Amanda Forst

Really interesting the paper from Journal of Managed Care & Specialty Pharmacy shared by Biosimilars Forum ... might the adalimumab biosimilar case in the US, if repeated with other #biosimilars, put at risk patients access to affordable therapies in the future due to a change in the #strategy of developers and manufactures of biosimilars? Food for thought ... #projectmanagement #businessdevelopment

1

Backed by the industry’s most experienced #IRT designers and specialists, Calyx IRT is the solution you can trust for effective #RTSM strategies that keep trials on track, even when they don’t go according to plan. Learn how. https://lnkd.in/g5ZzyK9T #ClinicalTrials #Randomization #TrialSupplyManagement

14

Partnerships start with collaboration and an understanding of client culture. It is important to understand if a potential vendor shares the same values through a comprehensive RFP that also measures problem solving and personality traits. It is not about what you have....It is how you are going to customize an approach that best serves the client.

9

Totally agree with Josh Bernoff here about naming your book. Catchy (title) plus briefly explanatory (subtitle) is the way to go. https://lnkd.in/gbxU7e7r Grab attention and memory. Then address understanding. Make both intriguing.

2

2 Comments

The power of our connected services at Inizio

4

If you still don't know what's in #FDA's 2024 Data Monitoring Committee draft guidance, now is the time to catch up. Learn the implications of key updates from Advarra experts, Barbara Schneider, Ph.D., MBA and James Riddle. #data #clinicalresearch #biostatistics

16

This content is intended for U.S. audiences only. The countdown to Chicago is on, as we gear up for #ASCO24 in less than two weeks! For the first time, @AstraZeneca will headline not one, but TWO back-to-back plenary sessions in LUNG as well as a late-breaking study in BREAST. Our team is focused on treating cancers at earlier stages and across subtypes while advancing medicines and combination therapies that attack the disease from all angles, evidenced by our strong, diverse research to be presented in Chicago. Behind every data point is a patient, who deserves a personalised therapy that will give them a longer and healthier life. For each one, we’re pushing the boundaries of science, and I can’t wait to highlight our research advances in the coming weeks. Stay tuned! 🔬 For a more detailed preview of our #ASCO24 data presentations, please see our press release https://lnkd.in/ehH7tqFc #CancerResearch #oncology #MedicalAdvancements

224

3 Comments

Discover how integrating adherence into your patient services program not only mitigates substantial risks, but also enhances program performance. Download here: https://bit.ly/4aByNM4  

11

Departing Words: Merck’s Ken Frazier Cautions Against Profit Maximization Pharma CEOs must balance optimizing access and profitability, former Merck CEO and soon-to-be ex executive chairman of the company said. Frazier says health care industry must come to table and admit the “system ain’t working,” talks about the need to protect democracy, in a sweeping interview at the STAT Summit. ....from the Citeline archives, via Sarah Karlin-Smith ********** In a court filing reported yesterday by Bloomberg Law reporter Celine Castronuovo, Amgen argues it will suffer “concrete harm” unless a federal judge quickly enjoins Colorado’s drug pricing board from moving forward with a payment cap for Enbrel. Like nearly all content in healthcare today, Amgen's storyline starts and sticks with the Standard Model, the cut-and-paste messaging that now sits at the extreme end of monotonous repetition. To wit: "Innovative medicines have enhanced and extended the lives of countless Coloradans. Recognizing the enormous investment of time and money needed to discover and develop these novel treatments, Congress rewarded those who bring new medicines to market with a period of patent exclusivity and pricing discretion. As numerous scholars have observed, the economic incentives provided by the federal patent system are crucial to Congress’s objective of promoting pharmaceutical research and development. One such medicine, Amgen’s pioneering drug ENBREL® provides life-changing relief to thousands of Coloradans who suffer from arthritis and other autoimmune diseases. Enbrel redefined the clinical course of moderate to severe rheumatoid arthritis...." etc., etc., etc., etc. All of which may be technically true, as "the scholars have observed", but if the objective for Amgen is an argument that persuades, the #StandardModel stopped working long ago. It also doesn't help when the 20 members of the Colorado drug pricing board and its advisory council come home from work and watch the local news, where the commercial breaks will be flooded with drug promotion, part of the media buy that comes from the industry spending $30 billion/year on DTC advertising. These things are connected. In a conversation with Bill Boulding, Dean of Duke University - The Fuqua School of Business around the same time as his interview with STAT, Frazier said one of the role's of business was in collaborating with government to reinvent the country. “The role of the private sector in the United States in helping to reinvent this country, over, and over, and over again, is important,” he said. “I think business has the talent, it has the resources, it has the capabilities of helping to change our country.” It's time to sweep the old concepts out of the saddle. The faster the drug market learns how to connect things differently, to 'see, say, sell and sustain' strategy at a system level, the faster it can start creating a different future for itself. #QuentinTarantino

10

1 Comment

#ASCO24 is just around the corner. It is sure to be another very busy, very interesting and very productive meeting. Why not take a break and join us for a relaxed, drop-in, networking lunch just a short walk from the venue? Come meet #IDDI founder and expert biostatistician Marc Buyse, #One2Treat CEO Sébastien Coppe, PhD and IDDI Medical Director & Oncologist Dr Everardo Saad. Have a light lunch and explore topics such as #ProjectOptimus, #trialoptimization, #regulatorystatistics, #patientcentricity and anything else you wish related to the efficient conduct of #oncology clinical trials!

1

❔ How do we position regional and community sites for success and mitigate risks for sponsors? ❔ In our new Oncology report, Parexel’s Karen McIntyre and Angela Hirst weigh in on why the traditional approach to site selection in oncology has created bottlenecks at major centers, potentially limiting patient access to life-changing therapies. 🚧 That’s why Parexel is bridging the gap by partnering with regional and community sites while still ensuring the high-quality standards of academic centers. Find out how: https://lnkd.in/etEhmCKC #ResearchSites #Oncology #NovelInsights

3

Every day a new story emerges about AI. But I’m really interested to see how we can make AI work for clinical trials. Could it even shorten time to market? To map its trajectory, we must look to its past. This Medidata Solutions article tells the story of AI in healthcare so far. And for anyone in life sciences, there’s a thought-provoking section on the value and challenges that come with bringing in AI and ML to the clinical research field. I’d love to hear what you think. Are you for or against AI in clinical trials? https://rebrand.ly/p90dwmd #Medidata #AI #MachineLearning #ClinicalTrials

20

Patients, healthcare professionals, payers, and other stakeholders can have vastly different views on the value of a particular product, often resulting in a struggle between prioritizing access to innovation and optimizing costs. Addressing the ramifications associated with misaligned incentives in the fee-for-service payment model has been a driving force in the pursuit of value-based care. Read more: https://ow.ly/YcV430sCN0A

36

Thoughts on this? >> Sanofi's trimmed oncology plans lead to $3B biobucks dent for IGM >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #biotech #pharmaceutical #productmarketing #healthcare #pharma

1

As the first round of MFP negotiations approach their conclusions this summer a next round of negotiations await with payers who will be armed with public knowledge of MFP levels. How will this impact contracting for MFP-negotiated products and for their competitors? Learn about our perspective on this emerging topic here:

5

I am excited to attend ASCO later this month and connect with industry colleagues on how we can partner to advance the development of treatments and access to patients across the globe! #ASCO #expandedaccessprograms #namedpatientprograms #compassionateuseprograms #patientaccess #sitemanagement #WEP #clinicaltrialsourcing #strategicdecentralizedtrialsolutions #marketaccess

7

I'm proud to work for Amplity, an organization uniquely prepared to meet the challenges faced by Healthcare Professionals in treating patients. If you've not had the opportunity to see Amplity Insights yet, please reach out to us. The breadth and detail around the millions of anonymized medical transcription data will knock your socks off! This short video from Christina DiBiase summarizes it so well.

23