Legal Issues in the Gene Editing Space: Lisa Taylor Ash, General Counsel at Shape Therapeutics
In this episode
Transcript
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 effectiveinhouse.com: 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.