During this session, the panelists discussed how stakeholders in the clinical research market can leverage new technologies to better identify subjects, optimize trial conduct and reduce costs. For example, common use cases...more
On June 26, 2024, the US Food and Drug Administration (FDA) released its much-anticipated draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies....more
7/16/2024
/ Clinical Trials ,
Comment Period ,
Diversity ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Life Sciences ,
Patient Privacy Rights ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation
On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited...more
9/6/2023
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Food and Drug Administration (FDA) ,
Healthcare ,
Informed Consent ,
IRB ,
Life Sciences ,
Medical Research ,
New Guidance ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Scientific Research
Remarkable progress in DNA and RNA sequencing have democratized the generation and analysis of genomic data across diverse industry sectors, including biopharmaceutical research, healthcare, consumer ancestry, law...more
In this session, panelists discussed common pitfalls that life sciences companies face as they explore ways to incorporate digital-health strategies into product and service offerings, as well as approaches for successful...more
Over the past few years, the life sciences and healthcare industries have experienced a notable increase in focus and interest in decentralized clinical trials (DCTs), in which some or all of the trial-related activities...more
Life sciences organizations have become some of the world’s most watched businesses and the industry as a whole is facing heightened scrutiny in light of the COVID-19 pandemic.
The transactional and regulatory issues as...more
You won’t want to miss four days of exclusive, virtual events that bring together industry leaders, emerging standouts, innovators and investors from across the industry landscape at the largest healthcare investment...more
1/6/2021
/ Business Development ,
Business Disruption ,
Business Strategies ,
Collaboration ,
Coronavirus/COVID-19 ,
Digital Health ,
Funding Arrangements ,
Health Care Providers ,
Health Technology ,
Healthcare Facilities ,
Hospitals ,
Innovation ,
Investors ,
Legislative Agendas ,
Life Sciences ,
Physicians ,
Private Equity ,
Regulatory Requirements ,
Webinars
You won’t want to miss four days of exclusive, virtual events that bring together industry leaders, emerging standouts, innovators and investors from across the industry landscape at the largest healthcare investment...more
1/6/2021
/ Biden Administration ,
Coronavirus/COVID-19 ,
Digital Health ,
Funding Arrangements ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Reform ,
Hospitals ,
Innovation ,
Investors ,
Joint Venture ,
Legislative Agendas ,
Life Sciences ,
Partnerships ,
Physicians ,
Private Equity ,
Special Purpose Acquisition Companies (SPACs) ,
Webinars
You won’t want to miss four days of exclusive, virtual events that bring together industry leaders, emerging standouts, innovators and investors from across the industry landscape at the largest healthcare investment...more
1/6/2021
/ Acquisitions ,
Biopharmaceutical ,
Business Valuations ,
Buyers ,
Coronavirus/COVID-19 ,
Digital Health ,
Funding Arrangements ,
Health Care Providers ,
Health Technology ,
Healthcare Facilities ,
Hospitals ,
Innovation ,
Investors ,
Life Sciences ,
Liquidity ,
Mergers ,
Partnerships ,
Pharmaceutical Industry ,
Physicians ,
Private Equity ,
Sellers ,
Telehealth ,
Webinars
You won’t want to miss four days of exclusive, virtual events that bring together industry leaders, emerging standouts, innovators and investors from across the industry landscape at the largest healthcare investment...more
1/6/2021
/ Coronavirus/COVID-19 ,
Digital Health ,
Funding Arrangements ,
Health Care Providers ,
Health Information Technologies ,
Healthcare Facilities ,
Hospitals ,
Innovation ,
Investors ,
Life Sciences ,
Physicians ,
Private Equity ,
Webinars
In a year marked by unexpected challenges and rapid change, staying connected with industry peers and keeping a watchful eye on market trends, policy developments and collaborations in the life sciences space is crucial to...more
10/15/2020
/ Acquisitions ,
Collaboration ,
Coronavirus/COVID-19 ,
Cross-Border Transactions ,
Diagnostic Tests ,
Digital Health ,
Due Diligence ,
Early Stage Companies ,
Health and Safety ,
Health Care Providers ,
Healthcare Facilities ,
Infectious Diseases ,
Innovation ,
Investment Banks ,
Investors ,
Life Sciences ,
Mergers ,
Physicians ,
Presidential Elections ,
Startups ,
Telehealth ,
Telemedicine ,
Vaccinations ,
Webinars
In a year marked by unexpected challenges and rapid change, staying connected with industry peers and keeping a watchful eye on market trends, policy developments and collaborations in the life sciences space is crucial to...more
10/15/2020
/ Acquisitions ,
Collaboration ,
Coronavirus/COVID-19 ,
Cross-Border Transactions ,
Diagnostic Tests ,
Digital Health ,
Due Diligence ,
Early Stage Companies ,
Health and Safety ,
Health Care Providers ,
Healthcare Facilities ,
Infectious Diseases ,
Innovation ,
Investment Banks ,
Investors ,
Life Sciences ,
Mergers ,
Physicians ,
Presidential Elections ,
Startups ,
Telehealth ,
Telemedicine ,
Vaccinations ,
Webinars
In a year marked by unexpected challenges and rapid change, staying connected with industry peers and keeping a watchful eye on market trends, policy developments and collaborations in the life sciences space is crucial to...more
10/14/2020
/ Acquisitions ,
Collaboration ,
Coronavirus/COVID-19 ,
Cross-Border Transactions ,
Diagnostic Tests ,
Digital Health ,
Due Diligence ,
Early Stage Companies ,
Health and Safety ,
Health Care Providers ,
Healthcare Facilities ,
Infectious Diseases ,
Innovation ,
Investment Banks ,
Investors ,
Life Sciences ,
Mergers ,
Physicians ,
Presidential Elections ,
Startups ,
Telehealth ,
Telemedicine ,
Vaccinations ,
Webinars
In a year marked by unexpected challenges and rapid change, staying connected with industry peers and keeping a watchful eye on market trends, policy developments and collaborations in the life sciences space is crucial to...more
10/13/2020
/ Acquisitions ,
Collaboration ,
Coronavirus/COVID-19 ,
Cross-Border Transactions ,
Diagnostic Tests ,
Digital Health ,
Due Diligence ,
Early Stage Companies ,
Health and Safety ,
Health Care Providers ,
Healthcare Facilities ,
Infectious Diseases ,
Innovation ,
Investment Banks ,
Investors ,
Life Sciences ,
Mergers ,
Physicians ,
Presidential Elections ,
Startups ,
Telehealth ,
Telemedicine ,
Vaccinations ,
Webinars
Across the US and EU, life sciences companies are pushing diagnostics, antibody testing, vaccines and other efforts forward to flatten the Coronavirus (COVID-19) curve. Our multidisciplinary cross-border life sciences team...more
5/5/2020
/ Acquisitions ,
Contact Tracing ,
Coronavirus/COVID-19 ,
Cross-Border Transactions ,
Diagnostic Tests ,
Digital Health ,
Divestiture ,
Due Diligence ,
Foreign Investment ,
Health Care Providers ,
Intellectual Property Protection ,
Joint Venture ,
Life Sciences ,
Medical Testing ,
Mergers ,
Partnerships ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Vaccinations ,
Virus Testing ,
Webinars
The Coronavirus (COVID-19) pandemic presents significant challenges for clinical trial sponsors. The US Food and Drug Administration issued guidance on March 19, 2020, that provides greater flexibility to adjust clinical...more
Throughout the past year, the healthcare and life science industries experienced a proliferation of digital health innovation that challenged traditional notions of healthcare delivery and payment, as well as product...more
1/29/2020
/ Anti-Kickback Statute ,
Biometric Information ,
California Consumer Privacy Act (CCPA) ,
Department of Justice (DOJ) ,
Digital Health ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Enforcement ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Regulatory Standards ,
Stark Law ,
Telemedicine
Introduction -
Throughout 2017, the health care and life science industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and...more
1/10/2018
/ 21st Century Cures Act ,
Artificial Intelligence ,
Biometric Information ,
Consumer Protection Act ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Information Technologies ,
Health Insurance ,
Life Sciences ,
OIG ,
Privacy Policy ,
Research and Development ,
TCPA ,
Telehealth
The 21st Century Cures Act, signed into law by President Obama on December 13, encourages biomedical research investment and facilitates innovation review and approval processes. Through National Institutes of Health (NIH)...more
On May 1, 2014, the White House released two reports addressing the public policy implications of the proliferation of big data. The first report is by the Executive Office of the President, entitled “Big Data: Seizing...more
5/13/2014
/ Barack Obama ,
Big Data ,
Data Breach ,
Data Protection ,
ECPA ,
Healthcare ,
Legislative Agendas ,
Life Sciences ,
Privacy Laws ,
Privacy Policy ,
Public Policy