Frontera Insight -No.04

No.04 General Issue No.4

Hello 2024

Goodbye 2023

Frontera

Insight

Chief Edito ：

Managing Editor ：

Proofread ：

Contributors：

Maggie Xue

Jackie Peng

Sunny Han

Eileen Kenney, Jiayan He, Jing Yu, Meng Li, Mandy Lu, Qian Wang, Suping Zhao, Tingting Chen, Wan Fang, Zhiyan Li, Yolanda Zhao

General Issue No.4

As the year draws to a close, we reflect on the journey we have taken together. 

Despite the challenges, we have made remarkable progress, and our dreams are within reach. The achieved milestones, patient testimonials, and researcher excitement are testaments to our collective efforts and determination.

Whether triumphs or setbacks, they are all part of our history. Let us embrace the memories of the past year as valuable experiences that have shaped us into who we are today.

As we look ahead to 2024, we are eager to face new opportunities and challenges, and to realize new hopes and achievements. The world will never cease to reward those who work hard and strive for excellence.

May we continue to make a positive impact on the world in 2024, and may we always find joy and purpose in our endeavors.

NO.01

- Trip to China- Ting & Zhongdong 

- Upstream/Downstream PD Team Profile

- Holidays in China And US

- How to "Win" Clinical Ultra-Low Temperature Refrigerators in 

Procurement Negotiations

- Internal Audit & Cross Audit

- Invoice Visible Everywhere

- VEGF Targeted Drug Innovation: "Once and for All" Gene Therapy

- Talking about "Unicorns"

- Talking about Equipment Life Cycle Management

Frontera News Brief

US-China Team Interaction

Science Class

Department Information

People in Frontera

Life Sharing

- Five-Team Challenge - Team Building in the US

- Full of Youth and Excitement - Team Building in China

- Celebrating Holidays Together

- Employee Recognition - US

- Getting to Know New Faces in Frontera

- Our Anniversary

- Tourism Sharing during the National Day Holiday—XuZhou

CONTENTS

要闻速递

Frontera Therapeutics announces CDE clearance to initiate clinical trial of a First-in-class gene therapy

Frontera Therapeutics announced CDE of China National Medical Products Administration (NMPA) has given clearance of the Investigational New Drug (IND) application to begin a clinical trial of an innovative gene therapy drug, FT-002, for the treatment of RPGR (Retinitis Pigmentosa GTPase Regulator) – associated X-linked Retinitis Pigmentosa (XLRP).

Frontera Therapeutics Initiates Phase II Clinical Trial for FT-001 in Hereditary Retinopathy Treatment

Frontera Therapeutics convened a meeting in Beijing on December 3 to conclude the Phase I clinical study of FT-001, and initiate the Phase II clinical study. The meeting was attended by esteemed clinical experts, including Professor Sui Ruifang, Professor Yu Weihong, and Professor Dai Rongping.

Congratulations to Dr. Ren Chao for Being Selected as ONE of the First Batch of "Pearl Elite Talents" in Pudong New Area in 2023

On 6th December, the 2023 Pudong International Talent Hub Forum under the theme of "Leadership, Momentum and Advancement” was held in Zhangjiang Science Hall, and Pudong New Area released the list of the first batch of award-winning talents of Pearl Project. Dr Ren Chao, Director of Translational Medicine, was successfully selected as one of the " Pearl Elite Talents " in Pudong New Area in 2023.

Frontera Therapeutics FT-002 Injection Study Results Showcased at the 2023 Asia-Pacific Vitreoretinal Society Conference

Frontera Therapeutics' FT-002 Injection is a potential first-in-class AAV product for the treatment of XLRP. Its preliminary clinical study results were presented at the 2023 Asia-Pacific Vitreoretina Society conference (Asia-Pacific Vitreo-Retina Society, APVRS). Professor Su Ruifang of Beijing Tongren Hospital was invited to participate in the Retina Medical Academic Forum themed "Preliminary safety and efficacy of an AAV gene therapy for RPGR-related X-linked recessive retinal pigment loss (XLRP) in a clinical trial.

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Frontera News Brief

 News Brief

5

NO.02

US-China Team 

Interaction

FT003-C101 Phase I Clinical Study Complete Low Dose Enrollment

On October 09, 2023, the low dose group administration of FT003-C101 Phase I clinical trial was completed. Since the start of the project on August 01, a total of 3 subjects in the low-dose group have been enrolled in just two months.

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US-China Team Interaction

Trip to China - Ting & Zhongdong 

US-China Team Interaction

The PD and RD teams in the US were the two departments that interacted the most with China team, and Ting and Zhongdong, as the heads of these departments, visited China in the final month of 2023. During their trip, they did the following:

1.Visit to Suzhou CMC Site

Ting and Zhongdong visited Suzhou CMC Site and were accompanied by the Manufacturing and QC teams throughout their tour of the laboratory and GMP workshop. They observed the filling production line in the formulation wrokshop. Ting expressed her deeper understanding of the large-scale production equipment and was amazed and commended  Suzhou CMC site for successfully establishing a complete GMP production line in just two years and producing multiple projects and batches of products. The cooperation between the US and China team is very efficient and successful.

2.Exchange

For Ting and Zhongdong, the most important thing about coming to China was to interact and exchange ideas with their online colleagues, like a "virtual meeting of internet friends".

Ting attended a team meeting in Suzhou for the small-scale study, where Baochuan gave an overview of the upcoming small-scale work to be carried out by the Suzhou team in 2024, and Ting provided valuable and constructive suggestions in terms of technology. Additionally, she held discussions and analysis with the Suzhou Manufacturing and QC teams regarding the technical transfer of FT-017. She also shared updates on the progress of the American project development and the technical issues encountered by the PD team, providing China team with more contingency ideas for future solutions to potential technical transfer issues.

Ting and Zhongdong attended the weekly meeting of China team on December 12th, during which they gained a more comprehensive understanding of the work status of each department of China team. They once again praised the efficient and close collaboration between China and US teams.

Zhongdong also had some 1*1 meetings with department heads of clinical-related

teams in Shanghai. On December 14th, he came to Suzhou to share technical insights for China Team. This allowed more colleagues in China to understand the latest scientific research updates on AAV design.

 Communication makes hearts and minds closer, and makes work smoother. Ting and Zhongdong's visit to China allowed the interaction between China and US teams, making us better understand the areas where we need to think from different perspectives in our work. As the number of interactions between China and US teams increases, we are more confident in the smooth transfer of the Frontera2.0 project. We believe that Frontera will be better tomorrow!

 Let's remember this brief but profound encounter through the delicious food. We look forward to our next reunion together!

US-CHINA TEAM INTERACTION

Chinese Holiday

December 25th to December 29th (Monday to Friday)

January 1st (Monday)

US Holiday

 January 1st (Monday)

8 days holiday from February 10th to 17th. February 4th (Sunday) and February 18th (Sunday) are working days.

US-CHINA TEAM INTERACTION

Upstream/Downstream PD Team Profile

Chris:  A cell culture guy with a love for the outdoors. Chris is a pillar in the upstream team, he’s been through lots of ups and downs with the company. Avid fisherman, golfer, and photographer. Inspired by his work and motivated to produce affordable and efficient global therapeutics. 

Jocelyn: A girl power that drives so many good things in upstream cell culture. Her skillful hands can do a lot of magic operations. She likes planting, hiking, and enjoying good food. 

Hung-Lun:Our newest addition to the dream upstream culture team. A father of 21-month-old daughter. As the tallest guy at Frontera (197cm), Hung-Lun enjoys skiing, jogging, and playing basketball.

Jeff：A downstream expert who purifies everything for everyone. If you need purified drug, just call him. A great team player who always gives and shares. Jeff likes board games, developing muscles at the gym and cooking.

Amanda: Freshly from college, we are very lucky to have Amanda join us. She has become very professional with purification toy, Akta! She likes rock climbing, sailing and hiking in her spare time.

Left to right: Amanda Su, Jocelyn Rodriguez, Ting Yang, Eric Tang, Jeff Kan, Chris Casey, Hung-Lun Hsu

Ting Yang from PD Dept.

Science Class

VEGF Targeted Drug Innovation: 

"Once and for All" Gene Therapy

According to World Health Organization data, age-related macular degeneration (AMD) and diabetic retinopathy (DR) are ranked 3rd and 5th in the global blinding eye disease.

AMD is the leading cause of visual impairment in the elderly worldwide, with approximately 190 million patients worldwide. According to the pathological features and clinical manifestations of AMD, AMD is divided into Dry Age-Related Macular Degeneration(dry-AMD) and Neovascular Age-Related Macular Degeneration (nAMD), in which nAMD accounts for about 10% to 20% of AMD patients.

DR is one of the most common microvascular complications of diabetes mellitus, with approximately 537 million adults worldwide suffering from diabetes in 2021, according to data from the 10th edition of the International Diabetes Federation. Among them, diabetic macular edema (DME) is the main cause of vision loss in DR patients, about 9 million patients with DME in China.

 Yanni Jiang from Medical Dept.

Visual distortion and central vision loss (images from NHS website)

NO.03

Science Class

Science Class

Talking about "Unicorns"

Unicorns are mythical creatures that are extremely rare and noble. The concept of "unicorn" was born in 2013 by Aileen Lee, an American venture capitalist, and refers to those startups that have the attributes of fast development speed, rarity, and being the target of investors.

Mengmeng Jin from RA and Project Management Dept.

The evaluation of the value of unicorn startups is generally conducted by third-party organizations. The five well-known foreign evaluation organizations mainly include "Unicorn Club" of TechCrunch (Aileen Lee), "Mobile Unicorn Club" of Digi-Capital, "Venture Unicorn Club" of CB Insights, "Startup Unicorn Club" of The Wall Street Journal, and "Unicorn Club" of Fortune Magazine.

Domestic evaluators mainly include the Torch High Technology Industry Development Center (usually in conjunction with the Administrative Commission of Zhongguancun Science Park and the Great Wall Enterprise Institute) and the Hurun Research Institute, etc. Many authoritative information agencies and research centers rely on their own databases to make evaluations, and their evaluation criteria are also slightly different.

Depending on different judgment criteria, such as the time of establishment, the amount of valuation, etc., unicorn enterprises have the following different designations.

● General unicorn: valuation of $1 billion - $10 billion;

● Super Unicorn: valuations over $10 billion；

● Potential Unicorns: companies with the potential to become unicorns;

● Quasi-unicorns: companies that have the potential to become unicorns in a short period of time;

● Emerging Unicorns: those that have been established for less than 2 years and have reached the unicorn standard.

Science Class

What is a "unicorn" startup?

Classification of Unicorn Startups

How are unicorn startups evaluated?

Some studies have shown that vascular endothelial growth factor (VEGF) is closely related to the occurrence, development and pathological outcome of nAMD and DME. VEGF promotes vascular endothelial cell proliferation, migration, and neovascularization by binding to the VEGF receptor (VEGFR) on the surface of vascular endothelium, and causes neovascular leakage and macular edema. Anti-VEGF drugs can effectively block the binding of VEGF to VEGFR on vascular endothelium, inhibit the action pathway of VEGF, reduce vascular endothelial permeability and inhibit the formation of neovascularization, thereby treating nAMD and DME caused by vascular leakage and neovascularization. 

At present, several drugs targeting VEGF have been approved for marketing worldwide, including aflibercept, ranibizumab, conbercept, etc., for the indications of nAMD and DME. However, traditional anti-VEGF drugs have a short half-life. In order to maintain efficacy, patients need frequent injections, which not only increase the risk of concurrent endophthalmitis, uveitis, iatrogenic vitreous hemorrhage, and retinal pigment epithelium tear, but also the inconvenience of frequent injections and high drug prices also reduce patient compliance. 

Therefore, in order to meet the long-term treatment needs of patients with nAMD and DME, gene therapy has become the most potential and effective treatment for ophthalmic diseases. At present, FT-003, developed by Frontera Therapeutics, carries the target gene aflibercept by AAV, via intravitreal injection to transfect retinal epithelial cells, photoreceptor cells, Muller cells, etc., to secrete aflibercept, block the binding of VEGF to VEGF and VEGFR, thereby inhibits the activity of VEGF, inhibits neovascularization and vascular leakage, and long-term effective expression, which is expected to achieve sustained efficacy in one dose, thereby meeting the clinical treatment needs of patients with nAMD and DME. 

Anti-VEGF gene therapy (pictured from International Journal of Ophthalmology)

Science Class

For pharmaceutical enterprises, the use of equipment is essential in various stages such as material storage, drug production, and quality control. An effective and standardized "equipment life cycle management" system should be established to ensure that all production and testing-related equipment is under effective control throughout its life cycle and that equipment activities are well documented to minimize contamination, cross-contamination, confusion, and errors occurring during the drug production process. This goal should be pursued by pharmaceutical enterprise equipment management.

The equipment life cycle can be roughly divided into three stages: pre-planning stage,service run stage,  the change and retirement stage. These three stages are further subdivided as shown in the figure.

I Equipment Pre-planning Stage: the user department proposes the equipment demand and drafts the URS(User Requirement Specification). The URS is jointly developed and reviewed and approved by experts from various departments (Manufacturingv, Engineering, Quality Control, EHS, etc.) and maintained and updated throughout the equipment life cycle. After the approval of the URS, the supplier designs and manufactures the equipment according to the URS and conducts DQ(Design Qualification), FAT(Factory Acceptance Test), and other processes. When the equipment is delivered, Engineering, user departments, and other units perform acceptance and commissioning, and the verification department performs  SAT(Site Acceptance Test),IQ(Installation Qualification),OQ(Operation Qualification),PQ(Performance Qualification) and other steps.

Leo Xu from EE Dept.

Science Class

In 2023, Frontera applied for "Suzhou Unicorn Cultivation Enterprise" and was successfully accepted. It is expected to be officially included in the list of cultivation enterprises in early 2024. Suzhou will provide rewards to inbound cultivation enterprises in the form of post research and development subsidies.

The unicorn journey of Frontera has just begun; "Jiangsu Unicorn Enterprise" and "National Unicorn Enterprise" are the distant places we are about to embark on. I hope that with the support of the governments, Frontera's technological capabilities and company reputation can be continuously improved.

In 2022, Forbes China screened 74 emerging unicorns in China out of more than 2,000 startups (with a single financing of more than RMB 200 million or USD 30 million), and Frontera is one of them.

Frontera and Unicorns

 Talking about Equipment 

Life Cycle Management

NO.04

Department

Information

II Equipment Service Run Stage: After the equipment has been confirmed and completed in the previous planning stage, it is delivered to the user. Before using the equipment, standard operating procedures and usage logs must be established. Daily cleaning and maintenance are also necessary. Maintenance personnel need to evaluate whether preventive maintenance is required. If so, a maintenance plan should be made and regularly performed according to the plan. If a fault occurs during use, contact maintenance personnel for repair. After troubleshooting, maintenance personnel need to review and analyze equipment faults and take measures to reduce the equipment failure rate, ensuring the normal operation of the equipment.

III Equipment Change and Retirement Stage: A change management process should be established throughout the entire life cycle of the equipment. During later use, software and hardware upgrade requirements may arise; production line switching may cause shutdown and activation; and the equipment will eventually undergo decommissioning upon reaching the end of its service period. All of these changes should be carried out under the control of the appropriate change management process to ensure that the entire life cycle of the equipment meets regulatory requirements.

All in all, in the management of pharmaceutical enterprises, equipment plays a very important role. Strengthening the life cycle management of equipment is mainly from the pre-planning stage, service run stage, and change and retirement stage. Technical personnel should constantly improve the management method and content to improve the actual effect of equipment life cycle management. This will ensure that equipment is used stably throughout its life cycle and complies with regulatory requirements.

Science Class

Department Information

Emily Zhang form SC Dept.

Department Information

The meeting was scheduled on the morning of October 12, 2023, after a brief greeting between both parties, they entered the main topic of discussion. As previously purchased the supplier's model of the refrigerator, everyone focused on confirming the parameters and performance of the model and product selection based on the new customer's needs. The professional personnel from the engineering and equipment department also started to challenge the shortcomings of the supplier's products, putting pressure on them, and causing some uncertainty about their own product confidence. Then, the next business negotiation began, at this time all the negotiators were energetic, focused, and constantly observing the supplier's mood and expression, as well as their reaction changes.

When the supplier gave their first round of quotation, we felt that the price exceeded our expectations, but they were the manufacturer, with an advantage of single source, at this time in order to grasp the initiative of the negotiation, everyone showed a lot of patience and did not rush for the negotiation result. We employed a roundabout approach, implying that we had conducted sufficient research on their competitors and had a high degree of cooperation with us. When we heard that we had sufficient research on competing products and competitor information, the three representatives of the supplier began to feel tense and whispered among themselves, and our colleagues also worked together and gradually put more pressure on them. After internal communication, the supplier gave their second round of quotation, but it still did not meet our expectations. At this time, we reaffirmed the future prospects of our clinical business and the increasing demand for ultra-low temperature refrigerators, continuously exerting pressure on them. Finally, the supplier offered a final discounted quotation on October 16.

Following repeated internal discussions, all issues were satisfactorily resolved, and the specifications, technical requirements, measurement, and other after-sales services required for clinical business were established. The commercial terms, including price, were drafted, and the initial agreement was prepared. After both parties completed the contract review process, the contract was signed.

How to "Win" Clinical Ultra-Low Temperature Refrigerators  

in Procurement Negotiations

Department Information

Internal Audit & Cross Audit

On November 15-16, Suzhou CMC Site held its fourth annual internal audit for 2023, focusing on the Manufacturing department. Furthermore, Frontera conducted a cross-audit between systems. The internal audit team and the cross-audit team worked together to perform a cross-departmental and cross-system audit with the goal of continuous improvement and enhancing inter-departmental communication.

Participants from various departments such as QC, Supply Chain, Engineering Equipment, RA, Clinical QA were invited to form a "Cross-Border" audit team. During on-site inspections assigned to them, the audit team not only checked document implementation but also gained insight into other departments.

Yingying Qian from QA Dept.

Department Information

The Manufacturing Department answered the questions from the audit team using their professional knowledge and professional dedication, demonstrating their professional abilities.

With the assistance of the cross-verification team led by RA and clinical QA, the two-day inspection work was not without gains/benefits. The internal audit concluded with a closing meeting where the observations were thoroughly communicated and confirmed. We sincerely hope that this audit can promote optimization in the related departments while also strengthening understanding and communication among various departments. At the same time, I would also like to express my gratitude to Sophie from RA and Phyllis from clinical QA for providing us with valuable suggestions and offering additional ideas and possibilities to enhance our work.

Those of you who have patiently read this article have naturally carefully identified the keywords hidden within it.

 Observations in  internal audit include critical observations, major observations, minor observations, and suggestions.

The process of  internal audit involves creating an internal audit plan, establishing an internal audit team, preparing for the internal audit (setting time and schedule), implementing the internal audit (first meeting, on-site inspection, last meeting), producing an internal audit report, receiving a reply report from the audited department, and transferring to the CAPA process for tracking.

Department Information

Invoice Visible Everywhere

Susan Liu from FA Dept.

Department Information

The invoice can be seen everywhere in our daily life, such as the catering service invoice for restaurant meals, the transportation service invoice for online car hailing and the accommodation service invoice for hotel accommodation. According to the regulations of the People's Republic of China on the Administration of Invoices, invoices refer to receipt and payment vouchers issued and collected during the purchase and sale of commodities, the provision or acceptance of services, and other business activities. Invoices include paper invoices and electronic invoices (also known as "all-electric invoices"). Common paper invoices include: Special VAT invoice, General VAT invoice, taxi invoice, special invoices for motor vehicles, tolls, train ticket and air ticket itinerary and quota invoice.

Special VAT invoices and General VAT invoices are often confused by people because their names are very similar. Special Invoice (usually called "Special Invoice") is a new type of invoice used in China in order to implement the new VAT system, compared with the general invoice used in daily operations (usually called "General Invoice"), the differences are as follows:

1.The printing authority of invoices are different: according to the new "Tax Administration Law" Article 22: " Special Invoices shall be printed by enterprises designated by the competent tax department of The State Council; other invoices shall, in accordance with the provisions of the competent department under The State Council, be printed by enterprises designated by the State Taxation Bureau and local taxation bureau of provinces, autonomous regions and municipalities directly under the Central Government, respectively. No invoices may be printed without the designation of the tax authorities as provided as above."

2.The invoice copies are different: Special Invoice has four copies as a whole while General Invoice only has three;

3.The use of invoices is different: Generally speaking, Special Invoice can only be purchased by enterprises approved by the tax bureau as VAT general taxpayers, while General Invoice are used by various other taxpayer companies engaged in business activities and tax registration. Enterprises approved by the tax bureau as general taxpayers can issue both Special Invoices and 

General Invoice. However, due to the different purposes of invoice receivers, the choice of invoice types may be different. The enterprise may not issue a Special Invoice to an individual in the name of individuals or unnamed individuals. If the individual provides the company information as the invoice title and uses this invoice for the reimbursement, Special Invoice can be issued.

4. The role of invoices is different: Special Invoice can be offset against VAT input tax (usually called "tax offset"), while General Invoice cannot. Therefore, it is recommended that employees give priority to Special Invoice or VAT electronic Special Invoice when receiving invoices.

At present, the digital economy is becoming a key force in reorganizing global factor resources, reshaping the global economic structure, and changing the global competition patterns. In order to implement the digital upgrade and intelligent transformation of tax collection and administration, the tax government has now promoted the use of electronic invoices all over the country. Electronic invoices have the same legal effect as paper invoices. Since 2020, China's vigorous promotion of the fourth phase of the Gold Tax (full name: Gold Tax Project Plan Phase IV) has improved the requirements for enterprise information foundation and data management capabilities. Compared Gordan

Tax Phase III, Golden Tax Phase IV enhances the information exchange and data sharing with the People's Bank of China, financial institutions, industrial and commercial administration and other regulatory departments, and increases the identity information and credit management of corporate shareholders, legal representatives and other relevant personnel, which will promote the tax collection and management reform from "tax control with invoice" to "tax control with digital technology", and accurately implement tax supervision. To build a powerful intelligent tax platform and achieve a tax co-governance pattern, the promotion of all-electric invoice plays a crucial role in this process. We also need to know that the Golden Tax Project is not simply used by taxpayers, it is mainly deployed in the internal network of tax authorities to achieve a more comprehensive monitoring of tax collection. At the same time, the Golden Tax Project will play a crucial role in tax burden calculation, analysis and comparison and other big data applications. Tax fraud and other illegal and criminal activities will be carried out after the crackdown to precise prevention in advance. Therefore, companies should not issue false invoices, at the same time, increase the vigilance on the rationality of received invoices and consistency with the business to prevent and improve tax risk management of the company.

NO.05

People in Frontera

Five-Team Challenge 

- Team Building in the US

The US office had a team building event on 10/5/23 in Harvard Square in Cambridge. We were broken up into 5 teams and were all given the same challenges to do as a team around Harvard University and the surrounding area. At the end, teams could choose to do a final wager on an unknown riddle. The winning team was team black (Amanda Su, Amy Jiang, Michael Lee, Mullu Tessema, Robert Lu and Yiling Fang) – photo of all participants attached.

People in Frontera

People in Frontera

Full of Youth and Excitement 

        - Team Building in China

On the afternoon of October 20th, China team went to a team building event by the Yangcheng Lake. where the sky was blue and the sun shone brightly. "The prominent package" frog alien welcomed every team member with enthusiasm, adding a beautiful green scenery to the playful and joyful atmosphere among the group members.

With the command of "Assembly",collegaues quickly gathered and lined up neatly, demonstrating the perfect blend of efficiency and camaraderie. The event kicked off with a simple but solemn "CEO Award" ceremony.

"ONE, TWO, THREE...", stretching, bending, twisting and jumping high to warm up before the game. This activity, which involves stretching and warming up the muscles, helped to loosen up the city dwellers who hadn't seen each other for a long time.

The following game of fun-filled frisbee brought the importance of teamwork to the forefront, with the all-female team winning the game with a score of 4-1, demonstrating the innovative and rigorous corporate spirit.

Qian Wang from EHS&Adimin Dept.

People in Frontera

As night fell, we were drawn to the charming atmosphere of the lakefront. Tents sprang up, flickering yellow lights illuminated the scene, and a feast for the senses unfolded as the bonfire was lit. Dancing to the beat of our feet, we let loose and sang loudly, our voices echoing across the lake. The joyful hours came to an end as the fireworks burst into life, painting the night sky with vibrant colors.

The gentle breeze was just right, making the most of the moment. When challenges arise, we stand together and work hard to overcome them. Looking towards the future, we hold hands and strive for excellence. Mountains and rivers will always cross paths, and the future is full of possibilities. We eagerly look forward to our next team building.

People in Frontera

Celebrating Holidays Together

Halloween is a holiday on October 31st each year and is celebrated by dressing up in costumes, going trick-or-treating (candy is given out to children by neighbors as they go door-to-door saying “trick-or-treat”), pumpkin carving, going to haunted houses and watching scary movies.

People in Frontera

Employee Recognition - US

Chris is always generous offering help to colleagues in need. Pretty often he comes in the weekend to help cover friend’s work, always generous to help. For this organizational capability, he keeps things in great order. His cell culture work is clean and never has contamination. He likes to plan things ahead of time, very careful and attention to detail type of employee - photo attached

Chris Casey & Jocelyn (nominated by Ting Yang):

Gina Zhang, Michelle Martin, Chinmay Patkar, Mullu Tessema (nominated by Yiling Fang): These dedicated people are the key to our success and I would like to recognize them.

• Gina has led the recent AAV5 optimization starting from molecular design, bacmid generation, to rBV and AAV production

• Michelle has done all the hands-on work including learning shake flask production from USP team. She has made hundreds of rBV stocks from all kinds of designs. So far they have performed 4 rounds of productions with 10-15 shake flasks each time.

• Chinmay and Mullu have been running infectivity assay for the samples from these productions, in order to provide direction on our development work. One sample testing takes 4 days. Together they have run over 20 samples in two weeks. Chinmay has also been organizing the AD team on FT-017 analytical method verification, development, qualification and transfer to QC. Mullu has been critical in providing PD testing support, especially quite a lot of STAT testing (with turn-around time less than 12 hours) running very late in the evenings.

Jocelyn and Chris make a dream upstream PD team. They partner very well with each other (always have each other’s back). With just two people, they have made significant contributions to the company. During the rhabdovirus free cell line generation project, Chris maintained cell passages for numerous clones, and ran a larger number of shake flasks and bioreactor runs for final clone selection. The team also was in charge of material generation for FT-011, FT-017 and FT-018 pre-clinical animal studies. The impeccable operation led to high quality production within a short time frame (this is a great collaboration between upstream and downstream team). In the second half of the year, Jocelyn has worked on optimizing baculovirus generation platform to shorten the process time and generate high quality of baculovirus that improve AAV productivity. At the end of the year, they are very busy working on adapting rhabdovirus free cell line for Frontera 2.0 programs. A lot of great progress has been made by this wonderful two-person team. 

Everyone who has helped us deserves to be thanked, thank you for your companionship, and may we not waste this precious encounter.

PEOPLE IN FRONTERA

Getting to Know New Faces in Frontera - CN

PEOPLE IN FRONTERA

Getting to Know New Faces in Frontera - US

I'm Lucas Van Gorder. I recently graduated from UPenn with a PhD in cell and molecular biology specializing in gene therapy and vaccines. When not in the lab I like to enjoy the outdoors. I do a little bit of everything from hiking to frisbee golf or camping. When I go outdoors my faithful dog, Lilly, is always by my side. Ask me for some pictures of her, I have plenty to share! 

I'm Jingsong Cao,I'm a pharmacologist and molecular biologist by training and has over two decades of experience directing drug discovery programs across various therapeutic areas, including liver metabolic and rare diseases, endocrinology, cardiovascular diseases, and oncology. Outside of work,I'm an active runner and has finished three marathons including this year’s Boston Marathon. i also enjoys reading and playing volleyball and soccer with friends during my spare time.

I'm Hung-Lun HsuI, I joined Frontera Therapeutics on October 2nd and have been working on AAV gene therapy since 2018, following the completion of my PhD. Prior to joining Frontera Therapeutics, I worked at Oxford Biomedica Solutions on the Vector Engineering team in Upstream PD. I am also the proud parent of a 21-month-old daughter and spend most of my spare time with her. When I have the opportunity, I enjoy skiing, jogging, and playing basketball. I'm thrilled to be part of the company and look forward to contributing to its growth.

Hi everyone- my name is Yogeshwar. My most recent position was at Homology Medicines, Inc. (HMI), where I led efforts to establish HMI’s GTx-mAb platform and conducted IND-enabling studies with development candidate (HMI-104) for complement-related disorder, Paroxysmal Nocturnal Hemoglobinuria (PNH). I am very excited to join Frontera Therapeutics and I look forward to working together with everyone!– photo attached.

I’m Li Huang from Medical Dept.I studied Ophthalmology with a masters degree obtained from Shanghai Jiao Tong University in 2017. After one year’s work in Shanghai Xinshijie Eye Hospital as a clinical physician, I went to Università degli Studi di Modena e Reggio Emilia in Italy to pursue a PhD degree in Regenerative Medicine.As for hobbies,I‘m quite interested in painting and photography.

I‘m Sophia Cui from CO Dept.,before join in Frontera, I worked for Novartis as SCRA/CRA II for more than 7 years, mainly responsible for site management from site selection to site closeout. I like travelling and cooking. 

I'm Hongbo Zhang from QA department. After graduating from Changchun University of Chinese Medicine, I have over 18 years of experience in the pharmaceutical industry. Prior to joining Frontera, I served as the QA director at Huahai Corporation, a biopharmaceutical company in China, where I managed the entire quality operations. I gained valuable experience in GMP quality systems, compliance, and CDE audits for the approval of commercial drugs.In my spare time, I enjoy traveling and watching movies.

I‘m Lico Lu from CO Dept. and I graduated from Nanjing University of Chinese Medicine with a major in Pharmacy. I worked as a CRA at Keymed for 2 years and was responsible for site monitoring.In my spare time, I enjoy playing football and badminton very much.

PEOPLE IN FRONTERA

1st Anniversary - China Team

PEOPLE IN FRONTERA

2nd Anniversary 

Cartera Wang-MF Dept.

Yingying Qian-QA Dept.

Zhengquan liu-MF Dept.

Mia Wang-QC Dept.

Mengmeng Jin-

RA and Project Management Dept.

Weiguo Li-QA Dept.

Jimmy Sun-FA Dept.

Minmin Lu-QC Dept.

Zhaodogn Jiang-MF Dept.

Jiayan He-QC Dept.

Eileen Kenney

Mullualem Tessema

Aiqun Li-QC Dept.

Serina Cheng-

RA and Project Management Dept.

Susan Liu

-FA Dept.

Wan Fang

-CO Dept.

Lulu Jin

-CO Dept.

Rui Zhu

-CO Dept.

Xinyan Li-CEO

Minghui Xue-CO Dept.

Xiaoqing Song-EE Dept.

3rd Anniversary - China Team

NO.06

Life Sharing

Life Sharing

"Going on a "soldier" trip for a two-day vacation: choosing to stay at home to binge-watch TV series, shopping at malls, or exploring nearby areas? This may be a question we repeatedly struggle with before the National Day holiday. My choice is to be a daring traveler who braves the crowds. In this sharing, I would like to introduce a hidden treasure city - Xuzhou.

Xuzhou, also known as "Pengcheng" has over 6,000 years of civilization and 2,600 years of urban history. At the end of the primitive society, Emperor Yao's disciple Pengzu established the state of Baodian in the Jiangsu region, which was one of the earliest cities to appear. Xuzhou is also the origin of Han culture, known as "Pengzu's homeland, Liu Bang's hometown, and Yue's capital." It is undoubtedly a hidden gem of small and niche tourist destinations.

Xuzhou has convenient transportation and numerous scenic spots, such as Yunlong Lake, Yunlong Mountain, Pengzu Garden, Baolian Temple, Guishan Han Tomb, Xima Stage, and more. You can truly appreciate the profound culture contained in these subtleties.

On this trip, I climbed Yunlong Mountain once again. Although the mountain may not be very high, the panoramic view of this historical city from the top is breathtaking. The distant echo of Yunlong Lake adds to the tranquility and beauty of the scenery.

Baolian Temple is undoubtedly the most impressive attraction of this trip. It is the dojo of Maitreya Bodhisattva and was built during the Northern and Southern Dynasties. It has a history of over 1,000 years, with several rises and falls. It's a must-see attraction that is highly recommended and is completely free of charge. Baolian Temple is truly awe-inspiring and well worth the visit.

Xuzhou has a lot of food that I was deeply attracted to during my college years. Barbecue is not lacking in Zibo, Shandong, and it brings together the characteristics of various regions. Rice noodles, pot chicken, lamb skewers, burritos, fire-roasted, fried skewers, etc., are definitely worth trying once

The two-day and one-night tour is packed, but it's far from boring. Xuzhou is indeed a treasure city with a diverse range of food and attractive attractions.

Jiayan He form QC Dept.

Tourism Sharing during the National 

Day Holiday—XuZhou

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

Suzhou, Jiangsu Province.