Orphan Drugs & Rare Disease
"Effective Orphan Drug Development in a Challenging Regulatory Environment"Presentation
RAPS Regulatory Convergence · Washington, DC · September 2017
"Lessons Learned from the Sarepta Exondys 51 Approval: The Evolving Role of Orphan Drug and Subpart H Flexibility in Drug Approval"Presentation
DIA Annual Meeting · Chicago, IL · June 2017
"Evidentiary Standards for Rare Diseases: How Much Data is Enough?"Presentation
Rare Diseases Webinar Series, DIA · July 2016
"The Evolving Regulatory Landscape for Orphan Drugs"Presentation
FDLI Annual Conference · Washington, DC · May 2018
"Introduction to Orphan Drug Development and Exclusivity"Presentation
New to Food and Drug Law Group, FDLI · Washington, DC · July 2014
"FDA's Flexibility in Subpart H Approvals: Assessing Quantum of Effectiveness Evidence"Publication
Food and Drug Law Journal · 2016
"Orphan Drugs"Publication
Bringing Your Pharmaceutical Drug to Market, FDLI · 2015
Drug & Biologic Development
"FDA's Expedited Programs: Understanding Which Program Best Suits Your Product"Presentation
FDLI Webinar · March 2022
"Optimizing Early Clinical Strategies to Support Breakthrough Therapy Designation"Presentation
DIA Annual Meeting · Chicago, IL · June 2017
"Breakthrough Therapy Designation: An Analysis of FDA's Precedents"Presentation
DIA Annual Meeting · Washington, DC · June 2015
"Regulatory Strategies to Employ When Your Study Doesn't Qualify for Breakthrough/PRIME"Presentation
MassBio Forum · Boston, MA · September 2019
"Choosing the Right Drug Approval Pathway: Speedier Approvals with Less Risk"Presentation
FDAnews Webinar · February 2018
"The New Drug Approval Process: NDA Submission and Review"Presentation
Introduction to U.S. Drug Law and Regulation, FDLI · November 2019
"Navigating the Approval Process for Drugs and Biologics"Presentation
FDA Boot Camp, ACI · September 2021
"Making the Most of Your FDA Interactions to Aid Preclinical or Other Preparatory Studies"Presentation
LSX CEO Forum · October 2020
"How FDA Really Works: Insights from the Experts — Navigating Alternative Pathways for Drugs and Biologics"Publication
FDLI Textbook · 2022
"Psychedelics & Drug Development — Key Considerations for Healthcare Industry and Life Sciences Companies"Publication
Goodwin Client Alert · May 2023
"Compliance Considerations for Virtual Ketamine Clinics"Publication
Law360 Expert Analysis · December 2022
Clinical Trials & Patient Experience
"Payment for Patient Recruitment in Clinical Trials: Legal and Ethical Issues Associated with Clinical Trials"Presentation
20th Global Cardiovascular Clinical Trialists Forum · Washington, DC · December 2023
"Legal & Statistical Principles Underlying Drug Regulation of Cardiovascular Therapies"Presentation
19th Global Cardiovascular Clinical Trialists Forum · Washington, DC · December 2022
"Patient Voice and Its Role in Bringing Meaningfulness into Selection of Clinical Outcome Measures"Presentation
DIA Annual Meeting · June 2020
"Special Protocol Agreements"Presentation
FDAnews Webinar · October 2016
"Clinical Trial Diversity Planning for Sponsors: What to Know About FDA's Recent Draft Guidance"Publication
Goodwin Client Alert · April 2022
"Conduct of Clinical Trials During the COVID-19 Pandemic: Recommendations from FDA"Publication
Goodwin Client Alert · March 2020
"Patients (May) Know Best: Leveraging the Patient Experience from Development to Commercialization"Publication
Goodwin Client Alert · September 2018
Hatch-Waxman, Exclusivities & Biosimilars
"Updates on Patent and Exclusivity Issues for Drugs, Orphan Drugs, and Biologics"Presentation
FDLI Annual Conference · Washington, DC · May 2023
"Hatch-Waxman and BPCIA Fundamentals: Understanding Follow-On Products and the Rules for Generic Entry"Presentation
FDA Boot Camp, ACI · March 2023
"FDA Approval is Coming: Part 1 — Securing Exclusivities and Maximizing Patent Term"Presentation
Goodwin Webinar Series · November 2022
"Exploring the Link between the FDA Approval Process and the Patenting of Drugs and Biologics"Presentation
Hatch-Waxman and BPCIA Essentials, ACI · October 2022
"Identifying and Comprehending Pre-Commercialization Concerns Relative to Small Molecules and Biologics"Presentation
Hatch-Waxman and BPCIA Essentials, ACI · October 2021
"Intersection of IP and FDA Law: Opportunities for Early-Stage Drug & Biologics Companies"Presentation
Goodwin · Boston, MA · October 2019
"Generics, Biosimilars, and Hatch-Waxman Law"Presentation
Food and Drug Law Seminar, University of Maryland School of Law · February 2020
"Priority Review Vouchers: Past Experiences, Legislative Reform, and Tips for Sponsors"Presentation
DIA Annual Meeting · Philadelphia, PA · June 2016
Advertising, Promotion & Compliance
"Promotion and Marketing of Prescription Drugs, Biologics, and Devices"Publication
FDA Deskbook, Practicing Law Institute · 2016
"Expanded Access Policy Disclosure and Federal Right-to-Try Law"Publication
Goodwin Client Alert · June 2018
"COVID-19: U.S., State Governments Expand Access to Telehealth Services; Reduce Other Barriers to Care"Publication
Goodwin Client Alert · March 2020
"The Regulation of Social Media: Whither FDA"Publication
Using Social Media in FDA-Regulated Industries, FDLI · 2010
Medical Devices & Combination Products
"Cross-Labeling and Devices Referencing Drugs"Presentation
DIA Annual Meeting · Boston, MA · June 2018
"Key Regulatory Considerations for Oncology Companies in 2023"Presentation
MedInvest Oncology Investor Conference · Boston, MA · June 2023
"Trends in Personalized Medicine"Publication
Regulatory Focus · 2013
"Commercialization of Healthcare in the United States"Publication
Thomson Reuters · 1st & 2nd Editions · 2013, 2015