David Hamby Email & Phone Number

Cary, North Carolina, Us

We have formed a new gene therapy manufacturing CDMO called Advanced Medicine Partners. The new company is a spin out from Jaguar Gene Therapy. AMP is operated by an experienced gene therapy team of ~55 employees with extensive manufacturing, analytical development, and QC testing expertise from AveXis/Novartis and Jaguar Gene Therapy. AMP developed the Zolgensma® manufacturing process and analytics and were responsible for end-to-end global product approval and commercialization. This team also successfully filed a new IND for Jaguar where there were no CMC comments received. This team knows how to get products approved and has worked together for decades. AMP has a proven development platform and has developed a robust and reproducible AAV manufacturing process and has successfully run over 350 total batches at its facilities. AMP’s innovative process is among the most productive in the industry and consistently generates >95% functional full capsids. Our manufacturing process has received extremely positive feedback from multiple regulatory bodies as part of multiple gene therapy programs. AMP’s process sciences and analytical infrastructure is operational today and available to rapidly move your development programs forward. I am excited to say that I have joined the company as VP, Business Development.

Waltham, Massachusetts, Us

August 2018 – April 2023• Legal and Contract Management combined into one Global Contracts and Legal team (GCL). Reporting directly to the VP, GCL. Managed a team of contract directors and managers.• Lead negotiator for key contracts within the strategic accounts representing over $2B in total contract value to encompass strategic clients such as Merck, Amgen, AbbVie, Pfizer, Sanofi, Takeda, BI, Moderna, Novo Nordisk and Roche. Successfully negotiated over $1B in take or pay contracts resulting in significant revenue growth.• Vast knowledge of advanced therapies to include large molecule BIO, VVS, MMS, mRNA and cell therapy.• The role title recently changed to Sr Director, GCL based on job architecture changes within Thermo Fisher.

Waltham, Massachusetts, Us

• Reporting directly to the VP, Finance. Established, implemented and executed the Global Contract Services plan through a team of contract directors and managers.• Lead negotiator for key contracts representing over $1B in total contract value to encompass large pharma, biotech and specialty pharma. Crafted the business deals to address items such as capital funding, liability, forecasting and volume commitments to represent the best interests of Patheon.• Designed and implemented a new contract template, process flow and database based on customer feedback resulting in 30% reduction in contract cycle time. • Signed 54 Master Development MSAs, 457 product specific development agreements, 11 commercial Master MSAs and 72 product specific commercial agreements in 2018 and was on track to exceed this number by 20% in 2019 without adding staff. • Designed and implemented a Condo MSA to capture dedicated suite or facility agreements to address unique technologies to fully utilize plant capacity.• President’s Club 2016 – Chosen by peers based on closing deals.

Waltham, Massachusetts, Us

• Reporting directly to the Executive VP, Global Strategy, Sales & Marketing. Manage the Directors, Commercial Quotations and Director, Sales Operations with a team of 25.• Created a combined PDS/Commercial proposal team with harmonization of job descriptions. Reviewed and implemented changes to the Commercial and Development proposal process to establish best practices and supported the integration of the API and Biologics business into the BDS group. Implemented several strategically placed price increases while maintaining conversion rates at ~40% within DP and 35% in PDS.• Implemented new processes for annual pricing reviews, annual stability programs and annual product reviews.• Designed and implemented the sales bonus structures to ensure appropriately designed incentives to move the business in the right direction. Compared existing programs with new models to understand the financial impact on the company and the Business Development Manager. Supported the calculations and administration of the Sales Incentive Compensation Plan. • Implemented Salesforce.com to the Global Sales and management team (225 people). Identified and implemented solutions that enhanced sales force effectiveness: e.g., reduced administrative time, improved productivity of the Sales team, improved the image of Patheon with customers, etc. Sales activity and awards increased by 50% in 2010 and had a strong correlation to the implementation of SFDC. Integrated 5 new facilities into SFDC.• Managed the reporting and analytics for all sales-related activities for Sales & Operations using Salesforce.com. Built and maintained various performance metrics, streamlining data capture and reporting utilizing Salesforce.com, EPM, BPM, SAP and similar databases. • Maintained and grew the Sales training function utilizing online training programs (Brainshark).

Waltham, Massachusetts, Us

• Reported directly to the Chief Marketing Officer and President NA. Managed two Directors of Business Development with 12 Business Development Managers and a Sales Services Manager.• Grew the revenue base at 11 global manufacturing sites and 6 development centers encompassing over 330 clients with approximately $700MM in 2010 (now a $2B business). • Involved in the refocusing of the sales team by implementing new sales tracking tools to help identify poor performers. Grew the sales force to better fit the customer base to develop a best-in-class business development group. Implemented sales strategies to grow new service offerings and specific initiatives to accelerate the commercial revenues of Patheon’s solid dose manufacturing sites.• Lead negotiator for significant contracts that involved capital sharing, volume commitments and price pressure that added more than 10% in revenues to the company and added significantly to the company’s profit margin. • Actively participated in strategic business reviews with executive level contacts within our client base.• Led routine senior management meetings to discuss sales activities, business initiatives, performance metrics and expenses.

Waltham, Massachusetts, Us

• Requested to establish a commercial sales group to grow the ongoing commercial revenues of Patheon’s 14 commercial manufacturing facilities. Managed the relationships with a select list of large pharma and specialty companies. Grew the revenues with this select list of clients by over 35%.• Actively participated in negotiating over 65 Manufacturing Service Agreements.• Established guidelines for commercial margins to ensure that appropriate EBITDA margins were achieved.• Reviewed and approved all NA commercial proposals as it related to price and margin.

Waltham, Massachusetts, Us

• Established Patheon as a pharmaceutical development company through the implementation of a business development team to sell preclinical to phase 3 validation services.• Expanded the client base from 50 clients to over 270 clients with revenues growing from $45MM in 2001 to $138MM in 2005. 19 NDA products were approved at Patheon facilities during this tenure.• Established processes to improve the RFP and proposal process. Turnaround time on PDS quotes was reduced to less than 10 business days resulting in a 15% increased win rate.