Michael A. Swit
Special Counsel

Duane Morris LLP
750 B Street, Suite 2900
San Diego, CA 92101-4681
USA

Phone: +1 619 744 2215
Fax: +1 619 923 2648
Email: MASwit@duanemorris.com

Michael A. Swit - LinkedIn Read Michael A. Swit's blog Watch video Import to Address Book

Michael A. Swit

Close
 
Watch video

Michael A. Swit's practice focuses on solving the legal challenges confronted by the pharmaceutical, medical device, and other life sciences industries in tackling the myriad of legal mandates enforced by the U.S. Food & Drug Administration. Mr. Swit has extensive experience counseling life sciences firms on the demands of compliance with FDA's statutory and regulatory requirements to develop and market safe and effective drugs, biologics, medical devices, IVDs and other products. He also has advised regulated firms on a wide range of FDA regulatory matters, including drug and device approvals, food labeling and safety issues, dietary supplement health claims, and regulatory issues in corporate acquisitions. His experience includes FDA development strategies, compliance and enforcement initiatives, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts.

Mr. Swit has been addressing critical FDA legal and regulatory issues since 1984. Before joining Duane Morris LLP, Mr. Swit served for seven years as vice president at a preeminent scientific and FDA regulatory consulting firm, where he developed and ensured execution of a broad array of regulatory and other services to clients, both directly and through outside counsel.

His multi-faceted experience includes serving for three and a half years as corporate vice president, general counsel and secretary of Par Pharmaceutical, a prominent, publicly-traded, generic drug company and, thus, he brings an industry and commercial perspective to his work with FDA-regulated companies. While at Par, he spearheaded Par's successful response to multiple federal and state criminal and civil investigations arising out of the actions of prior management. Mr. Swit then served for over four years as CEO of FDAnews.com, a premier publisher of FDA regulatory newsletters and other specialty information products for the FDA-regulated community. His private FDA regulatory law practice also has included service as counsel in the FDA practices of three international law firms, as well as a solo FDA practitioner.

Mr. Swit has taught and written on a wide variety of subjects relating to FDA law, regulation and related commercial activities, including, since 1989, co-directing a three-day intensive course on the generic drug approval process and editing a guide to the generic drug approval process, Getting Your Generic Drug Approved. A former member of the Food & Drug Law Journal Editorial Board, Mr. Swit also has been a prominent speaker at numerous conferences sponsored by such organizations as the Food & Drug Law Institute (FDLI), the Regulatory Affairs Professionals Society (RAPS), and the Drug Information Association (DIA).

Mr. Swit is a 1982 graduate of Emory School of Law and a magna cum laude graduate of Bowdoin College (1979), with high honors in history.

Representative Matters

  • Represented Maryland-based JADS International in addressing Disney/Marvel legal and technical concerns concerning JADS' innovative sunscreen wrist bands - which turn color to remind you to reapply sunscreen - by demonstrating that the product was outside FDA purview and worked as claimed.
  • Represented Kindstar Diagnostics Co. Ltd., in connection with its agreement with BG Medicine, Inc. for Kindstar to offer galectin-3 testing services for heart failure management in China (October 2012).
  • Secured FDA reversal of agency’s initial denial of 3-year exclusivity under Waxman-Hatch Act for OTC switch of drug previously available only via prescription. Involved detailed written submission to FDA on how law applied to particular factual scenario regarding client’s NDA for the Rx-OTC switch.
  • On behalf of a pharmaceutical firm pursuing approval of a product that combined both a drug and medical device, conducted detailed review of applicability of FDA’s “Combination Product” policies. Effort clarified for client when it would need to apply the drug and/or device regulations to its operations relative to a unique combination product that was awaiting imminent FDA approval.
  • Coordinated response of Canadian device manufacturer to FDA detention of devices allegedly misbranded by including claims outside allowed intended uses. Conducted detailed review of labeling claims, including website, Facebook and Twitter postings, to allow client to revise claims to enable it to reintroduce device into U.S. market.
  • Led strategy to fight FDA’s proposed withdrawal of client’s abbreviated new drug application for unique topical drug product. Representation involved detailed written submission, including coordination with expert witnesses. securing drug’s continued marketing.
  • Developed overall strategy leading to filing and approval of New Drug Application (NDA) for innovative drug/device combination narcotic product for breakthrough cancer pain.
  • Coordinated major remediation effort for device maker facing systemic QSR deficiencies following FDA inspection and Warning Letter; effort led to FDA follow-up inspection with just a single observation.
  • Served on detail for over six months as in-house regulatory vice president for biotech client involved with combination biologic/device product, allowing client to resume clinical studies that had been stalled.
  • Penned waiver requests under Pediatric Research Equity Act (PREA) as applicable to NDAs being filed by clients with innovative analgesic products being reviewed under FDA’s 505(b)(2) NDA process.
  • Prepared reply to warning letter issued to IRB resulting in IRB being able to continue operations without further FDA enforcement action.
  • Cleared import detention for importer of combination drug/device from China by conducting detailed label reviews and corrections to labeling.
  • Prepared detailed comments on proposed change to FDA OTC Monograph on hydrocortisone products.
  • Defended OTC drug client’s advertising from competitor’s challenge before National Advertising Division (NAD) of Better Business Bureau.
  • FDA counsel to major compounding pharmacy; led strategy to establish separate subsidiary to obtain formal FDA approval of specialty compounding formulations while maintaining compounding status.
  • Coordinated generic drug company's cooperation with federal criminal and congressional investigations leading to plea bargain agreement that allowed company to stay in business.
  • Developed and oversaw operations of first corporate ethics program for generic drug firm as part of firm’s rehabilitation program following plea bargain for illegal activities of prior senior management.
  • Negotiated agreement with Defense Logistics Agency successfully ending generic drug company's three-year suspension from federal government contracting.
  • Counseled on reclassification petitions for devices including under the FDA’s de novo process for downclassifying devices involving new technology that are automatically classified in most restrictive device class (III), but can be regulated under controls applicable to Class II devices.
  • Coordinated all aspects of recall of pharmaceutical, including securing health assessment, drafting recall letters and press releases, and coordinating with FDA.
  • Secured issuance of FDA regulatory letter against brand name drug firm making improper comparative claims.
  • Intensive review of cosmetic product’s labeling and advertising claims to ensure not “drug” in nature, as well as assessment of comparative and other claims under FTC standards.
  • Detailed review and analysis of impact of FDA’s then new T.E.A. (Time and Extent Application) regulations for OTC drugs.
  • Secured imposition of import alert on gray market Dial® soap (on behalf of “real” Dial®) by showing FDA that foreign-made Dial® contained color additives illegal in United States.
  • Led consortium of eight generic clients fighting FDA's withdrawal of new drug applications for generic versions of Persantine® (dipyridamole) allowing clients to remain on market.
  • Construed applicability of Investigational Use Only (IUO) and Research Use Only (RUO) regulations to marketing of line of diagnostic products.

Areas of Practice

  • FDA Compliance, Enforcement, and Regulation
  • Clinical Research
  • Life Sciences Transactions and Due Diligence

Admissions

  • California
  • U.S. District Court for the Eastern District of Virginia
  • U.S. District Court for the District of Columbia
  • U.S. Court of Appeals for the Fourth Circuit

Education

  • Emory University School of Law, J.D., 1982
  • Bowdoin College, A.B., magna cum laude, 1979

Experience

  • Duane Morris LLP
    - Special Counsel, 2012-present
  • Law Offices of Michael A. Swit
    - Partner, 2012; 2003-2004
  • The Weinberg Group, Inc.
    - Vice President, 2004-2011
  • Heller, Ehrman, White & McAuliffe LLP
    - Special Counsel, 2001-2003
  • McKenna & Cuneo LLP
    - Of Counsel, 1999-2001
  • Washington Business Information, Inc.
    - President and CEO, 1994-1998
  • Par Pharmaceutical Inc.
    - Corporate Vice President, General Counsel and Secretary, 1990-1993
  • McKenna, Connor & Cuneo
    - Associate, 1988-1990
  • Burditt, Bowles & Radzius
    - Associate, 1984-1988
  • Walstad, Kasimer, Tansey & Ittig
    - Associate, 1982-1984

Professional Activities

  • Food & Drug Law Institute (FDLI)
  • Drug Information Association (DIA)
  • Regulatory Affairs Professionals Society (RAPS)
    - Program Committee Member, RAPS Horizons Conference, 2007
  • BIOCOM (San Diego Regional Biotech Trade Association)
    - Co-chair, FDA Committee (2002-2003)
    - Planning Leader, Ethics Session and Clinical/Regulatory Workshops, CalBioSummit, 2003
    - Member, CalBIO Program Committee, 2005
  • Orange County Regulatory Affairs
    - OCRA) Discussion Group
    - Program Committee Member (2000 to present)
    - Co-Chairperson, Drug Track, OCRA Annual Conference (2001, 2002, 2003)
    - Co-Chairperson, Warning Letter Session (2005)
  • San Diego Regulatory Affairs Network (SDRAN)
    - Vice President, Programs, 2001 and 2002
    - Planning Committee, 2003 IND Conference

Board Memberships

  • Food & Drug Law Journal, FDLI, Member, Editorial Advisory Board, 1991-1995.
  • Good Clinical Practice: A Question & Answer Reference Guide, Expert Advisory Panel Member, Barnett International, 2011 to present

Civic and Charitable Activities

  • Board Member, National Organization for Rare Disorders (NORD), 1986-1994

Selected Publications

Selected Speaking Engagements

  • "The Sunshine Act: Understanding the Essentials of Compliance" and "Leaping the Valley of Death: Keys to Successfully Going from the Lab to the Clinic for Pharmaceutical Products," DIA 2014 50th Annual Meeting, San Diego, June 15-16, 2014
  • "Global Patent and Product Liability Challenges," 17th Annual FDA-OCRA Educational Conference, Irvine, California, June 4, 2014
  • "Generic Drug Labeling Proposed Rule and Safety Updates," DIA Webinar, May 15, 2014
  • "Navigating the Regulatory Landscape," Global Technology Community's 2nd Orphan Drugs Research & Commercialization Conference, San Diego, February 21, 2014
  • "Update on FDA Development for Biosimilars," Biosimilars and Follow-On Biologics 2014 Americas Conference, February 12, 2014
  • "Understanding Crucial Issues in the 510(k) Process," Compliance2Go Webinar, January 29, 2014
  • "11th BVS La Jolla Biotech Day Celebration," Biotech Vendor Services Seminar, La Jolla, California, December 11, 2013
  • "Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices," ComplianceOnline Seminar, Cambridge, Massachusetts, November 18-19, 2013
  • "Digital Health: The Smartest Use of Your Phone," Commercializing Software IP: High Tech, Digital Health & Education, Silicon Valley Chapter Meeting, Berkeley, November 13, 2013
  • "Drug Law: Understanding the Essentials of FDA's Authority over Innovative and Generic Pharmaceuticals," ComplianceOnline Seminar, Philadelphia, September 11-12, 2013
  • "Generic Drug Approvals," The Center for Professional Advancement, New Brunswick, New Jersey, August 13-15, 2013
  • "Creative Strategies in Dealing with FDA," PSC Creative Learning Webinar, July 10, 2013
  • "The Gamechanger: Analyzing the Legal and Business Impact of the Generic Drug User Fee Amendments," ACI Legal & Regulatory Summit on Generic Drugs, New York, July 17, 2013
  • "Informed Consent: Promise, Pledge, Contract or Platitude?" DIA 49th Annual Meeting, Boston, June 27, 2013
  • "How to Convert a New Device (PMA) into an Old (510(k)) Device: The De Novo 510(k)," DIA 49th Annual Meeting, Boston, June 26, 2013
  • "Regulatory, Clinical, and Quality Challenges in Contracting and Due Diligence: The Forgotten Keys to Biopharma Transactions," DIA 49th Annual Meeting, Boston, June 25, 2013
  • "DA Enforcement: Understanding the Agency's Authority, How Violations Occur, How to Prevent Them and How to Respond if Violations Do Occur," DIA 49th Annual Meeting, Boston, June 23, 2013
  • "FDASIA—Update on FDA Implementation," American Society for Quality, San Diego Chapter, San Diego, March 12, 2013
  • "Creative Strategies in Dealing with FDA," Compliance2Go Webinar, February 21, 2013
  • "Responding to FDA Inspections & Warning Letters," Compliance2Go Webinar, February 7, 2013
  • "FDA Regulation of Drug and Device Advertising & Promotion," ComplianceOnline, San Francisco, January 24-25, 2013
  • "FDA Regulation of Social Media," Compliance2Go Webinar, November 27, 2012
  • Speaker, "Legal and Regulatory Update— Health Care Reform and FDA Developments," BIOCOM Reimbursement and Market Access Series, San Diego, November 13, 2012
  • "Regulation of Dietary Supplements, Combination Products, and Veterinary Products," San Diego Regulatory Affairs Network Regulatory Affairs Certification Exam Review Course, San Diego, August 29, 2012
  • "Regulation of ANDAs, Orphan Drugs, OTC Drugs and Cosmetics," San Diego Regulatory Affairs Network Regulatory Affairs Certification Exam Review Course, San Diego, August 1, 2012
  • "Crisis Management for the FDA-Regulated Company," FX Audio Conference, May 22, 2012
  • "Internet Issues for Regulatory Professionals—FDA Regulation of Social Media," Orange County Regulatory Affairs Discussion Group, Irvine, California, April 17, 2012
  • Panelist, "FDA – Creative Strategies in Dealing with The Agency," San Diego, March 26, 2012
  • "Biosimilars – Wave of the Future or Child of The Privileged Few?" Licensing Executives Society San Diego Chapter, February 21, 2012
  • "The de novo 510(k) Process – The Impact of the New 2011 FDA Guidance," FxTranslations Audio Conference, February 15, 2012
  • "Crisis Management for Regulatory Professionals," Regulatory Affairs Professionals Society, Rising Leaders Program Audio Conference, December 15, 2011
  • "FDA Enforcement Activities In Clinical Trials Arena," FxTranslations Audio Conference, November 3, 2011
  • "Get to the Clinic on Time," LARTA NIH-CaliforniaP Commercialization Workshop, Los Angeles, November 1, 2011
  • "An Overview of Issued FDA Warning Letters: What Happened and What Can be Learned," ExL Pharma's 2nd Quality Oversight of Clinical Vendors Conference, Washington, D.C., October 18, 2011
  • "Regulatory Challenges in Executing Global Clinical Studies," The Conference Forum's 2nd Annual Executing Global Clinical Trials Conference, Philadelphia, September 15, 2011
  • "Regulation of Dietary Supplements," Lecture at SDRAN RAC Review Course, San Diego, August 25, 2011
  • "Regulation of Generic, OTC and Orphan Drugs, and Cosmetics," Lecture at SDRAN RAC Review Course, San Diego, July 27, 2011
  • "Quality Aspects of Due Diligence for Biopharmaceutical Transactions," DIA Annual Conference, Chicago, June 21, 2011
  • "FDA Enforcement," Tutorial at DIA Annual Conference, Chicago, June 19, 2011
  • "BioSimilars," Orange County Regulatory Affairs Discussion Group/FDA Annual Educational Conference, Irvine, California, June 9, 2011
  • "Regulatory, Clinical and Quality Challenges in the Regulation of Combination Products," The Weinberg Group Inc, Webinar, May 18, 2011
  • "Clinical Trial Registries," Association of Clinical Research Professionals Annual Conference, Seattle, May 3, 2011
  • "IRB Liability," Association of Clinical Research Professionals Annual Conference, Seattle, April 30, 2011
  • "Overview of FDA Issues for In-Vitro Diagnostics," Southern California Biotech Association, Costa Mesa, California, April 13, 2011
  • "Challenges of Orphan Drug Regulation," The Weinberg Group Inc, Webinar, February 23, 2011
  • "BioSimilars," RAPS Annual Conference, San Jose, California, October 25, 2010
  • "FDA Enforcement," RAPS Annual Conference, San Jose, California, October 25, 2010
  • "FDA Regulation of Combination Products," IIR Combination Products Conference, Baltimore, September 23, 2010
  • "Regulation of Generic, OTC and Orphan Drugs, and Cosmetics," Lecture at SDRAN RAC Review Course, San Diego, August 11, 2010
  • "Regulatory, Quality & Clinical Due Diligence: The Oft-Overlooked Keys to Successful Transactions," The Weinberg Group Inc, Webinar, June 23, 2010
  • "Informed Consent – Pledge, Platitude or Contract?" DIA Annual Conference, Washington, D.C., June 16, 2010
  • "FDA Enforcement, Tutorial at DIA Annual Conference," Washington, D.C., June 13, 2010
  • "Regulatory Developments for Drug Delivery," Third Annual Drug Delivery Summit, Arrowhead Conferences, San Francisco, May 14, 2009
  • "510(k) Process," BayBio Breakfast Meeting, Palo Alto, California, May 11, 2010
  • "Review of Key 2009 Cases," FDLI Annual Conference, Washington, D.C., April 22, 2010
  • "CAPA Program," OCRA, Irvine, California, March 10, 2010
  • "Drug Development in Today's Regulatory Environment," NanoTecNexus Webinar, March 4, 2010
  • "Ethical Issues for Clinical Trials," ACI International Clinical Trials Conference, New York, February 24, 2010
  • "How to Respond to a 483," SoCalBio FDA Audit Preparedness Workshop, Irvine, California, December 3, 2009
  • "FDA Enforcement," Amylin Pharmaceuticals In-House Lecture, San Diego, December 1, 2009
  • "Regulatory Pitfalls in Drug Development," American Chemical Society, San Diego Chapter, San Diego, November 18, 2009
  • "Drug Safety," SDRAN/OCRA Drug Development Conference, Carlsbad, California, November 4, 2009
  • Webinar on BioSimilars, RAPS, October 21, 2009
  • "FDA Law," Keck Graduate Institute, Pomona, California, October 7, 2009
  • "FDA Enforcement for Clinical Trials," MAGI West Coast Clinical Trials Conference, San Diego, October 6, 2009
  • "BioSimilars," Foley Life Sciences Day, San Diego, California, September 30, 2009
  • "ANDA vs, 505(b)(2): When and Why," The Weinberg Group Inc, Webinar, September 30, 2009
  • "Regulatory Update, Ophthalmic Drug and Delivery Summit," Pharmaceutical Education Associates, San Diego, September 22, 2009
  • "FDA Enforcement," The Weinberg Group Inc., Webinar, September 9, 20
  • Course on Generic Drug Approvals, In-House at Teva Parenterals, Irvine, California, September 1 and 2, 2009
  • "Regulation of Generic, OTC and Orphan Drugs, and Cosmetics," Lecture at SDRAN RAC Review Course, San Diego, August 12, 2009
  • "Drug Development," Biotech Vendors Services, San Diego, July 22, 2009
  • "Informed Consent," DIA Annual Meeting, San Diego, June 25, 2009
  • "Clinical Trial Registries," DIA Annual Meeting, San Diego, June 24, 2009
  • "How to Respond to a 483," SoCalBio FDA Enforcement Workshop, Los Angeles, June 12, 2009
  • "BioSimilars," Orange County Regulatory Affairs (OCRA)/FDA Annual Educational Conference, Irvine, California, June 10, 2009
  • "Drug Safety," Orange County Regulatory Affairs (OCRA)/FDA Annual Educational Conference, Irvine, California, June 10, 2009
  • "Corporate Health Panel," Orange County Regulatory Affairs (OCRA)/FDA Annual Educational Conference, Irvine, California, June 9, 2009
  • "Drug Safety: Perspectives on Industry's Duties in the Post-Vioxx Age," FDLI Annual Conference, Washington, D.C., April 22, 2009
  • "The Future of BioSimilars, BioGenerics, Follow-on Biologics – A Rose by any Other Name?" New York Biotechnology Association Annual Meeting, New York, April 21, 2009
  • "Crisis Management for Senior Regulatory Professionals," RAPS Horizons Conference, San Francisco, April 2, 2009
  • "FDA Enforcement Issues for Clinical Trials," ACI International Clinical Trials Conference, New York, February 26, 2009
  • "Roadmap to Emerging Regions – Clinical Trials in Developing Countries," ACI International Clinical Trials Conference, New York, February 26, 2009
  • "Overview of FDA Issues for In-Vitro Diagnostics," Southern California Biotech Assn, Pomona, California, February 13, 2009
  • "Overview of FDA Issues for Cardiovascular Devices," Southern California Biotech Assn, Laguna Hills, California, January 28, 2009
  • "The Forgotten Keys to Bio-Pharma Transactions – Regulatory, Clinical & Quality Challenges in Contracting and Due Diligence," Cambridge Healthcare Institute Second Annual Bridging the Business Development /Alliance Management Interface Conference, Boston, November 6, 2008
  • "Regulatory Aspects of Ophthalmic Drug Development," Pharmaceutical Education Associates Ophthalmic Drug Delivery Conference, San Diego, September 22-24, 2008
  • "Regulation of Generic, OTC and Orphan Drug and Cosmetics," Lecture at SDRAN RAC Review Course, San Diego, July 3, 2008
  • "FDA Enforcement," Tutorial at Drug Information Association (DIA) Annual Meeting, Boston, June 21, 2008
  • "Panel Discussion on Generic Biologics," Licensing Executives Society, San Diego Chapter, San Diego, May 20, 2008
  • "IRB Liability," Association of Clinical Research Professionals (ACRP) Annual Meeting, Boston, April 28, 2008
  • "Clinical Trial Registries – Panacea or Pablum?" Association of Clinical Research Professionals (ACRP) Annual Meeting, Boston, April 27, 2008
  • "Clearing the US and EU Regulatory Path to Product Approval," Swedish American Chamber of Commerce, Swedish-American Entrepreneurial Days, San Diego, April 9, 2008
  • "Crisis Management for Regulatory Professionals," Regulatory Affairs Professionals Society (RAPS) Horizons Conference, San Francisco, March 28, 2008
  • "FDA Regulatory Considerations for the Biomedical Start-Up," Israeli Life Sciences Fellows Program, Merage Foundation, Irvine, California, February 27, 2008
  • "The Food & Drug Administration Amendments Act of 2007 – Understanding the Drug Provisions," San Diego Regulatory Affairs Network, San Diego, February 26, 2008
  • "Keynote Presentation on FDA Regulatory Developments," Pharmaceutical Education Associates' 2nd Annual Skin Summit Conference, Philadelphia, February 20, 2008
  • "Regulatory Considerations for Medical Device Firms," NIH-CaliforniaP Webinar, LARTA, February 12 and 13, 2008
  • Panel Discussion on Biosimilars, BIOCOM Life Sciences Venture Network, San Diego, February 6, 2008
  • "International Drug Development," Pharmaceutical Education Associates Pipeline to Product Conference, Alexandria, Virginia, November 30, 2007
  • "Regulatory Pitfalls in Drug Development," Pharmaceutical Education Associates Pipeline to Product Conference, Alexandria, Virginia, November 30, 2007
  • "Compliance in Clinical Research," Eighth Annual Pharmaceutical Regulatory Compliance Congress and Best Practices Forum, Washington, D.C., November 8, 2007
  • "FDA Regulatory Strategies for Fast Growing Companies," LARTA NIH-CaliforniaP Commercialization Training Workshop, Marina Del Rey, California, October 17, 2007
  • "Keynote Presentation on FDA Regulatory Developments," Pharmaceutical Education Associates Annual Nasal Drug Delivery Conference, Philadelphia, October 4, 2007
  • "FDA Legislative Initiatives," RAPS Annual Conference, Boston, September 24, 2007
  • "Combination Products – Perspectives on FDA Regulation," BVS Orange County Biomedical Day, Costa Mesa, California, September 19, 2007
  • "FDA Regulatory Developments," Keynote Presentation at Pharmaceutical Education Associates Annual Ophthalmic Drug Delivery Conference, San Diego, September 10, 2007
  • "Regulation of ANDAs, OTC Drugs, Orphan Drug, and Cosmetics," Lecture at SDRAN RAC Review Course,, San Diego, August 14, 2007
  • "Clinical Trial Registries," Presented at the University of Southern California Regulatory Science Masters Program, Los Angeles, July 27, 2007
  • "Clinical Trial Registries," Presented at the American Conference Institute Managing Legal Risks in Clinical Trials Conference, San Francisco, July 16, 2007
  • "FDA Enforcement," Tutorial at the DIA Annual Meeting, Atlanta, June 17, 2007
  • "Keynote Presentation on FDA Regulatory Developments," Presented at the Pharmaceutical Education Associates Annual Drug Delivery Conference, San Diego, June 6, 2007
  • "The Impact of the Democratic Congress on the Biotech Industry," Moderated Panel at the BayBio Annual Meeting, San Francisco, April 26, 2007
  • "Guilty Until Proven Innocent: A Look at IRB Liability," ACRP Annual Conference, Seattle, April 23, 2007
  • Panel Discussion on Generic Biologics, FDLI Annual Conference, Bethesda, Maryland, April 12, 2007
  • "Lifecycle Management for Pharmaceutical Companies: A Generic Perspective," Presented at the RAPS Horizons Conference, San Francisco, March 29, 2007
  • "Non-Patent Market Exclusivity for Pharmaceuticals Under the Drug Price Competition and Patent Term Restoration Act of 1984 ('Waxman-Hatch')," San Diego County Bar Association, IP Section, San Diego, March 19, 2007
  • "FDA Regulatory Considerations for the Biomedical Start-Up," Israeli Life Sciences Fellows Program, Merage Foundation, Irvine, California, February 21, 2007