Brent A. Reinke,
Founder and Chairman
The Bio Science Alliance
Brent Reinke 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 early stage and venture backed companies to corporations with multi-national operations.
His clients are involved in a broad array of industries, including, biotech/life science, high-tech, telecommunication, software, venture capital, real estate and manufacturing. Mr. Reinke was named (i) in Los Angeles Magazine as a Southern California “Super Lawyer” for his work in the mergers and acquisition area; (ii) by the San Fernando Valley Business Journal as one of the “Emerging Business Leaders” in the 101 Corridor; and (iii) by the Pacific Coast Business Times each of the past six years as one of the “Who’s Who in Professional Services” in the Tri-Counties.
He is the Founder and Chairman of The Bio Science Alliance, an non-profit organization which was formed to facilitate the development and growth of a life science cluster for the San Fernando Valley and Ventura and Santa Barbara Counties region and is helping lead the effort to build the Gold Coast BioCenter, a life science “accelerator” to be located in the Thousand Oaks area. Mr. Reinke also played a leading role in establishing the first Southern California Chapter of Keiretsu Forum which is an angel network originally founded in the Bay Area.
Prior to joining Musick Peeler & Garrett, Mr. Reinke was a corporate partner with the international law firm of Reed Smith, LLP.
Ali has over 30 years of experience in law, business and marketing to contribute to the BioScience Alliance (BSA). She has extensive knowledge and expertise in project management, leadership, team development and marketing. Ali has worked with Brent Reinke, a corporate partner of Musick Peeler & Garrett, for more than 15 years and has 30 years experience working for Los Angeles based law firms, as well as the east coast based 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 forum along the 101 Corridor.
As the Executive Director of the BioTech Forum, Ali was focused on achieving the vision that founders John Dilts and Brent Reinke had for the 101 Corridor to provide a life science resource for education, relationships and connective interactions. It is her mission to accomplish that vision by directing the BioScience Alliance to successfully achieve those goals.
Dr. Jan Fang
President & CEO
Quality & Regulatory Management, LLC
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 extractable 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.
Jan brings her unique experience to BSA as an Advisor to the Management Committee and has been an integral part of BSA’s growth. Leading BSA’s Science and Innovation Interest Group (SIIG), her commitment to BSA is an outstanding testament of her loyalty to the life science community. Jan’s dedication is evident in the quality of resources and information by way of her many relationships which she brings to BSA events. We are privileged to have Jan as a valued member of the BSA Team.
VP Operations & Director of Creative Design
Bill has worked in the medical device industry for over thirty years in a variety of manufacturing, operations, and design roles. He holds several U.S. and International patents related to surgical implants and instruments, many of which have been successfully commercialized. His design activities range from direct product development and outside collaboration, to manufacturing process and equipment development. Bill is a board member of the Southern California Biomedical Council and Ventura County Workforce Investment Board, and he advises academic programs at UC Riverside, Moorpark College, and the national Community College Consortium for Bioscience Credentials.
Bill’s consistent presence at regional events speaks to his dedication to the region’s life science industry. He brings these new resources and information in an Advisory capacity to the Management Committee. Bill was instrumental, as Advisor to BSA’s Workforce Development Interest Group (WDIG), in guiding WDIG to independent success connecting the life science industry with local universities and secondary schools and the programs that emerged from this endeavor. Bill’s involvement in BSA’s growth is a valuable asset and we are privileged to have him as a member of the BSA team.