Walker Downey & Associates

MAR 2008 – Walker Downey & Associates, Inc. featured in Medical Device Development trade journal

March 2008 - Walker Downey & Associates, Inc. has been providing strategic solutions to its clients in the healthcare industry for over a decade. One simple telephone call or email will immediately connect customers with consultants in toxicology and biocompatibility, pathology and histology, quality and regulatory affairs, and contemporary statistics. Dedicated staff will apply their considerable experience to design and interpret specific biocompatibility testing packages in accordance with current best practice and international standards.

Walker Downey will assure that the “right tests are done right” and prepare written justification for these test selections (or waivers) for product submission. Working with its many preferred CRO partners, the company helps customers move their projects to the front of the line, keeping them on target for proposed product submission dates.

In addition to short-term testing strategies, many clients come to Walker Downey for help with their more expensive long-term testing, including chronic toxicity, carcinogenicity and reproductive toxicity. While it is advised to conduct this testing when it is warranted, more often than not this obligation can be met by expert risk assessment, as described and advised in the current ISO standards series.

Whether using chemical structure-activity-relationship models, particulate theorems, or rely on the available published scientific and clinical literature, Walker Downey can usually defend a test waiver. In this particular area more than any other, considerable time and money can be saved, while showing company commitment to ISO 10993-2 (animal welfare requirements) and the 3Rs (reduction, replacement, and refinement of animal testing).

For clients having trouble formulating a response to a reviewer question, the company calls on its writers of science and effective communicators to address these issues. With a response signed and approved by a recognized expert, reviewers will appreciate the effort.

AUG 2007 – WDA experts facilitate another 510K submission


August 2007 the breadth of experience at Walker Downey & Associates has prompted a Florida-based medical device company to retain these services through clinical testing. Walker Downey & Associates initially provided a due-diligence review of the company’s preclinical documentation for their respective device classification, and recommended additional tests to strengthen the 510(k) submission. Walker Downey & Associates contributed to the 510(k) submission by writing a biocompatibility testing summary, a risk assessment of active ingredients, and several Expert Opinions on related matters.

JUN 2007 – WDA provides solution to redundant international animal testing requests


June 2007 To assure compliance with international device safety testing guidance that may have undergone revision, officials in some countries may often request retrospective animal testing even when pertinent human safety data already exists. In a recent example, one of its clients asked Walker Downey & Associates (WDA) to respond to a request by the China State Food and Drug Association (SFDA) to explain why a 14-day intravenous toxicity study, as described in ISO 10993-11 (2007), recently revised and released by TC194/WG7, was considered sufficient for re-registration of a product that had been marketed in that country for 4-years, and elsewhere for as long as 25-years. The result? Dr. Dan McLain, President of WDA and the current Convener of ISO 10993-11, wrote letters to three agencies within SFDA stating that it was neither the intention nor the desire for Part 11 to be applied to any existing medical devices with a demonstrated history of safe clinical use. Furthermore, he noted that while delegates to his committee, which included experts from China, contended and agreed, that animal testing should serve as an informative and useful bridge to safe clinical testing, they also agreed that anecdotal or retrospective testing in animals, after demonstration of safe clinical use of a device, would serve no useful purpose and conflict with other TC194 standard recommendations. With respect to the Part 11 cited range in testing days for a subchronic intravenous toxicity study (i.e. 14 – 28 days), Dr. McLain also offered that if after a thorough evaluation of clinical data for a Class III device (permanent implant, direct blood contact), that has not undergone material or process changes, should any regulatory agency still conclude that additional testing is warranted then, in his opinion as Convener of TC194/WG7, a minimal 14-day intravenous exposure and/or implantation study (as proposed by client) would seem sufficient. The client device was successfully re-registered in China with the help of WDA.

Client: “the rapid and effective response by WDA helped us to address this issue to the mutual satisfaction of SFDA and our company and brought a much needed clarity to the even broader issue of conducting anecdotal/retrospective animal testing when pertinent human safety data already exist”.

WDA: “this was a classical case study of a regulatory authority wanting to do the right thing and seeking additional guidance in the form of an Expert Opinion. To the credit of our client, they recognized this as an opportunity to apply the basic principles of toxicology (i.e., that human safety data will usually supersede animal data), and were able to leverage the “spirit” of TC194 which calls for a responsible use of test animals.”

NOV 2006 – ISO 10993-18 used to facilitate a critical IDE submission (sterilization change)


November 2006 Walker Downey & Associates facilitated a client's critical IDE submission, which included a late-stage change in product sterilization method. Our strategy was to employ the ISO 10993-18:2005 standard (chemical characterization) to demonstrate equivalency of the two sterilization methods, thus supporting the relevance of the original biocompatibility safety data in the overall assessment of newly sterilized product. Walker Downey & Associates formulated the strategy, helped to place the ISO 10993-18 studies and then wrote the Expert Opinion to justify the position.

SEP 2006 – WDA facilitates $1 million dollar testing exemption for client


September 2006 Walker Downey & Associates helped design and coordinate a series of pivotal nonclinical studies for a biologic/device combination product that FDA/CBER/CDRH have accepted for application to the sponsors proposed future modifications to the product line. The strategic proposal for systemic toxicity, genotoxicity, and reproductive toxicity was well received by the FDA “as prepared” without modification. Two similar products described in the strategy documents were immediately exempted from similar testing based on the rationale provided. Preclinical cost savings to the sponsor for the two exempted products amounted to in excess of one million dollars.

OCT 2005 – WDA facilitates a VC-company rapid move through preclinical testing


October 2005 A newly formed venture capital-funded company with intellectual property rights to a novel technology conceived >20-years ago was now working expeditiously toward treatment of a new disease indication and sought Walker Downey & Associates guidance in the completion of IND-enabling studies. The company had strong research and development skills, but lacked the internal experience to complete the pivotal studies of their product. More specifically, the company required preclinical expertise in a porcine animal model in addition to a facility capable of conducting polymerase chain reaction (PCR) biodistribution studies. Walker Downey & Associates, Inc. was able to facilitate this testing. Walker Downey & Associates first designed the needed studies (two separate studies were run concurrently) by “concept protocol” for discussion at the client’s Type-B pre-IND meeting with the FDA. After receiving FDA concurrence (no changes were required in the concept protocols by FDA) Walker Downey & Associates then called on the expertise of their staff to evaluate and review all requirements of the studies, including protocol design, personnel qualification evaluation, review of financials and pricing schedules. The team from Walker Downey & Associates recommended several qualified CROs with comparators for decision-making. Once the facility was selected by the client, Walker Downey & Associates was asked to oversee the studies. Walker Downey & Associates in conjunction with the selected CRO was able to complete the required studies on time and on budget. The client’s IND was subsequently approved and they were able to proceed to Phase I clinical testing. They are currently designing Phase II and III clinical trials with their product.

MAY 2003 – Due diligence report by WDA favors partnership for $3.5B product market


May 2003 Dr. McLain, President of WDA, conducted preclinical due-diligence for a client interested in partnering with a smaller company with patent rights to a novel and proprietary hormone dependent prostate cancer vaccine. His due diligence report expressed “in favor” of the collaboration after minor selected issues were addressed. The client moved forward with the partnership based on this due diligence report and provided first-round financing. Unfortunately, the client was acquired by a larger company the following year and this particular partnership opportunity was dissolved. Subsequently, the smaller company established a partnership with an even larger international pharmaceutical company and expects to obtain clinical proof of principle for this product in the first half of 2007. Notably, prostate cancer is a serious condition that affects increasing numbers of men worldwide and is the most frequently diagnosed cancer in males. About one-third of all men have at least some cancerous prostatic cells at the age of 50, with the incidence increasing to as many as 90 percent at the age of 90. In the United States and Europe alone, about 80,000 men die each year from prostate cancer. The commercial opportunity for therapeutics targeting this market is predicted to reach $3.5 billion by 2007.

	Walker Downey & Associates, Inc.
Home Services About Us Links Contact Us

		News

			MAR 2008 – Walker Downey & Associates, Inc. featured in Medical Device Development trade journal March 2008 - Walker Downey & Associates, Inc. has been providing strategic solutions to its clients in the healthcare industry for over a decade. One simple telephone call or email will immediately connect customers with consultants in toxicology and biocompatibility, pathology and histology, quality and regulatory affairs, and contemporary statistics. Dedicated staff will apply their considerable experience to design and interpret specific biocompatibility testing packages in accordance with current best practice and international standards. Walker Downey will assure that the “right tests are done right” and prepare written justification for these test selections (or waivers) for product submission. Working with its many preferred CRO partners, the company helps customers move their projects to the front of the line, keeping them on target for proposed product submission dates. In addition to short-term testing strategies, many clients come to Walker Downey for help with their more expensive long-term testing, including chronic toxicity, carcinogenicity and reproductive toxicity. While it is advised to conduct this testing when it is warranted, more often than not this obligation can be met by expert risk assessment, as described and advised in the current ISO standards series. Whether using chemical structure-activity-relationship models, particulate theorems, or rely on the available published scientific and clinical literature, Walker Downey can usually defend a test waiver. In this particular area more than any other, considerable time and money can be saved, while showing company commitment to ISO 10993-2 (animal welfare requirements) and the 3Rs (reduction, replacement, and refinement of animal testing). For clients having trouble formulating a response to a reviewer question, the company calls on its writers of science and effective communicators to address these issues. With a response signed and approved by a recognized expert, reviewers will appreciate the effort. AUG 2007 – WDA experts facilitate another 510K submission August 2007 the breadth of experience at Walker Downey & Associates has prompted a Florida-based medical device company to retain these services through clinical testing. Walker Downey & Associates initially provided a due-diligence review of the company’s preclinical documentation for their respective device classification, and recommended additional tests to strengthen the 510(k) submission. Walker Downey & Associates contributed to the 510(k) submission by writing a biocompatibility testing summary, a risk assessment of active ingredients, and several Expert Opinions on related matters. JUN 2007 – WDA provides solution to redundant international animal testing requests June 2007 To assure compliance with international device safety testing guidance that may have undergone revision, officials in some countries may often request retrospective animal testing even when pertinent human safety data already exists. In a recent example, one of its clients asked Walker Downey & Associates (WDA) to respond to a request by the China State Food and Drug Association (SFDA) to explain why a 14-day intravenous toxicity study, as described in ISO 10993-11 (2007), recently revised and released by TC194/WG7, was considered sufficient for re-registration of a product that had been marketed in that country for 4-years, and elsewhere for as long as 25-years. The result? Dr. Dan McLain, President of WDA and the current Convener of ISO 10993-11, wrote letters to three agencies within SFDA stating that it was neither the intention nor the desire for Part 11 to be applied to any existing medical devices with a demonstrated history of safe clinical use. Furthermore, he noted that while delegates to his committee, which included experts from China, contended and agreed, that animal testing should serve as an informative and useful bridge to safe clinical testing, they also agreed that anecdotal or retrospective testing in animals, after demonstration of safe clinical use of a device, would serve no useful purpose and conflict with other TC194 standard recommendations. With respect to the Part 11 cited range in testing days for a subchronic intravenous toxicity study (i.e. 14 – 28 days), Dr. McLain also offered that if after a thorough evaluation of clinical data for a Class III device (permanent implant, direct blood contact), that has not undergone material or process changes, should any regulatory agency still conclude that additional testing is warranted then, in his opinion as Convener of TC194/WG7, a minimal 14-day intravenous exposure and/or implantation study (as proposed by client) would seem sufficient. The client device was successfully re-registered in China with the help of WDA. Client: “the rapid and effective response by WDA helped us to address this issue to the mutual satisfaction of SFDA and our company and brought a much needed clarity to the even broader issue of conducting anecdotal/retrospective animal testing when pertinent human safety data already exist”. WDA: “this was a classical case study of a regulatory authority wanting to do the right thing and seeking additional guidance in the form of an Expert Opinion. To the credit of our client, they recognized this as an opportunity to apply the basic principles of toxicology (i.e., that human safety data will usually supersede animal data), and were able to leverage the “spirit” of TC194 which calls for a responsible use of test animals.” NOV 2006 – ISO 10993-18 used to facilitate a critical IDE submission (sterilization change) November 2006 Walker Downey & Associates facilitated a client's critical IDE submission, which included a late-stage change in product sterilization method. Our strategy was to employ the ISO 10993-18:2005 standard (chemical characterization) to demonstrate equivalency of the two sterilization methods, thus supporting the relevance of the original biocompatibility safety data in the overall assessment of newly sterilized product. Walker Downey & Associates formulated the strategy, helped to place the ISO 10993-18 studies and then wrote the Expert Opinion to justify the position. SEP 2006 – WDA facilitates $1 million dollar testing exemption for client September 2006 Walker Downey & Associates helped design and coordinate a series of pivotal nonclinical studies for a biologic/device combination product that FDA/CBER/CDRH have accepted for application to the sponsors proposed future modifications to the product line. The strategic proposal for systemic toxicity, genotoxicity, and reproductive toxicity was well received by the FDA “as prepared” without modification. Two similar products described in the strategy documents were immediately exempted from similar testing based on the rationale provided. Preclinical cost savings to the sponsor for the two exempted products amounted to in excess of one million dollars. OCT 2005 – WDA facilitates a VC-company rapid move through preclinical testing October 2005 A newly formed venture capital-funded company with intellectual property rights to a novel technology conceived >20-years ago was now working expeditiously toward treatment of a new disease indication and sought Walker Downey & Associates guidance in the completion of IND-enabling studies. The company had strong research and development skills, but lacked the internal experience to complete the pivotal studies of their product. More specifically, the company required preclinical expertise in a porcine animal model in addition to a facility capable of conducting polymerase chain reaction (PCR) biodistribution studies. Walker Downey & Associates, Inc. was able to facilitate this testing. Walker Downey & Associates first designed the needed studies (two separate studies were run concurrently) by “concept protocol” for discussion at the client’s Type-B pre-IND meeting with the FDA. After receiving FDA concurrence (no changes were required in the concept protocols by FDA) Walker Downey & Associates then called on the expertise of their staff to evaluate and review all requirements of the studies, including protocol design, personnel qualification evaluation, review of financials and pricing schedules. The team from Walker Downey & Associates recommended several qualified CROs with comparators for decision-making. Once the facility was selected by the client, Walker Downey & Associates was asked to oversee the studies. Walker Downey & Associates in conjunction with the selected CRO was able to complete the required studies on time and on budget. The client’s IND was subsequently approved and they were able to proceed to Phase I clinical testing. They are currently designing Phase II and III clinical trials with their product. MAY 2003 – Due diligence report by WDA favors partnership for $3.5B product market May 2003 Dr. McLain, President of WDA, conducted preclinical due-diligence for a client interested in partnering with a smaller company with patent rights to a novel and proprietary hormone dependent prostate cancer vaccine. His due diligence report expressed “in favor” of the collaboration after minor selected issues were addressed. The client moved forward with the partnership based on this due diligence report and provided first-round financing. Unfortunately, the client was acquired by a larger company the following year and this particular partnership opportunity was dissolved. Subsequently, the smaller company established a partnership with an even larger international pharmaceutical company and expects to obtain clinical proof of principle for this product in the first half of 2007. Notably, prostate cancer is a serious condition that affects increasing numbers of men worldwide and is the most frequently diagnosed cancer in males. About one-third of all men have at least some cancerous prostatic cells at the age of 50, with the incidence increasing to as many as 90 percent at the age of 90. In the United States and Europe alone, about 80,000 men die each year from prostate cancer. The commercial opportunity for therapeutics targeting this market is predicted to reach $3.5 billion by 2007.





			Walker Downey & Associates, Walker Downey & Associates, Walker Downey & Associates, Walker Downey & Associates, Walker Downey & Associates, Daniel McLain, Daniel McLain, Daniel McLain, Daniel McLain, Daniel McLain, adverse, acute toxicity, analytical, anatomical, animal, animals, animal model, animal studies, ASQ, audit, autism, biology, biological, biological science, biotechnology, biopharmaceutical, biological warfare, biodefense, biomedical, biomedical science, BLA, carcinogenicity, carcinogen, cancer, chemistry, consumer products, clinical, clinical testing, clinical trial, clinical chemistry, chemistry, critical period, consulting, consultants, CFR, CTA, DART, DoD, development, developmental, developmental toxicology, device, disease, disease model, DNA, dosing, dose-response, dosage, drug, due diligence, EPA, efficacy, efficacious, embryology, embryo, embryogenesis, epidemic, environmental toxicology, expert witness, FDA, fetal, fetus, food safety, food science, food additives, forensic, forensic science, forensic examination, GLP, good laboratory practice, GMP, good manufacturing practice, GXP, GCP, good clinical practice, genetic toxicology, genetic toxicity, general toxicology, geriatrics, geriatric toxicology, guidelines, guidance document, harmful, harmful effects, hematology, histology, histopathology, health, healthcare, human health, ICH, IND, immunology, immunological, immunogenicity, immunotoxicology, investigation, in vitro, in vivo, juvenile, kinetics, liability, mathematical, mechanisms, medicine, medical, medical device, metabolite, molecule, model, model development, molecular biology, MHRA, MHW, NDA, neurotoxicity, OECD, organogenesis, organ weight, pandemic, PCR, PMA, pharmacology, pharmaceutical, pharmaceutical science, pediatric, pediatric toxicology, protection, preclinical, preIND, product safety, project, project management, program, program management, protocol, protocol development, quality, quality audit, quality assurance, quality management, regulatory, regulatory affairs, regulatory submission, rules, RAPS, reproductive, reproductive toxicology, reproduction, repeated dose, research, risk, risk assessment, risk management, risk review, safety, safety pharmacology, safety evaluation, science, standards, SOP, SOT, statistics, statistical, study, study director, toxicology, toxicology specialist, toxicity, toxicological, toxicokinetics, testing, test system, vaccine, vaccine development, vaccination, 510K, veterinary, WHO, biocompatibility, biological safety, immunochemistry, transgenic mouse, chronic toxicity, ISO 10993, AAMI, TAG 194, safety test, biosafety, sample size, biostatistics, statistician, biostatistician, equivalence, equivalent, substantially equivalent, better than, claim, performance, efficacy, statistical plan, database, data entry, double, Part 11, hypothesis, null, sponsor, literature, investigator brochure, research, study, trial, studies, response variable, endpoint, case report form, investigator, site, center, technical writer, CDRH, premarket notification, IDE, investigational device exemption, submission, approval, premarket, quality, competitive intelligence, corporate intelligence, medical market, market research, corporate spy, SCIP, training, seminar, conference, onsite, education, certification, survey, IVD, in vitro diagnostic, combination product. quality control Statistical process control DOE Design of experiments PQ IQ OQ Qualification validation SPC QA QC RA DMF Device master file Technology transferRun chart DMAIC Extractables Leach Leachables NAMSA Data management Data analysis Database Tissue Engineering Stability Stability study Modified general safety test ASQ ISPE Grant submissions , vaccine, vaccine development, vaccination, 510K, veterinary, WHO, biocompatibility, biological safety, i