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Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
Biosimilars -- Wave of the Future or Child of the Privileged Few?
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Biosimilars -- Wave of the Future or Child of the Privileged Few?

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Presentation on FDA\'s Regulation of Biosimlars Including an Overview of the February 2012 Draft Guidances

Presentation on FDA\'s Regulation of Biosimlars Including an Overview of the February 2012 Draft Guidances

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  • 1. Law Offices of Michael A. Swit Biosimilars -- Wave of the Future or Child of The Privileged Few? Licensing Executives Society (LES) San Diego Chapter February 21, 2012 Michael A. Swit, Esq. Michael A. Swit, Esq. Vice President, Life SciencesFDA Legal Services -- for the life of a Life Sciences Company www.fdacounsel.com
  • 2. Law Offices of Michael A. Swit Standard Disclaimers • Views expressed here are solely mine and do not reflect those of my firm or any of its clients. • This presentation supports an oral briefing and should not be relied upon solely on its own to support any conclusion of law or fact.FDA Legal Services -- for the life of a Life Sciences Company 2 www.fdacounsel.com
  • 3. Law Offices of Michael A. Swit What We Will Cover • Contrasting the Past – How Small Molecule Generics are Regulated and Early Attempts to Approve “Generic” Biologics • Biosimilars – Basic FDA Provisions of the Biologics Price Competition & Innovation Act of 2009 (BPCIA) – Patent provisions are not covered by today’s talk • The Draft Guidances – What Hath FDA Wrought? • Biosimilar User Fees – Paying the Way Forward? • Lessons for Licensing ExecutivesFDA Legal Services -- for the life of a Life Sciences Company 3 www.fdacounsel.com
  • 4. Law Offices of Michael A. Swit Contrasting The Past How Small Molecule Generics Are Regulated And Early Attempts To Approve “Generic” BiologicsFDA Legal Services -- for the life of a Life Sciences Company 4 www.fdacounsel.com
  • 5. Law Offices of Michael A. Swit The Past • Biologics approved under Public Health Services Act – until 2010, no abbreviated pathway – Precursor? -- Comparability Guidance, April 1996 • NDAs -- for few biologics (e.g., HGH, insulin) – were approved – No set criteria on appropriate data set to support approval – Evaluated on a case-by-case basis • Therapeutic Biologics – transferred from CBER to CDER – June 2003FDA Legal Services -- for the life of a Life Sciences Company 5 www.fdacounsel.com
  • 6. Law Offices of Michael A. Swit Bioequivalence • Lynchpin to traditional Waxman-Hatch generic approval process – depends on: – Pharmaceutical “equivalents” – active ingredient, dosage form, strength, etc., must be SAME – Highly unlikely with Biosimilars – • Characterization – still a challenge even for the innovators – clinical trials may be needed to show comparability after process changes • Chances of “equivalence” conclusions faint as even a single amino acid can throw off conclusion (e.g., HGH) • Lovenox – only 70% characterized (but, is under an NDA and approved under an ANDA in summer 2010)FDA Legal Services -- for the life of a Life Sciences Company 6 www.fdacounsel.com
  • 7. Law Offices of Michael A. Swit Bioequivalence … • Janet Woodcock, Director, Center for Drugs (before Congress, March 2007): – “there is general recognition that the idea of sameness, as the term is used in the generic drug approval process under the Federal Food, Drug, and Cosmetic (FD&C) Act and applied to small molecules, will not usually be appropriate for more structurally complex molecules of the type generally licensed as biological products under the Public Health Service Act.”FDA Legal Services -- for the life of a Life Sciences Company 7 www.fdacounsel.com
  • 8. Law Offices of Michael A. Swit Substitutability … • Substitution -- core of classic Generic Industry Business Model – Depends on therapeutic equivalence – Allows for minimal sales forces – Drives pricing down -- multiple generics common – the generic becomes a commodity • Biosimilar world – – Substitution – aka “interchangeability” -- may evolve, but on a very, very limited basis • Woodcock – must be able to handle repeated brand/follow-in switching without adverse events • Thus, business model will not be multiple generics & not a commodity – Without interchangeability, the Biosimilar IS a branded drugFDA Legal Services -- for the life of a Life Sciences Company 8 www.fdacounsel.com
  • 9. Law Offices of Michael A. Swit 2006 – FDA Approves Omnitrope® • A Biosimilar? – approved as a 505(b)(2) NDA – no interchangeability – extensive data requirements – rumored to cost well into eight figures, if not nine • No floodgates because the NDA pathway was limited to a handful of productsFDA Legal Services -- for the life of a Life Sciences Company 9 www.fdacounsel.com
  • 10. Law Offices of Michael A. Swit Biosimilars Basic FDA Provisions Of The Biologics Price Competition & Innovation Act Of 2009 (BPCIA)FDA Legal Services -- for the life of a Life Sciences Company 10 www.fdacounsel.com
  • 11. Law Offices of Michael A. Swit What Hath Health Care Reform Spawned? • Biologics Price Competition & Innovation Act of 2009 (BPCIA) – Creates an abbreviated pathway for “biosimilar” versions of biologics, but gives FDA great flexibility/discretion in how it implements statute • Key features – Abbreviated pathway created under the Public Health Service Act (PHSA) by adding Subsection (k) to Section 351 of the PHSA – Exclusivity – 12 years for new biologics – Complex handling of patents – FDA – flexibility granted in how it regulates biosimilarsFDA Legal Services -- for the life of a Life Sciences Company 11 www.fdacounsel.com
  • 12. Law Offices of Michael A. Swit What’s Required for a Biosimilar Application? • Must be biosimilar to Reference Product, by including: – Analytical studies to show your product is Highly similar to the Reference Product (RP) – i.e., the Biosimilar has no clinically meaningful differences from the RP in terms of safety, purity and potency, notwithstanding minor differences in clinically inactive components; and – Animal Studies – including toxicity studies; and – “A clinical study or studies” -- including assessment of immunogenicity and pharmacokinetics or pharmacodynamics • to show safe, pure and potent • in 1 (one) or more appropriate conditions of use for which the RP is licensed and intended to be used • FDA – can decide any of the above are unnecessaryFDA Legal Services -- for the life of a Life Sciences Company 12 www.fdacounsel.com
  • 13. Law Offices of Michael A. Swit Required for a Biosimilar Application … • Must use same mechanism(s) of action – if the MOA is known for the RP • Conditions of use in labeling -- have to be previously approved for the RP • Must match RP as to: – Route of administration – Dosage form – Strength • Facility in which manufactured, processed, packed or held – must meet standards designed to assure the biosimilar continues to be: Safe. Pure. Potent.FDA Legal Services -- for the life of a Life Sciences Company 13 www.fdacounsel.com
  • 14. Law Offices of Michael A. Swit Interchangeability • Not required – 351(k)(2)(B) • To prove interchangeability – 351(k)(4) – Drug must be biosimilar to RP – BP “can be expected to produce the same clinical result” as the RP “in any given patient” – If BP is administered more than once to patient, the risk in terms of safety or diminished efficacy of switching between the BP and the RP is “not greater than the risk of using the RP” without switching • How to study – multiple switch studyFDA Legal Services -- for the life of a Life Sciences Company 14 www.fdacounsel.com
  • 15. Law Offices of Michael A. Swit Miscellaneous Rules • Only One RP per BP application – 351(k)(5)(A) • Reviewing division – same as handled the RP – 351(k)(5)(B) • REMS authority under FDAAA -- applies to Biosimilars – 351(k)(5)(C) • Biologics approved under Section 505 of Federal Food, Drug, and Cosmetic Act as New Drug Applications (NDAs) – Can still be filed as NDAs (indeed, must be until an “innovator” BLA is approved) – However, if there is a BLA-licensed biologic that you want to use as the RP, the biosimilar application must be filed as a BLA – Ten years after enactment – all NDAs for biologics are deemed approved under Section 351 of PHSAFDA Legal Services -- for the life of a Life Sciences Company 15 www.fdacounsel.com
  • 16. Law Offices of Michael A. Swit Miscellaneous … • Guidances – Not required prior to approval of a biosimilar application • No biosimilar application yet approved; draft guidances published on Thursday, February 9, 2012 – Regulations – also not mandated – Product Class Specific Guidances • Can be issued • FDA – can issue one saying that the science is not sufficient to allow a biosimilar application – Later can be reversed – Absence of such a guidance does not mandate that a biosimilar application can be approved • Pediatrics – all the rules and benefits under 2007 FDAAA for both doing studies and pediatric exclusivity apply to biologicsFDA Legal Services -- for the life of a Life Sciences Company 16 www.fdacounsel.com
  • 17. Law Offices of Michael A. Swit Uncertainty … Was Rampant • How will FDA implement BPCIA? – Teva – announced it was pursuing full BLAs as of now – – Leah Christl, Ph.D. – Acting Director in CDER for Biosimilars • FDA – Public Meeting on Biosimilars – Oct. 5, 2010 Federal Register – 75 Fed. Reg. 61497 – Nov. 2 & 3, 2010 in Maryland (were webcast)FDA Legal Services -- for the life of a Life Sciences Company 17 www.fdacounsel.com
  • 18. Law Offices of Michael A. Swit Input FDA Sought at Hearing • Scientific and technical information on how to implement the statute • “Extra-statutory Issues” – Pharmacovigilance – Common or usual names – Safeguards on unsafe substitution – Bridging data needed when comparing a BP to an RP after prior studies done on BP vs. a non-U.S. biologic (e.g., in EU) The result ?? … the February 9, 2012 Draft Guidances …??FDA Legal Services -- for the life of a Life Sciences Company 18 www.fdacounsel.com
  • 19. Law Offices of Michael A. Swit The Draft Guidances – What Hath FDA Wrought?FDA Legal Services -- for the life of a Life Sciences Company 19 www.fdacounsel.com
  • 20. Law Offices of Michael A. Swit Three Draft Guidances • Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 -- “Q&A Guidance” or “Q&AG” – http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Gu idances/UCM273001.pdf • Scientific Considerations in Demonstrating Biosimilarity to a Reference (Protein) Product – “Scientific Guidance” or “SG” – http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Gu idances/UCM291128.pdf • Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product – “Quality Guidance” or “QG” – http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Gu idances/UCM291134.pdfFDA Legal Services -- for the life of a Life Sciences Company 20 www.fdacounsel.com
  • 21. Law Offices of Michael A. Swit What Did FDA Clarify? • Protein products – direct subject of new guidances, but guidance does provide general advice for other biologics subject to BPCIA • Three Key Messages: – Development process towards demonstrating biosimilarity -- should be “stepwise” – FDA’s evaluation will be on the “totality of the evidence” – The more you can analytically compare the BP to the RP and the closer the two products are in all key respects, the less you may need to do to (a) show biosimilarity, and (b) secure approval. “The more comprehensive and robust the comparative structural and functional characteristics are, the stronger the scientific justification for a selective and targeted approach to animal or clinical testing.” See SG at 9.FDA Legal Services -- for the life of a Life Sciences Company 21 www.fdacounsel.com
  • 22. Law Offices of Michael A. Swit What Did FDA Clarify … ? • Early interaction with FDA – – expected – but don’t do so until you : • can provide a plan for development; • have manufacturing process information – including planned methodology and assay validation; and • have preliminary comparative analytical data with the RP – may need to be frequent due to the stepwise approach to development contemplated • but no guidance on how often FDA will meet with you • Biosimilarity – type and amount of data, analyses, testing, etc., required will be determined on a product-specific basis.FDA Legal Services -- for the life of a Life Sciences Company 22 www.fdacounsel.com
  • 23. Law Offices of Michael A. Swit The “Stepwise” Approach 1 – Extensive Structural and functional characterization of RP and BP, including: – Mechanism of Action (MOA) – clinical relevance of any observed structural differences – clinical knowledge of RP and its class shows overall safety risk is low – availability of clinically relevant PD measure More you understand these, less you may need to do later 2 – Role of animal data in assessing toxicity, including immunogenicity assessment.FDA Legal Services -- for the life of a Life Sciences Company 23 www.fdacounsel.com
  • 24. Law Offices of Michael A. Swit Stepwise Approach … 3 – Comparative human PK and PD studies (if a clinically relevant PD measure exists) 4 – Comparative clinical immunogenicity studies 5 – Comparative clinical safety and effectiveness studies FDA – can waive certain requirements if “unnecessary in an application” under 351(k)FDA Legal Services -- for the life of a Life Sciences Company 24 www.fdacounsel.com
  • 25. Law Offices of Michael A. Swit Clinical Studies • Legal standard – “no clinically meaningful differences” between the BP and RP “in terms of safety, purity and potency …” – 351(i)(2)(B) of PHSA; 21 USC 262(i)(2)(B) • SG, at 12: – In general, the clinical program for a 351(k) application must include a clinical study or studies (including an assessment of immunogenicity and PK or PD) sufficient to demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product, as set forth in the PHS Act. – The scope and magnitude of clinical studies will depend on the extent of residual uncertainty about the biosimilarity of the two products after conducting structural and functional characterization and possible animal studies. – The frequency and severity of safety risks and other safety and effectiveness concerns for the reference product may also affect the design of the clinical program.FDA Legal Services -- for the life of a Life Sciences Company 25 www.fdacounsel.com
  • 26. Law Offices of Michael A. Swit Clinical Studies … • SG, at 16: – As a scientific matter, comparative safety and effectiveness data will be necessary to support a demonstration of biosimilarity if there are residual uncertainties about the biosimilarity of the two products based on structural and functional characterization, animal testing, human PK and PD data, and clinical immunogenicity assessment. – A sponsor may provide a scientific justification if it believes that some or all of these comparisons on clinical safety and effectiveness are not necessary. • Endpoints – can be different from sponsor’s own clinicals if “scientifically justified” – SG at 18.FDA Legal Services -- for the life of a Life Sciences Company 26 www.fdacounsel.com
  • 27. Law Offices of Michael A. Swit CMC Considerations • Quality Guidance – aimed at CMC considerations • Key attributes to analyze to show similarity: – Molecular weight – Complexity of protein, including higher order structure and post-translational modifications – Degree of heterogeneity – Functional properties – Impurity profiles – Degradation profiles denoting stability • Different excipients – possible, but need tox data (existing or new) to support use in formulationFDA Legal Services -- for the life of a Life Sciences Company 27 www.fdacounsel.com
  • 28. Law Offices of Michael A. Swit What Else Did FDA Clarify … ? • Do not have to secure approval of all “presentations” of the innovator’s product • Foreign comparative data on non-U.S. licensed innovator product – can be used: – “bridging” data will be needed – likely a clinical PK and/or PD study – could allow you to use data from an EU approval where the RP was “different from” the U.S. RP (e.g., different facility not covered by U.S. BLA approval)FDA Legal Services -- for the life of a Life Sciences Company 28 www.fdacounsel.com
  • 29. Law Offices of Michael A. Swit What Else Did FDA Clarify … ? • Interchangeability – not addressed in guidances in any detail, except that FDA states that “it would be difficult” to establish interchangeability in the initial 351(k) application “given the statutory standard for interchangeability and the sequential nature of that assessment.” See Q&AG, at 11. – Why? – not stated, but likely because the interchangeability standard under 351(k)(4)(A)(ii) is that the BP “can be expected to produce the same clinical result” as the RP “in any given patient…” • but, FDA may not allow extrapolation of data to all indications in first 351(k) applicationFDA Legal Services -- for the life of a Life Sciences Company 29 www.fdacounsel.com
  • 30. Law Offices of Michael A. Swit User Fees Paying Forward??FDA Legal Services -- for the life of a Life Sciences Company 30 www.fdacounsel.com
  • 31. Law Offices of Michael A. Swit User Fees for Biosimilars • FY 2012 – Subject to PDUFA rules • FY 2013 – 2017 – Proposal Sent to Congress – “BSUFA” • Four types of fees proposed – Developmental – Initial and Annual = 10% of the application fee under PDUFA until year filed or discontinued – Application – PDUFA fee less (-) cumulative payments under Developmental fee program – Establishment – same as PDUFA – Product – same as PDUFAFDA Legal Services -- for the life of a Life Sciences Company 31 www.fdacounsel.com
  • 32. Law Offices of Michael A. Swit Proposed User Fee Performance Goals • Application review – 70%/10 mos.; 90% by 2017 – Resubmittals -- 70%/6 mos.; 90% by 2017 • Supplements with Clinicals – 90%/10 mos. – Resubmittals – 90%/6 mos. • Manufacturing Supplements – 90%/6 mos. • Proprietary name review – – During development -- 90%/180 days – With BLA – 90%/90 daysFDA Legal Services -- for the life of a Life Sciences Company 32 www.fdacounsel.com
  • 33. Law Offices of Michael A. Swit Performance Goals … • Major dispute resolution – Written appeals – 90%/30 days • Clinical holds – Complete response -- 90%/30 days • Special Protocol Assessments – 70%/45 days; 90% by 2017FDA Legal Services -- for the life of a Life Sciences Company 33 www.fdacounsel.com
  • 34. Law Offices of Michael A. Swit Meetings Created Under User Fees … • Biosimilar Initial Advisory Meeting” -- (90 days after request package) -- initial assessment and general discussion of whether 351(k) is feasible for a product. No substantive review of data. • BPD Meetings – “Biological Product Development” – Type 1 -- (30 days) -- • necessary for an “otherwise stalled drug development program to proceed” • Special Protocol Assessment (SPA) • Important Safety Issue – Type 2 -- (75 days) – specific issue or questions; summary data only – Type 3 -- (120 days) – in-depth data review and advice meeting – Type 4 -- (60 days) – to discuss format and content of an application or supplementFDA Legal Services -- for the life of a Life Sciences Company 34 www.fdacounsel.com
  • 35. Law Offices of Michael A. Swit Lessons For The Licensing ExecutiveFDA Legal Services -- for the life of a Life Sciences Company 35 www.fdacounsel.com
  • 36. Law Offices of Michael A. Swit Traps for the Unwary • Development Plans – highly variable and will require considerable “stepwise” FDA input – – licensing payments – may be difficult to structure or should be tied to more interim milestones – time lines – still unpredictable as path has not been used • Omnitrope® – took at least 7 years (after initial FDA filing) • DMFs not allowed (QG) – sponsor must be able to control manufacturing either directly or consistent with a an arrangement contemplated by FDA’s 2008 guidance - - Cooperative Manufacturing Arrangements for Licensed BiologicsFDA Legal Services -- for the life of a Life Sciences Company 36 www.fdacounsel.com
  • 37. Law Offices of Michael A. Swit Traps for the Unwary … • Biosimilar products – trigger pediatric study requirements under PREA – Pediatric Research Equity Act – regarded as a new active ingredient unless found to be interchangeable • Multiple indications under a single 351(k) application – allowed, but will need to be justified scientifically. – SG did not clarify under what circumstances this might be allowed, but did list key factors to address (see SG at 19-20) – Key here – may be to select an indication that is most able to be extrapolated across multiple indicationsFDA Legal Services -- for the life of a Life Sciences Company 37 www.fdacounsel.com
  • 38. Law Offices of Michael A. Swit Traps for the Unwary … • Exclusivity – is retroactive, but there’s no “Orange Book” to look up when it expires – Can be extended via Pediatric Exclusivity • Patent Process – – very detailed; not same as Waxman-Hatch – “opening the kimono”FDA Legal Services -- for the life of a Life Sciences Company 38 www.fdacounsel.com
  • 39. Law Offices of Michael A. Swit Small vs. Large Molecule Realities • Small Molecule • Biosimilar – Therapeutically equivalent – Not therapeutically equivalent • Same molecule • Not same molecule – Substitutable – Substitutable only if interchangeable – Multiple generics of same – Multiple biosimilars for same innovator are common innovator less likely – Multiple generics drive price down – Price difference to brand likely smaller – Insurance coverage follows ANDA – Separate coverage likely needed for the approval Biosimilar – Marketing – cost sells; little need – Requires sales and marketing staffs to for sales & marketing staff drive utilization vs. “Brand” – Legal Pathway – clear under – Legal Pathway – clear(er) Waxman-Hatch Act – 505(j) • BPCIA – new Biosimilar App. • But can go full BLA • 505(b)(2) – case-by-case -- for 10 yrs. under BPCIAFDA Legal Services -- for the life of a Life Sciences Company 39 www.fdacounsel.com
  • 40. Law Offices of Michael A. Swit Questions? Call, e-mail, fax or write: Michael A. Swit, Esq. Law Offices of Michael A. Swit 1422 Caminito Septimo Cardiff by the Sea, CA 92007 Phone 760.452.6568 Fax 760.454.2979 Cell 760.815.4762 mswit@fdacounsel.com fdacounsel.comFDA Legal Services -- for the life of a Life Sciences Company 40 www.fdacounsel.com
  • 41. Law Offices of Michael A. Swit About your Speaker … Michael A. Swit, Esq. develops and ensures the execution of a broad array of regulatory and other services to clients. His expertise includes regulated product development strategies, compliance and enforcement initiatives, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts for drug, biologic, device, IVD, and other life sciences companies, as well as those in the food and dietary supplement industries. Mr. Swit has been addressing critical FDA legal and regulatory issues since 1984. His vast and 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. 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 has included service as Special Counsel in the FDA Law Practice Group in the San Diego office of Heller Ehrman White & McAuliffe and with the Food & Drug Law practice at McKenna & Cuneo, both in the firm’s Washington office and later in San Diego. He first practiced FDA regulatory law with the D.C. office of Burditt & Radzius. 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, he also has been a prominent speaker at numerous conferences sponsored by such organizations as RAPS, FDLI, and DIA. He received his A.B., magna cum laude, with high honors in History, from Bowdoin College and his law degree from Emory University School of Law. Mr. Swit is a member of the California Bar.FDA Legal Services -- for the life of a Life Sciences Company 41 www.fdacounsel.com

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