#generalcounsel and #regulatory guy working on #clinicaltrials, #marketing and #medicalaffairs in the #LifeSciences š
Philadelphia, Pa
Joined February 2010
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On deck tomorrow at DGE. If DTC, AI, transparency or telehealth touches your world, this matters.
bit.ly/4rMt5zi
#klf #kulkarnilawfirm #DTCCompliance #transparency #AI #influencers
I think the future is real time clinical trials and this is also a way to connect to real world evidence. I've already got some pushback from people saying this is a terrible idea. I disagree.
bit.ly/3Pbjvs5
Remember when we said that AI is going to replace doctors? Doctors are going ah, not today!!
bit.ly/4291LR8
Speaking at DGE in June on surviving the DTC, spending tracking, disclosures, influencers AI and more. Enforcement shifted hard inlate 2025, and many teams are still pretending nothing changed.
bit.ly/4rMt5zi
#klf #kulkarnilawfirm #DTC #Transparency
The news that Purdue Pharma has been sentenced for fraud and kickbacks hits differently when youāve actually dispensed the product.
bit.ly/4eiuzOl
#Pharmacy #HealthcareEthics #PurduePharma #OpioidCrisis #PatientSafety
Iāve always understood that the practice of medicine is primarily regulated at the state level. So Iām trying to reconcile that with the federal governmentās role here.
bit.ly/3P0yd4Z
Do you have any ownership in what looks like you, even if AI generated? bit.ly/4uqUgkE
Patients care about quality of life. For the LGBTQ+ community, that starts with feeling welcome at the clinic. š³ļøāš Involving patients in trial design is just better science.
Full story: buff.ly/h7PTczc
#PatientExperience #ClinicalResearch #klf #kulkarnilawfirm
I was asked to opine on the Medline IPO and alleged failure to disclose prior to its $6 billion IPO. What do you think?
#Medline #FDA #PatientSafety #klf #kulkarnilawfirm
SCOTUS says no to quotas, but yes to bigger funnels. If 10-20% of your target population is LGBTQ+, go where the patients are. Be intentional.
More on the law of DEI in research here: buff.ly/h7PTczc
#DEI #PharmaLaw #klf #kulkarnilawfirm
Regulatory guidance changes every 4 years, but clinical trials last a decade. Don't design your study for 2026 rules only to be rejected in 2030.
Check out my interview with @PennEidos:
buff.ly/h7PTczc
#ClinicalTrials #HealthLaw
Sponsors are pausing their LGBTQ+ inclusion efforts. But risk facing a different regulatory landscape at the time of approval.
Pull back the catapult now to launch stronger later: buff.ly/h7PTczc
#ClinicalResearch #FDARegulations #LifeSciences #HealthEquity #DEI
The regulatory "shield" for many compounding pharmacies has vanished. State Attorneys General are now stepping in and are looking for clinical errors, "research-grade" sourcing and marketing missteps.
Letās talk: buff.ly/lN7417y
#FDAEnforcement #KulkarniLawFirm #klf
Teaching forces you to explain things clearly. On March 31, Iāll be teaching life science entrepreneurship at the University of Delaware. I am focusing on how ideas survive contact with regulation. What should I be sure i talk about?
#klf #LifeSciencesBusiness #EntrepreneurLife
I hate sterile courses! I am teaching a class at the University of Delaware on 3/31 focused on life science entrepreneurship. Ever built, advised, or funded life sciences startups? You know how messy this really is. What is a "twist" you recommend they see them to give a taste?
The DOJās new Civil Rights Fraud Initiative turns compliance gaps into massive False Claims Act liability. Is your DEI program or federal grant certification a litigation magnet?
#klf #kulkarnilawfirm #DOJ #Pharma #MedTech
Later today I will present virtually to Cornell Sloan students on the impact of pharmacy and PBM disruptors. I look forward to a rigorous digital discussion on the future of pharmacy and pharmacy benefits.
#klf #kulkarnilawfirm #RetailPharmacy #HealthPolicy
Excited to be a virtual guest expert for the Cornell Sloan Program in Health Admin this March to discuss the evolution of PBMs.
Lets dive into the regulatory and market forces redefining the retail pharmacy experience.
#klf #kulkarnilawfirm #PharmacyLaw #CornellUniversity
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