Uma Sharma on LinkedIn: #onemms #onemms #datacro #gratitude #onemms (2024)

A much awaited draft guidance for our industry “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” (https://lnkd.in/eGRexGNj) was released by the FDA today. Please submit your comments within 90 days.These plans will allow sponsors to plan and recruit historically underrepresented populations and facilitate a meaningful risk-benefit profile discussion / appropriate label across the board when their products move to market. As a data CRO, #OneMMS has already been supporting sponsors with these plans and also with the ability to recruit a diverse population using our proprietary Datacise technology and geospatial mapping for clinical trials.

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As a leading data CRO specializing in regulatory submissions we at #OneMMS look forward to progress with the initiatives under the modernization of the New Drugs Regulatory Program (NDRP). This will add efficiencies at our end (e.g. the IR dashboard initiative among others) and allow industry and regulators to keep pace with recent advances and overall benefit-risk in an efficient manner.

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Join us and hear Ritchie Patton discuss the evolving regulatory landscape with pyschedelics. Mental health continues to be an area of huge unmet meet and we all have a responsibility towards patients with PTSD, anxiety, and other ailments while maintaining the highest regulatory standards. #OneMMS #dataCRO

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Tomorrow (June 17, 2024), I will be moderating a panel on “Getting to Regulatory Approval” at Longwood Healthcare Leaders Spring MIT conference. Promises to be an interesting 2-days with several industry peers, academic leaders and FDA focusing on various aspects of drug development.This has been a busy week and since several of our senior leaders were in town for meetings, I hosted them for a home-cooked meal. Work is life and life is work when you have one too many interests to pursue.I approach my dinners like New drug applications (NDAs or BLAs); the menu is the label that I must plan ahead and ensure adherence (I even annotated it -food origin flags), easier modules are done ahead of time (the décor, all the refrigerated desserts and prep work) and Module 2.5. is left for ~ 2 hrs. prior to guests arriving (shrimp, pasta etc.) thereby optimizing the benefit -risk 😉. Planning and cooking fusion food is a passion, and despite being a vegetarian, I don’t approach the meat dishes like a personal contraindication section and ensure fair-balanced options for all tastes. Over the years, experience has made me good at cooking what I don’t taste (so they say). Like our applications at #OneMMS, I do dabble with the menu with severalfirst-in-class / no precedence delicacies which adds to the challenge.Same approach, different scenario, overwhelming guest com approval (15-0, I am always a non-voting member) and a successful dinner.Label (menu) and press release (just the desserts) attached. Enjoy!! And looking forward to seeing many of you in Boston tomorrow.#Workislife #OneMMS #Regulatorysubmissions

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Join our COO, Chris Schoonmaker and me at the Spring MIT Forum (June 17, 2024) for an exciting panel discussion on regulatory approvals and many other discussions. The conference brings together leaders in our field for a productive 2-day in-person dialogue on several key topics. Approvals are the grand finale of the work we do and I wake up every day with renewed energy to support yet another drug/biologic/therapeutic option for patients globally. At #OneMMS, this is our passion and expertise, working with regulators and sponsors to enhance efficiencies one submission at a time while maintaining our data-focused efforts. #dataCRO #biometrics #submissions

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Datacise allows users to curate, analyze and visualize their own data in conjunction with multiple external data sources. Several layers of data can be displayed at once with infinite customization options that are easily accessible and dynamic. Request a demo and see how we can help. Excellent summary Kris Wenzel and Luke Ely. #OneMMS #DataCRO

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As my twins enter their senior year in college, I remind them of the value and importance of a mentor. A mom’s words often fall on deaf ears and the question back to me was “Who were my mentors? How did they help who I am? “Today, I choose to highlight 2 of them with sincere gratitude. Paul Hollenberg, PhD my graduate advisor, shattered every myth on authoritative leadership one reads or hears about in academia and industry. He encouraged ideas from everyone and never had a bone of judgmental prejudice despite being a leading expert on drug metabolism. Paul taught me much more than pharmacology; he established in me a sense of responsibility that a leader must see different points of views and pay it forward in every possible way. His lab was the ultimate amalgamation of students and post docs from around the world and in that diversity was established trust, acceptance and collaboration at the highest level with an end goal in mind. Paul, thank you, for instilling in me the value of being patient with those who need more help, kindness in every thought and deed, perseverance when things don’t work in your favor and most importantly paying it forward to science and community and always having a vision larger than individual success. I am truly blessed to have applied to and being accepted as your student 32 years ago.Mike Poole was my first supervisor in the pharma industry and my drug development mentor. All that I know today started with Mike. I never applied for the role he had posted, I was an HR surrogate for an already-filled position; and sincere gratitude to Mike for trusting me with the Lyrica pain trials. Mike is patience personified, a great listener and does not rush to judgment, all traits I have worked hard to incorporate throughout my career.A teacher at heart, Mike can explain complicated concepts with simplicity. He was and still is very approachable, and my learning there was access to leaders builds more leaders and is essential for an organization’s success. No task was too big or small for Mike; we closed studies together and made calls to sites as needed. From him, I learned a leader must be a doer and walk the talk.His mentorship in decision-making, win-win problem solving and in his words “listening to that inner voice in me, even if it is contrary to what everyone was saying” has played a huge role in my growth. Mike, that is one of the most valuable lessons from you I am grateful for, starting with an early amendment to the PHN study for CrCl to some management decisions at the present time. The power of your gut instinct does matter.Today, Mike continues to guide me on our board and mentor me as a leader to do better every day. And, let me remind you, he is the best neurologist, the world will ever see.It is an absolute privilege to share my mentors and their kindness in helping me be the person I am; and to my sons, thank you for the prompt that made me take a moment to draft this post.

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At #OneMMS we have worked with regulatory nuances with psychedelics and how best to navigate this unchartered terrain in drug development. Come hear Ritchie Patton talk and meet our teams in Boston this week at the 4th annual psychedelic and drug development conference for an insightful discussion.

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What an incredible honor especially since this is driven by colleague surveys. Congratulations #OneMMS. We have set the bar high in all regions globally.

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