Alexander Smith
Lex Smith is an independent consultant working in all areas of CMC product development. Mr. Smith holds a total of 35 years of experience in the pharmaceutical industry, working with both small and large pharma companies, including Burroughs Wellcome/GlaxoWellcome, UCB Pharma, Serenex, Inc., Viamet Pharmaceuticals, Fulcrum Pharma Developments and G1 Therapeutics. Lex has significant pharmaceutical development experience with solid dosage forms, instant and modified release, and parenteral dosage forms. Mr. Smith received a Bachelor of Science in Chemistry from UNC-CH and an MS in Pharmaceutical Chemistry from Lehigh University.
Over his career, Lex held positions of increasing responsibility in Pharmaceutical/Chemical Development, CMC Regulatory Affairs, and CMC project management. Previous roles include vice-president level positions in four companies, most recently, VP – Technical Operations for G1 Therapeutics with responsibility of drug substance and drug product development for three clinical stage compounds. Lex provided major scientific contributions for over 125 INDs and over 10 NDAs including Zyban® SR Tablets, Valtrex®Tablets, Retrovir® Capsules, Emtriva® Capsules, Keppra®Tablets and Trilaciclib Sterile Powder submitted June 2020. Additional experience includes GMP auditing and the preparation of Drug Master Files.
Ben Steinmetz
Ben Steinmetz comes to Persevere with a wealth of pharmaceutical experience and oncology expertise. Since 2018, he has functioned as a fractional Chief Commercial Officer, as he is doing for Persevere, for several pre-commercial and launch phase oncology companies.
In 2015, Ben joined Churchill Pharmaceuticals as SVP Commercial, leading the launch effort for a new oral anticancer agent in a >$4 billion market. Prior to Churchill, he was VP Reimbursement and Patient Access for GlaxoSmithKline and VP Policy and Payer Insight, Oncology/Biopharmaceuticals in GSK’s US managed care division. Ben was VP Global Commercial and Product Strategy, Oncology, and accountable for global launches and product management, scientific communications, and health outcomes for GSK’s oncology portfolio. Product responsibilities included therapeutic and supportive care products such as Votrient®, Tykerb®, Arzerra®, Arranon®, and Promacta® as well as many discovery and development stage products. Before joining GSK, he worked in senior roles at Exocell, a development stage biotechnology company, and Eastman Pharmaceuticals/Sterling Winthrop (now Sanofi).
Bradley J. Monk, MD, FACOG, FACS
Dr. Bradley Monk graduated at the top of his class from the University of Arizona College of Medicine-Tucson in 1988 and completed a residency in Obstetrics and Gynecology at the University of California, Los Angeles, in 1992. In 1995, after three fellowships in Medical Genetics and Gynecologic Oncology, Dr. Monk was appointed director of gynecologic oncology at Texas Tech University Health Services Center and, from 1998 until 2010, was associate professor with tenure of the Division of Gynecologic Oncology, Department of Obstetrics and Gynecology at the Chao Family Comprehensive Cancer Center, University of California Irvine Medical Center, and director of research in the Department of Obstetrics and Gynecology. Dr. Monk was then appointed director and professor in the Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Creighton University School of Medicine at St. Joseph’s Hospital and Medical Center in Phoenix, AZ. In 2016, he became a member of Arizona Oncology and part of the US Oncology Network. He was also appointed the US Oncology medical director of gynecologic oncology research. Dr. Monk is a fellow of the American College of Surgeons (ACS), the American College of Obstetricians and Gynecologists (ACOG), and the American Society for Colposcopy and Cervical Pathology (ASCCP), as well as being an active member of the Society of Gynecologic Oncology (SGO), American Society of Clinical Oncology (ASCO) and other professional organizations. He has authored more than 400 peer-reviewed articles along with more than 30 book chapters dealing predominantly with the prevention and chemotherapy of gynecologic malignancies and patient quality of life. He has led numerous clinical trials that have led to FDA approval of novel agents or changed the standard of care.
Daniel D. Von Hoff, MD, FACP
Daniel D. Von Hoff, M.D., F.A.C.P. FASCO, FAACR is a Distinguished Professor at the Translational Genomics Research Institute (TGen) in Phoenix, Arizona. He holds the Virginia G. Piper Distinguished Chair for Innovative Cancer Research at HonorHealth Clinical Research Institute and the Margaret Givan Larkin Endowed Chair in Developmental Cancer Therapeutics at Hoag Hospital and Medical Director of Research at McKesson Specialty Health for US Oncology Research. He is also Professor of Medicine at the University of Arizona and at the Mayo Clinic, Scottsdale, AZ and Distinguished Professor Department Medical Oncology and Therapeutic Research at the City of Hope.
Dr. Von Hoff’s major interest is in the development of new anticancer agents, both in the clinic and in the laboratory. He and his colleagues were involved in the beginning of the development of many FDA-approved agents we now use routinely, including: mitoxantrone, fludarabine, paclitaxel, docetaxel, gemcitabine, irinotecan, nelarabine, capecitabine, lapatinib, vismodegib, nab-paclitaxel, nal-IRI, pexidartinib and others. His clinical trial work has led to the approval of 3 of the 4 drugs approved by the FDA for the treatment of patients with advanced pancreatic cancer. At present, he and his colleagues are concentrating on the development of therapies for patients with advanced pancreatic cancer.
Dr. Von Hoff has published more than 741 papers, 143 book chapters and over 1186 abstracts. Dr. Von Hoff received the 2010 David A. Karnofsky Memorial Award from the American Society of Clinical Oncology for his outstanding contributions to cancer research leading to significant improvement in patient care and most recently the AACR Distinguished Public Service Award and a named lectureship in recognition of his extraordinary clinical research career and leadership in establishing the AACR/ASCO Methods in Clinical Cancer Research Workshop to educate and train young clinical investigators.
Dr. Von Hoff was appointed to President Bush’s National Cancer Advisory Board in 2004-2010. Dr. Von Hoff is the past President of the American Association for Cancer Research (the world’s largest cancer research organization), a Fellow of the American College of Physicians, and a member and past board member of the American Society of Clinical Oncology. He is a founder of ILEX™ Oncology, Inc. (acquired by Genzyme after Ilex had 2 agents, alemtuzumab and clofarabine approved by the FDA for patients with leukemia). Dr. Von Hoff is founder and the Editor Emeritus of Investigational New Drugs – The Journal of New Anticancer Agents; and past Editor-in-Chief of Molecular Cancer Therapeutics. He is a co-founder of the AACR/ASCO Methods in Clinical Trial Cancer Research Workshop, which has graduated more than 2400 clinical trial physicians.
Duane Sofia, PhD
Dr. Duane Sofia received his Ph.D. in Pharmacology from the University of Pittsburgh. He has over 45 years’ experience in the pharmaceutical industry as an active employee and more recently as a consultant. During his career Dr. Sofia has held increasingly responsible positions from Senior Research Pharmacologist to Director of Pharmacology and Toxicology and ultimately to Vice President of Preclinical Research. He has been intimately involved in the successful submission of a number of INDs, some of which led to NDA approval. He has been an active member of several professional societies including the American Society for Pharmacology and Experimental Therapeutics, the Society of Toxicology, and the American Epilepsy Society. He has authored or co-authored over 200 research articles in peer-reviewed journals dealing with the pharmacology, toxicology, drug metabolism and mechanism of action of experimental and newly developed drug therapies. In addition, he has authored or co-authored 11 book chapters. He also is the holder of 11 U.S. patents. Dr. Sofia has presented papers at numerous scientific meetings with abstracts totaling greater than 150.
Greg Bosch
Greg Bosch brings more than 35 years of leadership experience in the life sciences across pharmaceuticals, biologics, biosurgery, and medical devices. He has served as CEO of multiple healthcare companies, leading global commercial, operations, and R&D organizations, and has extensive experience in public and private company acquisitions, financings, and initial public offerings.
Prior to founding Persevere Therapeutics, Greg has led organizations through key value-creation milestones, including advancing drug candidates from early development into clinical studies and achieving market leadership positions in regenerative medicine. His prior roles include CEO of Panavance Therapeutics, CEO of Geistlich Pharma North America, and President and CEO of PuriCore PLC, where he led a successful IPO on the London Stock Exchange. Earlier in his career, he held senior leadership roles at Baxter International including General Manager of BioSurgery with international assignments in Europe. Greg holds a B.A. in Public Policy from Duke University and an MBA from DePaul University.
Hanns Moehler, PhD
Hanns Möhler is Professor em. at the Swiss Federal Institute of Technology (ETH), Zurich and the University of Zurich, Switzerland. He has held a professorship in pharmacology in the Department of Chemistry and Applied Biosciences, ETH Zurich, as well as in the Medical Faculty of the University of Zurich, where he was director of the Institute of Pharmacology.
He was the first director of the Swiss National Center of Neuroscience Research and director of the Center of Experimental and Clinical Pharma Sciences at the University and the University Hospital of Zurich. Prior to his academic positions, Hanns Möhler was vice-director in the Research Department of Hoffmann-La Roche, Basle, Switzerland.
His discovery of the benzodiazepine receptor and his work on sleep disorders, the regulation of anxiety states, the gene therapy of epilepsy and the neuronal organization of memory was honored by numerous awards. In recent years, his work has been focused on cancer therapy, in particular on transcription factors as drug targets. He is a member of the Swiss Academy of Medical Sciences and the European Academy of Sciences.
José Iglesias, MD
Dr. Jose Iglesias is Director of Apex Oncology, a clinical development consultancy focused in the areas of solid tumor oncology, and he is consulting Chief Medical Officer to Persevere Therapeutics. Dr. Iglesias brings 30 years of global experience in the pharmaceutical industry to Persevere, including large pharma and biotech. He has proven leadership in designing and leading all phases of oncology clinical trials, including large Phase 3 registration studies with over 2,000 patients. Since 2019 Dr. Iglesias has been an independent oncology consultant focused in the areas of solid tumor oncology, immuno-oncology and translational medicine, in early phase to mid-phase clinical development. Earlier in his career he held roles of increasing responsibility at Abraxix BioScience including Vice President of Global Clinical Development and Chief Medical Officer where he was responsible for worldwide development of Abraxane and all other pipeline molecules. Dr. Iglesias also served as Vice President of Clinical Development at Celgene where he was responsible for Phase 3 development of Abraxane for pancreatic, lung and metastatic breast cancer. He has also held senior level medical roles at Bionomics, Biothera, and Apobiologix where he oversaw the global clinical development of its oncology biosimilars program. He is widely conversant with regulatory bodies worldwide, government reimbursement agencies, oncology cooperatives and patient advocacy groups. He has extensively published in the oncology literature with over 8,000 citations. Dr. Iglesias graduated from medical school in 1986, spent 2 years as a fellow at Duke University and 2 years in oncology clinics and in private oncology and hematology practice prior to joining the pharmaceutical industry.
Kathryn Martin, PharmD
Dr. Kathryn (Kate) Martin is the President of Glenmere Research, a consulting firm located in Franklin Lakes NJ, that has been providing regulatory and medical editorial services to the pharmaceutical industry for more than 30 years. After receiving her BS from Northeastern University and PharmD from the University of Texas Health Science Center in San Antonio, Kate was the Director of Oncology Pharmacy Services for the Albert Einstein Cancer Center in the Bronx, NY. Her experience in the industry began at Lederle Laboratories in Pearl River, NY, in Medical Affairs and the Medical Research Division. Since founding Glenmere Research in 1995, Dr. Martin has provided regulatory and medical editorial services to large pharma and has assisted numerous small to mid-size companies with US, European, China, and Japan submissions. She has experience writing regulatory documents across the full product lifespan and is familiar with ICH guidelines, standardized templates, and electronic document management systems. Dr. Martin has written manuscripts that have been published in top tier journals including New England Journal of Medicine, Vaccine, Blood, and Contraception, as well as abstracts and posters at numerous domestic and international congresses including ASCO, ESMO, ACC, SABCS, and ASH. She has written content and developed internal medical education slide decks on topics including pathophysiology, therapeutic management, nonclinical and clinical data summaries, and competitive analysis. Her training and primary area of expertise is in oncology/hematology, including transplant and CAR-T therapy, and immunology.
Lisa Guttman
Lisa Guttman founded Practical Clinical over 15 years ago to provide global Clinical Operations expertise along with her two partners to clients predominantly in Oncology clinical trial planning and execution. She is a well-rounded global clinical research executive with over 30 years of pharmaceutical and biotechnology industry experience. Lisa has a unique multi-disciplinary background having worked across a wide variety of therapeutic areas and held leadership positions in multiple functions including Clinical Development and Medical Affairs. This breadth of expertise affords Lisa a unique cross-functional perspective that underlies her consistent success building and managing clinical programs and teams at Eli Lilly, Amgen, and Abraxis BioScience. Her innovative and practical approach to clinical research planning and execution are valued by Practical Clinical clients and vendor partners. Lisa is consulting Head of Clinical Operations for the GP-2250 Program at Persevere Therapeutics.
Molly McConomy
Molly is a Senior Vice President of Accounting & Reporting Advisory Services with Stout where she has overseen all accounting operations for the Persevere. Molly is responsible for the preparation of quarterly and annual operating budgets and financial projections. Molly has served as interim finance professional for several privately held and publicly traded biotechnology companies where she manages the financial close and reporting cycles as well as prepares quarterly and annual financial statements and notes thereto. Prior to providing accounting and finance consulting services for emerging growth companies, Molly spent five years as an assurance professional with KPMG, primarily serving companies in life sciences, healthcare services and technology industries.
Molly holds a Master of Business Administration degree and Bachelor of Science in Accounting from La Salle University.
Prof. Dr. med. Chris Braumann
Prof. Dr. Braumann is Chief of General, Visceral and Vascular Surgery at the E.v.K. Hospital Gelsenkirchen at the University of Duisburg-Essen Germany. He is also the Head of Molecular and Clinical Research of the Ruhr-University Bochum, Germany. He studied at Martin Luther University and the Free University of Berlin. He conducted research at the University of Cape Town, graduating in 1998 from Humboldt University, Berlin. In addition to his clinical work, Professor Braumann received support for interests outside of surgery, including molecular biology with a specialization in oncologic biology and molecular mechanistic regulation in adipositas. In 2005 Professor Braumann received the European Technology Award from the European Association of Endoscopic Surgery for the first description of the mechanism of an anti-coagulant substance.
Professor Braumann’s clinical expertise is in the areas of general, visceral minimally invasive, endocrinic, and tumor surgery. He has led numerous clinical trials and was a member of the ethics committee appointed by the senate of Berlin. Professor Braumann is a member of the German Society of Surgery, The German Society for Visceral Surgery and the European Association for Endoscopic Surgery.
Robert Coleman, MD
Dr. Robert Coleman is the Chief Medical Officer at the Vaniam Group. He was previously at US Oncology Research as its Chief Scientific Officer, and previously served as the Ann Rife Cox Chair in Gynecology and a professor in the Department of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center (MDACC), as well as executive director for MDACC’s Cancer Network Research Program. He is also a member of the board of directors for the Gynecologic Oncology Group (GOG) Foundation and co-director of GOG Partners. Dr. Coleman won the Rosalind Franklin Excellence in Ovarian Cancer Research Award (2018) and is a past president of the Society for Gynecologic Oncology (2015). He is the current president of the International Gynecologic Cancer Society. In 2020 Dr. Coleman was included in the top 15 Giants in Cancer Care program recognition program which celebrates the achievements of leading researchers and educators whose discoveries have helped propel the field forward and established the building blocks for future advances.
Robert Hrubiec, PhD, JD
Dr. Robert Hrubiec is an intellectual property attorney with over 25 years’ experience in all aspects of intellectual property, specializing in pharmaceutical, biotechnology and medical device/diagnostic patent management, strategic IP evaluation, litigation support, business development, mergers/acquisitions, licensing, FDA regulations, trademarks and patent preparation and prosecution. Dr. Hrubiec is currently the Consulting Intellectual Property Counsel for Persevere Therapeutics and is primarily responsible for providing general intellectual property consulting services, evaluating the company’s patents and patent applications, providing creative patent strategies to further protect key technologies and making intellectual property recommendations to upper management. Dr. Hrubiec is also the founder and President of Innoventiv IP, an intellectual property management and consulting company focused on advising high technology companies on legal matters, patent portfolio management, strategic planning, life-cycle management, licensing/acquisitions/confidentiality/clinical trial and other agreements, due diligence, maximizing value, cost reduction and litigation support. Prior to founding Innoventiv IP in 2012, Dr. Hrubiec was Vice President and Chief Intellectual Property Counsel at Cephalon, Inc., where he was responsible for creating, developing and managing the company’s global IP department as well as all IP aspects of business development. Prior to joining Cephalon in 1999, Dr. Hrubiec was an intellectual property attorney with GlaxoSmithKline and directed a research laboratory at Cytogen Corporation focused on cytotoxic agents conjugated to monoclonal antibodies for use in treating cancer. Dr. Hrubiec received his Ph.D. in synthetic organic chemistry from the University of Connecticut followed by a postdoctoral fellowship in pharmacology/molecular biology at the Yale Medical School Comprehensive Cancer Center. He obtained his law degree from the North Carolina Central University School of Law and is licensed in North Carolina, Pennsylvania and the USPTO.
Stanley J. Musial
Stan Musial is an accomplished executive with 30 years of leadership experience in the life sciences sector, serving as EVP and CFO for both private and public companies, including Promontory Therapeutics, Aruvant Sciences, Xenikos B.V., EryDel SpA and Egalet Corporation. He has raised nearly $1 billion in capital, guided companies through private raises and public offerings on NASDAQ. Mr. Musial has played a key role in operational strategy, organizational growth, product expansion, and M&A, and now serves as a fractional Chief Financial Officer to Persevere Therapeutics.
Thomas Herzog, MD
Thomas Herzog, MD, is the Deputy Director of the University of Cincinnati Cancer Center and is the Paul and Caroline Flory Endowed Professor of Obstetrics and Gynecology at the UC College of Medicine.
Dr. Herzog graduated from the University of Cincinnati College of Medicine in 1986. He completed his residency at Good Samaritan Hospital in Cincinnati followed by a fellowship in gynecologic oncology at the Washington University School of Medicine, St. Louis, before becoming a faculty member at Washington University and then director of the gynecologic oncology fellowship program. In 2004, he became the director of the division of gynecologic oncology at Columbia University and started the fellowship at Columbia and Cornell Universities.
Dr, Herzog is a National Institutes of Health- and American Cancer Society-funded researcher with over 320 published manuscripts. He’s also been in a leadership position of a number of national professional societies including the Society of Gynecologic Oncology, American College of Surgeons, for which he was also on the elected board of governors, the American Board of Obstetrics and Gynecology, and the American Society for Colposcopy and Cervical Pathology, among others. Dr. Herzog served as editor-in-chief of the journal Gynecologic Oncology Research to Practice and The Women’s Oncology Review in addition to being on the editorial boards for a number of other peer-reviewed journals. He currently serves as the Associate Director of the GOG-Partners clinical trials organization.
