Generation Bio Promotes Antoinette Paone, M.S., MBA to Chief Operating Officer

CAMBRIDGE, Mass., Feb. 10, 2022 (GLOBE NEWSWIRE) — Generation Bio Co. (Nasdaq: GBIO), a biotechnology company innovating genetic medicines for people living with rare and prevalent diseases, announced the promotion of Antoinette Paone to chief operating officer (COO). Ms. Paone has served as senior vice president and head of regulatory affairs and quality at Generation Bio since 2018.

“Antoinette has made significant contributions to shaping our strategic direction, and her leadership has also elevated our operational performance,” said Geoff McDonough, M.D., president and chief executive officer of Generation Bio. “Antoinette will now lead operations more broadly, including an integrated CMC, quality, and regulatory team, to deliver the internal GMP capacity to enable our goal of bringing novel medicines to broad populations of people living with genetic diseases.”

Ms. Paone brings over 20 years of pharmaceutical and biotech experience to the role and will be responsible for the coordinated execution of Generation Bio’s good manufacturing practice (GMP) capabilities including chemistry, manufacturing and controls (CMC), regulatory affairs, quality, supply chain, and operations.

“As we develop our closed-ended DNA constructs and lipid nanoparticle delivery system, it is critical to build GMP manufacturing capabilities to match the scale and breadth of our technology’s potential,” said Ms. Paone. “I’m excited to expand my leadership role to include manufacturing, a core pillar of our platform, and to enable end-to-end integration of our strategy and operations.”

Prior to joining Generation Bio, Ms. Paone provided regulatory leadership at Vertex Pharmaceuticals, where she was vice president and head of North American regulatory affairs strategy and also led the global regulatory affairs CMC department. Ms. Paone held earlier positions in chemical process research and development at Millennium Pharmaceuticals as well as Merck. She earned an MBA from Bentley College, an M.S. in organic chemistry at Yale University and a B.S. in chemistry at Fordham University.

About Generation Bio
Generation Bio is innovating genetic medicines to provide durable, redosable treatments for people living with rare and prevalent diseases. The company’s non-viral genetic medicine platform incorporates a novel DNA construct called closed-ended DNA, or ceDNA; a unique cell-targeted lipid nanoparticle delivery system, or ctLNP; and a highly scalable capsid-free manufacturing process that uses proprietary cell-free rapid enzymatic synthesis, or RES, to produce ceDNA. The platform is designed to enable multi-year durability from a single dose, to deliver large genetic payloads, including multiple genes, to specific tissues, and to allow titration and redosing to adjust or extend expression levels in each patient. RES has the potential to expand Generation Bio’s manufacturing scale to hundreds of millions of doses to support its mission to extend the reach of genetic medicine to more people, living with more diseases, around the world.

For more information, please visit www.generationbio.com. 

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for the company, including statements about our strategic plans or objectives, our technology platform, our research and clinical development plans, and preclinical data and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the identification and development of product candidates, including the conduct of research activities, the initiation and completion of preclinical studies and clinical trials and clinical development of the company’s product candidates; uncertainties as to the availability and timing of results from preclinical studies and clinical trials; whether results from earlier preclinical studies will be predictive of the results of later preclinical studies and clinical trials; uncertainties regarding the timing and ability to complete the build-out of the company’s manufacturing facility and regarding the new manufacturing process; expectations for regulatory approvals to conduct trials or to market products; challenges in the manufacture of genetic medicine products; whether the company’s cash resources are sufficient to fund the company’s operating expenses and capital expenditure requirements for the period anticipated; the impact of the COVID-19 pandemic on the company’s business and operations; as well as the other risks and uncertainties set forth in the “Risk Factors” section of our most recent annual report on Form 10-K and quarterly report on Form 10-Q, which are on file with the Securities and Exchange Commission, and in subsequent filings the company may make with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the company’s views as of the date hereof. The company anticipates that subsequent events and developments will cause the company’s views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date on which they were made.

Contact:

Investors 
Maren Killackey
Generation Bio
mkillackey@generationbio.com
541-646-2420

Media 
Lisa Raffensperger
Ten Bridge Communications
lisa@tenbridgecommunications.com
617-903-8783

Generation Bio Co. (Nasdaq: GBIO), a biotechnology company innovating genetic medicines for people living with rare and prevalent diseases, announced the promotion of Antoinette Paone to chief operating officer (COO). Ms. Paone has served as senior vice president and head of regulatory affairs and quality at Generation Bio since 2018.

“Antoinette has made significant contributions to shaping our strategic direction, and her leadership has also elevated our operational performance,” said Geoff McDonough, M.D., president and chief executive officer of Generation Bio. “Antoinette will now lead operations more broadly, including an integrated CMC, quality, and regulatory team, to deliver the internal GMP capacity to enable our goal of bringing novel medicines to broad populations of people living with genetic diseases.”

Ms. Paone brings over 20 years of pharmaceutical and biotech experience to the role and will be responsible for the coordinated execution of Generation Bio’s good manufacturing practice (GMP) capabilities including chemistry, manufacturing and controls (CMC), regulatory affairs, quality, supply chain, and operations.

“As we develop our closed-ended DNA constructs and lipid nanoparticle delivery system, it is critical to build GMP manufacturing capabilities to match the scale and breadth of our technology’s potential,” said Ms. Paone. “I’m excited to expand my leadership role to include manufacturing, a core pillar of our platform, and to enable end-to-end integration of our strategy and operations.”

Prior to joining Generation Bio, Ms. Paone provided regulatory leadership at Vertex Pharmaceuticals, where she was vice president and head of North American regulatory affairs strategy and also led the global regulatory affairs CMC department. Ms. Paone held earlier positions in chemical process research and development at Millennium Pharmaceuticals as well as Merck. She earned an MBA from Bentley College, an M.S. in organic chemistry at Yale University and a B.S. in chemistry at Fordham University.

About Generation Bio
Generation Bio is innovating genetic medicines to provide durable, redosable treatments for people living with rare and prevalent diseases. The company’s non-viral genetic medicine platform incorporates a novel DNA construct called closed-ended DNA, or ceDNA; a unique cell-targeted lipid nanoparticle delivery system, or ctLNP; and a highly scalable capsid-free manufacturing process that uses proprietary cell-free rapid enzymatic synthesis, or RES, to produce ceDNA. The platform is designed to enable multi-year durability from a single dose, to deliver large genetic payloads, including multiple genes, to specific tissues, and to allow titration and redosing to adjust or extend expression levels in each patient. RES has the potential to expand Generation Bio’s manufacturing scale to hundreds of millions of doses to support its mission to extend the reach of genetic medicine to more people, living with more diseases, around the world.

For more information, please visit www.generationbio.com. 

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for the company, including statements about our strategic plans or objectives, our technology platform, our research and clinical development plans, and preclinical data and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the identification and development of product candidates, including the conduct of research activities, the initiation and completion of preclinical studies and clinical trials and clinical development of the company’s product candidates; uncertainties as to the availability and timing of results from preclinical studies and clinical trials; whether results from earlier preclinical studies will be predictive of the results of later preclinical studies and clinical trials; uncertainties regarding the timing and ability to complete the build-out of the company’s manufacturing facility and regarding the new manufacturing process; expectations for regulatory approvals to conduct trials or to market products; challenges in the manufacture of genetic medicine products; whether the company’s cash resources are sufficient to fund the company’s operating expenses and capital expenditure requirements for the period anticipated; the impact of the COVID-19 pandemic on the company’s business and operations; as well as the other risks and uncertainties set forth in the “Risk Factors” section of our most recent annual report on Form 10-K and quarterly report on Form 10-Q, which are on file with the Securities and Exchange Commission, and in subsequent filings the company may make with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the company’s views as of the date hereof. The company anticipates that subsequent events and developments will cause the company’s views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date on which they were made.

Contact:

Investors 
Maren Killackey
Generation Bio
mkillackey@generationbio.com
541-646-2420

Media 
Lisa Raffensperger
Ten Bridge Communications
lisa@tenbridgecommunications.com
617-903-8783