Meet the Bryn Pharma Team

Before joining Bryn Pharma, Joshua co-founded a biotech start-up, leading acquisition of the company’s lead asset. In addition, he previously served as the Chief Operating Officer of Aerami Therapeutics, where he was responsible for multiple aspects of corporate and pipeline development, ranging from R&D to business development.

Before joining Bryn Pharma, Joshua was the co-founder of a start-up biotech in stealth mode, leading acquisition of the company’s lead asset. In addition, he served as the Chief Operating Officer of Aerami Therapeutics, where he was responsible for multiple aspects of corporate and pipeline development, ranging from R&D to business development. In that role, he spearheaded the clinical development program to enhance the company’s portfolio of inhaled products in pulmonary hypertension, successfully driving key clinical and regulatory milestones for the company’s lead asset. Prior to Aerami, Josh held senior executive roles in the contract research organization (CRO) sector at Syneos Health and within the WPP agency network. Prior to joining industry, Joshua was trained as a cellular immunology and cell biologist, holding a PhD from Duke University and completing post-doctoral training at New York University’s Skirball Institute.

Mr. Casey is a long tenured attorney and executive with over 30 years of experience in international business, acquisitions and divestitures, and deep knowledge of intellectual property, regulatory and legal strategy, with 25 of those years in life sciences companies and 15 of those as an executive level chief legal officer or general counsel. Prior to joining Bryn, Mark spent five years at Mallinckrodt Pharmaceuticals where, as Chief Legal Officer, he was responsible for the legal, compliance, government affairs and patient advocacy functions. In addition to his corporate responsibilities, he was also appointed as Executive Chairman of the Specialty Generics division for which he had overall responsibility. Prior to joining Mallinckrodt, Mr. Casey served as General Counsel and Secretary to Idera Pharmaceuticals (now Aceragen), Chief Legal and Administrative Officer for Hologic, Inc., as well as serving in legal roles of increasing responsibility with Cytc Corporation, (acquired by Hologic), Boston Scientific Corp., EMC Corporation and Digital Equipment Corporation. Mr. Casey is a graduate of Syracuse University with a Bachelor of Science degree in Electrical Engineering and he holds a Juris Doctor degree from Suffolk University Law School.

Jim has over 20 years of pharmaceutical industry experience. Prior to joining Bryn Jim held a variety of senior leadership positions at Sanofi covering a variety of functional areas including finance, forecasting, sales operations, business analytics, sales and market access. In his early career, Jim worked for Bethlehem Steel and served as a Captain in the Aviation branch of the United States Army. Jim has a Master of Business Administration, with a concentration in Finance, from Lehigh University. He earned a Bachelor of Science in Engineering Management, with a concentration in Civil Engineering, at the United States Military Academy at West Point. Jim is also a Chartered Financial Analyst.

Bryn Pharma's Co-Founder and Chief Inspiration Officer, Michelle Lobel, who has severe nut allergies, is the motivating force behind the Company and its drive to deliver a revolutionary product that addresses the needs of patients, doctors and caregivers. She is also the mother of two children who have severe nut allergies. Her search led her to create Bryn Pharma, a company driven to deliver a better alternative to epinephrine auto-injectors.

Prior to founding Bryn Pharma, Mrs. Lobel was a Vice President at IDEAL Fastener Corporation. When she began working at IDEAL, the firm was a North American manufacturer facing significant transformation challenges due to offshoring of production by the company’s customer base. Under her direct leadership, the firm initiated and grew to three company owned facilities in China and opened three sales and marketing offices to serve the offshore manufacturing capacity. During this process, Mrs. Lobel spent a full year negotiating and implementing a joint venture with a Chinese Manufacturer, a task with significant cross cultural and operational challenges. Mrs. Lobel’s experience at IDEAL has given her significant experience operating within unstructured entrepreneurial environments and in relentlessly pursuing solutions in a proactive fashion.

Michelle is extremely active in community leadership. She serves on the Board of Directors of the Food Allergy Fund, an organization dedicated to funding food allergy research focused on the underlying causes of food allergies and improved treatments for people with food allergies. Additionally, she volunteers at her children's various schools.

Michelle earned a B.A. in Economics from New York University.

Steven Hartman spent over 25 years as a private equity investor. When his neighbor, Michelle, approached him with the various problems with epinephrine auto-injectors and how the allergy community was at risk, he immediately recognized that there was an opportunity to find A Better Way to deliver the epinephrine medication. Steven’s background and experience executing complex business transactions was the perfect complement to Michelle’s vision and since then they have worked tirelessly to bring Bryn Pharma from an idea to a reality.

Prior to founding Bryn Pharma, Mr. Hartman was a Partner, Co-Chief Operating Officer, Chief Compliance Officer and General Counsel of a large middle market private equity firm. Mr. Hartman had various roles including participating as a voting member on all investment committees, responsible for all legal aspects of the private equity firm and its portfolio companies, responsible for all firm and portfolio company corporate governance. Mr. Hartman headed a team of investment professionals responsible for the negotiations of all investment activities from initial investment through investment realization and was responsible for creating complex legal, financial and tax structuring for all of investment activities. Steven was responsible for all domestic and foreign compliance matters for the firm and its affiliates.

Steven earned a BS from UC Berkeley and JD/MBA from UCLA.

Jerry joined Bryn Pharma in October 2023 and serves as the company’s VP of R&D, where he oversees the CMC, Regulatory and Clinical functions of the company.

Jerry has more than 20 years of experience in the pharmaceutical industry with a specialty in pulmonary and nasal drug delivery. Prior to joining Bryn, Jerry led the CMC, Clinical and Regulatory activities at Cyrano Therapeutics as Vice President, where he focused on developing a novel nasal spray for post-viral smell loss recovery. He has held leadership roles within Hikma Pharmaceuticals and Roxane Laboratories with focus on Regulatory Affairs and Clinical Development. His responsibilities included leading the submission and approval of 505b2 and ANDA drug products across many therapeutic areas and dosage forms, with a specific focus in combination drug/device products including multi-dose nasals, unit dose nasals, and dry powder inhalers. He is deeply experienced at integrating regulatory strategy into drug development and product lifecycle management.

Jerry earned his PharmD from The Ohio State University and MSc in Biochemistry from Ohio University, where he received graduate teaching honors.

Steve Killmeyer has over 15 years of Finance experience in the pharmaceutical, biotech, and medical device industries. In his last role, he was the Head of Finance and Strategy for Aimmune Therapeutics, the startup pharmaceutical venture of Nestle Health Science. Steve joined Aimmune after over 5 years in the Life Science M&A practice at Deloitte Consulting where he worked with Pfizer, Johnson & Johnson, Becton Dickinson, ICU Medical, and other companies on M&A growth strategy and integration. Prior to management consulting, Steve worked as a healthcare private equity investor at HealthCor Partners and healthcare investment banker at Merrill Lynch.

Steve received his MBA from The Wharton School at the University of Pennsylvania, and his B.S. in Finance from Carnegie Mellon University.

Dr. Karen Rance, DNP, CPNP, is joining Bryn Pharma as VP, Head of Medical Affairs. She formerly trained as an allergy, asthma, and immunology specialty NP and received her Doctorate in Nursing Practice from the University of Virginia. After 20 years in clinical practice and advising within the Pharmaceutical Industry, she entered the Pharmaceutical Industry full-time. Dr. Rance was formerly the North American Head of Medical Affairs for ALK Abello, a Global Pharmaceutical company specializing in Allergy Immunotherapy. She has impacted the industry with her leadership and innovative approaches to engaging healthcare providers and building medical advocacy. She is regularly an invited speaker at national Medical Affairs conferences and on industry podcasts. She led Industry leaders as the Industry Chair of the Allergy College of Allergy, Asthma, and Immunology Corporate Council between 2018-2020. She received the National Medical Science Liaison Society's top award and national recognition for leading her Medical Science Liaison team in 2022.

While in practice, she served on the National Institutes of Health's National Asthma Education and Prevention Program workgroup and the National Association of Pediatric Nurse Practitioners (NAPNAP) Asthma Clinical Expert Panel. She is the Founding Chair of the NAPNAP's Asthma and Allergy Special Interest Group. She served on the Board of Directors of the National Asthma Education Certification Board, as President of the Indiana Joint Asthma Coalition, and on the Allied Health Leadership Council of the American College of Allergy, Asthma, and Immunology. She regularly presented at National and State Allergy conferences throughout her years in practice, including the American Academy of Allergy, Asthma, and Immunology (AAAAI) and the American College of Allergy, Asthma, and Immunology (ACAAI). She has published in top scientific journals, including the Journal of Allergy and Clinical Immunology (JACI), Journal of Allergy and Clinical Immunology in Practice (JACI-IP), Annals of Allergy, Asthma & Immunology, and Allergy & Asthma Proceedings.

Jeff Evans serves as the Head of Manufacturing Operations, where he oversees all aspects of manufacturing and ensures that all product quality standards are met. He has over 18 years of healthcare medical device experience. Prior to joining Bryn, Jeff held a variety of leadership positions at Johnson & Johnson Vision Care in Supply Chain, Project Management, and R&D. In his most recent role, Jeff led a 130-person R&D New Product Introduction team to develop and deliver clearly defined manufacturing requirements, robust manufacturing processes, and highquality products with world-class technology transfer. A key theme throughout his assignments has been leading cross-functional teams to deliver new product innovation. Throughout his career, Jeff has been involved in multiple launches, including combination drug-device products and the first combination product contact lens. Prior to Johnson & Johnson, Jeff had assignments with General Electric Transportation Systems and was a founding member of a startup business in Homeland Security Consulting with TRC Companies, Inc. After graduating from the United States Military Academy with a degree in mechanical engineering, Jeff served as an infantry officer.

Prior to founding Bryn Pharma, Mr. Hartman was a Partner, Co-Chief Operating Officer, Chief Compliance Officer and General Counsel of a large middle market private equity firm. Mr. Hartman had various roles including participating as a voting member on all investment committees, responsible for all legal aspects of the private equity firm and its portfolio companies, responsible for all firm and portfolio company corporate governance.

Mr. Hartman headed a team of investment professionals responsible for the negotiations of all investment activities from initial investment through investment realization and was responsible for creating complex legal, financial and tax structuring for all of investment activities. Steven was responsible for all domestic and foreign compliance matters for the firm and its affiliates.

Steven earned a BS from UC Berkeley and JD/MBA from UCLA.

Marc Rapaport is the immediate past Chairman of the Board of Directors of Cedars-Sinai Medical Center (2016-2019), currently Chair of the Nominating Committee, and serves on, among others, the Executive Committee, Executive Personnel and Investment Committees. Marc has been active in the hospital’s Sports Spectacular since its inception in 1986 and a member of the Board of Governors for more than 25 years.

After practicing law in Los Angeles, he began his investment banking career at Drexel Burnham Lambert in 1983, where he served in a variety of positions including Executive Vice President and Co-Director of Domestic Capital Markets. In 1990, Marc cofounded the Capital Markets Division of Jefferies and Company, Inc., where he served as Executive Vice President. He was also a director of the Board of Directors of Jefferies and Company, Inc. and a member of the firm’s Executive Committee until 1994.

From 1995 until 1998, Marc was Chairman of the Los Angeles Galaxy and lead investor of L.A. Soccer Partners, LP, the operating group of the Galaxy; he was also one of the founders of Major League Soccer, LLC.

Since 2007, Marc has been the lead investor and Board member of Doctor Evidence, LLC, a specialty software services company operating in the healthcare space.

From 2013 until 2019, Marc was a Principal at Thorofare Capital, LLC an SEC registered investment advisor (RIA) that provides senior commercial mortgage debt to borrowers from of a series of captive Investor raised Funds.

Marc received his juris doctorate degree, cum laude, from Harvard Law School in 1981 and a Bachelor of Science, summa cum laude, from the Wharton School of the University of Pennsylvania in 1978.

With a reputation built on transforming businesses, creative innovation, and driving people culture, Lisa’s storied career has taken her from banking to Barbie, movies to music, Transformers to tech. While getting her Masters Degree in International Finance at Thunderbird, Lisa took a marketing class and became passionate about what drives consumers, switching her focus and leading her to become, at that time, the youngest marketing manager at Mattel, overseeing the Barbie brand internationally.

Parlaying her global marketing expertise, Lisa moved first to 20th Century Fox Home Entertainment, launching Titanic release to #1, then to 20th Century Fox Film as EVP of the global partnerships team, where her accolades included leading The Simpsons Movie's acclaimed marketing campaign, which won Ad Age's Creativity Award and Promotion of the Decade for its transformation of 7-Eleven locations around the country into Simpsons-branded Kwik-E-Marts. After nearly a decade at Fox, Lisa combined her background in toys and entertainment to help Hasbro bring its stable of intellectual properties to film and television with the launch of Hasbro Studios.

When Yahoo came calling, Lisa joined the leadership team as SVP of Platforms and Partnerships. Among many firsts, Lisa launched Live 365, a first-of-its-kind live streaming partnership with Live Nation that delivered live daily concerts from the year's most popular artists to Yahoo users throughout the world. That collaboration's success inspired Live Nation to tap Lisa to lead Strategic Partnerships for the CEO which then transitioned into their first CMO, Live Nation Concerts role.

For the past year, Lisa has been consulting for Microsoft Stores, AllBright, Illumination Animation, the Metrograph and Exploding Kittens on marketing as well as brand partnerships.

Mrs. Soper Diaz represents Tom Gores on the Bryn Pharma Board of Directors. As a senior-level executive at TGFO, Mrs. Soper Diaz provides leadership throughout the organization. Mrs. Soper Diaz is head of Human Resources and is a member of the TGFO Operating Committee and Estate Management Team.

Mrs. Soper Diaz is also Executive Director of the Tom Gores Family Foundation. TGFF focuses on charitable giving and philanthropic endeavors on both a regional and national level, including the Gores Family Allergy Center at Children’s Hospital Los Angeles.

Ms. Whitaker brings more than 30 years of extensive leadership and commercialization experience in pharmaceuticals, consumer products and medical devices to Bryn’s board. She has held senior-level executive leadership roles at Sanofi, GlaxoSmithKline, Bausch Health, and multiple CEO roles for private and public development stage companies. Most recently, Ms. Whitaker served as CEO of Aerami Therapeutics before taking on the Chair of the Board position in November 2020

Ms. Whitaker currently serves as a healthcare-focused advisor for private equity firms and as an independent director on the board of three public companies including Faron Pharmaceuticals (FARN:LSE), Caladrius (CLBS:NASDAQ), and Mallinckrodt. She also serves on the board of Curio Digital Therapeutics, Inc., a privately held women’s health focused digital therapeutics company and the Board of Trustees for the University of North Alabama. Prior to joining Aerami, Ms. Whitaker served in multiple C-suite roles for emerging biotechnology and specialty pharmaceutical companies. Prior to these roles, Ms. Whitaker served as the North America Pharmaceutical Region Head and President for Sanofi from 2011 to 2014, and as Senior Vice President from 2008 to 2011 at GlaxoSmithKline, where she ran their Cardiovascular, Metabolic and Urology business in the US. From 1992 to 2008, Ms. Whitaker held several commercial roles at GSK and a senior level global role as the Senior Vice President, Head of the Organizational and Leadership Development Center of Excellence based in London.

Dr. Dworaczyk has over 35 years of experience in the pharmaceutical, biotechnology, molecular diagnostic, medical device and CRO industry where he has held senior level positions in R&D, Global Operations, Business Development (L&A/M&A), Clinical Development, Strategic Planning, Project Management, Commercial Operations and healthcare analytics. Prior to joining Bryn Pharma, he directed the Life and Health Sciences Strategic Development effort at Oracle. He has also served as COO for Comprehensive Clinical Development, Sr. Vice President, General Manager & COO at Generation Health/MetaDiagnostic, a start-up focused on molecular diagnostics, genomics and personalized medicine, was COO for The Moffitt Cancer Center/M2Gen (for-profit subsidiary) and Sr. VP at Quintiles.

Dr. Dworaczyk's experience is broad and he has had global responsibilities including leading operational functions across multiple business units, genomics/biomarkers, translational research, patient targeted drug development, gene based trial matching, translational research, precision/personalized medicine, healthcare analytics/informatics, population health as well as the integration and effective use of Real World Data/Evidence and “Big/Complex” data.

David earned a B.S and M.S in Molecular Biology from the State University of New York at Buffalo and a PhD in Leadership and Administration from the University of Delaware.

Prior to founding Bryn Pharma, Mrs. Lobel was a Vice President at IDEAL Fastener Corporation. When she began working at IDEAL, the firm was a North American manufacturer facing significant transformation challenges due to offshoring of production by the company’s customer base. Under her direct leadership, the firm initiated and grew to three company owned facilities in China and opened three sales and marketing offices to serve the offshore manufacturing capacity. During this process, Mrs. Lobel spent a full year negotiating and implementing a joint venture with a Chinese Manufacturer, a task with significant cross cultural and operational challenges. Mrs. Lobel’s experience at IDEAL has given her significant experience operating within unstructured entrepreneurial environments and in relentlessly pursuing solutions in a proactive fashion.

Michelle is extremely active in community leadership. She serves on the Board of Directors of the Food Allergy Fund, an organization dedicated to funding food allergy research focused on the underlying causes of food allergies and improved treatments for people with food allergies. Additionally, she volunteers at her children's various schools.

Michelle earned a B.A. in Economics from New York University.

Ms. Loreaux has over 25 years of experience in the pharmaceutical industry. In her last role, she led Bryn Pharma as CEO starting in early 2023, before stepping down for personal reasons. Ms. Loreaux remains on the Board as a valuable resource and advisor for the company and leadership team. Prior to Bryn Pharma, she led Covis Pharma’s U.S. Operations as U.S. President. Sandy joined Covis in November 2021 after previously serving as Senior Vice President and General Manager, U.S. Critical Care for Mallinckrodt Pharmaceuticals. Prior to that, Sandy held Executive level roles as SVP, Head of Market Access at Mallinckrodt Pharmaceuticals and SVP, Head of Market Access, and Commercial Operations at Bausch Health. Ms. Loreaux spent the first 19 years of her career at Sanofi and its legacy companies in various roles of increasing responsibility across medical affairs, sales, marketing, and market access. Ms. Loreaux is a pharmacist by training and has a degree from Temple University School of Pharmacy in Philadelphia. As a mother of children who were diagnosed with life-threatening food allergies as infants, Ms. Loreaux brings a personal passion and commitment to bringing epinephrine delivery alternatives to market.

Mr. Humphries has more than 30 years of experience building and leading commercial-stage pharmaceutical organizations. He is currently the Chief Executive Officer of Isosceles Pharmaceuticals, a position he has held since May 2021. Previously, Mr. Humphries served as President of Ortho Dermatologics, a Bausch Health Company. Before joining Ortho Dermatologics, he served as President and Chief Executive Officer of the North American business of Merz, an affiliate of Merz Pharma Group, where he oversaw strategic direction and collaboration among three North American companies: Merz Pharmaceuticals LLC, Merz Aesthetics Inc., and Merz Pharma Canada Ltd. Before joining Merz, he served in several leadership positions with Stiefel Laboratories, including Chief Commercial Officer and President, where he spearheaded two significant acquisitions and led the global integration of Stiefel into GlaxoSmithKline. Earlier in his career Mr. Humphries served in executive roles in sales and marketing, business development, and international marketing for Allergan, concluding as vice president of its U.S. skincare business.

Jeff Hartness is a dynamic pharmaceutical, healthcare and biotech senior executive with more than 25 years of leadership and sustained success in creating and executing go-to-market strategies. He has launched dozens of products in a multitude of disease states including small molecules, specialty/biologics, devices, OTCs and generics.

Mr. Hartness is currently a member of Bausch Health Company’s (BHC) Global Executive Committee as Senior Vice President and Head of Market Access, Commercial Operations, Policy and Government Affairs. He focuses on the commercialization strategy of pricing, contracting and the creation of patient access to Bausch Health products, as well as the distribution of those products throughout the healthcare system.

Prior to joining Bausch Health, Mr. Hartness spent 15 years at Sanofi (SNY) in various leadership roles, including Product Launch Execution and as the Head of Pharmacy Benefit Managers, Employers and Specialty business. Mr. Hartness currently serves on the Board of Directors for Corganics, a privately held clinical cannabinoid life sciences company based in Dallas, Texas.

Jeff’s diverse background crosses all channels and segments of the pharmaceutical business making him a perfect fit to join our Bryn Pharma team.

Michael Kaseta is currently the Chief Financial Officer of Liquidia Corporation (Nasdaq: LQDA) since November 2020. Mr. Kaseta served as Chief Financial Officer of Aerami Therapeutics, Inc., a private biotech company focused on the development of improved therapies for the treatment of severe respiratory diseases, including pulmonary arterial hypertension, from January 2019 until November 2020, and served as Chief Financial Officer of Aralez Pharmaceuticals Inc., a former specialty pharmaceutical company (“Aralez”) (Nasdaq: ARLZ), from March 2018 until January 2019. Mr. Kaseta previously served as Head of Finance and Interim Chief Financial Officer of Aralez from November 2017 until March 2018 and Corporate Controller from September 2016 until November 2017. Prior to joining Aralez, Mr. Kaseta held various positions at Sanofi S.A., a global biopharmaceutical company focused on human health, including most recently Chief Financial Officer Sanofi North America, Global Services, from April 2015 through September 2016. Mr. Kaseta was previously the Vice President Sanofi NA Pharma Controlling from January 2013 through April 2015, Vice President, Sanofi Financial Shared Services from March 2007 through December 2013 and Director of Technical Accounting from 2005 to 2007. Mr. Kaseta has served as a director of Alimera Sciences, Inc. (Nasdaq: ALIM) since March 2023. Mr. Kaseta holds a BBA in accounting from James Madison University and is a CPA (inactive) licensed in the state of New Jersey.

Dr Lawrence M. DuBuske is affiliate physician at George Washington University Hospital in Washington, DC. He has been director of the Immunology Research Institute of New England in Gardner, Massachusetts, since its founding in 1989. He also serves as consulting physician at UMass Memorial Health – HealthAlliance-Clinton Hospital in Leominster, Massachusetts.

He earned his medical degree from Northwestern University in Chicago, Illinois. Following a residency in internal medicine at Barnes Hospital, Washington University in St. Louis, Missouri, he completed fellowships in allergy/immunology and rheumatology at Brigham and Women’s Hospital, Harvard Medical School in Boston.

Dr DuBuske has authored more than 300 articles and abstracts in peer-reviewed journals and numerous reviews and textbook chapters. He has been an investigator in more than 80 clinical trials and is an internationally acclaimed expert speaker on many topics, including allergic rhinitis, antihistamines, asthma, allergic diagnostics, allergen immunotherapy, latex allergy, and new therapies for allergic diseases, such as anti-IgE monoclonal antibodies and toll-like receptor 4 agonist-modulated allergen immunotherapy. He is a fellow of the American Academy of Allergy, Asthma, and Immunology and the American College of Allergy, Asthma, and Immunology and a member of the European Academy of Allergy and Clinical Immunology.

Dr Michael Pistiner is Director of Food Allergy Advocacy, Education, and Prevention for Mass General for Children’s Food Allergy Center in Boston, Massachusetts.

He earned his medical degree from the State University of New York Upstate Medical University in Syracuse, New York. He then completed his residency at NewYork-Presbyterian Hospital in New York, New York, followed by his allergy and immunology fellowship at Boston Children’s Hospital.

Board certified in allergy and immunology and pediatrics, Dr Pistiner’s clinical interests include infant food allergy and anaphylaxis prevention and management. He has coauthored numerous articles in peer-reviewed journals. He is a fellow of the American Academy of Pediatrics and a member of the American Academy of Allergy, Asthma, and Immunology and the American College of Allergy, Asthma, and Immunology.

Dr Michael S. Blaiss is clinical professor of pediatrics at the Medical College of Georgia at Augusta University in Augusta, Georgia. He also serves as an allergist at Good Samaritan Health Center of Gwinnett in Norcross, Georgia.

Dr Blaiss earned his medical degree from the University of Tennessee Center for Health Sciences in Memphis, Tennessee, followed by his residency at Le Bonheur Children’s Medical Center and fellowship in allergy/immunology at Ochsner Medical Foundation in New Orleans, Louisiana.

Board certified in pediatrics and allergy and immunology, Dr Blaiss has published more than 175 scientific peer reviewed articles and presented at more than 500 meetings and seminars throughout the world. He has also been a member of the editorial boards for the Annals of Allergy, Asthma, and Immunology, World Allergy Organization Journal, Journal of Asthma, Allergy and Asthma Proceedings, Hypersensitivity, and American Journal of Rhinology and Allergy. He is a past president of the American College of Allergy, Asthma, and Immunology (ACAAI) and has served on the board of directors for the American Board of Allergy and Immunology and the World Allergy Organization. In addition, Dr Blaiss has been president of the Tennessee and Louisiana Allergy Societies. He is a fellow of the American Academy of Allergy, Asthma, Immunology and ACAAI.

Dr. Dana Wallace has been practicing in the allergy field in Fort Lauderdale, Florida for more than 30 years. She has been with the Florida Center for Allergy & Asthma Care since August 2012 and works in the Emerald Hills office. Dr. Wallace is an Assistant Clinical Professor at Nova Southeastern University in Davie, Florida and at Florida Atlantic University in Boca Raton, Florida. She is a graduate of the University of Tennessee’s College of Medicine and completed a residency at Lenox Hill Hospital and a fellowship in Allergy and Immunology at Roosevelt Hospital. She is board certified in pediatrics and allergy/immunology. Dr. Wallace is immediate-past president of the American College of Allergy, Asthma & Immunology (ACAAI), currently on the World Allergy Organization Board of Directors, and has received the ACAAI Distinguished Service Award and the ACAAI Woman in Allergy Award. She is the ACAAI Website Associate Editor, ACAAI representative to the CDC Food Allergy/Anaphylaxis in School Task Force, Anaphylaxis Community Education Volunteer, and a member of the Finance, Budget, Nomination Committees, and ACAAI Foundation Board of Directors.

Dr Katherine Anagnostou is the Director of the Food Immunotherapy Program at Texas Medical Center and senior faculty at Baylor College of Medicine in Houston, Texas.

She earned her medical degree from Aristotle University in Thessaloniki, Greece. She then completed her residency in pediatrics at London School of Pediatrics and Child Health in England, where she also completed her fellowship in pediatric allergy and immunology. Dr Anagnostou earned her PhD from the University of Cambridge in Cambridge, United Kingdom.

Dr Anagnostou’s research interests include food immunotherapy, infant anaphylaxis, microbiome, and food allergy prevention. She had presented both nationally and internationally. She is a fellow of the American Academy of Allergy, Asthma, and Immunology and the American College of Allergy, Asthma, and Immunology, and she is a member of the European Academy of Allergy and Clinical Immunology.

Dr J. Wesley Sublett is a partner and director of clinical research at Family Allergy and Asthma based in Louisville, Kentucky, with 37 offices throughout Kentucky, Indiana, and Ohio.

He earned his medical degree from the University of Louisville School of Medicine followed by his internship and residency in pediatrics at the University of Louisville–Kosair Children’s Hospital. He completed his fellowship in allergy and immunology at the University of Cincinnati.

Board certified in both pediatrics and allergy and immunology, Dr Sublett has authored numerous scientific papers and book chapters in the field of allergy and immunology. He has extensive clinical trial experience and is an invited lecturer regionally and nationally. Currently, Dr Sublett serves as president of the Greater Louisville Allergy Society and chair of the American College of Allergy, Asthma, and Immunology (ACAAI) Drug and Anaphylaxis Committee. He is a fellow of ACAAI and a member of the American Academy of Allergy, Asthma, and Immunology.

Dr Matthew Greenhawt is a professor in the Department of Pediatrics, Section of Allergy and Immunology at Children’s Hospital Colorado and the University of Colorado School of Medicine in Aurora, Colorado. He also serves as director of the Food Challenge and Research Unit at Children’s Hospital Colorado.

Dr Greenhawt earned his medical degree from Tufts University School of Medicine in Boston, Massachusetts. He then completed his residency in pediatrics at NewYork-Presbyterian Morgan Stanley Children’s Hospital and NewYork-Presbyterian Columbia University Irving Medical Center in New York, New York, followed by his fellowship in allergy and clinical immunology at the University of Michigan in Ann Arbor, Michigan. He also earned his Master of Business Administration degree from Tufts University and his Master of Science degree in health and healthcare policy from the University of Michigan.

Board certified in pediatrics and allergy and immunology, Dr Greenhawt’s research interests include shared decision making, food-allergic diseases health services research, and food allergy public policy. He has authored numerous peer-reviewed articles, abstracts, and book chapters. He is a member of the American Academy of Allergy, Asthma, and Immunology, the American College of Allergy, Asthma, and Immunology, and the American Academy of Pediatrics.

Dr Vivian Hernandez-Trujillo is clinical professor at Florida International University Herbert Wertheim College of Medicine in Miami, Florida. She also serves as medical director for the Division of Allergy and Immunology at Nicklaus Children’s Hospital (formerly known as Miami Children’s Hospital) in Miami. She is also founder of Allergy and Immunology Care Center of South Florida in Miami Lakes.

She earned her medical degree from Albany Medical College in Albany, New York. She then completed her pediatric residency at Nicklaus Children’s Hospital, followed by her allergy and immunology fellowship at The University of Tennessee Health Science Center, Le Bonheur Children’s Hospital, and St. Jude Children’s Hospital in Memphis, Tennessee.

Board certified in pediatrics and allergy and immunology, Dr Hernandez-Trujillo’s clinical and research interests include food allergy, anaphylaxis, and primary immunodeficiency disorders. She has lectured both nationally and internationally and has authored numerous articles in peer-reviewed journals and textbook chapters. She is a fellow of the American Academy of Pediatrics, the American Academy of Allergy, Asthma, and Immunology, and the American College of Allergy, Asthma, and Immunology.

Dr Jay A. Lieberman is associate professor in the Department of Pediatrics at the University of Tennessee Health Science Center in Memphis, Tennessee. He also serves as staff physician at Le Bonheur Children’s Hospital in Memphis.

Dr Lieberman earned his medical degree from the University of Tennessee Health Science Center. He then completed his residency in internal medicine at Washington University in St. Louis, Missouri, followed by a fellowship in allergy and immunology at Mount Sinai Hospital in New York, New York.

Board certified in internal medicine and allergy and immunology, Dr Lieberman’s clinical interests include food allergy, eosinophilic esophagitis, primary immune deficiencies, and common variable immune deficiency. He has coauthored numerous articles in peer-reviewed journals and a book chapter. He currently serves as chair of the Food Allergy Committee for the American College of Allergy, Asthma, and Immunology (ACAAI), member of the Joint Task Force Practice Parameter Committee, executive board member on the American Board of Allergy, Asthma, and Immunology, and as an associate editor for the Annals of Allergy, Asthma, and Immunology. He is a fellow of the American Academy of Allergy, Asthma, and Immunology and ACAAI.

Dr David M. Fleischer is director of the Allergy and Immunology Center and section head of Allergy and Immunology at Children’s Hospital Colorado in Aurora, Colorado. He also serves as associate professor of pediatrics at Children’s Hospital Colorado and the University of Colorado School of Medicine in Aurora.

Dr Fleischer earned his medical degree from Emory University School of Medicine in Atlanta, Georgia. He then completed his residency and fellowship in pediatrics at The Johns Hopkins University School of Medicine in Baltimore, Maryland.

Board certified in pediatrics and allergy and immunology, Dr Fleischer’s research interest includes treatments for food allergy. He has authored numerous peer-reviewed articles and has lectured both nationally and internationally. He is a fellow of the American Academy of Allergy, Asthma, and Immunology and the American College of Allergy, Asthma, and Immunology and a member of the European Academy of Allergy and Clinical Immunology.

Dr. J. Wesley Sublett is a partner and medical director of clinical research at Family Allergy & Asthma, based in Louisville, Kentucky, with multiple offices throughout Kentucky, Indiana, Ohio, and Tennessee. He is a graduate of Saint Louis University (MPH) and the University of Louisville School of Medicine. Board certified in both pediatrics and allergy/immunology, Dr. Sublett completed his internship and residency in pediatrics at the University of Louisville – Kosair Children’s Hospital. He completed his fellowship in allergy, asthma, and immunology at the University of Cincinnati. Currently, Dr. Sublett serves on the ACAAI Board of Regents, is president of the Greater Louisville Allergy Society, and is the chair of the ACAAI Drug and Anaphylaxis Committee.

Dr David I. Bernstein is professor emeritus of medicine with the Department of Internal Medicine at the University of Cincinnati College of Medicine. He is also principal investigator at Bernstein Clinical Research Center, LLC, in Cincinnati, Ohio.

Dr Bernstein earned his medical degree from University of Cincinnati College of Medicine, followed by his residency in internal medicine at Cleveland Clinic Hospital. He completed his allergy subspecialty training in adult and pediatric allergy and clinical immunology at Northwestern University Medical Center in Chicago, Illinois.

His research center has conducted more than 900 clinical trials in adult and pediatric patients for asthma, seasonal and perennial allergic rhinitis, eczema, hives, atopic dermatitis, chronic obstructive pulmonary disease, hereditary angioedema, chronic cough, and sublingual immunotherapy. Board certified in diagnostic laboratory immunology, Dr Bernstein is a fellow of the American Academy of Allergy, Asthma, and Immunology, the American College of Allergy, Asthma, and Immunology, and the American College of Physicians.

Max M. April, MD, FAAP, FACS is Professor of Otolaryngology and Pediatrics at NYU Langone Health in New York City. He attended medical school at Boston University and his residency in Otolaryngology at the combined Boston University/Tufts University program followed by a fellowship in pediatric otolaryngology at Johns Hopkins Hospital in Baltimore. He has over 60 peer reviewed publications and has presented numerous papers and talks regionally, nationally and internationally. He is a co-host of the ENT show on Doctor Radio on Sirius XM.

Tim Warneke has over 25 years of pharmaceutical development experience. These experiences range across large (Ciba-Geigy and Abbott Laboratories) to mid-size (King Pharmaceuticals) pharmaceutical companies and the world’s largest contract research organization (Quintiles). Mr. Warneke has leveraged his expert knowledge of the Code of Federal Regulations, ICH Guidelines, Good Clinical Practice and Good Laboratory Practice to provide operational excellence in support of numerous INDs and NDAs throughout his career.

Operationally focused, he has been responsible for clinical study conduct across all phases of pharmaceutical development from single center studies to large multi-national clinical trials utilizing a wide array of therapeutic areas including: Cardiology/Vascular Diseases, Dermatology, Devices, Endocrinology, Gastroenterology, Healthy Volunteers, Hepatology (Liver, Pancreatic, Gall Bladder), Infections and Infectious Diseases, Musculoskeletal, Nephrology, Neurology, Oncology, Orthopedics/Orthopedic Surgery, Pediatrics Podiatry, Psychiatry/Psychology, Pulmonary/Respiratory Diseases, Rheumatology and Vaccines.

Mr. Warneke began his career at Northwestern University in the Department of Community Health and Preventive Medicine coordinating the clinical activities of the landmark NHLBI funded CARDIA study from its initial year in 1983 to 1988.

Kenneth Dretchen, Ph.D. is currently the Chief Science Officer and Vice President for Mesa Science Associates. The company provides consulting services to academic institutions and the pharmaceutical industry in providing expertise in all aspects of the drug approval process. He previously served as a Professor (40 years) and Chairman (16 years) of the Department of Pharmacology and Physiology at Georgetown University Medical Center prior to his retirement in 2016. He currently hold the title of Professor Emeritus and continues to teach at the Medical School. Previously at Georgetown University, Dr. Dretchen had direct responsibility for the Animal Care and Use Committee, the Institutional Review Board, Radiation Safety and all research involving biohazards. He has also served as the Dean of Research for the Medical Center and the Senior Associate Vice President for Regulatory Affairs having oversight of all the pre-clinical and clinical research activities. Over the last twenty years he has investigated the toxicity of the major chemical and biological threat agents and served as the liaison for the university to the federal government for all of the regulatory aspects associated with the entire research portfolio.

During the first three years of its existence, Dr. Dretchen served as a subject matter expert and was a 24/7 on call advisor to the Department of Homeland Security for biologic and chemical threat agents. From 2007 – 2010 he served as a member of the National Biodefense Science Board reporting directly to the Secretary of Health and Human Services. This board provided advice to the secretary on issues such as emerging and infectious diseases, chemical and biological threat agents, and H1N1 influenza.

Dr. Dretchen’s work also includes successful collaborations with industry including one of the largest defense contractors in the development of a rapid stand-alone detection system for biological threat agents based upon DNA analysis. This project resulted in the important development of specific nucleic acid probes for anthrax, plague and dengue fever. His accomplishments also include the characterization of the toxin, Ricin. He has published approximately 150 articles in peer reviewed high impact journals such as Science and Nature in areas related to neuropharmacology, neurotoxicology and pharmacokinetics.

Dr. Dretchen served as a consulting pharmacologist for King Pharmaceuticals on a study involving clinical trials to assess the pharmacokinetics and side effects of midazolam given intramuscularly via an auto-injector. Several years ago Dr. Dretchen was appointed to the Scientific Board of Ameritox Ltd. Ameritox Ltd. provides rapid urine drug monitoring. He was an investigator in a clinical trial sponsored by the company describing the identification of a new metabolite of aripiprazole (Abilify) in urine that was correlated with the oral administration of the parent drug. He currently serves as a Co-Investigator for the subcontract awarded by the University of California San Diego to Mesa Science Associates for their multi-center National Institutes of Health grant dealing with the development of antidotes against cyanide poisoning.

Dr. Claude Piché is a co-founder and the President and CEO of Locemia Solutions. At Locemia, Claude led the creation and development of Baqsimi, a needle-free, nasal formulation of glucagon for the treatment of severe hypoglycemia. Eli Lilly acquired the product in late 2015 and is launching the product globally. Prior to forming Locemia, Claude worked at private, public, and start-up biopharmaceutical companies with hands-on experience in research, regulatory affairs, marketing, operations and business development.

Claude is an active angel investor and serves as an advisor and/or board member to several biopharmaceutical start-ups.

He holds degrees from the University of Saskatchewan (DVM) and the University of Calgary (MSc). He is the author or co-author of over 30 peer-reviewed scientific publications and over 40 scientific abstracts and presentations. He is also a co-inventor on several patent applications.

Robert Oringer has over 35 years of experience as an entrepreneur, investor, and board leader in healthcare, primarily in diabetes medical devices, drug delivery, and services. Thanks to his extensive experience, as well as his strong background in enabling technologies, Robert brings a unique perspective in guiding development of novel products and approaches to the self-management of diabetes and its complications.

Robert is Chairman of Locemia Solutions, Inc., a Montreal-based specialty pharmaceutical company whose initial work was directed at making severe hypoglycemia rescue simple through the development of an innovative needle-free glucagon nasal powder that is easy to teach, easy to carry, and easy to use. Locemia’s glucagon nasal powder assets were sold to Eli Lilly in October, 2015 and have subsequently been approved for sale in 2019 under the brand name BAQSIMI by the USA FDA and Health Canada.

Robert is an active early stage diabetes investor, having been involved in the funding of companies such as Agamatrix (Salem, New Hampshire), Bigfoot Biomedical (Palo Alto, California), Glysens (San Diego, California), WellDoc (Baltimore, Maryland), HelpAround (Tel Aviv, Israel), Biolinq (San Diego, California) and dLife (acquired by Veria Living in 2014). He is a board advisor at AgaMatrix and HelpAround, providing guidance on the development of innovative technologies, as well as product, marketing, and business development strategies.

Robert received his Bachelor’s degree with a concentration in Entrepreneurial Management from the Wharton School of the University of Pennsylvania.

Dr. Melinda Braskett is the Associate Medical Director of the Gores Family Allergy Center at Children's Hospital Los Angeles and an Assistant Professor in Clinical Pediatrics at Keck School of Medicine at University of Southern California. She is a board certified allergist and clinical immunologist. She is also board certified in pediatric medicine.

Dr. Braskett graduated with honors from the College of Physicians and Surgeons at Columbia University in New York City. She completed her internship and residency at Children’s Hospital Los Angeles, and her fellowship in Clinical Immunology and Allergy at the David Geffen School of Medicine at UCLA. Prior to coming to CHLA in February of 2016, she was an Assistant Clinical Professor at UCLA where she refined her expertise in high risk food and drug allergy procedures as Medical Director of the UCLA Food and Drug Allergy Care Center. Her clinical focus includes oral immune therapy (OIT) for food allergy and eosinophilic food allergies.

Following a four-year tour in the U.S. Air Force, Mr. Mesa joined Rodana Research Corporation and until 2011 was continuously employed by Rodana and its successor organizations including: Survival Technology Inc., Meridian Medical Technologies Inc., King Pharmaceuticals Inc. and Pfizer. While at these companies Mr. Mesa was one of the named inventors of the device that became known as the EpiPen© Next Generation. In 2011, Mr. Mesa left Meridian/Pfizer and formed Mesa Science Associates where he serves as President and CEO.

During Mr. Mesa’s career, he played key roles in the development of both the original and the next generation EpiPen© and EpiPen Jr© auto-injectors. In the epilepsy field he managed the development of auto-injectors and training materials for two important epilepsy studies: the NIH funded RAMPART© Study and the King Pharmaceuticals RESCUE© Study.

Mr. Mesa served as Meridian Medical Technologies primary technical interface with the U.S. Military Chemical Biologic Medical Systems/Medical Identification and Treatment Systems (CBMS/MITS) for pharmaceutical and drug delivery programs. He was the principal investigator for the development of the Antidote Treatment Nerve Agent Auto-Injector (ATNAA). His work with the ATNAA program eventually led to an FDA approved companion product, The DuoDote© Auto-Injector. The DuoDote© is now available in the U.S. for use by first responders in the event of a chemical attack against the civilian population. Most recently he successfully managed the midazolam based Advanced Anti-Convulsant (AAS) clinical program intended for military use.