Stephen Paul Mahinka
Email: smahinka@morganlewis.com
- Washington, D.C.
-
1111 Pennsylvania Ave., NW
Washington, DC 20004-2541
Phone: 202.739.5205
Fax: 202.739.3001
Publications
| Date | Type | Title |
| 05/02/2012 | Presentation | Update on the Biosimilars Competition and Innovation Act: Overview and Life Cycle Planning for Biosimilars, presented at the BioNJ Diamond Circle Board of Trustees Meeting |
| 03/05/2012 | Outside Publication | Consumer Financial Protection Bureau: What It Is, What to Expect, BNA's Daily Report for Executives |
| 02/17/2012 | LawFlash/Client Alert | FERC Reaffirms Policy for Assessing Horizontal Market Power |
| 02/09/2012 | LawFlash/Client Alert | FDA Issues Three Draft Guidances for Biosimilars |
| January 2012 | Morgan Lewis Title | The Consumer Financial Protection Bureau (CFPB): What It Is and What to Expect |
| 2011 | Outside Publication | Co-author, Prescription, Drug Promotions and Marketing, FDLI’s Food and Drug Law Regulation 2011, 2nd edition |
| 12/05/2011 | Presentation | Comparative Effectiveness Research: Impact on Pharmaceutical Pricing and Marketing, presented at the QI Productions Conference on Integrating Comparative Effectiveness Research, Philadelphia |
| 12/01/2011 | Outside Publication | FTC/DOJ Final Policy Statement on Accountable Care Organizations:
Important Antitrust Issues Remain Unanswered, BNA's Health Law Reporter |
| 10/31/2011 | LawFlash/Client Alert | FTC/DOJ Final Policy on Accountable Care Organizations: Important Antitrust Issues Remain Uncertain for Healthcare Collaborations |
| 10/18/2011 | Presentation | The CFIUS Review Process: Trends and Challenges, presented to the Delegation of the State-owned Assets Supervision and Administration Commission (SASAC), People’s Republic of China |
| 09/23/2011 | Presentation | The Biosimilars Competition and Innovation Act: Overview and Life Cycle Planning for Biosimilars, presented at American Conference Institute’s FDA Boot Camp, Boston |
| 06/06/2011 | Presentation | New Government Healthcare Policies -
Impact on Growth and Investment in the Biopharma Industry, presented at the US – Japan Health Sciences Dialogue 11th Annual Meeting, Philadelphia |
| 05/23/2011 | LawFlash/Client Alert | FDA Requests Comments on the Development of a User Fee Program for Biosimilar and Interchangeable Biological Products |
| 03/03/2011 | LawFlash/Client Alert | China's New National Security Review Process for Foreign Investments: U.S. CFIUS Review Moves East |
| 01/21/2011 | Outside Publication | Prevent Legal Risk, Be Successful in the U.S. Market, China Enterprise News (View Article) |
| 01/07/2011 | LawFlash/Client Alert | FDA Food Safety Modernization Act Summary |
| 12/23/2010 | LawFlash/Client Alert | FDA Food Safety Modernization Act Greatly Expands FDA Enforcement Powers |
| 12/14/2010 | Presentation | The Antitrust Merger Review Process |
| 12/13/2010 | Presentation | The CFIUS Review Process |
| 10/28/2010 | Presentation | Preparing for a Biotechnology M&A – Corporate and Regulatory Insight to Keep Ahead of the Competition |
| 10/14/2010 | Presentation | Implications of DOJ / FTC Revised Merger Guidelines |
| 10/07/2010 | LawFlash/Client Alert | FTC Releases Proposed "Green Guides" Revisions |
| 07/20/2010 | Presentation | Potential Effects of Healthcare Reform Law on the Medical Device Industry and its Customers |
| 07/12/2010 | Outside Publication | Proposed Merger Reform's Effects On FERC Analysis, Law360 |
| 05/11/2010 | Presentation | Life Sciences Mergers and Acquisitions: How Healthcare Reform Will Change Your Partnership Strategy, presented at a Elsevier Business Intelligence Webinar |
| 04/22/2010 | Presentation | How Regulatory Structures are Taking into Account Scientific Developments in Assessing Approved Food Contact Products, presented at the 2010 Food and Drug Law Institute
Annual Conference, Washington, D.C. |
| 04/19/2010 | LawFlash/Client Alert | Healthcare Reform Law: Comparative Effectiveness Provisions Concerning Healthcare Products and Services |
| November/December 2009 | Outside Publication | 21st Century Toxicology and its Implications for FDA Regulation of Food-Contact Substances, FDLI Update |
| 10/01/2009 | Presentation | New Trends Affecting Pharmaceutical and Medical Device Life Cycle Risk Management, presented at the Fourth National FDA Regulatory Symposium, Washington, D.C. |
| 07/16/2009 | Presentation | Detecting Off-Label Promotion Issues That Can Derail a Life Sciences M&A, presented at ACI's 6th Annual Pharmaceutical Counsel's Guide to Off-Label Communications, Philadelphia |
| 03/27/2008 | Presentation | Solving the Challenges of Regulatory Compliance Through Technology, presented at the 51st Annual Food and Drug Law Institute/FDA Conference, Washington, D.C. |
| 03/13/2008 | Presentation | Critical Regulatory Concerns that Must be Addressed in a Life Sciences M&A, presented at the American Conference Institute, New York |
| 2008 | Outside Publication | The Centrality of Regulatory Due Diligence in Life Sciences M&A (Chapter 2), Life Sciences Mergers and Acquisitions (Aspatore Books) |
| 11/08/2007 | Presentation | How Are New Safety Concerns Affecting FDA Approvals and CMS Reimbursement of Bio/Pharma Products, presented by The Center for Business Intelligence |
| 10/02/2007 | Presentation | Regulatory Trends Affecting Product Approvals and Reimbursement of New Drugs and Biologics, presented at the 8th Annual Philadelphia-Japan Health Sciences Dialogue, Philadelphia |
| 06/18/2007 | Outside Publication | New Risks, New Plan: Drug Safety Concerns Show Need for Sophisticated Risk Management, Legal Times, Vol. 30, No. 25 |
| 04/13/2007 | Presentation | Panel Discussion with the Director of the FDA Center for Drug Evaluation and Research, presented at the 50th Annual Food and Drug Law Institute/FDA Conference, North Bethesda, MD |
| 03/15/2007 | Presentation | The Six Regulatory Issues That MUST Be Addressed in a Life Sciences M&A, presented to the American Conference Institute, New York |
| 03/02/2007 | Presentation | Potential Challenges to Pricing of Biotech Products: Medicare/Medicaid and Related Pricing Developments, presented at the 2007 BIO General Counsels' Committee Meeting |
| 2006/07 | Outside Publication | Overview of Healthcare Fraud Investigations in the U.S., PLC Cross-border Life Sciences Handbook 2006/07 |
| 08/24/2006 | Presentation | Risk Management Strategy for the Pharma and Biotech Product Lifecycle: New Regulatory and Legal Focus and Approach, presented at the 2nd Annual FDA Regulatory and Compliance Symposium, Harvard University, Cambridge, MA |
| 06/18/2005 | Presentation | Starting or Expanding a Pharma/Biotech Business in the U.S.: New Legal and Regulatory Issues, presented at the 6th Annual Philadelphia-Japan Health Sciences Dialogue, Japan America Society, Philadelphia |
| 05/24/2005 | Presentation | Pharmaceutical Industry Mergers: Anticipating Antitrust Issues and Surviving the Investigation, presented at the American Conference Institute In-House Counsel Forum on Pharmaceutical Antitrust, Washington, D.C. |
| November 2004 | Outside Publication | Licensing in the Pharmaceutical Industry: Strategies and Questions Regarding Antitrust Premerger Notification, FDLI Update |
| July/August 2004 | Outside Publication | New Medicare Act Provides New Competitive Landscape for the Pharmaceutical Industry, FDLI Update, Vol. 36 |
| 2004 | Outside Publication | Applying Antitrust Law Effectively: The Importance of Simplifying Complexity, Winning Antitrust Strategies (Aspatore Books) |
| 03/17/2004 | Presentation | How to Preserve Your Antitrust Immunity for Lobbying and Obtaining State Actions, presented at the Morgan Lewis Trade Association Teleseminar Series |
| 02/03/2004 | Presentation | "Off-Label" Communications at Risk: Changes and Challenges to Reimbursement for Prescription Drugs, presented to the Washington Legal Foundation, Washington D.C. |
| 01/01/2004 | Outside Publication | The Role of Pharmaceutical Licensing in Product Lifecycle Management: Litigation and Settlement Under the Hatch-Waxman Act (Chapter 8), Licensing Deskbook (Loislaw) |
| 06/23/2003 | Presentation | FDA Approval of Generic Biologics: Adverse Effects on Industry Innovation and Valuation, presented at the Biotechnology Industry Organization Annual Conference, Washington, D.C. |
| April 2003 | Outside Publication | Pharmaceutical Licensing in Product Lifecycle Management: Litigation and Settlement Under the Hatch-Waxman Act: Parts One and Two (March and April 2003), Licensing Journal |
| 02/28/2003 | Outside Publication | FDA Must Clarify Drug Makers' Ability to Publicly Defend Products, Litigation Legal Foundation Legal Update, Vol. 13, No. 7 |
| 10/01/2002 | Presentation | FDA Approval of Drugs Under Section 505(b)(2): Potential Expansion and Legal Concerns, presented at the Regulatory Affairs Professionals Society Annual Conference, Washington, D.C. |
| 08/01/2002 | Outside Publication | FDA Challenges to Pharmaceutical Company Control of Product Lifecycle Management, FDLI Update |
| 04/17/2002 | Presentation | Outstanding Issues for FDA's Center for Drug Evaluation and Research Affecting Pharmaceutical Product Lifecycle Management, presented at the Food and Drug Law Institute Annual Conference, Washington, D.C. |
| 03/18/2002 | Outside Publication | A Beautiful Space: A Real Estate Special Report, Legal Times, Vol. 25, No. 11 |
| March 2002 | Outside Publication | Pharmaceutical Pricing: System Changes And Global Effects, Metropolitan Corporate Counsel |
| October 2001 | Presentation | Dealing With Antitrust Questions in Mergers and Acquisitions, presented at the Utility M&A Conference, San Antonio |
| October 2001 | Morgan Lewis Title | The Microsoft Ruling |
| August 2001 | Outside Publication | U.S. Pharmaceutical Pricing: System Changes and Global Effects, Life Sciences Industry Report |
| May 2001 | Outside Publication | Preclosing Cooperation in Energy Mergers: Antitrust Issues and Practical Concerns, Project Finance Monthly |
| January 2001 | Outside Publication | It's Worse Than You Think: US Regulatory Changes Require Pharmaceutical Company Attention, International Financial Law Review: Competition & Antitrust (Special IFLR Supplement) |
| November 2000 | Outside Publication | Preclosing Cooperation in Energy Mergers: Antitrust Issues and Practical Concerns, The Electricity Journal |
| 09/04/2000 | Outside Publication | Expect Big Change in Drug Pricing System, The National Law Journal |
| 04/07/2000 | Presentation | Antitrust Issues in Electricity Mergers and Joint Activities, presented at the Edison Electric Institute Legal Conference, Colorado Springs, CO |