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Medical Experts
Home / Solutions / Medical Experts

Medical Experts

One source for a wide range of Medical knowledge across many therapeutic areas

Biotech and MedTech companies have little room for error when it comes to clinical development of new projects in early- to late-stage clinical phases. This means there is a great need to find the right partners to support decision making and to enhance the likelihood of successful product development. LINK Medical is a strategic partner with the experts and experience needed to get you to the next step on time and on budget. Read about our Medical Experts and don’t hesitate to contact us about your product development needs, we are eager to support you in your success in bringing new products to patients who need them most.

LINK Medical’s Medical Director, Clinical Operations, Rikard Reneland, M.D., Ph.D., works together with a network of experienced medical consultants; Kim Simonsen, Paul Willems, and Austin Smith. Our Medical Director provides strategic leadership and together with the consultants cover a wide range of knowledge across many therapeutic areas. We are especially strong in oncology, vaccines, autoinflammatory diseases and rheumatology, neurology, CVD, diabetes, and rare diseases. The team of medical experts at LINK Medical can provide the following expertise and services across diverse disease areas:

  • Study design and protocol medical operability
  • Clinical development
  • Medical and scientific support for regulatory interactions
  • Medical monitoring
  • Risk management in projects from a medical perspective
  • Safety signal evaluations
  • Scientific investigations and literature review

Rikard Reneland, M.D., Ph.D.

Medical Director, Clinical Operations

Rikard.reneland@linkmedical.eu

Rikard has 20 years of biopharmaceutical experience focused on clinical development and clinical operations, with experience from small biotech to big pharma companies.

Rikard works out of the Uppsala office, Sweden, as Medical Director, Clinical Operations. In addition to his role as Medical Expert he also serves as the Link Medical contact person for the independent Medical Experts.

After graduating as MD from Uppsala University, Rikard did a Ph.D. in preventive cardiology while working as an investigator. Shortly after receiving his license to practice, he started his industry career in a pioneering small biotech company developing pharmacogenetic tests to predict response to drugs. After 6 years as Medical Advisor in early biotech and small pharma, Rikard began work as Medical Advisor at the Nordic Baltic Clinical Study Unit at Sanofi, providing first-line medical support in studies of all phases and across disease areas for twelve years. He also held positions as Country Medical Lead Immunology at Roche and Global Safety Physician at Sobi before joining Link Medical in 2022.

Rikard has a particular interest in the interface between medical science and clinical operations as it is reflected in protocol design, feasibility, and site selection. His long experience working in Clinical Operations across disease areas in the Nordic Baltic region has awarded him a solid understanding of the conditions for performing clinical trials in this territory.  With the goal of enhancing clinical trial efficacy, he has initiated activities related to improving communication and relationship with the site.  He has also participated in initiatives to utilize electronic medical records and biobank data as tools for feasibility and site selection.  Rikard has a Diploma in Pharmaceutical Medicine from Karolinska Institute.  He is listed as the author of 37 scientific publications on PubMed.

Expertise in therapeutic areas/types of studies:

  • Diabetes and metabolic syndrome
  • Cardiovascular disease
  • Immunology includes rare autoinflammatory conditions
  • Covid-19
  • Degenerative CNS disease
  • Myeloma

Particular experience in:

  • Genome-wide association studies
  • Feasibility
  • Study design and protocol development
  • Epidemiology
  • Pharmacogenetics
  • Safety sections of regulatory submission dossiers
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Paul Willems, MD

Medical Expert – Consultant
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Paul has almost 30 years of (bio)pharmaceutical industry experience, focused on clinical development, clinical trial safety, pharmacovigilance, and benefit-risk management.

Located in Belgium, he works as an independent medical advisor serving primarily small companies both at development and post-marketing stage on an international level.

He started his industry career, by joining a major vaccine manufacturer, shortly after graduating as MD from Liège University, Belgium. There, he evolved in a number of different positions in clinical development and related functions before moving to pharmacovigilance. Later, he joined a small start-up company as Global Head of Pharmacovigilance, contributing to the licensure process for a first-in-class drug both in Europe and the United States, and accompanying the product through its first years on the market. Finally, he settled to his current position as independent medical advisor in clinical development and pharmacovigilance, widening his expertise to a broad variety of products (small molecules, biologicals, medical devices) and therapeutic areas.

His broad experience across projects, processes, and medical functions within pharmaceutical industry, both in headquarter and country office roles, offers him a deep understanding of integrated processes from clinical trial set-up and strategy to interpretation of results and their translation into clinical sections of prescriber/product information and other regulatory documents.

Expertise in therapeutic areas/type of studies:

  • Vaccines (all types: live, inactivated & subunit vaccines; conjugate & adjuvanted vaccines; adult & paediatric use)
  • Autoimmune diseases
  • Oncology
  • Ophthalmology
  • (Paediatric) Infectious diseases
  • Biologicals
  • Genetically modified vectors (application in areas of Advanced Therapy Medicinal Products & Vaccines)
  • Medical devices

Particular experience in:

  • Pharmacovigilance
  • Pharmacovigilance inspections
  • Benefit-Risk management
  • Clinical Trial Safety
  • Paediatric & Adult clinical trials
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Kim Simonsen, MD

Medical Expert – Consultant
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Kim has worked 35 years in the pharmaceutical industry after 5 years in clinics after graduating from Copenhagen University in departments specialised in internal medicine (gastroenterology, respiratory, cardiology) and throughout with a special interest in clinical pharmacology. In industry he has focused on clinical drug development.

Most of Kim’s career has taken placed in Denmark, but he has also worked for four years in Switzerland and for the last 11 years has been living and working in Belgium.

Kim acquired a Diploma in Pharmaceutical Science from the University of Cardiff, 1990 and a Diploma in drug and device development from Copenhagen Business School, 1997.
He has extensive and worldwide experience in drug development and has learned from interactions with authorities in the EU, US, Japan, and China for scientific advice as well as through submissions.
He has worked across multiple therapeutic areas with small molecules, biologicals, and extract-based products.

Although his primary experience is within clinical development, he has also had managerial responsibility for non-clinical activities, manufacturing and quality management.
He has throughout his career been involved in training activities and given lectures in specialist training for physicians in Clinical Pharmacology in Denmark, lectures in pharmaceutical drug development at the Association of the Pharmaceutical Industry in Denmark and at Copenhagen and Aalborg University. He also carried out training for colleagues in medicine and pharmaceutical science.

Expertise in therapeutic areas/types of studies:

  • Cardiovascular disease
  • Pulmonary disease
  • Allergy
  • Immunology
  • Endocrinology
  • Neurology
  • Rheumatology
  • Medical devices

Particular experience in:

  • Clinical Drug Development
  • Clinical Pharmacology
  • Clinical Trials
  • Device development
  • Quality Management

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Austin Smith,

MD, PMD, BAO, MRCPSI

Medical Expert – Consultant
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Austin is a dual trained Medical Oncologist and Pharmaceutical Physician. He has 3 decades of experience evenly split across clinical practice and international clinical development advisory roles.

His clinical experience was mainly oncology, with a grounding in clinical oncology, but also substantive time in malignant hematology, before finishing in medical oncology with a special interest in upper GI and neuro-oncology.

Austin’s clinical experience has been primarily in clinical development and has led teams that delivered the pivotal studies for ipilimumab and did the first in human clinical work on Olaparib (first in class PARPi) up to post-approval real-world evidence studies to extend the license to additional indications outside ovarian cancer. Austin has also recruited both scientific advisory boards and patient advocacy groups to help with patient-centric support of clinical studies

Austin holds a Diploma in Pharmaceutical Medicine and is a member of the Oncology and Clinical Trials working group for the Faculty of Pharmaceutical Medicine. Austin has led several Scandinavian biotechs from exploratory clinical studies and assisted with regulatory meetings with FDA, EMA, and 9 other regulatory bodies.

Expertise in therapeutic areas/types of studies:

  • Oncology
  • Radiopharmaceuticals
  • Immunology
  • Dermatology

Particular experience in:

  • Clinical Drug Development
  • Regulatory Strategy
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