Our mission is to advance the treatment paradigm for mucus mediated lung diseases.

Jogging patient on beach

Aer Therapeutics is a clinical-stage biopharmaceutical company dedicated to delivering a therapeutic solution to patients suffering from muco-obstructive lung diseases.

Our initial focus is chronic obstructive pulmonary disease (COPD) with other muco-obstructive lung diseases to follow, including asthma, cystic fibrosis, primary ciliary dyskinesia, and non–cystic fibrosis bronchiectasis.

Aer Therapeutics is a clinical-stage biopharmaceutical company dedicated to delivering a therapeutic solution to patients suffering from muco-obstructive lung diseases.

Our initial focus is chronic obstructive pulmonary disease (COPD) with other muco-obstructive lung diseases to follow, including asthma, cystic fibrosis, primary ciliary dyskinesia, and non–cystic fibrosis bronchiectasis.

Our Company’s Background

Our technology was developed in Dr. John Fahy’s airway biology laboratory at the University of California San Francisco (UCSF) in collaboration with Dr. Stefan Oscarson’s glycochemistry laboratory at University College Dublin and Dr. Anne Marie Healy’s pharmaceutics laboratory at Trinity College Dublin. The efforts of this research consortium have led to over $18M in NIH funding, resulting in the identification of our lead therapeutic candidate (AER-01), establishment of preliminary safety and efficacy profiles, and the production of clinical trial API.

Aer Therapeutics Team

We are led by an experienced management team with an established track record of success in the development of drug-candidates.

Management Team

Irina Gitlin

Irina Gitlin, PhD

Vice President, Research and Development

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Blair Capel

Director of Finance

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Rony Nasrallah

Associate Director, Technical Operations

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Jordan Low

Director of Clinical Operations

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Board of Directors

John Fahy MD MSc

Founder

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Rishi Gupta, JD

Partner, OrbiMed

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Thomas P. Mathers

Executive Chairman

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Christy Shaffer, PhD

Partner, Hatteras Ventures

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Tim Shannon, MD

Partner, Canaan Partners 

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Investors

Anne Marie Healy

Trinity College Dublin

Dr. Healy holds a personal Chair of Pharmaceutics and Pharmaceutical Technology in the University of Dublin, Trinity College Dublin (TCD) and an Adjunct Professor appointment in the School of Chemical and Bioprocess Engineering in University College Dublin. She has a B.Sc. in Pharmacy and a Ph.D. in Pharmaceutics, both from the University of Dublin.

She joined the School of Pharmacy, TCD in 1992 as a Lecturer in Pharmaceutics. In 2010 she was elected Fellow of Trinity College. Professor Healy’s research is focused on obtaining an increased understanding of the physicochemical properties of active and excipient materials used in a variety of different dosage forms, and on harnessing that knowledge to improve product design in terms of in vitro and subsequently in vivo performance.

Jordan Low

Director of Clinical Operations

Jordan joined Aer Therapeutics as Director of Clinical Operations in April 2023.  He has successfully managed all phases of clinical trials in the US and globally during his 10+ years of experience working in clinical research.

Throughout his career, Jordan has worked at both small and large companies, but he has a special affinity for life science startups. Prior to his current role, Jordan was leading the Clinical Operations Department at Avalyn Pharma working to develop an inhaled anti-fibrotic therapy for interstitial lung disease. Jordan received his B.S. in Biology from the University of Washington.

Rich Franco

Head of Operations and Strategy

Rich joined Aer Therapeutics as Head of Operations and Strategy in May 2023.

In his over 30 years of experience in the industry he has worked for both emerging and large companies in a wide array of capacities. In his most recent role at Eiger BioPharmaceuticals he served as Chief Regulatory Affairs Officer, and oversaw the US, EU, and UK submissions and approvals of Zokinvy (lonafarnib) for the treatment of Progeria. Zokinvy is the first and only drug approved to extend the survival of patients with Progeria.

While at Eiger he also led the company’s regulatory efforts across a diverse pipeline of small and large molecules. Rich also served as VP and GM of Bausch Health’s hospital and pain divisions where he oversaw the approval and launch of Relistor tablets (methylnaltrexone bromide), hospital/GPO contracting, and a national sales team.

Before joining Bausch he was an Officer at Sprout Pharmaceuticals where he played an important role in guiding Addyi (flibanserin) through a successful advisory committee decision, the building of a comprehensive REMS program, and FDA approval. Addyi was the first drug approved for female sexual dysfunction. Early in his career he spent over a decade at GSK serving in positions of increasing responsibility.

Rich received Bachelor of Art degrees in Marketing and Communications from Michigan State University. He received his Master of Business Administration from the University of North Carolina, Chapel Hill.

Rony Nasrallah

Rony Nasrallah

Associate Director, Technical Operations

Rony Nasrallah is an Associate Director of Technical Operations leading CMC activities at Aer Therapeutics.

Prior to his current role, he lead external drug substance manufacturing efforts and supported process and analytical development as a Senior Specialist in CMC at Istari Oncology, an RTP based clinical stage immunotherapy company. He also served as a BioProcess Engineer at Novartis Gene therapies where he supported site start-up, clinical manufacturing, and process validation for ZOLGENSMA®.

Rony received his B.S. in Biomedical Engineering from North Carolina State University and his PMP certification from the Project Management Institute.

Blair Capel

Blair Capel

Director of Finance

Blair joined Aer Therapeutics as Director of Finance in January 2023. Prior to Aer, Blair served as Director of Finance at Locus Biosciences, an RTP based company developing bacteriophage-based precision medicine.

Blair has a background in finance and accounting and prior to his biotech experience he was in business valuation consulting at Deloitte & Touche and public accounting at PwC. Blair has a Master of Accounting degree from the University of Southern California. Blair also passed the CPA exam in California although he is not actively licensed.

Kelly Otto

Kelly Otto

Head, Research and Development

Kelly has over 25 years of industry experience and over 15 years working in respiratory diseases. In her current role as Head of Clinical Development, Kelly provides strategic direction for the executive team and oversite and leadership for clinical development activities at Aer.

Prior to her current role, Kelly was Senior Vice President of Clinical Development and Operations at Avalyn Pharma working to develop an inhaled anti-fibrotic therapy for interstitial lung disease.  Over her career, she has worked with the Cystic Fibrosis Foundation Clinical Trials Network and was instrumental in the development and approval of the inhaled antibiotic therapies Cayston® at Corus and TOBI® at PathoGenesis, both for the treatment of pseudomonal airway infections in patients with cystic fibrosis.  At Amgen, she supported the approval of the BLA for NEUPOGEN®.

During her career, Kelly has been responsible for teams with a wide array of clinical development functions and involved in all phases of development. Kelly has been on teams leading to 4 FDA approvals, and has participated in meetings with advisory boards as well as US, EU, and UK regulatory authorities.

Kelly received her Master’s degree In Statistics from Florida State University.

Mark Dransfield, MD

Dr. Dransfield is Professor of Medicine and the Director of the Division of Pulmonary, Allergy and Critical Care. He completed his medical degree at the University of North Carolina at Chapel Hill in 1997, followed by residency in internal medicine and fellowship training in pulmonary and critical care medicine at the University of Alabama at Birmingham, where he served as Chief Fellow. He has been on the faculty at UAB since 2003. Dr. Dransfield is also the Ben Branscomb Endowed Chair in Pulmonary Disease and the Medical Director of the UAB Lung Health Center and a member of the both the American Society of Clinical Investigation and Southern Society of Clinical Investigation. Dr. Dransfield's primary clinical interests include chronic obstructive pulmonary disease (COPD) and lung cancer.

Thomas P. Mathers

Thomas P. Mathers

Executive Chairman

Tom Mathers is the co-founder of Allievex Corp. and serves as its President and CEO, and director. He is also a partner at Pappas Capital, a dedicated life science venture capital firm focused exclusively on investing in the life sciences sector, where Tom focuses primarily on company formation.

Prior to Pappas Capital and Allievex, Tom was the President and CEO of CoLucid Pharmaceuticals, Inc. (NASDAQ: CLCD), which focused on the development of lasmiditan for the acute treatment of migraine headaches. Eli Lilly & Company acquired CoLucid in March 2017 in an all-cash transaction for $1 billion. Prior to CoLucid, Tom was President and CEO of Peptimmune, Inc.; President and CEO of Cell Based Delivery, Inc.; Vice President and General Manager of Cardion AG; and Vice President of Strategic Development at Genzyme Corporation.

Tom currently serves as on the board of directors for the Biotechnology Industry Organization, where he is active in the areas of capital formation, bioethics, intellectual property, and regulatory policy. He also serves as a business advisor to the Progeria Research Foundation, DADA2 Foundation and is currently serving on the Department of Veteran’s Affairs Research Advisory Committee on Gulf War Veterans’ Illnesses. Previously, he has served as a Trustee of Butler University, as a director for LifeSci Acquisition Corporation II (NASDAQ: LSAQ), which was acquired in 2021 by Science37 (NASDAQ: SNCE), and as a board observer for 4D Molecular Therapeutics, Inc. (NASDAQ: FDMT). 

From 1988 to 1991, Tom served as a captain in the United States Army and was awarded several medals for his services as an AH-64 Apache helicopter pilot in the Gulf War.

Education:
United States Military Academy at West Point (BS in Engineering)

Christy Shaffer, PhD

Partner, Hatteras Ventures

Seasoned entrepreneur and biotech executive, Christy Shaffer, Ph.D. has 30 years of experience in the life science industry. Following her career as a clinical scientist, international project leader and Associate Director of Pulmonary and Critical Care Medicine at Burroughs Wellcome Co., she joined Inspire Pharmaceuticals in 1995 as the first, full-time employee. She was responsible for raising over $300m for the company, including taking the company public in 2000. As President and CEO, Christy grew the company from 20 scientists to nearly 250 employees with revenues of over $100 million. Under her leadership, Inspire was named as “Best Place to Work for Scientists” by the Scientist magazine, and “Best Place to Work in North Carolina.” Christy retired from Inspire in 2010 and the company was acquired by Merck in 2011. She joined Hatteras in 2011 as the Managing Director of Hatteras Discovery and became a general partner in 2016.  

Christy currently serves as a board member of five Hatteras portfolio companies: Artizan Biosciences (Chair), Clearside Biomedical, Aer Therapeutics, Trefoil Therapeutics, and Perfuse Therapeutics. Christy is a receptor pharmacologist by training, earning her Ph.D. in Pharmacology from the University of Tennessee Health Science Center, Memphis TN in 1985. She received her post-doctoral training at The Chicago Medical School and the University of North Carolina at Chapel Hill.

Rishi Gupta

Rishi Gupta, JD

Partner, OrbiMed

Rishi is a Partner at OrbiMed. In addition to Aer, he serves or has served on the boards of Enliven Therapeutics, Verona Pharma, Charm Therapeutics, DELFI Diagnostics, Pionyr Immunotherapeutics, Turnstone Biologics, Modis Therapeutics, NeuroPace, Avitide, Dimension Therapeutics, Symbiomix Therapeutics, ChemoCentryx, and Sientra. Rishi has also been actively involved with OrbiMed’s investments in Acceleron Pharma, CoGenesys, Supernus Pharmaceuticals, Adimab, Receptos, Aragon Pharmaceuticals, Seragon Pharmaceuticals, Alector, Arsanis, Biotie, Invitae, and ORIC Pharmaceuticals. Prior to OrbiMed, Rishi worked as a healthcare investment banker at Raymond James & Associates, a Manager of Corporate Development at Veritas Medicine, and was a summer associate at Wachtell, Lipton, Rosen & Katz.

Rishi received a J.D. from Yale Law School and an A.B. in Biochemical Sciences from Harvard College. 

Tim Shannon

Tim Shannon, MD

Partner, Canaan Partners

Over the past 30 years, Dr. Timothy Shannon has been an entrepreneur, executive, researcher, professor, and practicing physician. He also serves or has served on the boards of several Canaan portfolio companies, including Halda Therapeutics, Arvinas, CytomX , IDEAYA Biosciences, NextCure, RallyBio, Normunity, Novira Therapeutics, Civitas Therapeutics, and Vivace Therapeutics.

Previously, Dr. Shannon was President and Chief Executive Officer of CuraGen, a biopharmaceutical company focused on oncology, after serving as Executive Vice President of R&D and Chief Medical Officer. He also held positions of increasing responsibility for Bayer’s Pharmaceutical Business Group, including Senior Vice President of Global Medical Development. Prior to his career in industry, he was an Assistant Professor in the Pulmonary and Critical Care Division at Yale University School of Medicine.

Dr. Shannon received his B.A. in Chemistry from Amherst College, his medical degree from the University of Connecticut, and completed his postgraduate medical training at the Beth Israel Hospital of Harvard Medical School and Boston University.

Stefan Oscarson

University College Dublin

Stefan Oscarson is Professor in Chemical Biology at University College Dublin (UCD), Ireland, a position he was recruited to in 2006, funded by a SFI (Science Foundation Ireland) Professor Recruitment Grant, to build up a Medicinal Chemistry & Chemical Biology BSc programme and Chemical Biology research within the newly started Centre for Synthesis and Chemical Biology (CSCB).

Stefan’s research area is carbohydrate chemistry and glycoscience, both at a pure and applied level, with focus on development of new protecting group and glycosylation methodologies as well as synthesis of biologically active glycans and glycoconjugates. Stefan has collaborated with multiple major vaccine companies (Pfizer, Novartis, Aventis-Pasteur, and GSK) on vaccine research. Stefan received his undergraduate training at Stockholm University (SU) (BSc in Chemistry, Mathematics, and Physics, 1978, and a MSc in Microbiology). He conducted his post-graduate studies in Organic Chemistry at SU in the internationally renowned carbohydrate research group supervised by Professors Bengt Lindberg and Per Garegg, being awarded his PhD in 1985. 

Jim Shaffer

President and CEO

Jim is a seasoned biotech executive with over 25 years of experience working for emerging biotechnology and large pharma companies. Jim joins us from Eiger Biopharmaceuticals, a publicly traded company, where he served as Chief Business Officer from August 2014 to July 2021.

Jim initially led corporate development and the IPO process for Eiger raising over $200M from 2015-2019. He was also responsible for Global Business Development/ Alliance Management, Commercial Analysis and Manufacturing for five orphan drug programs and four separate products including small molecules, a large molecule and a peptide. Jim was responsible for negotiating multiple technology and product licenses from Stanford, UPenn/CHOP, Merck, BMS, JNJ, and Nippon Kayaku.

Additionally, Jim served as Chief Commercial Officer at Clinical Data and Halozyme Therapeutics from 2007 to 2011 and 2011 to 2014, respectively. While at Clinical data, Jim was responsible for creating and executing the plan that led to the company’s sale to Forest Labs in 2011 for $1.2B. Prior to joining Clinical Data, Jim served as the Vice President of Sales and Marketing for New River Pharmaceuticals wherein led the launch plan for Vyvanse (lisdexamfetamine dimesylate) for the treatment of ADHD. He supported the sale of the company to Shire for $2.6B in 2007. Jim earned an M.B.A. from the Fisher School of Business as well as a B.S. from The Ohio State University.

Mark Eisner

CMO – Fibrogen, Genentech

Dr. Eisner is the Chief Medical Officer FibroGen where he oversees all global clinical development and regulatory affairs for FibroGen. Dr. Eisner brings nearly 30 years of academic, biopharmaceutical, and drug development experience, from early clinical phase through post-commercialization. Prior to joining FibroGen, Dr. Eisner was at Genentech, a member of the Roche Group, and was Senior Vice President and Global Head of Product Development Immunology, Infectious Disease, and Ophthalmology. ​He received his M.D. degree from the University of Pennsylvania School of Medicine. He also received a M.P.H. degree from the University of California, Berkeley School of Public Health.

Maarten Kraan

CMO – AM Pharma

Dr. Maarten Kraan bring over 25 years of biopharmaceutical industry experience to Aer, with previous senior roles in clinical development of respiratory products. Dr. Kraan is currently a full time CMO with AM-Pharma, a company with late-stage clinical development programs in acute kidney injury. Before joining AM-Pharma, Maarten was at Pierre Fabre S.A., a multinational pharmaceutical company, where he was the head of Research & Development and responsible for the R&D strategy (France). Dr. Kraan is a board-certified rheumatologist and holds an M.D. and Ph.D. in Immunology from Leiden University.

Mario Castro

University of Kansas

Dr. Castro is a renowned expert in asthma management and clinical trials. He serves as the principal investigator for the Kansas City site of the American Lung Association Asthma Clinical Research Centers (ACRC) and Chairs the Protocol Committee for ACRC. He is studying what makes severe asthma different from milder forms in the Severe Asthma Research Program (SARP). He is also studying potentially new treatments and biomarkers for severe asthma in the Precision Interventions for Severe and Exacerbation-prone asthma (PrecISE) study. Lastly, he is using new imaging techniques, such as CT and hyperpolarized gas MRI, to study how the lung remodels in asthma and as a potential target for treatment.  

Colin Reisner

CEO and Co-Founder – DevPro Biopharma

Colin is a physician and innovative leader with more than 25 years of international experience at large pharmaceutical companies and start-up biotech, including: AstraZeneca, Pearl Therapeutics, GlaxoSmithKline, Novartis, and Boehringer Ingelheim. Prior to DevPro Biopharma Colin held a dual role of CEO, Pearl Therapeutics, and SVP, Head of Late Respiratory, Inflammation and Autoimmunity at AstraZeneca. Colin has been involved in the development of over 20 life changing medications.

Colin is a well-respected thought-leader who often presents at international congresses, and has published over 50 papers in high quality journals including: NEJM, JAMA, Lancet Respiratory, and Chest. A Diplomate of the American Board of Allergy and Immunology, Fellow of the American College of Chest Physicians, American Academy of Allergy Asthma & Immunology, and active member of the American Thoracic Society, Colin has a passion for improving the lives of patients.

Chris Goss

University of Washington

Dr. Christopher Goss is a Professor of Pediatrics in the Division of Pulmonary and Critical Care Medicine at the University of Washington Medical Center in Seattle. He also serves as a co-director of the UW Adult Cystic Fibrosis Center.  He is the co-Executive Director of the Cystic Fibrosis Therapeutics Development Network (TDN) Coordinating Center at Seattle Children's Research Institute.  He has been the chair of the Comparative Effectiveness Working Group for the CF Foundation since 2006.  Dr. Goss received his MD from University of Colorado School of Medicine.

Sally Wenzel

University of Pittsburgh

Dr. Wenzel is a Professor of Medicine and Immunology at University of Pittsburgh. She holds Rachel Carson Chair in Environmental Health and is a Chair of Department of Occupational & Environmental Health. She is also an Acting Director of University of Pittsburgh Asthma Environmental Lung Health Institute @UPMC. Dr. Wenzel’s laboratory has focused on understanding both the subtypes of human asthma and the combination of environmental and genetic factors which drive them.

Her work encompasses use of large epidemiologic/research databases, including those both local and national, to define patient characteristics and relationships to environmental triggers, but also to include studies of specific human immunology, both in human samples and model systems. 

Bruce Montgomery

CEO – Avalyn Pharma

Dr. Montgomery is the CEO Avalyn Pharma. Dr. Montgomery has extensive pharmaceutical company experience in drug development, operations, and financing. He has raised over 400 million dollars in venture or public financings. He has authored 26 US Patents and over 50 peer reviewed publications. Dr. Montgomery has been responsible for three complete drug approvals: aerosolized pentamidine, tobramycin solution for inhalation, aztreonam lysine for inhalation (the first three FDA approved inhaled antimicrobials); from invention to advisory board presentations. 

Kathleen Lopiano

Kathleen Lopiano

Advising CFO, CPA MBA
Ernst & Young, Smith and Nephew, BioVentus

Kathy is a financial executive with 25 years' experience and has delivered significant value for organizations in terms of both financial and operational success. She has extensive experience with family owned, private equity-backed and publicly held corporations and partnerships. Kathy has completed more than a dozen acquisition/divestiture transactions including negotiation, financing and post-merger integration. Through this experience she has developed a disciplined approach to help management teams evaluate opportunities based on both financial modeling and strategic goals.

In the last 10 years, she has completed divestiture, acquisition and startup operations across the U.S., Europe, Canada, and Asia. Kathy spent the first ten years of her career at Ernst & Young LLP and then later served in various companies as a Controller and CFO. In her 25 years' experience, Kathy's diverse industry background includes retail, manufacturing and distribution, biomedical, and financial services. She earned her B.S. in Accounting at Belmont Abbey College and her M.B.A. from Wake Forest University and is a Certified Public Accountant (CPA) since 1991.

Irina Gitlin

Irina Gitlin

Vice President, Research and Development

Irina Gitlin, PhD is leading the preclinical development activities at Aer Therapeutics. 

Previously she was a co-investigator and the drug development lead at the University of California San Francisco (UCSF) on the translational NIH grant “Thiol-saccharides as mucolytics for airway disease” that now comprises the technology platform of Aer Therapeutics. 

Irina also held prior roles with UCSF Catalyst Program, an accelerator focused on advancing academic discoveries towards commercialization, and at Arsenal Medical, an early-stage medtech company focused on novel biomaterials.  Irina holds a PhD from Harvard University from the laboratory of George Whitesides and a BS degree in Chemical Engineering from University of Illinois at Urbana-Champaign.

John Fahy

John Fahy

Founder

John Fahy is Professor of Medicine and the Michael S. Stulbarg Endowed Chair in Pulmonary Medicine at the University of California, San Francisco. He directs the Severe Asthma Faculty Practice at UCSF where he manages patients with complex asthma who need careful diagnostic evaluation and tailored treatment, including with therapeutic proteins. John also directs the UCSF Airway Clinical Research Center which focuses on human-based studies of disease mechanisms in asthma, COPD, and cystic fibrosis.

John’s research program has been continuously funded by the NIH for over 25 years.  His clinical research unit and laboratory aims to uncover disease mechanisms and to develop disease biomarkers and novel treatments for airway disease. His clinical research is enabled by methods his group has optimized for application in human studies to advance knowledge about patterns of airway inflammation and pathologic airway mucus gels.

John is a highly regarded academic physician scientist. He was elected to the American Association of Physicians (AAP) in 2016, received scientific accomplishment awards from the American Thoracic Society in 2015 and 2017, and was awarded the European Respiratory Society (ERS) Gold Medal in Asthma in 2019 in recognition of his excellence in asthma research. John received his medical school training from University College Dublin in Ireland in 1985 and completed training in internal medicine in Dublin before moving to San Francisco in 1989 for sub-specialty training in Pulmonary and Critical Care Medicine at the University of California San Francisco. He completed a master’s degree in Molecular Medicine at Trinity College Dublin in 2003 during sabbatical leave from UCSF.