Patheon has formed Patheon Certified Consultants, a new consulting capability comprised of industry veterans. These consultants will provide independent advice to emerging biotech and pharmaceutical companies, as well as their investors, helping address early-, mid- and late-stage CMC questions in drug development.

This group of proven professionals has collectively brought to market more than 200 pharmaceutical products, including some of the largest blockbusters in the world. “The team possesses a remarkable depth and range of strategic and practical expertise that is unmatched by any other consulting service available today,” said a Patheon statement. The Certified Consultants roster includes:

• Leah Appel – 20 years of development experience at Bend Research and INTERx. Co-inventor of more than 35 drug delivery patents and applications.
• Brett Berner – 30 years of product development experience at Depomed, Cygnus and Ciba. Ten marketed products and 30 drug delivery patents.
• Lynn Van Campen – 30 years of development experience at Pfizer, Boehringer Ingelheim, Inhale/Nektar and the University of Wisconsin. Contributed to 18 marketed products.
• Joe Fix – 30 years of development experience at CyDex, NanoSystems/Elan, Yamanouchi and Alza. Contributed to 24 patents including four NECs, 13 LCMs, four OTCs and three generics.
• Larry Gatlin – 25 years of experience, including Genentech, Glaxo and Pfizer. Multiple patents, INDs and NDAs, more than 20 publications.
• John Kent – 30 years of development experience at Theravance, Syntex and Allergan. More than 20 products and CMC, IND and NDA filings.
• Bob Lipper – 30 years of product development experience at Pfizer and BMS. Ushered multiple products through the R&D process.
• Doug Mendenhall – 35 years of experience at Abbott, Glaxo/GSK and Merck. Contributed to 70 commercial products.
• George Mooney – 30 years of development experience at Boehringer Ingelheim, Lederle and Pfizer. One-hundred NME INDs, 15 NCEs, NDAs and more than 30 products.
• Ann Newman – 20 years of experience at BMS and SSCI/Aptuit. Contributed to eight commercial products.
• Rodney Pearlman – 30 years of development experience at Lilly, Genentech and Valentis. Chief executive officer of two start-ups, Saegis and Nuon.
• Mark Staples – 27 years of experience with early and mid-stage companies. Contributed to the launch of three products, both biologic and small molecule.

According to a Patheon statement, “All professionals are equipped to serve as a critical advisor or hands-on partner to organizations of any size as they make their critical decisions to transition molecules from discovery to development and scale-up.” The company stressed that these consultants will offer “world-class independent advice.”