Alex Cheng

SynteraBio is a CGT company working on translational inhalation mRNA technology for respiratory disease treatment and plasmid DNA for metabolic diseases. We're also promoting clinical application of stem cell and NK cell products.

Shanghai Sprucecloud Medical Technology provides innovative medical solutions and technical services to help pharmaceutical companies achieve greater efficiency during clinical development of their innovative drug candidates. We're lazer-focused on the medical monitoring activities involved with clinical trials, to provide e-platform for CROs, biotech and pharma companies medical team to perform medical monitoring more efficiently and reduce the workload ofthen required in traditional way of monitoring.

Wakefield is a US-based dedicated clinical CRO serving small to mid-size biotech companies. We can offer FDA IND submission and phase I/II clinical operation full-spectrum services in the US.

Leading the clinical development team at Advaccine.

Clinical development strategy, regulatory agency communication, and medical affairs.

1、Provide medical/scientific guidance on projects 2、Provide medical consulting service regarding phase I – IV clinical research studies. 3、Serve as a resource to identify experts to serve as consultants to Company or Sponsors or for various Sponsor committees (e.g., Steering Committee, Data Safety Monitoring Committee, Adjudication Committee, etc.) 4、Function as a medical monitor (during business and/or non-business hours) for various clinical studies reviewing study related materials as per contract (protocol, investigator’s drug brochure, informed consent form template, case report forms, etc.) and interacting (with appropriate documentation of the contact) with sites, internal and external team members in an effort to help maintain patient safety and the medical/scientific integrity of the study. 5、Provide project specific/therapeutic training. 6、Conduct a medical review of patients’ safety and laboratory data. 7、Review and identify queries pertaining to individual Serious Adverse Events to assist the Sponsor in establishing an accurate safety profile for their IP/IMP. 8、Draft Medical Monitoring Plan if contracted. 9、Assist in the preparation of clinical development plans in collaboration with others. 10、Liaise with expert opinion leaders and to organize expert opinion leader meetings when requested by internal or external clients. 11、Support business development activities (provide input into proposals, bids, and protocols/synopses; attend/ present at client proposal meetings, etc.)

1. Identification/mapping of KOLs 2. Develop professional relationships with the targeting KOLs and build advocacy and gain contributions of KOLs . 3. Proactively Visit, Track, Collect, analyze and reports targeting KOLs insights that may impact Astellas development plans /trial designs, launch strategies and tactics, medical education programs tailored to physicians' education needs 4. Provide and discuss scientific information and data regarding new launched products to healthcare professionals to ensure quality and accuracy of key medical and scientific information on new treatment options by face to face visits speaker training and scientific communications. 5. Scientific support of speaker training activities in the region with timely feedback. 6. May function as the Astellas medical speaker to present at Astellas/Society sponsored activities for up-to-date data based scientific and clinical information on Astellas product(s). 7. Liaise and provide up-to-date medical support to facilitate listing of products in medical guidelines, RDL, formularies as appropriate. 8. Manage unsolicited requests /objections comply with SOP and China legal and regulatory requirements. 9. To learn more about a KOL’s clinical interest/specialty, current research, future research plans, or research capabilities. 10. To evaluate the capability of an investigator for inclusion in CIT. 11. To follow-up on ISR proposals generated by KOLs. 12. Contribute to the identification and recommendation of appropriate KOLs involvement in participation in ACN sponsored PMS from assigned region. 13. Provide medical support and training to regional ACN colleagues (eg. Marketing, sales reps, market access etc.) 14. Share feedback of targeting KOLs advocacy and contribution.

Collaborate with internal and external customers in providing the necessary information for the best use of company's products. I'm mainly responsible for the selection and interpretation of up-to-date products-related medical literatures. Besides, I work closely with Medical Affairs and Medical Science Liaisons to create, maintain and update database of local standard medical summary documents for key product queries and 400 hotline. And, I'm also involved in clinical trial protocol development and company-wide brand team building.

Composing continuing medical education material and drug promotion leaflets for pharmas like Novartis, Bayers, and I also have the opportunity to play a role in marketing strategy seminars of these pharmas.

Medical editing,novelty search at Medical Information Department

My major is medical informatics, with medical courses along the four years and a short period of internship in an affiliated hospital.