Yang (Frank) Gao, Ph.D., EMBA

PharmGo provides professional drug R&D strategy and regulatory affairs consultancy as well as intellectual property consultancy for any client needs license-out/develop/commercialize medicinal products in China.

serves as the Chief Strategy Officer and Senior Partner at Shanghai BRL Medicine Co., Ltd., responsible for company pipeline and development strategy, oversighting the CMC R&D, technical transfer and commercial plan, clinical development strategy, quality system establishment and regulatory strategy of gene and cell therapy products, as well as leading portfolio and project management and digitalization. Assisted the CEO to achieve the company's transformation from a university laboratory to a modern pharmaceutical company by establishing plan management, procedure management, organization management, strategy management and culture management.

Achievements in PAREXEL  20+ Drug development trainings for biotech companies in US, JP, EU and CN  40+ Gap analysis for CN and US INDs and NDAs/BLAs covering small and large molecular products as well as technical transfers  5+ Due diligence  10+ BD roadshow as regulatory expert in US, JP and CN  20+ Analysis of regulatory policies  20+ Presentations in industry conference  10+ Companies’ long-term development and regulatory consultant Responsibilities:  Drug development strategy development  Regulatory plan development  Regulatory project supervision and leadership  Thought leadership  Consulting activities and relationship management  Business Development.

Achievements in Ascentage o Initiated an integrated regulatory strategy for each molecular in the pipeline– submission plan, clinical development plan, CMC development plan, patent plan, business plan, marketing access plan and competitor prediction, etc. Provided a dashboard with dynamic intelligence for CEO and CMO to make decision. o Set up RA department development plan, budget plan and each member’s career development plan o Successfully lead a team with members located in four cities o Initiated a regular cross-functional communication model to help projects move forward smoothly and with a clear regulatory endpoint. o Lead four INDs within 6 months in which two US INDs and one China IND got approval. o Completed five annual reports and one supplement submission o Organized face-to-face meeting with agency which help an IND approval in China Responsibilities: o Manage all INDs in both China and USA. o Develop and execute registration strategy. o Prepare and submit the dossier. o Arrange regulatory communications, including all types of meetings with CFDA/FDA.  Establish and maintain a top-level regulatory system and team.  Provide regulatory guide to cross functions by the timely and professional interpretation on new regulation, policy and technical guideline on innovative drug.

Position In Eli Lilly and Company 1. Provide technical support on product registration policy and strategy for Lilly and Lilly joint venture partners. 2. Lead cross-functional teams to minimize regulatory impacts to all Lilly marketed products. 3. Collaborate with Lilly global cross-functional teams to develop strategy for CMC changes during R&D and lifecycle. 4. Delivery China CMC regulations and technical requirements to Global teams. 5. Responsible for registering medical device in China. Position In RDPAC CMC Council 1. Screen hot CMC topics and recruit talents from member companies to set up task forces to deal with CMC issues. 2. Lead CMC Variation Task Force and Stability Task Force to assist member companies to deeply understand CFDA regulations and guidelines, representative industry to communicate/negotiate with CFDA on technical issues.

1.Review CMC of various-staged dossiers, including IND, NDA, ANDA applications and Post-approval changes, especially on the therapeutic areas of psychiatric, neurology, surgical nutrition and cancer. 2. Review BE of ANDA. 3. As technical adviser, take part in on-site inspection, domestic and overseas. 4. Draft CMC and BE technical guidelines. 5. Coach new CMC reviewers. 6. Provide training to industry.