Administrative
Peter K. Miller – Chief Executive Officer, Board of Directors
Peter became involved with OptiNose after accepting a request to join the Company’s Board in 2008. While serving in this role he became familiar with OptiNose’s unique drug delivery technology and was convinced of the significant potential of the product. In 2009 Mr. Miller, in coordination with the original founders, led a significant capital raise allowing OptiNose to move forward with clinical trials and the commercialization process. In 2010 he also accepted the role of CEO. Since then, Mr. Miller has overseen the relocation of the Company’s headquarters from Oslo, Norway, to Yardley, PA, and the expansion of the OptiNose team. He also remains a member of the Company’s Board of Directors.
Mr. Miller was previously the Co-Founder, CEO and President of Take Care Health Systems a company which revolutionized healthcare by operating medical clinics inside Walgreen’s retail pharmacies. Along with co-founder Hal Rosenbluth, Peter helped create an industry which is seen as transformational innovation that is disrupting the U.S. Healthcare system. Peter, with co-founder, conceptualized the idea, hired a world-class management team, raised over $90 million in private equity/venture and sold their company to Walgreens in less than 4 years. Mr. Miller served as a vice president in the Walgreens Health and Wellness Division and remained CEO for Take Care Health Systems for 3 years after the sale to Walgreens and grew the clinic operation to over 400 clinics nationwide.
Prior to founding Take Care Health Systems, Mr. Miller worked for health care industry leader Johnson & Johnson. Mr. Miller served in a variety of marketing and general management roles and was Worldwide President of Johnson & Johnson - Merck Consumer Pharmaceuticals, a $500 million dollar consumer pharmaceutical company and President of Janssen Pharmaceutica a $4 billion dollar pharmaceutical company. During his 15 year career with Johnson & Johnson, Mr. Miller also played an integral role in building multimillion and multibillion-dollar brands such as Tylenol, Motrin, Imodium, Pepcid, Duragesic, Risperdal and Aciphex.
Mr. Miller earned an economics degree from Trinity College and an M.B.A. from the Kellogg School of Management at Northwestern University.
Ramy A. Mahmoud, M.D., MPH – Chief Operating Officer
Dr. Mahmoud joined OptiNose in 2010, assuming a leading role in starting the new U.S.-based organization. He is responsible for all the operations of the company, including setting corporate strategies, medical device development, manufacturing and supply chain, clinical research, finance, staffing and human resource system development.
Dr. Mahmoud came to OptiNose from Johnson & Johnson, where he was Chief Medical Officer, Worldwide Vice President of Evidence-based Medicine, and a member of the Global Management Board of Ethicon, a multibillion dollar multinational Johnson & Johnson company. During 14 years with Johnson & Johnson, Ramy spent 3 years in senior management in the Medical Devices & Diagnostics sector, and 11 years in the Pharmaceutical Sector. In addition to management board responsibilities at several global and U.S. operating companies, he provided direct functional leadership for a wide range of functions in both R&D and Commercial organizations, including Pre-Clinical Research, Clinical Development, Medical Affairs, Medical Information, Scientific Liaisons, Clinical Operations, Outcomes Research, and Health Economics & Reimbursement. Dr. Mahmoud also made key contributions in many other areas, including business development, strategic sales force planning, government affairs, and strategic marketing. Ramy participated in the early or late development and/or launch of dozens of pharmaceutical and medical device products spanning multiple therapeutic categories, including blockbusters such as RISPERDAL, DURAGESIC, and CONCERTA.
Earlier in his career, Dr. Mahmoud served as an officer in the United States Army, earning the rank of Lieutenant Colonel. During this time, including 10 years on active duty and an additional 10 years in the Army Reserves, he assumed diverse military roles including battalion surgeon and flight surgeon, and was awarded a number of commendations and decorations. His government service also encompassed various academic, patient care, and research positions, culminating as head of the Department of Epidemiology at the Walter Reed Army Institute of Research and inaugural leader of a policy research and analysis activity in support of the Assistant Secretary of Defense (Health Affairs). During this tenure he worked in both developing and developed countries, and collaborated with a wide range of public health officials.
In addition to his achievements in government and business, Dr. Mahmoud is also an accomplished international scientist and researcher, having published more than 50 peer-reviewed papers and textbook chapters, including in journals such as the New England Journal of Medicine and Annals of Internal Medicine, lecturing frequently and having mentored many graduate students and other trainees. He has also served as a scientific reviewer for journals and textbooks in his diverse areas of research expertise, including the Journal of the American Medical Association, Medical Decision Making, American Journal of Psychiatry, Biological Psychiatry, Federal Practitioner, Journal of Tropical Medicine & Hygiene, Textbook of Military Medicine (editor: Kelley), Infectious Disease (editor: Mandell), and others.
Ramy is a highly accomplished physician and organizational leader, holding a Masters in Healthcare Management & Policy from the Harvard School of Public Health and an M.D. from the first Honors Program in Medical Education at the University of Miami. Dr. Mahmoud earned board certification in both Public Health/Preventive Medicine and in Internal Medicine. He has contributed in multiple national organizations, including the examination subcommittee of the American Board of Preventive Medicine; the National Quality Forum Measure Prioritization Advisory Committee; the Advanced Medical Technology Association (AdvaMed) Chief Medical Officers’ Forum; the American College of Preventive Medicine executive committee and GME and bioterrorism and disaster preparedness committees; as President of the Association of Preventive Medicine Residents; RPS member of the Association of American Medical Colleges (nominee of ATPM); the Pharmaceutical Research and Manufacturer's Association (PhRMA) "Working Group on Outcomes Research"; the American College of Neuropsychopharmacology working group on methodologic standards for evaluation and publication of pharmacoeconomic research; as a Senior Scholar in the Department of Health Policy at Thomas Jefferson University; and many others.
Michelle Janis – Vice President, Finance
Michele joined Optinose in 2011 and is responsible for managing all accounting and finance activities within the Company. Michele brings over 15 years of accounting and financial management expertise from a variety of roles in both development stage companies, as well as, publicly traded organizations with international operations. Prior to joining Optinose, Michele served as the Director of Business Analysis and Planning at Take Care Health Systems, a Walgreens Company, where she was responsible for leading financial and business analytics for strategic initiatives, including the budgeting and forecasting process for over 350 retail health clinics located within select Walgreens stores.
Prior to joining Take Care Health Systems, Michele simultaneously served as CFO/Controller to several pharmaceutical and technology-based early stage companies prior to joining The National Digital Medical Archive, which specialized in medical imaging storage and analytics technology.
Earlier in her career, Michele also served as the CFO for Creative Labs' OEM division, a worldwide leader in products for the personal computer industry, where she oversaw the accounting and financial operations of a $300 million dollar division, encompassing manufacturing, distribution and sales, as well as, Corporate Controller for Atlantic Dairy Cooperative, a $600 million dollar milk distributor and dairy products manufacturer, which subsequently merged with Land O' Lakes.
Michele earned a Bachelor of Science in Accounting from West Chester University and an MBA in Finance from La Salle University.
Tammy R. McCauley – Chief Administrative Officer
Tammy joined OptiNose in 2010 and is responsible for managing logistical operations for the Yardley location. Tammy comes to OptiNose from Take Care Health Systems, where she worked with OptiNose CEO Peter Miller. At Take Care Health Systems, Tammy coordinated and managed all aspects of the CEO’s and COO’s daily schedules. She served as project manager for major office space expansion projects at the location. Tammy has extensive account executive and administrative professional experience within the health care industry. Tammy also worked as a consultant for clients such as Johnson & Johnson and Synergy Healthcare Communications, among others.
Tammy earned a Bachelor of Arts Administration from Cabrini College in Radnor, Pennsylvania.
Anniken Monsøy – Office Manager
Anniken joined OptiNose in 2004 and is responsible for managing logistical and administrative operations for the Oslo location.
Anniken comes to OptiNose from Cerealia AS, where she coordinated and managed all aspects of the cantina facilities and call center. She served as the PA to the CEO and the Assistant Director and was responsible for the internal information and newsletter. Anniken has extensive experience in sales and administration within different branches.
Anniken earned a Master of Arts from Østfold College in Halden, Østfold.
Elisabeth Nuttall – Office Manager
Elisabeth Nuttall is the Office Manager for OptiNose. She joined the company in 2005 and is responsible for the daily management of the office and administration, including human resources, pensions and personnel matters.
Elisabeth has 20 years of legal secretarial and personal assistant experience, including paralegal work and research and information. Prior to joining OptiNose, Elisabeth worked at Dechert Law Firm in London. She was the secretary to the senior partner within the Corporate and Securities Department, including mergers and acquisitions, joint ventures and private equity. Elisabeth has also previously worked at Beall Chaplin & Hathorn Attorneys, Bell Dewar & Hall Attorney, Joel Melamed & Hurwitz and Moodie & Robertson Attorneys.
Commercial & Business Development
Frank A. Closurdo – Chief Marketing Officer
Frank joined OptiNose in 2010 and is accountable for leading all commercialization efforts for OptiNose’s products, driving the overall corporate and branding strategy for the company, and managing OptiNose’s communications strategy.
Prior to joining the OptiNose team, Frank served as Executive Director, Commercial Development, at Pfizer, where he led the market development strategies and drove several commercialization initiatives for the launch of the global Alzheimer’s disease franchise. Before the merger of Pfizer and Wyeth Pharmaceuticals, he held the position of Executive Director, Strategy Development - Insight Partner, at Wyeth, where he led the development strategies for the Neuroscience portfolio including positioning for the potential Alzheimer’s blockbuster, bapineuzumab.
Frank spent the majority of his career at healthcare leader Johnson & Johnson (J&J) and its affiliate companies. During his 15 years with J&J, he progressed through a variety of diverse roles of increasing accountability in marketing, sales, and communications, receiving multiple internal awards and recognitions for performance excellence. He eventually rose to the position of Director, Strategic Marketing and Planning, where he led the development of a global strategic foundation and infrastructure for Marketing Excellence within the pharmaceutical and medical device sectors of Johnson & Johnson. During his tenure at J&J, Frank worked on multi-million dollar and multi-billion dollar brands including TYLENOL, MOTRIN, REMICADE, CYPHER Stent and DePuy Orthopedics.
Frank earned a Bachelor of Arts in Business Administration from Wayne State University, Detroit, Michigan.
Helena Kyttari Djupesland – Vice President of Business Development, Founder
Helena served as OptiNose’s CEO from 2000-2010, when current CEO Peter Miller joined the company. Helena is in charge of business development & licensing, partnerships, strategic alliances, and strategic collaborations. In her role as CEO, Helena raised funds (total 22 million Euros) and negotiated venture capital deals from 2001 until 2005. She also led recruiting efforts and was in charge of managing clinical development for Phase II studies.
Prior to OptiNose, Helena spent five years at Kvaerner Energy, Thermal Power (acquired by GE Company) where she was Vice President Operations responsible for delivering turnkey power plants with a turnover of more than $ 500 million. In this role Helena was leading the Project Management, Engineering, Procurement and Manufacturing. She was previously contracts manager approving and negotiating commercial terms of sales deals and negotiating and settling contractual disputes with clients and partners. She also spent nine years at Storebrand International Reinsurance, the largest Norwegian insurance company, gaining extensive experience in international business, risk evaluations, and negotiating and closing deals.
Helena graduated from the Law School at the University of Athens. She also earned a Master’s Degree in Administrative Science from the University of Paris II and a Master of Business Administration from the Norwegian School of Management. She speaks fluently four languages.
John L. Pickering – Director of Business Development
John joined the company in 2010 and is responsible for helping to develop key areas of OptiNose’s strategy and business. This includes product commercialization in the United States and globally, determining product pipeline opportunities for internal development or external partnering, and isolating other companies with proprietary molecules that would benefit from the OptiNose drug delivery technology.
John has 25 years of experience in both large and emerging pharmaceutical companies, healthcare technology, medical diagnostics and pharmaceutical marketing services. He also brings extensive commercial experience including business development, managed care, institutional, long-term care field sales management and field sales.
Prior to joining the OptiNose team, John served as Director of Business Development at Quintiles where he was responsible for developing strategic business relationships with key stakeholders in the pharmaceutical and biotechnology industries. John focused on commercial service offerings at Quintiles that primarily included contract sales and health management solutions.
Before joining Quintiles, John worked for TMS Health, Ortho Biotech, Boston Medical Technologies, ParkStone Medical Information Systems and Glaxo Wellcome, Inc.
John earned a Bachelor of Arts in Business Administration from Rutgers University.
Medical & Clinical Development
Per G. Djupesland, M.D., Ph.D. – Chief Scientific Officer, Founder
Per G Djupesland, MD, Ph.D. is the inventor of the patented, bi-directional nasal drug delivery technology and the main Founder of OptiNose. He has been Chief Scientific Officer (CSO) of OptiNose since 2000 and is in charge of the research activities at OptiNose, as well as, ongoing clinical studies designed to demonstrate the broad advantage of the bi-directional delivery system, including the recently completed Phase II studies in nasal polyposis, migraine and chronic rhinosinusitus.
Per is an Otorhinolaryngologist (ORL) with a specialization in rhinology and has a Ph.D. in the field of nasal physiology and aerodynamics from the University of Oslo. He is world renowned expert, with over 25 years of clinical experience also spanning ORL, infectious diseases, epidemiology and surgery. He has been Clinical Research Fellow at the Hospital for Sick Children and Toronto General in Toronto, Canada, primarily studying the role of Nitric Oxide in the upper airways. His Ph.D. is focused on nasal physiology and aerodynamics in infants.
Per is the author of over 80 articles in international medical journals, has lectured at numerous conferences and has filed 35 patent families/patent applications. He holds a MD from University of Oslo 1982, Diplom d´Úniversite´ (Master) from Paris, France and a Ph.D. from the University of Oslo.
John Messina – Vice President of Clinical Development
John Messina is the Vice President of Clinical Development for OptiNose. He joined the company in 2010. John leads the clinical teams in the development and implementation of all clinical programs, as well as for regulatory submissions and interactions with regulatory agencies.
Prior to joining OptiNose, John served as Vice President of Clinical Operations and Strategic Planning at at Cephalon, Inc where he was a leader in the development, planning and execution of all company clinical programs, which included oncology, CNS, pain and respiratory therapeutic areas. While at Cephalon he also led the clinical development programs for analgesic products through NDA submissions and product launch. Additionally, John has worked at Purdue Pharma L.P., Novartis Pharmaceuticals Corp. and Sandoz Pharmaceutical Corp. He has conducted clinical trials in all phases of development. Throughout his career John has served as a clinical lead for multiple NDA submissions and product launches and he has published extensively within the fields of analgesia and CNS clinical research.
John earned a Doctor of Pharmacy Degree from Purdue University in West Lafayette, Indiana. He also completed an Industrial Clinical Pharmacy Fellowship at Rutgers University in New Brunswick, New Jersey.
Jennifer Carothers – Senior Director of Clinical Development
Jennifer Carothers is a Senior Director of Clinical Development at OptiNose. She joined the company in 2010. Jennifer is responsible for the operational oversight of the Phase III clinical development program for OptiNose’s drug delivery devices.
Prior to joining OptiNose, Jennifer worked for Johnson & Johnson where she served in a variety of roles in the clinical research and benefit risk management. While at JJPRD/Global Clinical Operations she was a member of the Phase I Leadership team, accountable for strategic planning and successful execution of large and small molecule FIH and late development Phase I global programs for Oncology, Immunology, and Metabolic. While at Janssen and Ortho McNeil Janssen Scientific Affairs, Jennifer managed a successful global registration program from clinical development to e-submission for a new indication in psychiatry. Jennifer has extensive experience in the conduct of Phase 1-4 trials and has co-authored numerous articles in the area of psychiatry.
Additionally, Jennifer has worked at Mitsubishi Pharma America, Innovative Clinical Solutions, TD., and the University of Pittsburgh’s Epidemiology Department.
Jennifer earned a Bachelor of Science in Biology and a Master of Business Administration.
She also holds a Doctorate of Science in Communication and Information Systems from Robert Morris University.
Colette Kosik-Gonzalez – Senior Director of Clinical Development
Colette Kosik-Gonzalez is a Senior Director of Clinical Development at OptiNose. She joined the company in 2010. Colette is responsible for the operational oversight of the Phase III clinical development program for OptiNose’s drug delivery device.
Prior to joining OptiNose, Colette served as Director, Clinical Project Scientist at Johnson & Johnson’s Ortho-McNeil Janssen Scientific Affairs. In that role, Colette was responsible for the operational oversight of all clinical trial conduct, outcomes research programs and other program activities across the CNS product portfolio. During her 8 year career at Johnson & Johnson, Colette conducted and supervised global clinical trials, led innovative EDC solutions initiatives, and developed and implemented cross functional project teams. During her 15 year research career, Colette worked in industry pharmaceutical and academic settings and has experience in psychiatric scale development and validation. Colette has extensive experience in the conduct of Phase 3, 3B and 4 trials and has co-authored numerous articles in the area of psychiatry.
Colette earned a Bachelor of Science in Psychology and a Master of Arts in Psychology from the State University of New York at New Paltz.
Regulatory & Quality
Peter Fernandes, M. Pharm., Vice President, Regulatory Affairs and Quality
Peter joined the company in 2011 and is responsible for the US and global regulatory strategy development, and regulatory filing for our unique range of bi-directional nasal drug-delivery products. In addition he will also support the setting up and monitoring of the quality systems and pharmacovigilance functions within the organization.
Peter has 22 years of US and global pharmaceutical development experience. He has served in several senior leadership positions, as Head of the US Development Site at Nycomed, Vice President of Regulatory Affairs and Quality Assurance at Altana Pharma and Vice President of Regulatory Affairs at Novartis. In addition, he has had extensive hands on regulatory and project leadership experience at Boehringer Ingelheim, Scios-Nova and Wyeth-Ayerst.
Peter has a proven track record with successfully leading cross-functional teams resulting in US and global approvals of products that are now well-recognized blockbusters. His first success at Boehringer Ingelheim (BI) was with FLOMAX, leading the NDA filing, one cycle approval and trade name negotiations with the US FDA in 1996. His 12 years of dedicated regulatory support for SPIRIVA HandiHaler, starting from its pre-IND phase in 1993 to its global NDA filings resulting in approvals in US, EU, Japan and 40 other countries by 2005. For this, he received three prestigious BI President’s Awards for his exemplary leadership.
In 2005, as part of the Altana Pharma team, Peter completed the company’s first eCTD for OMNARIS in allergic rhinitis resulting in a one cycle FDA approval in 2006. Peter was instrumental in re-designing the regulatory strategy of a previously failed Phase III program for DAXAS in COPD. This re-designed Phase III program finally resulted in the EU approval in 2010 and US FDA approval in 2011. Peter has had accountability for a diverse spectrum of products -- biologics, small molecules and drug-device combinations -- across a wide-range of therapeutic areas -- respiratory, cardiovascular, urology, gastrointestinal and oncology. He has led four FDA Advisory Committee Meetings (ACM) and delivered the opening regulatory presentations at two of these meetings. Peter has established an efficient working relationship with the FDA Staff at both the Division and Office levels.
Peter holds a Masters in Pharmacy and Clinical Pharmacology from the Grant Medical College, University of Bombay.
Tony Flint – Head of Regulatory and Quality Assurance
Tony has been with the company since 2005. Tony is responsible for ensuring OptiNose’s products are in compliance with the U.S. Food and Drug Administration (FDA) and European regulatory requirements.
Tony has 23 years of experience in the medical device and pharmaceutical industry, including experience in research and development, manufacturing, clinical and regulatory affairs, and quality assurance. He is also a qualified engineer and auditor.
Previously, Tony worked in regulatory affairs for Thermocore Medical Ltd. where he was responsible for managing the subcontract manufacturing of the company’s cardiovascular catheter products, European and United States clinic and regulatory activities, quality assurance, pre-clinical investigations and strategic reimbursement.
Tony earned a Bachelor of Science in Electronic Engineering from Bangor University of North Wales. He also earned a Ph.D. from Cardiff University in Dynamic Analysis of Cortical Bone.
Supply Chain & Device Development
Robert Useller – Vice President, Manufacturing and Supply Chain
Bob joined the company in 2010 and is responsible for third party supplier selection/contract development, material procurement, commercial manufacturing, logistics, inventory management and the distribution of Optinose products.
Previously, Bob served as the Vice President of Supply Chain Management at Aton Pharma, Inc., where he was responsible for the identification, selection and management of a number of contract manufacturers and third party service providers. Prior to that position, Bob spent more than 30 years at Johnson & Johnson where he held leadership positions in logistics, package development, procurement and manufacturing. During his tenure, Bob gained expertise in multi-site operations assessment, new plant start-ups, global process excellence initiatives, performance metrics development and leadership training and development.
Bob earned a Bachelor of Arts in Biology from LaSalle University in Philadelphia.
Colin Sheldrake – Head of Device Development
Colin has been at the company since 2004. Colin is responsible for the design, development and manufacturing scale-up of OptiNose’s nasal delivery devices. Additionally, Colin chairs OptiNose’s patent committee to ensure the intellectual property portfolio and patent filing is in line with the business need.
Previously, Colin worked in design and development for Chiron Vaccines, PowderJect Pharmaceuticals, Rolls-Royce and Lexcel Technology. He has made numerous inventions in the field of delivery devices and holds several patents.
Colin has a Bachelor of Engineering and a D. Phil. in gas turbine aerodynamics from Oxford University.