Dr. Stephen Weber| Regulatory Affairs|Best Researcher Award

Dr. Stephen Weber| Regulatory Affairs|Best Researcher Award

Dr. Stephen Weber at The Johns Hopkins School of Medicine,United States

PROFILE  

scopus

🎓📚Education and Training:

  • University of Michigan, B.S. in Psychology/Zoology (1976), with high honors and Phi Beta Kappa.
  • University of Michigan Medical School, M.D. (1980), recognized as a Grossman Fellowship Recipient and member of Alpha Omega Alpha.
  • Completed internship and residency at the University of California, Davis (1981-1985).
  • Completed advanced fellowships in Fracture Surgery in Switzerland (1985) and Arthroscopy in Virginia (1986).

✅🏅Academic and Professional Appointments:

  • Assistant Professor of Orthopedics, Johns Hopkins School of Medicine, focusing on shoulder surgery since 2016.
  • Clinical and team physician roles at prestigious institutions, including University of California, Davis, and professional sports organizations.
  • Orthopedic practice experience at Sacramento Knee and Sports Medicine (1986-2016).

📖📝Regulatory Science Expertise:

  • Former Medical Officer at the FDA (2016-2019), with leadership in reviewing orthopedic devices, including shoulder arthroplasty and biologics.
  • Published numerous peer-reviewed articles and FDA white papers on biologic responses to metal implants, real-world evidence, and SMART devices.

🏆🎖️Certifications and Awards:

  • Board-certified by the American Board of Orthopaedic Surgery with a Sports Medicine Subspecialty.
  • Recipient of the Lifetime Achievement Award and Neer Circle honors from AAOS.
  • Multiple editorial positions, including the Journal of Shoulder and Elbow Surgery and the American Journal of Sports Medicine.

🎓Publication 

Incidence of anatomic total shoulder arthroplasty vs. reverse total shoulder arthroplasty in cuff intact osteoarthritis in males vs. females 70 years or older

  • Authors   :Navarro, R.A., Kody, M.T., Sanchez-Sotelo, J., Taylor, S.A., Williams, G.R.
  • Journal    :Seminars in Arthroplasty JSES
  • Year         :2024

Iatrogenic Excessive Clavicle Resection as a Complication of Arthroscopic Distal Clavicle Excision

  • Authors   : Meshram, P., Saggar, R., Lukasiewicz, P., Weber, S.C., McFarland, E.G.
  • Journal    :Orthopedics,
  • Year         :2024

Staying out of trouble: FDA regulation of orthobiologics and the shoulder surgeon

  • Authors   : Weber, S.C., McFarland, E.G.
  • Journal    :Journal of Shoulder and Elbow Surgery
  • Year         :2024

Editorial Commentary: Arthroscopic Bone Grafting Using Suspensory Fixation for Anterior Glenohumeral Fixation With Bone Loss May Supersede the Latarjet Procedure Using Coracoid Transfer

  • Authors   :Weber, S.C.
  • Journal    :Journal of Arthroscopic and Related Surgery
  • Year         :2024

American Shoulder and Elbow Surgeons perspectives on political advocacy

  • Authors   :Cronin, K.J., Calcei, J.G., Port, J., Gulotta, L., Schlegel, T.F.
  • Journal    :Journal of Shoulder and Elbow Surgery
  • Year         :2024

 

Mrs. Anke van Engen|Pharmaceutical Policy and Regulation | Best Researcher Award

Mrs. Anke van Engen |Pharmaceutical Policy and Regulation|Best Researcher Award|

Mrs. Anke van Engen atIQVIA,Netherlands

PROFILE  

Scopus

 

Early Academic Pursuits 🎓

Anke van Engen’s academic journey began at the University of Leiden in the Netherlands, where she pursued a Master of Science (MSc) degree in Chemistry, specializing in Bio-organic Chemistry. Her passion for understanding the intricate mechanisms of chemistry and its application to life sciences laid a strong foundation for her future endeavors. Her academic pursuits were not confined to the classroom; she also completed an internship in biochemistry at the Institute of Fundamental Sciences, Massey University in New Zealand, in 1999. This experience provided her with hands-on exposure to research and innovative scientific methodologies, marking the beginning of her profound interest in health economics and outcomes research.

Professional Endeavors 🏢

Anke’s professional journey began in 2000 as a PR Assistant at KPN Research, where she gained experience in communications and public relations within the research and innovation sector. However, her true calling was in consultancy, which she pursued by joining Quintiles Consulting in 2001 as an Associate Consultant. Her initial work focused on health economics (HE) modeling, including decision tree and Markov models, patient chart analyses, and market scans. Anke quickly progressed within the company, taking on roles with increasing responsibility, such as Consultant, Senior Consultant, and eventually Consulting Director.

During her time at Quintiles, Anke developed a unique understanding of innovative technologies for supporting clinical and health outcomes studies. She became instrumental in the development of health economic models used in key submissions to organizations like NICE (National Institute for Health and Care Excellence) and SMC (Scottish Medicines Consortium). Her expertise in market access (MA) strategy, value argument development, and health economics led to her appointment as the Principal at Quintiles Advisory Services, where she led the development of the HTA Accelerator—an online platform that became the flagship product for market access solutions.

In 2017, Anke transitioned to IQVIA, where she continued her trajectory of success. She took on roles such as Senior Principal and Managing Principal, leading international teams and developing EMEA-specific offerings in health economics and market access. Her leadership and strategic insights have been crucial in shaping the payer evidence solutions landscape across the EMEA region.

Contributions and Research Focus 🧠

Anke van Engen’s contributions to the field of health economics, outcomes research, and market access are substantial. Her work has focused on developing integrated solutions that provide strategic insights for life sciences companies, enabling them to navigate the complex landscape of health technology assessments (HTAs) and market access requirements. Her leadership in the development of the HTA Accelerator platform has been particularly impactful, offering a comprehensive solution for gathering payer insights and facilitating launch readiness.

Anke’s research focus extends beyond practical applications to thought leadership in the industry. She has consistently contributed to the development of innovative methodologies and best practices in health economics and market access, helping to advance the field and improve the commercial success of pharmaceutical products.

Accolades and Recognition 🏆

Throughout her career, Anke has received numerous awards and accolades that reflect her expertise and influence in the field. Notable among these are the ISPOR Best Podium and Poster Awards, which she received in 2012 and 2011, respectively, for her work on understanding the complexities of HTA networks and the stakeholder decision-making process in the UK. Her contributions have been recognized at various international conferences, where her issue panels have consistently ranked among the top-attended sessions. In 2014, she won the Sharktank contest for best innovation, securing investment for the HTA Accelerator platform—a testament to her innovative thinking and ability to drive impactful solutions.

Impact and Influence 🌍

Anke van Engen is widely respected by her colleagues, clients, and the broader industry for her deep expertise, strategic vision, and collaborative approach. Her ability to build long-lasting partnerships with clients and deliver consistent results has made her a trusted advisor in the life sciences sector. She has played a pivotal role in shaping the market access landscape in Europe and beyond, influencing the way companies approach payer evidence strategies.

🎓Publication 

Use of External Comparators for Health Technology Assessment Submissions Based on Single-Arm Trials

  • Authors   :Patel, D., Grimson, F., Mihaylova, E., van Engen, A., Kim, J
  • Journal    :Value in Health
  • Year         :2021