Michael Hellerstein

Leader of Product Development group at Vaxxinity, a vaccine company seeking to democratize health through development of its unique technologies against Alzheimer's, Parkinson's, and other indications mainly in the fields of neurodegenerative disorders and chronic diseases. Responsible for IND-enabling development of Vaxxinity products including coordination, management, and execution of the activities necessary to bring novel APIs and vaccine products from R&D into clinical development. Responsibilities include project mangement, manufacturing process development, analytical development and qualification, and IND-enabling nonclinical studies.

Founded Hellerstein Consulting to provide consulting services to biotechnology companies and academic institutions. Managed and grew a consulting business. Provided Quality, regulatory, and scientific consulting services to multiple clients with a variety of needs. ACCOMPLISHMENTS • Founded the business. In less than 18 months, increased client base to 7 and employment to 3.5 FTEs. • Created full Quality Management Systems for three clients. • Provided critical gap-filling services that enabled clients to advance their products in development. RESPONSIBILITIES • Created documents and implemented programs for clients; built clients’ Quality Systems (GLP, GMP, ISO 9001, ISO 17025). Provided outsourced Quality Assurance services including document and data review, internal and external audits, corrective actions and investigations. • Drafted and reviewed CMC sections for regulatory filings. Advised clients on Quality and regulatory strategy. • Managed finances and performed accounting for the business. Obtained permits, negotiated contracts and agreements. Created promotional materials, updated web page, built relationships and alliances.

Product development leader for COVAXX, a vaccine company seeking to democratize health through development of its unique technologies against COVID-19, Alzheimer's, Parkinson's, and other indications. Responsible for providing technical leadership to preclinical, bioanalytical, and validation groups; cross-functional coordination of research activities and laboratory operations; establishment of priorities for research and development projects; and project management. Contributor to quality strategies and systems and to regulatory strategies and submissions.

Regulatory and Quality leader at Kiel Laboratories, an innovative drug development company focused on addressing unmet medical needs through creative strategies, advanced laboratory analysis, and strategic partnerships. Responsible for submissions to FDA, interactions with FDA, and internal and external Quality management.

Co-founded Responsive BioServices, a CRO providing laboratory testing in the fields of virology and immunology along with a suite of complementary services. RBS's core service offering is the development, execution, and reporting of viral load and immunogenicity testing of samples from clinical trials and animal studies. We also provide a broad range of supporting and ancillary services including assay validation, quality and regulatory support, reference standard production and characterization, and scientific consulting. For more info see www.itsrbs.com

Regulatory, Quality, and operational leader for GeoVax, a cutting-edge vaccine company. Responsible for project management, regulatory affairs, GxP compliance, QC, QA, validation, outsourced manufacturing. ACCOMPLISHMENTS • Led the company’s successful bid for a $7.8 million NIH Staged Vaccine Development contract; responsible for management of the work under that contract. • Standardized and improved Regulatory Affairs processes; implemented SOPs and an electronic regulatory communications management system. • Introduced and implemented formal project management of the company’s vaccine development efforts, improving efficiency and organization of operations. • Improved and expanded the Quality Management System, bringing it into compliance with Phase 1 cGMP and current industry practices. • Successfully investigated and resolved numerous Quality incidents including OOSs and a contamination incident at a contract manufacturer. RESPONSIBILITIES • All responsibilities of Director, Quality Control (2006-2012), plus: • Government Contracting: Responsible for proposal generation and management of contracted and subcontracted work. • Regulatory Affairs: Serve as company interface with FDA (CBER); interact with CBER through teleconferences and written communications. Draft, submit and manage Master Files and INDs. Develop and implement regulatory strategies. Perform, manage, and monitor regulatory processes. • Project Management: Manage the company’s product development and outsourced manufacturing projects and large, complex projects for Regulatory, Quality, R&D and general operations.

In a consulting role, continued to fulfill the responsibilities of Director, Quality Control (2006-2012).

Led Quality operations at GeoVax. Maintained GxP compliance in internal and outsourced operations. Responsible for all core Quality functions including validation, vendor management, training, document control, investigations and audits. ACCOMPLISHMENTS • Expanded scope of in-house GxP testing operations from two tests to more than ten. • Developed electronic systems for purchasing, inventory, document control and general operations. Accelerated processes, provided traceability and access through electronic systems. • Managed cGMP outsourced production for two cell banking campaigns, three bulk manufacturing campaigns, and fill-finish of four lots of sterile injectable product. • Managed the 2009 relocation of GeoVax from an incubator to its current space. Directed the build-out of GeoVax's current lab. RESPONSIBILITIES • All responsibilities of Scientist (2005-2006), plus: • Quality Control Management: Managed development and execution of GxP-compliant analytical methods for release and stability testing of GeoVax products. Supervised up to four scientists. • Regulatory Affairs – CMC: Authored CMC text for IND and Master Files. Participated in Pre-IND meeting. • Quality Assurance and Training: Managed document control. Carried out investigations and internal audits. Developed core QA procedures, including deviation reporting and corrective action. Developed and managed the GxP-compliant GeoVax training program. Starting with a minimal framework, built policies and procedures for quality management. Trained employees and implemented company-wide systems. • Outsourcing and Vendor Management: Managed outsourced manufacturing, testing, and storage of vaccines, and outsourced validations. Performed external audits including audits of contract manufacturers and testing labs. Designed and implemented vendor management program.

Joined GeoVax as a laboratory scientist focused on improvement of existing cell-based assays and introduction of molecular biology test methods. Developed, executed, and qualified analytical methods for Quality Control and characterization testing of GeoVax vaccines. ACCOMPLISHMENTS • Developed, demonstrated, performed, and reported a cell-based attenuation test, enabling initiation of a clinical trial upon release of a clinical hold by FDA. • Standardized the execution and reporting of analytical testing, improving efficiency and reducing need for repeat testing. • Introduced analytical method qualification and validation to the laboratory. Initiated qualification of potency tests. RESPONSIBILITIES • Analytical Method Development: Developed and improved analytical methods, including potency tests currently reported to FDA. • Validation: Managed internal validation program, including qualification and validation of processes and equipment. • Technical Writing: Responsible for creation of a wide variety of documents including policies, procedures, work instructions, protocols, and reports. • Equipment Management: Designed and implemented procedures for equipment use and maintenance.

Co-founded Blue Sky Biotech, Inc., a contract research company; built and managed the laboratory operations. ACCOMPLISHMENTS • Built laboratory from scratch. Acquired equipment on used market, developed research protocols, and brought laboratory online within two months. • Introduced offerings across a wide spectrum of services for pharmaceutical research and development. • Established quality control of custom products using standard analytical methods. RESPONSIBILITIES • Directed projects and managed workflow. Hired, trained, and managed a laboratory team of seven scientists and technicians. • Provided molecular biology, protein expression and purification, and fermentation services. • Established vendor accounts, negotiated pricing, and developed laboratory supply system.

In protein chemistry department at Pfizer technology center, performed protein expression and purification studies and generated proteins for drug discovery projects. ACCOMPLISHMENTS • Improved efficiency and throughput of operations through standardization and automation of procedures. • Developed and implemented rapid and nonradioactive enzymatic activity assays, allowing rapid functional testing of proteins in the protein chemistry laboratory. • Named to participate in global working groups with members from worldwide Pfizer sites. RESPONSIBILITIES • Cloned target genes from cDNA libraries, provided recombinant proteins to Pfizer customers in high-throughput screening and crystallography groups. • Evaluated novel technologies for cloning, expression and protein purification. • Expressed proteins in bacterial and yeast systems. Developed fermentation methods.

Performed testing and product development of monoclonal antibodies for use in signal transduction research.

Assisted scientists in the laboratory of Kevin Struhl.

Assisted in laboratory testing of experimental veterinary vaccines.