After Ocular Therapeutix‘s (NSDQ:OCUL) founder & CEO, Amar Swahney, stepped down earlier this year, pharma executive Antony Mattessich stepped in to assume the corner office. He signaled some major changes to the company’s business strategy in a call with analysts last month, including an attempt to ‘aggressively seek new partnerships’ and ‘enhance [the company’s] credibility’.
As Ocular recalibrates following its personnel shakeup and a second rejection from the FDA for its hydrogel plug, Dextenza, it has also tapped Dr. Michael Goldstein as chief medical officer.
“We are pleased to further strengthen our executive leadership team with the appointment of Mike as our chief medical officer,” Mattessich said in prepared remarks. “Mike brings a deep expertise in both biopharmaceuticals and ophthalmology, and possesses the vision and clinical leadership skills required to realize the Ocular’s full potential. His experience will be critical as we prepare to initiate multiple clinical trials, including our second Phase 3 trial with OTX-TP for the treatment of glaucoma and hypertension, our pilot human clinical trial with OTX-TIC for the treatment of glaucoma and hypertension, and our Phase 1 clinical trial with OTX-TKI for the treatment of serious retinal diseases.”
Prior to his role at Ocular, Goldstein served as CMO of Applied Genetic Technologies Corp., and CMO & VP of clinical research at Eleven Biotherapeutics.
“I believe Ocular’s hydrogel technology platform offers tremendous potential to improve patient and physician outcomes across a wide range of diseases and conditions,” Goldstein added. “I look forward to applying my expertise and working with the team to help ensure the strategic advancement of Ocular’s diverse portfolio of clinical-stage development programs.”
Lyndra preps for clinical development with new hires
Lyndra last month hired Dr. Kelly Lindert to serve as SVP of clinical development & strategy and Jacqueline Schumacher as VP of regulatory.
“As Lyndra prepares to transition into a clinical stage development company, we are focused on improving patient health outcomes through improved adherence and sustained, steady state pharmacokinetic profiles. Our unique method of sustained local gastrointestinal delivery is a game changer for patients and caregivers,” Lyndra chief scientific officer & co-founder Andrew Bellinger said in prepared remarks. “Kelly and Jackie are joining Lyndra’s leadership team at an important time for the company as we move into our first clinical trials. With substantial expertise in clinical and regulatory development, we expect both will help us execute on our ambitious clinical development goals for 2017.”
“I am elated to join this team at such an exciting time,” Lindert added. “I’m impressed how Lyndra as a new startup has moved quickly through preclinical to preparing to initiate first-in-human clinical studies in just a little over two years. I am honored to lead our Clinical Development efforts, and I look forward to accelerating our ability to execute as a clinical stage company.”
“I am thrilled to be a part of this team as it enters a new chapter in Lyndra’s history,” Schumacher said. “I believe there is enormous potential to partner with worldwide regulatory agencies to deliver meaningful, differentiated products to patients, and I look forward to what we can accomplish together.”
Former U.S. surgeon general joins Proteus Digital Health’s board
The 18th U.S. surgeon general, Dr. Regina Benjamin, has joined the board of directors of Proteus Digital Health, the company announced last month.
She served as ‘America’s Doctor’ from July 2009 to 2013 and is also the founder & CEO of BayouClinic in Alabama.
“I am honored and excited to join the board of Proteus Digital Health. As a nation, we are facing increasing challenges with chronic illnesses such as hypertension, diabetes, heart disease, hepatitis, behavioral health, and now opioid addiction. Digital Medicines can bring innovative and effective ways to treat these conditions that easily fit into the patient’s daily lifestyle. This will allow patients to have an active role in their own treatment,” Benjamin said in prepared remarks. “Digital Medicines have great promise for improving millions of people’s lives: I want to ensure they will also be available to our most vulnerable patients.”
Rebiotix names head of regulatory affairs
Rebiotix Inc., said last week that it appointed Edward Burd to head of regulatory affairs.
Previously, Burd has worked at the FDA’s Center for Biologics Evaluation and Research as a senior staff fellow. He has also served as global regulatory leader for Allergan in dermatology, facial aesthetics and neurology.
“The appointment of Dr. Burd as head of regulatory affairs is an important addition to Rebiotix’s leadership team as we continue to enhance our regulatory expertise and begin preparing for a potential BLA submission for RBX2660 following the recent initiation of our Phase III clinical trial,” president & CEO Lee Jones said in prepared remarks. “Dr. Burd possesses extensive knowledge of FDA and CBER processes, having worked both on the inside reviewing applications and at small and large biotech companies preparing application packages for review. His experience will be key as we advance RBX2660, and subsequently RBX7455, toward registration and potential approval.”
Mylan appoints chief HR officer
Mylan (NSDQ:MYL) this week named Dennis Zeleny as chief human relations officer.
Most recently he has served as SVP & chief HR officer at Sunoco. He has also worked as SVP of global HR at DuPont.
“Dennis has an extensive track record and passion for HR’s role as a strategic business partner in large organizations, especially ones with a unique growth story and global presence like Mylan,” CEO Heather Bresch said in prepared remarks. “Dennis is another example of our continued efforts to build out our already-strong executive leadership team with best-in-class experience and capabilities, and he will be instrumental in helping us achieve our mission and business goals and strengthening the passionate culture that has allowed Mylan to succeed for more than 55 years.”
“Mylan’s journey over the last decade into the global leader it is today has been remarkable, as has its unwavering focus on its mission of expanding access to high quality medicine,” Zeleny added. “The opportunity to lead HR in service of this unique organization and its workforce of 35,000 is exciting. I am honored to join Mylan’s strong and experienced leadership team as we navigate today’s dynamic healthcare environment in continued pursuit of our mission.”