Mark Backer, PhD
General Manager
mbacker@alavabp.com
Dr. Backer has technical management experience in the development and manufacturing of a wide variety of biopharmaceuticals including antibodies, proteins, viral-based vaccines and cell therapies. He also has business experience as a biotech startup CEO, and was founding chairman of the contract manufacturing firm Molecular Medicine BioServices (now a division of SAFC Pharma, a Merck KGA company). Dr. Backer’s industry experience began in 1978, when he was the seventh employee of Genentech and initiated its pilot manufacturing operations. He led pioneering efforts in large-scale cell culture technology and ex-vivo expansion and transfection of stem cells. Prior to forming Alava in 2013 he was Sr. VP, Technical Operations with Jennerex with responsibility for all CMC operations. He also served as CEO of Vaxart (viral-based oral vaccine platform), VP Technical Development with Protein Design Labs, and previously served in positions of increasing responsibility with firms including Aviron (now MedImmune Vaccines), Systemix, IDEC, and Eli Lilly. Dr. Backer received a PhD in Chem. Engineering from the University of Washington, and a BS in Chemistry from Stanford University. In addition to managing Alava, he has also served since 2013 as a volunteer industry advisor to the Stanford SPARK Program in Translational Medicine.
Alava has several dozen consultants available to support your technical development, manufacturing, Quality, Regulatory and project management needs. Please contact us to discuss the best fit for your projects.
Our team includes:
- World class technical development executives in upstream and downstream process development and drug product development, each with over 20 years experience at Genentech
- Process, formulation and analytical experts with experience developing leading-edge cell and gene therapy products as well as antibodies
- Several senior Quality Assurance consultants with advanced medicine experience, and the team depth to install and manage Quality Management Systems for clients. Our team includes a consulting Qualified Person to support European clinical operations.
- Regulatory affairs experts through VP level including a former FDA advanced therapy group leader, and regulatory operations including eCTD file preparation and submission
Additional Alava contractors and consultants provide the following capabilities:
Project Management
Alava has technical project managers with extensive experience in the pharmaceutical, biotechnology and medical device industries, supporting development projects from discovery into clinical development and commercialization. We specialize in vendor selection and supporting outsourced development and cGMP manufacturing. Alava will work with your team to coordinate CMC with clinical and corporate planning, and achieve the best outcomes for your project.
Facilities and Manufacturing Operations
Alava has manufacturing, facilities and operations experts from Manager through VP level. We can support Operations strategic planning, supply planning, COGS analysis, logistics, interim management, or person-in-plant activities. Our Quality team provides audits and support for IQ/OQ/PQ, validation and remediation of observations.
Supply Chain
Our Clinical Supply Chain experts will work closely with your clinical operations team to achieve timely and well-controlled delivery of clinical trial materials.