Welcome on As-Iris Web Pages

Strategy Consulting & Executive Coaching for Life Sciences Companies

About As-Iris

Who are we ?

Anne Dupraz Poiseau, Ph.D , President

I have worked for over 27 years in the industry in the field of health product development and regulatory strategy and have extensive international experience as a project manager, team and department leader.

I co-created a strategic and regulatory consulting company (Meditest International: 1999-2002) then participated as a member of the management team of two other companies (VCLS: 2009-2016 and Orchard Therapeutics: 2016-2022) in their growth strategy (from a few employees to 200+) and international development before creating the company As-Iris, SASU.

My technical expertise includes regulatory and health product development strategy, with a specialization in Advanced Therapies (gene therapy, cell therapy and tissue engineering) as well as rare disease indications. In my various leadership positions, as Chief Development and Regulatory Officer at Orchard Therapeutics Limited or Executive Vice President at Voisin Consulting Life Sciences, I have been able to appreciate the importance of combining technical excellence and collaborative dynamics to carry out successful and efficient development projects, regulatory submissions and all business transformation projects.

I trained in executive coaching at the Paris Coaching School and have been certified in June 2023.

With this experience and rich understanding of organizations and interpersonal relationships, I am keen to support each executive and leadership team to help them mobilize all their potential and optimize their performance by developing their personal, relational and /or organizational skills. Each of us being an actor of change, this contributes to meaningful, more efficient and more humane organizations.

A commitment to "Behave "

The Iris, symbol of beauty, comes from the Greek term meaning “rainbow”. It's a wild or garden flower of many varieties, all superb!

Each of us has our own palette of colors and skills. The challenge is to combine them,

  • either individually, to give meaning, power and beauty to our actions,
  • or collectively, to build bridges, to interact effectively and respectfully, and to create a complementary team driven by a shared vision and common goals, bringing out the best in each of the team members.

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Our services

  1. Accompany : Executive coaching
  2. Strategy : Development and regulatory strategy for healthcare products

Executive Coaching

What is Executive Coaching ?

It's a personalized support based on confidentiality. Thanks to a privileged, strong and trusting partnership with the coach, Executive Coaching helps to take the necessary step back, to develop new practices, and to bring out positive avenues of development to achieve the desired objectives.

Executive coaching provides a space-time for change and transformation.

Who is Executive Coaching for ?

Leaders, from C-Suite to team leaders.

When to ask for Executive Coaching ?

As soon as there is a wish to fill a "gap" between the current situation and the desired situation in relation to one's work. Coaching can be particularly beneficial and impactful for leaders in certain situations:

  • "Breaking" the feeling of loneliness by providing an independent sounding board for senior leaders, allowing them to take a step back and gain some perspective on the daily pressures that follow on from one another, and to work on their posture
  • Preparing for future role or career changes
  • Taking on a new or different role
  • Overcoming difficulties in achieving professional goals
  • Overcoming relational or communication problems at work
  • Overcoming a problem of finding one's place and being recognized by one's peers, hierarchy and/or team
  • Overcoming a work/life balance problem
  • Managing stress at work

Team or organization coaching

When to use team or organizational coaching ?

You are a leader, from C-suite to team leader and you need to :

  • organize and mobilize your team(s) around a transformation project (strategic, organizational or cultural) and/or support them in these transformations.
  • strengthen the efficiency of your team(s)
  • strengthen your team's unity and cohesion
  • manage a team in a multi-cultural context
  • strengthen managerial practices
  • define a shared vision, mission and values for your organization etc...

Modalities

In person coaching (location to be defined with the company). Possibility of preparation by videoconference

Partnership with Humanim, a management consulting firm specializing in the healthcare industry.

Development and regulatory Strategy for healthcare products

Our offer

We help you define the optimal strategy for your healthcare products based on our experience and in-depth knowledge of global regulatory pathways.

We act as part of your extended team, providing experienced professional support to complement your team skills and assets.

A robust regulatory strategy is a key factor of success as it allows timely inputs and risk mitigations into the different aspects of the development, and help coordinating the different activities needed for an efficient and streamlined product development and a rapid approval.

Our strategic services include for instance:

Due dilligence

Advisory Board

Guide product development through the different regulatory frameworks to allow a global approach; identify appropriate regulatory pathways and accelerated routes to approval when possible

Review development and regulatory plans before implementation, identify risks and opportunities and propose substantiated alternatives when needed

Align the regulatory strategy with the product development plan in line with your objectives

Define, prioritize and/or review interactions plans with regulators

Provide strategic review on your regulatory applications, including making sure the key messages are clear and distilled consistently and coherently throughout the applications

Prepare and lead interactions with regulators, help identifying questions to the agencies, developing robust briefing packages, rehearsing for oral presentation and planning for different scenarios depending on agencies' feedback

Guide you through the pre-BLA, pre-MAA preparatory activities

Act as a sounding board for your teams

Development and regulatory Strategy for healthcare products

You can benefit from the following experience et expertise

Before creating As-Iris, Anne was Chief Regulatory and Development Officer at Orchard Therapeutics Limited (“Orchard”). In this position, Anne led Orchard’s global regulatory strategy and coordinated program leadership and management. She explored innovative pathways to expedite the development and licensing of the company’s pipeline of transformative medicines. Notably, under her leadership, Libmeldy® was approved in the EU for the treatment of children with Metachromatic Leukodystrophy (MLD).

Anne brings 30 years of experience of tackling R&D, clinical and regulatory challenges within life sciences companies. Prior Orchard, she was Executive Vice President at VCLS (Voisin Consulting Life Sciences), a global consulting firm, where she was also actively involved in the design, preparation and management of a high number of regulatory applications at all stages of product development (from product regulatory classification, clinical trial applications to registration file).

Over the years, Anne has developed very effective communication links with regulatory authorities, including the Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA). She participated in a large number of interactions with the agencies, including preparatory activities for Biological License Applications (BLAs) and Marketing Authorization Applications (MAAs), Scientific Advice procedures on product development plans as well as Pediatric Investigation Plans and regulatory designations (e.g. Orphan Drug Designations (ODD), Regenerative Medicine Advanced Therapy (RMAT) and Breakthrough Therapy Designations (FDA) or PRIority Medicines (PRIME) scheme (EU)).

Strategic thinker, Anne advises on product development in numerous therapeutic areas and notably for rare indications with high unmet medical needs, where accelerated pathways are of paramount importance to better serve the patients at need. Anne possesses extensive expertise in human Cell, Tissue and Gene Therapies, so called Advanced Therapy Medicinal Products (ATMPs). Bringing together scientific and regulatory expertise in this area, she actively participated in the elaboration of the European ATMPs' Regulation through Industry Associations and worked closely with the European Medicines Agency (EMA) on related guidelines.

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