Chief Executive Officer and Chairman of the Board
Mr. Seth has 20+ years experience in investment banking (Laidlaw & Co., Cowen & Co.), equity research (Bear Stearns, Commonwealth Associates) and in the pharmaceutical industry (Pfizer, Warner-Lambert, SmithKline) in strategic planning, business development and R&D project management. Formerly, Mr. Seth was the Chairman of the Board of Relmada Therapeutics Inc., a publicly listed, specialty pharmaceuticals company focused on pain therapeutics. Mr. Seth has received his M.S. degree in Pharmaceutical Science from the University of Oklahoma and his M.B.A. with a concentration in finance from NYU Stern.
Mark Berger, M.D.
Chief Medical Officer
Dr. Berger joins Actinium from Kadmon Corporation where he was Senior Vice President, Clinical Research. In this role he was responsible for all clinical aspects of new drug development including designing and managing clinical trials in oncology indications (non-small cell lung cancer and glioblastoma) and non-oncology indications (chronic graft versus host disease and polycystic kidney disease). Dr. Berger joined Kadmon after serving as Chief Medical Officer of Deciphera Pharmaceuticals. Prior to Deciphera, Dr. Berger was Vice President for Clinical Development at Gemin X Pharmaceuticals where he led the clinical strategy, design and management of clinical trials for two novel oncology agents including obatoclax, a pan Bcl-2 inhibitor. Based on the results of a randomized Phase 2 clinical trial of obatoclax, Gemin X was acquired by Cephalon in March of 2011 for a total consideration of $525 million including $225 million in an upfront cash payment.
Before his work with biotechnology companies, Dr. Berger held key positions in two global pharmaceutical companies. Dr. Berger previously served as Group Director, Medicine Development Centre-Oncology for GlaxoSmithKline. In this position Dr. Berger managed the development of Tykerb (lapatinib) in lung and breast cancer where he designed and led two Phase 2 clinical trials before planning and leading a 399 patient pivotal Phase 3 trial that resulted in the FDA approval of Tykerb in breast cancer. In addition, he managed the Lapatinib Expanded Access Program (LEAP) that enrolled over 4000 patients on a global basis. Dr. Berger began his career in drug development at Wyeth Research where he led the planning and execution of the pivotal Phase 2 trial for Mylotarg, which was the first antibody targeted chemotherapy agent and targeted CD33, similar to Actimab-A. He presented the Mylotarg clinical data at the FDA’s Oncology Drug Advisory Committee meeting, after which Mylotarg received accelerated FDA approval for patients with relapsed AML.
Dr. Berger has a B.A. in biology from Wesleyan University and received his M.D. from the University of Virginia School of Medicine. He did his Hematology-Oncology fellowship at the University of Pennsylvania where he was an Assistant Professor of Medicine, and also was a Research Fellow at the Ludwig Institute for Cancer Research and the Imperial Cancer Research Fund, both in London. Dr. Berger is board certified in internal medicine, hematology and medical oncology.
Dale L. Ludwig, Ph.D.
Chief Scientific Officer
Dr. Ludwig has worked for 20 years in oncology antibody drug discovery and development at Eli Lilly and Company and at ImClone Systems, Inc., until its acquisition by Eli Lilly where he supported the development and successful launch of several biologic oncology drugs including Erbitux®, CyramzaTM, Portrazza®, and LartruvoTM as well as the clinical advancement of 10 additional therapeutic antibodies. Most recently, Dr. Ludwig served Chief Scientific Officer/Vice President of Oncology Discovery Research - Biologics Technology. In this role he was responsible for directing antibody discovery and development for oncology biologics and contributed to key strategic and project advancement efforts. Dr. Ludwig was a member of the Oncology Research Senior Leadership Team and directed the empowered antibody drug discovery programs that included collaborations with Immunogen and Zymeworks.
Prior to the acquisition of Imclone by Eli Lilly and Company, Dr. Ludwig served as Head of Molecular & Cellular Engineering at IMClone Systems Incorporated. In this capacity, Dr. Ludwig served as core team leader for several IND filings and phase 1 advancements for novel antibodies. In addition, he directed and oversaw the full spectrum of drug development including antibody discovery, screening, selection, engineering, optimization, cloning and expression. He was also tasked with establishing meaningful preclinical collaborations with key academic investigators and industry leaders. Post-acquisition he was the research representative to the ImClone-Lilly Transition Team.
Before his work in the biotechnology industry, Dr. Ludwig trained as a postdoctoral associate in the DNA Damage and Repair Group of the Los Alamos National Laboratory and as a postdoctoral fellow in the Department of Molecular Genetics, Biochemistry and Microbiology at the University of Cincinnati College of Medicine. Dr. Ludwig has a B.S. in biology with a concentration in microbiology from James Madison University and received his Ph.D. in Microbiology from East Carolina University.
Chief Commercial Officer
As an accomplished commercial leader, Mr. Kapur brings to Actinium a proven track record of delivering strong commercial results. At Johnson & Johnson, Anil culminated his 15-year tenure serving as Vice President, Commercial Leader, Hematology Franchise, within the Global Commercial Strategy Organization where he launched transformational block-buster products IMBRUVICA®, and DARZALEX®. At Baxalta, Anil served as Vice President, Global Head of Commercial and Portfolio Strategy, Oncology Division shortly after the Company was created until its acquisition by Shire in 2016. Most recently, Anil worked at Bristol-Myers Squibb as Vice President, Head of Early Assets, Biomarkers & External Innovation, Worldwide Oncology Commercialization. Anil joins Actinium from BMS, where he was the Vice President, Head of Early Assets, Biomarkers & External Innovation within the Worldwide Oncology Commercialization organization and helped advance the company's leading Immuno-Oncology portfolio. Prior to this position, Anil was the Vice President & Global Head, Oncology Commercial Portfolio & Product Strategy at Baxalta and a member of the Oncology Leadership Team. In this role, Anil also led the Joint Strategic Committees responsible for advancing the early Immuno-Oncology partnerships with Symphogen and the allogeneic CAR-T partnership with Precision Bio-Sciences.
Anil built a distinguished career spanning 15 years at Johnson & Johnson where in his last role, he served as the Vice President, Commercial Leader for the Hematology Franchise with responsibility for the development and execution of global commercial strategy and launch plans for all Hematology in-market, late-stage development, and early pipeline assets. He is credited with significantly shaping the clinical development plans and successful launch and growth of multiple Oncology blockbuster products including IMBRUVICA®, DARZALEX®, and VELCADE®. At J&J, he led the IMBRUVICA® Joint Commercial Committee (JCC), established between J&J and Pharmacyclics, and built and led the global team that launched DARZALEX®, the first biologic for Multiple Myeloma. Anil also held leadership roles of increasing complexity and responsibility in US Marketing, US Regional Sales, and within the Asia-Pacific Regional Oncology organization covering 14 markets including Japan, China, Australia and Korea.
Anil has an MBA from the Fuqua School of Business at Duke University, a MS in Industrial Engineering from Louisiana Tech University, and a Bachelor of Engineering from the Birla Institute of Technology, India.
Nitya Ray, Ph.D.
Executive Vice-President, Head of Product Development, Manufacturing and Supply Chain
Dr. Ray joins Actinium from CytoDyn, Inc. where he was Sr. Vice President of Manufacturing and CMC Team Leader. At CytoDyn Dr. Ray developed robust and cost effective manufacturing processes for an antibody therapeutic drug candidate, currently in two Phase 3 clinical studies intended to treat and prevent HIV infection. Dr. Ray led a successful regulatory meetings with the FDA while simultaneously developing strategies for process development, scale-up, validation, commercial manufacturing, and supply chain to support potential commercialization of the CytoDyn’s HIV therapeutic drug candidate. Prior to CytoDyn, Dr. Ray spent 15 years at Progenics Pharmaceuticals, Inc., a radiopharmaceutical therapeutic and diagnostic company, most recently as Senior Vice President, Manufacturing. At Progenics, Dr. Ray led the development of scalable manufacturing processes and achieved order-of-magnitude cost reduction through improved productivity and scale. In addition, Dr. Ray built process and product development teams for Progenics’ small molecule, biologics, and radiopharmaceuticals that developed innovative processes for various phases of clinical development and commercial manufacturing. Dr. Ray supported in-house cGMP biologics manufacturing for Phase 1–3 clinical development and managed relationships with Contract Development and manufacturing Organizations (CDMO’s) on a global basis. Dr. Ray also worked at Hoffman-La Roche with a focus on biopharmaceuticals and Verax Corporation in roles of increasing responsibility. Dr. Ray has a Ph.D. in Biochemical Engineering and an M.S. in Chemical and Biochemical Engineering from Rutgers University and a B.S. in Chemical Engineering from Jadavpur University.
Principal Financial and Accounting Officer
Mr. O’Loughlin joined Actinium in October 2015 as Vice President, Finance and Corporate Development, with almost a decade of life sciences industry experience gained from previous positions in investment banking and publicly traded life sciences companies. Prior to Actinium, from June 2015 to October 2015, Mr. O’Loughlin worked at J. Streicher LLC as an investment banker, from August 2012 to June 2015 Mr. O’Loughlin held the position of Vice President, Corporate Finance and Development and was a corporate officer at Protea Biosciences, Inc., a publicly traded life sciences tools company. Previously, From June 2010 to June 2012, Mr. O’Loughlin held corporate development positions with Caliber I.D., a publicly traded diagnostics company. Mr. O’Loughlin previously worked in investment banking at Jesup & Lamont where he focused on the biotechnology and life sciences industries. Mr. O’Loughlin has a B.S. in Business Administration with a concentration in finance from Ramapo College of New Jersey.
David Gould, M.D.
Senior Vice President, Corporate Development and Affairs
Dr. Gould joined Actinium in 2014, initially as SVP Finance and Corporate Development before assuming his current position in 2016, which includes responsibilities for corporate and business development, as well as medical and corporate affairs. Prior to joining Actinium, he had 15 years of healthcare sector investment experience across the life sciences spectrum. From 2003 to 2013 he was a Principal and Partner at Merlin Nexus, a specialized late-stage private equity firm which invested in emerging public and late-stage private biotechnology and medical device companies. There he was part of an investment team which generated consistently strong, benchmarked returns, driven in part by a disciplined focus on clinical data and unmet medical need, including oncology.
Prior to that, David was a Vice President at Dresdner Kleinwort Capital, as part of their Global Private Equity healthcare investment team based in New York and London. He managed direct investments in life sciences companies, had several Board observer roles, and also contributed to healthcare fund-of-funds activities. He gained additional experience there in pharmaceutical equity research. Dr. Gould received a MD from Jefferson Medical College, of Thomas Jefferson University in Philadelphia. He also received a M.B.A. in Finance from Stern School of Business, New York University and a B.S. in Molecular Biology from the University of Wisconsin - Madison.
Dr. Vijay Reddy, M.D., Ph.D.
Vice President, Clinical Development
Dr. Reddy is a physician scientist (MD., Ph.D.) who focused his clinical practice in the area of bone marrow transplantation, and hematological oncology. His clinical experience includes attending physician at Shands Hospital, University of Florida, and as Medical Director for adult BMT program in Orlando. Dr. Reddy's training includes a Ph.D. in cancer immunology, clinical fellowship at the Princess Margaret Hospital, University of Toronto and research fellowship at the Dana Farber Cancer institute, Harvard Medical School. Prior to joining the pharmaceutical industry, Dr. Reddy was Professor of Medicine at the University of Central Florida. As a practicing clinician, Dr. Reddy participated in several clinical trials in the field of bone marrow transplant as an investigator, physician advisor or advisory board member. He has served as inspector for the Foundation of Accreditation of Cellular Therapies (FACT). He is currently an Editorial Board Member for Biology of Blood and Marrow Transplantation and has authored over 50 publications in hematology/oncology and BMT journals.
Dr. Reddy joined Actinium from Pharmacyclics LLC, an Abbvie company, where he was Senior Medical Director, Oncology Medical Affairs. In this role, Dr. Reddy worked on the Ibrutinib program in CLL, MCL and chronic graft versus host disease (GVHD), along with additional indications. Previously, he worked at Medimmune (AstraZeneca) as Medical Director, Early clinical development, Immuno-Oncology R&D. Prior to Medimmune, Dr. Reddy worked at Janssen, a Johnson & Johnson company as Medical Director, Oncology. He brings his extensive clinical, scientific and industry expertise in bone marrow transplant and hematological malignancies to Actinium.
Robert Daly, Ph.D.
Vice President, Head of Clinical Operations
Dr. Daly has more than 20 years of experience in clinical operations, clinical research and product development at pharmaceutical, biotechnology and contract research organizations. During his career, Dr. Daly has executed large, late-stage, international clinical studies with thousands of patients across hundreds of sites. Having worked at both drug development companies and CROs, Robert has valuable perspectives on the drug development process and clinical operations. He has managed multiple functions and departments in the development of drug candidates for indications for unmet needs and has extensive experience interacting with the FDA.
Prior to joining Actinium, Dr. Daly served as Vice President, Clinical, at CTI BioPharma, where he led research and development activities for Clinical Operations supporting the company's two Phase 3 programs for Pacritinib, a JAK2/FLT3 inhibitor for patients with Myelofibrosis. Previously, Dr. Daly was Vice President, Development Operations at Durata Therapeutics, Inc., until its acquisition by Actavis, plc. At Durata, Dr. Daly managed multiple departments including all R&D, Clinical Monitoring and Operations, Project Management, Biostatistics and Data Management supporting Dalbavancin, a lipoglycopeptide antibiotic approved for patients infected with methicillin-resistance Staphylococcus aureus. Dr. Daly served as Executive Director, Clinical Operations and Head, Global Medical Sciences and Medical Affairs for Portola Pharmaceuticals, Inc. While at Portola, Dr. Daly managed a 7,000 patient, 450-site Phase 3 trial in 30 countries that led to the approval of the Factor Xa Inhibitor Betrixaban for patients with venous thrombosis. Dr. Daly also directed Portola's activities in oncology for an orally available kinase inhibitor aimed at hematologic cancers and inflammatory disorders. During Dr. Daly's career, he also gained valuable clinical research, clinical operations and product experience at companies including KAI Pharmaceuticals, Inc., Artisan Pharma, Inc., Theravance Biopharma, Inc., Millennium Pharmaceuticals, Inc., DuPont Pharmaceuticals Company and KOS Pharmaceuticals, Solvay Pharmaceuticals and SmithKline Beecham Pharmaceuticals.
Jehan Rowlands, Pharm. D.
Vice President, Head of Regulatory Affairs
Dr. Rowlands is a seasoned and experienced regulatory strategist whose career spans eighteen years at companies such as Forest (now Allergan), Sanofi, Otsuka and NPS Pharma. Throughout his career, Dr. Rowlands worked closely with the FDA to develop and execute regulatory strategies for drug candidates for a wide range of therapeutic indications. Prior to Actinium, he worked at InfaCare Pharmaceutical, Inc., a specialty pharmaceutical company focused on the neonatal and pediatric patient populations, where he was Vice President, Head of Regulatory Affairs. In September 2017, Mallinckrodt acquired InfaCare for a total of $425 million inclusive of upfront and potential milestone payments. At InfaCare, Dr. Rowlands developed a regulatory strategy that resulted in stannsoporfin being granted Fast Track Designation by the FDA and an agreement with the FDA that a New Drug Application (NDA) could be filed upon successful completion of a Phase 2(b) trial. Dr. Rowlands has a B.S. in Pharmacy as well as a Doctor of Pharmacy (Pharm.D.) degree from Rutgers University. He also completed a post-doctoral pharmaceutical industry fellowship jointly sponsored by Rutgers University and Hoffmann-La Roche.
Vice President, Controller, Finance
Gary possesses over 25 years of finance and accounting experience in the healthcare industry where he has worked at large, global pharmaceutical companies as well as emerging biotechnology companies. Prior to Actinium, Gary served as Controller of Bellerophon Therapeutics, Inc. a publicly traded medical device company. Previously, he served as Vice President, Finance at Cogentix Medical, Inc. a publicly traded revenue generating medical device company. Earlier he was Vice President, Finance and Principal Financial and Accounting Officer at Genta Incorporated, a publicly traded biotechnology company that was developing drug candidates for patients with cancers. He also worked at Geller & Company as Manager Financial Analysis, Planning & Reporting where he provided services to a private client with revenue in excess of $3 billion. Gary began his career at Warner-Lambert, which was ultimately acquired by Pfizer. At Pfizer/Warner-Lambert, Gary had roles of increasing responsibility, including Director, Financial Planning & Reporting and Director Consolidated Management Reporting in the Corporate Controllers Group. Gary has an MBA in Finance from Carnegie-Mellon University and a B.S. in Accounting from the University of Connecticut.