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Michael Lenardo, M.D., Chief, Molecular Development of the Immune System Section NIAID/DIR, joins Rich Bendis on BioTalk to discuss his work at NIH, his recent election to the National Academy of Medicine, and advice for fellow scientists

Listen now on Google Podcasts http://bit.ly/2Ws6L0v, Apple Podcasts https://apple.co/2WupsAq, and TuneIn http://bit.ly/2Pve2ex

Michael Lenardo attended the Johns Hopkins University and graduated with a Bachelor of Arts in Natural Sciences in 1977. He then attended Washington University in St. Louis, Mo. and obtained his Doctor of Medicine (M.D.) in 1981. He carried out clinical and research training at the University of Iowa from 1981-1985. He was then a Research Fellow at the Whitehead Institute for Biomedical Research at Massachusetts Institute of Technology with an adjunct appointment at Harvard Medical School. During this time, he carried out molecular biology research under the mentorship of Nobel laureates David Baltimore and Philip Sharp. He was then appointed Section Chief in the National Institute of Allergy and Infectious Diseases, National Institutes of Health from 1989 to the present, directing research on T-lymphocyte regulation, HIV-1, and genetic diseases of the immune system. He has served on the editorial boards for the European Journal of Immunology, the Journal of Experimental Medicine, Science magazine, and Biology Direct. He is an Adjunct Professor of Pathology at the University of Pennsylvania School of Medicine, and a Visiting Fellow at Cambridge University. He has founded or co-founded several joint research programs including the NIH-Oxford-Cambridge Biomedical Research Scholars, the NIH-University of Pennsylvania Immunology Program, the NIH-Marshall Scholars, the NIH-Rhodes Scholars, the National M.D./Ph.D. partnership program, and the NIH-Institut Pasteur Infectious Disease and Immunology Program.

Dr. Lenardo has published over 200 scholarly works and holds a number of medical patents. He discovered the propriocidal mechanism of immune regulation and his work has defined several genetic diseases of the immune system including the Autoimmune Lymphoproliferative Syndrome, Caspase-8 deficiency syndrome, and X-linked magnesium deficiency with EBV and neoplasia (XMEN) disease. He is currently the Director of the Clinical Genomics Program and Chief of the Molecular Development of the Immune System Section, National Institute of Allergy and Infectious Diseases, National Institutes of Health. Among his honors and awards, he is Officer of the Most Excellent Order of the British Empire (O.B.E.), conferred by Queen Elizabeth II, March, 2006 and a Fellow of the American Association for the Advancement of Science, the American Academy of Arts and Sciences, National Academy of Science and the National Academy of Medicine.

He is married to Lesley-Anne Furlong, M.D. and has two sons, Brian and Timothy.

The National Institute of Allergy and Infectious Diseases (NIAID) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

NIAID has "intramural" (in-house) laboratories in Maryland and Montana, and funds research conducted by scientists at institutions in the United States and throughout the world. NIAID also works closely with partners in academia, industry, government, and non-governmental organizations in multifaceted and multidisciplinary efforts to address emerging health challenges such as the pandemic H1N1/09 virus.

 
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Super Angel Investor, Faz Bashi, MD, guests on BioTalk from the BioHealth Capital Region Investor Conference to talk about his background in Immunology/Virology, Venture Investing, and coming to the BioHealth Capital Region.

Listen on Google Podcasts bit.ly/2qR2cRE, Apple Podcasts apple.co/32Ta8A3, and TuneIn bit.ly/2Nip5VJ.

Dr. Faz Bashi, M.D., has a background in Immunology and Virology from UCSF. Faz is the Chair of the Medical Device Screening Committee of Life Science Angels and is an active member of the LSA screening committee for Biotechnology and Pharmaceuticals. He is also the Chair of the Angel Capital Association’s Life Sciences Syndication Group, is a member of the Berkeley Angel Network, and was one of the founding members of Healthtech Capital, where he served two years on the Board of Directors.

He is an adjunct professor in the Integrative Health Studies program at the California Institute of Integral Studies. Faz is an active advisor to the UCSF Clinical and Translational Science Institute. He had worked previously at San Mateo Medical Center developing and implementing special clinical projects targeted towards helping those who are under-served, which included projects focused on TeleDermatology, Diabetic Retinopathy, Screening, and advancements in electronic medical records. Faz is an active consultant to Coleman Associates as a Deep Dive expert, and he coaches public health clinics and safety net organizations on improving their workflow processes. He currently serves as an External Advisory Board Member at The Johns Hopkins University’s Center for Bioengineering Innovation and Design.

 
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Cartesian Therapeutics’ President & CEO Murat Kalayoglu, MD, Ph.D., guests on BioTalk from the BioHealth Capital Region Investor Conference to talk about developing novel cell and gene therapies, building his company in the region, and also being an investor.

Listen now on Apple Podcasts https://apple.co/2pNSKhr, Google Podcasts http://bit.ly/2qCatIU, and TuneIn http://bit.ly/2Wb14DP

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 and autoimmune diseases. Before 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 (NYSE:AGN). 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 (NASDAQ:HWAY). Dr. Kalayoglu is a board-certified ophthalmologist who completed his residency and research fellowship at Harvard, MD/Ph.D. in immunology at the University of Wisconsin-Madison, and MBA from the MIT Sloan School of Management.

Founded in 2016, Cartesian is a fully-integrated, clinical-stage biopharmaceutical company developing novel cell and gene therapies to treat cancer and autoimmune diseases. All of the company’s products are manufactured internally at the company’s wholly-owned cGMP manufacturing facility in Gaithersburg, MD. Cartesian has three programs in clinical development. The lead product, Descartes-08, is a CD8+ CAR T-cell therapy with a defined and predictable half-life, enabling repeat dosing to maximize potency while minimizing risk of toxicity. Descartes-08 is currently in Phase I/II clinical trials to treat patients with multiple myeloma.

 
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New Enterprise Associates Partner, Sara Nayeem, M.D., Joins Host Rich Bendis to Discuss Her Career, Venture Capital, and BioPharma

Sara Nayeem, M.D., is a Partner at New Enterprise Associates (NEA). Sara joined NEA's healthcare team in 2009 and focuses on investments in biopharmaceutical companies. She serves on the boards of Centrexion, Complexa, Cydan, Imara, and Tiburio. She previously served on the boards of Vtesse (acquired by Sucampo), Mersana (MRSN) and Therachon and as a board observer for Loxo Oncology (LOXO, acquired by Lilly), Tesaro (TSRO, acquired by GlaxoSmithKline), Clementia (CMTA, acquired by Ipsen), Nightstar (NITE, acquired by Biogen), Ziarco (acquired by Novartis), Omthera (OMTH, acquired by AstraZeneca), Epizyme (EPZM), Millendo (MLND) and Zyngenia. She has also been involved in other NEA investments such as Prosensa (RNA, acquired by BioMarin), Metacrine, and 3-V Biosciences. She also serves on the board of BioHealth Innovation Management. Prior to joining NEA, Sara was an Associate with Merrill Lynch’s Global Healthcare Group, where she advised biotechnology, pharmaceutical and medical device companies on numerous mergers, acquisitions and financing transactions. Previously, she worked as an Investment Banking Analyst at Morgan Stanley. She has conducted basic science research in mammalian cardiac development and clinical research in age-related macular degeneration. Sara concurrently earned her MD (cum laude) and MBA from Yale University, where she was a Yale MBA Scholar. She received her AB (magna cum laude) in Biology from Harvard University.

Listen now on iTunes (https://apple.co/2o1V6Il), Google Podcasts (http://bit.ly/2oGqQ6h), and TuneIn (http://bit.ly/2ndZGmO).

 
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Dr. Zan Fleming, M.D. and Thomas Seoh of Kinexum join Biotalk host Rich Bendis to discuss the company, Metabesity, and their upcoming 2019 Conference in Washington, DC

Listen now on Google Podcasts http://bit.ly/2kaI8Xt, iTunes https://apple.co/2kc7jsG, and TuneIn http://bit.ly/2lMk79l

Dr. Alexander Fleming is Founder and Executive Chairman of Kinexum, a company with diverse expertise in developing drugs, biotech products, medical devices and digital health technologies. He is also Executive Vice-President of Tolerion, a biotechnology company developing disease-modifying treatments for type 1 diabetes and other autoimmune diseases. Dr. Fleming received his M.D. and internal medicine training from Emory, fellowship training in endocrinology at Vanderbilt and metabolism at National Institutes of Health, where he was a senior fellow. 

At the US Food and Drug Administration from 1986-98, Dr. Fleming was responsible for the therapeutic areas of diabetes, other metabolic and endocrine disorders, growth and development, nutrition, lipid-lowering compounds, and reproductive indications.  He led reviews of landmark approvals including metformin and the first statin, insulin analog, PPAR-agonist, and growth hormone for non-GH deficiency indications. He conceived and directed the first FDA pilot project to utilize the internet for regulatory communication and represented FDA on the expert working groups for Good Clinical Practices and General Considerations for Clinical Trials of the International Conference on Harmonisation (ICH) and participated on other ICH committees including the Common Technical Document working group.  

Dr. Fleming remains active in supporting the development of diabetes-related preventions, treatments, devices, and digital technologies.  He serves on the joint technology working groups of the European Association for the Study of Diabetes and American Diabetes Association. 
  

Thomas Seoh is President and CEO of Kinexum, a strategic advisory firm that provides regulatory, clinical, CMC and other translational guidance for life science product development.  He is an entrepreneur/executive who has held senior leadership positions in public and private pharmaceutical, biotech and medical device companies for over 25 years. 

Mr. Seoh began his career as a corporate attorney in New York and London, then assumed legal management positions with the Consolidated Press group in Livonia, MI, then the ICN Pharmaceuticals group in Costa Mesa, CA.  He next became VP, General Counsel and Secretary, and later, SVP Corporate and Commercial Development, of Guilford Pharmaceuticals, a NASDAQ-listed company in Baltimore which commercialized GLIADEL® wafer for glioblastoma multiforme and developed the propofol pro-drug LUSEDRA® and small molecules for Parkinson’s disease.  He then became CEO of venture-backed Faust Pharmaceuticals in Strasbourg, France, with a repurposed compound in Phase II for Parkinson’s patients, a re-positioned molecule for Duchenne muscular dystrophy and a GPCR drug discovery platform. 

Mr. Seoh subsequently served in leadership positions of medical device startups developing an ex vivo liver dialysis device, a novel mechanical thrombectomy device for Deep Vein Thrombosis and stroke and a state-of-the-art neurocatheter, and a plant-based skin substitute wound dressing.  He has served on industry-university advisory boards at Johns Hopkins School of Medicine and the University of Maryland Baltimore County.  He holds an AB in Philosophy and History and a JD from Harvard University.

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Bob Kramer joins BioTalk to discuss his history with Emergent, his vision for the company, and Emergent’s commitment to the BioHealth Capital Region.

Mr. Kramer serves as president and CEO and as a member of the Board of Directors. He was appointed as CEO and as director effective April 2019 and has served as president since March 2018. Mr. Kramer also served as chief operating officer from March 2018 to March 2019. Prior to this, Mr. Kramer served as executive vice president and chief financial officer from September 2012. Mr. Kramer first joined Emergent in 1999 as its CFO. From 1999 until his retirement in 2010, he held various executive positions with the last being president of Emergent Biodefense Operations Lansing. Mr. Kramer returned to the company in 2011 as the interim head of the biosciences division, and then as interim executive vice president, corporate services division. Prior to joining Emergent in 1999, Mr. Kramer held various financial management positions at Pharmacia Corporation, which subsequently merged with the Upjohn Company in 1995 and eventually became part of Pfizer Inc. Mr. Kramer serves on the board of the U.S. Chamber of Commerce. Mr. Kramer received an M.B.A. from Western Kentucky University and a B.S. in industrial management from Clemson University.

Listen now on iTunes (https://apple.co/2P2fYfO), Google (http://bit.ly/2KKg47H), and TuneIn (http://bit.ly/2LPtYab).

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For the first time, a BioTalk look inside BioHealth Innovation, Inc. (BHI) with Entrepreneur-In-Residence (EIR) Dr. Ethel Rubin

Dr. Ethel Rubin leads a venture team that helps prepare and connect lifescience companies with capital, ensuring strategies that hit valuation inflection points, achieve strategic goals, and prepare for a product launch. She has previously held corporate leadership roles in global clinical strategy and medical affairs at Medtronic, plc, was Chief Scientific Officer of BioFortis, Inc. (acquired by Quintiles-Quest JV) and CSA Medical, Inc., is President of life sciences business development advisory firm Innovative BioStrategies, LLC, and a venture partner at various funds. She has over 25 products in the marketplace garnering 9 figure sales revenue, was instrumental in multiple M&As, partnerships & collaborations, and advises hundreds of CEOs in preparation for seed to series B financing each year. Ethel has held board seats at tech incubators and numerous business and clinical Advisory boards.  Dr. Rubin earned a Ph.D. in Biochemistry and Biophysics from the University of Rochester School of Medicine & Dentistry and a certificate in corporate governance for Board of Directors service from The George Washington University School of Business.

Listen now on iTunes (https://apple.co/318CzZv), Google (http://bit.ly/30WiQfg), and TuneIn (http://bit.ly/2LPtYab).

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MaxCyte Founder, President and CEO Doug Doerfler joins BioTalk to discuss his history and the growth of the company. He also shares advice for entrepreneurs

Mr. Doerfler has more than 35 years of experience in the discovery, development, commercialization and international financing of biotechnology products and companies. He was a founder of MaxCyte in July 1998. Previously, Mr. Doerfler was President, CEO and a Director of Immunicon Corporation, a cell-based therapy and diagnostics company. He also held various executive positions with Life Technologies, Inc.(now Thermo Fisher Scientific). Mr. Doerfler plays an active role as a life sciences industry advocate, serving as Chair Emeritus of the MTC and on the executive committee of BIO.

Listen now on iTunes (https://apple.co/318CzZv), Google (http://bit.ly/30WiQfg), and TuneIn (http://bit.ly/2LPtYab).

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AMPEL BioSolutions Co-Founder and COO/CSO, Dr. Amrie Grammer guests on BioTalk to discuss building the Company in Charlottesville, VA, her work and recognition at NIH, and being a leader from the southern part of the BioHealth Capital Region.

Dr. Amrie Grammer is the Majority Owner and Co-Founder of AMPEL BioSolutions, located in downtown Charlottesville Virginia. Amrie is a Translational Immunologist specializing in human Autoimmune Diseases. She trained at UVA (BS Chemistry, MS Pharmacology) before receiving her PhD in Immunology at UTSW Medical Center at Dallas. Amrie was recruited to the NIH to establish the B Cell Biology Group in the Autoimmunity Branch of NIAMS during the human genome sequencing project. She received multiple NIH awards for her work comparing signaling pathways and genes expressed in patients vs healthy individuals, including the prestigious Director’s Award.

Amrie founded AMPEL in 2013 to bring precision medicine to individual patients, especially those suffering from lupus to whom she has dedicated her career. Over the last six years, she has used her knowledge to design and implement a pipeline to predict disease activity and the “right drug for the right patient at the right time”. In addition, top drugs she identified for repositioning into lupus have had positive clinical trials. Amrie is a member of Sigma Xi and Sigma Delta Epsilon. She serves as a Chair of the UVA Alumni Board of the professional Chemistry Fraternity, Alpha Chi Sigma. In December 2016, Amrie was elected to the Board of Directors of the Virginia Biotechnology Association (VA Bio). She is also a board member of the University of Virginia Fralin Art Museum (2011-present).

Listen now on Google Play bit.ly/2CzdnA9, iTunes, apple.co/2Arsfze, TuneIn bit.ly/2M60Wmx.

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Dr. Marco Chacón sits down for a new episode of BioTalk to talk about his Founding of Paragon to its recent sale to Catalent, his current role with the University of Maryland Baltimore, and being a Leader in the BioHealh Capital Region

Marco A. Chacon, Ph.D., is the Assistant Vice President of Industry Alliances at the University of Maryland, Baltimore. As a seasoned biopharmaceutical executive and entrepreneur, Dr. Chacon works with the leadership team at UMB leading special projects to grow the BioPark tenant base and to strengthen the University’s research collaborations with industry.

Dr. Chacon is the Founder and Chairman of Paragon Bioservices, Inc., a Contract Development and GMP Manufacturing Organization (CDMO) located at the University of Maryland BioPark in Baltimore. With  ~500 employees and 230k square feet of space, Paragon specializes in the development and GMP manufacturing of viral vectors and vaccines.

Dr. Chacon is also the Founder of IRAZU Biodiscovery, a regenerative medicine company seeking to develop therapeutic interventions to induce hypoxia tolerance and neuroprotection as described in experimental models of caloric restriction and hibernation, as well as during the neonatal period in mammals.

Dr. Chacon’s academic interests include control of metabolism, oxygen homeostasis and the regenerative potential of tissues and organs.

Dr. Chacon received a B.S. degree from Youngstown State University and a Ph.D. Degree from the University of Maryland, College Park. He currently serves on the Board of Trustees of the UMB Foundation and was appointed in 2016 to the Life Sciences Advisory Board by Governor Lawrence J. Hogan, Jr.

Listen now on Google Play bit.ly/2CzdnA9, iTunes, apple.co/2Arsfze, TuneIn bit.ly/2M60Wmx.

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Dr. Andrew Lees, founder and Chief Scientific Officer of Fina Biosolutions, holds over 25 patents and is the author or co-author of more than 70 peer-reviewed papers. He holds a B.S. in Chemistry from Harvey Mudd College and a Ph.D. in Biophysics from The Johns Hopkins University. GlaxoSmithKline, the Serum Institute of India, the Chengdu Institute of Biological Products, and others all use conjugation chemistry (CDAP) developed by Dr. Lees in their S. pneumonia and meningococcal conjugate vaccines. He received the Johns Hopkins University Distinguished Alumni Award in 2019 for his efforts in making conjugate vaccines affordable for low-income countries.

Dr. Lees is also an associate professor at the University of Maryland School of Medicine’s Center for Vaccine Development, an affiliate at the University of Maryland Bioprocessing Scale-Up Facility, and an adjunct professor in the Department of Medicine at the Uniformed Services University. He teaches protein chromatography through the post-graduate level and is a frequent speaker on conjugation chemistry and biotech entrepreneurship. 

Listen now on Google Play bit.ly/2CzdnA9, iTunes, apple.co/2Arsfze, TuneIn bit.ly/2M60Wmx.

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Crystal R Icenhour, PhD, is one of the rising stars of American biotechnology. After more than 25 years in medical research and biotech, she was named founding CEO of Aperiomics, a company that harnesses the power of next-generation sequencing to identify any known pathogen (bacteria, virus, fungi or parasite) in a single test. Aperiomics is the only company of its kind and scope in the world. Throughout Dr.Icenhour’s career, she has demonstrated strong leadership in business and science and has dedicated herself to “bridging the translational gap between these two worlds.”

Dr. Icenhour is an expert in infectious disease diagnostics and her mission is to change the entire thinking about pathogen diagnosis. Up to 75% of infections are never accurately diagnosed, leaving millions of people suffering from chronic infection. Aperiomics, under her leadership, has developed a technology that identifies all known pathogens – every bacteria, parasite, virus, and fungus – from clinical samples in one test.

Dr. Icenhour holds two patents, has authored and co-authored numerous research articles and theses, and has been a prolific speaker and presenter at scientific conferences.  She has served on review panels for National Science Foundation and Environmental Protection Agency and National Institutes of Health Small Business Innovation Research (SBIR) grants.  She is also an adjunct assistant professor at Duke University Medical Center’s Division of Infectious Diseases in their Department of Medicine.

Before Aperiomics, Dr. Icenhour was president and chief science officer for Phthisis Diagnostics in Charlottesville, VA, a research and development company focused on development of easy-to-use molecular diagnostics for intestinal parasites. While a postdoctoral fellow at the Mayo Clinic College of Medicine, she was the first to identify and characterize Pneumocystis melanins.

Dr. Icenhour serves as Chairman of VirginiaBIO and was chosen to participate in the SpringBoard Enterprises 2016 class of women-led companies.  She is a member of, Sigma Xi, Medical Mycology Society of the Americas, Association for Molecular Pathology, and the American Society for Microbiology. The Kauffman Foundation and Center recognized her as 2012 Entrepreneur of the Year.

Dr. Icenhour received her PhD in Pathobiology and Molecular Medicine from the University of Cincinnati Medical School of Graduate Studies in 2002.  She conducted postdoctoral research in the Thoracic Diseases Research Unit at the Mayo Clinic College of Medicine from 2002-2005 and in the Department of Infectious Diseases at Duke University Medical Center from 2005-2006.  She has been involved in local and national postdoctoral associations including the Mayo Research Fellows Association Executive Committee (president), the Duke University Postdoctoral Association (chair of membership committee), and the National Postdoctoral Association (2008 chair).

Listen now on Google Play bit.ly/2CzdnA9, iTunes, apple.co/2Arsfze, TuneIn bit.ly/2M60Wmx.

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Recorded at the National Capital Consortium for Pediatric Device Innovation Competition in College Park in front of a live audience!

Laurie Strongin is Founder and CEO of the Washington, DC-based Hope for Henry Foundation which is reinventing the pediatric patient experience in hospitals around the country. Laurie’s work with Hope for Henry and the memoir she published, “Saving Henry,” have placed her at the forefront of supporting the rights of patients and their families and the responsible use of new medical technologies. Laurie’s advocacy has led her to service on the nation’s preeminent science policy and bioethics panels. Her activism has produced op-eds in national newspapers; appearances on television and radio; collaborations with Congressional leadership; and recognition from the White House. An in-demand inspirational speaker, Laurie has been featured as a People magazine “Heroes Among Us” and was the subject of profiles in the USA Today and the Washington Post and on Good Morning America. Laurie serves on the board of directors of the National Marrow Donor Program/Be the Match; on the Advisory Committee to Disney’s “Team of Heroes,” and on the Advisory Committee of the Association of Child Life Professionals. Learn more athttps://hopeforhenry.org/.

Listen now on Google Play bit.ly/2CzdnA9, iTunes, apple.co/2Arsfze, TuneIn bit.ly/2M60Wmx.

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President and CEO Rich Bendis sits down with industry leaders to talk about the forum and their views on the growth of the region.

In Part 1 his guests are John Trainer, VP and one of the partnering heads at AstraZeneca, Chris Frew, CEO of Workforce Genetics & President of BioBuzz Media, and Alex Philippidis, Senior Editor of Genetic Engineering & Biotechnology News.

Listen now on Google Play bit.ly/2CzdnA9, iTunes, apple.co/2Arsfze, TuneIn bit.ly/2M60Wmx.