In a special session held immediately after the close of the American Academy of Ophthalmology (AAO) Retina Subspecialty Day program, Susan Desmond-Hellmann, MD, MPH, president, product development, Genentech, implored the ophthalmology community to work in collaboration the company in the interest of achieving the common goal of better patient care.
In a special session held immediately after the close of the American Academy of Ophthalmology (AAO) Retina Subspecialty Day program, Susan Desmond-Hellmann, MD, MPH, president, product development, Genentech, implored the ophthalmology community to work in collaboration with the company in the interest of achieving the common goal of better patient care.
Speaking on behalf of the manufacturer regarding its decision to stop distribution of bevacizumab (Avastin) to compounding pharmacies, Dr. Desmond-Hellmann told attendees that in the short time she had to speak, she would not be making a corporate presentation defending the development of ranibizumab (Lucentis) or the recent actions relating to bevacizumab. She also expressed hope that ophthalmologists recognized recent efforts the company had made toward achieving a resolution as well as the challenges it faces operating in a highly regulated industry.
Dr. Desmond-Hellmann emphasized that the manufacturer will not interfere with the ophthalmologist's prescribing choice.
"However, we cannot jeopardize our commitment to tens of thousands of other patients who are counting on us to produce the medicines they need by risking FDA action against us," she said.
She also stressed that the manufacturer is willing to do everything possible to make sure patients have access to ranibizumab. To that end, the company is actively working to address existing concerns and aims to implement changes that will expedite patient access to treatment.
Dr. Desmond-Hellmann pointed out that the manufacturer is committed to addressing unmet therapeutic needs in ophthalmology, and she acknowledged the important role of ophthalmologists in the development of ranibizumab as a treatment for age-related macular degeneration (AMD) and its investigation in other indications. The premarketing program of ranibizumab for AMD together with its current active clinical development program, which includes ongoing phase III trials in diabetic macular edema and retinal vein occlusion as well as nearly 50 investigator-sponsored trials under review, underscore the progress and promise that are possible through cooperation, she said.
"There are thousands of patients who come to you desperate for their sight and you have nothing to help them. That will continue to be the case if we don't put our collective efforts together towards solutions," Dr. Desmond-Hellmann said.
She relayed that in 1995, the manufacturer was embroiled in a somewhat similar situation with oncologists regarding the development of trastuzumab (Herceptin) as an adjuvant treatment for a serious and deadly form of breast cancer. However, through the help and collaboration of leading oncologists and patient advocates, a resolution was achieved that led to that drug's approval and changed the prognosis of affected women in the future.
Reflecting on that history, Dr. Desmond-Hellmann ended by saying she hoped she might be invited back to the 2017 annual meeting of the AAO and be able to relate to the audience how the manufacturer and ophthalmologists made together the conscious decision to stop resisting one another and work together to achieve more than either could do alone.
"On behalf of Genentech, you have my commitment we will do everything possible to make this a reality," Dr. Desmond-Hellmann said.