Alava Biopharm Partners expands, offers nonclinical development and regulatory affairs consulting along with CMC support

San Mateo, CA – November 2014 – Alava Biopharm Partners LLC, a privately held consulting and contracting firm, has added depth and scope to its development services. The company was founded in early 2013 with a focus on biological products and Chemistry, Manufacturing and Controls (CMC) services. In 2014 the initial team of seven senior consultants and a similar number of more junior consultants has nearly doubled, providing improved bandwidth and a wider scope of services. In addition to CMC services, senior consultants have been added to initiate support for nonclinical/toxicology activities, and Regulatory Affairs. Additional team members were added with small molecule experience. For each area, Alava has depth and can provide a good value.

New Alava team members include:

Peter Bach, PhD, MBA: Nonclinical development and toxicology. Peter led these functions with AstraZeneca (MedImmune) and Celltech.

Robert Bayer, PhD: led downstream operations for antibody-drug conjugate programs at Novartis, and purification at Genentech Oceanside facility.

Gregory S. Blank, PhD: Downstream processing and manufacturing. Greg led the late stage development group at Genentech including defining approaches to viral clearance.

Patty Kiang, PhD: Drug product manufacturing and delivery device expert. Led the development of several pre-filled syringe applications while at Genentech, and supported delivery device developers in the US and Asia. Patty is expert in assessing extractables/leachables.

Bill Turner: Regulatory Affairs. Bill led Regulatory and Quality functions for Dynavax, and Regulatory Affairs for MedImmune Vaccines.

Bio sketches for the new team members can be found at www.alavabp.com. Additional consultants have joined Alava to provide depth and particular expertise, including an experienced project manager, a senior manufacturing/operations executive, a senior cell therapy development and manufacturing expert, and experts in small molecule development and analytics, eCTD regulatory publishing, and bioassay development.