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Lean Stability: Global Regulatory Reception -Successes and Challenges of Recent Case StudiesAnita L. Freed Pfizer Worldwide Research & Development

Global Chemistry, Manufacturing and Controls

05-Apr-20161

Applications of Science and Risk-Based Concepts to Stability

• Examples we have discussed:

– Modeling, ASAP strategies, analytical method development and validation strategies, etc.

– Applied to both small and large molecules

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“risk-based” concepts

and principles

• Are regulatory agencies accepting of such strategies and if so, in what way? Focus: lean stability strategies applied to new chemical

entities (NCEs) throughout their lifecycle

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Agenda• Brief overview of lean stability• Clinical stability of NCEs

– Do clinical guidances allow– Examples of strategies – Case studies

• Registration and post-approval stability of NCEs– Do registration and post-approval guidances allow– Examples of strategies – Case studies

• Summary• Acknowledgments• References

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What is Lean Stability?• A lean stability strategy is a science, risk-based alternative approach

to stability studies

– Leverages enhanced knowledge and allows focus on the highest risk attributes and time points, thereby improving efficiency and expediting results without impacting safety, efficacy or quality

– Our “toolkit” may include modeling, statistical approaches, ASAP (accelerated stability assessment program), stability risk assessments (SRAs), etc.

– Can be applicable at all stages of development and to all product types

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ASAPmodeling

Statistics

SRAs

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Inclusion of Lean Stability Approaches in Regulatory Dossiers

Goal: To use a science and risk based approach to meet regulatory expectations for stability requirements and enable a more efficient and expeditious availability of product to patients

– Achieve approval (clinical, registration, post-approval changes (PAC))

– Ensure product quality throughout its lifecycle

– Spend resources and $$ in places that add value

Provides benefits to industry, regulatory agencies and patients

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Industry• More efficient

product quality assurance

• A focus on meaningful data

• Fewer product “surprises/failures” in the field

Agency• Product reviews

focused on meaningful data

• More efficient review process

• Fewer product “surprises/failures” in the field

Patients• Timely access to

medicines facilitated

• High quality, well understood products

• Undisturbed supply of their medicines

Lean Stability Strategies in Clinical Development (NCEs)

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Phase 1Phase 2

Phase 3

8 –

12

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5

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CTA MA

One FDA approvedmedicine

Phase 4

scientific / technical understanding, manufacturing experience increases

Update CTA (clinical trial application)

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Do Clinical Stability Guidelines Allow?

• Guidances are generally not prescriptive, global expectations vary and are not always consistent, e.g.– Dependent upon stage of development vs expect ICH Q1 application– Inclusion and acceptance of proposed stability protocols, DS retest and

DP use period assignments– “The shelf-life should be defined … extrapolation may be used …”– Acceptance of scientific justification

• Further challenge: inclusion of the “expiry” on the label is required in some countries

• Most/all agree that a commitment to assess the stability of the clinical (or representative) supplies in parallel to the clinical studies and throughout its duration should be included

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Examples of Lean Stability StrategiesStrategy Comments

Apply DS stability data (solely) to simplified/DS-based dosage forms, e.g. DS in a bottle or capsule

Justification included in the clinical trial application (CTA; includes referencing section S.7 in P.8)

Assign initial DS reveiw period of 18M based on 1 week 70⁰C/75%RH data

Commitment for ‘formal’ program included in CTA

Use ASAP to determine packaging and long-term storage conditions as well as to set the initial use period

Data, conclusions and commitment for ‘formal’ program included in the CTA

Use ASAP to assist in assessing whether a DS or DP change in process, composition or packaging affects stability, and thus need for additional stability program

Inclusion in CTAs is case dependent

Reduce testing protocol (e.g. time points, tests, conditions) based on supportive data

Inclusion of explicit justification in the CTA is case dependent

Eliminate DS assay testing if it is the same lot as the reference standard

Justification included in the CTA

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These strategies have been prosecuted for 5 to 10 + years and have been included in clinical filings in many regions (USA, EU, Canada, Emerging Markets (EM))

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CASE STUDIESInclusion of Lean Stability Strategies in Clinical Dossiers

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Compound A: Initial Phase 3 study; bond formation steps changed compared to stability lot (60M data provided)Included in CTA: Description of the ASAP study, results and conclusions; comparison of release results. No testing commitment made. Retest date of 60M retained.

Submissions: US, Korea, China, Spain, France, Hungary, Japan*, Mexico*, Russia*, Slovakia, Brazil, Canada, Germany, Hong Kong*, India, Peru*, Poland, South Africa*, Sweden, Turkey, Argentina*, Thailand, Australia*, Austria, Belgium, Denmark, France, Greece, Ireland, Italy, Switzerland, UK, New Zealand*

Responses: Only query/comment came from China• Did not question the review period assignment, • Request DS from the new route be placed on a confirmatory stability study

*Not all countries required Stability Sections in the CTAs

Use of ASAP to Assess DS Process Change

Table 3. Summary of Use Period Limiting Degradants from an Accelerated Stability Study

Condition Duration Level of Use Period Limiting Degradant

70ºC/10% RH 35 Days NMT 0.05%70ºC/75% RH 35 Days NMT 0.05%80ºC/10% RH 35 Days NMT 0.05%80ºC/40% RH 35 Days NMT 0.05%

Overall: This approach has been used globally and has been successful in gaining approval without queries in most cases.

Reference: Timpano R, Freed AL, Clement E, Masse K, Ryan K “Accelerated Stability Assessment Program (ASAP) Regulatory Strategies” in Accelerated Stability Assessment Program (ASAP): Fundamentals and Pharmaceutical Industry Practices edited by Qiu F and Scrivens G, in preparation (2016)

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Assay Exclusion: Working Standard is the Same Batch

Compound B: Initial Ph 2a study

Included in the CTA: Justification for not including assay, e.g. identical storage, results would be reflective of method accuracy rather than degradation, HPLCmethod is stability-indicating

Submissions: US, Canada, Hungary, Slovakia, Romania, Bulgaria, India, Philippines*, Taiwan*, Turkey*

Responses: No comments/queries

*Not all countries required Stability Sections in the CTAs 11

Overall: This approach has been used globally and has been successful in gaining approval without queries in most cases,

• Exception: Canada• In two additional cases, we were asked by Belgium to include this test in future

submissions for that particular product. We have also been queried by Czech Republic, which we were able to successfully address by providing assay using mass balance approach with the commitment to set up a future lot on stability and monitor assay.

Use of ASAP to Justify Change in Tablet Film-Coat ColorCompound C: Initial Phase 3 study; change in IR tablet film-coat color compared to development lot on stability (6M)

Included in the CTA: • Blue film-coat contains more pigments; accelerated comparison study – similar stability • Description and conclusion of development lot’s ASAP study - stable for NLT 36M at

labeled conditions and proposed packaging. Use period (18M) retained. • Committed to test clinical tablets, but with reduced conditions and time points for the

long-term conditions (30⁰C/75%RH – 6, 12, 24 and 36M); 3 time points for accelerated

Submissions: US, Korea, China, Spain, France, Hungary, Japan*, Mexico*, Russia*, Slovakia, Brazil, Canada, Germany, Hong Kong*, India, Peru*, Poland, South Africa*, Sweden, Turkey, Argentina*, Thailand, Australia*, Austria, Belgium, Denmark, France, Greece, Ireland, Italy, Switzerland, UK, New Zealand*

Responses: No comments or queries received.

*Not all countries required Stability Sections in the CTAs12

Further note: This approach was further tested in a subsequent global Ph 3 study whereby a differing film-coat was used and the ASAP information was not provided, but that from the tablets discussed herein (12M) was provided as supportive. The use period based on the development lot was retained.

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Compound D: Initial Ph 2a study using enabling tablets; no tablet stability data available at the time of submissionIncluded in CTA: Description of ASAP study, results and conclusions

Submissions: US, Canada, Bulgaria, Hungary, India, Philippines*, Romania, Serbia, Slovakia, South Africa*, Taiwan*, Turkey. Responses: Only query/comment came from Serbia - requested additional stability information and that testing protocol and extension protocols align with ICH Q1guidelines; however, no question on initial use period assignment.

*Not all countries required Section P.8 (stability)

Use of ASAP to Assign 12 Month Initial DP Use Period

Table 1. Stability Protocol for Compound A 0.5% Compacts

Overall: This approach has been used globally and has been successful in gaining approval for an initial 12 month clinical use period without queries in most cases.

Reference: Freed AL, Clement E, Timpano R. Regulatory Responses to the use of various lean stability strategies in early development. Regulatory Rapporteur. 2014; 11(7/8): 5-8.

Lean Stability Strategies in Initial Registration and Post-Approval (PA) Dossiers (NCEs)

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Emerging Markets Project Enhancements, e.g. Line Extensions

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Phase 1Phase 2

Phase 3

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12

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CTA MA

One FDA approvedmedicine

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Do Registration & PA Stability Guidelines Allow?

• Guidances give more prescriptive expectations / requirements

• Several (e.g. ICH, WHO, country/regional) include use of alternative approaches when scientifically justified, e.g. • ICH Q1A(R2): “The guideline seeks to exemplify the core stability data

package for new drug substances and products, but leaves sufficient flexibility to encompass the variety of different practical situations that may be encountered due to specific scientific considerations and characteristics of the materials being evaluated. Alternative approaches can be used when there are scientifically justifiable reasons.

• WHO: “…alternative approaches can be used when they are scientifically justified…”

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Do Registration & PA Stability Guidelines Allow?

• But… There are numerous country-specific regulations, guidances and expectations, in addition to and often times regardless of regional ones

– “We are aligned! Now, let me get out our check list…”

– Expectations can be very “dynamic” in some countries/regions

– Added challenge is each reviewer’s opinion may vary

• Opportunity: Often times regulators are open and inviting for discussions, and show interest in science-and risk-based approaches

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Lean Stability Strategies in the Initial Registration Dossier

• In general ICH/registration studies (e.g. on pilot batches) to support the initial marketing application (MA), product expiry should not be lean

– This data represent the foundation for all subsequent stability protocols including that for post-approval changes (PACs)

– Potential exception is use of bracketing and matrixing

• Application of lean strategies to post-approval stability commitments at registration or as part of a post-approval commitments could be considered

– Risk can be managed by implementation of mitigation strategies in the ‘background”

– Potential to discuss with regulators

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Examples of Registration and PA Lean StrategiesStrategy Comments

Monitor fewer storage conditions, e.g. only at 30⁰C/75%RHto support all filing zones and global labeling requirements

Justification is included in the submission

Monitor reduced time points, e.g. annually

Employ bracketing or bracketing and matrixing when applicableMonitor only those attributes that are SQRAs or the single SLLAConsider including planned/anticipated post-approval changes (PACs) in the initial MA (e.g. in a post-approval change management protocol) as possibleUsing ASAP, SRA, statistics, etc. to assess PACs, thereby reducing number of lots, time points, etc.

18SQRA = stability related quality attributes; SLLA = shelf life limiting attribute

These proposals should be the easiest to justify due to the vast amount of product knowledge and stability data available to leverage

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CASE STUDIES

Inclusion of Lean Stability Strategies in Initial Registration and Post-Approval Dossiers

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Compound E: Stable DS – filed with 6M ICH/registration data

Proposal: For both PA confirmation and annual stability commitment protocols

• Tests: Appearance and Purity only (confirmed as potential SLLA’s)

• Time points: First checkpoint was 12M, then 24M and 36M

• Condition: 25⁰C/60%RH only

Results

• Successfully achieved in US, EU, Switzerland, Japan, Canada, Australia, Israel, India, Argentina, Taiwan, Thailand, Russia, El Salvador, China, Panama, Guatemala, Honduras, Saudi Arabia, Peru, Costa Rica, Dominican Republic, Turkey, UAE, Curacao, Kuwait, Hong Kong, Bahrain, Uruguay, Chile, Lebanon

• Malaysia and Singapore: Site Specific stability data from the commercial site was needed, but the lean testing protocol was accepted.

Lean DS PA Protocols in an Initial Registration Dossier

Reference: Colgan ST, Timpano RJ, Roberts M, et al. Opportunities for lean stability strategies. J Pharm Innov. December 2014, 9:4, 259-271.

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Compound F: Combination product consisting of a complex MRformulation w/ multiple strengths with common pellets – filed with 36MICH/registration data in US, 36M shelf-life

Proposal

• No shelf-life confirmation proposed as primary batches was at commercial scale and site

• Annual lots– Committed to testing only one lot of one strength, as release and stability data

demonstrated to be comparable in all cases, with no strength-related trends– Tests: Water content and assay not tested on stability– Time points and condition: initial, 12M, 24M and expiry at 25⁰C/60% RH

Results: Queries on annual lot proposals• Water: 2 rounds of queries - agreement was to not add to specification

but to monitor; once sufficient data generated, either update (CBE-30) or once sufficient justify non-addition (general correspondence)

• Assay: Added with plan to file a PAS once further stability data is available to justify removal

CBE-30 = Changes-being-effected in 30 days; PAS = prior approval supplement

Lean DP PA Protocols in an Initial Registration Dossier

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Compound G: Stable, well understood DP (IR capsule) – filed with 12M ICH/registration data

Proposal

• To confirm shelf life: – Non-printed capsules for 2 of 3 lots for 2 of 3 strengths (low commercial volume)– Time points and conditions: 6, 12, 24, 36M at 30⁰C/75%RH; 6M at 40⁰C/75%RH

• Annual lots:– Test appearance, degradation products and dissolution as potential SLLA;

formation of a specified degradation product is the only SRQA that trended– Time points and condition: only 0, 12, 24 and 36M at 30⁰C/75%RH

Results• US requested assay be included and sampling points for confirmation of shelf life

be added (sponsor agreed)• Chile: approved confirmation of shelf life strategies for 1 of 2 packaging types• Submissions have taken place/are pending in numerous countries/regions

globally…stay tuned.

Lean DP PA Protocols in an Initial Registration Dossier

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Compound H: DP line extension of a stable established product (new formulation; tablet) – filed with 12M ICH/registration data

Proposal: For both PA confirmation and annual stability commitment protocols

• Tests: Appearance, degradation products and disintegration only, as these were confirmed as encompassing SLLAs

• Time points: First checkpoint was 12M, then 24 and 36M

• Condition: 30⁰C/75%RH only

• No commercial site stability data provided in the registration dossiers submitted to markets that required site specific stability data

– Provided ICH/registration stability data only; ICH lots manufacturing activities took place at sites other than that used commercially

– Shelf-life based on ICH stability data

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Lean Protocol and Exclusion of Site Specific Stability

Reference: Diaz D, Lynch ML, Oblessuc R, Ventura A, Colgan ST “Lean stability -A test case for the implementation of scientific advances into the LatAm regulatory framework” manuscript in preparation 2016.

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Market RegStatus

Stability Data ProvidedICH/Registration Commercial Site Comment

Australia

Approved

12M RT and 6M acc

None

Lean Post Approval

Commitment

Switzerland 12M RT and 6M accTurkey 12M RT and 6M accHong Kong 24M RT and 6M accArmenia 12M RT and 6M acc

6M RT and 6M acc full data

Azerbaijan 12M RT and 6M accGeorgia 12M RT and 6M accKazakhstan 12M RT and 6M accThailand 24M RT and 6M accTaiwan 12M RT and 6M acc

RT = room temperature; Acc = accelerated

QueriesQueries● Hong Kong BOH requested justification and validation that manufacturing

processes were identical.● Taiwan requested the inclusion of microbial testing in the Post Approval

Commitment stability protocol.

Reference: Diaz D, Lynch ML, Oblessuc R, Ventura A, Colgan ST “Lean stability -A test case for the implementation of scientific advances into the LatAm regulatory framework” manuscript in preparation 2016.

Lean Protocol and Exclusion of Site Specific Stability

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Market RegStatus

Stability Data ProvidedICH/Registration Commercial Site

Singapore

Approved

24M RT and 6M acc 12M RTIndonesia 24M RT and 6M acc 12M RT and 6M accUkraine 24M RT and 6M acc 12M RT and 6M accKuwait 24M RT and 6M acc 12M RT and 6M accUAE 24M RT and 6M acc 12M RT and 6M accJamaica 24M RT and 6M acc 12M RT and 6M accCosta Rica None 12M RT and 6M accEl Salvador None 12M RT and 6M accHonduras None 12M RT and 6M accMexico 24 mo RT and 6 mo acc 12M RT and 6M acc

RT = room temperature; Acc = accelerated

Additional Challenges Action

Commercial site data was required or thedossier would not pass its validation stage

Provided data

Agencies would not accept ICH/registrationstability data at all and/or Sections 3.2.P.8.2Post-Approval Stability Protocol andCommitment and 3.2.P.5.6 Justification ofSpecifications

Provided lean commercial stability data,declarations for omission of testing andjustification of stability testing and frequencyreduction

Reference: Diaz D, Lynch ML, Oblessuc R, Ventura A, Colgan ST “Lean stability - A test case for the implementation of scientific advances into the LatAm regulatory framework” manuscript in preparation 2016.

Lean Protocol and Exclusion of Site Specific Stability

SUMMARY

The Regulatory Reception of Lean Stability Strategies (NCEs): Clinical and Registration / Post-Approval

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Overcoming Regulatory Challenges: Things to Consider

• Engage in discussions with the Health Authority when at all possible

• Include clear and concise justifications in the initially submitted dossier

– Don’t forget to include pertinent discussion of your “toolkit”, i.e. modeling, statistics, SRAs, ASAP, etc.

• Be prepared to provide additional data, justification

• Be flexible

• Be prepared to be told ‘no’ more than once

• Be prepared to compromise

• Don’t be afraid to try again, e.g.

– Once additional data is available (statistics can be a powerful tool!)*

27*Reference: Freed AL, Vukovinsky K, Colgan ST “Stability and Statistics: How Do We Know When to Go Lean?” manuscript in preparation 2016.

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• We are making progress – but success has been variable

• Lean approaches for investigational supplies appear to be more readily accepted by the Regulators compared to post-approval applications

• Lean approaches for line extensions have been the most successful

• For initial MAs, lean post-approval proposals for DS are more likely to be accepted compared to DP proposals

• There are inconsistencies between agencies and in some cases within the same agency (on different products)

Lean Stability Strategies (NCEs): Overall Observations

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• Continue to socialize concept internally (across division) and externally (industry forums globally, white papers)

– Focus on meaningful data and risk-based strategies

– Move away from including “check box” testing in dossiers

• Partnership with other companies to identify best practices and facilitate ongoing dialog with regulators.

• Continue to capitalize on alternative approaches allowed in current country regulatory guidances.

What is Next?

How Can I Help?

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Project level:Include in dossiers, engage regulators

Present: internally and externally

Publish: in peer-reviewed journals, books

Work with industry partners and regulators: Engage in dialogues, provide feedback on draft guidancesand regulations

This will take some time but the benefits to patients, regulators and industry are real.

One company / person cannot resolve, but together over time we can make a difference!

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Acknowledgments

Steve ColganDorys DiazBeth KendserskyRob TimpanoElise ClementJen BrownSusan BerlamSue DecoteauThérèse Debiak-KrookKevin RyanKeith MasseKevin Fields

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A Few References• Freed AL, Clement E, Timpano RJ. Regulatory Responses to the Use of Various Lean Stability

Strategies in Early Drug Development. Regulatory Rapporteur, 11, 7/8 (2014).• Colgan ST, Timpano RJ, Roberts M, et al. Opportunities for lean stability strategies. J Pharm

Innov. December 2014, 9:4, 259-271.• Diaz D, Lynch ML, Oblessuc R, Ventura A, Colgan ST “Lean stability - A test case for the

implementation of scientific advances into the LatAm regulatory framework” manuscript in preparation (2016)

• Freed AL, Vukovinsky K, Colgan ST “Stability and Statistics: How Do We Know When to Go Lean?” manuscript in preparation (2016)

• Colgan ST, Hofer J, Norris K, Timpano RJ, Vukovinsky K, Waterman, K. Lean Stability. AAPS News Magazine, Sept 2015; 14-18

• Colgan ST, Watson J W, Whipple R D, Nosal R, Beaman J V, DeAntonis D M. The Application of Science- and Risk-Based Concepts to Drug Substance Stability Strategies. J. Pharm. Innov. 7:205-213 (2012)

• Waterman KC, Colgan ST, A Science-Based Approach to Setting Expiry Dating for Solid Drug Products. Regulatory Rapporteur, 5, 7/8 (2008)

• Acken B, Alasandro M, Colgan S, Curry P, Diana F, Li Q C, Li J, Mazzeo T, Ringnall A, Tan, Z J, Timpano R. Early Development GMPs for Stability An Industry Perspective (Part IV). Pharm. Tech, September:64-70 (2012)

• Li QC, Qui F, McWilliams W, Pape C, Song J J, Swanek F, Wang Z-J, Cohen K, O’Connor D. Best Practices for Drug Substance Stress and Stability Studies During Early Stage Development. Part III – How to Make Science-and Risk-based Stability Testing Decisions for Drug Substance Batches Produced after Manufacturing Process Changes. J. Pharm Innov Published online 30 October (2013). 33

FDA Perspective on Stability Modeling and Method Development Strategies for Large

Molecules—Case Studies

Ashutosh Rao, Ph.D., U.S. Food and Drug Administration, Silver Spring, Md.

Abstract and biography not available at this time.

AAPS Workshop on Accelerating Pharmaceutical Development Using Predictive Stability Approaches

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