Draft:Tessie M Che

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Tessie Mary Che (born August 19, 1950, Taipei, Taiwan) is a Taiwanese-American scientist, pharmaceutical entrepreneur, and philanthropist. She is best known as co-founder, Senior Vice President of Corporate Affairs, and Chief Operating Officer of Optimer Pharmaceuticals, Inc., the biopharmaceutical company that developed fidaxomicin (DIFICID®) — the first antibiotic in a new class approved by the U.S. Food and Drug Administration (FDA) for the treatment of Clostridioides difficile-associated diarrhea. She holds a Ph.D. in physical-inorganic chemistry from Brandeis University, a B.S. in chemistry from Illinois State University, and an additional B.S. in chemistry from Fu-Jen Catholic University in Taiwan, and is named on more than twenty U.S. patents in materials synthesis and applications. She served as Chairperson and General Manager of Amaran Biotech in Taiwan from 2013 until her retirement in early 2026, and is co-founder of the Ren Che Foundation, a Seattle-based philanthropic organization.

Early Life and Family Background

Tessie M. Che was born on August 19, 1950, in Taipei, Taiwan, into a family with deep roots in public service and diplomacy. Her father, George Y.S. Che, served as a diplomat representing the Republic of China (Taiwan) in postings overseas during her childhood years, with the family residing at different periods in New York and Vancouver, Canada. These years abroad gave the young Tessie early immersion in English-speaking international environments, and a cross-cultural fluency that would define her career across multiple continents.

Following her father's diplomatic assignments, the family settled in Millbrae, California, on the San Francisco Peninsula, where Tessie spent her adolescent years.

Education

1. Fu-Jen Catholic University and Illinois State University

Tessie returned to Taiwan for university, enrolling at Fu-Jen Catholic University in New Taipei City to study chemistry. It was there that she met Michael N. Chang, a fellow chemistry student who would become her husband, lifelong scientific partner, and co-founder of multiple pharmaceutical ventures. Both graduated with bachelor's degrees in chemistry from Fu-Jen.

She also holds a B.S. in chemistry from Illinois State University in Normal, Illinois.

2. Graduate Study

For advanced graduate training, Tessie attended the University of Washington in Seattle and the University of Illinois at Urbana-Champaign, before completing her doctorate at Brandeis University in Waltham, Massachusetts, where she earned a Ph.D. in physical-inorganic chemistry. Following her doctorate, she conducted post-doctoral research at Columbia University in New York City.

Early Industrial Career

1. Celanese Corporation

Tessie joined Celanese Corporation, the major specialty chemicals and advanced materials company, as a research scientist. Her earliest U.S. patent dates from this period: U.S. Patent 4,642,394 — "Production of Propanediols" — was filed July 16, 1985, granted February 10, 1987, assigned to Celanese Corporation, and lists Tessie M. Che as sole inventor. The patent describes a catalytic process using tungsten and Group VIII metal systems for the selective synthesis of propanediols.

2. Hoechst Celanese Corporation

As Celanese merged with Hoechst to form Hoechst Celanese Corporation, Tessie pivoted toward advanced photonic materials. She co-invented multiple patents in **nonlinear optical (NLO) materials and sol-gel glass composites, collaborating with colleagues including Alan Buckley, Thomas M. Leslie, James B. Stamatoff, Dagobert E. Stuetz, Donald R. Ulrich, Gunilla E. Gillberg-LaForce, and Marie Borzo. These patents describe composite microporous inorganic oxide glass monoliths incorporating organic NLO components and liquid crystalline phases, with applications in optical switching, signal processing, and photonic devices.

3. EniChem S.p.A. / Istituto Guido Donegani (Italy)

Her career then took her to northern Italy, where she worked with EniChem S.p.A. — the materials and chemicals arm of the Italian state energy company ENI — and its research institute, Istituto Guido Donegani, in Novara. This chapter deepened her expertise in sol-gel glass processing for optical applications. U.S. Patent 5,182,236 — "Gradient Index Glasses and Sol-Gel Method for Their Preparation," filed September 24, 1991 and granted January 26, 1993 — lists her among the inventors alongside J. Brian Caldwell, Mark A. Banash, Robert M. Mininni, and Victor N. Warden. Gradient-index (GRIN) glasses, in which the refractive index varies continuously across the material, are used in fiber optic coupling, telecommunications, and medical imaging.

4. Exxon Mobil Corporation and Aventis Pharmaceuticals

Returning to the United States, Tessie held research and management positions at Exxon Mobil Corporation and Aventis Pharmaceuticals, Inc. (now part of Sanofi), accumulating what SEC filings describe as over twenty years of combined industrial experience across large-company research, management, and operations spanning petrochemicals, materials science, and pharmaceutical production.

5. M and D Precision Science Group

From 1994 to 1996, she served as Chief Operating Officer and Vice President of M and D Precision Science Group, Inc., a biotechnology company. This was her decisive transition into executive leadership.

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Life at Windy Bush Farm, Newtown, Pennsylvania

During the years when her children were young, Tessie and Michael Chang made their home at Windy Bush Farm, a rural property in Newtown, Bucks County, Pennsylvania, where they raised their two children, Michele and Michael. Bucks County's pastoral landscape and proximity to Philadelphia's biopharmaceutical corridor provided both family grounding and professional connectivity during this chapter of their lives. The experience of community and stewardship at the farm would later find expression in the environmental and social priorities of the Ren Che Foundation.

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Pharmanex and Early Entrepreneurship

In 1994, Tessie co-founded Cinogen Pharmaceuticals, Inc. (also known as Zhejiang Cinogen Pharmaceutical Co., Ltd.) in China, serving in a leadership role from 1994 to 1996. Cinogen specialized in the sourcing and pharmaceutical-grade development of natural product ingredients.

Cinogen was subsequently acquired by and merged into Pharmanex, Inc., the natural healthcare company co-founded by Michael Chang in 1994. At Pharmanex, Tessie served as Director of Quality Assurance and later Senior Director of Ingredient Sourcing from 1995 to 1999. In 1998, Nu Skin Enterprises, Inc. (NYSE: NUS) acquired Pharmanex; Michael Chang joined Nu Skin as Chief Science Officer, and Pharmanex became the scientific foundation of Nu Skin's supplement business.

Optimer Pharmaceuticals In 1998, Tessie M. Che and Michael N. Chang co-founded Optimer Pharmaceuticals, Inc., incorporated in Delaware and headquartered in San Diego, California at 10110 Sorrento Valley Road. Tessie formally assumed her executive role in November 1999, serving — as documented in the company's U.S. Securities and Exchange Commission (SEC) filings — as Senior Vice President, Corporate Affairs and Chief Operating Officer. Michael Chang served as President and Chief Executive Officer. The publicly published obituary of Michael N. Chang, prepared by the family, describes Optimer as built by "Michael & Tessie from 1998–2011" with a core team that grew to fifty people.

Optimer's strategy focused on hospital specialty anti-infective drugs, particularly treatments for Clostridioides difficile infection (CDI) — the gram-positive bacterial pathogen responsible for the most common hospital-acquired infection in the United States and a major cause of severe, often life-threatening diarrheal illness.

The company licensed fidaxomicin — a narrow-spectrum macrolide antibiotic derived from the natural compound tiacumicin B — and advanced it through clinical development under the codes OPT-80 and PAR-101. Tessie personally built and led Optimer's CMC (Chemistry, Manufacturing and Control) team through the entirety of this process: the most operationally demanding phase of drug development, requiring process scale-up, quality system construction, and comprehensive regulatory documentation.

In December 2010, Optimer submitted its New Drug Application (NDA) to the FDA. The FDA granted Orphan Drug designation and a six-month Priority Review. On May 27, 2011, the FDA approved fidaxomicin as DIFICID® for the treatment of CDI in adults — the first new antibiotic approved in a new class to treat this infection in 25 years. Approval was based on two double-blind, randomized, multi-centre Phase III trials in 1,105 combined patients demonstrating non-inferiority to vancomycin in clinical cure rates and significantly superior sustained response and recurrence rates. European approval as DIFICLIR® followed a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in September 2011, and the drug was also approved in Canada.

Tessie has said publicly that Optimer achieved the DIFICID registration for approximately USD 175 million — pointing to it as evidence that disciplined, operationally precise drug development can achieve results far more efficiently than large-company incumbents.

Optimer was listed on the NASDAQ Stock Exchange under the ticker OPTR from 2007 to 2013. In October 2013, Cubist Pharmaceuticals completed its acquisition of Optimer for $535 million. Cubist was subsequently acquired by Merck & Co. in January 2015, making DIFICID a Merck product.

Living on the Water in San Diego

During her years building Optimer in San Diego, Tessie lived aboard a boat in San Diego Harbor, reflecting a deep love of the sea and water, and the adventurous spirit that has characterized her life across many cities and countries.

The Loss of Michael N. Chang

On December 28, 2022, Dr. Michael Nientse Chang passed away suddenly of a heart attack at his home in Nevada, with Tessie at his side. His publicly published obituary — written by his children Kelly Chang, Michael Chang Jr., and Michele Wong — described him as "a deeply cherished husband, father, brother, grandfather and friend" and Tessie as his "soulmate and beloved partner." Memorial services were held in Taipei at the Taipei City Church on February 18, 2023, and at Fu-Jen Catholic University on February 17, 2023. The Ren Che Foundation was designated by the family to receive memorial donations in his honor.

OBI Pharma

Michael Chang established OBI Pharma, Inc. in April 2002 as a wholly-owned subsidiary of Optimer, focused on oncology and biologics — principally immunotherapies targeting cancer. As Taiwanese investors provided increasing funding, diluting Optimer's ownership stake, OBI was formally spun off in 2012 and subsequently listed on the Taipei Exchange (4174.TWO) in 2015. OBI's scientific focus has centered on cancer therapeutic vaccines targeting the Globo H carbohydrate antigen — overexpressed on many solid tumors — and antibody-drug conjugate (ADC) platforms. In 2020, OBI Pharma acquired approximately 67% equity of Amaran Biotech through a stock-for-stock exchange, making Amaran a subsidiary.

Amaran Biotech

1. Taking the Helm

In late 2012, on a visit to Taiwan, Tessie was asked to help stabilize Amaran Biotech, a contract development and manufacturing organization (CDMO) located in the Hsinchu Biomedical Science Park, at a moment when the company's general manager had fallen seriously ill. She became interim General Manager in 2013 and, recognizing the long-term value of both the company and Taiwan's broader biopharmaceutical ecosystem, committed to the role permanently. She served as Chairperson and General Manager of Amaran from 2013 until her retirement in early 2026.

2. Strategic Transformation

When Tessie arrived, Amaran's primary focus was producing a botulinum toxin-similar product. After rigorous engineering evaluation and risk assessment, she redirected the company toward specialty pharmaceutical contract manufacturing — reasoning that a dedicated botulinum toxin facility would be prohibitively costly for the available market volume. This reorientation became the foundation of Amaran's subsequent growth.

Under her leadership, Amaran built a new manufacturing facility during 2013–2015, achieving PIC/S GMP certification from Taiwan's Food and Drug Administration (TFDA) in June 2017, with recertification in 2019, and full qualification audits by U.S. and EU regulatory agencies and third-party auditors. The facility specializes in the isolation and purification of natural products, proteins, and complex molecules difficult to produce under GMP conditions.

A landmark achievement was the 2022 introduction of Taiwan's first fully automated robotic aseptic drug filling line, using the Cytiva (Vanrx) SA25 robotic system — enabling high-quality, low-waste filling of high-value biologics including protein therapeutics, antibody drugs, and nanoparticle-based drugs, with a filling accuracy of 99.99%. Amaran completed the installation during the COVID-19 pandemic through remote collaboration with international engineers who could not travel to Taiwan — a feat Tessie highlighted in her award acceptance speech in 2025.

Amaran also developed AB-801, a GMP-grade, high-purity QS-21 saponin-based vaccine adjuvant, making Amaran one of very few CDMOs worldwide capable of producing this material under GMP conditions. Saponin-based adjuvants including QS-21 are used in major vaccines such as GSK's Shingrix and the Novavax COVID-19 vaccine. In January 2026, Amaran became the first adjuvant supplier in Taiwan to receive an FDA Acknowledgement Letter for a Type II Drug Master File (DMF) for AB-801.

Amaran's motto under Tessie's leadership: "Work locally. Think and act globally."

Awards and Recognition

Tessie M. Che received industry recognition, particularly in her years at Amaran and upon her retirement:

1. Taiwan Biopharma Excellence Awards 2025 — "Best CDMO in Automated Aseptic Filling" (IMAPAC; March 26, 2025, Hilton Taipei Sinban): Awarded to Amaran Biotech; Tessie delivered the acceptance speech, describing the team's achievement in completing robotic installation remotely during COVID-19.

2. Asia-Pacific Biopharma Excellence Awards 2025 — "Bioprocessing Excellence in Taiwan" (IMAPAC; March 12, 2025, Singapore): Awarded for Amaran's development of the AB-801 adjuvant.

3. Asia-Pacific Biologics CDMO Excellence Awards 2025 — "Best Fill-Finish" (IMAPAC; September 2025): Recognizing Amaran as the leading fill-finish CDMO in Asia-Pacific. - Asia-Pacific Biopharma Excellence Awards 2026 — "Bioprocessing Excellence in Taiwan" (IMAPAC; March 12, 2026, Singapore): Amaran received this award for a second consecutive year.

4. Women's Leadership in Biologics Manufacturing Award (IMAPAC; ABEA 2026, March 12, 2026, Singapore): Presented personally to Dr. Tessie Che as retired Chairperson and General Manager of Amaran, in recognition of her leadership and contributions to biologics manufacturing — the capstone honor of her executive career.

5. Stellar Biotechnologies Board of Directors (September 2013): Appointed to the board of Stellar Biotechnologies, Inc. (OTCQB: SBOTF; TSX Venture: KLH), a biopharmaceutical company focused on keyhole limpet hemocyanin (KLH) for cancer immunotherapy. Amaran made a concurrent $5 million investment in Stellar's $12 million private placement.

Patents

Tessie M. Che holds more than twenty U.S. patents in materials synthesis and applications, spanning her career at Celanese, Hoechst Celanese, and EniChem / Istituto Guido Donegani. Confirmed issued patents include:

| US 4,642,394 | Production of Propanediols | Celanese Corporation | 1987 | Sole inventor |

| US 5,182,236 | Gradient Index Glasses and Sol-Gel Method for Their Preparation | EniChem S.p.A. / Istituto Guido Donegani S.p.A. | 1993 | With Caldwell, Banash, Mininni, Warden |

| Multiple NLO/sol-gel patents | Nonlinear Optical Media; Liquid Crystalline Glass Composites | Hoechst Celanese Corp. | 1990s | With Buckley, Leslie, Stamatoff, Stuetz, Ulrich, Gillberg-LaForce, Borzo |

(A complete list is searchable via the USPTO Patent Full-Text Database (patft.uspto.gov) or Google Patents under inventor name "Tessie M. Che.")

Scientific Publications

Tessie M. Che has authored numerous peer-reviewed scientific publications in physical-inorganic chemistry, sol-gel materials science, nonlinear optical composites, and pharmaceutical chemistry. Her publication record is indexed in Web of Science, SciFinder, and Google Scholar.

Philanthropy: The Ren Che Foundation Tessie M. Che and Michael N. Chang founded the **Ren Che Foundation** (EIN: 47-5595677), a Seattle, Washington-based private philanthropic organization that received its IRS ruling in 2016. The name combines Ren (仁) — meaning benevolence in Chinese — and Che, reflecting a commitment to compassionate community investment. The foundation is headquartered at 24 Roy Street, Seattle, WA.

The foundation's board is led by the family on a voluntary, uncompensated basis: Kelly Chang (President/Director), Michele Wong (Secretary/Director), Derek Wong (Vice-President/Director), and Michael Chang (Treasurer/Director). Following Michael N. Chang's death in December 2022, the family designated the Ren Che Foundation to receive memorial donations in his honor.

The foundation has distributed approximately $489,000 across 22 grants as of available tax records, with grantmaking active in Washington, Massachusetts, and Idaho. Annual giving peaked in 2022 at approximately $259,000 across fourteen grants. Total assets are approximately $1.4–1.5 million.

Areas of investment include:

Clean energy and climate equity: The 2019 "Solarize the Land Trust" initiative, in partnership with Spark Northwest and the Homestead Community Land Trust, funded solar installations on ten permanently affordable homes in South Seattle. Outreach was conducted in fourteen languages to ensure diverse household participation.

Arts and youth education: Support for the Northwest Symphony Orchestra's Symphony for Students program, which brings live classical music performance and musician mentorship to school-age children in the Highline and Federal Way School Districts.

Domestic violence and housing stability: Funding for LifeWire's Housing Stability Program, which helps families navigate the choice between abusive situations and homelessness.

Other initiatives in Indigenous community support, environmental conservation, and public health in the Pacific Northwest and beyond.

Personal Life and Interests

Tessie M. Che and Michael N. Chang were married for decades, sharing a life that spanned Taipei, New York, Vancouver, Millbrae, New England, Bucks County, San Diego, and Taiwan. Their children are Michele (now Michele Wong) and Michael (Kelly) Chang; they also have grandchildren.

Legacy

Over more than four decades, Tessie M. Che contributed to materials science, pharmaceutical manufacturing operations, and biopharmaceutical entrepreneurship at every level — from sole-inventor bench chemist to co-founder and COO of a NASDAQ-listed company. She has worked at or co-founded companies across three continents, holding leadership roles at Celanese, Hoechst Celanese, EniChem, Exxon Mobil, Aventis, M&D Precision Science, Cinogen, Pharmanex, Optimer, Amaran Biotech, and Stellar Biotechnologies.

Her most consequential achievement remains the co-founding and operational leadership of Optimer Pharmaceuticals, and the development of fidaxomicin (DIFICID®) — a drug that continues to treat patients globally for one of medicine's most persistent and dangerous hospital-acquired infections. As the driving force behind Amaran Biotech from 2013 to 2026, she elevated Taiwan's pharmaceutical manufacturing standards, introduced the country's first robotic aseptic filling technology, guided AB-801 to FDA Drug Master File acknowledgement, and led the company to multiple international industry awards. Through the Ren Che Foundation, she and Michael Chang built a philanthropic platform investing in clean energy access, arts education, domestic safety, and community resilience.

References

1. Stellar Biotechnologies: "Stellar Biotechnologies, Inc. Appoints Tessie Che, Ph.D. to Board of Directors" (September 25, 2013). Fierce Biotech / StellarBiotechnologies.com.

2. PharmaBoardroom: "Tessie Che — Chairperson & GM, Amaran Biotech, Taiwan" (September 16, 2019).

3. U.S. SEC EDGAR — Optimer Pharmaceuticals, Inc. DEF 14A proxy statement (2009). https://www.sec.gov/Archives/edgar/data/1142576/000110465909023334/a09-9144_1def14a.htm

4. U.S. SEC EDGAR — Optimer Pharmaceuticals, Inc. Form 8-K (September 30, 2011). https://www.sec.gov/Archives/edgar/data/0001142576/000110465911054362/a11-27186_18k.htm

5. Wikipedia — Optimer Pharmaceuticals. https://en.wikipedia.org/wiki/Optimer_Pharmaceuticals

6. Obituary of Dr. Michael Nientse Chang (張念慈博士), Ever Loved (everloved.com/life-of/michael-chang/obituary/), published December 2022, created by Kelly Chang, Michael Chang Jr., and Michele Wong.

7. FDA Drug Approvals — Fidaxomicin (DIFICID), approved May 27, 2011.

8. GlobeNewswire — "Amaran Biotech Wins Asia-Pacific Biopharma Excellence Award 2025" (March 13, 2025).

9. GlobeNewswire — "Amaran Biotech Wins 'Best CDMO in Automated Aseptic Filling'" (March 27, 2025).

10. PR Newswire — "Amaran Biotech Wins Asia-Pacific Biologics CDMO Excellence Award for 'Best Fill-Finish'" (September 11, 2025).

11. Amaran Biotech corporate website (amaran.com.tw / amaranbiotech.com) — board profile noting Women's Leadership in Biologics Manufacturing Award (ABEA 2026, March 12, 2026).

12. GeneOnline News — coverage of ABEA 2025 and Taiwan Biopharma Excellence Awards 2025.

13. Ren Che Foundation (renchefoundation.org) and Charity Navigator profile (EIN 47-5595677).

14. Google Patents — US 4,642,394; US 5,182,236. Justia Patents — inventor profile, Tessie M. Che.

15. San Diego Business Journal — "Trius Therapeutics and Optimer Pharmaceuticals Acquired by Cubist Pharmaceuticals" (July 2013).

16. PharmaBoardroom — "Michael Chang — Founder and Chairman, OBI Pharma, Taiwan" (2019).

17. OBI Pharma — "Who We Are" (obipharma.com).

18. Wikipedia (Chinese) — 張念慈 (Michael Chang). https://zh.wikipedia.org/zh-tw/張念慈