ADAM AMDUR was first diagnosed with severe obstructive sleep apnea (OSA) in 2008, more than thirty years after he first showed symptoms. As he struggled to learn how to manage this chronic illness, he was able to successfully identify the early symptoms and seek treatment for his then two-year-old daughter. In 2012 Amdur first joined the only existing national patient advocacy association, the American Sleep Apnea Association (ASAA), to learn everything he could to help himself and his daughter. Eventually he took the lead in the association’s evolution from a twenty-five-year-old physician-run organization into an entrepreneurial patient-driven, public-health advocacy association. The ASAA launched a new crowd-sourcing campaign, #Sleeptember.Org, in Fall 2015, which tackles long-term recruiting, retention, and sustainability efforts for patient-powered research activities utilizing all relevant channels of social media and technology.

Amdur was the first Patient Principal Investigator and co-founder of the Sleep Apnea Patient-Centered Outcomes Network (SAPCON), funded as part of the Affordable Care Act’s national Patient Centered Outcomes Research Network PCORnet. He worked to bring together patient leaders from each patient-powered research network (PPRN) and clinical data research network (CDRN) at a special patient retreat in order to discover a common patient voice as it relates to research best practices and collaboration with diverse stakeholders. He is also participating on the Clinical Trials Translation Institute (CTTI) issues surrounding the use of mobile devices in clinical trials. CTTI is the non-profit arm of the FDA.

Amdur is also one of the founding investigators of the SleepHealth Apple ResearchKit Mobile Study powered by IBM Watson HealthCloud and a co-investigator on the O2VERLAP Study with COPD Foundation and the American Sleep Apnea Association funded by the PCORnet PPRN Demo award.

Amdur has given presentations at both community and professional conferences as a patient advocate including the National Institutes of Health’s Workshop of the Precision Medicine Initiative. Most recently, he participated in the Everyone Included White House Medx meeting and appeared in many print and live news interviews presenting the patient’s perspective on research and advocacy.

Adam is also currently writing a dynamic and interactive memoir, Asleep at the Wheel: Living with Sleep Apnea, in hopes of putting a face to this disease to better educate the public about its cause and treatment and promote research in collaboration with www.MetroDigi.com

Linda currently serves as PCOA Lead working across Pfizer’s therapeutic categories addressing efforts to develop, validate and use clinical outcomes assessments (COAs) as endpoints for providing evidence of medical treatment benefit, product differentiation, labeling and value. Linda has served patients and the pharmaceutical industry for the past 20 years in similar roles at Wyeth, Janssen, Shire and Pfizer. Linda has developed and/or validated dozens of COAs across multiple therapeutic categories including Rare Disease, Neuroscience, Gastroenterology, Pulmonology, Dermatology, Rheumatology and Women’s Health. Linda is trained as a statistician (North Carolina State University).

Victoria (Vicky) DiBiaso, is the Global Head of Clinical Operations Strategy & Collaboration within Sanofi’s R&D; organization.

In her position, she manages an international team accountable for Sanofi’s development stage portfolio overseeing protocol optimization, global trial feasibility, competitive intelligence, the global investigator network and patient partnerships supporting an informed R&D; model.

She and her team are responsible for ensuring collaborations with patient groups, as well as clinical trial physicians and coordinators, for protocol design considerations and robust patient community engagement strategies. She also has a large focus on clinical trial innovation ranging from technology to competitive intelligence to adequately inform decisions and patient facing activities. Their primary mandate is to optimize clinical trials from all aspects related to patients and investigator sites so that meaningful medications can come to market sooner.

Vicky has over 20 years of global experience ranging from phase I-IV drug development in rare disease biotech and multi-therapeutic specialty large pharma. She’s worked across multiple platforms such as devices, small molecules, biologics and gene-therapies.

Vicky is a frequent speaker at international industry conferences and is repeatedly quoted in industry publications related to clinical trial innovation and patient collaboration. In 2013 she was listed as one of CenterWatch’s Top 20 Innovators changing the face of clinical trials. In 2014, she was featured in the Wall Street Journal and has guest lectured on the role of patient, investigator and industry collaborations. She is a volunteer for the Michael J Fox Foundation for regional public engagement, a Research Ambassador and Team Fox co-captain. She also is a volunteer advisor for the Critical Path Institute (Parkinson’s).

Vicky holds a Master’s in Public Health and a Bachelor of Science in Nursing.

Jennifer Dudinak, Pharm D is Vice President Global Regulatory Affairs Oncology and Head, Pharma Regulatory Therapeutic Teams at GlaxoSmithKline. Her primary strategic focus is to lead global regulatory therapeutic teams across the R & D portfolio and Franchises to deliver innovative global regulatory strategies and drive development and implementation of policies and strategies for optimization of drug development. Jennifer has worked across all phases of drug development, including small molecules and biologics, for over 20 years. She has held multiple senior leadership roles in regulatory across a variety of disease areas (e.g. oncology, virology, immuno-inflammation, ophthalmology) with an emphasis on precision medicine and development of novel approaches to advance regulatory pathways. Jennifer has overseen numerous global regulatory filings and approvals in her career, including NCEs, combination therapies and medicines with a companion diagnostics. Jennifer received a Bachelor of Pharmacy and Doctorate of Pharmacy from Rutgers University. Jennifer joined GSK from Roche/Genentech where she served for over 15 years. Prior to that, Jennifer practiced in community, retail and hospital pharmacy as well as a founding member of Heart to Hearts, a non-profit women’s wellness organization with the aim to empower women through education.

EMMANUEL FOMBU MD, MBA is a physician, entrepreneur, medical futurist, patient advocate, author, speaker and innovative healthcare executive with vast experience in venture capital, private equity, medical affairs and clinical development in the pharmaceutical, device, imaging and molecular diagnostics industries as well as bringing quality experience to healthcare delivery. He is an adamant advocate for value-based healthcare and a leader in the design and execution of clinical trials using innovative digital technology to evaluate complementary health approaches and their integration into real world health care. He is also passionate about patient education, mhealth, real world evidence generation, personalized medicine, genomics, nanotechnology, big data, artificial intelligence, machine learning, internet of things, blockchain technology and digital medicine. Dr Fombu is also an external advisory board member on nanotechnology at the Massachusetts Institute of Technology’s MIT.nano project.

Dr Fombu did his clinical training at Emory-Crawford Long Hospital and holds an MBA from both the Cornell SC Johnson College of Business in Ithaca, NY and Smith School of Business at Queens University in Ontario, Canada. He lives in New York City.

Jessica Grossman, MD is the CEO of Medicines360. She has been a board member of Medicines360 since 2011. Dr. Grossman is a seasoned industry executive with a proven track record leading successful women’s health companies.

As a medical technology executive, she brings a wealth of experience in product development and commercialization and the ability to accelerate profitable business models.

Prior to joining Medicines360, Dr. Grossman served as president and founding CEO of Sense4Baby, Inc., where she closed a $4-million series A investment and within 18 months of joining the organization, led the company to a successful acquisition following FDA clearance, CE mark, and early commercialization.

Dr. Grossman was also Founder and President of Gynesonics, an early stage medical device company focused on minimally invasive solutions for women’s health, where she raised over $22 million in venture capital financing. Under her leadership, she invented and developed the first intrauterine ultrasound guided radiofrequency ablation device for fibroid tumors.

She has also been a Medical Director at Ethicon Endo-Surgery, part of the Johnson and Johnson family of companies. Dr. Grossman holds numerous patents and has published several peer reviewed articles. She has performed research at the Beth Israel Deaconess Medical Center, one of the teaching hospitals of Harvard Medical School.

Dr. Grossman earned her MD at Thomas Jefferson University and her undergraduate degree with honors from Brandeis University.

Usman Iqbal is a Senior Director, Medical Affairs & HEOR at Trevena, Inc. Usman has 12+ years of diverse experience spanning clinical medicine, R&D;/Med AFF, Health economics & outcomes research across academia and biopharmaceutical. His experience spans number of different therapeutic areas including Neuroscience, as Senior Medical Affairs Leader at AstraZeneca, and Oncology, as former Head of Sanofi Oncology, Global Evidence & Value Development (GEVD). As part of both R&D; and Med Affairs in different bridging roles, Usman has had been responsible for Portfolio Prioritizations, Patient centric trial designs, Integrated Medical Affairs Planning, and end-to-end Evidence generation based on Multidisciplinary Stakeholder engagement (Patient, Provider, Payer), Market insights and Relative Medical Value Assessment Platforms. Prior to working in the industry that also includes Amgen and Boehringer Ingelheim, Usman was at the Boston University Health Outcomes Technology Group as a senior research fellow and served as a research consultant for Veterans Affairs Pharmacy Benefit Management (VA-PBM), the Centers for Medicare &, Medicaid Services’ Health Outcomes Survey Initiative (CMS-HOS), the Agency for Healthcare Research and Quality (AHRQ), and the National Committee for Quality Assurance (NCQA). Usman has authored more than 50 publications and his research experience encompasses patient & physician evaluations in BIG Data and large integrated health care systems with a specific focus on comparative effectiveness, patient centered outcomes, physician profiling, and patient access solutions. Usman received his MD from Allama Iqbal Medical College, Lahore, Pakistan and Master of Public Health and Master of Business Administration from Boston University.

Helen has more than 15 years’ experience in in the Pharmaceutical industry, working for several companies and academic institutions in both the UK and the US. Helen joined Bristol-Myers Squibb almost five years ago, and transitioned her career from a director in public affairs and corporate communications to advocacy relations and patient engagement. Currently, Helen leads advocacy, diversity and patient engagement strategy for Bristol-Myers autoimmune and oncology portfolio in R&D.; Helen interacts with a broad variety of patient facing organizations and groups to identify collaboration opportunities in order to better understand and incorporate patient, caregiver and advocacy perspectives in clinical studies.

Helen completed his undergraduate studies at the University of Southampton, U.K., and received her Ph.D. from the University of Cambridge, U.K., studying the molecular genetics of Multiple Sclerosis in the Department of Medicine.

Jake LaPorte is Head of Digital Development at Novartis and responsible for leading the company’s digital efforts within their Global Drug Development organization. Jake began his career at McKinsey & Company, where he was a leader in their Pharmaceutical R&D; practice, during his six-year tenure, developing an expertise in large, complex transformations and innovation. It was on a fateful, extended journey in Asia-Pacific, however, where Jake read Ray Kurzweil’s The Singulatiry is Near and became captivated by the possibility of digitizing the Pharmaceutical R&D; engine – he has focused his career on the realization of this concept ever since. Subsequently, he co-founded Snapdragon Chemistry, with the Head of the Chemistry Department at MIT, which seeks to enable companies to implement continuous flow chemistry in discovery, development and manufacturing, with the ultimate goal of fully digitizing chemical synthesis. Snapdragon Chemistry was recently recognized by Launch.org as a top 5 innovator in Chemistry and was joined by multi-billion dollar companies such as Dow Chemicals and Wiley Sciences. Prior to joining Novartis, Jake held various leadership positions at PPD, Inc, where he collaborated with executives to develop and implement C-level, strategic initiatives, including a long-term transformation to create industry-leading approaches to clinical development in key therapeutic areas.

Jake completed his PhD in Organic Chemistry from Harvard University, where he was an HHMI doctoral fellow, and received his BSc in Biochemistry and Mathematics, summa cum laude, from the University of Delaware.

Sara Latham is the Chief Operating Officer and Executive Vice President of Global Strategy at the COPD Foundation, a nonprofit organization dedicated to improving the quality of life for those affected by chronic obstructive pulmonary disease (COPD), a progressive lung disease affecting more than 30 million Americans.

In addition to overseeing the Foundation’s care delivery, education, communications and community outreach departments, Ms. Latham spearheaded the strategic development and launch of COPD360social, a digital collaboration platform, uniting patients, family members, caregivers and medical professionals in the form of a novel online social community composed of 32,000 members in over 120 countries. Ms. Latham is also responsible for COPD Global, the Foundation’s newest initiative seeking to unite global advocacy organizations in a common mission of raising awareness of chronic obstructive pulmonary disease worldwide.

Prior to joining the COPD Foundation, Ms. Latham worked in various positions in the healthcare, nonprofit and technology sectors for international global communications firms.

Ms. Latham earned a Bachelor of Arts in Art History and European History from the University of Pennsylvania and pursued advanced graduate study at the Johns Hopkins School of Medicine.

Meghan McKenzie is an Associate Director, Sr. Clinical Program Leader in Genentech’s Research and Early Development (gRED). In Clinical operations, she manages complex programs in neurology, ophthalmology, oncology, rheumatology and immunology and is leading gRED’s Patient Centricity team and the work-life integration team. gRED’s Patient Centricity vision is to empower Early Clinical Development to obtain and amplify the patient voice to improve development planning, trial design, and trial execution.

Meghan has worked across all phases of drug development for over 20 years in clinical operations, data management and as a site study coordinator.

Meghan received her Bachelor’s in Economics at UNC- Chapel Hill and her Master’s in Biology: Human Physiology at San Francisco State University. Before joining Genentech in 2005, Meghan held various positions at a CRO, a research site, at NASA in their Human Research Center as well as at nonprofit think tanks in Washington, D.C.

She and her husband (a veterinarian) have two dogs, a snake, and they enjoy music and extensive travel with their 17-year old daughter, when they can get her attention.