Wednesday, March 30, 2016
Dr. Zbigniew Markowski has stepped down, for personal and family reasons, from his positions as chief executive officer of Helix BioPharma and chairman of Helix Polska. Helix BioPharma is a biopharmaceutical company developing innovative drug candidates for the prevention and treatment of cancer. Dr. Sven Rohmann will replace Markowski, effective immediately.
Eurotrials, a CRO specialized in Europe and Latin America, is pleased to announce the opening of its new office in Mexico City, Mexico. The new office strengthens the company’s presence in Latin America and further boosts its growth and expansion, providing full operational coverage in this key emergent region.
LakePharma, a provider of integrated solutions covering the biologics CRO space, has acquired Blue Sky BioServices, a CRO specializing in protein and antibody production and assay services. The combined company will be known as LakePharma, and is now the largest dedicated biologics CRO in the U.S., providing a broad range of protein and antibody-related development services to the pharmaceutical and biotechnology markets. Blue Sky BioServices is a portfolio company of Ampersand Capital Partners and as part of the transaction, Ampersand made an investment into LakePharma to support growth initiatives.
Evotec has announced the formation of a spin-off company in the field of nanoparticle-based therapeutics to treat immunological disorders. Epidarex Capital, EMBL Ventures and Gimv participated together with Evotec in the EUR 14 million ($ 15.75 million) Series A round of Topas Therapeutics. Evotec will remain the largest shareholder after the financing round.
ORIG3N, a regenerative medicine provider, and Sharp Edge Labs, a drug discovery and development company focused on genetic disorders, have entered into a drug discovery alliance. As part of the alliance, ORIG3N will make patient-derived cells available to Sharp Edge Labs for use in their drug discovery platform for genetic disorders.
Certara, a global biosimulation technology-enabled drug development company, has announced that its regulatory and medical consultancy, Synchrogenix, has introduced an artificial intelligence- (AI-) enabled solution to meet the data transparency requirements of the clinical and drug development market. Those detailed requirements were published by the EMA on March 2 as Policy 70.
The Pulse on Study Conduct by Elizabeth Weeks-Rowe
The young woman who stepped into the aisle had an earnest vibrancy about her. She was engaged in a lively phone conversation that continued even while she arranged luggage in the overhead bin and took her seat next to me. Boarding an airplane was secondary to her exciting conversation. From what I could gather, she and some colleagues had resolved a major issue during their business trip. She had performed well and received special recognition from her employer.
A clinical trial in which volunteers were infected with dengue virus six months after receiving either an experimental dengue vaccine developed by scientists from the National Institutes of Health (NIH) or a placebo injection yielded starkly contrasting results. All 21 volunteers who received the vaccine, TV003, were protected from infection, while all 20 placebo recipients developed infection. The study, published in Science Translational Medicine, underscores the importance of human challenge studies, in which volunteers are exposed to disease-causing pathogens under carefully controlled conditions.