Dr. Shugene Lynn is the Chief Executive Officer and a member of the Board of Directors of United BioPharma (UBP). She also serves as a board member of several companies within the UBI group. Prior to joining UBP in January 2019, she was the executive vice president of corporate development at UBI Asia, responsible for corporate strategic planning and financing.
She has been with the UBI group since 1999,beginning as a bench scientist with increasing responsibility from project to program management, to corporate development, and has been associated with every step along the path of UBI growth in Asia. She was the first scientist in the UBI group to be engaged in the antibody humanization platform, and has since led a team to build the therapeutic monoclonal antibody process development platform, and brought the HIV drug candidate UB-421 from cell line development to clinical phase I and II stages. During her tenure at UBI Asia,the company was awarded 11 government research grants, and sponsored three monoclonal antibody drug candidates into clinical trials.
Dr. Lynn received her B.S. in plant pathology and Ph.D. in life sciences from the Institute of Zoology both from National Taiwan University. She completed her postdoctoral training at Academia Sinica and received the Outstanding Postdoctoral Fellow Award in 1998 for her eight first author publications in international journals.
1. What kind of clinical trials did UBP undertake to be COVID-19 approved?
UBP as a vender for the drug substance we fully support our client’s need for their clinical or commercial supply. The status of our client’s vaccine for the COVID-19 is PhI and PhII in Taiwan. PhIII is planned to global.
2. What are your thoughts on the FDA’s recent changes to their drug approval process?
For many years, drug companies have expressed concern that clinical trials can be costly and time-consuming, serving to delay the introduction of important new drugs to the marketplace. Since the late1980s, the FDA has instituted a number of programs to streamline the process for certain products, including "Fast Track," "Priority Review," "Accelerated Approval" and "Breakthrough Therapy designation."
the pharmaceutical companies must apply to the agency in order to participate in the programs. Recently, for example, the FDA has approved several treatments and diagnostic approaches via accelerated processes as part of the response to the COVID-19 pandemic. In response to the sudden spread of the epidemic, pharmaceutical companies can quickly develop vaccines or other products based on their experience. It's great for the pharmaceutical company if there are policies in place to get products to market quickly.
3. What are some of the challenges and opportunities that you have encountered as a Chief Executive Officer and a member of the Board of Directors of United BioPharma (UBP) during this Pandemic?
The challenges are the emergency for COVID-19 related drug/vaccine development, and raw material shortage that impacted our GMP production capability caused by COVID-19.Therefore, the stock management will be more and more important for the resent years.
The unmet need forCOVID-19 treatment as well as the vaccination will be the niche market for UBP.UBP’s seize the opportunity to cooperate withCentral Academia to expand our portfolio to therapeutical monoclonal antibody forCOVID-19 treatment. Further, for the most important, UBP play a crucial role ofCOVID-19 vaccine development program owned by our client. As a DS supplier of this vaccine program, UBP successfully completed all CMC related task from DNA synthesis, cell line development all the way to 2000L commercial scale GMP production to support their IND submission within only six months.
This is a good opportunity to show that UBP have the capability to rapidly develop a drug in a very stressed condition without any quality scarified. It also demonstrates UBP can immediately response to what the market needed based on our firmly experiences accumulated by the past ten years.
4. Please share with us how your team helped manufacturers cope with their production and operations during this crisis?
We believe that integration capabilities area very important thing and a core element of manufacturing and supply chain management. Seamlessly connecting with the development and production depends on the experience. However, technology could also help the whole process. In drug research and development, the use of big data platforms for viral gene sequencing, protein screening, and new drug research and development can greatly shorten the time against viruses. Using digital analysis of inventory and supplier management, greatly reducing the risk caused by rapid production can be done.
5. What do you foresee will be the next pharma industrial trend?
The global healthcare contract development and manufacturing organization (CDMO) market size is anticipated to reach USD 388.3billion by 2028, expanding at a CAGR of 8.6%. Increasing outsourcing of R&D is one of the major factors contributing to the market growth. Increase in the outsourcing by pharmaceutical companies, growing pharmaceutical industry, and support of CDMOs in reducing the operational and capital expenses are some of the major factors anticipated to propel market growth over the forecast period.
As a CDMO provider, UBP synesis our capability to release a platform service for our client. Platform-based biologics development will be the next pharma industrial trend. How to produce high-yield and low-risk products more quickly will be an important trend in the future. Platformization is required for the experience and technology of various pharmaceutical companies. How to effectively achieve upstream and downstream development and large-scale production in a short period of time will be a challenge for every CDMO company.
6. What is the new normal for United BioPharma (UBP) operation this year?
United BioPharma (UBP) is committed to the business of biopharmaceuticals and has proposed a dual-engine strategy. One is the development and licensing of its own products to treat the huge unmet global needs; the other is to provide customers with one-stop biopharmaceutical development and production.
For innovation, UBP continues to maintain the spirit of research, striving to bring solutions to patients. UBP has the best-in-class protein drug for UB-421 which is the innovative HIV Infectious Disease Therapeutic Monoclonal Antibody and UB-221 which is the Innovative Anti-IgE Monoclonal Antibody. Furthermore, UB-621 is the first in class protein drug for Anti-HSV which could neutralizes both HSV-1 and HSV-2.
As for the CDMO services, UBP commits to the development, manufacture and sales of biological drugs, as well as related technical services. Due to the rapid mutation of the virus, it is the most common thing we encounter today to come up with solutions to emergencies and be ready to adjust to all the changes at any time.
7. What are some other potential drugs in trials right now for United BioPharma (UBP)?
UBP has two engines for its business model. One is the CDMO services, and the other is the innovation drug development. We care about the unmet medical need, and we are eager to achieve the cure.
UB-421 is the innovative HIV Infectious Disease Therapeutic Monoclonal Antibody and enters the PhIII trial in the US. The number of HIV cases reached 37.7 million in 2020. UB-421 will be the only one drug for the functional cure for the HIV patience.
UB-621 is the Innovative Anti-HSV Monoclonal Antibody and enters PhII trial in China.UB-621 is for global genital herpes treatment market which was valued at USD2,215.34 million in 2021. This potential new drug will be the first in class treatment for the Drug resistance problem and Chronic suppression. UB-221 is the innovative Anti-IgE Monoclonal Antibody. The Global Allergic Asthma Therapeutics Market to Surpass US$ 8,209.0 Million by End of 2027. The most encouraging thing is that UB-221 is a bio better of Xolair which is the first FDA-approved biologic used in the treatment of asthma.
8. What do you see as some of the biggest challenges that UBP faces in this biopharmaceutical market?
Time and quality are the most important factors for the drug development. If shorten the development time it is hard to study the drug more and has a stable process which may affect the product quality. Therefore, not only for our pipeline but also for our client’s pipeline, it is a big challenge to balance the development time and production quality.
Furthermore, in the biological drug market, the support of experience is required which means all the check and process will be highly rely on human. The automation of the whole line production will be a very difficult technology and challenge. How to connect all the steps more intelligently will be a major issue that UBP and all biopharmaceutical companies need to think about. The potential risk and validation of automation in all steps is one of the most important considerations.