Sign in to view Amit K.’s full profile
Welcome back
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
or
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
Greater Boston
Contact Info
Sign in to view Amit K.’s full profile
Welcome back
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
or
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
5K followers
500+ connections
Sign in to view Amit K.’s full profile
Welcome back
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
or
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
View mutual connections with Amit K.
Welcome back
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
or
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
View mutual connections with Amit K.
Welcome back
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
or
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
Sign in to view Amit K.’s full profile
Welcome back
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
or
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
About
Welcome back
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
Experience & Education
-
Vertex Pharmaceuticals
********* **** *********, ***** ******* *** ******** ******* *******
-
************* ********** ************
********* **** *********, ******
-
***
****** ************ *** ******
-
******** ****** ********** - ****** ****** ** ********
******** ** ******* (**)
-
-
***** ********** ****** ** ***
****** ** *** (**)
-
View Amit K.’s full experience
See their title, tenure and more.
Welcome back
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
or
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
Organizations
-
Tepper School of Business, Carnegie Mellon
Business Board of Advisors
- Present -
The Vertex Foundation
Board Chair
- PresentThe Vertex Foundation is committing to over $500M in philanthropic giving and donations from 2017-2027
-
Eiger BioPharmaceuticals
Board Member
- PresentChair, Nominations and Governance Committee Member, Compensation Committee
-
Imagine An Answer to Kids' Brain Cancer
Board Member
- Present -
Team Impact
National Board Member
- -
Stanford University Center for Longevity Studies
Advisory Board Member
- -
MassBio
Board Member
-
View Amit K.’s full profile
Sign in
Stay updated on your professional world
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
Other similar profiles
-
Jonathan Biller
United StatesConnect -
Carmen Bozic MD
Boston, MAConnect -
Samantha Ventimiglia
Senior Vice President at Vertex Pharmaceuticals
Chevy Chase, MDConnect -
E. Morrey Atkinson
Boston, MAConnect -
Mike Tirozzi
Greater BostonConnect -
Nina Devlin
Boston, MAConnect -
Ludovic Fenaux
Boston, MAConnect -
Jenny Inglefield
Boston, MAConnect -
Duncan McKechnie
Greater BostonConnect -
Deborah Ebert Long MD
Boston, MAConnect -
Bastiano Sanna
Boston, MAConnect -
Ali Mohamadi
Chevy Chase, MDConnect -
Felicia Pagliuca
Boston, MAConnect -
Robert Coughlin
Greater BostonConnect -
Kristin Murray
Gloucester, MAConnect -
John LaRocca
New York City Metropolitan AreaConnect -
Blaine McKee
Cambridge, MAConnect -
Howard Hacker
Dallas, TXConnect -
Dana O'Brien
Portland, Maine Metropolitan AreaConnect -
Renu Vaish
Wayne, PAConnect
Explore more posts
-
COTA
COTA Announces Extended Collaboration with FDA to Advance the Use of Real-World-Data in Cancer Research New York, May 22, 2024– Today, COTA announced an extension of its research collaboration with the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence. Under the collaboration, the two organizations will continue to jointly develop and implement research projects to advance the use of real-world data (RWD) and explore the potential strengths and limitations of using real-world evidence (RWE) for regulatory purposes. This collaboration serves as an extension of the agreement between COTA and the FDA established in 2018. To date, the partnership has yielded numerous oncology research studies that have been presented at the annual meetings of the American Society of Hematology (ASH) and the American Association for Cancer Research (AACR). The collaboration has been extended for an additional 5 years, focusing on leveraging real-world evidence to strengthen regulatory decision-making. COTA and the FDA will evaluate RWD study designs and analytic methods through the collaborative development of priority, clinically meaningful research questions regarding care, treatment, and outcomes of patients with cancer. “We are excited to continue our work with the FDA to explore the use of real-world data in oncology research and drug development,” said C. K. Wang, COTA’s chief medical officer. “Collaboration with institutions like the FDA are critical to advancing the speed and accuracy in which new drugs are evaluated and made available to patients.” This collaboration will facilitate the use of new oncology data sources to support the mission of the OCE Scientific Collaborative. Additionally, the collaboration will support a better understanding of the use of therapies and associated diagnostics in real-world settings, along with exploration of the modifiable and non-modifiable factors influencing outcomes in real-world practice to inform regulatory science objectives. #realworlddata #realworldevidence #fda #oncologyresearch #cancerresearch #pharma #oncology
111
3 Comments -
William Sarraille
Part 2 on #BMS’ and #Janssen’s #IRA Loss: The 1st Amendment Claim I posted earlier on how the U.S. District Court for New Jersey took BMS and Janssen to the wood shed on their #Takings Clause challenge to the #inflationreductionact. Today, I take a look at why the court rejected their #1stamendment claim. Although I wasn’t much of a fan of this argument at first, I do think there are some weaknesses in the court’s decision, which can be exploited in the inevitable appeal to follow. The Claim: The best version of the 1st Amendment claim that plaintiffs asserted was what is called an “unconstitutional conditions” argument. Under that doctrine, the government can’t condition even a benefit it offers on a party surrendering a #constitutional right. Plaintiffs contend that, even assuming they are willing to accept a #Medicare “fair price”, they must sign an agreement that endorses that “fair price” rhetoric—even though they believe that it isn’t a “fair price”—that it’s actually a price control. To stay in the federal programs and not be subjected to a huge penalty, they have to sign a contract that endorses the gov’s political messaging. The Court’s Rejection: The court wasn’t buying what plaintiffs were selling. For the court, signing a contract that replicates the statutory language is conduct, not speech. Further, to the extent that plaintiffs’ speech was affected, the effect is only “incidental”. Finally, the court tries to nail the lid over the coffin of plaintiffs’ claim by stating that, “[n]otably, nothing in the statute prevents Plaintiffs from publicly criticizing the Program”, before or after the agreement is signed. My Take: This “three layered” argument is classic district court strategy to insulate a decision from appellate reversal, and my gut tells me that, in the Third Circuit, where this appeal is headed, it’s likely to be successful. But there are 3 things that really bug me about this decision. First, it’s naive at best, and disingenuous, at worst, to say that this contract and its impact is merely “incidental” from a speech perspective. Nothing about the IRA and the existential, bare-knuckled fist fight that has broken out around it is merely “contractial” or simply “incidental”. Second, we already have seen how the gov has seized on #drug makers’ decision to enter into “negotiations” to win political points—to build its political message that the IRA really is a “negotiation” and that the process is “fair”. Do you really think that the gov won’t use a drug makers’ signature on a contract that formally accepts a “fair price” for political purposes? If you do, there’s this bridge I’d like to talk to you about. Third, if the President does trumpet a drug makers’ endorsement of “fair price” when it signs an IRA contract, will it really matter that before or after the manufacturer says that wasn’t its intent? I don’t think so. Not hardly. #partd #freespeech #drugpricing #drugdevelopment Nyah Phengsitthy
8
-
Kendalle Burlin O'Connell, Esq.
We started out Q1 with cautious optimism and the numbers continue to show the confidence was warranted. Biopharma M&A activity more than doubled nationally during the year’s first three months, coinciding with a rebound in venture capital deals as well as a flurry of IPOs. These are all good signs that the drug development cycle is normalizing and should translate into additional funding being available at the seed and Series A stages. Certain to be on the minds of funders and startups attending #AlignSummit24 on Thursday! https://lnkd.in/erEiJm6S
112
5 Comments -
World Pharmaceutical Frontiers
🌐 ONO Pharmaceutical Acquires Deciphera for $2.4 Billion, Expanding Cancer Care Horizons! 🧬 ONO PHARMA USA has made a strategic move by acquiring Deciphera Pharmaceuticals for $2.4 billion. Deciphera, now operating as an independent subsidiary from its Waltham headquarters, brings its specialized cancer treatments and research into ONO’s portfolio. This deal involves a 74.7% premium on Deciphera's last share price, highlighting ONO's commitment to enhancing its oncology offerings. Among the standout products from Deciphera is QINLOCK, approved for treating gastrointestinal stromal tumors in over 40 countries, along with promising candidates like vimseltinib. ONO's CEO, Gyo Sagara, commented, "This acquisition enlarges our oncology portfolio and propels our business development in key markets. We admire Deciphera’s innovative spirit and look forward to our joint future." Steve Hoerter, CEO of Deciphera, shared, "This partnership boosts our ability to enhance cancer care, delivering significant value and hope." Discover more about this transformative deal here: https://lnkd.in/g4-gk3St Stay at the forefront of pharmaceutical innovations by following World Pharmaceutical Frontiers. #Oncology #Pharmaceuticals #HealthcareInnovation #MergersAndAcquisitions #WorldPharmaceuticalFrontiers 🌍
5
-
Dr. Timos Papagatsias
Thoughts on this? >> Penn, Gene Therapy Program director motion to dismiss lawsuit alleging unethical, illegal conduct - The Daily Pennsylvanian >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #healthcare #competitivemarketing #biotech #pharma #pharmaceutical
-
Mohit Manrao
It’s undeniable that the current health disparities at the local levels are increasing, and more individuals are falling through the cracks. Now, more than ever, we must harness innovation and collaboration to address these health disparities and improve equitable access to care for everyone. In my recent interview with Michael Gibney from PharmaVoice, we explored how AI is becoming a game-changer in tackling health disparities in cancer care. From pioneering screening initiatives to data-driven insights, the opportunities in leveraging AI to bridge the gap in health outcomes is endless. Innovation isn't just about developing ground-breaking treatments; it's about making sure those breakthroughs reach all populations who needs them. Everyone, regardless of their ZIP code, deserves access to cutting-edge cancer treatments. AI presents a tremendous opportunity to address these disparities head-on. Collaborating with diagnostic companies and AI innovators, we're using data to expose the disparities in care and address screening and access issues head-on. Our goal is steadfast: to leave no one behind in the battle against cancer. Together, we can eliminate the ZIP code lottery in cancer care and pave the way for a more equitable healthcare system. Read more from my recent interview here: https://lnkd.in/eEg5h_pv #HealthEqutiy #AI #Innovation #Leadership
521
11 Comments -
Avalere
#AvalereExpert Mark Gooding moderated a panel at #BIO2024 on access and affordability considerations for patients and manufacturers in a post-#IRA world. Read highlights from his conversation with Anna Hyde, Valerie Reynolds, and Eric Gascho: https://lnkd.in/e_F3NZqM #patients #patientsupport #healthpolicy #healthcare #InflationReductionAct
21
-
Alethium Health Systems
Day 2 Highlight at World Orphan Drug Congress in Boston 🌐 Industry insights on partnering in the rare disease space struck a chord with us. Panelists discussed the advantages of partnerships between large and small biopharma and pharma companies. While established organizations can bring more resources to the development of medical treatments, smaller companies often have a deeper understanding of rare diseases and innovative approaches to problem-solving. 💡 Our agile team at Alethium Health has designed our clinical trial platform to anticipate nuanced needs and challenges before they happen. We’ve optimized trials by adjusting for patient or caregiver struggles, such as incorporating televisits and providing additional translations, to make clinical trials globally accessible at exceptional speed, reduced costs, and minimal risk. 🚀 #ClinicalTrials #OrphanDrugCongressUSA #DigitalClinicalTrials #RareDisease
4
-
Chemenu
BMY announced new four-year Sotyktu (deucravacitinib) data demonstrating durable response rates and consistent safety in moderate-to-severe plaque psoriasis. Deucravacitinib is a specific, oral, intracellular TYK2 inhibitor that targets immune responses driven by type 1 IFN and IL-23 that contribute to psoriasis pathogenesis, including IL-17 production and Th1/Th17 polarization. Chemenu team is always committed to developing more compounds for drug discovery. Here come the related building blocks we can provide: https://lnkd.in/gcZukP_i 👇 #Chemenu #BMY #Sotyktu #deucravacitinib #psoriasis #TYK2inhibitor #type1IFN #IL-23 #IL-17production #Th1/Th17polarization #drugdiscovery #buildingblocks
-
CLAUDIA VASCONCELOS (She-Her-Hers)
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/dXTCpAsV #ParexelBiotech #ResearchSites #Oncology #NovelInsights
-
Jacob Bell
For the second year in a row, BioPharma Dive has won the Jesse H. Neal Award for Best Industry Coverage. Our submission included stories on a patent cliff threatening many of the pharmaceutical industry's top-selling medicines; a gene therapy that has sparked hope but also served as a major test to the FDA; and an in-depth look at a high-profile ALS treatment center and its never-before-attempted clinical trial. Congrats to the entire BioPharma Dive team, Ned Pagliarulo Gwendolyn Wu Delilah Alvarado Jonathan Gardner and Ben Fidler. Links to those stories are below: #biotech #pharmaceutical #biopharma As ALS research booms, one treatment center finds itself in the spotlight https://lnkd.in/e-N9dvWX ‘The luckiest of the unlucky’: A Duchenne gene therapy brings hope to families — and tests the FDA https://lnkd.in/eqZP7jCj Big pharma’s looming threat: a patent cliff of ‘tectonic magnitude’ https://lnkd.in/eSt29cCa
29
-
Kendalle Burlin O'Connell, Esq.
Appreciate John Glasspool’s op/ed in the Boston Business Journal. He brings the perspective of a CEO of a Cambridge-based #biotech, MassBio member Anthos Therapeutics, to the debate over the White House’s plans to use Bayh-Dole as a blunt instrument to force price controls. The reality is that any effort to use “march in” rights like this would hurt innovation, chill the collaborative relationship between research institutes and small biotechs (which are the lion’s share of Massachusetts’ industry) when it comes to advancing early science, and do nothing to address the price of drugs. You can’t argue with Bayh-Dole’s success: 6 million jobs, $2 trillion in economic output, thousands of startups, and 200+ drugs and vaccines. As John points out, we can’t go back to a time when science sat on shelves instead of getting into medicine cabinets. https://lnkd.in/ezkNndKA cc: The Bayh-Dole Coalition
32
3 Comments -
Blue Matter
The annual meeting of the American Society of Clinical Oncology (ASCO) ended this week. Members of our team were there. Here's brief summary of the key themes that stood out from the meeting >> https://lnkd.in/ePVjs2ZH Authors: Mary Lee, Shankar Sundar, & Tahel Noy #oncology #cancerresearch #biotech #pharmaceuticals #ASCO2024 #ASCO24
40
-
Applied Clinical Trials Magazine
📹In the fifth and final part of this video interview series, Ken Getz, executive director and research professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine and Steve Young, chief science officer, CluePoints look ahead to the future of risk-based quality management and what adoption will look like
9
-
Joan Koerber-Walker
This June 21, 2024 NYT article focuses on "powerful forces that often escape attention, because they operate in the bowels of the health care system and cloak themselves in such opacity and complexity that many people don’t even realize they exist. They are called pharmacy benefit managers. And they are driving up drug costs for millions of people, employers and the government." #WorthReading #Healthcare #DrugCosts #PatientAdvocacy #HealthInsurance #PBMs https://lnkd.in/gV4rdgQG
8
-
AJMC - The American Journal of Managed Care
A panel of experts, led by Ryan Haumschild PharmD, MS, MBA, CPEL, discuss the impact chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) have on patient quality of life and explore current treatment strategies in CLL and SLL management. Watch the series here: https://bit.ly/4aXuhr2 #CancerCare
5
-
InScienceWeTrust BioAdvisory
https://conta.cc/3VYfeJm Sanofi has decided to shut down Kiadis Pharma N.V., a biotech firm specializing in natural killer (NK) cell therapies, just three and a half years after its acquisition for $357 million. The termination was related to a clinical trial for SAR445419, an off-the-shelf NK cell therapy for R/R AML. Similarly, Genentech, a Roche subsidiary, has terminated a $3 billion partnership with Adaptimmune. Adaptimmune remains focused on advancing its late-stage autologous pipeline, particularly its afami-cel therapy for advanced synovial sarcoma. Despite an intensifying geopolitical headwind, a small group of China biotech insiders have found out a success formula that leverages the booming China biotech innovations to achieve industry-leading success. In a Fierce Biotech article, some insiders, including our editor Leon Tang, share their experiences and advice on how to leverage Chinese innovations. Our editor Leon Tang proposes a provocative idea: Chinese innovative asset + US clinical development + Global fundraising and deal-making = success.
1
-
The START Center for Cancer Research
Exciting developments are underway at START as we head to the #ASCO2024 Annual Meeting. We're proud to showcase the groundbreaking research led by Dr. Amita Patnaik, MD, FRCPC, Co-Director of Clinical Research at START San Antonio, through three compelling poster presentations: 1. Preliminary results of a phase 1, first-in-human, dose escalation study of the anti-CCR8 cytolytic antibody, CHS-114 (formerly SRF114) in patients with advanced solid tumors. (Co-authored by Dr. William McKean, Clinical Investigator at START Mountain Region) 2. A phase 1 trial evaluating the safety, tolerability, PK, and preliminary efficacy of QTX3034, an oral G12D-preferring multi-KRAS inhibitor, in patients with solid tumors with KRASG12D mutation. 3. An open-label phase 1 study to investigate SGNCEACAM5C/SAR445953 in adults with advanced solid tumors (SGNCEA5C-001). Join us to explore these significant advancements in cancer treatment and their implications for future research. We encourage you to connect with our Principal Investigators at ASCO. Schedule a meeting with our team: https://lnkd.in/eicXPt2T #OncologyResearch #ASCO2024 #ClinicalTrials
40
-
Medical Dialogues
JnJ Seeks USFDA Approval For Tremfya For Moderately To Severely Active Crohn's Disease Johnson & Johnson has announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of TREMFYA (guselkumab) for thetreatment of adults with moderately to severely active Crohn’s disease. This marks the second submission to the FDA for TREMFYA in inflammatory bowel disease this year following an application in March for moderately to severely active ulcerative colitis. The latest submission includes results from the Phase 3 GALAXI program, which was featured as a late-breaking oral presentation at Digestive Disease Week (DDW) 2024 last month. The GALAXI 2 and GALAXI 3 studies were the first-ever double-blind registrational head-to-head trials to demonstrate superiority versus ustekinumab in Crohn’s disease. TREMFYA successfully met the co-primary endpoints for both SC maintenance doses (200 mg every 4 weeks [q4w] and 100 mg every 8 weeks [q8w]) compared to placebo in each individual study and demonstrated superiority to ustekinumab in multiplicity-controlled endoscopic endpoints based on data pooled from both studies. David Lee #johnson&johnson #johnson&johnsonnews #USFDA #tremfya #guselkumab #crohnsdisease #inflammatoryboweldisease #ulcerativecolitis
1
Explore collaborative articles
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
Explore More