Archives: Speakers

Melanie has worked in Quality since starting her career in 2007 and spent six years with a pre-clinical CRO before making a switch to software and the clinical trial industry. Started working for endpoint Clinical in 2013 and has worked with the Quality leadership team in building up the quality management system. She has helped endpoint establish a robust remote client audit and inspection support program that allows the company to respond to requests and questions efficiently and in a timely manner.

Puja is a senior manager within the Analytics and Modelling team in Deloitte LLP’s Audit and Assurance service line. She has over 10 years post qualification experience as a chartered accountant. She worked at as a statutory auditor for several years before focussing on helping audit teams with their analytics and the excel models they receive from the entities they audit and supports in the provision of assurance services. She is passionate about inclusion and diversity and co-chairs the firm’s Multicultural Network which has almost 2000 members.

Dr. Karin Hoelzer directs Policy and Regulatory Affairs for the National Organization for Rare Disorders (NORD®). In this role, Karin provides strategic direction to advance NORDs federal policy and regulatory priorities. She works closely with key rare disease partners across the pharmaceutical and biological space to ensure the policy landscape supports innovative approaches and new treatments to help rare disease patients, and adequately incorporates patient preferences and perspectives in therapy development. Her role also involves extensive legislative and communication engagements to advance rare disease policy priorities.

Dr. Hoelzer is a health policy, risk analysis, and biomedical research expert, with extensive intellectual property and regulatory expertise across most FDA-regulated products. Most recently, she worked at Maximus, Inc. where she established and led a new health data analytics division to provide more timely data and better insights to government clients in support of the public health response to the COVID-19 pandemic.

Prior to working at Maximus, Inc., Dr. Hoelzer served as Senior Officer for Health Programs at The Pew Charitable Trusts where she led policy and regulatory efforts to improve the federal oversight of a variety of FDA-regulated products. Dr. Hoelzer joined Pew from the Food and Drug Administration (FDA), where she served as Risk Analyst. In this role, she assessed and quantified the expected impact of changes to FDA policy and regulatory practice.

Prior to joining FDA in 2010, Dr. Hoelzer worked as Biomedical Researcher for Cornell University. She received a PhD in comparative biomedical sciences from Cornell University and a Doctor of Veterinary Medicine degree from the University of Veterinary Medicine in Hannover (Germany).  Since 2014, she is also a  registered patent agent with the U.S. Patent and Trademark Office, and remains active in the biomedical research space. This includes serving as Editor in Chief for a major peer-reviewed international biomedical research journal and as the Executive Director for the professional association representing veterinarians in DC.

Julie Breneiser is the Executive Director of the Gorlin Syndrome Alliance (GSA). Prior to her position as director, Julie served as volunteer Board President for the GSA. She and her two young adult children are affected with Gorlin syndrome, a rare genetic disorder caused by a tumor suppressant mutation that can affect every organ system. Her early career began as a Physician Assistant followed by teaching preschoolers with disabilities.

The work that Julie does with the GSA focuses on collaboration with industry to bring new and/or potential treatments to clinical trial. She also provides individual support to affected patients and their caregivers along with educating health care providers about this rare disease. In November of 2021, Julie was honored with an appointment to the Patient Engagement Collaborative at the FDA. This group of patients and advocates works to achieve more meaningful patient engagement in medical product development and other regulatory discussions at the FDA. Julie previously served as a consumer reviewer for the National Institutes of Health and the Department of Defense’s Congressionally Directed Medical Research Program. She speaks nationally and internationally raising awareness of Gorlin syndrome.

Noopur’s motivation stems from her desire to help mitigate treatment access challenges seen across indications. She is focused on strategic patient-centered drug development that bridges scientific gaps and cuts through red tape across the drug supply chain. She is determined to increase access to treatments to help fulfill current unmet needs. Her approach stems from the patient journey, ensuring it is integrated throughout the drug development life cycle. In her role as Director of Medical Affairs, Noopur nurtures Xentria’s key relationships with patient experts, key opinion leaders and clinical investigators.

Prior to her role at Xentria, Noopur was the Research Director at the Foundation for Sarcoidosis Research where she played a key role in the development and execution of the organization’s scientific research agenda. Noopur has also worked as Clinical Site Manager for Synexus Clinical Research in Chicago, where she was responsible for operationalizing clinical trials. Noopur held several roles at Lurie’s Children’s Hospital Chicago where she managed over 25 industry-sponsored trials. She has also been an active participant in the Therapeutics Development Network with the Cystic Fibrosis Foundation. Noopur earned a B.S.in Kinesiology from the University of Michigan.