc.

Michael Nestor, Ph.D.

Scientific Engagement Lead, Johnson & Johnson Innovation – JLABS @ Washington, DC As the Scientific Engagement Lead for Johnson & Johnson Innovation – JLABS @ Washington, DC, Michael is responsible for external engagement with regional academic research institutions, start-ups and investment partners and portfolio management. Prior to that, Michael served as the Executive Branch American Association for the Advancement of Science, Science and Technology Policy Fellow in the Office of Science at The Department of Energy and as the Director of Neural Stem Cell Research at The Hussman Institute for Autism.  Michael received his PhD in Neuroscience from The University of Maryland, School of Medicine and completed postdoctoral fellowships at the National Institutes of Health and The New York Stem Cell Foundation, where he was also a Staff Scientist.

Ulyana Desiderio, PhD

Director, BioHealth and Life Sciences, Maryland Department of Commerce Ulyana Desiderio serves as the Director of BioHealth and Life Sciences at the Maryland Department of Commerce.  She leads efforts that support the growth of Maryland’s life sciences ecosystem, including job creation, capital investment and new business formation. Prior to joining Commerce, Ulyana served as Chief Scientific Officer for the American Society of Hematology, the largest international medical association dedicated to blood diseases.  Ulyana holds B.S. degrees in Biological Sciences and Chemistry from Drexel University and a PhD in Biochemistry and Molecular Biology from the Johns Hopkins Bloomberg School of Public Health.

Steven Walker

Chair, Maryland Life Sciences
Senior Director, Global Marketing - Early Portfolio Strategy, GSK

Steven is currently the Head of Global Marketing - Early Commercial Strategy for Vaccines at GlaxoSmithKline (GSK). He has provided strategic and tactical leadership to biotechnology and pharmaceutical companies around the world for over 20 years. His past business and research experience, has been focused primarily on life science products and companies with a focus on new product strategy and in-line product commercialization within the fields of immunology, respiratory, inflammation, dermatology, rheumatology, infectious disease, vaccines, cardiovascular disease and neuroscience. Steven has diverse global experience creating corporate, regulatory and commercial strategies for life-science companies. Steven is also the founder of the Cellandtech Group, LLC an international commercial strategy and analytics firm, serving life-science companies. Prior to joining GSK, Steven was Chief Business Officer for an international regulatory consulting firm based in Alexandria, Virginia and also worked for other industry leading biotechnology and pharmaceutical companies. Outside of work, Steven continues to demonstrate his passion of science and shares his leadership, as a Board Director for Maryland Tech Council and as an Advisor to life science entrepreneurs. He holds an MBA, MHA and BS in Neuroscience from the University of Pittsburgh.