Episode 33

Legal Issues in the Gene Editing Space: Lisa Taylor Ash, General Counsel at Shape Therapeutics

Episode summary

Introduction: 0:00

  • Introducing Lisa Taylor Ash, General Counsel of Shape Therapeutics. 
  • Merging a deep passion for science with law to forge a career as a biotech GC.

Leading legal through two major acquisitions: 2:48

  • Folding Pharmacyclics into Abbvie and Juno Therapeutics into Celgene.
  • Representing the smaller company in an M&A process.
  • Positioning your company as the expert on the product and its related legal concerns.
  • Trusting your own experience with the product and regulations.

Developing personalized medicines: 8:56

  • Breaking down the decades-long process from research to innovative medical breakthroughs.

Lessons for lawyers dealing with M&A: 12:11

  • Recognizing that legal issues rarely impact deal dynamics.
  • Emphasizing clarity with your business partners.
  • Advocating for your company’s expertise and established policies.

Leaving large companies after an acquisition: 14:06

  • Favoring small biotech companies because of their position at the forefront of cutting edge science.
  • Gaining the ability to work on all legal-related aspects of a product.

Launching an independent consulting firm: 15:51

  • Converting your expertise and experience about biotech and healthcare law into a business. 
  • Preferring the consultant relationship over one in which you offer legal advice.
  • Working with forty different healthcare companies over an eighteen-month period.
  • Calling on your network and venture capital to build a client list.

Offering practical advice for starting a consulting business: 19:39

  • Moving forward with your plan regardless of whether you have GC experience.
  • Trusting your gut on who you should or should not work with.
  • Assessing the value and establishing longterm relationships.
  • Building your confidence and prioritising directness.
  • Taking equity versus charging an hourly rate.

Returning to an in-house role at Shape Therapeutics: 24:37

  • Valuing the variety of working experiences in consulting but preferring the depth of in-house work.
  • Explaining the science behind RNA programming at Shape Therapeutics and the developing field of personalized medicine.

Legal issues related to gene editing: 30:47

  • Reshaping a drug development and regulatory framework to deal with individual questions of personalized medicine. 
  • Working with the FDA and global regulatory authorities to create new frameworks for patients.

Building public trust in gene therapy companies: 32:57

  • Cooperating with regulatory authorities and developing new systems for informed consent.
  • Dealing with AI-related questions surrounding privacy, IP rights, trade secrets, and legal and ethical issues.

The future of AI and gene editing: 35:41

  • Bolstering rapid experimentation and finding solutions that humans may not have considered.
  • Bringing biology and computer science together.

Creating an essential legal resource at 36:51

  • Identifying repeating themes and issues working in-house at different companies.
  • Emphasizing the importance of understanding and being a partner in the business.
  • Offering a resource to share core lessons and answer important questions.
  • Getting a chance to interview other lawyers and share their experiences.
  • Exposing young lawyers to what it means to be an in-house lawyer.

Book Recommendations: 41:35

  • The Effective Executive by Peter Drucker
  • Anything by Adam Grant
  • High: A Journey Across the Himalaya, Through Pakistan, India, Bhutan, Nepal, and China by Erika Fatland
  • Dune by Frank Herbert

What you wish you had known as a young lawyer: 44:03

  • Understanding that there is a different path forward than writing legal briefs for lawyers interested in business problems.

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Tyler Finn
Head of Community & Growth, SpotDraft
Lisa Taylor Ash
General Counsel, Shape Therapeutics

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