Therapeutic Innovation Australia’s Post

Target Product Profile (TPP) – How to make it a strategic document? That was the theme tackled last Tuesday by Carlo Chiavaroli and Karina Saakyan from Voisin Consulting Life Sciences (VCLS) during a workshop organized at Biopôle Lausanne. What is a TPP ?  TPP summarizes all the hurdles a company would have to face from discovery to market in order to address a specific medical condition. It comprises among others pre-clinical, clinical, regulatory, market access plans, but also practical (dosage, administration…) and geographic information. TPP is an essential document applicable to all health products including #Pharma #Biotech, #Medtech and #DigitalHealth. It’s a living document that evolves with the maturation of the product development. What is the purpose of a TPP? 1 | TPP allows to coordinate different stakeholders in the company from science to business, including external stakeholders such as investors. 2 | In essence, TPP allows to define where you are heading and get on the right tracks to be faster than the competition. Want everybody in your company to be aligned? Go for your TPP(s)! Thank you Carlo, Karina and Hubert R. for sharing your expertise with such a passion!

County Durham life sciences firms set to grow after being snapped up by Dutch group "MTL Projects and Mark Thompson Lifesciences have been sold to Normec Group" https://lnkd.in/d36YgPbD

A long awaited peek at how German regulators plan to integrate EU-HTAR into their established ways of working. As expected no real surprises, given that the working model for JCA leans closely into the learnings of 14+ years of AMNOG. The focus of this draft proposal is mostly on timing, lack of repetition and integration of perspectives from both National and European reports. It also makes the point strongly that value assessment (as opposed to clinical assessment) remains a strictly national domain. Interesting times in the months ahead! We're doing a lot of work in this space at a strategic, organisational design and predictive level through our JCA-lab and PICO predict along with broader consulting initiatives. Do reach out if you want an informal chat or to discuss any questions you might have. #JCAReady #PICOpredict #EUHTA

🎤 Speaker Spotlight: David Vincent, CEO/ B.Sc., MPH, PhD🎤 We’re thrilled to announce, David Vincent, CEO/ B.Sc., MPH, PhD, Chief Scientific Officer (CSO) at VTI Life Sciences, as a featured speaker at the Cleaning Validation 2025 event! 🌟 Join us in January! https://lnkd.in/gqgdqd2n #CleaningValidation #CleaningValidation2025 #PharmaceuticalInnovation #PharmaEd #QualityAssurance #CleaningProtocols #ValidationTesting #PharmaQuality #ProcessValidation

Feasibility has become a source of contention between sponsors and sites. In this Drug Development & Delivery article, Matthew Jones and Julia Scanlon delve into the key elements of a strategic feasibility framework, designed to cultivate positive site-sponsor relationships. Read now: https://bit.ly/4c0OYmY

The kick-off of our new CARA Life Sciences Starter Pack (teams of 5-150 users either within larger organisations or as a smaller organisation) has the cherry on the cake of the first 3 customers! #LifeSciences #CARAPlatform #SmallBusinessSolutions #RegulatoryCompliance #Pharma #Biotech

We see sustained strong appetite for life science regulatory services globally given the significant incremental value and cost savings that life science sponsors can realize through expediting the regulatory approval process. This category of outsourced life science services remains one of the least outsourced areas today, albeit with one of the fastest projected growth rates and with substantial runway to grow. Moreover, this expertise carries highly strategic value for services providers, as it can serve as the tip-of-the-spear offering, driving early, meaningful, and regular engagement with life science clients, as well as high-impact, high-margin, high-predictability, reoccurring, and entrenched relationships with sponsor clients. Read more about our key perspectives on the market dynamics, growth drivers, and valuation considerations, including recent precedent M&A transactions: https://hubs.li/Q02LGrgY0

We’re thrilled to announce the launch of Forever North Partners LLC (FNP) new website, designed to serve the particular needs of the life sciences community. As industry leaders in commercialization, we understand the unique challenges life sciences companies face in navigating product development, regulatory pathways, and market entry. To address these challenges, Forever North Partners LLC has created the CASMEC™ System—a groundbreaking, fully integrative approach that streamlines every phase of commercialization, from initial concept through to sales and market success. By consolidating project management, regulatory compliance, and commercialization support, the CASMEC™ System accelerates time-to-market. This innovative system is now available on our new website, www.forevernp.com, offering clients an accessible resource to explore how the CASMEC™ System can support your journey to market success. We invite you to explore our new site (www.forevernp.com) to learn more about the CASMEC™ System, our Collabornaut™ team, and how Forever North Partners LLC can drive your life sciences innovations to new heights. Looking forward to your responses and hopefully gaining new friends and colleagues in the Life SCiences Community. Eric Reese, PhD, CEO - Cofounder John A. Morris, MBA, MCPC, COO - Cofounder Forever North Partners LLC #Commercialization #LifeSciences #ClinicalTrials #Sales #Marketing #CreativeDesign #DigitalMedia #Pharma #PharmaManufacturing #IntellectualProperty #HumanResources #ClinicalResearch #BusinessDevelopment #DrugDiscovery #DrugDevelopment #PharmaTechnology #DrugDelivery #Diagnostics #MedicalDevices

‘Navigating the Biopharma Services Lanscape: Current Trends and Future Perspectives’ at BIO-Europe - interesting discussions regarding price vs value in service providers. Speed, flexibility, dependability and quality are key considerations when delivering novel molecules to the clinic, not just cost, and a track record of delivering success commands a premium Sygnature Discovery #BioEurope

As a drug developer in a complex industry, you need to remain at the forefront of scientific innovation while ensuring scientific integrity and responsibility. Join Laura Lotfi on July 18 for a live webinar, Unlock Hidden Insights: Virtual Control Groups as a Data-Driven Novel Method, where she will discuss the practical and regulatory steps for implementing VCGs into future nonclinical studies. https://okt.to/CpQHZm #drugdevelopment #virtualcontrolgroups