Actinium Pharmaceuticals, a biopharmaceutical company developing innovative targeted therapies for cancers lacking effective treatment options, announced that Dr. Mark Berger has been appointed chief medical officer effective immediately. Dr. Berger joins Actinium with significant drug development expertise that includes the planning and execution of clinical trials that led to the FDA approval of Mylotarg for acute myeloid leukemia (AML) while at Wyeth Research (now Pfizer), and Tykerb for breast cancer while at GlaxoSmithKline. He also has experience in patient care and lab-based cancer research. Dr. Berger will report to Sandesh Seth, Actinium’s executive chairman.
“Dr. Berger has a stellar track record in hematology/oncology research and drug development that makes him perfectly suited for the position of chief medical officer at Actinium,” said Sandesh Seth. “Dr. Berger led the development of Mylotarg, which like Actimab-A, is a CD33 targeting agent. Mylotarg remains the only drug approved in AML in the last several decades, and Dr. Berger was integral to Mylotarg’s approval as highlighted by his presentation to ODAC. This along with Mark’s many other accomplishments in drug development, medical training and research experience gives us great confidence in his ability to build a robust clinical development organization to execute on the clinical development of Iomab-B, Actimab-A and our future clinical programs.”
“I am impressed with the potential for Actinium’s radioimmunotherapy technology,” Dr. Berger said. “The data to date on Iomab-B and Actimab-A are very compelling and suggest that radioimmunotherapy has the potential to be safe and effective particularly in difficult clinical indications such as bone marrow transplant conditioning in patients with AML, or in the treatment of older patients with AML. I am excited to join the Actinium team and look forward to executing on a clinical development strategy that will bring these therapies to approval.”
In addition, Dr. Dragan Cicic, Actinium’s previous chief medical officer, has been appointed to the newly created position of chief technology officer. In his new role, Dr. Cicic will be responsible for leveraging Actinium’s alpha particle immunotherapy (APIT) technology platform to further expand Actinium’s clinical pipeline. Dr. Cicic will also be responsible for driving strategic initiatives including research collaborations and partnerships as well as continuing to expand relationships with the medical and scientific communities.
“Actinium’s growth and progress particularly in 2016 has been transformative and Dr. Berger’s joining is a continued step in that direction,” said Dr. Cicic. “I am excited to work with Dr. Berger and am confident that he will have a lasting impact on the execution of our late stage clinical trials. I welcome my new responsibilities and look forward to having the opportunity to focus extensively on our APIT platform to create value by laying the groundwork for new clinical programs and through strategic initiatives.”
Dr. Berger joins Actinium from Kadmon 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 II 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 II clinical trials before planning and leading a 399 patient pivotal phase III 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 II 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.