Rikke Winther

MSc in Pharmacy from Copenhagen University

Role in PharmNovo: Clinical outsourcing lead.

Company: WIN Outsourcing Consult.

Resumé: Rikke is highly specialized and globally experienced within Pre-clinical and Clinical R&D, Business Development and Contract/Outsourcing Management and has worked in the CRO and Pharmaceutical industry within these fields for more than 25 years.

For almost two decades, she headed up the R&D Outsourcing & Contracts Management R&D function at Lundbeck where she was globally responsible for all R&D outsourcing matters covering contractual, operational and relationship related activities with all CROs/vendors as well as complex research collaborations agreements with academia. Rikke has significant experience in developing and executing a broad variety of outsourcing strategies and is a strong negotiator with a win-win approach to retaining positive relationships with all stakeholders.

Prior to her employment at Lundbeck, Rikke worked for five years within bio-analytical research and clinical development in hospital/academia settings. This was followed by four years of employment in a larger CRO (International Project Manager followed by setting up the CRO’s first South East Asia office working as Business Development Manager and Line Manager in Singapore).

Rikke has since 2013 been a Steering Committee member of the Pharmaceutical Contract Management Group (PCMG.org.uk) in Europe.

Member of:

Operational team

Latest news

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July 1, 2025

CTA submission for PN6047

PharmNovo AB is pleased to announce that the clinical trial application (CTA) for a Phase IIa proof of concept (PoC) study investigating the safety and efficacy of lead candidate PN6047 in patients with neuropathic pain has been submitted in Spain. The full title of the application is: “Randomized Double-Blind Placebo-Controlled Cross-Over Trial of the Safety, Tolerability, and Efficacy of PN6047 HCl in Peripheral Neuropathic Pain Characterized by Mechanical Allodynia.” Based on a strategic company decision, PharmNovo has submitted the CTA, in the first instance, to the Spanish Health Authorities only. Submission to the Czech Republic and Poland, the two other countries in which the trial will be conducted, is planned to take place following approval in Spain, which is expected by October 2025. Subject to additional investment, patient enrolment is expected to start by Quarter 1 2026.

PharmNovo at the LSX World Congress in London

May 19, 2025

PharmNovo at the LSX World Congress in London

Take the opportunity to listen to Per von Mentzer, CEO, presenting PN6047 at the LSX World Congress in April 2025 in London. PharmNovo is redefining pain management with PN6047, a first-in-class Delta Opioid Receptor Agonist (DORA), safer, non-addictive solution for neuropathic pain. Unlike traditional opioids, PN6047 eliminates concerns of side effects, abuse potential, and tolerance. With a proven safety profile from Phase I trials and a market projected to exceed EUR 13 billion by 2033, PN6047 is set to be a game-changer.

March 12, 2025

Positive FDA feedback for PN6047

PharmNovo has received positive and constructive feedback from the FDA for its lead drug candidate, PN6047, a selective delta opioid receptor agonist aimed at treating peripheral neuropathy with allodynia. Following a successful pre-IND meeting in January 2025, the FDA provided valuable guidance on the Phase IIa study design and had no critical comments on the CMC or non-clinical data. This paves the way for IND submission by the end of 2025 and a Phase IIa clinical trial application in Europe (Spain, Poland, Czech Republic) by Q3 2025.

Pioneering approach to treat neuropathic pain

February 26, 2025

Pioneering approach to treat neuropathic pain

PharmNovo has recently published an article in MedNous, highlighting the pioneering approach to tackling neuropathic pain without the risks traditionally associated with opioids. The lead candidate, PN6047, targets the delta-opioid receptor – offering pain relief without addiction or sedation. Arrangements for a Phase II trial have now been completed, marking a crucial step toward a safer alternative for millions suffering from chronic pain. With the opioid crisis still a major concern, innovative, non-addictive treatments like PN6047 are more urgent than ever.