Events

Kurt Karst will be presenting “REMS Studies and Generic Entry: Exploring the Latest Regulatory Conundrum Affecting Pharmaceutical Patent Life Cycle Strategies” at ACI’s 12th Annual Maximizing Pharmaceutical Patent Life Cycles conference. New York, NY

Ricardo Carvajal is speaking on “Food Safety Modernization Act Implementation Update” and “New Dietary Ingredients” at the ASQ Food, Drug, and Cosmetic Division’s 22nd West Coast Conference on Dietary Supplement Challenges: cGMPs, Analytical, FSMA, NDI, and More. Paradise Pier Hotel at Disneyland Resort Anaheim, CA

Wes Siegner is a panelist for the “NDI Guidance: Light or Darkness at the End of the Tunnel?” section of the Seventh Annual Nutrition Law Symposium. Thanksgiving Point Golf Club Lehi, UT

Roger Thies will be speaking on “FDA Update” at the Specialty Pharma Association Fall Conference. Marriott Marquis Hotel & Marina San Diego, CA

Wes Siegner speaking at Specialty Pharma Association Conference on “Overview of Claims and Marketing Strategies for Medical Foods, Foods for Special Dietary Use, and Dietary Supplements”. Marriott Marquis Hotel & Marina San Diego, CA

Kurt Karst will be speaking on “FDA Regulation of Generic Drugs” at the Informa Global Generic Strategy Summit. Kempinski Hotel Bristol Berlin, Germany

Anne Walsh will be a panelist on “Qui Tam (Whistle Blowers) and Fraud Claims – Current Strategies and Developments” at the Greater Philadelphia Alliance for Capital & Technologies Medtech Luncheon. Applebrook Country Club 100 Line Road Malvern, PA 19355

Katie Bond speaking on “How ‘Competent and Reliable’ is Your Scientific Evidence? Meeting the FTC’s Substantiation Standards for Health-Related Advertising” at the Colorado Bar Association Advertising Law.

Jeff Shapiro is speaking at the RAPS Webcast: Advertising, Promotion and Labeling – Marketing in a Regulated Environment. 11:00 am5:30 pm EST

On July 26, 2011, Hyman, Phelps & McNamara, P.C. filed a request for a one-year comment period to allow affected businesses adequate time to respond to a lengthy and controversial draft guidance on New Dietary Ingredient (“NDI”) notifications that FDA issued earlier this month.

Jeff Shapiro will be presenting “Introduction to the Combination Product Sector” at the Clinical and Regulatory Strategies for Combination Products Conference. Baltimore, MD

Kurt Karst will be speaking on “180-Day Exclusivity Forfeiture” at the FDLI Conference: Brands, Generics, and Hatch-Waxman-New Challenges; Unabated Controversy. The Westin City Center Washington, DC

Jef Shapiro is presenting an audio conference on the appeals processes available for medical device companies when FDA takes an adverse action during premarket review of a 510(k) or PMA. He will discuss practical tips and advice on how to resolve a dispute with …

Dave Clissold has been named to the Board of Advisors of Analgesic Clinical Trial Innovations, Opportunities, and Networks (“ACTION”). ACTION is a public-private partnership aligned with FDA’s recently launched Initiative for the Advancement of Regulatory Science. ACTION is designed to benefit the public …

Ricardo Carvajal will be speaking on “The Reportable Food Registry One Year Later: Best Practices for Reporting Events While Minimizing Exposure to Government Investigation or Private Litigation” at the ACI Food Safety Regulatory Compliance Summit. Chicago, IL

Ricardo Carvajal will be presenting at the IFT Annual Meeting. His topics include: Nutrition Labeling Requirements for FDA Nutrition Labeling Requirements Nutrient Content, Structure/Function and Health Claims Other Claims: Production, Processing, and Marketing Create and Evaluate Your Own Food Label The Legal Aspects of Food Allergen Labeling and Control

Jeff Shapiro will be speaking on “Premarket Notification Background, Substantial Equivalence and Techniques for Identifying Predicates for 510(ks)” and on “Advertising and Labeling” at the RAPS Medical Device Submission & Compliance Strategies for the US Market conference. RAPS Training Facility Rockville, MD

Josephine Torrente will be moderating a session titled “From Qualitative to Quantitative-Benefit Risk Models and Patient Perspectives” at the FDLI conference: Issues and Answers – Advancing Risk Evaluation and Mitigation Strategies and Benefit-Risk Management to the Next Level. The Westin City Center Washington, DC

Frank Sasinowski will be presenting at the NORD Partners in Progress celebration. Washington, DC

Kurt Karst will be speaking on “Mastering Regulatory Maneuvers Essential to PIV Litigation” at the ACI Paragraph IV Disputes Conference. New York City, NY

Bob Dormer will be speaking on “Compliance Strategies for the Medical Device Industry” at the Florida Medical Device Symposium. He is also on the Panel Discussion entitled “Current FDA Issues”. Hilton St. Petersburg Carillon Park St. Petersburg, FL

Jeff Shapiro speaking on “When a 510K or PMA Goes Off Track: What Are the Options for Appeal” at the Association of Medical Diagnostics Manufacturers (AMDM) Annual Meeting. Bethesda North Marriott Hotel and Conference Center Bethesda, MD

Hyman, Phelps & McNamara, P.C. is pleased to announce that Linda S. Carter has joined the Firm as a Regulatory Scientist. Linda, who will primarily assist HP&M’s drug development group, brings significant experience and expertise in shaping regulatory policies, particularly Comparative Effectiveness Research, Personalized Medicine, …

Kurt Karst will be speaking on “Disease Subsetting” at the World Orphan Drug Conference. Hilton Embassy Row Washington, DC

Jeff Wasserstein will be speaking on “Our Hearts are a-Twitter: Social Media and Therapeutic Products” at the 54th Annual FDLI Conference. Ronald Reagan Building International Trade Center 1300 Pennsylvania Avenue, NW Washington, DC

Jeff Shapiro will be speaking on “Communicating Effectively with the FDA and Collaborating with the Agency When Implementing a Recall” at ACI’s Drug and Device Product Recalls Summit. The Union League Philadelphia, PA

Kurt Karst will be conducting the Thompson audio conference: Navigating the Orphan Drug Designation Process, & the Benefits of Obtaining Designation. 2:00pm to 3:30 pm

Jeff Wasserstein will be speaking on “Fear Not Pharma: Revolutionizing Your Marketing Strategies to Adapt to Social Media Platforms” at the ACI 9th Expert Regulatory Guide to Advertising, eMarketing and Promotions for the Pharmaceutical Industry conference. The Union League Philadelphia, PA

Josephine Torrente will be speaking on “Expediting Cancer Therapies” at the conference on Regulating the Drug Treatment of Cancer. Sponsored by the University of Washington Schools of Law, Medicine, Public Health & Pharmacy. Room 138 William H. Gates Hall University of Washington Law School Seattle, Washington

Jeff Gibbs moderating the CDRH Breakout Session of the DIA “Marketing Pharmaceuticals 2011: Workshop for Regulatory Professionals and Promotional Review Teams” Washington Marriott Wardman Park Washington, DC

Ricardo Carvajal will be a co-moderator for a session on the impact of the Food Safety Modernization Act at the ABA’s First Annual Workshop on Food and Supplements, Section of Ligation, Food and Supplements Subcommittee of the Products Liability Committee. The Coca-Cola Company 1 Coca Cola Plaza Atlanta, …

Kurt Karst will be speaking on “Generic Drug Preemption” at the Generic Pharmaceutical Association annual meeting. Hilton Orlando Bonnet Creek Orlando, Florida

Jeff Gibbs will be a panelist for the American University Washington College of Law Founders’ event: Personalized Medicine: Ethics, Privacy, DNA and the Future of Medicine 10:00 AM to 3:00 PM American University Washington College of Law, Room 603 4801 Massachusetts Avenue, NW Washington, DC

Josephine Torrente will be speaking on “The New Drug Approval Process: New Drug Research and Development” at the FDLI Introduction to Drug Law and Regulation conference. The Westin Washington, DC

Jeff Shapiro will be speaking on “Legal Issues in Physician-Owned Device Companies” at the Physicians and Physician Organizations Law Institute. The Cosmopolitan of Las Vegas Las Vegas, NV

Kurt Karst will be presenting “New Trends and Challenges in PTE Litigation: Key Cases to Watch” at ACI’s “The Life Sciences Lawyer’s Guide to Patent Term Adjustment and Patent Term Extensions” conference. Downtown Conference Center New York, NY

Ricardo Carvajal speaking on “Unintended Components/Contaminants of Food” at the FDLI Food Week Conference. Washington, DC

BioCentury This Week TV will broadcast a program concerning the latest thinking about how to create a sustainable economic model for both orphan drug developers and payers. The program, titled “The Economics of Orphan Drugs  Why Successful Cures Bring Challenges for Patients and …

Jeff Gibbs will be part of the panel on “Aligning The Regulators and Industry To Accelerate Personalized Medicine Benefits” at the Personalized Medicine World Conference. Silicon Valley, CA

Hyman, Phelps & McNamara, P.C. is pleased to announce that Anne K. Walsh has joined the firm as Of Counsel. Prior to joining the firm in January 2011, Ms. Walsh served as an Associate Chief Counsel with the U.S. Food and Drug Administrations Office …

Doug Farquhar and John Fleder will be conducting the audio conference: Are Attorneys the FDA’s New Enforcement Target? 2:00 pm ET Duration: 60 minutes

Diane McColl has been elected Vice-President of the Council of the International Society for Regulatory Toxicology and Pharmacology (“ISRTP”). ISRTP provides an open public forum for policy makers and scientists promoting sound toxicologic and pharmacologic science as a basis for regulation affecting human safety and …

Kurt Karst will be conducting a Pharmalot webinar on “Navigating The FDA Accelerated Approval Process”. 1:00 PM ET Duration: 1 Hour

Jeff Shapiro will be leading the RAPS webinar and simulcast on “Updates on the FDA 510(k) Clearance Process”

Ricardo Carvajal will be one of the speakers for the Personal Care Products Council Webinar: Product Labeling, Assignment Processes and Global Harmonization of INCI Names. 12:30PM to 2:00PM ET

Susan Matthees will be speaking on “Registration and Listing for Medical Devices” at the FDLI Introduction to Medical Device Law and Regulation conference. Westin South Coast Plaza Hotel Costa Mesa, CA

John Gilbert will speaking on “State and Federal Legal Update on Controlled Substances” at the 8th Annual Controlled Substances Industry, Pharmacy and Listed Chemicals Conference. Crystal Gateway Marriott Arlington, VA

Dara Katcher Levy will be speaking on “Analyzing the Current Pharma Communication Landscape” at the Pharmaceutical Compliance: Off-Label Drug Promotion Conference. Philadelphia, PA

Dave Clissold will be presenting “Clinical Data Falsification” at the Fifth Annual FDA Inspections Summit. Bethesda North Marriott Hotel & Conference Center 5701 Marinelli Road Bethesda, MD 20852

United Therapeutics Corporation (“UTC”), a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions, unveiled a plaque honoring Frank Sasinowski for his contributions to UTC’s development of its REMODULIN (trepostinil) …