Frontera Insight No. 06

FRONTERA INSIGHT

● Innovation ● Efficiency ● Integrity ● Rigor

2024.06   General No.6

contents

1

Preface

2

 NEWS BRIEF

- The Treatment of nAMD with anti-VEGF Agents

- Everyone is a Chief Quality Officer

3

US-CHINA TEAM INTERACTION

4

SCIENCE CLASS

- Long-distance Running: His Pace, Our Scenery

- The cooking method of braised pork in brown sauce

- Justin’s Costa Rica Trip

- Persistence leads to Harvest

- Journey in Children’s Day

- "Sherlock Holmes" in Frontera

- Conquering Cell Counting Challenges

- Training on New Drug Development Process and rAAV Drugs Introduction 

- Excerpt from Reading "Nonviolent Communication"

5

DEPARTMENT INFORMATION

6

PEOPLE IN FRONTERA

- Employee Recognition - US

- Teambuilding in US Team

- Getting to Know New Faces in Frontera

- Our Anniversary

- The Dragon Boat Festival Activities in CN

7

LIFE SHARING

Chief Editor ：

Managing Editor ：

Proofread ：

Contributors：

Maggie Xue

Jackie Peng

Sunny Han

Eileen Kenney, Jiayan He,

Jing Yu, Meng Li, Mandy Lu,

Qian Wang, Sarah Myers, Suping Zhao,

Tingting Chen, Wan Fang,

Zhiyan Li, Yolanda Zhao

● NEWS BRIEF

Frontera Showcase at the International Conferences in May 2024

Frontera Therapeutics is excited to announce its participation in several esteemed conferences in May 2024, where it presented groundbreaking research across multiple therapeutic areas, including ophthalmology, blood and cardiovascular diseases.  The conferences are the 2024 Retinal Cell and Gene Therapy Innovation Summit, the 2024 American Ophthalmology Congress, and the 27th Annual Meeting of the American Society for Gene and Cell Therapy (ASGCT).

Frontera Unveils Preliminary Clinical Results for FT-002 Injection at Retinal Cell and Gene Therapy Innovation Summit 2024

Frontera Therapeutics is pleased to announce significant advancements in our clinical study of FT-002, presented at Retinal Cell and Gene Therapy Innovation Summit in the United States on May 3, 2024.Professor Sui Ruifang, from Peking Union Medical College Hospital, was invited to present the clinical results, titled “Preliminary safety and efficacy of an open-label, dose-escalating genetic drug FT-002 in patients with x-linked retinal pigmentary degeneration (XLRP) associated with RPGR gene variants”.

Frontera Therapeutics’s Quality Control for rAAV Gene Therapy Products Presented at the 23rd China Biological Products Annual Conference 2024

May 16-18, 2024— the 23rd China Biological Products Annual Conference was held in Guangzhou, China. Dr. Li Aiqun, Director of QC, Frontera Therapeutics, was invited to participate in the symposium of “Immune Cells, Stem Cells and Gene Therapy” and focused on “Quality Control of rAAV Gene Therapy Products: Challenges of Next Generation Sequencing and Residual DNA Detection” were presented.

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2

3

PREFACE

Preface

The summer solstice is upon us again, the days are clear, the daytime is long, and roses bloom freely.

We are living in an era of challenges and opportunities, and the Cell and Gene Therapy (CGT) industry is in the midst of rapid development.

We are also in the fog of a downward capital cycle, with poor financing and blocked IPOs triggering a series of chain reactions, and biopharmaceutical companies that were in a hurry in the past are actively looking for a way through the fog.

Just as every rose has its own flowering period, waiting for any time that is not missed to draw nutrients and achieve self-growth.

Please believe that there is no wasted path in life. Everyone should learn to grow and fulfil themselves, to develop insight and resilience, to dare to think and act, to reduce internal conflicts, and to empower themselves with new strengths.

My dear colleagues, grab your “blooming period” to learn! Work and live with a learning mindset, and use your talents and abilities to gain self-confidence and inner abundance. Each day will be better than yesterday.

FT-003 nAMD Phase I Clinical Study Enrollment Completed

4

The FT-003 injection successfully completed the enrollment for the nAMD Phase I clinical study on June 13, 2024, marking a solid first step in the clinical research for the treatment of neovascular age-related macular degeneration (nAMD).

Frontera has successfully completed FT018 DC nomination

5

Yiling: I was born in Urumqi, Xinjiang, China. Went to Peking University in Beijing, majoring in Biophysics working on protein structures using x-ray crystallography. Been with the AD team for over 4 years since the beginning of Frontera Therapeutics.

Justin: I was born in Massachusetts (MA), USA; studied Dietetics Nutrition & Food Science at the University of Vermont. My other occupations were laboratory based in food science and cannabis industries. Been an AD member for 2 years in August this year. My family is pretty boring ; one fact about my family I guess would be that my sister is adopted from South Korea, and she just graduated from University of Syracuse.

Helen: I was born in Nantong China; studied at Peking University and Queens University focusing on organic chemistry and kinetic chemistry; and at Emmanuel college for MS in Biopharma Management. I have worked 10+ years as a medicinal chemist in research, 10+ years as analytical chemist in PD/AD. I joined Frontera 2 years ago. I love my husband and daughter, and my parents in China…they stay with me regardless of highs and lows in life.

Michelle: I was born in MA, USA. My BS was in Microbiology, MS in Biotechnology. Previously I’ve worked at Shire and uniQure, I will have been a member of the AD team for 3 years this June. I live with my dog Potato, my cat Pepper and my husband Justin; I admire his kindness, patience, and humor, and his knowledge of 70’s music.

Linrui: I was born in Ningxia, China. I got my bachelor’s degree from China Pharmaceutical University and the master’s degree from Northeastern University. I have been with the AD team around 3 years.

Gina: I came from Wuxi China and went to college in Nanjing Medical University majoring in clinical medicine and later graduated from Fudan University Shanghai Medical School majoring in Pathology. After I came to the US, I got my Ph.D. at Rutgers University majoring in Molecular Genetics, Microbiology, and Immunology (MGMI). I have been with the AD team for almost 4 years. I am married and have two school-aged kids and I enjoy spending time with my kids a lot.

Chinmay: I was born in Bombay (Mumbai), India and after my Masters (in Biotechnology), I came to Purdue University, USA to complete my PhD in Molecular Virology. Then after a post-doc in Immunology and a couple of other jobs I tricked Yiling into hiring me at uniQure, and then followed her to Frontera in Sep 2020. My parents are in India, sister in Dubai and I live in Natick, MA with my wife and 11-year-old son (who keeps getting less cute and more mischievous everyday 😊).

● US-CHINA TEAM INTERACTION

Show host: A big welcome to the Analytical Development (AD) team! You all look beautiful in your Prada lab coats with your Louis Vuitton lab notebooks and Gucci pipettes. To start, tell us something about yourself and your family. Yiling, you first – 

● US-CHINA TEAM INTERACTION

● 要闻速递

● 教育宣传册

PART 3

US-CHINA TEAM INTERACTION-AD Profile

Show host: Wow, so many achievements! Who outside of the AD team in the US site do you interact with regularly and what do you admire most about them?

Yiling: PD team; they overcome challenges in every single project. And Eileen, who takes care of all the daily needs, big or small, cannot function without her for sure!

Justin: PD has a lot of good technical expertise and communication through presentations.

Helen: Finance department. They are super helpful and friendly and generous – have to mention their help with the recent big money outsourced work for QC😊.

Michelle: Outside of the AD team I interact the most with Brendan. I admire his physical comedy. He’s always pretending to trip and fall.

Linrui: I would say I have good relationships with most of them; everyone has different vibes.

Gina: Outside of AD, I interact with a few other previous team members, and I interact with Steven the most probably as my son is attending Lexington Chinese School where he is the principal.

Chinmay: PD team rocks! Recently, I have interacted more with the in vivo team as well (Therese and Deepthi); they are so intelligent, hardworking, helpful and in general very cool to be around.

Show host: Ok, so who in China do you interact with regularly? What do you admire most about them?

Yiling: QC team; the most friendly and highly efficient QC team I’ve ever worked with. RA team; so thorough and detail-oriented, yet very collaborative during all the IND filings.

Justin: I don’t have an answer to this one; but I hope to start interacting more with the China team.

Helen: Aiqun/Chunhong/Mia/QC team. They are smart, diligent, and beautiful.

Michelle: Mia, I admire her work ethic, communication skills, and patience.

Linrui: Mia. She is a very hard-working person; we always joke that she is always working and never sleeps.

Gina: I lived with Mia for a month when I was in Suzhou and really enjoyed working and interacting with her.

Chinmay: QC team is awesome, but I love working with Serina too. She is super hardworking, very knowledgeable, detail-oriented, and friendly; a pleasure to work with (hopefully she goes easy on me during the next IND submission 😉).

● US-CHINA TEAM INTERACTION

● US-CHINA TEAM INTERACTION

Show host: So, what is your favorite part about working in the AD group?

Yiling: We are a fantastic team, like a family supporting each other in and outside of work.

Justin: My favorite part of the AD team is collaborating/working with one another, very open communication, and good leadership.

Helen: AD team has super nice team leaders and members.

Michelle: I love how supportive and helpful our team is.

Linrui: AD is a very sweet and lovely group; working with them is my favorite part.

Gina: My favorite part of working in AD is the team environment and collaborative spirit of everyone in our team.

Chinmay: AD team is so smart, helpful, hardworking, and friendly, and it all starts with the leader. The best thing I can say is that I look forward to coming to work every day because I know it will be a productive and fun day with the AD team.

Show host: Hmm, AD is really a tight and supportive group. What team project did you enjoy completing the most? Why?

Yiling: FT-003, cross the globe method transfer completed seamlessly.

Justin: FT-017 qualification work has been a good step up from previous career experience. Vector titer qualification lead has been a good experience as well.

Helen: Forced degradation study for FT-004/-002/-003, three projects done in one action.

Michelle: Cell-line development; I enjoyed learning new techniques.

Linrui: FT-001. Because this is where both Frontera and I began, where we started to embark on our journey together.

Gina: I like every project that I worked on and don’t really have a preference much as I believe that there is something interesting in everything.

Chinmay: Every project has unique challenges and so are fun to work on. I like the ‘DP In-use studies’ for all programs because I get to play pretend doctor for a few days.

● 教育宣传册

PART 4

SCIENCE CLASS

● SCIENCE CLASS

Show host: China team is very good indeed. Ok final question, If AD team had a motto, what would it be?

Yiling: “We are stronger together”.

Justin: “When life gives you lemons, extract with HPLC-grade water, centrifuge at 10,000 RPM at 2C for 15-min. Use RP-HPLC for ascorbic acid and folate determination. See SOP for further details”.

Helen: “A tradition of innovation”.

Michelle: “We stick together like glue”.

Linrui: “Another day, Another Slay!”

Gina: “It is all about the details”.

Chinmay: “Teamwork makes the dream work”.

Show host: Those were some great responses. Thanks to the AD team for joining us tonight. Let’s take a group photo, and then a quick 10-minute break before the next guest.  

“Audience claps and cheers….”

● US-CHINA TEAM INTERACTION

● 科普课堂

● SCIENCE CLASS

● SCIENCE CLASS

There are currently multiple anti-VEGF biologics for the treatment of nAMD, including bevacizumab, ranibizumab, aflibercept, brolucizumab, conbercept, and faricimab. Anti-VEGF drugs currently available for the treatment of nAMD in China include ranibizumab, Conbercept, aflibercept, and faricimab. Ranibizumab is a recombinant human monoclonal antibody Fab fragment approved by FDA targeting VEGF-A and is the first anti-VEGF drug approved by the NMPA and started to treat nAMD in 2011.Conbercept is a fusion protein class of anti-VEGF drugs that inhibit VEGF-A, VEGF-B, and PIGF, and was approved for nAMD in 2013.Aflibercept is also a human fusion protein targeting VEGF-A, VEGF-B, and PIGF, which was approved in China in 2018. Unlike the former, faricimab, which targets both anti-angiopoietin-2 and VEGF-A, was approved in January 2024.

These commonly used anti-VEGF drugs require frequent and sustained intraocular injections to maintain efficacy, which increase the risk of complications such as endophthalmitis. In addition, the inconvenience of frequent injections and high prices reduce patient compliance, the development of gene therapy provides a new treatment modality for nAMD. FT-003, a gene therapy product for nAMD, developed by Frontera therapeutics, uses AAV as a gene delivery vector with high safety and strong transfection ability. It can make retinal and choroidal cells long-term express anti-VEGF protein, thus meeting the long-term stable therapeutic effect, and is expected to become a new therapeutic method to meet the clinical treatment needs of patients with nAMD.

The Treatment of nAMD with anti-VEGF Agents

Age-related macular degeneration (AMD) is a major cause of severe visual impairment and blindness in developed countries. According to its clinical manifestations, AMD can be divided into dry age-related macular degeneration (dry AMD) and wet age-related macular degeneration (wAMD). Among them, wAMD is also known as neovascular age-related macular degeneration (nAMD). Its pathogenesis includes abnormal angiogenesis and formation of macular neovascularization (MNV) or choroidal neovascularization (CNV), which can lead to vascular leakage, hemorrhage, edema and ultimately fibrous scar formation, leading to loss of vision.

Li Huang,  Medical Dept.

In the pathogenesis of nAMD, a series of mediators, including kinases, cytokines and growth factors, are involved in this complex process, among which VEGF plays an important role in the formation and increased permeability of neovascularization. Therefore, the use of vascular endothelial growth factor (VEGF) inhibitors has made significant progress in the treatment of nAMD in the past decade. The VEGF protein family includes VEGF-A, VEGF-B, VEGF-C, VEGF-D and VEGF-E, and PIGF, etc. VEGF-A is a key factor of nAMD and has the main ability to promote angiogenesis and vascular permeability. Therefore, the treatment of nAMD mainly focuses on VEGF-A and its receptors. Clinical evidence shows that intravitreal injection of anti-VEGF drugs can inhibit neovascularization and reduce vascular leakage, thus playing a therapeutic role.

Corporate culture is of great significance to quality management. Establishing concepts is the top priority in everything, so is the quality management. The best strategy gives ideas, the middle strategy gives methods, and the bottom strategy gives money. Corporate culture has a significant impact on quality management, as it directly determines the perception, attitude, and values of each individual in the organization towards quality. The concept of "Everyone is a Chief Quality Officer" encourages everyone to be a guardian of quality and to contribute together to improving product quality and culture. Leaders should make decisions when necessary, lead everyone to take action together, and avoid the problem from flowing out and harming drug users and stakeholders.

● SCIENCE CLASS

● SCIENCE CLASS

When it comes to quality, it seems to us more like a subjective feeling, even if you do not know its official definition, but everyone can talk about it. It's like when you get together to discuss mobile phone satisfaction, which one works better, everyone can comment on it and add in technical terms like pixels, RAM, processor, battery life, etc., and talk about it with a big smile on their face. Although few people understand cell phone manufacturing, this does not prevent us from discussing it together. Today, everyone is a mobile phone user, rely on the mobile phone to obtain information, establish a connection, we can talk about our opinion on “Quality” of our phones.  

This is similar to the situation of quality in enterprises. Quality is not a advanced technology like rockets or missiles, but it affects the results of internal business execution and the perception of external customers towards products and services. In our industry, it is how patients will feel about the safety, efficacy and use of drugs in the future.

When I write about the topic of "everyone is a Chief Quality Officer", I think of two scenes. The first one is that after my first child was born in 2012, I entrusted people around the world to buy baby formula, covering Taiwan, Australia, and the United States. Wherever there are relatives and friends, they are helping me buy baby formula.

At that time, the domestic XX baby formula incident was still a shadow in the hearts of many mothers. They dared not buy domestic baby formula and were ashamed to be looked at by foreigners with strange eyes when checking out at supermarkets in foreign countries.

Another scenario is when a friend asked me about my plans for future career development after leaving a familiar industry field during my resignation. I said I wanted to get more in touch with the quality field, explore the unknowns I didn't know, and become a Chief Quality Officer someday in the future. In these two scenarios, quality is related to self-esteem and values, and quality is the starting point of value and dignity.

After years of quality work, there are still many confusions and anxieties due to some quality issues. There are also some insights that I would like to share with you:

Everyone is a Chief Quality Officer

Phyllis Wu, Clinical Quality Dept.

At the Generic Drugs Forum (GDF) on April 26, 2022, U.S. Food and Drug Administration (FDA) officials claimed that Abbreviated New Drug Application (ANDA) submitted by companies with a weak culture of quality were more prone to data integrity issues than those submitted by companies with stronger culture. FDA officials stated that companies with a good quality culture demonstrate a leadership commitment to creating a work environment that supports product integrity and quality, encouraging open and transparent communication between all levels, especially in reporting errors and deviations. By establishing standards and providing education and training, employees are made aware that data quality is the responsibility of every individual within the organization.

PART 5

DEPARTMENT INFORMATION

The quality objectives at all levels of the enterprise are consistent and unswervingly improved continuously. Protecting the safety, rights and health of subjects is always our most important consideration, which takes precedence over scientific and social interests. Ensuring the scientificity of the trial, avoiding the exposure of subjects to unnecessary risks, and ensuring the reliability of clinical data are the basic safeguards for conducting clinical studies. 

The division of labor and cooperation among various departments has always been guided by this goal, and everyone's goals are consistent and unswerving. What we need to continuously improve are the communication mechanisms, collaborative models and methods that prevent us from achieving this goal. 

Encourage pushing to the "high wall" between departments and introducing new concepts and methods in the process of achieving goals and continuous improvement.

Assist employees in enhancing their job competency and enable them to work effectively. The dedication and effective work of employees are based on their recognition of the value of their work and their own competence in the job. Continuous job training and education can enable employees to be competent in their positions and work effectively.

Quality requires the spirit of craftsmanship. Do the right thing and do it well. Do everything well in your position and strive for excellence.

Every employee in the organization is a Chief Quality Officer. As Chief Quality Officers, we continue to practice together:

     Integrity

   Clear goals and the courage to take responsibility 

    Care and respect for subordinates

    Overall thinking

    Be diligent and eager to learn

    Optimistic and enterprising, persevering and persevering

   Have the courage to admit mistakes and be fearless 

     Quick simplification from chaos

     Being indifferent to fame and fortune

One day, after using FT-001, FT-002, FT-003... our patient will marvel at the quality of Frontera manufacturing in China. We will also marvel that everything is worth it.

● SCIENCE CLASS

● DEPARTMENT INFORMATION

"Sherlock Holmes" in Frontera

Jing Yu, QA Dept.

Anyone who discovers a deviation should report it  immediately, protect the scene, and preserve any physical evidence. If it’s not possible, consider other methods such as taking photos or recording details. Preserve evidence as much as possible for the subsequent deviation investigation.

During the deviation investigation, each investigator needs to become a "Sherlock Holmes," using evidence and tools to unravel and find the root cause. So what skills does an excellent "Sherlock Holmes" need to master?

Deviation refers to any situation that deviates from approved procedures or standards, it includes deviations from standard operating procedures, test methods, quality standards, or any other formal documents, as well as deviations from any process standards or normal states.

In our work, we often talk about "deviations" with dread. Next, we will introduce how to handle deviations so that we can learn from them, achieve the improvement of the process, avoid the repetition of the problem, and make the continuous improvement of the quality system.

With the above two skills, "Sherlocks" can successfully find the "root cause" of the deviation. Once this culprit is found, "Sherlocks" should not let it off easily but should establish a series of "CAPA" items to both bring it to justice and prevent it from recurring.

There is a Chinese saying: "Break the pot to ask the end."

By continuously asking "why" about a problem point, the root cause can be traced. The key is to avoid subjective or presumptuous assumptions and logical traps、start from the result、follow the chain of cause and effect, and ultimately finding the root cause of the original problem.

"Sherlocks" can use this skill in simple deviation investigations.

When using the Fishbone Analysis Method, first identify the major causes, typically categorized as "People, Machines, Materials, Methods, Environment." Use brainstorming to find the elements for each major cause; then classify and organize the elements to clarify their subordinate relationships; finally, analyze and select the important elements.

"Sherlocks" can use this skill in complex deviation investigations.

● DEPARTMENT INFORMATION

● DEPARTMENT INFORMATION

The occurrence of the incident originated from the analysis of data, which revealed discrepancies in the cell count results between the Chinese and American teams. The cell viability results from the Chinese team's experiment were generally lower than those from the American team. In order to clarify the reasons for the above, in the lead  of Peng Yang and Haiwei Zhang, the upstream team took the initiative to investigate and progressively delved into the issue.

First, the problem was traced back to the software of the Vi-CELL XR cell counter analyzer. A careful comparison of the analyzer's parameter settings revealed differences in Cell Sharpness. After modification, the cell counting results were significantly unreasonable and erroneous, ruling out the parameter settings.

Conquering Cell Counting Challenges

Houjuan Mao, MF Dept.

A series of three experiments were designed and carried out for two consecutive days: Experiment 1 involved directly counting the cell suspension using Vi-CELL XR; Experiment 2 involved counting the cell suspension diluted 1:1 with medium using Vi-CELL XR; Experiment 3 involved counting the cell suspension diluted 1:1 with trypan blue using Vi-CELL XR and microscope. 

Next, attention turned to the hardware of the Vi-CELL XR cell counter analyzer. It was most likely that the multi-valve and reagent pack of the analyzer itself were the cause. 

Finally, the focus shifted to the differences in the analyzer models used by the Chinese and American teams. In response, an application was actively made to the BECKMAN manufacturer to obtain the same model, Vi-CELL BLU, used by the American team. With a rigorous and practical approach, cells were revived, expanded through three generations, and then subjected to production cultivation and virus infection. For three consecutive days, viability was tested using both Vi-CELL XR and Vi-CELL BLU analyzers, as well as microscope. The results showed that Vi-CELL BLU had the highest values among the three, thus confirming that the inconsistencies in the experiment results between China and the United States were due to different  models.

The inconsistency in the data had been explained. Thanks to the dedication and cooperation of the MFG team in this experiment, we have achieved our goal!

● DEPARTMENT INFORMATION

Results from Experiments 1 and 2 were consistent, ruling out the multi-valve as the cause. Vi-CELL XR yielded higher counts than microscope, ruling out the reagent pack. It was concluded that there were no issues with the Vi-CELL XR cell viability analyzer equipment itself.

● DEPARTMENT INFORMATION

● DEPARTMENT INFORMATION

If we use nonviolent communication, be kind, observe carefully, learn to listen to my feelings, express my needs, and accept the answers I don't want to hear. That will allow us to create a more productive relationship at work, so that the flower of friendship can flourish in you and in me.

As the saying goes, "A good word warms the winter and a bad word hurts the winter." Violent communication in daily life is very common. In violent communication, negative emotions lead people to be angry and irritable, which is easy to aggravate the conflict or make things worse. The book Nonviolent Communication not only teaches us a communication skill, but also transmits a philosophy of life, teaching us how to deal with human relationships in a more peaceful and understanding way.

Two elements of nonviolent communication: observation without comment and how to express inner feelings. Learned how to look at facts more objectively and express our feelings and needs in a more constructive way. This will lead to more peaceful conversations and ultimately work together to find solutions to problems and enjoy the pleasant experience of non-violent communication.

"Observation without comment is the highest form of human intelligence." Read this sentence at a rough glance and it feels simple. A careful look, but found that it tells a simple truth: when we go to observe the words and deeds of others, most will take their own a trace of commentary. When we jump out of the eyes of scrutiny, we can record the truth in more detail.

In May, the first reading club organized by the Administration Department opened with the classic book "Nonviolent Communication". After reading in groups, the members contributed and sent their learning after reading. Excerpts of some of heartfelt feelings as below, let's walk into this communication handbook.

Excerpt from reading Nonviolent Communication

Joyce Wang, Admin Dept.

Training on New Drug Development Process and rAAV Drugs Introduction 

May of the year is always the busiest time for financial department to deal with annual closing, audit, budget review, tax filing and so on. We team members are busy like carrying cells shuttling through time tunnel with eyes and brains covered with numbers. Even so, we still keep in mind to expand our cross-functional expertise. This time we invited Sophie Song, Senior Director of RA and Project Management Department to bring to us wonderful training courses - new drug development process and rAAV drugs introduction.

During the training, Sophie introduces the general process of drug registration, new drug development and the product process related to finance. Sophie showed the team such a complex and long process of new drug development including drug discovery, preclinical research, clinical trials, new drug application, production and marketing and so on with her easy-to-understand and professional language, elegant and confident demeanor and rich and wonderful PPT content that our team gained a better understanding of the above process, key points and challenges of each stage, thus laying a good foundation for our partnership with all other teams in the future.

Jimmy Sun,  FA Dep.

Through this training course, our team obtained great insights and benefited a lot. Not only did they understand the innovative thinking of drug development, risk management, cross-functional teamwork, compliance with regulations and market-oriented thinking, but also taking our daily work into consideration we had a sensory understanding of the cold numbers and new thinking about the meaning behind the numbers. At the same time, it enhanced the team’s sense of responsibility and mission of finance.

Professional training across function help us grow in our career development. We will continue to learn and apply the new knowledge and new thinking we have learned to our future work to contribute to the faster and better development of our company.

● DEPARTMENT INFORMATION

Get rid of self-correction and transform negative emotions; Have a grateful mind and accept appreciation appropriately.

"Free yourself and help others." The internal conflicts that often lead to depression can be resolved with nonviolent communication. In this article, the author tries to guide us to learn to break away from old patterns, reflect on and change harmful habits and behaviors, free ourselves from self-criticism, and help others to recognize their true needs and desires.

By using nonviolent communication to express gratitude and appreciation, we should not only be grateful, but also learn to accept others' appreciation. When we use nonviolent communication to express appreciation and gratitude, we do so purely to celebrate life and not to receive anything in return. Use the three elements of gratitude to let the other person fully receive our appreciation and gratitude. To accept others' appreciation and gratitude appropriately, and to celebrate with each other happily, is also a kind of non-violent communication conveyed by the author.

● DEPARTMENT INFORMATION

Chapter 5,Chapter 6

Deeply appreciated the art of communication and learned how to express yourself more authentically and effectively, while also learning how to listen to others. These skills have not only improved my personal relationships, but also my communication skills at work and in social situations.

 Making requests is an important part of the communication process, and here are some principles: Be clear about needs, be specific about requests, avoid orders, use positive language, consider the other person's needs, listen to feedback, express gratitude, and be flexible.

Living in nonviolent communication means listening to others' observations, feelings, needs, and requests, no matter what words they may use to express themselves. Then, we can choose to respond to what they mean and repeat what we understand.

 Communication between people is not only about talking, but also about listening. Listening is objective and focused on the other person's feelings, not our own subjective thoughts and feelings. Learn to put yourself in the other person's shoes and understand what the other person really needs.

As the saying goes, you can love others better by loving yourself. Nonviolent communication is achieved by exploring your own needs and expressing them in a way that makes you heard. Everyone is unique, and everyone's needs are different. Don't worry about what others think, just follow your own needs and act. There are not so many "have to do" things.

There's a chapter in the book that I really like: Love yourself. Perhaps the most critical application of nonviolent communication is to teach us to be kind to ourselves, to use the "mourning" and "self-forgiveness" of nonviolent communication so that we can stop blaming ourselves, gain something, and be free.

No matter how varied and hardcore the methods, true communication is a dialogue and understanding of the heart. In my future life, I will strive to apply the concepts and techniques of nonviolent communication to better communicate with others and to build deeper relationships with others. In addition, nonviolent communication can also help us to know ourselves better. By expressing our feelings and needs, we can gain a clearer understanding of our inner world and adjust our attitudes and behaviors.

Employee Recognition - US

We would like to recognize Helen and Justin for their exceptional work in developing the new residual detergent method for FT-017 program. Process development decided to change Triton X-100 to a new detergent for cell lysis and viral inactivation. Due to the tight timeline, there was only 2-3 weeks for AD team to establish a brand new method to detect the residual new detergent in order for the process team to make a decision on the final detergent selection. Helen has screened dozens of columns within a week and together with Justin, they have developed two methods for different detergents when not knowing which one would be the final detergent. At the same time, they kept communicating all the progress with QC to make sure QC can have everything ready for method transfer. This is a great achievement in such a short time.

● PEOPLE IN FRONTERA

● PEOPLE IN FRONTERA

● DEPARTMENT INFORMATION

PART 6

PEOPLE IN FRONTERA

● PEOPLE IN FRONTERA

● PEOPLE IN FRONTERA

Teambuilding in US Team

May 16th,The US office had a teambuilding event with Xinyan at Nashoba Valley Winery in Bolton , MA. We had a lovely wine tasting where everyone really enjoyed learning about and tasting 8 different wines. After the tasting, we had a nice lunch onsite and spent some time bonding.

It’s my pleasure to recognize Hong Duan’s great contributions to the company’s pipeline program development. Hong has demonstrated great leadership in leading program development evidenced by recent completion of DC nomination for FT018. Hong has shown strong resilience under pressure, always worked hard and been positive and her communication is also getting better and better. Besides her contribution to program FT018, Hong also helped internalize the bac-to-bac system for AAV production last year. As a program leader, Hong’s performance and growth in the past 2 years is prominent. Overall, Hong is a very competent and invaluable contributor to the RD team and Frontera.

● PEOPLE IN FRONTERA

● PEOPLE IN FRONTERA

4th Anniversary - US

3rd Anniversary - US

Zhongdong Shi - R&D Dept.

Yiling Fang - PD Dept.

 Gina Zhang - AD Dept.

Jeff Kan - PD Dept.

Chris Casey - PD Dept.

Michelle Martin - AD Dept.

I am Xuting Fan, who joined the Clinical Operation Department as CRA II on May 28, 2024. My work place is in Tianjin, and my hometown is in Heilongjiang. I am a warm and hearty Aries, and I love playing badminton.

Michelle Wang

Getting to Know New Faces in Frontera - CN

Liangdong Zhu

Xuting Fan

My name is Liangdong Zhu, and I joined the Clinical Operation Department as CRA II on June 11, 2024. My work place is in Shanghai, and my hometown is in Panzhihua, Sichuan Province. I am an Aquarius who is curious and eager to learn, and I like playing badminton just like upstairs.

My name is Michelle Wang, and I joined as the Executive Director of Business Development Department on June 13, 2024. My work place is in Shanghai and my hometown is in Shanxi. I am a diligent and firm Capricorn, and I love photography.

3rd Anniversary - CN

Allision Jia - FA Dept.

Maggie Xue - HR Dept.

Sophie Song - RA and Project Management Dept.

Zhuang Niu - EE Dept.

Selina Zhu - EHS & Adimin Dept.

Hai Wei Zhang- MF Dept.

Guangzhi Zhou - MF Dept.

Layne Chen -  QA Dept.

Bennett Wang - IT Dept.

Juan Zhang - QC Dept.

● PEOPLE IN FRONTERA

● PEOPLE IN FRONTERA

2nd Anniversary - US

Helen Feng - AD Dept.

Amy Jiang - R&D Dept.

Jocelyn Rodriguez - PD Dept.

The Dragon Boat Festival Activities

Wan Fang, CO Dept.

The Dragon Boat Festival is not only a day to commemorate Qu Yuan, but also a time for us to celebrate together. In this traditional festival, the company has carefully planned a series of activities for us, so that we have the opportunity to deeply experience and inherit traditional Chinese culture in our busy work.

● PEOPLE IN FRONTERA

● PEOPLE IN FRONTERA

2nd Anniversary - CN

1st  Anniversary - CN

Jie Hu - QC Dept.

Feng Chen - EE Dept.

Qianqian Chen - QC Dept.

Jing Yu- QA Dept.

Yanli Wu- MF Dept.

Likun Yang- SC Dept.

Luna Zhang - FA Dept.

Yue Zhang - CO Dept.

Cloris Ren - Translational Medicine Dept.

Phyllis Wu - Clinical Quality Dept.

2/Fishing sachet for fun

Sachet, is an indispensable element of the Dragon Boat Festival, it not only carries a good meaning, but also is full of holiday aroma. The sachet fishing activities are organized by the company, allowing us to experience a unique fun in a relaxed and pleasant atmosphere. Every time we caught a sachet, it seems that we caught a piece of luck and blessing.

3/Hang mugwort leaves, pray for health 

Mugwort leaf, with its unique aroma and exorcism effect, has become one of the symbols of the Dragon Boat Festival. The company hungs mugwort leaves in the office area, which makes our working environment full of holiday atmosphere. At the same time, we also had the opportunity to hang mugwort leaf with our own hands, praying for health and peace for our families and ourselves.

1/Shoot Five poisons, win Zongzi 

Shooting the "five poisons" is a traditional custom of the Dragon Boat Festival, symbolizing the eviotion of disease and bad luck. The company prepared a unique archery competition for us, so that we could experience the ancient people's ritual sense of exorcism and avoiding epidemics while shooting arrows. Whenever the arrow hit the target, we not only won delicious Zongzi, but also gained laughter and applause from colleagues.

Through participating in these activities, we not only feel the charm of traditional festivals, but also deepen our understanding of each other in the interaction. The celebration of the Dragon Boat Festival is not only the inheritance of traditional culture, but also a sublimation of our team spirit.

In this festival full of Zongzi and moxa fragrance, we created an unforgettable memory together. Let us take this memory, continue to creat a better in work and lift together, hand in hand moving forward!

● 员工动态

PART 7

LIFE SHARING

● PEOPLE IN FRONTERA

Ingredients: 500g pork belly, 1 star anise, 1 cilanth leaf, 50g scallions, 30g ginger slices, appropriate amount of salt, 25g soy sauce, 30g cooking wine, 25g rock sugar, 15g canola oil.

We first cut the pork belly into 3~ 4cm square pieces. Add cold water to the pot, and a little onion ginger, yellow rice wine, blanch the pork belly to remove the fishy taste. Boil the meat for 5 minutes. Remove and let dry. Put a little oil in a casserole dish, add rock sugar, and saute until sugar brown. Melt the rock sugar thoroughly, fry it until it is slightly colored, then put in the meat cubes and stir-fry. Stir-fry the meat cubes until the oil is out, then pour in the rice wine and soy sauce and stir-fry. Stir fry until the rice wine evaporates, and the soy sauce is evenly adsorbed on the meat. Pour boiling water into the pot, and the water is equal to the meat. Then, add scallions, ginger slices, cilantro leaves, star anise. Cover the pan and simmer over low heat for more than 60 minutes. When the meat is cooked, pick out the spring Onions, ginger, star anise and cilantro leaves. Add a little salt, and then reduce the juice over high heat, then out of the pot.

1, stir-fry sugar color into a light yellow can be, mainly to play the role of bright red meat, fried color will be bitter, can not be eaten.

2, braised meat must be selected with the skin of pork belly, the most delicious is the skin and fat.

3, the most important trick is to blanch the meat first to fish, and then stir-fry, stir-fry has been out of oil, so can fat and not greasy.

The entrance of the meat is fragrant, the taste is excellent, and the bite aftertaste is endless, at this time, you need a big bowl of rice. A mouthful of oil is the so-called solution to thousands of worries.

● 生活分享

● LIFE SHARING

Dear friends, today we're going to talk about something a bit different not celebrity gossip or office rumors, but the daily life of a mysterious person among us. He is our colleague who insists on running every morning. Don't roll your eyes just yet; this is much more interesting than scrolling through social media!

In the early morning, when most people are still struggling with their beds, he has already started his morning run. Yangcheng Lake, Dushu Lake, Jinji Lake, and Yinshan Lake have all become his running playgrounds. He has a promise with the sun; every morning, he greets the sun and then begins his "Morning Run Fighting."

Whether it's a scorching summer or a bittering winter, he is never absent. If it's raining heavily outside, he runs up and down the stairs in the building, as if playing a vertical version of "Parkour." Some might call him "crazy," but every run is a moment for him to challenge himself and show his determination.

As a man, he doesn't pursue the perfection of the figure as crazily as the beauties do, so I guess, long-distance running for him is not just about keeping fit and having a strong body, but also about becoming the most popular guy among the square dance aunts and the master photographer after retirement. Every photo he takes while running is stunning. Perhaps he sees running as a ladder to achieve his goals, every step bringing him closer to his dreams.

Persistence and determination, like a positive energy, have infected everyone around us. Seeing his unwavering persistence every day, the team members have also started their own exercising plans. Yoga, hiking, cycling, healthy eating—while others are competing with children's education and grades, his team has already started competing in fitness. He shows us with his actions: persistence can sometimes be really tiring, but it's also pretty cool!

His long-distance running is the best interpretation of persistence and determination. He tells us with his actions that no matter how great the difficulties and challenges we face, as long as we persevere, we will definitely achieve our goals. In life, at work, in study... Gradually, his pace has become our scenery, our motivation.

Finally, let's play a "Guess Who He Is" game to unveil his mysterious veil.Guessing guessing go go go, dear friends!

Long-distance Running: His Pace, Our Scenery

Braised pork is a "hard dish" for the young and old to satisfy cravings and hunger, but the production process is very challenging. Burning is not good either with fishy or poor taste, how to make soft rotten smooth tender, fat but not greasy braised meat? Let's take a look.

The cooking method of braised pork in brown sauce

● 生活分享

Hello Frontera Family,

My trip to Costa Rica was one of many highs, crossing off bucket list items and taking advantage of a once in a lifetime trip. My girlfriend and I took the opportunity to drive throughout the country, partook in many adrenaline-pumping adventures, like ziplining over canyons, rappelling down waterfalls, and white water rafting in level 5 rapids. Using guided tours, we were able to spot and identify numerous native flora and fauna that inhabit the beautiful and lush rain forests and scenic volcanic mountains of the country. They have a saying in Costa Rica, “Pura Vida”, which translates to “Pure Life”. To me, Pura Vida means taking time to occasionally break free from the monotonous daily life we live comfortably in. To leave your comfort zones, take (calculated) risks, live your life to the fullest, and to partake in activities that make you feel free. Life is too beautiful to just let pass by.

Justin, AD Dept.     

● LIFE SHARING

●LIFE SHARING

 There are many mountain roads, once you choose, you just move on

After taking the step of climbing the mountain soon, we found that there is a fork in the road, after choosing a fork in the road, the mountain road was not a fork in the road, the people walking along the road will slowly get separated. But after choosing all the way forward, you will find that the end will meet again eventually. Just like in the work, we will have differences with our partners for a long time, but as long as the result is the same there is no need to argue too much.

 Every step on the way to the top counts, as long as you focus on your feet

Because of understimating enemy, not preparing very professional equipment, in the process of the mountain, we encountered the hot sun, rain and wind, every step is full of fatigue and resistance, watching the sky gradually blackened, and tried to cover up the fear of telling ourselves: no matter how long it is behind, as long as the foot of this step is safe, then it will be safe to reach the summit. When I saw the "golden top" of the monument, I immediately understood the significance of persistence. As in the work, there will always be various difficulties, maybe you will be irritable, maybe you want to give up, but grinding your teeth and do this one thing at the moment, you will find that the later will slowly become smooth.

 Go with each other and help each other out of their own rhythm

Partners who starting together, because of different physical strength, are always in the situation of catching up, thinking of catching up with the fast pace of the partner, the whole person is quite tired. Then find the same rhythm of the companion is very important. When the rainstorm came, the mountain road became unusually slippery, and we could only barely grasp the rope to move forward,but   hearing the encouragement of our companions will bring us confidence, and I was full of confidence to move forward. At work, because of our different abilities, we often try to catch up with others and later we are physically and mentally tired. Sometimes if we slow down to find our own rhythm, we will find that we get twice the result with half the effort.

The trip to Wugong Mountain told us to be brave. We will not be younger than today, perhaps life means to set out to find more, the scenery of the top of the mountain will only bu known when you insist climbing up. Just like work, if we don't start, then we will never know how the result is sticking to it will have a harvest eventually!

Jiayan He, QC Dept.

● LIFE SHARING

Persistence leads to Harvest 

Who can say no to nature? With the catchy "youth cost nothing, with the Wugong Mountain under my feet", the small partners of QC department set foot on the journey of Wugong Mountain with high morale. From the body as light as a swallow to an inch difficult to walk, although the return is full of fatigue, but the trip if worthy. Talking about the process of climbing make us think of various aspects during the work, which gain us a lot. 

● LIFE SHARING

Journey in Children’s Day

Children's Day, a festival full of laughter and laughter, is a children's fes, but also a good time for adults to rub up their childhood memories. This year, our three families chose the Suzhou Wangshan scenic spot as a celebration site, not only for its beautiful scenery, fresh air, but also there rich outdoor activities, very suitable for adults and children to go hiking. 

Meng li, RA and Project Management Dept.

On Saturday afternoon, three families arrived in an open green area near the Wangshan scenic spot in Suzhou. Fresh air, warm sunshine and green scenery interweave into a vivid picture. At the beginning of the barbecue, they were in a flurry, "Can't kindle mode" and "Too fierce mode" toggle back and forth. Then they all sat around the grill, with the charcoal crackling and fumes of the fumes giving off the alluring smell of the barbecue. The children were chasing and playing, while the adults were flipping the kebabs and talking about the dribs of life. Food gradually became golden and crisp, even the eaters didn't forget to say "no diarrhea is the highest level of barbecue" joke. Laughter, conversation and hissing barbecue constitute a harmonious movement that forgot everyday troubles and immersed itself in this simple and pure joy. 

Preface: Outdoor BBQ

Education brochure

Early on Sunday morning, the children urged for reuniting to climb the mountain. Wangshan Scenic Area is located in the suburbs of Suzhou, where the scenery is beautiful, trees,shade the ground. Arriving at the scenic spot, the first thing that cames into view is are pieces of lush bamboo forest, with the breeze blowing, bamboo leaves rusted, as if welcoming of our arrival.

Chapter I: Close to Nature

We chose the route of climbing from the exit. Children were excited to run in front, all wanted to be first, adults were leisurely behind,  reminding the children to pay attention to safety from time to time. The steps were steep up and down, but everyone was cheerful, encouraging and moving forward together. We also met many children of the same age. 

Chapter II: Adventure on Mountaineering, Challenging Yourself

We passed by a lake which attracted the attention of the children. They drew the water with warter gun to play, and competing to see who shoots farther; suddenly they saw a father standing on the lake bridge, the direction of the water collective change, while the father couldn't do but run. On an open field at the top of the hill, there was a guard wall, which was the favorite of children who liked to play war games; the children pretended to be hiding under the wall and made a shotgun gesture at the "enemies"(tourists) outside the walls. These simple games let the adults seem to return to their childhood. 

Chapter III: Parent-child Game, unlimited Joy

The Children's Day trip to Wangshan in Suzhou has left us many good memories. Here, we not only enjoyed the gift of nature, but also experienced the warmth and happiness of the family. This holiday is not only a holiday for children, but also a reminder to our adults: even if we can not really return to childhood, we can choose to maintain a childlike heart, to be a person with light in eyes, love in the heart, enthusiasm for the benefit of mankind. 

Conclusion: Re-starting

Barbecue Queen-Serina

Three little guys at the foot of the hill

● LIFE SHARING

Address (Boston): One Patriot Park,Bedford, MA 01730,USA

Address (Shanghai): Unit 1001, 10th Floor, Building C,Chamtime Plaza,

Lane 2889, Jinke Road, Pudong New Area, Shanghai

Address (Suzhou): Unit 101, Building 8,No. 1 Xinze Road,Biobay, SIP,

Suzhou, Jiangsu Province.