New Jersey-based contract development and manufacturing organization (CDMO), Simtra BioPharma Solutions, specializing in sterile injectables has appointed Mike Schaefers as chief commercial officer and head of business development.

Schaefers, who joins the firm with almost two decades of experience, will oversee global commercial operations to drive business growth, enhance customer relationships, and lead the company’s market expansion efforts.

“Mike Schaefers has a unique blend of strategic insight and hands-on operational expertise,” said Franco Negron, CEO of Simtra BioPharma Solutions. “[He] understands the complexities of our industry and will be a key driver in our efforts to enhance our market presence and deliver exceptional value to our clients.”

Previously, Schaefers served in leadership roles at LTS Lohmann Therapie-Systeme AG, Aenova Holding GmbH, and West Pharmaceutical Services. He developed company strategies for business growth, managed business collaborations and partnerships, and led key acquisition and integration activities.

“I am thrilled to join Simtra BioPharma Solutions at such an exciting time in the company’s growth,” said Schaefers. “I look forward to working with the talented team here to continue building on Simtra’s success and to contribute to the company’s ongoing mission of excellence in the CDMO space."

Tanvex BioPharma 

Biosimilar-focused CDMO Tanvex has appointed Stephen Lam as its chief executive officer. Joining the firm in September 2024, Lam succeeds Henry Chen, who will remain chairman until the closing of Tanvex’s acquisition by Bora Group. 

Lam has over 35 years of experience and will be responsible for ensuring the successful integration of the firm into Bora’s CDMO arm, Bora Biologics. He will oversee Tanvex's day-to-day operations, including its global CDMO operations and the commercialization of its biosimilar pipeline. 

“I am honored to take on the role of CEO at Tanvex,” said Lam. “By integrating Tanvex’s established commercial biologics manufacturing with Bora’s strong reputation, industry leading quality, and proven process-development expertise, we can serve our customers no matter where they are in their drug development lifecycle, from first-in-human studies through to commercial launch.”
Lam has previously worked at Lonza, Amgen, and Patheon. Most recently, he served as vice president and general manager, head of biologics at Thermo Fisher Scientific.

Enzene Biosciences 

Enzene, an Alkem Laboratories subsidiary, has appointed Norm Stoffregen as senior vice president (SVP). Additionally, he will head the CDMO’s recently established Princeton, NJ facility and Enzene’s biologics manufacturing division, leading the final stages of work to commission the India-based firm’s 54,000 square-foot facility.  

Stoffregen will supervise all operations at the site, where the company intends to transfer-in existing customers’ manufacturing projects and expand to add further bioreactor capacity, employing a workforce of 300 by the end of 2025. 

“I am delighted to welcome Norman to Enzene,” said Himanshu Gadgil, CEO of Enzene Biosciences. “His knowledge of the facility, our colleagues, customers, and suppliers will be invaluable as we develop our customer base and expand operations.” 

Significantly, Stoffregen has experience building manufacturing businesses, having worked in the area since 2015 at a facility owned by Bristol Myers Squibb. 

Before joining Enzene, Stoffregen headed a PTC Therapeutics sited, before which he led Bristol Myers Squibb’s Hopewell facility since 2015. 

“Existing and new customers see the powerful opportunities that continuous biologics technology brings, not least by providing flexibility and lowering the cost of manufacturing,” Stoffregen said.  

“We are already in discussion with biopharma companies keen to progress programs for the domestic market and beyond, and in the next 18 months we expect to ramp up our production capacity and capabilities and grow our pipeline of work with biotech and pharma companies in early phases of development.”