Patients are at the center
of all we do.

We leverage our team’s proven drug development track record to identify, develop and transform molecules into important medicines.

We acquire molecules that we believe have unrealized therapeutic potential. We then apply our unique expertise to optimize each molecule’s preclinical and clinical development plans to enable marketing approval and/or a successful exit.

Lipidio Pharma is focused on advancing therapeutics to treat two very distinct indications, obesity and sebaceous hyperplasia. Lipidio is headquartered in San Diego, CA.

Leadership

J. Gordon Foulkes, Ph.D.
CEO & Director

J. Gordon Foulkes, Ph.D.

Dr. Gordon Foulkes Ph.D. has more than 25 years in the biopharmaceutical industry. Dr. Foulkes served as the founding CEO of Excaliard Pharmaceuticals from 2007 to 2009, and resumed that role in 2010 to lead the acquisition of Excaliard by Pfizer in 2011. He also served as Executive Chairman of Redwood BioSciences from 2012 until its acquisition by Catalent in 2014. From 2005 to 2010, Dr. Foulkes served as Managing Director at RiverVest Ventures, where he represented the RiverVest’s investments in Mpex (acquired by Axcan in 2011), CGI Pharmaceuticals (acquired by Gilead in 2010), Cabrellis (acquired by Pharmion in 2007 [now Celgene]), Conforma (acquired by Biogen in 2006), Excaliard (acquired by Pfizer in 2011) and MacroGenics (which completed an initial public offering in 2013). Previously, he headed R&D, in multiple biotechnology companies, including OSI Pharmaceuticals, acquired by Astellas for $4 billion in 2010 and Aurora Biosciences acquired by Vertex for $590M. He has had a lead role in securing more than 15 corporate partnerships, resulting in over $350 million in revenues, as well as directly participated in raising over $215 million in private and public offerings. Prior to joining Industry, Dr. Foulkes held academic positions at both MIT and the MRC (UK).

David Bullough, Ph.D.
CSO

David Bullough, Ph.D.

Dr. David Bullough has over 25 years of pharmaceutical research and development experience, with a specialty in the development of small molecules and emerging new therapeutic modalities in multiple therapeutic areas. At Thesan, Dr. Bullough was the Head of Nonclinical Drug Development from 2016 to 2018. He previously served as the Chief Scientific Officer at Viking and was also an Executive Director at Pfizer, where he led multiple global therapeutic teams advancing metabolic disease candidates from discovery into early development. Dr. Bullough was also VP Preclinical Development at RaNA, a company developing new approaches to treating rare genetic central nervous system disorders. Dr. Bullough was previously VP of Preclinical Development at Metabasis, where he was responsible for Nonclinical Safety, DMPK, Bioanalytical, and Pharmaceutical Development, and for leading project teams developing novel drugs targeting the liver and liver pathways for the treatment of oncology, antiviral, and metabolic diseases. Prior to joining Metabasis, Dr. Bullough was with Gensia, where he managed Cardiovascular Pharmacology and led a number of major discovery and development projects. Dr. Bullough was a research faculty member at UCSD in La Jolla, CA and received his Ph.D. in Biochemistry from the University of Cambridge in the UK.

Roman Dvorak, MD, Ph.D.
CMO

Roman Dvorak, MD, Ph.D.

Dr. Dvorak has 25+ years of clinical research experience. He started his industry career in J&J and Pfizer working on their programs targeting metabolic diseases, planning, and running programs from Phases1-3, including serving at the Global Clinical Leader of a Phase 3 program of Pfizer’s CB-1 receptor antagonist. While working on this program, he led the development of Pfizer’s proprietary, state-of the art non-pharmacological program for weight loss and served as one of the industry representatives on the FDA panel developing the guidance document for the development of weight loss drugs. Dr Dvorak was also part of the Vivus team, which after two FDA advisory committees, secured approval for Qsymia for weight loss, and as VP Clinical Development of Carmot Therapeutics, which was recently acquired by Roche for $2.7B. Roman has also served as CMO at several companies developing drugs for obesity, type 2 diabetes, NASH and also rare obesities such as Prader-Willi syndrome, utilizing variety of mechanisms of action including GLP-1, GLP-1/GIP, GLP-1/glucagon and serotonin/norepinephrine and dopamine reuptake inhibitors. He received MD degree from the 1st Faculty of Medicine, Charles University, Prague; his PhD in human performance and pharmacology from Oregon State University and completed post-doctoral fellowship at the Metabolic Research Unit, Dept. of Medicine, U. of Vermont College of Medicine where his research focused on identification of interventions targeted to reduce the risk of development of type 2 diabetes and cardiovascular disease in women.

George Mooney, Ph.D.
Head of Pharm. Sciences

George Mooney, Ph.D.

Dr. George Mooney has over 30 years industrial experience, most recently as EVP for pharmaceutical sciences at Thesan. Previously, George was VP for the Exploratory Development Portfolio at Pfizer, as well as VP of Pharmaceutical Sciences, Pfizer Europe. While extensively experienced in the CMC area (Chemistry, Manufacturing and Controls) George has led and managed multi-disciplinary Teams at all stages of Drug Development. Other former companies include at GD Searle, Boehringer Ingelheim (USA) and American Cyanamid (Lederle) Co. Dr. Mooney has been associated with 30+ NDAs and sNDA’s, most notably Voriconazole (Vfend oral and IV for the acute treatment of Aspergillosis which required co- development of special excipient) and Viagra (Sildenifil for the treatment of Erectile Dysfunction). Additionally, throughout his career he has been responsible for over 80 IND filings, primarily covering NCE’s across the majority of therapeutic areas and associated routes of delivery (Oral, Parenteral, Inhalation, Topical and Ophthalmic). Significant Topical and Ophthalmic experience has been gained in the development of Prostaglandins, Antibiotics and most recently a novel peptide for the treatment of AMD. He qualified as a Pharmacist in the UK (B.Pharm, MSc University of London) and gained his PhD at University of Kansas in Pharmaceutical Sciences. He is a William Pitt Fellow at Pembroke College Cambridge UK, a member of the American Association of Pharmaceutical Scientists and of the Royal Pharmaceutical Society of Great Britain.

Raksha Shah, M.B.A.
COO

Raksha Shah, M.B.A.

Ms. Raksha Shah has 30 years of leadership experience in large pharma companies like Novartis and GlaxoSmithKline (GSK) and technology and life science start-up companies. She currently serves on the Joint Steering Committee of Poseidon Ventures ($65M Deerfield Management – UCSD Venture); and as a mentor to early stage companies in her capacity as the chancellor-appointed, life science Entrepreneur in Residence at UCSD. She was most recently the Founder, Chief Executive Officer, and Board Chair of Obsidio Therapeutics, a first in class small molecule Oncology Company. Prior to Obsidio, she was a founder of two tech start-ups, the first, a documentation software company where she served as Chief Financial Officer and the second an audit automation software company, Reliant Solutions where she served as Chief Operating Officer and Board Director. Upon moving to southern California from the UK in 1988, she joined Ciba-Geigy/Novartis in sales and sales management positions. In the UK, as a marketing leader for GSK, she developed the strategic plans and executed the successful global launch and commercialization of two of GSK’s drugs. She received her BSc. in Biology and her MBA in Finance & Marketing in the UK.

Greg Tibbitts CPA, M.B.A.
CFO

Greg Tibbitts CPA, MBA.

Mr. Greg Tibbitts is a CFO with over thirty years’ corporate finance, operations and technical accounting expertise. Detailed knowledge of technical accounting issues and regulatory requirements relevant to publicly-traded and privately-held technology companies. Significant experience with the U.S. Securities and Exchange Commission. Former companies include, Smart Wires Inc, Accriva through its acquisition by Werfen Life ($380M), CryoCur a publicly traded company, acquired by Boston Scientific, and Elitra Pharma acquired by Merck and as a Senior auditor at E&Y. Greg has help 10 companies negotiate through M&A transactions.

Craig M. Audet, Ph.D.
EVP Regulatory Affairs

Craig M. Audet, Ph.D.

Dr. Craig Michael Audet is the founder of WRS Regulatory Consultants, a consulting firm specializing in pharmaceutical regulatory strategy and submission development. Dr. Audet is a senior executive with 35+ years of experience in the global pharmaceutical and biotechnology industry, spanning multiple therapeutic areas. His experience covers the regulatory aspects of discovery research, clinical R&D, health authority submissions and approvals, commercialization, and marketing. He has been involved in the development and commercialization of numerous drugs, including Lipitor (cholesterol lowering), Exubra (inhaled insulin), Caduet (cholesterol and blood pressure lowering), Ambien (insomnia), Plavix (acute coronary syndrome), Belviq (weight loss), and Adstiladrin (bladder cancer). Dr. Audet has held strategic leadership positions as Sr. Director, Global Therapeutic Area Leader at Pfizer, VP US Regulatory Affairs at Sanofi, and SVP Global Regulatory Affairs at Arena Pharmaceuticals. Dr. Audet holds a BS in biology/pre-medicine from Boston College and a PhD in public health with a specialization in community health from Walden University and served as an adjunct Associate Professor at Temple University’s School of Pharmacy.

Charles N. Ellis, M.D.
EVP Clinical Dermatology

Charles N. Ellis, M.D.

Dr. Ellis the former Chief Medical Officer at Lipidio and Professor Emeritus of Dermatology in the University of Michigan Medical School. For nearly forty years, Dr Ellis served the University of Michigan Department of Dermatology in multiple roles including as William B. Taylor Professor and Associate Chair; director of the Residency Training Program; and director of the Clinical Research Unit. While directing the Research Unit, he designed and managed over 300 clinical trials in dermatology and published more than 250 journal articles and book chapters. The importance of his publications has made Dr. Ellis one of the dozen most influential and cited dermatologists worldwide. He was the Founder and Director of the Medical Center’s Department of Service Excellence. Dr. Ellis was also Chief of the Dermatology Service at the VA Ann Arbor Hospital, where he continues his teaching and clinical practice. Dr. Ellis has been named an Honored Member of the American Academy of Dermatology. At the University of Michigan, he received the H. R. Johnson Award for Leadership in Diversity. In the University’s Health System, Dr. Ellis was chosen as an Inaugural Member of the Medical School’s League of Educational Excellence and named to its Academy of Medical Educators. Dr. Ellis received his medical degree from the University of Michigan Medical School with Distinction in Research and served his residency in the University’s Department of Dermatology.

Directors and Strategic Executive Advisors

John Maraganore, Ph.D.

John Maraganore, Ph.D.

Executive Strategic Advisor to the CEO

Dr. John Maraganore served as the founding CEO and a Director of Alnylam from 2002 to 2021, where he built and led the company from early platform research on RNA interference through global approval and commercialization of the first four RNAi therapeutic medicines, ONPATTRO^®, GIVLAARI^®, OXLUMO^®, and Leqvio^®. At Alnylam, he also led the company’s value creation strategy, building $25B in market capitalization and forming over 20 major pharmaceutical alliances. He continues to serve on the Alnylam Scientific Advisory Board. Prior to Alnylam, he served as an officer and a member of the management team for Millennium Pharmaceuticals, Inc., where he was responsible for the company’s product franchises in oncology, and cardiovascular, inflammatory and metabolic diseases, in addition to leadership of M&A, strategy, and biotherapeutics functions. Before Millennium, he served as Director of Molecular Biology and Director of Market and Business Development at Biogen, Inc. where he invented and led development of ANGIOMAX^®. John is currently a Venture Partner at ARCH Venture Partners and Atlas Ventures, an Executive Partner at RTW Investments and a Senior Advisor at Blackstone Life Sciences. He is also a member of the Board of Directors of the Biotechnology Industry Organization, where he served as Chair from 2017-2019. In addition, John serves on the Board of the Termeer Foundation – committed to continuing the legacy of the late Henri A. Termeer, as Chair of the n-Lorem Foundation Advisory Council – committed to meeting the needs of patients with nano-rare diseases. Dr. Maraganore received his Ph.D. from the University of Chicago.

J. Gordon Foulkes, Ph.D.

Jay Birnbaum, Ph.D.

Jay Birnbaum, Ph.D.

Dr. Jay Birnbaum is a dermatology consultant specializing in ethical and OTC drugs, medical devices, and cosmeceuticals. His experience spans the areas of discovery, formulations, clinical, regulatory and marketing. He has been involved in the development and commercialization of numerous drug and consumer products and brands, including Lamisil antifungal products, Cyclosporine Neoral and Elidel for inflammatory skin diseases, Apligraf living skin equivalent, Kybella for submental fat and LaPrairie Skin Caviar. Dr. Birnbaum is a co-founder & former Chief Medical Officer of Kythera Biopharmaceuticals (acquired by Allergan in 2015), and co-founder & Chief Scientific Officer of Hallux Pharmaceuticals. Dr. Birnbaum was VP Clinical Research and then VP Global Project Management, at Novartis/Sandoz, where he was also responsible for strategic planning and development of the company’s dermatology portfolio. Previously, he held management positions at both the Medical and Consumer Product Divisions of American Cyanamid Company (Wyeth). He has served as a member of the board of directors of Sonoma Pharmaceuticals (Nasdaq:SNOA), Hallux Inc., and Excaliard Pharmaceuticals (acquired by Pfizer in 2011), and many Science Advisory Boards. He received his Ph.D. in pharmacology from the University of Wisconsin.

William D. Humphries, M.B.A.

William D. Humphries, M.B.A.

William D Humphries has more than 30 years of experience building and leading commercial-stage pharmaceutical organizations. Currently, Bill is the CEO Officer of Isosceles Pharmaceuticals, a position he has held since May 2021. Prior to his role at Isosceles, he served as President and Group Company Chairman, Ortho Dermatologics of Bausch Health Companies, as well the President and CEO of the North American business of Merz, an affiliate of Merz Pharma Group. Before joining Merz, he served in a number of leadership positions with Stiefel Laboratories, including as its Chief Commercial Officer and President, through their acquisition by GlaxoSmithKline. Prior to Stiefel, he was the VP of Allergan’s U.S. skincare business.

In addition, Bill currently serves as the Chairman of the board for both Clearside Biomedical and STRATA Skin Sciences, and as a Director for both Aclaris Therapeutics and PhaseBio. He received a BA from Bucknell University and an MBA from Pepperdine University.

Nancy J. Hutson, Ph.D.

Nancy J. Hutson, Ph.D.

Dr. Nancy J. Hutson served as Senior Vice President, Pfizer Global R&D and Director of Pfizer’s largest pharmaceutical R&D site in Connecticut, where she led a team of 4,500 (primarily scientists) with a budget in excess of $1 billion annually. This was a time of tremendous growth for Pfizer leading to the discovery and development of dozens of important medicines. Earlier in her career at Pfizer, Dr Hutson built the Department of Metabolic Disease which had research in diabetes, obesity, osteoporosis, and cardiovascular including modulating lipids and anti-hypertensives. After leaving Pfizer in 2006, Dr. Hutson went on to leverage her in-depth knowledge and understanding of research, drug development and business issues in a variety of both large and small biopharmaceutical companies. Currently, Dr. Hutson serves as a board member of Endo International, plc (ENDP), BioCryst Pharmaceuticals, Inc. (BCRX) and PhaseBio Pharmaceuticals, Inc (PHAS). She was previously a Director of both Cubist Pharmaceuticals until 2015, when it was purchased by Merck ($8.4B) and Inspire Pharmaceuticals, Inc. until 2011 (also acquired by Merck). In these positions Dr. Hutson has gained in-depth biotechnology Board experience and has been able to aid biotech companies in mastering the complexities of drug discovery and development.

Dr. Hutson has received many professional honors during her career. Most recently she was named one of the most influential Female Directors by Women, Inc Magazine, November 2019. Dr. Hutson holds a Bachelor of Arts degree from Illinois Wesleyan University and a Ph.D. degree from Vanderbilt University. She completed a Postdoctoral fellowship in Biochemistry at University of Oxford.

Alana B. McNulty, M.B.A.

Alana B. McNulty, M.B.A.

Over her career, Alana McNulty has led or played a key role in transactions with an aggregate value greater than $2 billion, including private and public financings, mergers and acquisitions, corporate partnerships, and debt financings. She was most recently the Chief Business Officer of eFFECTOR Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on pioneering the development of a new class of oncology drugs known as selective translation regulator inhibitors (STRIs). She also served as Chief Financial Officer for eFFECTOR for more than eight years. Prior to eFFECTOR, Ms. McNulty served as Chief Financial Officer of a number of biopharmaceutical companies, including Lumena Pharmaceuticals, Inc. (acquired by Shire plc), Excaliard Pharmaceuticals, Inc. (acquired by Pfizer Inc.), BrainCells Inc., and Elitra Pharmaceuticals, Inc. Prior to that, Ms. McNulty was Head of Corporate Development and a General Manager of a business unit at Advanced Tissue Sciences, Inc.

Ms. McNulty received a B.A. in biology with high honors from UC Santa Barbara, where she graduated Phi Beta Kappa, and an MBA from the Anderson School of Business at UCLA.

Advisors

Andrew Blauvelt, MD, MBA

Andrew Blauvelt, MD, MBA

Former NIH Investigator, OHSU Professor, and OMRC President

Dr. Blauvelt is an Investigator (and former President) at the Oregon Medical Research Center (OMRC), a site dedicated to performing high quality clinical research studies in dermatology. Previously, he held senior staff positions at the NIH (Senior Investigator), Oregon Health & Science University (Professor) and the Portland VA Medical Center (Chief). Dr. Blauvelt is a renowned expert in Langerhans cell biology, T cell immunology, virology, psoriasis, and atopic dermatitis. He has published over 350 papers and spoken across the world on these topics. In recent years, he has been the international lead/senior investigator on a number of important clinical trials, including PSTELLAR, FEATURE, CLEAR, IXORA-R, VOYAGE 1, ECLIPSE, IMMhance, BE ABLE 1, BE ABLE 2, BE READY, BE RADIANT, OASIS-1, POETYK PSO-1, CHRONOS, ECZTEND, JADE REGIMEN, HEADS UP, ADhere, and STRATUM. Dr. Blauvelt is also an elected member of the American Society for Clinical Investigation, the International Psoriasis Council, the International Eczema Council, and the Scientific Advisory Committee of the National Psoriasis Foundation. In 2021 and 2022, he made the lists of Highly Cited Researchers, representing the top 1% of cited scientists in the world. He received his medical degree at Michigan State University, and a healthcare MBA at Oregon Health & Science University.

Lawrence Eichenfield, M.D.

Lawrence Eichenfield, M.D.

Dr. Eichenfield is the Distinguished Professor of Dermatology and Pediatrics, Vice Chair of Dermatology and Chief of Pediatric & Adolescent Dermatology at the UCSD and Rady Children’s Hospital, San Diego. Dr. Eichenfield’s clinical and research interests include acne, atopic dermatitis, psoriasis, pediatric infections, vascular lesions, neonatal dermatology, laser surgery, and skin signs of systemic disease. He has published over 400 journal articles, chapters and books. He has served in leadership roles on developing the guidelines & consensus statements for multiple dermatological conditions, including acne, rosacea, atopic dermatitis and psoriasis. Dr Eichenfield has directed more than 100 clinical trials. He served as Editor-in-Chief of Pediatric Dermatology for 12 years and serves on the editorial boards of multiple journals and periodicals. In addition, Dr. Eichenfield directs the Rady/UCSD Eczema and Inflammatory Skin Disease Center, is past president of the Society for Pediatric Dermatology, past Board member of the American Academy of Dermatology (AAD), a founder and past Co-Chair of the Pediatric Dermatology Research Alliance (PeDRA), and a founding member and past President of the American Acne and Rosacea Society (AAD). Dr. Eichenfield has been honored as a recipient of the Children’s Hospital of Philadelphia Benjamin Ritter Award, excellence in teaching awards from UCSD and multiple American Academy of Dermatology Presidential Citations. Dr. Eichenfield received his medical degree from Mount Sinai School of Medicine, was a pediatric resident and Chief Resident at Children’s Hospital of Philadelphia and completed his dermatology residency at the Hospital of the University of Pennsylvania.

James Mackay, Ph.D.

James Mackay, Ph.D.

James Mackay is Founder, President and Chief Executive Officer of Aristea Therapeutics and has over 25 years of development and commercialization expertise in the pharmaceutical industry, including 6 drug product approvals across multiple therapeutic areas. Prior to founding Aristea and Lipidio Pharma, he was President and Chief Executive Officer of Ardea Biosciences, Inc., following the company’s acquisition by AstraZeneca in 2012. James was instrumental to setting up an innovative model for Ardea Biosciences that retained the biotech’s independence and accountability for the development of the gout franchise while also developing a synergistic and collaborative relationship with the parent company, AstraZeneca. Prior to Ardea, James held senior executive positions at AstraZeneca where he led the development and commercialization of drugs across a range of therapy areas. and managed significant global functional departments.

James plays a pivotal role in the San Diego Ecosystem and currently sits on the Board and Executive Committee of CONNECT and sits on the Board of BIOCOM. He is a former Board member of the San Diego Economic Development Corporation (EDC). James holds a BS in Genetics and a Ph.D. in Medical Genetics from Aberdeen University, Scotland.

Robert Matheson, MD

Robert Matheson, MD

Investigator OMRC

Dr. Matheson is an Investigator at Oregon Medical Research Center (OMRC), a clinical trial site performing high quality clinical research studies in dermatology, and a former President & owner of the Center. He was also a former Clinical Professor at the Department of Dermatology, Oregon Health Science University. Dr. Matheson practiced medical, surgical, and cosmetic dermatology in a private clinic in Portland, Oregon, for twenty years, followed by twenty years as a clinical investigator with OMRC. He has served as Principal or Sub-Investigator in over 400 clinical trials in medical and cosmetic dermatology and immunology, published numerous papers, and served on advisory boards for multiple pharmaceutical companies. Cosmetic trials have included topical agents for facial hyperpigmentation, facial erythema, male and female pattern alopecia, facial hair growth, injectable neuromodulators for facial creases and lines and for axillary and palmar hyperhidrosis, and injectable dermal fillers for facial volume loss and creasing. As a subspecialty, he has to date treated over 500 Japanese nationals with severe recalcitrant atopic dermatitis. He received his undergraduate degree in mathematics from the University of Utah and his medical degree from the University of Utah.

Alan Saltiel, Ph.D.

Alan Saltiel, Ph.D.

Professor Alan Saltiel first moved to the University of California, San Diego to create the Institute for Diabetes and Metabolic Health in 2015, where he now directs that Institute, as well as the UCSD/UCLA Diabetes Research Center, and serves as Professor of Medicine and Pharmacology.

Previously, Dr. Saltiel was the founding Director of the Life Sciences Institute of the University of Michigan, and John Jacob Abel Professor in the Life Sciences. Under Dr. Saltiel’s leadership, the Institute became home to 30 faculty and over 400 scientists in all areas of life sciences. Dr. Saltiel also served as the Distinguished Research Fellow and Senior Director/Vice President of Cell Biology at Parke Davis Pharmaceutical Research (now Pfizer), and directed drug discovery activities in diabetes, obesity and cancer. He was responsible for preclinical studies on troglitazone, the first thiazolidinedione approved for the treatment of type 2 diabetes. He also developed the first MEK inhibitors for the treatment of cancer-the first received FDA approval for melanoma and other cancers. Dr. Saltiel has received numerous awards, including the Rosalyn Yalow Research and Development Award from the American Diabetes Association, the Hirschl Award, the John Jacob Abel and the Goodman and Gilman Awards from ASPET, was elected as a fellow of the American Association for the Advancement of Science, and elected to membership in the American Society of Clinical Investigation and to the National Academy of Medicine. He has made important contributions to our understanding of the cellular actions of the hormone insulin, and the inflammatory links between obesity and type 2 diabetes, including the development of new drugs and drug targets. He has nineteen issued patents and published over 300 original papers with over 58,000 citations and H-Index of 108. Professor Saltiel received his AB in Zoology from Duke University and his Ph.D. in Biochemistry from the University of North Carolina.