Avinash Desai, MD
Executive Vice President of Clinical Development, Operations and Medical Affairs
Dr. Desai is an industry veteran in the hematology and oncology field, most recently serving as Vice President, Head of U.S. Medical Affairs – Oncology at Glaxo Smith Kline (GSK). Over the course of his twenty-five-year career, Dr. Desai has successfully designed and implemented clinical development, U.S. and global medical affairs, and life cycle management plans for a variety of pharmaceutical products. This has included participation in multiple INDs, NDAs, and sNDA submissions and efficiently managing the product Scientific Advisory Boards (SAB) and Data and Safety Monitoring Boards (DSMB) for hematology, oncology and therapeutic candidates. At GSK, he established the U.S. medical affairs oncology team that oversaw the launch readiness plans for three novel oncology products—Blenrep® in multiple myeloma, Zejula® in ovarian cancer, and dostarlimab in endometrial cancer. In addition to GSK, Dr. Desai has overseen the clinical development, implementation and delivery of oncology life cycle management plans for various oncology therapies at several leading global pharmaceutical companies, including Eli Lilly & Company (Lilly), Janssen Pharmaceuticals, Inc. and Takeda, Inc. Prior to GSK, he was the VP of Global Medical Affairs at Lilly, during which time he oversaw the global medical affairs team for Lilly's GI Oncology portfolio. Earlier in his career, Dr. Desai contributed to the approval of Janssen's myeloma drug Darzalex® (daratumumab) and leading and strategically executing medical affairs activities globally for Velcade® (bortezomib). Prior to Janssen, Dr. Desai was responsible for the international development of oncology products in solid tumors and hematological malignancies at Sanofi, where he successfully executed pivotal trials that led to NDA submission for Jevtana® (cabazitaxel).
Dale L. Ludwig, Ph.D.
Chief Scientific & Technology 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.
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.
Mamata Gokhale, Ph.D., RAC
Vice President, Global Head of Regulatory Affairs
Familiarity with all phases of drug development allows Dr. Gokhale to align nonclinical and clinical development with regulatory strategies and implementing them at regional and global levels and seamlessly transition between INDs, NDAs/BLAs (United States) and CTAs/IMPDs, MAAs (EU). Dr. Gokhale’s regulatory experience includes developing regulatory strategies for small molecules, monoclonal antibodies, cell and gene therapies, leading and managing regulatory interactions, requesting orphan drug, breakthrough therapy and fast track designations and pediatric vouchers, resolution of clinical hold issues, developing target product profiles, core data sheets and conducting labeling negotiations.
Dr. Gokhale also has highly complementary and relevant clinical experience that includes developing study concept documents and protocols, interacting with Key Opinion Leaders and data safety monitoring committees, drafting and reviewing Protocols and Investigator Brochures, compiling and reviewing clinical study reports, project management, conducting study feasibility, evaluating budgets for clinical trials, pharmacovigilance and resolution of audit findings.
Dr. Gokhale earned her Ph.D. from the University of Bombay (accredited in United States), trained as postdoctoral fellow at Johns Hopkins University (School of Medicine and Johns Hopkins Bloomberg School of public Health) and as a staff fellow at the FDA. Dr. Gokhale has the RAC certification from RAPS and Associate training in the ISO 9001:2000 Quality Management System. Dr. Gokhale maintains academic ties with the University of Southern California by lecturing at its International Center for Regulatory Science.
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.
Mark Kubik, MBA
Chief Business Officer
Prior to joining Actinium, Mark served as CBO at OncoImmune, where he headed its business development function and led a process and transaction whereby the company was sold to Merck for $425M upfront with potential additional contingent regulatory and sales milestones and royalties. Prior to OncoImmune, Mark held positions in business development and led transformative and award-winning deal making at AvantGen, Abgenix (now Amgen), Protein Design Labs (PDL), XOMA, Seattle Genetics (now Seagen), MacroGenics, Glenmark Pharmaceuticals, i2 Pharmaceuticals / Velocity Sciences, and Invenra, among others. In addition to the M&A transaction between OncoImmune & Merck, important deal highlights for Mark, include a global co-development agreement on behalf of Abgenix (now Amgen) with Immunex for Vectibix® (panitumumab), an ex-US strategic alliance on behalf of Seattle Genetics with Takeda for Adcetris® (brentuximab vedotin) (nominated by Recombinant Capital / Allicense for consideration as 2009 "Alliance of the Year") and a multi-program bispecific mAb discovery collaboration on behalf of MacroGenics with Gilead (won Licensing Executives Society (LES) Alliance of the Year in Life Sciences Award in 2013).
Mark received his MBA in Finance from the Leeds School of Business at the University of Colorado-Boulder and his BA (cum laude) in Molecular, Cellular and Developmental Biology (MCDB) from CU-Boulder.
Dr. Mary Mei Chen, M.D., Ph.D.
Vice President, Clinical Development
Dr. Chen received training in both hematology (M.D.) and immunology (Ph.D.) followed by over twenty years of clinical research and development experience, including over ten years of biopharmaceutical industry experience and five years as a practicing hematologist. During her time in industry, she has led global, cross-functional teams in the design and execution of first-in-human clinical trials as well as trials in Phase 1 through Phase 3 in patients with AML, multiple myeloma, and breast cancer. She has contributed to the preparation and submission of regulatory documents and attended regulatory meetings to support Investigational New Drug (IND) and NDA applications in the US, EU, and other regions. Over the course of her career, she has authored over 50 peer reviewed publications in high impact journals. Dr. Chen joins Actinium from GlycoMimetics, Inc., where she led multiple clinical trials including the global pivotal Phase 3 study of uproleselan (GMI-1271-301), which is enrolling 380 patients with R/R AML at approximately 50 centers across nine countries. In this effort, Dr. Chen managed relationships with study investigators, created necessary protocols, Investigational Brochures, and target product profiles. Previously, Dr. Chen held the position of Medical Director, Global Clinical Lead–Clinical Science at Takeda Pharmaceuticals International where she developed clinical trials and protocols for T-cell and B-cell targeting therapies for oncology and inflammatory diseases. In this role, she successfully led multidisciplinary teams in the submission of an IND and Clinical Trial Application. Prior to Takeda, Dr. Chen worked at Pfizer (Wyeth), as Translational Medicine Team Lead-Translational Immunology. In this role, Dr. Chen supported biomarker development to support clinical development in hematology, oncology and inflammatory diseases for biologic and small molecules. At Pfizer, she contributed to the scientific, clinical and commercial development of the R&D pipeline and coordinated clinical development plans and protocols.
Prior to the biopharmaceutical industry, Dr. Chen was a researcher at the Harvard Medical School, Brigham and Women's Hospital in the Department of Immunology, Rheumatology and Allergy, initially as a Postdoctoral Fellow before becoming Faculty Member, Instructor in Medicine. Mary received her Ph.D. in Immunology from Chiba University, Graduate School of Medicine in Tokyo, Japan. She completed her postdoctoral fellowship in the department of infection and host disease at Chiba University. Dr. Chen received her Doctor of Medicine degree from Shanghai Jiao Tong University, School of Medicine.
Qing Liang, PhD, DABR
Vice President, Head of Radiation Sciences
Qing Liang, PhD, DABR brings highly relevant experience to Actinium related to the advancement and innovation of radiation-based therapies for improved therapeutic outcomes. Her research focus and interests revolve around radiation dosimetry, Monte Carlo Simulation, Knowledge Based Image Dose Optimization and Management, and imaging protocol optimization. Dr. Liang is a Medical Physicist certified by the American Board of Radiology and prior to Actinium was Medical Physicist and Assistant Professor at Fox Chase Cancer Center at Temple University (Philadelphia, PA). Prior to that, she had worked at Mercy Health System (Janesville, WI), Turville Bay MRI & Radiation Oncology (Madison, WI), University of Wisconsin Hospital (Madison, WI), and UW Accredited Dosimetry Calibration Laboratory (Madison, WI). Dr. Liang has extensive knowledge on Radiation Physics, Radiation Dosimetry (Therapeutic and Imaging Dose), Radiation Protection and Safety, Health Physics and Radiobiology. Dr. Liang is currently an active member of the American Association of Physicist in Medicine and currently servers on three professional committees and task groups. She received BS and MS in Material Science and Engineering from Tsinghua University, Beijing, China, and earned her PhD in Medical Physics from University of Wisconsin-Madison, Madison, WI.
Chief Executive Officer and Chairman of the Board
Mr. Seth has 25+ years of experience in investment banking (Laidlaw& Co (UK) Ltd., Cowen & Co.), equity research (Bear Stearns, Commonwealth Associates) and in the pharma industry (Pfizer, Warner-Lambert, SmithKline in strategic planning, business development and R&D project management). Mr. Seth was chairman of Relmada Therapeutics Inc., a specialty pharma company focused on CNS therapeutics, which he helped co-found. Mr. Seth has an MBA in Finance from New York University; an M.S. in the Pharmaceutical Sciences from the University of Oklahoma Health Center and a B.Sc. in Chemistry from Bombay University. He has published several scientific articles and was awarded the University Regents Award for Research Excellence at the University of Oklahoma. Mr. Seth was designated as Regulatory Affairs Certified by the Regulatory Affairs Professionals Society which signifies proficiency with U.S. FDA regulations. He has several patents related to use of radiopharmaceuticals as conditioning agents for adoptive cell therapies and as therapeutic combinations.
Chief Financial Officer
Mr. O’Loughlin joined Actinium in October 2015 as Vice President, Finance and Corporate Development and was named Principal Financial Officer in May 2017 and Chief Financial Officer in July 2020. Steve possesses nearly fifteen years 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 company developing and commercializing mass spectrometry imaging and bioanalytic technologies and services. Previously, From June 2010 to June 2012, Mr. O’Loughlin held corporate development positions with Caliber I.D., (formerly Lucid, Inc.) a publicly traded company developing and commercializing VivaScope ®, an FDA cleared diagnostic device for the non-invasive assessment of the skin for skin cancer and other dermatologic conditions. 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.
Dr. Vijay Reddy, M.D., Ph.D.
Vice President, Clinical Development & Head of BMT
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.