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Where In The World Should I Conduct My Pivotal Clinical Trial?

RWE (Real World Experience) from RWP (Real World People)!

September 16, 2020 @ 12:00 PM 1:00 PM

The COVID pandemic has certainly forced us to re-think the whole paradigm of conducting clinical trials. From design, site and CRO selection, patient recruitment, data management, to execution, the world of clinical trials has been altered significantly in 2020… and most likely beyond.

Here are some relevant questions you should be asking yourself and that we will be asking our panelists in today’s webinar:

  1. Can patients be allowed to participate in clinical research from virtually anywhere?
  2. What considerations should I be thinking about if I want to implement a virtual, hybrid, or decentralized trial?
  3. What mobile health technologies are applicable for which conditions?
  4. What is the value of RWD (Real World Data) and RWE (Real World Evidence) and how do I best collect and leverage that asset?
  5. Can AI and Machine Learning help me convert patient data into actionable insights that are both interoperable and easily integrates into my eTMF (Trial Master File)?
  6. How can we create smarter protocol amendments that don’t delay patient recruitment and necessitate long regulatory approvals?
  7. What are the safest places in the world for me to plan a clinical trial in the next year?
  8. What pearls and pitfalls can the panelists share from their COVID related experiences?
  9. Are there any incentives out there I should be looking at?
  10. What is the one important thing that I, as a sponsor, didn’t think of, and will most likely be surprised by?

Moderators:

Jeffrey Hausfeld, M.D., M.B.A – Chairman of the Board and Chief Medical Officer at BioFactura, Inc., Chairman and Co-Founder SoPE

Jeffrey Hausfeld, M.D., M.B.A., F.A.C.S., has served on the national board and committees of specialty medical societies since he began his practice in Otolaryngology/Facial Plastic Surgery in 1982. He is an Associate Clinical Professor of Surgery at George Washington University School of Health Sciences and an alumnus of the Yale University School of Medicine. Dr. Hausfeld is widely published in the medical literature, is the pioneer of innovative laser surgery techniques, is the author of a lay oriented medical book on snoring and sleep apnea, and has appeared on numerous local and national television and radio shows as a medical expert. He has also served as a health care consultant, spokesperson, and executive coach for multi-national pharmaceutical companies, health care firms, as well as the U.S. military. Dr. Hausfeld  stepped down from his clinical duties after receiving a Masters in Business Administration from Johns Hopkins University. Dr. Hausfeld is presently developing assisted living facilities specializing in Alzheimer’s and dementia care. He serves as a consultant to several healthcare/life science startups in diagnostics, devices, biotech and Health IT. He also serves on the Investment Advisory Board of the Center for Innovation Technology’s Life Science Gap Fund. The fund supports promising healthcare and life sciences ventures in the Commonwealth of Virginia. Dr. Hausfeld is the Chairman and Founder of the Society of Physician Entrepreneurs (www.sopenet.org ), a global network focused on educating healthcare and life science professionals in Bioentrepreneurship and Innovation. Dr. Hausfeld is orchestrating the Series C  Financing of BioFactura (www.biofactura.com) and acted as the lead investor in previous rounds. He serves as Chairman of the Board of BioFactura as well as their Chief Medical Officer as the company develops its Biosimilar platform as well as its novel Bio-defense therapeutics.

Rania Nasis, MD, MBA
Director, Society of Physician Entrepreneurs (SoPE) and New York Tristate Chapter Co-Leader

Rania is a physician entrepreneur and seasoned operator with a passion for building companies to address unmet needs in healthcare. She is the founder of Starlings, an advisory firm that works with early stage healthcare startups on strategy, operations and product-market fit. She is also a Director of the Society of Physician Entrepreneurs (SoPE), a non-profit global biomedical and healthcare innovation network. She has a wide breath and depth of experience across a multitude of areas in healthcare, including digital health, aging tech, biotech, life sciences, devices, and diagnostics. She has previously held senior leadership roles within multiple healthcare startups. 

She received her MD from New Jersey Medical School, MBA from the Paul Merage School of Business at University of California at Irvine and BS from Drexel University.

Speakers:

Mike Burfield, National R&D Tax Partner, Team Leader
Mike has been providing R&D Tax Incentive advice in a professional capacity since 1991 making him one of the most experienced professionals in this space in Australia.

In his corporate career, Mike has founded, grown and exited many start-up tech companies, developed IP in food, engineering and software sectors, and licensed his patents and IP to multinationals. Mike is a director of numerous technology companies, including many Australian subsidiaries of USA and Asian medtec and biotechnology companies undertaking clinical R&D in Australia.

Mike is a respected corporate advisor and a director of multiple Australian subsidiaries of multinationals conducting R&D in Australia. Mike has built a leading national reputation and track record in preparing successful, compliant R&D applications that have supported over $1 billion in R&D investments.

Yvonne Lungershausen
Yvonne began her career in academic “bench” research with Adelaide University and CSIRO. Yvonne then moved into clinical trials research at a dedicated Phase I unit where she was one of the first in Australia to test a new chemical entity in healthy volunteers, giving rise to what is now a strong Phase 1 sector in Australia. Yvonne also spent time in the biotech world as Clinical Development Manager then moved into senior Contract Research Organisation (CRO) roles. With 25+ years of clinical trial experience gained across most therapeutic areas, Yvonne brings a deep understanding of all phases of the drug development process.

With a passion for exceeding client expectations, Yvonne is highly regarded within the industry for her expertise and ability to solve complex clinical trial issues. In 2009 Yvonne Lungershausen became a Founding Member of CPR Pharma Services (CPR) as it spun out from the University of South Australia.

As a key member of the CPR Senior Management Team, she was responsible for the clinical operations side of the business. Then in January 2019 CPR Pharma Services split into two separate service companies, analytical services (Agilex Biolabs) and clinical services (Avance Clinical). Yvonne was appointed as CEO of Avance Clinical and has since rapidly built the company into Australia’s leading CRO for biotech’s – attracting innovative biotech clients from USA, EU, and Asia and winning awards for quality and service.

Matthew Amsden, CEO of ProofPilot
ProofPilot is a platform to design, launch, and participate in trials. With “Proof” and “Pilot” part of the company’s name denoting how important the concepts of building evidence and data in the pilot process.

ProofPilot’s customers are both large enterprises that use ProofPilot to test their own innovations and innovations they’d like to try (Google, Partners Healthcare, Eli Lilly), and very early-stage startups looking to quickly and cost-effectively test product concepts in real-life settings. ProofPilot works across healthcare verticals including pharma, medical device, academia, digital health, and the broad nutrition, health & wellness space.

The company’s main offices are in New York but have studies and pilot programs running around the world in 19 different languages. 

Dr. Vlad Bogin, MD, FACP, Founder and CEO of Cromos Pharma

Dr. Bogin founded Cromos Pharma (www.cromospharma.com), an international full-service CRO 15 years ago. He has been involved in drug development for over 20 years, from basic discovery research to clinical trial design and multinational phase III and IV trials. As a director at Boehringer Ingelheim, he was in charge of late-stage development of a leading cardiology product. 

As the Chairman of the Board at Medistem Inc., Dr. Bogin was instrumental in advancing the company from the preclinical to the clinical stage. Dr. Bogin maintains active medical license and hospital privileges in the state of Washington and is an advisor to numerous companies and non-profit organizations. Dr. Bogin is an author of many peer-reviewed articles, book chapters, and patents.

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