Richard Erwin Email & Phone Number

San Carlos, Ca, Us

Executive Director at Addario Lung Cancer Medical Institute (ALCMI, voiced as “Alchemy”)

London, Gb

Clientele include: US defense & governmental agencies (DOD, JPEO, DARPA, NIH, NIAID, VRC network), academia, start-up biotech, mid-tier pharma - vaccine global pandemic preparedness, infectious disease rapid response, academic monoclonal antibody platform spinoff (new company formation), global rare disease pivotal registration trials oversight (FDA product approval), sickle cell wound healing patch (startup), and FDA/BIMO corporate & site-level PAI (inspection) readiness (x2 FDA product approvals; BLA & NDA).

PaxVax (PXVX) - a specialty vaccine company with a commercial focus on travel and biodefense• Led the successful execution and completion of the company's ph3 registration program for oral cholera vaccine (VaxChora) leading to FDA approval.• Oversee the build-out of a global clinical development organization for this CA-based emerging vaccine biotech, with responsibilities for: clinical operations, CRAs, CPMs, CROs, data mgmt, stats, medical writing, and clinical finance.• Functional Area Head: Clinical Operations, Clinical Monitoring, Clinical Project Mgmt, Clinical Quality, Clinical Data Management & Statistics, Clinical Finance, and all Outsourcing solutions.• Newsworthy Achievements for my team (we launched & completed 3 pivotal registration studies across USA and Australia; on-time, on-budget, positive endpoints)...Fierce Vaccines (7/3/14) PaxVax oral cholera vaccine succeeds in PhIII challengeshttp://www.fiercevaccines.com/story/paxvax-oral-cholera-vaccine-succeeds-phiii-challenges/2014-07-03Fierce Vaccines (12/9/14) PaxVax meets primary endpoints in PhIII cholera vaccine trialhttp://www.fiercevaccines.com/story/paxvax-meets-primary-endpoints-phiii-cholera-vaccine-trial/2014-12-09Fierce Vaccines (12/16/15) FDA accepts PaxVax BLA and grants Priority Reviewhttp://www.fiercevaccines.com/story/fda-accepts-paxvaxs-bla-cholera-vaccine-grants-it-priority-review/2015-12-16Fierce Vaccines (6/10/2016) PaxVax's cholera vaccine wins FDA nodhttp://www.fiercepharma.com/vaccines

Durham, North Carolina, Us

Quintiles; Semio – an Eli Lilly & Company joint-ventureEngagement Director, Eli Lilly & Company (Indianapolis)• Subject Matter Expert (SME) and Advisor to numerous drug development teams for global strategic clinical development planning, optimizing, and execution.• Engagement Director & Strategic Design Consultant Facilitator for top-tier CIDD pharmaceutical clientele (global) embedded fulltime at Eli Lilly & Company corporate center (Indianapolis, IN).• Strategic Health Care Consultant & Client Engagement Director for new strategic design & planning services (Quintiles, Center for Integrated Drug Development CIDD) using advanced, novel, and proprietary systems (Semio). Semio is a Center-of-Excellence partnership between the world's largest CRO (Quintiles) and flagship pharmaceutical giant Eli Lilly Pharmaceuticals - and takes an innovative approach to strategic clinical research planning that harnesses global intelligence-gathering models & advanced modeling and simulation visualizations.

Washington DC branch office director for Paris-based biotech firm (reporting to CEO & CMO), responsible for overseeing North American clinical research operations. Responsible for management of all office business affairs (staff, studies, payroll, supplier, etc). Oncology & HIV.

SUMMARY:Founded (3) high-growth start-up clinical research operations: British Biotech (BBPL), Neurocrine BioSciences (NBIX), and International Partnership for Microbicides (IPM). Clinical development team portfolio program manager for cardio & urology (Otsuka). CRO responsible P&L head for clinical monitoring business division: SFBC-Clinical (now PharmaNet), and Monitoring Force USA.CHRONOLOGICAL:2006-2008Monitoring Force USA, Washington DCDirector, Clinical Monitoring & Project Management2005-2006IPM, Wash DC; Africa capacity-building (RSA, Kenya, Uganda, Rwanda, Tanzania)Director, Global Clinical Operations2003-2005SFBC-Clinical (now PharmaNet), Charlotte, NCDirector, Clinical Monitoring Network (USA/CDN)2000-2003Otuska Pharmaceuticals (OTS), Rockville, MDSenior Director, Project Management1996-2000Neurocrine BioSciences (NBIX), San Diego, CADirector, Clinical Research1994-1996British Biotech Inc. (BBPL), Annapolis, MDManager, Clinical Operations

Thousand Oaks, Ca, Us

CRA on Neupogen (G-CSF) oncology:• CRA on Neupogen (G-CSF) oncology pivotal & peri-approval phase III trials. My accomplishments on the pivotal registration trials for Neupogen led to my appointment as lead CRA for a highly experimental ex-vivo stem cell factor clinical research program involving novel cell separation column technologies.• Responsible for overseeing trial conduct to FDA and Amgen expectations at investigative sites throughout USA and Canada.