The Key to Success
is in Our People.
We are focused on the development of novel drugs, targeting TGF-β, for the treatment of fibrotic diseases. We use a potent, topically applied drug, to inhibit TGF-β for the treatment of skin and lung fibrosis. The drug has been specifically engineered to act locally, thereby minimizing the potential risks of systemic exposure with this target.
J. Gordon Foulkes Ph.D.
Dr. Gordon Foulkes has more than 30 years of experience in leading and investing in biopharmaceuticalresearch and development companies. These include serving as the founding CEO of Excaliard Pharmaceuticals leading to its the acquisition by Pfizer in 2011. He also served as Executive Chairman of Redwood BioSciences from 2012helping to negotiate and guide the company through a successful staged 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 inMpex (acquired by Axcan in 2011), CGI Pharmaceuticals (acquired by Gilead in 2010), Cabrellis (acquired by Pharmionin 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, and served on the boards of multiple biotechnology companies, including OSI Pharmaceuticals (Nasdaq: OSIP) acquired by Astellas for $4 billion in 2010, Aurora Biosciences (Nasdaq: ABSC) acquired by Vertex in 2001 for $590M and Elitra Pharmaceuticals (acquired by Merck). At OSI, he pioneered the early development of cell-based high-throughput drugscreening and oversaw multiple drug discovery and development programs, including the discovery of the anti-cancer drug Tarceva, an EGFR kinase inhibitor. In operational executive management positions, he has had a lead role in securing more than 15 corporate partnerships, resulting in over $350M in recognized revenues, as well as directly participated in raising over $230M in private financings, IPOs and follow-on public offerings. Prior to joining the biopharmaceutical industry, Dr. Foulkes held academic positions at both the Massachusetts Institute of Technology and the Medical Research Council (UK). Dr. Foulkes obtained a First Class Honors BSc degree from the University of Wales and his Ph.D. from the University of Dundee, Scotland.
David A. 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.
George Mooney, Ph.D.
Dr. George Mooney has over 30 years of industry experience. Previously, Dr. Mooney 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), he has also led and managed multi-disciplinary teams at all stages of drug development. Other former companies include at GD Searle, BoehringerIngelheim (USA) and American Cyanamid (Lederle). Dr. Mooney has been associated with 30+ NDAs and sNDAs, 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). George 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). In the area of inhalation product development, he played a major role in the reformulation of both AlupentÒ and BerotecÒ nebulizer solutions, the development of Ipatropium MDI, Dry Powder inhalation of steroid and disease modifying agents and, more recently, product development of several nebulized products for MPEX corporation. Significant topical and ophthalmic experience has been gained in the development of steroids, prostaglandins, antibiotics, metabolic and disease modifying and most recently a novel peptide for the treatment of age-related macular degeneration. He is a William Pitt Fellow at Pembroke College Cambridge UK, a member of the AAPS, the Royal Pharmaceutical Society and the author of numerous patents in the field of drug delivery. He qualified as a Pharmacist in the UK (B. Pharm., MSc University of London) and gained his Ph.D. at University of Kansas in Pharmaceutical Sciences.
Charles N. Ellis, M.D.
Karen M. Boezi
Karen Boezi has been involved in building, leading and investing in biopharmaceutical companies for more than 30 years. Karen was the CEO of Redwood Bioscience, leading the company through its successful sale to Catalent (CTLT) under a staged acquisition option, which she closed in less than four years after joining the founding team. Redwood, now a division of Catalent Biologics, continues to be a pioneer in developing antibody-drug conjugates (ADCs) and toxin-linker technology for improving oncology care. Based on research from the lab of Nobel Laureate, Carolyn Bertozzi, PhD, the Redwood division now has a pipeline of 10 ADCs, four of which have been already out-licensed.
Prior to joining Redwood, Karen was a founding Partner of Thomas, McNerney & Partners (TMP), a health care technology-focused venture firm with $600 million under management. She launched TMP with a colleague from Warburg, Pincus, where she was part of the seed stage life science team, and a partner from Coral Ventures, where she was a General Partner. TMP was recognized for managing one of the top performing 2006 vintage venture funds globally. During her venture career, she invested in 15 companies that went public and/or were acquired including Coulter Pharmaceuticals (CLTR, acquired by Corixa for $900M) which commercialized one of the first radiolabeled conjugates, Bexxar. She launched three companies with scientific founders including NeXagen (NXGN/NXTR) which led to the commercialization of Macugen after the Gilead Sciences (GILD) acquisition for $550M and Eyetech spin-out (EYET, acquired by OSI), at which time Somalogic (SLGC) also was spun-out. Karen began her career as a member of Alex. Brown & Sons’s health care and insurance corporate finance teams. Most recently, Karen has been an angel investor and advisor to academic scientists founding biopharmaceutical companies, including Design Therapeutics (DSGN), Bioniz (acquired by EQ) and Acrigen Bioscience, a gene-editing company on whose Board she serves. She graduated Phi Beta Kappa with a B.S. in Economics from the Wharton School at the University of Pennsylvania.
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.
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.
Arthur M. Krieg, MD
Dr Krieg has worked on developing oligonucleotides as drugs since the 1980s and is widely recognized as a renowned world leader in the field. Dr. Krieg co-founded the first antisense journal, Nucleic Acid Therapeutics, which he edited for 16 years, and the Oligonucleotide Therapeutics Society, for which he recently served as President. In 1994, Art discovered the immune stimulatory CpG DNA motif, which led to a new approach to immunotherapy and vaccine adjuvants. Based on this technology, Art co-founded the Coley Pharmaceutical Group in 1997, where, as their CSO, he led the discovery and development of 4 novel oligonucleotides into the clinical, including the CpG 7909, now in the approved vaccine, Cyfendus. In 2008, Coley was acquired for $165M and incorporated into Pfizer as a key component of their vaccine strategy in cancer, allergy, asthma and autoimmune diseases. Art served as CSO of Pfizer’s Oligonucleotide Therapeutics Unit. In 2011, Art co-founded RaNA Therapeutics as their CEO, which subsequently became Translate Bio and was acquired in 2021 by Sanofi for $3.2B. In 2015, Art founded Checkmate Pharmaceuticals to develop novel oligonucleotides for cancer immunotherapy and served as their CSO until its acquisition by Regeneron in 2022 for over $250M. He has published more than 250 scientific papers (h-index = 131) and is an inventor on >50 issued US patents. Art graduated from Haverford College in 1979 and received his MD from Washington University. Since 2017, Art has also been an adjunct Professor in the UMass Chan Medical School RNA Therapeutics Institute.
Most recently Art founded his fourth biotech company, Zola Therapeutics, with the goal of developing a new generation of immunostimulatory oligonucleotides for cancer immunotherapy.
Lamont R. Jones, MD, MBA.
Dr. Jones is Associate Chief Medical Officer of the Henry Ford Medical Group (HFMG). He is a renowned surgeon scientist who studies the pathogenesis of keloid disease, clinical biomarkers and therapeutic targets in keloid disease, and lectures extensively in these areas in countries worldwide.
Dr. Jones, also serves as professor of otolaryngology at Michigan State University, and has an established record as a facial plastic and reconstructive surgeon.
Dr. Jones is a graduate of Xavier University of Louisiana and completed medical school and otolaryngology, head and neck surgery, training at the University of Michigan, a facial plastic and craniofacial reconstructive surgery fellowship at SUNY UpState Medical University, and an executive MBA from Michigan State University Broad School of Business. He has extensive board experience and volunteers his time locally and on international medical mission trips.
Leadership
J. Gordon Foulkes, Ph.D.
Co-Founder, Chief Executive Officer and Director
Karen Boezi
Chief Operating Officer
David A. Bullough, Ph.D.
Co-Founder, Chief Scientific Officer
Charles N. Ellis, M.D.
Chief Medical Officer
George Mooney, Ph.D.
Co-Founder and Executive VP Pharmaceutical Sciences
Greg Tibbitts CPA, MBA.
Chief Financial Officer
Kay Chandler
Kay Chandler is chair of Cooley’s global life sciences industry practice and Co-chair of the Women’s Initiative. Kay specializes in representing public and private life sciences companies in a wide range of commercial and corporate matters that are critical to their businesses. She counsels biotechnology, biopharmaceutical, diagnostic, and device companies on complex U.S., global and regional transactions, including technology and product licenses, acquisitions, and divestitures; research, development, and commercial collaborations; supply, distribution, and manufacturing agreements; and profit-sharing and co-promotion arrangements. Kay previously worked closely with Dr. Foulkes to negotiate the sale of Excaliard Pharma to Pfizer. In the past year, example deals she has worked on include from Artiva Biotherapeutics’ worldwide collaboration with Merck, to Neurocrine Biosciences’ strategic partnership with Takeda, to Horizon Therapeutics acquisition of Viela Bio.
Kay is recognized as a leading lawyer in the nation. In 2019, she was selected as an honoree for the Women, Influence & Power in Law awards in the collaborative leadership category. She has been recognized in Chambers USA: America’s Leading Lawyers for Business 2009–2020 editions in the category of Life Sciences: Commercial (National and California). She has been recognized by Legal 500 as a key lawyer in Healthcare: Life Sciences. She has been named to the Best Lawyers in America in the category of Biotechnology Law and previously named San Diego Biotechnology Lawyer of the Year by Best Lawyers of America. Kay obtained her JD from the University of Michigan Law School. She currently serves on the Leadership Council of the University of Michigan Life Sciences Institute and the External Advisory Board of Michigan Drug Discovery.
Nancy Hutson
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 an annual budget in excess of $1B. 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), PhaseBio Pharmaceuticals, Inc (PHAS) and Lipidio Pharma. 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, for $430M). 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 Ph.D. degree from Vanderbilt University.
Steven Bender Ph.D.
Dr. Steven Bender has over 25 years of drug discovery experience primarily focused in Oncology and, more recently, in Immuno-Oncology that spans both small molecule and biotherapeutic approaches. He has been an independent consultant since late 2019 and joined Boxer Capital as an Entrepreneur in Residence in early 2021. From 2011 until 2019, Dr. Bender led a group of approximately 60 cancer biologists and immunologists as the Executive Director of Cancer Therapeutics the Genomics Institute of the Novartis Research Foundation (GNF). During that period, GNF teams progressed 4 candidates to the clinic, and 2 more achieved FIH in 2020. Dr. Bender was at Agouron/Pfizer from 1993 until 2011, where he was involved in numerous drug discovery programs initially as a medicinal chemist and project leader and then as the Oncology Therapeutic Area Leader for the Pfizer La Jolla site. FDA-approved products from the Pfizer La Jolla Oncology research program during this period include axitinib, crizotinib, and glasdegib. Dr. Bender received his Ph.D. in Organic Chemistry and postdoctoral training in mechanistic enzymology, both at Harvard University.
Robert Lafyatis M.D.
Dr. Lafyatis is an academic rheumatologist with over 20 years’ experience in treating patients with systemic sclerosis, designing and conducting early phase clinical trials in SSc and investigating pathogenic mechanisms of SSc. He has a broad background in understanding SSc, including studies of SSc murine models, innate immune pathogenesis, mesenchymal cell biology and dermal fibrosis. He currently directs the Scleroderma Center at the University of Pittsburgh and a National Institutes of Arthritis Musculoskeletal and Skin Disease, Center of Research Translation focused on understanding pathogenic mechanisms in SSc. He has co-organized the biennial International Workshop for Scleroderma Research for the past 10 years and the Keystone Fibrosis meeting in 2016. His research spans molecular and cellular biology, to clinical trials and outcome measures. In particular, he has used transcriptomic and proteomic approaches to understand human SSc, discovered and validated biomarkers of SSc skin and lung disease and has applied these in several clinical trials. In the last four years his laboratory has been focused on applying single cell RNA-sequencing and other single cell technologies to understanding SSc pathogenesis, recently describing alterations in dermal and lung fibroblasts and macrophage heterogeneity in SSc and idiopathic pulmonary fibrosis. He has also pioneered the use of scRNA-seq technology in several clinical trials.
Toby Maher M.D.
Prof. Maher has spent the last 15 years specializing in the management of all forms of pulmonary fibrosis and orphan interstitial lung diseases (ILD). He previously ran the ILD unit at Royal Brompton Hospital, London seeing more than 1500 new ILD patients per year. Since June 2020 he has been Director of ILD at Keck Medicine of USC. He remains Professor of Interstitial Lung Disease at Imperial College London and is British Lung Foundation Professor of Respiratory Medicine. His research interests include; biomarker discovery, the lung microbiome and host immune response in the pathogenesis of IPF and clinical trials in interstitial lung disease. He has been involved in >50 trials in fibrotic lung disease from phase 1b through to phase 4 and including those assessing IPF, scleroderma, rheumatoid arthritis and inflammatory myositis. Overall, he has recruited > 1000 patients into interventional studies. He has given expert opinion to FDA and EMA. He is an associate editor for American Journal of Respiratory and Critical Care Medicine and is on the Editorial Board of Lancet Respiratory Medicine. He has authored over 270 papers and book chapters on pulmonary fibrosis.
Paul Wolters M.D.
Dr. Paul Wolters is an academic pulmonologist specializing in pulmonary fibrosis. He has been on faculty at UCSF since 1999 where his primary clinical interest is caring for patients with interstitial lung diseases (ILDs). Dr. Wolters is the director of biological research for the UCSF ILD program and he leads a research group whose efforts are directed toward understanding the cause of various forms of pulmonary fibrosis including idiopathic pulmonary fibrosis (IPF), hypersensitivity pneumonitis and scleroderma associated pulmonary fibrosis. His research group currently focuses on investigating the role(s) epithelial cell dysfunction, senescence reprogramming and telomere dysfunction play in these disease processes. To achieve these goals, the group studies biological samples, including highly purified populations of lung epithelial cells, obtained from patients to identify how the tissues and cells are different from normal patients. This analysis should provide clues to the causes of lung fibrosis. Dr. Wolters received in his M.D. degree from the University of Minnesota; trained in internal medicine at the University of Colorado, and pulmonary and critical care medicine at UCSF.
Leroy Young M.D.
Dr. Leroy Young is a renowned plastic surgeon specializing in research. He trained in plastic surgery at Washington University. He remained at Wash. Univ. for 20 years, practicing plastic surgery and conducting research, ending his career there as an endowed Professor of Plastic Surgery. Dr Young then continued his plastic surgery and research in private practice at Body Aesthetic Plastic Surgery and Skincare until he joined Mercy Hospital in 2014. Dr. Young has designed and conducted numerous clinical trials, many of them related to wound healing and scarring including keloids. Dr. Young worked previously with Drs. Foulkes and Birnbaum at Excaliard Pharma, as one of the two PIs developing a drug to prevent hypertrophic scarring.
Nunzio Bottini
Dr. Bottini is the Founding Director of the Kao Autoimmunity Institute (KAI) at Cedars-Sinai Medical Center, and a member of the new KAI-based Cedars-Sinai Scleroderma Program. His laboratory is NIH funded to carry out research on molecular mechanisms of autoimmunity with focus on regulation of signal transduction in immune cells and fibroblasts. His studies in scleroderma are focused on the regulation of fibroblast signaling by phosphatases. The start from tissues and cells obtained from patients to generate hypotheses followed by mechanistic testing in cellular and animal models in order to validate drug targets and biomarkers of disease. Dr. Bottini received his M.D. from the University of Rome in Italy where he also obtained his Ph.D. and completed his internship and residency. He received postdoctoral research training in signal transduction at the Sanford Burnham Prebys Medical Discovery Institute in La Jolla, and completed a clinical fellowship in Rheumatology at the UC San Diego. Before his recruitment to Cedars-Sinai in 2022 he was a Professor with tenure at UC San Diego, where he also served as the Rheumatology Section Head.
Jay E. Birnbaum
Dr. Jay Birnbaum is a dermatology consultant specializing in ethical and over-the-counter drugs, medical devices, and cosmeceuticals. His 35+ years of industry experience span the areas of discovery research, formulations, clinical R&D, regulatory and marketing. He has been involved in the development and commercialization ofnumerous drug and consumer products and brands, including Lamisil antifungal products (one of the world’s largest dermatology brands), Cyclosporine Neoral and Elidel(for inflammatory skin diseases), Apligraf (the first bioengineered, living skin equivalent), Kybella (a first in class injectable product for reducing submental fat) and SkinCaviar (the centerpiece of the LaPrairie Skin Care brand for the past 30 years). Dr. Birnbaum is a co-founder & former Chief Medical Officer of Kythera Biopharmaceuticals (acquired by Allergan in 2015), co-founder and Chief Scientific Officer of Hallux Pharmaceuticals, and the former EVP Global Product Development at Thesan. Prior tostarting his own consulting company, Jay was VP Clinical Dermatology, Immunology and Transplantation 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. In addition to his product development responsibilities, he led corporate initiatives to harmonize world-wide clinical trial procedures in therapeutic areas at Novartis/Sandoz. Previously, he held various management positions at both the Medical and Consumer Product Divisions of American Cyanamid Company (Wyeth). Dr. Birnbaum has broad relationships in industry and academia and has published extensively on his work in drug development. He has served as a member of the board of directors of Sonoma Pharmaceuticals (Nasdaq: SNOA), and ExcaliardPharmaceuticals where he worked closely with Dr Foulkes, driving the clinical development program (acquired by Pfizer in 2011). He received his Ph.D. in pharmacology from the University of Wisconsin.
Brian Berman, MD., PhD.
Dr. Brian Berman is Professor Emeritus of Dermatology and Dermatologic Surgery at The University of Miami Miller School of Medicine and has had the honor of serving as a member of the Board of Directors and Vice President of the American Academy of Dermatology. He is also the Past President of the American Dermatological Association. Dr. Berman is Secretary of the American Cutaneous Oncology Society, He also serves on the Scientific Advisory / Editorial Boards of The European Journal of Dermatology, SKINmed, Journal of Clinical and Aesthetic Dermatology, Dermatology Digest, and SKIN. In addition to caring for patients at Skin and Cancer Associates in Aventura, FL, Dr. Berman is Co-Director of the Center for Clinical and Cosmetic Research continuing his broad-based clinical research program while focusing on the study of the control of scarring and skin cancer. He has presented at over 300 dermatologic conferences and authored more than 300 peer-reviewed publications and multiple book chapters.
Dr. Berman has consulted in many aspects of drug development, research, Phase I-IV, drug approvals, sales and marketing, including pivotal efforts on imiquimod (Aldara, Zyclara), ingenol mebutate (Picato), tirbanibulin (Klisyri), photodynamic therapy (Levulan, Ameluze) and superficial radiation therapy (Sensus). Previously, he also consulted for multiple dermatology companies that were acquired; notably Ivax (acquired for $7.4B by TEVA), 3M (pharmaceutical operations acquired by Graceway $875M and their, European pharmaceutical business for $857M by Meda), Dermira (acquired by Lilly for $1.1B) and Peplin (acquired by Leo for $287M).
Professor Christopher Denton, Ph.D., FRCP
Professor Denton is Professor of Experimental Rheumatology at University College London (UCL) and a consultant Rheumatologist at the Royal Free Hospital in London.
He leads a large clinical and translational research programme in scleroderma at the Royal Free Hospital and co-ordinates multidisciplinary care for more than 1500 patients, the largest center for scleroderma in the UK. He currently chairs the UK Scleroderma Study Group (UKSSG). and previously served as President of the Scleroderma Clinical Trials Consortium (SCTC) and a Counsellor and Treasurer of the EULAR Scleroderma Trials and Research Group (EUSTAR). He is Associate Editor for Arthritis Research & Therapy & for Arthritis and Rheumatology.
He has been the lead investigator for many recent major clinical trials in systemic sclerosis and published extensively on laboratory and clinical aspects of connective tissue disease. Professor Denton studied medicine at Guy’s Hospital in London, obtained a PhD from UCL and trained in Rheumatology and Medicine in London.
Mark L. Jewell, M.D.
Among plastic surgeons around the world, Dr. Jewell is a recognized leader in plastic surgery. Dr. Mark Jewell, served as 2005-06 President of the American Society for Aesthetic Plastic Surgery (ASAPS), the leading professional organization of board-certified plastic surgeons. Practicing in Eugene, Oregon, he is the former United States National Secretary for the International Society for Aesthetic Plastic Surgery (ISAPS). He also served as a Governor for the National Endowment for Plastic Surgery. Dr. Jewell is a former member of the Board of Directors for the American Society of Plastic Surgeons (ASPS) and former vice president of the Aesthetic Surgery Education and Research Foundation (ASERF). Currently, he is the director of the ISAPS Global Alliance and Breast Implant Task Force.
Dr. Jewell is a graduate of the University of Kansas School of Medicine, graduating with honors as the top student in surgery. His general surgery training was at Harbor-UCLA Medical Center in Torrance, CA, followed by a burn fellowship at Los Angeles County USC Medical Center, and a plastic surgery residency at the University of Tennessee Clinical Education Center, Erlanger Hospital, Chattanooga, Tennessee.
In 2003, ASAPS awarded Dr. Jewell the Tiffany Award for best scientific presentation. He held the prestigious Joyce Kaye Lectureship from 1998 to 2004 and has taught numerous scientific courses and authored multiple scientific journal articles and book chapters as well as the ASPS Patient Consultation Resource Guide for informed consent. He served as the co-chair of the Joint ASPS-ASAPS Breast Implant Task Force for plastic surgery that was successful in returning silicone gel breast implants to the marketplace.
Dr. Jewell has published over 125 peer-reviewed scientific papers, books, and book chapters. Notably, he has published peer-reviewed scientific publications on his medical device research, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), breast feeding following breast augmentation, a Special Topic Original research article for Aesthetic Surgery Journal entitled “Betadine and Breast Implants”, as well as clinical research regarding antisense oligonucleotide drugs to reduce skin fibrosis (hypertrophic scarring) after surgery.
Paul Atkins, Ph.D.
Dr. Paul Atkins has over 35 years of global pharmaceutical experience in the development, manufacture, and commercialization of inhaled medicines. He currently is President of Inhaled Delivery Solutions LLC a company providing consulting services to a number of pharmaceutical and biotech companies and serves on a number of Advisory and Operational Boards. Previously he served as President/CEO of Oriel Therapeutics a start-up company utilizing a unique technology to facilitate inhaled drug delivery and powder movement. During Dr. Atkins tenure at Oriel, the company raised over $35M in venture and angel funding. The company was acquired in 2010 by Novartis. At Novartis, Dr. Atkins was Vice President of Operations and was responsible for all technical, technology transfer, regulatory and quality aspects of a variety of inhaler development programs.
Previously, Paul served as Global Director, Respiratory Therapeutic Development, Delivery Systems at GlaxoSmithKline where he had responsibility for integration of technical, commercial, and manufacturing strategy related to inhaled delivery systems. Prior to Glaxo, he held positions of increasing responsibility at Aventis (Fisons) (US) and Upjohn (Pfizer) (UK and US). These roles were primarily focused on the development of a range of pharmaceutical products.
Paul has consulted for the United Nations on the development of inhaled medicines for many years and is currently a member of the United Nations Medical and Chemical Technical Options Committee (MCTOC). He was part of the Intergovernmental Panel on Climate Change that was awarded the Nobel Peace prize (along with Vice President Al Gore) in 2007. Dr. Atkins has a PhD in Physical Organic Chemistry from Kings College, University of London, UK.
Jayne E. Hastedt, Ph.D.
Dr. Jayne E. Hastedt has over 35 years of experience in pharmaceutical product development, for the last 15 years as the Managing Director of JDP Pharma Consulting. She has had management and technical leadership responsibilities for the development of small molecules, peptides, and proteins using various dosage forms, routes of delivery, and technologies and has supported successful US and European regulatory product approvals. Her experience includes leading physicochemical characterization and CMC development activities spanning early drug product development through product registration. She has supported the development of oral, transdermal, and oral controlled release dosage forms, and specializes in inhaled drug product development. She is currently co-leading an initiative within the Product Quality Research Institute’s (PQRI) Biopharmaceutical Technical Committee (BTC), to develop an inhalation-based Biopharmaceutics Classification System (iBCS) for inhaled drugs. Over her career, Dr. Hastedt has had the opportunity to work at Johnson & Johnson/ALZA, Nektar (Inhale), GSK (Glaxo Wellcome) and Boehringer Ingelheim. She received her MS and PhD degrees from the University of Wisconsin – Madison School of Pharmacy under the guidance of Professors Wright and Zografi. In 2021, she received an Honorary Citation of Merit from the University of Wisconsin-Madison for her contributions to the field of Pharmacy.
Independent Board Members
Kay Chandler, J.D.
Nancy Hutson, Ph.D.
Clinical & Scientific Advisors
Paul Atkins, Ph.D.
Craig M. Audet, Ph.D.
Executive Vice President, Regulatory Affairs
Steven Bender, Ph.D.
Brian Berman, MD., PhD.
Jay E. Birnbaum, Ph.D.
Co-Founder & Executive VP, Clinical Development