Combination Products Regulation Conference

February 28 – March 1, 2019 | Arlington, VA

Hilton Crystal City at Washington Reagan National Airport

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DAY ONE | THURSDAY, FEBRUARY 28

7:30 REGISTRATION & WELCOME COFFEE

8:00 CHAIRPERSON’S OPENING REMARKS

8:10 OPENING ICE-BREAKER: INSIGHTS INTO REGULATORY INTELLIGENCE COLLECTION STRATEGIES
With continuously evolving requirements and standards released from health authorities in the USA and internationally, regulatory affairs teams face the ongoing challenge of remaining abreast of changes impacting combination products. As various methods are applied throughout the industry to ensure timely awareness of new rules, the opening ice-breaker will kick off the conference with the chance for all participants to meet new attendees and connect through short, engaging discussions. In this interactive session, participants are encouraged to share perspectives on key insights into regulatory collection intelligence best practices. In addition, participants have the opportunity to immediately build contacts with industry peers, kicking off the event networking platform.

 

8:30 CO-PRESENTATION: HUMAN FACTORS DESIGN AND USABILITY FOR OPTIMIZING INSTRUCTIONS FOR USE

  • Design criteria for human factors & usability studies
  • Assessing differing patient needs & environmental factors
  • Merging human factors findings with regulatory requirements
  • Team collaboration to target content for intended patient population

Anoop Padival, PhD, ABBVIE

Edward Halpern, PhD, ABBVIE

 

9:30 HUMAN FACTORS ENGINEERING CONSIDERATIONS FOR SELECTING PLATFORM DRUG DELIVERY DEVICES

  • Applying human factors engineering (HFE) to platform drug delivery devices
  • Selecting drug delivery devices based on HFE-focused due diligence
  • Evaluating device suitability to intended users, environments, & scenarios
  • Scaling HFE work for a particular drug and indication
  • Potential opportunities to bridge HFE end-products between platform devices

Andrea Dwyer, Managing Human Factors Specialist, EMERGO by UL

 

10:15 COFFEE & NETWORKING BREAK

 

10:30 OVERCOMING CHALLENGES IN CLINICAL STUDY DESIGN & DRUG-DEVICE EVIDENCE BRIDGING
With two constituents in a combination product, clinical studies must be constructed to simultaneously test both components and yield data proving that the drug and device perform as intended, and are safe for patient use. Clinical and regulatory affairs executives are often challenged with the study design as the clinical hypothesis is complex to define for both parts together, and must put in relation the dependency of one component on the other. Additionally, combination product teams therefore seek effective methods to bridge evidence for both the drug and device elements for regulatory submission documents.

  • Formulating the hypothesis & both parts’ interdependence
  • Study design to evaluate both components simultaneously
  • Bridging drug & device evidence for regulatory submission

Bob Laughner, ASTRAZENECA

 

11:15 EXCHANGE GROUPS: REGULATORY SUBMISSION CHALLENGES SPECIFIC TO DEVICE & PHARMACEUTICAL COMPONENTS
Many regulatory executives have developed expert knowledge on either medical device or pharmaceutical regulations, based on work experience in the industry, and now require education on the field they may be less familiar with in order to ensure a holistic approach to combination product regulatory requirements. This peer-to-peer learning session allows device experts to join together in a group led by a pharmaceutical executive, and discuss challenges to acquire enhanced knowledge about the pharmaceutical regulatory landscape. Additionally, pharmaceutical teams will discuss with a device expert in the small group format to pose concerns and understand device specific regulations.

DEVICE GROUP: Steven Bruun, WL GORE & ASSOCIATES

PHARMA GROUP: Dan Visco, MERCK

 

12:00 LUNCHEON FOR ALL PARTICIPANTS

 

1:15 PANEL: OPTIMIZING PRIMARY MODE OF ACTION DETERMINATION & PROCESS TO APPEAL FDA DECISIONS
One of the most prominent areas of challenge is for combination product teams lies in classifying the product as a drug or a device through establishing the primary mode of action, which affects regulatory pathways, the lead FDA center, and the organization’s overall strategy. In order to maximize chances for the company’s perspective of the PMAO to also be adopted by the FDA, combination professionals aim towards securing the best understanding possible of the Agency’s analysis process regardless of ongoing grey areas and lack of transparency. In addition, with the risk of having the FDA disagree with the PMOA, executives must also be familiar with the appeal process should they wish to pursue the regulatory team’s initial determination.

  • Methods of determining an unclear primary mode of action
  • Regulatory strategy shift in the case of opposite FDA determination
  • Practices to effectively navigate the jurisdiction appeal process

MODERATOR:
Lina Kontos, Counsel, HOGAN LOVELLS

PANELISTS
Jeff Gibbs, HYMAN, PHELPS, & MCNAMARA

Darin Oppenheimer, MERCK

Suchitra Basu, DEPUY SYNTHES

 

2:00 EUROPEAN MDR 2017/745: NEW PROVISIONS & EFFECT ON COMBINATION PRODUCTS
The EU MDR 2017/745 introduces a completely new approach to combination product regulatory compliance within the territory, spanning all operations from product development to testing and CE mark approval. With the transition period ending in May 2020, regulatory affairs teams are prompted to revise and update strategies accordingly, demanding for a robust understanding of new provisions. Although both devices and pharmaceutical experts notice an increase in the workload due to the impending deadline, pharmaceutical organizations are more heavily impacted and face the challenge of entering a completely new regulatory framework.

  • Comparison of EU MDD & EU MDR for combination products
  • Regulatory organizations involved in products assessment
  • Changes to assessment & approval process for both constituents
  • Defining the impacts of Article 117 of EU MDR 2017/745

Waiss Faissal, GMED NORTH AMERICA

 

2:45 COFFEE & NETWORKING BREAK

 

3:15 MANEUVERING AN UNCERTAIN REGULATORY LANDSCAPE IN ASIAN MARKETS
Part 1: Focus On Regulatory Requirements In China & Japan

  • Regulatory updates affecting combination products
  • Specific areas of consideration for submissions
  • Comparison of requirements with US FDA demands
  • Suchitra Basu, PhD, DEPUY SYNTHES

3:50 Part 2: Updated Compliance In Malaysia & Taiwan

  • Combination product requirement challenges in Malaysia & Taiwan
  • Update on new registration rules for products in Malaysia
  • Combination product submissions & pathways in Taiwan

Darin Oppenheimer, PhD, MERCK

 

4:15 REGULATORY UPDATE & CLARIFICATION ON THE DEVICES REFERENCING DRUGS PATHWAY
In the absence of a viable regulatory process for medical devices meant to be used in conjunction with a legacy or generic pharmaceutical product without needing to change the drug component’s initial label, or file a new NDA, the FDA is exploring the development of a new product category. The considered Devices Referencing Drugs (DRDs) regulatory pathway could potentially enable medical device manufacturers to proceed without becoming a drug sponsor, and obtain approval solely for the device intended to be used with the pharmaceutical component. While promising, the new category is still unclear as the frontier with combination products remains confusing for both the pharmaceutical and device industries alike, demanding for an in-depth interpretation of the new pathway.

  • Reasoning behind FDA’s newly proposed category
  • Comment period extension & challenges raised
  • Industry action to conform to DRD requirements
  • Implications for device & pharmaceutical companies

Lina Kontos, HOGAN LOVELLS

 

5:00 CLOSING REMARKS & DAY 1 CONCLUSION

5:00-6:00 COCKTAIL HOUR SPONSORED BY Q1 PRODUCTIONS

6:00 CONTINUED NETWORKING: FACILITATED GROUP DINNERS