Quality Assurance Clinical Research

Carleton Southworth, MS, RAC

**** ********* **** #***, ***** Bend, IN 46614 574-***-**** (Mobile)

******************@*****.***

SUMMARY

In-depth biostatistical and data analysis experience

Significant experience interacting with FDA in person, by phone, and written; uncommonly

successful in addressing written FDA questions, especially statistical questions at DePuy

Recent hands-on experience in clinical affairs, biostatistics, quality assurance

Wrote more articles at DePuy than all others in my department combined including five (5) JBJS

(American) and one (1) JBJS (British). Many white papers written for multiple clients.

Demonstrated ability to support PMA submissions

Familiar with FDA and EMEA guidance

Uncommonly strong writing and problem solving skills

Contributions to clinical trial, biostatistics, orthopedic and neurosurgical literature

Medical device inventor (orthopedic and neurosurgical)

Ability to work independently and proactively in multidisciplinary teams

Experience with multiple drug/devices

Proficient in SAS, Minitab

Extensive case report form design experience

Experienced in: Ortho, CV, CNS, biologics, spine, combination drug/device

EDUCATION

AB Psychology, Cum Laude, Vassar College, Distinction for Exceptional Research awarded

MS I/O Pysch., Univ. of Tenn. Knoxville, instructor Management Science Department

Ph.D. course work complete, Univ. of Tenn., Knoxville (Ph.D. not completed)

EMPLOYMENT HISTORY

GForce Life Sciences (Biologics Client) 2016-2017

Clinical Affairs and Biostatistical Consultant

Contributed to protocol development leading to a successful IDE application

Provided statistical support for a biologic device abstract

Kept clinical trial on-track during a period of staff shortage

Successfully negotiated clinical budgets at numerous sites

Wrote SAP for a clinical trial involving imaging, laboratory results, and clinical data

Maintained study documentation and regulatory compliance

Negotiated successful IRB application at a central IRB and assisted with site IRB applications

Redbock (Medical Device Capital Equipment & Disposables Client) 2014-2016

Statistical Process Control and Validation Consultant

Statistical process validation for a client under a consent decree with FDA

Inventiv Health (IVD Client) 2013-2014

Biostatistics Consultant

In vitro diagnostic statistical support

Comprehensive biostatistical support for cutting-edge IVDs

American Research Partners (Current) 2010-Present

(Functional service provider providing services to multiple companies)

Director Biostatistics and Regulatory Affairs

Biostatistical support for an IDE and PMA (sharps disposal)

Dermatological product statistics support (EU clinical study)

Support for numerous orthopedic clinical trials

Statistical support for regulatory submissions and peer reviewed articles

Cardiovascular / Biotech interventions

Regulatory strategy and submission consulting

Protocol development

Process validation and improvement

Johnson & Johnson (DePuy / Mitek / Codman / DePuy Spine; Neuro and Orthopaedic products)

Manager Biostatistics (hands-on working manager) 2006 – 2010

Supervise international team of four biostatisticians and a senior technical writer

Responsible for statistical support of four PMA applications

Genetic marker predictive validity

Responsibilities of Project Leader Biostatistics position

Project Leader Biostatistics and Data Management 2004 – 2006

Responsible for developing a database that captures DePuy clinical outcomes

Spearhead effort to publish and present DePuy clinical results

Statistical lead for computer aided surgery, hip and trauma products

Provide statistical support to Product Development and Emerging Technologies groups

Assist in the design and analysis of international clinical studies

Supervisory responsibilities

Responsibilities of Biostatistician III position

Project Leader Biostatistics and Outcomes Research 2000 – 2004

Supervised up to four direct reports, including non-exempt and professional employees

Contributed to the development of methods designed to collect healthcare reimbursement data

Assisted in selecting and validating Oracle Clinical (part 11 compliant software)

Responsibilities of Biostatistician III position

Biostatistician III 1999 – 2000

Analysis plans and protocols for IDEs and studies of commercial products

PMA and 510k statistical reports (primarily using SAS)

Provide statistical analysis, editorial assistance and write peer reviewed articles

Interface with FDA and answer questions pertaining to submissions

Software selection and evaluation

Provide statistical support for several drug/device and biologic products including the PROSTALAC hip (now commercially distributed).

Support Quality Assurance and R & D with respect to experimental design and statistical analysis requirements

Johnson & Johnson Professional, Inc.

Sr. Clinical Research Associate 1994-1999

Designed, conducted and analyzed the results of a clinical trial for an image-guided surgical navigation system for neurosurgery. This included writing the protocol (and developing the measurement system for assessing system accuracy), designing the database (in Access), analyzing the results in SAS, writing all statistical reports for submission to the FDA, monitoring the study, and controlling the inventory of investigational devices. The product was approved for commercial distribution sooner than expected.

Provided technical support to neurosurgeons and R & D professionals for peer reviewed publications in neurosurgery and othopaedics

Supported a combination Drug/Device (Monitoring, statistical analysis, reports to FDA, created clinical databases in Medlog and Access, managed clinical inventory)

Supported QA and R & D with respect to experimental design and statistical analysis

Codman and Shurtleff (Johnson & Johnson)

Sr. Regulatory/Clincial Affairs/Biostatistician 1991-1994

Sr. Quality Engineer 1989-1991

Wrote 510ks, interfaced with FDA, participated in all aspects of clinical study management

Evaluated engineering changes with approval authority; determined whether a 510k was needed

Statistical Quality Assurance including statistical process controls for injection molding

Wrote guidance documents for upper management on reimbursement, software validation, and preproducation quality assurance

Developed a process control system that identified improperly milled silicone elastomer, saving money and possibly preventing a recall

Supported the Bactiseal shunt (a combination drug-device) in the following capacities; protocol development, database design and creation, site initiation, site monitoring, investigational device inventory management including distribution and accounting, FDA interface and reporting

Sikorsky Aircraft, United Technologies (Aerospace)

Quality Systems Engineer/Statistician 1987-1988

Process Validation; Statistical QA & SPC (machining, plating). Initiated a machine tool capability study, saving $450,000.00; created division-wide policies and procedures

Wrote a statistical report in connection with a multi-billion dollar recall

George W. Moore, Inc (High Volume Machined Products)

Quality Control Manager 1986-1987

Saved #1 account by controlling critical dimension with an innovative use of SPC; responsible for customer correspondence, MRB, and supervising set-up and production inspectors

Cambridge Machined Products (Medical Device Components)

Quality Department Manager 1985

Responsible for all aspects of quality assurance. Supervised seven inspectors. Audited suppliers and interfaced with medical component and automotive component customers

TECHNOLOGY

Statistical Analysis Software: SAS/STAT, SAS/GRAPH, SAS/BASE, Minitab

Microsoft Word, Microsoft Excel (with Visual Basic), PowerPoint

Computer Operating Systems including: MS Windows

Psychometrics (questionnaire design)

GRADUATE LEVEL QUANTITATIVE COURSES

Statistics I

Statistics II

Statistics III

Experimental Design I

Experimental Design II

Quasi-Experimental Design

Quantitative Employee Selection

Multivariate Statistics

Program Evaluation (Quantitative Methods)

Psychometrics

Statistical Software (SAS, SPSS, BMDP)

In addition to these courses, which were specifically aimed at teaching quantitative methods, many other courses were taken in the field of industrial and organizational psychology aimed at teaching practical uses for applied statistics. The entire program was aimed at approaching industrial psychology from a quantitative perspective. Experimental design applied to field research, the design of instruments intended to collect subject self-reported data, and statistical methods for analyzing results were emphasized in this program.

Formerly certified as a quality engineer (CQE); 830th individual in the country to attain certification in regulatory affairs (RAC).

JOURNAL REVIEWER

Peer reviewer for Clinical Orthopaedics and Related Research 2006 - 2013

JOURNAL EDITOR

Editorial board member, The Investigator Sponsored Trials Journal 2012-2013

AWARDS

Johnson & Johnson Global Leadership Profile Award 2007

Johnson & Johnson Standards of Leadership Award 2006

Innovation Day – Winning Team Member 2003

CLINICAL TRIALS

Biologic Device for OA treatment

Dermatological Device

Sharps Disposal

Anti-infective (orthopedic)

PCR Studies

bioNexia Rapid Tests

Vitek-MS

Bactiseal

Hakim Programable Shunt

Acustar (computer surgical navigation)

S-ROM/ZZT Cup

TruMatch (computer aided surgery)

Multi-center knee navigation

Single-center knee navigation

Anchor-Peg glenoid

Bone substitute

Nerve stimulation study (pilot)

Total ankle study

Restore (SIS) study

HA hip study

Extended ROM knee study

Pinnacle hip study

Trilock hip

C-stem hip

Analgesic study

Antibiotic device

Artificial disc

Aneurysm coil

Global shoulder

CTA Head

Minimally invasive knee

Minimally invasive hip

Surface replacement hip

Ceramic on Cermic hip

Artificial spinal disc

Genetic marker

Hyaluronic Acid

PRESENTATIONS AND PUBLICATIONS

Southworth, Carleton. Making Sense of Biostatistics: Outliers in Clinical Data. Journal of Clinical Research Best Practices. Vol. 8, No. 6, June 2012.

Southworth, Carleton. Optimizing Sample Size. Journal of Clinical Research Best Practices. Vol. 8, No. 6, June 2012.

Southworth, Carleton. Making Sense of Biostatistics: Randomization. Journal of Clinical Research Best Practices. Vol. 8, No. 4, April 2012.

Wirth M, Loredo R, Garcia G, Rockwood C, Southworth C, Iannotti J. Total shoulder arthroplasty with an all-polyethylene pegged bone-ingrowth glenoid component: a clinical and radiographic outcome study. JBJS 2012;94:260-267.

Southworth, Carleton; Close, Nicole; Nichols, Thomas. Biostatistics for mere mortals. Presentation at MAGI’s Clinical Research Conference, Las Vegas, NV, October 23-26 2011.

Southworth, Carleton (program chair); Bowman, Clawson; Cooper, Jeffrey. Investigational Device Exemption (IDE) applications. Presentation at MAGI’s Clinical Research Conference, Las Vegas, NV, October 23-26 2011.

Southworth, Carleton. Study Registration Loopholes. Journal of Clinical Research Best Practices. Vol. 7, No. 7, July 2011.

Carothers, Joshua; Kim, Raymond; Dennis, Douglas; Southworth, Carleton. Mobile Bearing Total Knee Arthroplasty: A Meta-Analysis. Journal of Arthroplasty, Vol. 26, Issue 4, 537-542, 2011.

Southworth, Carleton. Bringing a new product to market and beyond: when and how statisticians can grease the chute by reducing uncertainty. Presentation at The MWDG of the ASQ Biomedical Division Meeting, University of Indianapolis, April 28, 2011.

Wirth, Michael; Loredo, Rebecca; Garcia, Glenn; Southworth, Carleton. Clinical and radiographic evaluation of a tussue-ingrowth glenoid component. Scientific Presentation. The Texas Orthopaedic Association 2010 Annual Meeting, April 22-24, 2010.

Moradi, Babak; Kertzner, Michael; Dela Rosa, Mylene; Southworth, Carleton; Vail, Thomas; Schmalzried, Thomas. Patient Characteristics Influence Total Hip and Hip Resurfacing Outcomes. Poster No. 105, New Orleans, AAOS 2010 Proceedings.

Kindsfater, Kirk; Barrett, William;Dowd, James; Zovkic, Vesna; Southworth, Carleton. Midterm Survival of a Multi-Liner Acetabular Cup: 1593 Consecutive Total Hip Replacements. E-Poster No. 400, Vienna, 10th EFORT Congress, 2009.

Boese, CK, Gruen, TA, Spitzer, AI, Gorab, RS, Southworth, CB, Cassell, MJ, Suthers, K. Cemented triple-tapered polished femoral stems: intermediate multicenter study results. Israeli Orthopaedic Association Proceedings: Tel Aviv, December 19-20, 2006. Published in Journal of Bone and Joint Surgery (British) 2008, Issue SUPP_III, 506, 90-B: 506-b.

Dowd, James; Kindsfater, Kirk; Barrett, William; Southworth, Carleton; Dalury, David. Large Femoral Heads can Help Reduce Risk of Dislocation in Total Hip Arthroplasty. The Journal of Arthroplasty, Volume 23, Issue 2, February 2008.

Dowd, James; Kindsfater, Kirk; Barrett, William; Southworth, Carleton; Dalury, David. Large Femoral Heads can Help Reduce Risk of Dislocation in THR. Podium No: 060, San Francisco California, AAOS 2008 Proceedings.

Wirth, Michael; Southworth, Carleton; Larsen, Mitchell; Fox, Joel; Rockwood, Charles. The Effect of Anatomical Reconstruction Following HA for Proximal Humerus Fractures. Podium No: 011, San Francisco California, AAOS 2008 Proceedings.

Dowd, James; Kindsfater, Kirk; Barrett, William; Southworth, Carleton; Dalury, David. Large Femoral Heads can Help Reduce Risk of Dislocation in THR. Paper No. 13, Dallas Texas, AAHKS 17th Annual Meeting 2007.

Kindsfater, Kirk; Barrett, William; Dowd, James; Southworth, Carleton; Cassell, Marilyn. Midterm Survival of the Pinnacle Multi-Liner Acetabular Cup in a Prospective Multi-Center Study. Poster No. PO77, San Diego, California, AAOS 2007 Proceedings.

Barrett, William; Kindsfater, Kirk; Dowd, James; Southworth, Carleton. Delayed Hypersensitivity in Total Hip Replacement with Metal-On-Metal Bearings. Poster No. 4, San Diego, California, Western Orthopaedic Association’s 71st Annual Meeting 2007.

Wirth, Michael; Ondrla, Jeff; Southworth, Carleton; Kaar, Ken; Anderson, Brett C.; Rockwood, Charles A. Replicating Proximal Humeral Articular Geometry with a Third Generation Implant: A Radiographic Study in Cadaveric Shoulders. The Journal of Shoulder and Elbow Surgery. Vol. 16, No 3S, 2007.

Wirth, Michael; Tapscott, Stacy; Southworth, Carleton; Rockwood, Charles. Treatment of Glenohumeral Arthritis with a Hemiarthrplasty, Surgical Technique. The Journal of Bone and Joint Surgery (American) 89:10-25. 2007.

Wirth, Michael; Lim, Moon Sup; Southworth, Carleton; Laredo, Rebecca; Kaar, Ken; Rockwood, Charles A. Compaction Bone Grafting in Prosthetic Shoulder Arthroplasty. The Journal of Bone and Joint Surgey (American) 89:49-57, 2007.

Wirth, Michael; Tappscott, Stacy; Southworth, Carleton; Rockwood, Charles. Treatment of glenhumeral arthritis with a hemiarthroplasty: a minimum five-year follow-up outcome study. The Journal of Bone and Joint Surgery (American). 88:965-973; May 2006.

Wirth, Michael; Southworth, Carleton; Rockwood, Charles. Mid-term Results of Hemi-Arthroplasty versus Total Shoulder Arthroplasty: 5 year Minimum Follow-up. Paper No. 280, Chicago Illinois, AAOS 2006 Proceedings.

Wirth, Michael; Rockwood, Charles; Southworth, Carleton; Swenning, Todd. Mid-term Results of Treating Glenohumeral Arthrosis with a TSA: A 5 – 10 Year Outcome Study. Paper No. 281, Chicago Illinois, AAOS 2006 Proceedings.

Jacobs, Michael; Gorab, Robert; Mattingly, David; Trick, Lawrence; Southworth, Carleton. 3-6 Year Results of a Prospective Randomized Study Using an S-ROM Stem and a Metal-on-Metal Articulation for Primary Hip Replacement. J. Arthroplasty Feb; 19(2): 260, 2004.

Masri, B.A., Duncan, C.P., Wentworth, S., Southworth, C. PROSTALACâ (PROSthesis of Antibiotic Loaded Acrylic Cement) Hip Temporary Prosthesis System. 69th Annual Meeting Proceedings AAOS, Feb. 13-17, Dallas, Texas 2002.

Lazarus, M.D., Jensen, K.L., Southworth, C., Matsen, F.A. The Radiograpnic Evaluation of Keeled and Pegged Glenoid Component Insertion. The Journal of Bone and Joint Surgery (American). Vol. 84-A No.7 pp. 1174-1182, July 2002.

Wentworth, S.J., Masri, B.A., Duncan, C.P., Southworth, C. B. Hip Prosthesis of Antibiotic-Loaded Acrylic Cement for the Treatment of Infections Following Total Hip Arthroplasty. The Journal of Bone and Joint Surgery (Supplement) Page 123-128 NDN- 224-0343-1569-8. December 2002.

Rockwood, C.A., Tapscott, S., Southworth, C.B., Wirth, M.A. The Long Term Results of Treating Glenohumeral Arthrosis with a Hemiarthroplasty: A 5 – 10 year Outcome Study. Pebble Beach, October 2002.

Ondrla, J., Wirth, M., Kaar, K., Southworth, C., Rockwood C. Replicating Proximal Humeral Articular Geometry: A Radiographic Study in Normal Shoulders. 8th International Congress on Surgery of the Shoulder, Apr. 23-26, Cape Town, South Africa, 2001.

PUBLICATIONS WITH ACKNOWLEDGMENT OF CONTRIBUTION

Johal, H., Buckley, R., Le, I., Leighton, R. A Prospective Randomized Controlled Trial of a Bioresorbable Calcium Phosphate Paste (α-BSM) in Treatment of Displaced Intra-Articular Calcaneal Fractures. The Journal of Trauma. Vol. 67, No. 4, Oct. 2009.

Stout, Michael. Randomization Made Easy. Paper PO04, Pharmaceutical SAS Users Group Annual Meeting Proceedings, 2007.

Orfaly, R.M., Rockwood, C.A., Esenyel, C.Z. and Wirth, M.A. A Prospective Functional Outcome Study of Shoulder Arthroplasty for Osteoarthritis with an Intact Rotator Cuff. J. Shoulder Elbow Surg., Vol. 12 No. 3, pp. 214-221 May/June 2003.

Casha, S., Fehlings, M.G. Clinical and radiological evaluation of the Codman semiconstrained load-sharing anterior cervical plate: prospective multicenter trial and independent blinded evaluation of outcome. J. Neurosurg (Spine 3) 99: 264-270, 2003.

Wirth, M., Korvick, D., Basamania, C., Toro, F., Aufdemorte, T., and Rockwood, C. Radiographic, mechanical, and histologic evaluation of 2 glenoid prosthesis designs in a canine model. J Shoulder Elbow Surg, Vol. 10 No. 2, pp. 140-148 March/April 2001.

Pollack, I.F. et al. A Randomized, Controlled Study of a Programmable Shunt Valve Versus a Conventional Valve for Patients with Hydrocephalus. Neurosurgery, Vol. 45 Issue:6, Page 1399-1411, Dec. 1999.

Hamilton, J.V., Schmidt, M.B., Greer, K.W. and Shah, C. Improved UHMWPE through the control of sterilization dose and atmosphere. Radiat. Phys. Chem. Vol. 52, Nos 1-6, pp. 283-288, 1998.

PATENTS AND PENDING PATENTS

US7763080 B2

Implant System with Migration Measurement Capacity. Sole inventor,

Issued 7/27/2010.

US 7390310 B2

Shunt Valve Locking Mechanism (originator of primary invention claim), Issued 6/24/2008.

US 200******** A1

Apparatus and Method for Advancing Synovial Fluid in a Prosthetic Joint. Sole inventor, Issued 12/5/2006.

US 6755866 B2

Prosthetic Stem with Bearings. Sole inventor, Issued 6/29/2004

US 5935084

Inflatable pressure indicator. Sole inventor, Issued 8/10/1999

US 200******** A1

Prestressed Implant. Primary Inventor, Published 6/23/05, pending.

EP1426022 A2

Apparatus for Advancing Synovial Fluid in a Prosthetic Joint

EP1391187 A1

Prosthetic Stem with Bearings

EP0904728 A2

Implantable Pressure Indicator

JP2004181249 A

Apparatus and Method for Sending Synovial Fluid into Prosthesis Joint

JP2004130108 A

Joint Prosthesis, Hip Joint Prosthesis, Stem Component, Bearing for Joint

Prosthesis, and Method for Performing Joint Arthroplasty

JP11218455 A

Inflatable Indicator

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