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Brent Reinke |
Brent is a corporate partner in the Westlake Village office of Musick, Peeler & Garrett. His corporate practice emphasizes the areas of mergers and acquisitions, venture capital, advising emerging growth companies, corporate securities and finance, strategic alliances and licensing. He represents numerous technology and “brick and mortar” companies who are in various stages of development, ranging from venture backed companies to corporations with multi-national operations. His clients are involved in a broad array of industries including biotech/life science, healthcare, high-tech, telecommunications, software, venture capital, real estate and manufacturing. |
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Ali Schulze, Executive Director |
Ali has over 30 years of experience in law, business and marketing to contribute to the Bio Science Alliance (BSA). She has extensive knowledge and expertise in project management, leadership, team development and marketing. Ali has worked with founder, Brent Reinke, for more than 15 years and has 30 years experience working in LA based law firms, as well as the east coast firm, Reed Smith. Ali has been the Executive Director of the Gold Coast Business Forum (GCBF), a nonprofit business education and networking organization for 12 years, where she puts her organization skills and marketing experience into practice. She has been able to help build GCBF into the premier business networking organization along the 101 Corridor. |
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Jamie Jamshidi has over 24 years of industry experience, including small molecules and large molecule biologicals. She retired from Amgen, Inc., in 2007 after 17 years of service with the company. Some of Jamie’s major accomplishments include launching Amgen, Inc.’s first two commercial products, Epogen® and Neupogen®. Jamie was a key team member in the start-up of numerous new Amgen CGMP facilities in the U.S., Puerto Rico and Europe. She helped establish a number of new departments at Amgen, including Contract Manufacturing and Small Molecule Quality Assurance. She was also instrumental in helping Amgen obtain approval of their first small molecule product, Sensipar®. Jamie was the key Amgen Quality Assurance representative at several FDA and other regulatory inspections at contract manufacturing sites. She has extensive knowledge and expertise in the areas of product regulations, Quality Assurance, Manufacturing, Validation, Analytical Labs, Regulatory Submissions, Regulatory Inspections (PAI), Project Management, Managing Contract Manufacturing facilities, Technology Transfer and Team Leadership. In March 2007 Jamie started the PQC Consulting, Inc., a consulting firm providing expert technical services, solutions, and training to pharmaceutical and biopharmaceutical companiesworldwide. The firm’s name converted to Quality and Regulatory Management in 2011. Jamie has a broad understanding of the entire drug development process for both large molecule proteins and small molecules. She has extensive knowledge of U.S. FDA Current Good Manufacturing Practices (CGMP), Current Good Laboratory Practices (CGLP) and Current Good Clinical Practices (CGCP), European and Japanese drug manufacturing regulations, ICH guidelines, and Qualified Person (QP) requirements under EU Directives, and World Health Organization (WHO) regulations.Jamie also has extensive experience in the development and commercialization of pharmaceuticals and biotechnology at all process stages, including Drug Substance (API), Drug Product, Packaging, and Labeling. |
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Paul Meyer |
Currently the CFO of Cynvenio Biosolutions in Westlake Village, California, Paul Meyer is an experienced finance executive with a 25-year track record in senior roles at start-up and Fortune 500 companies. Prior to joining Cynvenio, he ran a financial consulting business focused on early-stage, technology companies. Previously, he was with Interlink Electronics, [NASDAQ:LINK] a developer of intuitive interface technologies for business and home applications, for sixteen years serving as CFO and Executive Vice President. Paul has experience establishing companies in Japan and China and has served as a CPA with a Big Four firm. He chairs the Los Angeles chapter of TechAmerica, the largest high tech trade association in the US. Paul received a BA in Economics from the University of California, Los Angeles. |
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Jan Fang |
Dr. Jan Fang has more than 17 years of successful experience in pharmaceutical industry working for Pfizer and Amgen with extensive knowledge and experience of drug product development from early development to global market application, from aseptic injectable products to solid dosage forms including combination products containing 2-3 APIs. Jan has extensive hands on experience supporting global CMC regulatory filings, from IND, NDA, post-marketing improvement to regulatory queries. Jan has successfully supported PAI inspections from multiple regulatory agencies at commercial manufacturing sites, R&D site, as well as CROs and CMOs. Jan is an expert of cGMP/cGLP practice. She has successfully established GMP analytical testing lab in a research environment. She has developed, authored and/or approved many SOPs, Training Manuals, and Guidelines and provided a highly scored training course on How to Set UP a GMP Laboratory in a Research Environment at an international conference Jan is known for her science based, quality and compliance driven approach. She has been one of the key contributors to many cross-functional process initiatives to streamline drug development. Jan is also known for her phase appropriate and fit-for-purpose development approach including quality systems, regulatory filing, specification setting, method development and validation. Jan is an expert of cleaning and cleaning verification. She had successfully led the effort to establish cleaning and cleaning verification process at Amgen, where the DP manufacturing facility is utilized for both development and GMP purposes, to allow flexibility for early development use as well as compliance for GMP production. As an industry leader of bio-relevant in vitro dissolution testing, she had organized and co-chaired a well-received AAPS symposium on Applications of Bio-relevant USP IV Dissolution Method in Pharmaceutical Development. In addition, Jan is an expert of extratable and leachable (E/L) challenges. She was a Pfizer E/L site expert and a member of Amgen E/L committee. She has in-depth knowledge and expertise of systematic development for potential E/L matter and had numerous experiences to identify and mitigate E/L challenges for both injectables and solid dosage forms. Jan had successfully transferred technologies to numerous CMOs and CROs and had extensive experience working with CMOs and CROs. Her knowledge and experience of drug development and quality enabled Jan to evaluate, select and manage CMOs and CROs very effectively. She is one of the key contributors who developed Amgen’s commercial contract manufacturing footprint. Jan also has great knowledge and experience of QbD for process and product development and has presented multiple posters at AAPS conferences. She also has in-depth knowledge of QbD in analytical testing, from understanding methods and testing results to regulatory filing using Analytical Target Profile (ATP). Jan has 30 plus peer reviewed publications/external presentations. She is fluent in both English and Chinese. |
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Wayne R. Pearl, a former Vice President at Amgen, Inc., and a veteran of 34 years in protein chemistry and biotechnology, was a key contributor to Amgen’s growth and success during its earliest stages, and was directly responsible for managing functions that established Amgen as the world’s premier biotechnology company. Wayne’s experience in process development, manufacturing, quality, and biotechnology experience has few equals. He was directly responsible for many of Amgen’s successes. Wayne is a true biotech pioneer, having helped to start up functions which became key driving forces for Amgen’s early success in developing protein therapeutics. In leading many other functions throughout the company, Wayne’s efforts helped Amgen to sustain its excellence in both clinical product development and commercial activities. Wayne’s career began at the University of Pennsylvania Medical School, working on the isolation and characterization of enzymes from neuroblastoma. He later joined Pittman-Moore, Inc., in developing diagnostic kits, vaccines, and therapeutic products. Wayne’s 22-year career at Amgen included the establishment of the Clinical Manufacturing Group, the successful startup and management of two drug substance facilities (including production of the blockbuster product Neupogen®), development and leadership of Amgen’s international Quality Assurance organization, directing the European logistics center, and vice presidency positions in logistics, manufacturing, and clinical operations. |
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Bill Pratt |
Bill Pratt is VP of Operations and Director of Creative Design for Kinamed, Inc, a Camarillo based medical device company specializing in surgical implants Camarillo based medical device company specializing in surgical implants and instruments. He has over 25 years experience in the device industry, starting on the factory floor and progressing through various technical and management positions. Bill also serves on the Workforce Investment Board of Ventura County, and the Board of the Southern California Biomedical Council. He holds a BA in Environmental Studies from the University of California, Santa Cruz. |
